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Pet and Animal Health M&A What’s the Scoop on the Industry's Latest Shake-ups by EOS Intelligence
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Pet and Animal Health M&A: What’s the Scoop on the Industry’s Latest Shake-ups?

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The pet and animal health market has seen a recent surge in M&A, signaling shifting dynamics within the industry. While rising pet ownership and increasing pet care awareness are creating positive momentum for the sector, broader trends are pushing major players to venture into the industry.

Many European players are focusing on cross-border acquisitions

M&A activity is particularly robust in Western markets

A significant number of mergers and acquisitions observed recently in the industry indicate a desire for major players to consolidate their positions and expand geographically in a bid to build their global presence and diversify revenue sources. Many companies pursuing geographic diversification are targeting Western markets with well-established pet care, mainly due to high disposable incomes, advanced veterinary services, and a cultural tendency to indulge pets.

An example of such a move is the 2023 acquisition of UK-based Kin Vet Community by Perwyn Capital, a European private equity (PE) investor, to gain entry into the UK veterinary services market. This acquisition aims to capitalize on the UK veterinary services market’s significant growth, which has risen from US$6.4 billion in 2021 to almost US$8 billion in 2023.

The UK-based veterinary sales and service provider, Animalcare Group acquired Australia-based Randlab in 2024 to strengthen its presence in the equine veterinary market. With this acquisition, Animalcare Group will be able to bolster its existing product portfolio and expand from the UK and Europe into Australia and New Zealand.

Similarly, Sweden-based investment company EQT Partners acquired VetPartners, a veterinary care network spread in Australia and New Zealand, in 2023. This move will not only help EQT enter the Australian and New Zealand veterinary markets but also help gain a strategic position in the veterinary industry with a network of 267 clinics and hospitals.

Experts believe that all these recent acquisitions indicate a desire of players to solidify their industry presence and widen their customer base, especially in the lucrative Western markets.

Central Europe is also experiencing a notable uptick

While M&A activity is the strongest in Western markets, some companies are also looking to Central Europe to search for their acquisition targets. An example is the 2024 acquisition of Bratislava-based VetCare Group by AniCura, a Swedish veterinary care provider owned by US-based Mars. This acquisition will add ten clinics to AniCura’s portfolio, three in the Czech Republic and seven in Slovakia. This strategic move also marks AniCura’s entry into the Czech and Slovak markets, significantly expanding its footprint in Central and Eastern Europe and complementing AniCura’s existing presence in Poland.

The developing markets are also grabbing players’ attention

A few players are also showing interest in developing markets such as Asia and Africa, where pet ownership is increasing, but veterinary and pet healthcare infrastructure remains underdeveloped.

Strategic acquisitions are increasing in Africa

Africa is a particularly lucrative investment zone with a favorable market situation for able players interested in investing in the continent’s animal health sector. This is due to barriers in local drug manufacturing, lack of local vets in private practice, and shortage of veterinary drugs.

A recent example of such an investment is Dutch-based animal nutrition company Nutreco’s 2024 acquisition of AECI Animal Health in South Africa. With this acquisition, Nutreco intends to utilize AECI’s expertise in animal nutrition to bolster its operations in South Africa. This move is also expected to allow Nutreco to tap into AECI’s distribution network and manufacturing facility in Burgersdorp, expanding its footprint in Africa’s crucial markets.

Similarly, in 2022, Ireland-based Bimeda acquired Afrivet, an animal health product distributor based in South Africa. This acquisition facilitated Bimeda’s entry into the African animal health products industry.

Foreign players are targeting the growing Asia-Pacific market

The Asia-Pacific (APAC) animal health market is also seeing similar interest from many competitive players. The pet care market in Asia, though still developing in several areas, is experiencing rapid growth. Countries such as China, India, and Japan are seeing a rise in pet ownership and heightened awareness regarding pet health. This makes it a great place for players looking to concentrate on various growth strategies, including collaborations, partnerships, agreements, and M&A, to strengthen their market presence.

An example of a recent strategic acquisition in the Asian market was France-based animal health company Virbac’s purchase of Japanese ORIX Corporation’s animal health subsidiary, Sasaeah, in 2024. The acquisition will help position Virbac as a leader in Japan’s farm animal vaccine market, particularly in the cattle sector. Sasaeah already has a strong presence in Japan and develops a wide range of veterinary products for both farm and companion animals. With this acquisition, Virbac will also gain Sasaeah’s local manufacturing facilities in Japan and Vietnam and its R&D capabilities. It will also strengthen Virbac’s status as a major player in the Japanese animal health market and offer opportunities for further expansion throughout Asia.

Virbac also acquired in 2023 a majority stake in Globion, a poultry vaccines company located in India, as part of its strategy to enter the avian vaccines market in the region and expand its geographic reach.

Similarly, in 2022, Germany-based Symrise AG, the parent company of Diana Pet Foods, which provides palatants for the pet food industry, acquired Wing Pet Food, a leader in pet food palatability in China. This acquisition gave Symrise access to the APAC markets.

Though the acquisition efforts are much lower in the developing markets, with favorable conditions such as increasing pet ownership and rising demands for efficient veterinary care, interested players can expect an overall improvement in market conditions and attractiveness in the future.

Major players are vying for smaller companies in a bid to grow product portfolios

Beyond increasing the geographical reach, the M&A activities aimed at expanding and strengthening companies’ product portfolios are also a significant trend observed in the animal health industry. Many big players are eyeing smaller firms to build comprehensive portfolios that can compete more effectively against other industry giants.

An example is the 2024 acquisition of Boston-based Invetx, which specializes in protein-based animal therapeutics and monoclonal antibody (mAb) development, by UK-based Dechra Pharmaceuticals. This acquisition enhanced Dechra’s specialty therapeutics portfolio for pets and provided access to the growing mAbs market. It will also introduce new technological capabilities, strengthen Dechra’s pipeline, and create significant future growth opportunities for the company.

Similarly, in 2024, the NJ-based Merck Animal Health acquired Indiana-based Elanco Animal Health’s aqua business to enhance Merck’s position in the aquaculture sector. This includes medicines, vaccines, supplements, and nutritional products for aquatic species, as well as two manufacturing facilities located in Vietnam and Canada and a research center in Chile. With this acquisition, Merck aims to strengthen its extensive portfolio, including warm and cold water products, vaccines, anti-parasitic treatments, and nutritional supplements.

Many other acquisitions materialized in 2024 in a similar vein. This includes Animalcare Group’s acquisition of Randlab to enter the equine care market and Australia and New Zealand’s animal health market. Also, South Korea-based Easy Bio acquired US-based Devenish Nutrition to bolster its feed additive and premix operations in North America.

Players are focusing on consolidation to bolster their veterinary service offering

The veterinary services segment is also seeing robust consolidation. Several corporate buyers acquired independent clinics and businesses to strengthen their market position and access the robust customer base of the target companies. Significant consolidation has been visible in the USA and globally for the past three decades.

A recent example is Norway-based veterinary dental care provider EMPET acquiring Smadyrklinikken, a Norway-based provider of veterinary services, including surgery and emergency care, in 2023. EMPET also acquired a Norway-based horse treatment clinic, Hesteklinikken Bergen, in 2024, further expanding its veterinary treatment scope.

Similarly, in 2024, Miami-based at-home veterinary care provider The Vets merged with Boston-based BetterVet, a mobile veterinary service provider, to combine the strengths of both companies and enhance their pet healthcare services across the USA.

Another acquisition along the same line in 2024 was that by Pavo, part of the Netherlands-based ForFarmers‘ global equine organization, which acquired Thunderbrook Equestrian, operating primarily in the UK and Ireland. Thunderbrook offers a diverse range of products, including conventional and organic horse feed, supplements, and herbs, supported by a strong distribution network and online presence. Experts expect this acquisition to enhance Pavo’s distribution capabilities.

Private equity firms are also targeting pet health firms

It is not only businesses within the veterinary or pet sector that are acquiring clinics and animal health businesses, but also companies from other industries and PE firms.

One example is the 2024 acquisition of Ireland-based veterinary products manufacturer Chanelle Pharma by Exponent Private Equity, a UK-based PE firm. Chanelle specializes in R&D and has a prominent position in the market as a producer of generic pharmaceuticals for both human and veterinary use. This acquisition offers Exponent many opportunities for investments in product development and R&D.

Similarly, UK-based PE firm Apax Partners, in 2023, acquired stakes in US-based pet care software service provider Petvisor to focus on accelerating innovation and to position itself as a market leader in the pet software segment.

This trend will continue since the pet care market is expanding remarkably. According to Fortune Business Insights, an India-based market research firm, the global pet care market valued at US$246.7 billion in 2023 is expected to reach US$427.8 billion by 2032. Experts anticipate that this significant growth fueled by the increasing trend of pet ownership will prompt more PE firms to invest in the pet care market.

Pharmaceutical and vaccine segment is seeing acquisitions with rising pet diseases

The growing demand for specialized pet treatments is driving M&A in the pharmaceutical and vaccine segments of the pet health industry. The rising cases of pet and livestock infections and increasing zoonotic diseases are creating a strong demand for improved treatments, conveniently available medicines, and vaccines. This has prompted many players to divert their attention toward acquiring companies in the veterinary pharma segment to gain market access.

An example is the 2024 acquisition of Iowa-based animal pharmaceuticals and vaccines manufacturer Diamond Animal Health by Minnesota-based animal compounding pharmacy, Veterinary Pharmaceutical Solutions. Experts see this acquisition as the first step in VPS’s plans to grow its capabilities, market presence, product offerings, and research capabilities.

Another example is the 2023 acquisition of PetMedix, a UK-based firm developing species-specific therapeutic antibodies for pets, by US-based Zoetis, a global animal health firm. With this acquisition, Zoetis has gained access to PetMedix’s portfolio of antibody drug candidates targeting unmet clinical needs in dogs and cats with chronic and terminal diseases, including oncology and inflammatory diseases.

Similarly, the US-based Better Choice Company‘s acquisition of Canada-based Aimia Pet Healthco in 2024. This move will allow Better Choice to lead internal clinical trials focused on addressing the increased demands for treating obesity-related issues in cats and dogs.

In 2023, Zoetis acquired Germany-based veterinary care company Adivo, which focuses on creating animal therapeutic antibodies. This acquisition will allow Zoetis to leverage Adivo’s existing libraries of species-specific antibodies, facilitating the creation of a diverse array of new veterinary products.

The vaccine market in emerging economies such as Asia-Pacific is also seeing some scattered M&A activity. Virbac’s 2023 acquisition of a majority stake in India-based poultry vaccines company Globion to venture into the growing avian vaccines market can be seen as an instance of this budding trend.

Preventive care and wellness players are becoming attractive targets

A 2023 survey published by the American Veterinary Medical Association indicated that 76% of pet owners consider their pet’s safety and health a top priority. This disposition has also started influencing how pet owners choose food for companion animals, prompting them to opt for organic and healthy treats. All these have made diagnostics, preventive care, and sustainable health a hot topic among interested players, leading to some major acquisitions.

Wellness and preventive care players are attractive acquisition targets

Many acquisitions in the animal health industry are also focused on wellness and preventive care businesses. The factors driving this trend are the rising awareness among pet owners about the advantages of preventive healthcare, early disease detection, and overall wellness of the pets in the long term.

An example is the 2024 acquisition of US-based treat and pet care company Riley’s Organics by Skane-based Swedencare‘s subsidiary business, Pet MD Brands, marking its entry into the organic dog treat market in the U.S. The acquisition will give Pet MD access to Riley’s premium organic dog treats and nutritional supplements targeting coat and skin health, liver support, ear care, etc.

Similarly, Antelope, a US-based company that offers premium pet care products and services, has acquired My Perfect Pet, a US-based brand known for its ‘gently cooked’ dog and cat food. With this acquisition, Antelope can strengthen its portfolio with My Perfect Pet’s nutritionally balanced pet food without preservatives.

Veterinary diagnostics surge as acquisitions drive segment growth

The veterinary diagnostics sector has also seen some recent acquisitions. Mars, currently a leading name in the pet health segment, acquired Cerba HealthCare’s stake in the French veterinary diagnostics firms Cerba Vet and Antagene. Mars made a similar decision in 2023 when it acquired US-based Heska, a veterinary diagnostic and specialized solutions provider. All these acquisitions can help Mars position itself as a major competitor in the pet diagnostics sector.

Similarly, in 2024, US-based Ollie, a subscription service for fresh dog food, acquired Dig Labs, a diagnostic company that delivers real-time health screenings for pets, including stool analysis and weight management. This acquisition also aims at helping pet owners monitor their pet’s food intake and get personalized food intake recommendations to prevent health issues.

We expect the veterinary diagnostics segment to grow significantly, and M&A activity will continue accelerating in the coming years.

EOS Perspective

The flurry of M&A activity in the animal health sector highlights the industry’s significant potential. Along with the existing trends, experts believe there are many more segments interested and able players looking to consolidate their position in the industry can focus on.

Online and mobile pet care is a promising area for businesses considering investment or acquisition within the pet health sector. Companies that can effectively navigate this space will likely capitalize on the increasing demand for online services, likely through acquiring businesses with an established customer base to strengthen their portfolio. It will also help firms enhance their competitive edge through a digital-first approach. The 2024 acquisition of The PharmPet Co by Pharmacy2U, both UK-based firms, can be seen as one of the early steps in this direction. This merger will allow Pharmacy2U to offer pet medicines online to customers.

A nascent trend that could offer opportunities in the future is pet owners’ increasing interest in their pets’ gut and microbiome health. Experts believe this inclination of pet owners will increase in the coming years, creating a massive market for pet foods and supplements, especially those containing probiotics and gut-supporting formulas. This will make profitable businesses in the pet supplement segment a lucrative option for able and interested players to focus on.

Read our related Perspective:
 Poop to Pills: Is FMT the Future of Veterinary Medicine?

Sustainable and eco-friendly products are another segment with growing attractiveness thanks to the ever-increasing environmental awareness. As in many other markets, pet owners will seek products that consider environmental impact. With consumers aligning their choices with eco-friendly solutions, we can expect major brands to merge or acquire companies making eco-friendly pet products. The 2024 merger of Chr. Hansen and Novozymes, both Denmark-based firms, to create Novonesis is an example. With this merger, the new company aims to develop microbial solutions and enzymes while focusing on minimizing chemical use and advancing climate-neutral practices.

Personalized Image-Guided Therapy Medicine's New Crystal Ball by EOS Intelligence
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Personalized Image-Guided Therapy: Medicine’s New Crystal Ball?

Precision and personalized care are becoming the keys to unlocking better patient care in modern medicine. With personalized medicine image-guided therapy (IGT) systems offering physicians better control over therapy decisions, the healthcare industry hopes discomfort and uncertainty will give way to reliability and healing.

IGT enhances surgical precision and treatment management

IGT is an approach that uses various imaging technologies to plan, perform, and evaluate surgical procedures and treatments. There are two main groups: traditional surgeries enhanced by imaging technology and newer procedures that use imaging and specialized instruments to treat internal organs and tissues without surgery.

The IGT systems, such as Dutch Philips’ Azurion and American Varian’s Halcyon, help improve minimally invasive procedures by offering real-time imaging support during interventional techniques, especially in cardiology and oncology. They also aid in precise navigation and treatment delivery.

Azurion’s IGT system offers various clinical suites, including Coronary, Onco, and Neuro suites, tailored to a particular surgery. This customization can make a surgeon’s work easier. Many IGT systems also integrate with hemodynamic systems and similar interventional tools that give surgeons more information.

On the other hand, advanced imaging platforms such as the 1788 visualization platform by US-based Stryker, TIVATO 700 by Germany-based Zeiss, and VISERA ELITE II by US-based Olympus specifically work in open surgical settings, providing high-definition imaging that enhances visibility during more invasive procedures.

IGT employs imaging modalities and technological innovations for disease management

The most commonly used imaging modalities in IGT are X-rays, ultrasound, MRI, and CT scans, which provide detailed cross-sectional images of the body. Other supporting technologies include angiography, ultrasound, tracking tools, surgical navigation systems, and integration software.

IGT also offers invaluable insights into disease diagnosis and management of minimally invasive procedures. Significant advancements have been made in this field in recent years owing to developments and integration of innovations such as artificial intelligence (AI), big data, deep learning, sensor fusion, and advanced signal processing.

Personalized Image-Guided Therapy Medicine's New Crystal Ball by EOS Intelligence

Personalized Image-Guided Therapy Medicine’s New Crystal Ball by EOS Intelligence

IGT and advanced visualization systems complement each other in cancer surgeries

Applying advanced visualization systems for open cancer surgeries adds a competitive aspect to the image-guided therapy landscape. Systems such as Stryker’s 1788 have the potential to be a viable option in low-resource environments or hybrid surgical settings. Such facilities may view it as a cost-effective and simpler substitute for comprehensive IGT systems for certain cancer surgeries.

The competition could also intensify in niche applications where minimally invasive tumor resection overlaps with interventional oncology. This is especially true for hospitals that aim for a one-stop surgical solution without high investment in IGT infrastructure.

However, the IGT systems have a different clinical role, being particularly effective in procedures such as catheter-based interventions or radiotherapy, where accurate imaging is extremely critical. Therefore, the competition may be nuanced, depending on the specific surgical approach, as the two technologies could also complement each other by providing tailored solutions for distinct surgical techniques and scenarios.

IGT sector is rapidly growing in minimally invasive and specialized procedures

The IGT market has seen rapid development, especially in the post-pandemic era. The global IGT systems market was US$5.5 billion in 2023 and is estimated to reach US$8.9 billion by 2032, according to an India-based market research firm, IMARC. The company also forecasts the market to grow at a CAGR of 5.4% from 2024 to 2032.

Several factors drive this growth, including IGT’s ability to offer better health outcomes in treating severe conditions such as cancer, its application in treating old age-related conditions, such as stroke and vessel blockage, and the surge in demand for minimally invasive procedures.

Rising cancer cases are boosting sector growth

The American Cancer Society estimates that approximately 20 million new cancer cases were diagnosed, and 9.7 million people died from cancer worldwide. The number of cancer cases is expected to reach 35 million by 2050. The high prevalence of cancer has increased the need for innovative treatment options with limited damage to healthy cells. Oncologists and patients are now opting for IGT, such as image-guided surgeries and radiotherapy, to treat cancers, including severe and complex ones.

For example, hepatocellular carcinoma, the most common liver cancer, is a challenging disease to treat. A 2010 study published in Insights into Imaging, a peer-reviewed open-access journal, indicated that due to the advanced stage of the disease at diagnosis and limited donor availability, only 10–15% of HCC patients are eligible for surgical resection or liver transplantation. Surgical options are primarily reserved for patients with solitary, asymptomatic HCC and well-preserved liver function without significant portal hypertension or elevated bilirubin levels. Also, systemic chemotherapy has largely been ineffective for HCC.

Image-guided procedures can offer doctors detailed imaging data to aid diagnosis, patient risk assessment, and treatment planning during the early detection stages. Image-guided catheter-based techniques are used for treating larger lesions or more extensive liver involvement seen in intermediate-stage HCC, and ablative procedures are employed for early-stage HCC.

Minimally invasive image-guided therapies can also extend survival, preserve more healthy liver tissue (crucial for cirrhotic patients), allow for potential retreatment, and serve as a bridge to transplantation.

Growing geriatric population is also contributing to sector expansion

The rising geriatric population is also driving the need for image-guided therapies. UN estimates there were 761 million people aged 65 or older globally in 2021. This number is expected to rise to 1.6 billion in 2050. Age is a significant factor in determining the likelihood of developing serious conditions such as cancer. According to the National Cancer Institute (NCI), the average age of individuals diagnosed with cancer is 66, indicating approximately half of all cancer cases are diagnosed in people aged 66 and older.

Older people are also at a higher risk of suffering from severe post-procedural complications, especially in the case of invasive surgeries. IGT-supported therapies, especially minimally invasive surgeries, can help doctors treat geriatric patients with limited adverse effects.

Advancements in minimally invasive procedures and cancer radiotherapy are on the rise

The rising demand for minimally invasive procedures is another factor driving the increasing adoption of IGT systems. A 2015 study published in JAMA Network, an open-access medical journal, indicated that minimally invasive surgeries have fewer postoperative complications, provide better outcomes, and reduce healthcare costs. This has prompted many physicians and patients to choose IGT system-based minimally invasive therapies in treating complicated conditions that may otherwise require longer hospital stays and repeat visits.

The growing number of developments in cancer radiotherapy is also an important factor propelling the IGT market forward. AI in radiation therapy enhances the accuracy and precision of treatment. In image-guided radiotherapy (IGRT), AI-based algorithms are used to analyze images taken during treatment and make adjustments to the treatment plan in real time. This enables clinicians to target tumors with greater precision, reduce the amount of irradiated healthy tissue, and improve treatment outcomes.

Several premier institutions, such as Cancer Research UK, London-based Medical Research Council (MRC), and US-based Stanford Medicine, are involved in cancer radiotherapy research to develop cancer imaging, diagnostics, and minimally invasive treatment platforms. With the radiotherapy market will likely reach US$12.51 billion by 2029, according to a 2024 report by India-based market research firm Mordor Intelligence, these efforts can contribute to the growth of the IGT sector.

IGT therapies allow for prompt and low-risk interventions

The introduction of IGT into personalized medicine has had a crucial impact on patient outcomes. IGT enables healthcare professionals to diagnose and treat serious conditions more rapidly. This prompt initiation of treatment reduces the risks associated with delayed interventions.

An example of an IGT system offering better treatment management is Philip’s Azurion Lung Edition, a 3D imaging and navigation platform that streamlines the diagnosis and treatment of lung cancer. The system combines tableside CT-like images with real-time X-ray guidance and advanced tools to support guided procedures. It is specifically designed for bronchoscopy procedures and enables clinicians to perform minimally invasive biopsy and lesion ablation in a single procedure. This reduces the need for additional procedures and speeds up diagnosis.

IGT systems also offer a precise, real-time visualization of the therapy site, enabling highly targeted interventions. This level of accuracy can minimize complications and failures during procedures. For example, IGRT used in cancer treatment enables oncologists to target tumors while sparing healthy tissues precisely, reducing side effects and boosting treatment success rates. Surgeons also better comprehend spatial relationships between the tumor and vital organs or blood vessels when they can access high-resolution images highlighting the essential structures during the procedure.

Minimally invasive nature of IGT therapies minimizes complication and disability risks

IGT procedures are minimally invasive in nature. This reduces the trauma caused by the procedure, reducing the risk of complications. Patients can recover faster from IGT procedures, reducing hospital stays and lowering the likelihood of hospital-acquired infections and other potential complications. A 2022 study published in the National Library of Medicine’s (NLM) online portal indicated that image‐guided procedural techniques reduce risks, prompt faster recovery, and shorten hospital stays.

IGT’s minimally invasive nature also reduces the risk of disability post-treatment. In the case of complicated surgeries such as brain tumor removal, surgeons use techniques such as intraoperative MRI (iMRI) to get a detailed map of the tumor and surrounding brain structures before and during surgery. This allows for more precise resection of the tumor and reduces the risk of injury to critical brain areas, thereby lowering the possibility of neurological damage and associated disabilities. A 2014 article published in NLM’s online portal indicated that using iMRI improved surgical outcomes, including increased tumor resection and survival rates and decreased risk of neurological deficits.

IGT systems offer interventional tools supporting surgeons in complex procedures

Advanced IGT systems now come with integrated interventional tools, which can be especially beneficial during complex or delicate procedures. For example, Azurion, an IGT platform developed by Philips, has interventional tools integrated into the imaging system. It offers procedure cards that allow clinicians to pre-program routine tasks and preferences, as well as an interface for performing various procedures in interventional labs.

Integrations such as these can help surgeons make informed and data-driven decisions during procedures, allowing them to make mid-procedure adjustments. Such flexibility is crucial, particularly in complex surgeries or when treating conditions such as cardiovascular diseases.

Development high costs and cybersecurity issues hinder adoption

Despite offering numerous benefits to patients, the developers of IGT systems face several challenges.

Huge R&D costs and market competition are impacting new players

The significant financial burden of research and development in this field is one major obstacle for companies, especially newer ones entering the market with limited budgets. Developing advanced imaging technology that seamlessly integrates with therapeutic tools requires substantial investments in software and hardware.

Also, these systems require continuous refinement to ensure optimal accuracy and adaptability, as they must be able to accommodate diverse patient anatomies and conditions. This is a time-consuming and costly process. Consequently, only established companies with significant R&D budgets may be able to compete in the market.

Not just the R&D budget but also leading players’ brand equity is a significant challenge for new players trying to enter the IGT systems market. The newer entrants face intense competition from established players such as Philips, GE Healthcare, and Siemens. These companies have been in the market for years and have a strong foothold in terms of market share and brand recognition. This can make it challenging for new players to establish themselves in the sector, limiting innovation and market growth.

New companies can attempt to tackle this and make inroads into the market by forming partnerships with hospitals and public health initiatives to drive the adoption of their IGT systems.

High upfront costs are affecting the widespread adoption of IGT devices

The IGT devices’ market prices reflect the high R&D costs. Almost all IGT systems have high upfront costs. For example, an interventional radiology suite can cost anywhere between US$1 million to over US$3 million, depending on its sophistication. This can make acquiring and implementing IGT systems prohibitively expensive for many healthcare providers, particularly smaller or publicly funded organizations.

While healthcare providers can pass on the cost to patients, it can also cause many other challenges. Even with insurance coverage, some patients may not be able to afford certain procedures or treatments when the out-of-pocket expenses are significant. Consequently, this can reduce the overall demand for IGT devices, negatively impacting sales for manufacturers.

Companies can try tackling this issue by offering price flexibility and discounts for large orders or entering into long-term contracts with healthcare providers to help maintain demand. They may also offer leasing or subscription-based payment models instead of selling devices outright. This could encourage purchases by healthcare providers, allowing them to spread out the costs over time and lighten the upfront financial burden on patients.

Cybersecurity challenges are threatening patient care and security

Another significant challenge in adoption is cybersecurity and data management issues. A 2024 fact sheet by the US Office of the Director of National Intelligence indicated that there has been a 128% increase in healthcare ransomware attacks in 2023 over 2022 in the USA. As a result of these attacks, American hospitals have faced disruptions to medical procedures, patient care, and operations, including delayed procedures, diverted patients, rescheduled appointments, and strained acute care provisioning.

IGT systems generate and store vast amounts of imaging and procedural data on the cloud. Any security breach can lead to privacy leaks and misuse of patient data. Attackers can also maliciously embed images or reports and manipulate medical images, thereby delaying procedures and patient care and causing loss of life. This complexity often leads to hesitation in adoption, particularly for institutions that lack the necessary IT infrastructure.

Many companies are addressing this issue by creating devices with secure design and in-depth defense approaches. An example is Philip’s Azurion, which offers a six-layer protection to combat cyberattacks.

EOS Perspective

IGT systems promise to improve patient outcomes and revolutionize healthcare in the long run, particularly in treating serious medical conditions such as cancer. While there are some challenges to address in order to strengthen widespread adoption, with rapid developments underway in technologies such as AI and augmented reality, IGT can play a greater role in disease treatment in the coming years.

Currently, studies are underway using AI and machine learning to predict the response to minimally invasive image-guided therapies. Similarly, AI-based algorithms are also being developed to monitor tumor motion, reduce treatment uncertainty, and improve treatment precision.

One promising direction new entrants can push for is more portable and cost-effective IGT solutions. Research to miniaturize imaging devices and develop affordable hardware could make IGT systems more accessible to a broader range of healthcare providers, even those in remote areas, thereby expanding the market. Also, as costs come down and standardization improves, hospitals and clinics of varying sizes will be more likely to invest in IGT technologies.

In the short term, larger, well-funded players are likely to continue to lead the way in adopting and refining IGT systems. These companies have the resources to invest in technology and training, enabling them to push the boundaries of personalized medicine. However, as the technology matures and becomes more affordable, smaller players will increasingly be able to capture a market share.

New Directions in Alzheimer’s Diagnostics Will Blood Tests Replace CSF and PET by EOS Intelligence
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New Directions in Alzheimer’s Diagnostics: Will Blood Tests Replace CSF and PET?

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Around three-fourths of dementia cases continue to remain undiagnosed even though the incidence of Alzheimer’s disease (AD) is rapidly growing across the globe. AD affects about 60-80% of dementia patients worldwide. Early diagnosis of AD is critical in forging beneficial medical care strategies and enhancing patient outcomes. Current AD diagnostic tests, such as cerebrospinal fluid (CSF) and PET scans, are either invasive or associated with side effects and are generally expensive. This calls for developing less invasive, safer, faster, and more accurate AD diagnostics, such as blood tests.

Blood-based tests promise accurate and non-invasive AD diagnosis

Researchers are developing less invasive and less costly blood tests that are likely to be more accurate than contemporary tests. There are currently two types of AD diagnostics blood-based tests: the phosphorylated tau217 (ptau217) test and the amyloid beta (Aβ) 42/40 plasma ratio test.

The ptau217 biomarker has the potential to differentiate AD from other neurodegenerative diseases, as ptau217 levels can be high in AD patients before the onset of clinical symptoms. Studies have proved that ptau217 tests can detect AD early on and monitor disease progression.

The Aβ 42/40 plasma ratio tests detect amyloid beta protein plaques in the brain that cause cognitive impairment. Due to the lack of a certified reference standard for measuring plasma Aβ42 and Aβ40’s absolute values, ptau217 may be better than an amyloid beta ratio test. However, both tests are accurate enough to diagnose AD.

Notably, ptau217 blood tests are believed to give up to 95% accurate results when coupled with CSF tests as against 90% accuracy of CSF when used as a standalone method. At the same time, amyloid beta (Aβ) 42/40 ratio tests are known to give around 80% accuracy in detecting amyloid positivity.

Many laboratories and diagnostic companies have designed or are designing ptau217 assays. C2N Diagnostics, Quanterix, Quest Diagnostics, and Laboratory Corporation of America (LabCorp) offer ptau217 laboratory-developed tests (LDTs).

Low cost of blood-based AD tests can also be a growth-driving factor

A major push towards blood-based AD diagnostics comes from the tests’ lower cost in comparison to PET and CSF. The cost of blood tests typically ranges from US$200 to US$1,500, depending on the test provider.

The cost of PET ranges from US$1,200 to US$18,000, while the average price of CSF tests is around US$4,000 (in both cases, the actual cost depends on the type of facility, location, and the extent of insurance coverage).

As of 2023, Medicare and Medicaid covered PET scans for AD in the USA outside clinical trials. Therefore, AD patients need to pay around 20% of the PET cost, which translates to US$240-US$3,600, even after insurance coverage.

Considering the high share of dementia and AD cases remaining undiagnosed, there is a chance that the lower cost of blood-based tests can help contribute to higher accessibility to testing and ultimately improve the early detection rate.

Large AD diagnostic players partner with smaller ones to develop new tests

In an attempt to develop ptau217 assays, major diagnostics companies tend to recognize the development progress made by smaller players. ALZpath, a novel AD diagnostic solutions provider, is the pioneer of the ptau217 antibody, which helps in the early detection of the disease. Large players such as Roche and Beckman Coulter are enticed by the synergistic opportunities ALZpath offers.

In June 2024, Roche partnered with ALZpath, an early-stage biopharmaceutical company specializing in AD diagnostics, to launch the plasma ptau217 In-Vitro Diagnostic (IVD) test. As per the partnership, Roche will use ALZpath’s ptau217 antibody to design and commercialize an IVD test to detect AD with the help of Roche’s Elecsys platform.

In July 2024, Beckman Coulter also partnered with ALZpath to utilize ALZpath’s proprietary ptau217 antibody to detect AD on Beckman Coulter’s DxI 9000 Immunoassay Analyzer.

AD diagnostics firms receive funding from various sources, including drugmakers

Constantiam Biosciences, a bioinformatic analysis firm, received a US$485,000 Phase 1 SBIR grant (Small Business Innovation Research) from the National Institute on Aging to develop a tool for deciphering risk variants pertaining to AD and related dementias (AD/ADRD) in September 2024.

Biogen and Eli Lilly invested in the Diagnostics Accelerator, a funding initiative started in 2018, at the Alzheimer’s Drug Discovery Foundation (ADDF) in 2020. The Diagnostics Accelerator has invested over US$60 million across 58 projects, most of which are blood tests. In its Q4 2023 earnings call, Biogen emphasized its support for developing tau biomarker diagnostics and pathways. Its partner, Eisai, has invested around US$15 million in C2N Diagnostics and collaborated with IVD companies such as Sysmex, among others. In September 2024, ADDF invested US$7 million in C2N Diagnostics to further develop blood-based AD detection tests.

Other investors have also identified the opportunities AD diagnostic offers. A 2024 market research report by Market Research Future estimated that the AD diagnostic industry would nearly double, from US$4.5 billion in 2023 to US$8.8 billion in 2032.

FDA stands as an accelerating force for blood-based tests via breakthrough device designation

For a while now, the FDA has been granting breakthrough device designation (BDD) to devices that could address life-threatening diseases with unmet medical needs. BDD facilitates the expedited development, review, and assessment of medical devices, ensuring quicker access for patients and medical professionals. It would not be too ambitious to conclude that strong positive evidence from several uses and studies of ptau217 tests is likely to compel the FDA to approve them for use in the near future. The first sign of this is that the FDA is granting BDD status to multiple ptau217 blood tests.

In March 2024, the FDA granted BDD to Simoa ptau217 by Quanterix. This blood test can detect AD in patients with cognitive ailments even before signs and symptoms start to appear.

In April 2024, the FDA gave BDD to Roche’s Elecsys ptau217 plasma biomarker test to augment early diagnosis of AD. Roche partnered with Eli Lilly to develop this blood test that will widen and accelerate AD patients’ access to diagnosis and suitable medical attention and care.

In early 2019, the FDA gave BDD to C2N Diagnostics’ blood test to detect AD. The BDD status of AD blood tests will likely accelerate the development, review, and assessment processes of these tests, improving patient outcomes.

Some FDA-approved AD drugs have used blood tests in clinical trials. Eli Lilly’s Kisunla and Esai/Biogen’s Leqembi have successfully utilized C₂N Diagnostics’ Precivity-ptau217 blood biomarker in their clinical trials. The FDA approved both drugs to manage AD. This improves the chances of this blood test getting approved by the FDA.

Lumipulse G β-Amyloid 1-42 Plasma Ratio test by Fujirebio Diagnostics received BDD from the FDA in 2019. The company submitted an FDA filing for the Lumipulse G ptau217/β-Amyloid 1-42 Plasma Ratio IVD test in September 2024. If approved, this test will become the first commercially available blood-based IVD test in the USA to detect AD.

EOS Perspective

There has been considerable progress in developing blood-based assays for AD diagnosis by pharma and diagnostics companies. However, a good portion of the liability for their products not reaching market readiness faster lies (and will probably remain to lie) on the approving authorities that are unable to accelerate the administrative steps.

Some blood tests, such as PrecivityAD, are approved for safe use in the EU but are still not in the USA. While such approval is typically a time-consuming process and requires a thorough investigation, the blood tests will enter the market at a larger scale across several geographies only if the authorities fast-track their approvals. This is particularly applicable to blood tests previously successfully used in clinical trials for approved AD drugs and for tests that have already attained BDD status from the FDA.

As an example, PrecivityAD by C2N Diagnostics received BDD status in 2019 from the FDA. However, the FDA has still not approved the blood test for safe use in the USA. This is still despite the fact that PrecivityAD and other C2N Diagnostics’ assays have been utilized in over 150 AD and other research studies across the USA and abroad. FDA’s time-consuming and lengthy review procedures and bureaucratic reasons are some of the factors responsible for the delay in approval. In addition to this, C2N Diagnostics needs to submit some more evidential data pertaining to the accuracy of PrecivityAD, which is likely to take time to produce.

These procedural and administrative impediments, along with the time taken by the device makers to present the data to the FDA, will likely continue to put a brake on the blood-based tests becoming available to patients in the near future.

The situation will remain so, given the FDA’s recent decision to regulate new LDTs involving diagnostic tests that use body fluids such as blood, saliva, CSF, or tissue on similar lines as medical devices (meaning LDTs must comply with the same standards as medical devices). As per this regulation, LDTs need to prove the accuracy of their tests. This decision will have both winners and losers in the AD stakeholder ecosystem.

Researchers and physicians are looking at this regulation with a positive stride as this step will reduce the number of tests with unconfirmed accuracy from the market in the USA. This is undoubtedly a positive change for patients’ safety, reducing the number of misdiagnoses and accelerating correct diagnoses.

On the other hand, smaller start-ups and diagnostic companies are not likely to benefit from this decision as it will restrict the development of new innovative tests vis-à-vis large diagnostic companies. Overall, the decision will likely decelerate the approval of blood-based AD tests or at least will require much more paperwork and proof of accuracy from the device makers. This decision will take effect in multiple phases over four years, starting from July 2024.

On the research and development side of the Alzheimer’s disease diagnostics space, a certain level of symbiosis between drug producers and diagnostic solution providers will continue to impact the market positively. Drugmakers are partnering with or investing in diagnostic companies to leverage the latter’s innovative blood-based biomarkers (BBBM) technologies in the clinical trials of their own drug candidates. This trend is likely to continue.

Not only drugmakers but also more prominent healthcare diagnostics companies, such as Roche and Beckman Coulter, are partnering with early-stage biopharmaceutical companies, such as ALZpath, to develop and commercialize AD ptau217 tests. Collaborations such as these are a testimony to the fact that it is mutually beneficial for AD industry stakeholders to work in tandem to advance AD diagnostics research, a significant growth-driving factor for the market.

Pet Wearables – Are Companies Barking up the Right Technology by EOS Intelligence
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Pet Wearables – Are Companies Barking Up the Right Technology?

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As the human wearables market begins to mature, a lot of interest and developments are also happening in the pet wearables space. An increasing number of pet owners becoming more technologically savvy has fueled product innovations in this segment, which traditionally was limited to GPS tracking. While location tracking continues to be the largest piece of the pie, other solutions, such as health monitoring devices, have been gaining prominence. However, this segment is still in its infancy and is toying with several technologies, such as biometrics, radar, and acoustic technology, to develop functional, accurate, and price-effective devices.

The last decade has witnessed exponential growth and advancements in human wearables. However, recent years have also seen the trend of wearables permeating the pet market. With upcoming technological advancements, the industry is expected to witness double-digit growth over the next six years and expand into new territories.

Read our related Perspective

Poop to Pills: Is FMT the Future of Veterinary Medicine?

ID tracking is the largest category, health monitoring is growing the fastest

The pet wearables market is primarily bifurcated into four applications: ID tracking, behavior control, safety, and health monitoring. At the moment, the largest category within the market is ID tracking solutions, which comprise GPS—and RFID-based trackers that help identify and locate pets. One of the leading players in this space is US-based Tractive, which provides a GPS collar that allows pet owners to know the exact location of their pets at all times.

The fastest-growing category is health monitoring. This segment encompasses devices that monitor a pet’s vitals and general health and raise an alarm in case of any irregularities. Growing pet obesity cases have resulted in pet owners choosing health monitoring devices for their pets. A popular product in this space is the PetPace Smart Collar by US-based pet wearable company, PetPace, which tracks physiological metrics such as pulse, respiration, temperature, heart rate variability (HRV), activity level, and posture. Along with GPS tracking and emergency alerts, it helps in early symptom detection and disease management.

The behavior control segment, which is still relatively small, covers products that help teach pets appropriate behavior, such as bark collars, which deter dogs from barking continuously. An innovative and popular product in this category includes the PetSafe Treat & Train Remote Reward Dog Trainer by US-based pet-tech company PetSafe. The product allows pet owners to dispense treats remotely through an electronic trainer to induce calm behavior in case of distracting situations, as well as allows owners to reward their pets in case of good behavior.

The smallest category is safety, which is largely an extension of ID tracking and comprises pet cameras that capture a pet’s movement. Mr. Petcam is a US-based company that provides collar-mounted HD video cameras for dogs or cats, allowing pet owners to see what their pets see in the yard, at home, or during walks.

Pet Wearables – Are Companies Barking up the Right Technology by EOS Intelligence

Pet Wearables – Are Companies Barking Up the Right Technology? by EOS Intelligence

The industry is undergoing both organic and inorganic growth

Pet adoption increased significantly during the COVID-19 pandemic as people were confined to their homes and lacked social and emotional connection. As per the American Society for the Prevention of Cruelty to Animals, one in five Americans purchased or adopted a pet during COVID-19.

Many of these pet owners are adept in technology and spend vast sums of money on their pets. As pets are increasingly considered family members and with growing concerns for their health and well-being, pet wearables are experiencing a surge in popularity. The success of wearable technology for humans further fuels this trend. Moreover, increasing costs of veterinary services and treatments have propelled pet owners to invest in health and prevention-based wearables. Therefore, the industry is expected to grow significantly, especially in Europe and North America, in the coming years.

However, that being said, the industry is in its nascence and is highly fragmented at the moment. There is a large number of players fueled by several start-ups and new entrants. The industry is seeing a surge in acquisitions as players in the pet care and tech space are looking to expand their offerings to include pet wearables. Moreover, growing interest from venture capital firms is also resulting in large investments in companies showing promise in this space.

One of the leading players in the pet market, Mars Petcare, launched Companion Fund in 2018 and Companion Fund II in October 2023. The US$100 million and US$300 million venture capital funds, respectively, have been created to invest in start-ups in the pet care space, including pet wearables. Earlier, in 2016, Mars Petcare acquired the Whistle pet monitor and GPS tracker, similar to a Fitbit for dogs, for about US$117 million. This provided Mars Petcare an entry into the pet wearables space.

Several other players in the technology space have also acquired companies to expand their business to cover pet wearables. In 2019, Florida-based IoT company Smart Tracking Technologies acquired Link AKC for an undisclosed amount. This wearable pet technology company developed GPS-enabled dog collars and won the Best Innovation award at CES 2017 in the wearable technology category.

In April 2023, Ultrack, a leading global GPS tracking solutions provider, signed a contractual agreement to acquire and market Supreme Product’s wearable GPS-based Pet Tracker. The device is expected to have multiple features, such as health monitoring, behavior modification, predictive analytics, social media integration, and virtual fences.

Similarly, in May 2023, Datamars, a global data solutions company, acquired Kippy, an Italy-based GPS tracking and activity monitoring solution provider. Kippy collar’s main features include GPS tracking, customized activity monitoring and analysis, reminders and access to vet records, temperature alerts, tone and vibration training controls, a built-in flashlight, and the ability to create safe places for the pet.

While several companies are adopting the inorganic growth strategy, there is also a lot of venture capital interest, especially in ID tracking, which is the largest product category and acts as an entry point device for many customers in the pet wearables space. In 2021, Austria-based leading pet tracking company Tractive raised US$35 million Series A round (led by Guidepost Growth Equity) to expand its offerings in the USA. Similarly, in 2021, Fi, a US-based pet wearable start-up, received US$30 million in Series B funding (following a Series A funding of US$ 7 million in 2019) for its smart pet collars to expand its footprint across the USA.

Pet wearables companies seek the right tech for pet health monitoring

While most technologies used in pet wearables are fairly similar to those used in human wearables (such as GPS), one of the key differentiators is the effectiveness of biometric sensors for health monitoring. Biometric sensors are widely used in human wearables, although given the fur presence in animals, they are somewhat ineffective in the case of pets. Thus, pet wearables depend on other contactless sensors such as radar and acoustic. However, these have their own functional and developmental challenges.

Among these, acoustic sensors are some of the oldest and are used by one of the market leaders, PetPace. Acoustic technology uses sound waves to monitor a pet’s heart rate, heart rate variability (HRV), and respiratory rate. Players such as PetPace and Inupathy use this technology in their smart collars. Moreover, in 2020, the Bioengineering Department at Imperial College also developed wearable technology for sniffer dogs based on acoustic sensors.

While this technology is fairly widely used for clinically monitoring health for both humans and pets, there are certain challenges when it is translated into wearables for pets. Given external factors, such as background noise and motion artifacts, the PetPace collar is said to have only 53% heart rate detection sensitivity (i.e., in 53% of the cases, the standard deviation from measurements by PetPace and ECG was within 10%) based on a study conducted in 2020. However, based on another 2017 study, the device’s pulse monitoring accuracy levels can be much higher at 94.3%.

That being said, Tokyo-based Inupathy also uses acoustic sensors to capture a dog’s heart rate and HRV and displays colors and patterns on its pet collar to depict emotional state and heartbeat ranges. For instance, the calmest state is depicted with deep blue, whereas the most excited state is bright red. While the company claims to have 90% accuracy when compared with ECG monitors, the collar is marketed as a device to broadly understand the mental and physical state of the pet instead of accurately monitoring and projecting heart rate readings.

Thus, while acoustic technology can be used in pet wearables, it has limitations, especially regarding accuracy. With the PetPace collar being priced at about US$150 (with a monthly subscription of US$15) and Inupathy at US$200, the customer must be able to find value in the readings. One of the initial companies using acoustic sensors, Voyce, went out of business in 2016 due to slower-than-expected acceptability.

Acoustic sensors-based solutions by themselves may not be a sound product offering, however, when clubbed with other technologies and solutions, they can offer a wholesome solution to the pet owner. This can be seen in the case of PetPace Smart Collar, which, along with acoustic-based health monitoring, has additional offerings such as thermometers for temperature detection, 6-D accelerometers for activity, calories, and posture calculation, and GPS for location tracking.

A more promising and upcoming technology for health monitoring in pets is radar technology. The technology uses radio waves to enable continuous and contactless heart and respiration rate monitoring. While it is relatively new, it is expected to have better accuracy when compared with acoustic sensors. Two companies, France-based Invoxia, and Taiwan-based ITRI, launched smart collars with radar technology in 2022. Invoxia’s smart collar is priced competitively at US$99 (with a monthly subscription of US$13). It uses embedded artificial intelligence and miniaturized radar sensors to track a dog’s health. In addition, it monitors a dog’s daily activity, such as walking, running, scratching, eating or drinking, barking, and resting. The device has an accuracy of 98% for heart rate detection.

Similarly, ITRI also launched its smart wearable device, iPetWear, in 2022. The device uses contactless micro-physiological radar sensing technology to monitor a pet’s health. The sensor can monitor a pet’s heart rate, respiratory rate, sleep cycle, and activity levels through the detection of pulse and chest motion through its lower-power Doppler radar technology. The device claims to have an error rate of under 10% for heart and respiration rate and under 5% for activity monitoring. The device is priced at US$80.

Given the improved accuracies and competitive pricing of these products, it is safe to say that radar technology-based sensors can disrupt pet health monitoring wearables. However, this technology is difficult to develop, and at the moment, only a limited number of companies have managed to commercialize it.

Companies are also exploring ways to make biometric sensors effective for pets, even though furry pets present a challenge for such sensors. This is seen in the case of Invoxia, which had previously launched the radar-based Smart Collar. At CES 2024, Invoxia launched another pet wearable device, the Invoxia Minitailz Smart Pet Tracker. The tracker uses advanced miniaturized biometric sensors along with AI to track respiratory and heart vitals and detect anomalies in the behavior of both dogs and cats. In addition, it tracks a pet’s location and daily activities and can differentiate between types of movement. It also claims to be the first pet collar in the market to detect atrial fibrillation (AFib). The device also seems to have high accuracy (similar to radar technology) as it claims to have 97-99% accuracy rates for monitoring respiratory and heart vitals. The product, priced at US$99 with a monthly subscription cost of US$8.30, is relatively new in the market, and its effectiveness is yet to be established.

If Invoxia Minitailz Smart Pet Tracker is successful and delivers on its promise (with regard to accuracy and functionality), several other players will likely also explore biometric sensors for pet health monitoring.

Other technologies, such as LiDAR and infrared, are also being explored as potential alternatives. However, there are not many commercially successful solutions based on them yet.

Potential risk of data breach is one of the biggest threats to pet wearables

Given the expanding scope of all these technologies, the pet wearable market is booming. However, it comes with its own set of challenges. While companies claim to have high accuracy rates, no FDA approvals are required for pet wearables at the moment. Thus, there is no way to verify the actual effectiveness of these devices. Moreover, since they deal with critical health conditions, a missed reading or a misdiagnosis can have dire consequences. Pet owners can also not consider these devices to be a replacement for their vet visits at large, and the devices can only act as information gatherers that can help vets make quicker diagnoses.

The industry is also facing a significant obstacle in the form of substandard battery technology. Given the number of features on each device (such as GPS tracking, health monitoring, two-way communication, etc.), its continuous and real-time work requirement, and the limited lifespan of lithium-ion batteries, companies have difficulty providing sufficient battery life for their devices. In several cases, pet owners find that the battery gets discharged sooner than they can recharge it. Therefore, the device loses its purpose since it is meant to provide continuous real-time data to be effective. To mitigate this, companies are looking into other battery options, such as lead acid (less efficient than lithium-ion) and silicon carbide (a more expensive option).

Another issue with these devices is the potential risk of data breaches. Wearables collect large amounts of data about pets and pet owners. In a 2019 study by Bristol University, pet wearable devices collected four times more data about the pet owner than about the pet itself. If this data is not properly secured, it could result in data leaks and cyberattacks and put the owner at risk.

EOS Perspective

With pet ownership increasing, the market for pet wearables will undoubtedly grow. Moreover, as human wearables continue to permeate our daily lives, it is natural that pet owners are looking for a similar advanced level of monitoring for their beloved companions.

The market, which started with single functionality tracking devices, is now moving towards more complex and technologically advanced solutions. While tracking and GPS-based devices continue to form a significant portion of the market at the moment, several leading players in the space (such as Tractive) are now integrating other functionalities with their location-tracking offerings.

Thus, the market is expected to move towards multi-functional solutions that offer basic features such as tracking along with advanced features such as activity and health monitoring. Also, within health monitoring, offerings will continue to differ based on complexity. For instance, some devices offer insights only into weight and temperature changes, while more advanced devices offer heart and pulse rate monitoring. As seen in the case of human wearables, the market is likely to move towards the latter as continuous advanced health monitoring becomes a standard way of managing well-being for both humans and pets.

Given the industry’s nascence, fragmented market, lack of big established brands, and low brand loyalty, the products’ key differentiating factors are likely to remain competitive pricing, advanced offerings, and effective technology.

For this, it becomes essential for companies to stay ahead of the curve and to explore possible technologies, beyond what is effective in human wearables. Therefore, companies that are investing in exploring suitable technologies, such as radar and biometrics, for advanced features, such as heart rate monitoring, are likely to emerge as market leaders in the long run.

Moreover, the pet wearables market is likely to also benefit from integration with pet insurance in the future. Both industries have synergies as the insurance sector can gain from health-based data derived from pet wearables. On the other hand, increasing demand for pet insurance is expected to provide a push to the pet wearables market, as pet owners who track and monitor their pet’s health can negotiate better and more competitive insurance rates.

Undoubtedly, the industry is poised for steady and strong growth. The market will likely consolidate, while players offering technologically advanced wearables focused on health monitoring and priced at around US$100-150 will emerge as leaders.

The Rise and Fall of Cue Health Market Lessons and Implications by EOS Intelligence
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The Rise and Fall of Cue Health: Market Lessons and Implications

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Cue Health, the portable COVID-19 test maker, reached its zenith during the pandemic’s peak, securing investments and contracts from both government and private sectors. The company was lauded for its user-friendly, rapid-response COVID-testing kits. At its peak, Cue Health’s products were seen as game-changers, with the potential to revamp the healthcare sector by providing accurate at-home diagnostic results within minutes. However, sales of these testing kits plummeted before Cue Health could diversify and establish other revenue streams, leading to a series of layoffs and, ultimately, the shutdown of its operations.

As the public focus shifted away from the pandemic, so did the demand for testing. For Cue Health, the COVID-19 test was essentially their sole product, and this decline in demand marked the onset of turbulent times.

In the past few years, Cue Health struggled to maintain its market position and technological edge, focusing on restructuring and streamlining its operations. The company engaged in talks with potential investors and stakeholders, which did not materialize. It also implemented several cost-cutting measures to remain afloat amid financial turbulence, but these were insufficient to counter the broader economic challenges that Cue Health faced. Its share prices declined steadily, and several rounds of layoffs followed.

The final blow came when the FDA issued a warning letter and a safety alert on May 10, 2024, asking users and healthcare providers to discard Cue Health’s product. The FDA discovered unauthorized changes made to Cue Health’s COVID-19 testing kits. This ultimately led to Cue Health’s winding down operations and filing for bankruptcy in May 2024 after laying off all its employees.

Cue Health’s business failures: A look at three critical oversights

Absence of recurring revenue streams: The company’s COVID-19 testing device was a one-time purchase, and it did not need any consumables or refills. This prevented the development of a recurring revenue model, such as subscription-based services or ongoing product sales, which is essential for financial stability and sustained revenue stream. Dependence on the one-time test kit sales implied that once its demand subsided, there was no consistent income to support operations.

Top-heavy business model: Cue Health employed many individuals in leadership positions, a common mistake that start-ups tend to make. This resulted in high salary costs, even amidst financial turbulence, eventually leading to several layoffs.

Moreover, the company struggled with financial management and strategic planning. Efforts to engage with investors and stakeholders did not yield results, further compounding the company’s financial crisis.

Narrow focus: Cue Health’s business model heavily depended on a single product, the COVID-19 testing kit, which nearly constituted its complete product portfolio. This singular focus left the company vulnerable to the declining demand for COVID-19 testing kits, and it was not able to pivot quickly to diversify product offerings. Moreover, the company was also unprepared for post-pandemic market realities, which led to its decline.

Cue Health’s wind down: Repercussions for diagnostics sector and investors

Regulatory and compliance implications: Cue Health’s regulatory challenges highlight the critical need for compliance and transparency in product modifications. Consequently, other companies in the diagnostics and medical devices sector may now encounter heightened regulatory scrutiny by the FDA. To stay afloat and avoid similar pitfalls, these companies must invest more in compliance, ensuring all products meet regulatory and quality standards. This could result in better overall product quality and safety across the industry, although at a higher cost to the device makers.

Industry lesson: Cue Health’s trajectory – from swift growth to sudden downfall – serves as a case study for industry players to understand the risks associated with over-reliance on a single product and the importance of portfolio diversification. Companies operating in the diagnostics sector should leverage the company’s experience to reevaluate business strategies and enhance risk management practices.

Investor sentiment: Cue Health’s downfall, despite the substantial funding and a successful IPO, could lead to more cautious investor behavior and diminished confidence in healthcare start-ups, particularly those with a singular product focus. For future investments, investors may demand more scrutiny and rigorous due diligence. Consequently, companies may be pressured to build diversified product portfolios and more sustainable business models to mitigate risks associated with market fluctuations and regulatory challenges.

EOS Perspective

Cue Health’s shutdown highlights the volatility and unpredictability of the MedTech sector, underlining the importance of regulatory compliance, portfolio diversification, and market adaptability. While innovation and growth are imperative for staying competitive in the diagnostics sector, striking a balance with robust financial planning and risk management practices is equally important.

For other diagnostics companies, Cue Health’s downfall serves as a cautionary tale, emphasizing the importance of building sustainable business models that can withstand market fluctuations and external pressure. For investors and stakeholders, it accentuates the requirement of stringent due diligence and risk assessment for high-stakes investments in emerging health technologies.

Despite Cue Health’s closure, its journey is important. The company leaves behind a legacy of innovations, diagnostic tools, and resourceful healthcare delivery models. Other diagnostics companies can build on Cue Health’s technological foundation, learning from its experiences to navigate the complex healthcare technology landscape.

FemTech A Game-Changer in Womens Healthcare by EOS Intelligence
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FemTech: A Game-Changer in Women’s Healthcare

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Women’s healthcare is one of the most neglected and understudied fields in the healthcare sector. Despite substantial advances in medical sciences in recent years, there still exists a huge gap in the treatment of diseases that are specific to women. FemTech focuses on addressing some of these gaps and offers the potential to help tackle the longstanding issues of women’s health.

FemTech developed as an answer to inadequate healthcare for women

According to a 2018 article published in Our World in Data, a UK-based online scientific publication, human life expectancy has increased tremendously from 30 to 73 years during the last two centuries (1800–2018). But this leap has not been reflected in women’s life quality. A 2024 report published by the World Economic Forum and the McKinsey Health Institute indicated that women live 25% longer in poor health than men, although they typically outlive males.

FemTech, a group of technology-enabled solutions such as diagnostic tools, wearables, products, software, and services, aims to tackle women’s health issues, such as maternal, reproductive, menstrual, and sexual health, as well as menopause. An example is the UK-based Flo Health app that tracks ovulation and the menstrual cycle, offers customized health insights and tips, and a closed community for sharing concerns and queries. US-based Natural Cycles is another example. This application provides personalized insights based on each user’s menstrual cycle patterns. This novel approach to improving women’s health and well-being has been gaining more importance in recent years.

Several challenges slow down progress and widespread acceptance

While FemTech offers promising solutions to help diagnose and manage many health issues affecting women that were previously overlooked, several challenges are awaiting interested players.

One major bottleneck players face is the scarcity of investments. Many investors still consider FemTech a niche sector and shy away from investing compared to other healthcare fields. This situation is slightly improving, as the industry has seen an increase in investment in recent years. Data from Dealroom, an Amsterdam-based provider of data and insights on start-ups and tech ecosystems, indicated that the venture capital (VC) funding into FemTech startups reached US$2.1 billion in 2021, an all-time high.

Despite this increase in investment in FemTech, the total funding for this sector still trails other sectors, especially if it is female-led. The CEO of a leading US-based fertility tracker Mira, said in an interview with Forbes that though 70% of FemTech startups are female-founded, male-owned businesses tend to raise more capital.

Investors and lenders often have unconscious biases against female entrepreneurs, affecting their willingness to invest in female-led businesses, according to a 2020 study published in the Journal of Financial Economics, a peer-reviewed financial journal. Also, women might only have restricted access to male-dominated fundraising sources, including crowdfunding websites, angel investors, and VC firms. Similarly, the traditional male dominance in some areas, such as technology and finance, can also lead to power imbalances in fundraising and limit the options available to women.

Insufficient R&D support is another major challenge faced by players in the FemTech sector. This can be seen from the fact that a significant proportion of the funding allocated to healthcare R&D is not focused on issues that directly impact women’s health and well-being, with a meager 4% dedicated to this area according to a 2018 article published in Forbes. This insufficient funding can cause innovation stagnation, set back product development, and reduce market opportunities.

The inadequate representation of women in clinical trials is another difficulty faced by FemTech companies. This lack of representation has created a knowledge gap in understanding important facets of women’s health, such as female anatomy, physiology, health issues, etc. A 2022 study published in Contemporary Clinical Trials, a peer-reviewed journal, showed that though women constitute 50.8% of the US population, just 41.2% of those involved in clinical trials were female. This creates a certain lack of awareness of how women’s bodies work, making it challenging for FemTech businesses to develop effective solutions.

Cybersecurity issues are also creating challenges in the development of FemTech. A joint study by Newcastle University, Royal Holloway, University of London, and ETH Zurich found serious privacy, security, and safety concerns that could put users at risk. The research indicated the danger of leaking sensitive information, such as fertility, medical data, etc., to third parties.

Cultural and social taboos are another bottleneck faced by FemTech companies. Female-specific issues such as postpartum depression and premenstrual syndrome are rarely openly discussed. This makes bringing societal focus to FemTech products a difficult task.

FemTech A Game-Changer in Women's Healthcare by EOS Intelligence

FemTech A Game-Changer in Women’s Healthcare by EOS Intelligence

FemTech industry is seeing significant development in some segments

Though confronting numerous challenges, FemTech remains a promising industry for interested players with its projected market growth. The FemTech market, estimated at US$40.2 billion in 2020, is expected to reach US$75.1 billion in 2025, according to a 2021 report by the US-based market research agency Arizton Advisory & Intelligence.

General health and wellness is the fastest-growing segment

FemTech offers several solutions for improving women’s health across various segments, with general health and wellness companies attracting the most VC investment, followed by reproductive health and contraception.

The general health and wellness segment combines digital health clinics, mental health services, and direct-to-consumer products. Since companies in this segment focus on broad-ranging solutions that address multiple issues, demand for them is expected to rise.

An example is Maven, a New York-based company offering a holistic solution encompassing pre- and post-pregnancy care. This virtual clinic provides 24/7 access to healthcare professionals, including mental health therapists, relationship consultants, and sleep coaches. In 2022, Maven attracted US$300 million in funding from prominent investors and individual strategic partners.

Another example is Stockholm-based Grace Health, acquired by Penda Health, a Kenyan medical care chain in 2023. It uses an automated health assistant called Grace to monitor and understand women’s sexual and reproductive well-being and receive timely reminders and notifications. The company is also expanding its local footprint in key African markets, including Nigeria, Kenya, and Ghana, to solidify its position as a market leader in these regions.

Reproductive health segment is also seeing strong demand

The reproductive health segment and menstruation care are also expected to continue holding the interest of investors and customers alike. According to the NIH, in the USA, 20% of women are now having their first child after turning 35, owing to a greater emphasis on education and career. With increasing age, some women may experience difficulty before, during, or after pregnancy. Women will also need to effectively and accurately track their fertility to make informed reproductive choices. This is likely to greatly contribute to in increased demand for FemTech reproductive health solutions.

An example is the Clue App, a Germany-based fertility tracker that leverages user data to compute and predict individuals’ periods and PMS. In 2023, the company raised US$7.6 million in funding and partnered with global universities such as the University of Exeter to bridge the diagnosis gap for women’s health conditions. This collaboration is expected to create new trends in managing female health issues.

Oncology products are now aimed at individuals and medical professionals

Development is also underway in the oncology segment. An example is Nevada-based Cyrcadia Health developing a breast monitor that tracks changes in breast tissue temperature over time to aid in the detection and risk management of breast cancer. The monitor consists of two patches that track temperature changes and send the data anonymously to the Cyrcadia Health core lab. This data is analyzed using machine learning (ML) algorithms and predictive analytics software to identify and categorize abnormal circadian patterns in healthy breast tissue. The results are then delivered to healthcare providers. This solution, when it becomes available in the market, is expected to enable women to take more proactive control of their breast health.

Cancer continues to be a leading cause of women’s death both in middle-income and high-income countries, according to a 2017 article published in Cancer Epidemiology, Biomarkers & Prevention, a peer-reviewed journal. Therefore, the focus on FemTech oriented at breast cancer and cancer in general is expected to gain momentum in the future.

Stigmatized conditions and marginalized subpopulations are increasingly addressed

Many FemTech companies are now exploring areas beyond menstrual and reproductive care and addressing stigmatized and unmet conditions such as preterm birth, endometriosis, pelvic care, and sexual health.

An example is London-based Elvie, a company that addresses pelvic floor dysfunction, a common and often overlooked health issue affecting many women. According to the NIH, 27% of women aged 40-59 and 37% of women aged 60-79 experience some form of pelvic floor dysfunction. Elvie has developed a Kegel trainer that uses biofeedback technology to improve pelvic and sexual health through five-minute workouts. The development of these solutions is expected to persuade more women to seek treatment and improve the diagnosis of these health conditions.

Similarly, apps are also being introduced for different sections of the population such as LGBTQ+, black women, and women from low and middle-income societies. US-based InovCares, an app designed to address the crisis of maternal mortality affecting Black women, is an example. This virtual OB-GYN platform connects users with culturally sensitive healthcare professionals who cater to various health needs, including fertility, childbirth, and breastfeeding.

Solutions are being developed in various geographies

While FemTech solutions development is concentrated in the USA and Europe, it is also visible in developing geographies such as Africa and Southeast Asia. An example is Indonesia’s BukuBumil which provides information on various aspects of pregnancy, including fertility, maternal health, baby immunizations, family planning, and post-pregnancy care in the Indonesian language. The platform also allows users to track a baby’s development and milestones.

Another one is Ethiopia-based YeneHealth, a multilingual and culturally responsive platform with AI-powered trackers for menstrual cycle, pregnancy, and medication management.

AI and ML are expected to shape the future of FemTech

Technological advancements are creating waves in the FemTech industry. Many companies are developing smart wearables and AI-powered solutions. Zurich-based Ava Women has developed a wearable, the Ava bracelet (available without prescription), to track hormonal changes. It allows users to monitor their ovulation and detect potential health issues. Ava’s technology uses big data and AI to provide accurate and personalized insights.

Similarly, Ovum, an Australia-based health management app, currently in its pilot phase, offers an AI health assistant designed for women to generate a dataset to improve treatments and diagnostics of various conditions. The app integrates and stores medical records, allowing users to track their health and receive personalized recommendations. This comprehensive data repository is crucial for complex or chronic conditions such as endometriosis, where a diagnosis can take years.

Experts believe the widespread use of AI and ML in FemTech apps will help players provide more accurate and data-driven solutions to users. AI can also analyze large datasets and use predictive analytics to anticipate health risks, such as gestational diabetes or pre-eclampsia.

EOS Perspective

The FemTech landscape, though still developing, is expected to expand more and grow quickly, especially with the increasing discussion around female health, Amazon CTO Werner Vogels commented at the 2023 AWS re:Invent conference, the largest conference in the cloud computing community. He has highlighted the significant potential of FemTech to transform the female healthcare system, specifically considering that women make up 50% of the population and account for 80% of consumer healthcare decisions.

FemTech has also the potential to significantly impact the healthcare sector and the global economy as a whole in the coming years. A 2024 report by the McKinsey Health Institute indicated that improving women’s health could boost the world economy by at least US$1 trillion annually.

The market is expected to see FemTech players widen their business scope, offer multiple services, and address a broader set of health issues. An example of this trend is UK-based Peppy, which initially helped organizations better support their women staff members after they had a baby, but now also deals with menopausal issues. This shift demonstrates a broader approach to women’s health under a single solution and reflects a development towards more comprehensive and inclusive offerings within FemTech.

Since FemTech is still developing, extensive R&D can be expected in the coming years. Experts believe health issues affecting older women also offer interested parties a research investment opportunity. Even now, in discussions and debates regarding FemTech, the diseases suffered by older women get overlooked. This makes it a promising area for future developments.

As the FemTech market expands, it is likely to attract collaborations from players operating outside the healthcare sector. One of the first examples of this was seen in August 2021, when the French cosmetic giant L’Oréal partnered with Clue to research the connection between the menstrual cycle and skin health to improve its skincare products. Such collaborations, whether just publicity stunts for cosmetic companies or not, can help put FemTech solutions on the map of legitimate tools close to women’s health. Considering that FemTech is still considered a niche sector, this can draw attention to the relevance of this market and its players and, consequently, stimulate investment.

Over the long term, women-led companies are expected to create more effective FemTech solutions that identify and cater to women’s unique healthcare requirements. The key factor behind it is that women are better placed to understand the health issues affecting women. A 2022 study published in Harvard Business School’s digital research publication Working Knowledge has also indicated that female-led research teams are more likely to study conditions that impact both genders than male-led ones. With more women stepping into STEM (science, technology, engineering, and mathematics) roles and female-led FemTech start-ups emerging, there is a promise of a more comprehensive scope of FemTech solutions.

A 2023 article published in Harvard Business Review noted an important trend that may positively affect the FemTech market: female investors are more likely to invest in and support female entrepreneurs. This suggests the potential for more capital flowing into women-led businesses, including in FemTech. As more women take on senior leadership roles in both FemTech startups and VC firms, this could substantially propel the industry growth.

Gut Matter - Will FMT Change How We Look at Disease Treatments by EOS Intelligence
by EOS Intelligence EOS Intelligence No Comments

Gut Matter: Will FMT Change How We Look at Disease Treatments?

Converting poop to pills was something unimaginable a few years ago, but now Fecal Microbiota Transplant (FMT) is taking the medical world by storm. This revolutionary technique, which promises to treat a wide range of diseases, from GI disorders to mental health issues, is becoming popular due to its success in treating recurrent clostridioides difficile infection (CDI), a serious infection that can damage the colon. FMT offers tremendous opportunities but also has challenges that players should consider if they want to thrive in this industry.

FMT is a procedure in which feces from a screened, healthy donor are transplanted into a recipient to balance the gut microbiota. This procedure can help treat certain infections and lessen the severity of some gut health issues.

Gut infections are usually treated using antibiotics, which can occasionally destroy beneficial bacteria. A 2000 study published in the Journal of Microbiology, a delayed open-access journal of the American Society for Microbiology, indicated that CDI recurring in around 15% to 35% of people is caused by antibiotics disrupting the gut microbiota and its balance (gut dysbiosis). Dysbiosis has been linked to several chronic illnesses, such as cardiovascular disease, inflammatory bowel disease (IBD), diabetes, and colorectal cancer (CRC).

FMT is highly efficient in treating recurrent CDI, with a cure rate of 90%, according to a 2015 study published in the American Journal of Gastroenterology. Numerous trials to understand the efficacy of FMT in treating conditions such as obesity, liver disease, ulcerative colitis, Crohn’s disease, Parkinson’s disease (PD), and IBS are underway. There are also some pre-clinical studies in progress to understand the potential of FMT in treating illnesses such as diabetes, skin issues, lung diseases, and autism.

This article is the second in EOS Perspectives' coverage 
of Fecal Microbiota Transplantation in animals and humans.

Read our related Perspective:
 Poop to Pills: Is FMT the Future of Veterinary Medicine?

FMT is showing promising growth

The human FMT sector is expected to grow at a CAGR of 5.1% and reach US$3.15 billion by 2031, according to a 2023 report published by India-based market research company The Brainy Insights.

The key factor influencing this growth is the rising incidence of GI disorders. According to the GI Alliance, a US-based network of gastroenterology providers, around 20 million Americans have chronic digestive disorders. Similarly, the CDC estimates that there are around 500,000 cases of CDI reported annually in the USA, and about 9% of elderly patients die within a month of contracting healthcare-associated CDI. All these have influenced the growth of FMT, which offers a promising solution to several conditions.

Other factors influencing the FMT sector growth are the rising patient awareness and interest in preventive healthcare and the emergence of effective probiotic strains.

There are several biotechnology companies currently involved in R&D and product development. Australia-based BiomeBank became the first company to get approval from a competent authority to market its FMT-based CDI solution called Biomictra Faecal Microbiota (colonoscopic, enema, and upper GI delivery) in November 2022. This was followed by the FDA approval of US-based Rebiotix-Ferring Pharmaceuticals’ REBYOTA (rectally administered) in the same month. Seres Therapeutics, a US-based company, has also received FDA approval for its orally delivered product Vowst (SER-109) for treating CDI in April 2023. Following Seres’ footsteps, Rebiotix-Ferring is now conducting trials to develop an oral alternative, RVX7455.

US-based Finch Therapeutics is another major company developing solutions presently undergoing phase-3 studies for diseases such as chronic hepatitis B and autism. Its solution, CP101, for treating CDI, has been discontinued.

Gut Matter Will FMT Change How We Look at Disease Treatments by EOS Intelligence

Gut Matter Will FMT Change How We Look at Disease Treatments by EOS Intelligence

The FMT sector is grappling with a multitude of pressing challenges

The FMT sector has the potential to treat numerous GI and other related disorders effectively. However, the business landscape is still marred by several challenges that players must consider.

Lack of consensus about policies is making development challenging

Regulatory hurdles are one major roadblock players face. The FDA currently regulates FMT as an unapproved biologic medicine. There is a lack of uniform guidelines for FMT, causing variations in processes, such as donor screening and processing.

The FDA took its first step toward FMT regulation in 2013. It released a set of guidelines removing the need for investigational new drug (IND) applications when FMT is used for treating CDI unresponsive to standard treatments if medical practitioners secure informed consent. However, this application is needed when FMT is used for other reasons, including safety studies.

The FDA drafted new guidance in 2016, which was finalized in November 2022. In this guidance, the FMTs acquired from stool banks are exempt from regulatory discretion. Also, the IND requirements will be waived if some conditions are fulfilled, such as getting informed consent from patients or authorized representatives and screening and testing stool under the supervision of competent healthcare professionals. There should also be no known potentially serious safety concerns, such as issues with improper handling or storage, or issues with administering product collection without the proper testing or screening. All these increase the procedural burden for healthcare practitioners. However, the FDA has indicated no regulatory policies for stool banks to reduce the administrative burden of private practice settings without the support of research staff.

Due to the significant variation in gut microbial composition among samples, FMT fails to satisfy EU drug classification requirements. Also, since human cells are not an active component of fecal matter, FMT is not covered by EU Directive 2004/23, which deals with the safety and quality of human tissues and cells. Therefore, the European Medicines Agency (EMA) has authorized the member states to regulate FMT however they see fit.

This lack of consensus has led to diverging regulatory policies, causing uncertainties for interested players and making developmental activities challenging, particularly in Europe. But despite this, many companies, such as Rebiotix-Ferring Pharmaceuticals, are making leaps in R&D.

Donor selection has social, ethical, and financial challenges

Another bottleneck that needs to be addressed is the availability and selection of suitable donors. There is a debate regarding whether the patient should know the donor or not. Also, the ideal donor should be free from chronic illnesses or infections and willing to donate. The donor is screened for obesity, antibiotic resistance, microbiome diversity, oncogenic potential, a history of antibiotic use, and risky behaviors such as drug abuse.

Stool banks require donors to follow several restrictions, such as maintaining BMI, abstaining from unhealthy eating habits such as spicy foods or saturated fatty acids, and avoiding travel to infection-prone tropical regions for an extended period. With that, donor dropout is high due to the considerable commitment needed, according to a 2019 study published in Gastroenterology, the official journal of the American Gastroenterological Association (AGA).

FMT implementation is also facing several social and ethical challenges with questions such as donor compensation, gender of the donor, donor and patient vulnerability, and commercial use of fecal matter.

Companies can launch educational drives targeted at patients and ideal donors to raise their awareness about FMT, tackle social resistance towards the procedure, and build trust with prospective donor candidates and patients. This can help reduce people’s reluctance to participate in FMT procedures.

The procedure remains risky, especially for vulnerable population

FMT is associated with an increased risk of transmitting infections such as Shiga toxin-producing E. coli (STEC) and enteropathogenic E. coli (EPEC) from the donor to the receiver. Immunocompromised patients are at a higher risk of developing side effects, according to a 2020 study published in Digestive Diseases and Sciences, a peer-reviewed journal. Similarly, a 2019 case study published in the New England Journal of Medicine, a journal of the Massachusetts Medical Society, showed a fatal infection contracted by an elderly immunocompromised individual following an FMT procedure.

Another challenge is the very few pediatric clinical trials, which makes it difficult for physicians to make the best judgments for when to initiate FMT therapy in children.

To tackle safety-related challenges, the FDA released safety advice in 2019 and 2020 regarding the possible risk of severe, potentially fatal infections associated with the procedure. Companies such as Boston-based OpenBiome have promptly modified their sample screening methodology to identify such infections.

Lack of studies on long-term effects

The lack of understanding of the long-term changes FMT can cause in a patient’s microbiota is another challenge. Several studies reveal that liver diseases, cancer, cardiovascular diseases, etc., can develop due to microbiota dysbiosis. Investment in R&D by interested and capable players can help medical professionals understand the long-term implications and complications of FMT and identify feasible solutions, which can pave the way for widespread treatment acceptance.

The sector’s future appears bright, underpinned by extensive development

FMT is a highly effective treatment for recurrent CDI. New developments have been taking place in many areas, such as administration modes, stool collection, and storage, and interested players can find opportunities in these areas. The FDA is also becoming more accepting of FMT-based treatments that show good results. This is shown by the approval of Rebyota and Vowst, both of which were more effective in reducing recurrent CDI compared to placebo in randomized controlled trials.

Stool banking and processing is another area ripe with opportunities for interested players. Conventionally, fresh stool is used for FMT, but this can increase the cost of the procedure. Stool banks are being developed to facilitate cost-effective and safe treatment. An example is OpenBiome, the USA’s first and biggest public stool bank. Stool banks can also make the standardization of stool processing and donor selection easier, according to a 2019 report published by the European Helicobacter and Microbiota Study Group.

Players can also form collaborations with healthcare professionals and research institutions to offer FMT treatments and support microbiome research. Many government organizations are also showing interest in the development of FMT therapies. The GBP500,000 grant awarded by the Biotechnology and Biological Sciences Research Council (BBSRC), a part of UK Research and Innovation, in 2022 to Norwich-based Quadram Institute (QI) to build and equip a new FMT research facility is an indication of this.

Investing in the development of FMT treatments can revolutionize the treatment of several diseases, and companies that can invest in research can gain a head start in the competition. Rigorous R&D is going on to develop FMT solutions for conditions such as obesity, depression, cancer, pediatric diseases, and autoimmune disorders such as Crohn’s disease.

A 2023 trial conducted by the US-based Emory University School of Medicine also showed that FMT can reduce the colonization of multidrug-resistant organisms in kidney transplant patients. Investigators believe more research in this field can help improve transplant success rates and decrease the chances of infection. Individual case studies have shown great improvement in cure rates for certain diseases, including mental health conditions, but more research is needed to present a solid case for product development.

EOS Perspective

FMT is gradually establishing itself as a promising solution for recurrent CDI and is expected to create waves in the treatment of numerous physical and mental health conditions despite facing several challenges.

Improvements in donor selection, early identification of certain conditions with better risk assessment, and increased treatment efficiency can be expected with ongoing research expanding the knowledge base of the medical community.

Experts are also looking into FMT’s potential as an adjunct therapy in treating diseases such as tuberculosis, and it is expected to open the door to interested players to create personalized and targeted FMT-based treatments for various diseases.

Studies are also being done to understand and substantiate the potential of gut microbiota to anticipate diseases such as IBD and CRC using AI (Artificial Intelligence) and ML (Machine Learning). ML can be used to identify biomarkers in the gut microbiota to aid in the early detection of CRC. These studies, when extended to FMT, are expected to help medical professionals identify ideal donors and improve treatment efficiency.

The Brainy Insights, in its 2023 report, predicts a growth in the probiotic infusion segment owing to the increasing studies on diabetes management. Therefore, competitive players interested in FMT can also diversify their portfolios by including consortia (multi-population systems with a broad spectrum of microbial species) and probiotic products that have the potential to offer regulated, standardized treatments. This can help them get an edge over their competitors.

Several oral FMT solutions are currently in phase-1 and phase-2 clinical trials, and many are geared toward treating conditions other than recurrent CDI. For example, US-based Vedanta Biosciences is developing FMT therapeutics for IBD, food allergies, solid tumors, etc. As research continues, it is expected that investigators will be able to identify the bacterial strains that can treat different diseases and isolate and mass-produce them, leading to a decrease in stool collection and processing and a reduction in stool transplant-related infections, but this development is expected to occur very far in the future.

Although marred by several challenges, FMT is well-positioned in the microbiome industry to obtain FDA approval and (with time) widespread acceptance. Right now, interested players can expect good returns by investing in oral FMT development, stool banking, and R&D.

Poop to Pills Is FMT the Future of Veterinary Medicine by EOS Intelligence
by EOS Intelligence EOS Intelligence 1 Comment

Poop to Pills: Is FMT the Future of Veterinary Medicine?

Fecal Microbiota Transplant (FMT), the transfer of healthy gut bacteria from a donor to a recipient to treat a myriad of conditions, has been gaining traction rapidly in recent years. Though the human FMT market has stolen the spotlight, the animal segment is also quietly blooming as a niche area, presenting a unique business opportunity for enterprising players.

The global human FMT market, estimated at US$2.11 billion in 2023, is projected to reach US$3.15 billion by 2031 with a CAGR of 5.1% between 2023 and 2031, according to a 2023 report published by India-based market research company The Brainy Insights. The animal FMT market is undoubtedly smaller, but it is difficult to determine its exact size due to a lack of consistent data on exact use. Also, while the human segment has many players, such as UK-based Microbiotica, US-based Finch Therapeutics, and US-based Rebiotix, Inc., the animal segment has a few competitors, such as Amend Pet and AnimalBiome, both US-based companies.

This article is the first in EOS Perspectives' coverage 
of Fecal Microbiota Transplantation in animals and humans. 

Read our related Perspective: 
Gut Matter: Will FMT Change How We Look at Disease Treatments?

Veterinary FMT is slowly but steadily growing

Increasing pet ownership is one of the most important factors influencing the growth seen in the veterinarian FMT sector. The American Pet Products Association (APPA), a Connecticut-based NPO, conducted a 2021–2022 National Pet Owners Survey, which found that 70% of US households own a pet, an increase from 56% in 1988 and 67% in 2019. A 2022 report published by HealthforAnimals, a Belgium-based global animal health association, indicated that owners are becoming more aware of their pets’ health needs. Similarly, a 2012 State of Pet Health Report released by Banfield Pet Hospital, a US-based veterinary hospital chain, has shown an increase in chronic diseases in cats and dogs.

The high incidence of diarrhea in pets also affects the FMT adoption rate. A 2008 report published in The Veterinary Record, a UK-based peer-reviewed journal, states that one of the most frequent causes of pet owners seeking veterinary care is acute diarrhea (AD).

Antibiotics are frequently used in the treatment of AD in dogs, 45% to 70%. The use of antibiotics in dogs can cause imbalances in the gut microbiota, leading to other diseases. This makes it essential to have a more holistic approach to managing pet diseases without disrupting their gut health.

The FMT sector is marred with several challenges

Though the FMT procedure offers many benefits, large-scale adoption still faces numerous challenges.

Empirical and scientific evidence is still lacking

A 2021 article published in Gut Microbes, a journal from the UK-based publishing company Taylor & Francis, indicated that the experimental information provided in preclinical FMT protocols is extremely uneven and/or lacking. The study suggested the reason for this is the lack of reliable guidelines for reporting requirements that would support efforts to replicate the study and, eventually, yield reproducible research. Many papers considered in the study lacked information on core aspects; for example, 92% had no reliable data about anaerobic conditions needed for FMT prep, and 49% had no information on efficient fecal material storage.

There is also currently minimal scientific information available in the field of veterinary FMT. Moreover, there is very little information on the therapeutic effectiveness of FMT in small animals such as dogs and cats, according to a 2016 article published in Veterinary Medicine (Auckland, N.Z.), a peer-reviewed journal. The article suggests that though adverse effects are limited in human patients, assessing whether the procedure is safe in animals is difficult.

Regulatory framework is in its infancy

Regulation is a bit complex in veterinary FMT. While there are not many specific regulations for veterinary FMT, the FDA considers FMT treatments used to prevent or treat diseases in animals as a new drug. Marketing new veterinary drugs in the USA without an approved or abbreviated new drug application is illegal. These require the manufacturer to submit information proving that a proposed generic medication is equivalent to an approved reference-listed drug (RLD) in terms of quality, safety, and efficacy. The lack of detailed clinical studies in the veterinary segment can slow down regulatory clearance. The Center of Veterinary Medicine, the US department approving drugs for pet animals, does not have any specific regulatory policy regarding the use of FMT either.

Veterinarians lack experience

Lack of technical expertise and procedural experience can also hinder FMT adoption. A 2022 study published in Topics in Companion Animal Medicine indicated that 71% of veterinarians had never performed FMT. These results were based on 155 responses from 13 different countries.

Risk of transmitting disease phenotypes is high

FMT can transmit disease phenotypes, including obesity and metabolic disorders such as diabetes, according to a 2020 study published in Medicine in Microecology, a peer-reviewed journal. Similarly, changes to the gut microbiota, such as exposure to antibiotics or the transfer of cecal material (fecal material from the bottom right quadrant of the cecum, a part of the large intestine), can affect disease phenotypes, such as an elevated risk of colitis.

Donor selection is difficult and pricey

The selection of an ideal donor is another challenge. The donor animal should be free from all kinds of parasites and pathogens and without any history of gastrointestinal diseases. Similarly, the donor should have no history of behavioral issues and should be of ideal weight. There should also be no history of antibiotic use within six months before the sample collection. Stool banks must thoroughly test the samples used for FMT, increasing procedural costs and hindering widespread acceptance and adoption of the technique among pet owners and veterinarians.

Poop to Pills Is FMT the Future of Veterinary Medicine by EOS Intelligence

Poop to Pills Is FMT the Future of Veterinary Medicine by EOS Intelligence

Numerous investment opportunities are available for interested players

Though veterinary FMT is still in its infancy, businesses still have several investment opportunities in this sector.

Focusing on extensive R&D

Veterinary FMT is a promising sector, but more research is needed to support product and service development. Since the current competition is concentrated on rigorous R&D, interested players capable of making risky research investments will likely gain an upper hand over their competitors.

The research so far has been promising, and the extensive R&D helps drive the market and build the necessary base for FMT to be recognized as a separate category for approvals. A 2022 study published in Frontiers in Immunology, a journal of the International Union of Immunological Societies, has indicated that several studies were conducted in the field of FMT from 2001 to 2021. This study analyzed key aspects such as donor selection, efficacy, and adverse effects. The incidence of minor and serious adverse effects after an FMT procedure was found to be 11.63% and 1.59%, respectively, while the overall efficacy was 76.88%.

The results from this study are promising, but they also indicate that more research is needed to understand and confirm the efficacy, safety, and quality of FMT treatments in animals. The FDA is more likely to approve these therapies with more robust evidence from newer studies, giving market players more opportunities.

Even though there is currently a lack of consensus or evidence-based standards regarding FMT dosage or donor screening for animals, a recently established international expert organization, the Companion Animal Fecal Bank Consortium, is developing guidelines in these domains. This can also be considered as a first step towards prompting FDA approval.

Developing the oral delivery route

Market players can find opportunities in developing FMT treatments administered through oral rather than nasoesophageal or rectal routes. Currently, the FMT delivery route is one of the critical bottlenecks in the more widespread adoption of the therapy.

Both nasoesophageal and rectal delivery routes are considered more efficacious but are associated with considerable risks. Nasoesophageal treatments use endoscopes that cause discomfort and aspiration and make it difficult to assess the colon mucosa or get mucosa tissue samples. In rectal FMTs, colonoscopes and anesthesia are involved, the latter often being a significant risk to the pet patient, deterring pet owners from choosing FMT. Both rectal and nasoesophageal routes are also associated with a risk of perforation, bleeding, infection, etc.

Conversely, the oral delivery route is generally preferred due to non-invasiveness and ease of use. However, oral FMT takes longer to reach the large intestine and has been perceived as less effective.

Market players can attempt to meet the preference for the oral route by building on a few research studies showing the good efficacy of oral FMT in pets. While research on animals is still limited, research in humans can be extended to identify approaches to improved efficacy of oral FMTs in treating animal GI infections. One such research was a 2017 study published in JAMA Network Open, an open-access journal by the American Medical Association, which indicated that in humans, oral FMT had efficacy in the treatment of C. difficile infection similar to that of rectal FMT.

One of the pioneers in this area is AnimalBiome, which developed an oral Gut Restore Supplement in an enteric-coated capsule (a coating that protects the medicine from the stomach’s acidic environment before it reaches the intestine and reduces side effects). The company conducted a pilot study in 2019 to observe the impact of the capsule on 40 dogs and 72 cats suffering from IBD. The study found that symptoms improved in 83% of the cats and 80% of the dogs. As the availability of such FMT solutions is still meager, there is plenty of room in the market for businesses to follow AnimalBiome’s footsteps and invest in creating oral FMT solutions.

Driving adoption through at-home administration kits

Another growth area for players is the development of user-friendly oral at-home administration kits for more straightforward treatment requirements. There is a demand for such easy-to-administer at-home solutions in the animal FMT space, as getting the pet to a vet is typically stressful for both the animal and the owner.

A 2011 survey published in the American Veterinary Medical Association (AVMA) journal indicated that out of 2,188 dog and cat owners polled, 38% of dog owners and 58% of cat owners said their pet “hates” visiting the vet. If FMT has to be repeated or spread over multiple visits, the treatment process is also time-consuming, further decreasing the likelihood of completing the therapy.

At-home application solutions can help make significant inroads into FMT acceptance, as pet owners are more likely to opt for such treatments rather than in-hospital procedures whenever possible.

Increasing specialization and targeted treatments

Developing more target FMT treatments (specific to animal breeds or conditions) appears to be a good area of opportunity. Currently, studies are being carried out to develop farm-specific FMT to treat various conditions in cattle.

A 2022 article published in PLOS One, a peer-reviewed journal, investigated the effects of farm-specific FMT on pre-weaned calves. The study indicated that FMT-treated calves’ alpha-diversity (indicating microbiota richness) had increased. It also suggested that the success of FMT will improve with proper criteria for donor selection. This offers scope for further investigation for market players to develop such targeted therapies.

Expanding through complementary products

Players can grow their FMT business by building a range of products to complement FMT therapies, such as specialized probiotics or microbiome health supplements.

A 2015 study published in BMJ Open, an open-access medical journal, has indicated that the gut microbiome can be strengthened and balanced in humans with the help of proper diet, probiotics, prebiotics, and FMT. Researchers are now looking into the positive impact of probiotics on animal health, such as improvement in digestion, lowered risk of gastrointestinal diseases, etc. With support from such research studies, players can work to offer comprehensive treatment and maintenance product lines.

Working on awareness through educational initiatives

Apart from immediate business opportunities, players might also have to get involved in activities that inform, educate, and help build the FMT market. Though it is a promising emerging therapy, very little information is available on veterinary FMT. In order to reap long-term rewards, businesses should spotlight and promote FMT and its positive effects on animal health to the vet community and the public by launching educational drives, conferences, and other similar initiatives. Existing players already recognize this need. For instance, Amend Pet, a major company in the veterinary FMT segment, has free educational courses in the form of RACE (Registry of Approved Continuing Education)-approved videos for veterinarians.

Increasing adoption through collaborations

Further, players in the FMT space should collaborate with veterinary hospitals and other organizations dealing with animal health to work with them and increase FMT adoption.

An example of this is the strategic collaboration between Amend Pet and the Association of Shelter Veterinarians (ASV) that started in May 2023. With this partnership, Amend Pet plans to offer easy-to-use and affordable FMT treatments to shelter dogs. The ASV has over 2000 veterinary professionals and 23 student chapters worldwide. Partnerships such as this can be expected to raise awareness about FMT among the public and veterinary sector, leading to improved adoption rates.

EOS Perspective

While veterinary FMT still has a long way to go before becoming a mainstream therapy, it is already an exciting field with many expected developments.

The spectrum of animal health conditions that can be treated or managed with FMT will continue to expand to include immune system disorders, metabolic conditions, and behavioral issues. Progress in the animal FMT space will likely be linked to research done in human FMT, as these studies can be extended to animal healthcare or at least be a starting point for animal FMT-specific research, revolutionizing veterinary treatments.

Improvements in donor selection processes, such as more stringent and advanced inspection of the donor’s gut microbial diversity and behavior evaluation, can be expected as many studies are now being done to understand the connection between behavior and gut microbes.

Rapid technological development, especially in AI, is expected to influence veterinary FMT as well. AI-powered equipment might be used for guided rectal FMT treatments to improve the procedures’ accuracy. This is likely to be safer for the animal and can prompt pet owners to choose FMT to treat their pet’s gastrointestinal issues. Companies investing in research can expect growth in this field.

All these developments, if accompanied by simultaneous partnerships between industry players and veterinary clinics, offer a promising future for the animal health FMT. The return on investment in this sector might not be immediate. For now, the industry needs to prioritize driving adoption, educating and disseminating knowledge, and gathering scientific data and empirical evidence to build a sound understanding of FMT in veterinarians, pet owners, and regulatory bodies. Nonetheless, the industry prospects are promising, and the players can expect the long-term benefits to be substantial.

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