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Bridging the Gap between MDx Testing and Point-of-care by EOS Intelligence
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Bridging the Gap between MDx Testing and Point-of-care

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The COVID-19 pandemic brought innovation and investment to the in vitro diagnostics (IVD) market, opening new pathways to simplify and expand testing. The previously complicated and time-consuming molecular testing gradually started moving towards rapid testing, changing how we manage healthcare. The growing popularity of rapid testing gave way to self-sampling and at-home sampling, which is set to bring molecular testing closer to patients. Another noticeable transformation the industry witnessed post-pandemic was the rise of molecular testing at point-of-care (POC), which is set to disrupt the way clinicians deliver accurate diagnoses in record time.

The latest generation of IVD devices is focused on providing quick diagnosis and being cost-effective. This has led to IVD companies focusing on developing simpler and less invasive sample collection methods, such as self-sampling tests.

IVD innovation is also transforming molecular testing to make healthcare more accessible. To a certain extent, dependence on laboratories is gradually decreasing with molecular testing available at POC. A key development in this area is the use of multiplex assay, which allows to test for multiple pathogens simultaneously, allowing for early diagnosis.

Molecular testing moving near-patient

After using antigen tests during COVID-19, demand for molecular testing for a variety of diseases at POC has risen drastically. In 2023, the industry faced an acute shortage of skilled laboratory staff, further increasing the need for molecular testing to move near-patient. This has resulted in physicians and patients preferring molecular tests at POC (MPOC). Some prominent industry players, such as Cepheid, Abbott, and BioFire, offer CLIA-waived PCR instruments and multiplex assay tests for the POC setting. A CLIA-waived certification allows tests to be performed at a doctor’s office by a non-technician instead of other more complex MDx tests requiring specialized technicians.

Moving these multiplex molecular tests near-patient is revamping the IVD landscape, positively impacting both the patients and payers. Early diagnosis with POC diagnostics empowers physicians with evidence-based decision-making at an early stage. Moreover, with multiplex assays increasingly being used for MPOC and delivering results within 10-25 minutes (in the case of respiratory assays), the wait time for patients to receive the correct diagnosis has reduced substantially. This results in clinicians being able to start with proper treatment on the patient’s first visit, thus reducing the total number of patient visits. Consequently, physicians are also able to accommodate a higher number of patients.

In fact, MPOC could become a critical element of the value-based care model in the USA. The value-based program incentivizes healthcare providers/physicians to provide quality healthcare. With MPOC offering quicker turnaround time and lower testing costs, physicians/payers will likely be better incentivized and motivated to deliver high-quality services.

Growing demand for self-sampling/at-home sampling

The pandemic raised public awareness regarding the use of self-sampling kits and increased demand for them. Further, the FDA granted Emergency Use Authorization to multiple assays during the pandemic to quickly onboard self-test kits and penetrate the US households with this novel testing method.

Driven by the convenience, cost-effectiveness, and accessibility offered by self-sampling kits, they are becoming increasingly popular, particularly amongst the aging population that needs tools and technologies to manage health at home. It is also proving to be a sustainable testing method, as it can be used for preventative screening as well as allows for discretion for patients who may not prefer to get tested in a laboratory or by a physician, particularly in case of sexually transmitted infections (STIs).

Additionally, unlike OTC tests, molecular diagnostic tests allow for better accuracy in results and are recognized by the FDA for clinical diagnosis use. This has given confidence to healthcare providers to advocate self-sampling, as they stand to benefit from bringing care to patients’ homes, eventually reducing healthcare expenses. In a value-based setting, at-home testing proves to particularly benefit physicians who are able to eliminate unnecessary patient visits.

For the prominent industry players, at-home testing represents a key opportunity area to grow in the niche direct-to-consumer testing segment. Companies are also using these tests as an opportunity to target the rural population who do not have easy access to laboratories. Besides infectious and respiratory diseases, companies are now trying to foray into other treatment areas, such as human papillomavirus (HPV). Self-sample collection for HPV has begun in Europe with BD’s Onclarity HPV assay.

EOS Perspective

Establishing a strong foothold in both self-sampling and MPOC segments is seen as a sizeable business opportunity for stakeholders of the IVD market. In the near term, it is likely for the IVD players to continue launching new assays and technologies to expand offerings.

For self-sampling, MDx players have been focusing on infectious diseases, and there still is a vast untapped market for self-sampling at home, specifically when testing for STIs. In November 2023, LetsGetChecked became the first company to secure FDA approval for chlamydia and gonorrhea at-home sample collection. This has opened doors for other players to enter this niche market, and they are likely to jump on the bandwagon by seeking FDA approvals for their STIs self-sampling kits. Major players, such as Hologic, are already gathering data to launch a self-collection device for STIs. Hologic’s Aptima Swab for STIs multi-testing is approved in the EU, and the company is now conducting trials to get approval in the USA.

In the near term, a noticeable trend in the MPOC segment is expected to be the focus of MDx players on developing multiplex assays that follow the ‘one-size-fits-all’ approach. There is a growing demand from physicians for multiplex assays that allow them to test for multiple viruses and deliver results in under four hours. Companies have already started to take matters into their own hands by focusing their R&D efforts on developing panels and preparing them for FDA approval and CLIA waiver. Becton Dickinson announced the launch of its first molecular diagnostics POC instrument, BD Elience, by 2025. The device is expected to allow panel testing for respiratory and sexually transmitted diseases.

Although the self-sampling and MPOC segments present many opportunities for the IVD stakeholders, some roadblocks may hinder their development and adoption. For instance, multiplex assay reimbursement schemes may hamper their widespread adoption in the POC setting. Per the latest guidelines, reimbursement schemes for multiplex assays are less favorable than those for singleplex assays. Furthermore, at present, there are no reimbursement schemes in place to reimburse for self-sampling at home, so patients are required to pay out-of-pocket.

Several players face a crucial challenge for at-home collection: proving to the FDA that the self-sample collected is not contaminated or poorly taken. FDA requirements for approval of these tests are very stringent and demand that companies prove the adequacy of the sample collected by patients to match that of laboratory collection.

Despite these challenges, self-sampling and MPOC present untapped opportunities for many IVD players seeking to expand their capabilities and offerings to position themselves better in the MDx market.

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.

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.

Powering Healthcare Diagnostics with AI by EOS Intelligence
by EOS Intelligence EOS Intelligence No Comments

Powering Healthcare Diagnostics with AI: a Pipe Dream or Reality

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The growing paucity of radiologists across the globe is alarming. The availability of radiologists is extremely disproportionate globally. To illustrate this, Massachusetts General Hospital in Boston, USA, had 126 radiologists, while the entire country of Liberia had two radiologists, and 14 countries in the African continent did not have a single radiologist, as of 2015. This leads to a crucial question – how to address this global unmet demand for radiologists and diagnostic professionals?

Increasing capital investment signals rising interest in AI in healthcare diagnostics

The global market for Artificial Intelligence (AI) in healthcare diagnostics is forecast to grow at a CAGR of 8.3%, from US$513.3 million in 2019 to US$825.9 million in 2025, according to Frost & Sullivan’s report from 2021. This growth in the healthcare diagnostics AI market is attributed to the increased demand for diagnostic tests due to the rising prevalence of novel diseases and fast-track approvals from regulatory authorities to use AI-powered technologies for preliminary diagnosis.

Imaging Diagnostics, also known as Medical Imaging is one of the key areas of healthcare diagnostics that is most interesting in exploring AI implementation. From 2013 to 2018, over 70 firms in the imaging diagnostics AI sector secured equity funding spanning 119 investment deals and have progressed towards commercial beginnings, thanks to quick approvals from respective regulatory bodies.

Between 2015 and 2021, US$3.5 billion was secured by AI-enabled imaging diagnostics firms (specialized in developing AI-powered solutions) globally for 290 investment deals, as per Signify Research. More than 200 firms (specialized in developing AI-powered solutions) globally were building AI-based solutions for imaging diagnostics, between 2015 and 2021.

The value of global investments in imaging diagnostics AI in 2020 was approximately 8.8% of the global investments in healthcare AI. The corresponding figure in 2019 was 10.2%. The sector is seeing considerable investment at a global level, with Asia-based firms (specialized in developing AI-powered solutions) having secured around US$1.5 billion, Americas-based companies raising US$1.2 billion, and EMEA-based firms securing over US$600 million between 2015 and 2021.

As per a survey conducted by the American College of Radiology in 2020 involving 1,427 US-based radiologists, 30% of respondents said that they used AI in some form in their clinical practice. This might seem like a meager adoption rate of AI amongst US radiologists. However, considering that five years earlier, there were hardly any radiologists in the USA using AI in their clinical practice, the figure illustrates a considerable surge in AI adoption here.

However, the adoption of AI in healthcare diagnostics is faced with several challenges such as high implementation costs, lack of high-quality diagnostic data, data privacy issues, patient safety, cybersecurity concerns, fear of job replacement, and trust issues. The question that remains is whether these challenges are considerable enough to hinder the widespread implementation of AI in healthcare diagnostics.

Powering Healthcare Diagnostics with AIPowering Healthcare Diagnostics with AI

AI advantages help answer the needs in healthcare diagnostics

Several advantages such as improved correctness in disease detection and diagnosis, reduced scope of medical and diagnosis errors, improved access to diagnosis in areas where radiologists are unavailable, and increased workflow and efficacy drive the surge in the demand for AI-powered solutions in healthcare diagnostics.

One of the biggest benefits of AI in healthcare diagnostics is improved correctness in disease detection and diagnosis. According to a 2017 study conducted by two radiologists from the Thomas Jefferson University Hospital, AI could detect lesions caused by tuberculosis in chest X-rays with an accuracy rate of 96%. Beth Israel Deaconess Medical Center in Boston, Massachusetts uses AI to scan images and detect blood diseases with a 95% accuracy rate. There are numerous similar pieces of evidence supporting the AI’s ability to offer improved levels of correctness in disease detection and diagnosis.

A major benefit offered by AI in healthcare diagnostics is the reduced scope of medical and diagnosis errors. Medical and diagnosis errors are among the top 10 causes of death globally, according to WHO. Taking this into consideration, minimizing medical errors with the help of AI is one of the most promising benefits of diagnostics AI. AI is capable of cutting medical and diagnosis errors by 30% to 40% (trimming down the treatment costs by 50%), according to Frost & Sullivan’s report from 2016. With the implementation of AI, diagnostic errors can be reduced by 50% in the next five years starting from 2021, according to Suchi Saria, Founder and CEO, Bayesian Health and Director, Machine Learning and Healthcare Lab, Johns Hopkins University.

Another benefit that has been noticed is improved access to diagnosis in areas where there is a shortage of radiologists and other diagnostic professionals. The paucity of radiologists is a global trend. To cite a few examples, there is one radiologist for: 31,707 people in Mexico (2017), 14,634 people in Japan (2012), 130,000 people in India (2014), 6,827 people in the USA (2021), 15,665 people in the UK (2020).

AI has the ability to modify the way radiologists operate. It could change their active approach toward diagnosis to a proactive approach. To elucidate this, instead of just examining the particular condition for which the patient requested medical intervention, AI is likely to enable radiologists to find other conditions that remain undiagnosed or even conditions the patient is unaware of. In a post-COVID-19 era, AI is likely to reduce the backlogs in low-emergency situations. Thus, the technology can help bridge the gap created due to radiologist shortage and improve the access to diagnosis of patients to a drastic extent.

Further, AI helps in improving the workflow and efficacy of healthcare diagnostic processes. On average at any point in time, more than 300,000 medical images are waiting to be read by a radiologist in the UK for more than 30 days. The use of AI will enable radiologists to focus on identifying dangerous conditions rather than spend more time verifying non-disease conditions. Thus, the use of AI will help minimize such delays in anomaly detection in medical images and improve workflow and efficacy levels. To illustrate this, an AI algorithm named CheXNeXt, developed in a Stanford University study in 2018 could read chest X-rays for 14 distinct pathologies. Not only could the algorithm achieve the same level of precision as the radiologists, but it could also read the images in less than two minutes while the radiologists could read them in an average of four hours.

Black-box AI: A source of challenges to AI implementation in healthcare diagnostics

The black-box nature of AI means that with most AI-powered tools, only the input and output are visible but the innards between them are not visible or knowable. The root cause of many challenges for AI implementation in healthcare diagnostics is AI’s innate character of the black box.

One of the primary impediments is tracking and evaluating the decision-making process of the AI system in case of a negative result or outcome of AI algorithms. That is to say, it is not possible to detect the fundamental cause of the negative outcome within the AI system because of the black-box nature of AI. Therefore, it becomes difficult to avoid such occurrences of negative outcomes in the future.

The second encumbrance caused by the black-box nature of AI is the trust issues of clinicians that are hesitant to use AI applications because they do not completely comprehend the technology. Patients are also expected to not have faith in the AI tools because they are less forgiving of machine errors as opposed to human errors.

Further, several financial, technological, and psychological challenges while implementing AI in healthcare diagnostics are also associated with the black-box nature of the technology.

Financial challenges

High implementation costs

According to a 2020 survey conducted by Definitive Healthcare, a leading player in healthcare commercial intelligence, cost continues to be the most prominent encumbrance in AI implementation in diagnostics. Approximately 55% of the respondents who do not use AI pointed out that cost is the biggest challenge in AI implementation.

The cost of a bespoke AI system can be between US$20,000 to US$1 million, as per Analytics Insights, while the cost of the minimum viable product (a product with sufficient features to lure early adopters and verify a product idea ahead of time in the product development cycle) can be between US$8,000 and US$15,000. Other factors that also decide the total cost of AI are the costs of hiring and training skilled labor. The cost of data scientists and engineers ranges from US$550 to US$1,100 per day depending on their skills and experience levels, while the cost of a software engineer (to develop applications, dashboards, etc.) ranges between US$600 and US$1,500 per day.

It can be gauged from these figures that the total cost of AI implementation is high enough for the stakeholders to ponder upon the decision of whether to adopt the technology, especially if they are not fully aware of the benefits it might bring and if they are working with ongoing budget constraints, not infrequent in healthcare institutions.

Technological challenges

Overall paucity of availability of high-quality diagnostic data

High-quality diagnostic and medical datasets are a prerequisite for the testing of AI models. Because of the highly disintegrated nature of medical and diagnostic data, it becomes extremely difficult for data scientists to procure the data for testing AI algorithms. To put it in simple terms, patient records and diagnostic images are fragmented across myriad electronic health records (EHRs) and software platforms which makes it hard for the AI developer to use the data.

Data privacy concerns

AI developers must be open about the quality of the data used and any limitations of the software being employed, without risking cybersecurity and without breaching intellectual property concerns. Large-scale implementation of AI will lead to higher vulnerability of the existing cloud or on-premise infrastructure to both physical and cyber attacks leading to security breaches of critical healthcare diagnostic information. Targets in this space such as diagnostic tools and medical devices can be compromised by malware or software viruses. Compromised data and algorithms will result in errors in diagnosis and consequently inaccurate recommendations of treatment thereby causing stakeholders to refrain from using AI in healthcare diagnostics.

Patient safety

One of the foremost challenges for AI in healthcare diagnostics is patient safety. To achieve better patient safety, developers of AI algorithms must ensure the credibility, rationality, and transparency of the underlying datasets. Patient safety depends on the performance of AI which in turn depends on the quality of the training data. The better the quality of the data, the better will be the performance of the AI algorithms resulting in higher patient safety.

Mental and psychological challenges

Fear of job substitution

A survey published in March 2021 by European Radiology, the official journal of the European Society of Radiology, involving 1,041 respondents (83% of them were based in European countries) found that 38% of residents and radiologists are worried about their jobs being cut by AI. However, 48% of the respondents were more enterprising and unbiased towards AI. The fear of substitution could be attributed to the fact that those having restricted knowledge of AI are not completely educated about its shortcomings and consider their skillset to be less up-to-date than the technology. Because of this lack of awareness, they fail to realize that radiologists are instrumental in developing, testing, and implementing AI into clinical practice.

Trust issues

Trusting AI systems is crucial for the profitable implementation of AI into diagnostic practice. It is of foremost importance that the patient is made aware of the data processing and open dialogues must be encouraged to foster trust. Openness or transparency that forges confidence and reliability among patients and clinicians is instrumental in the success of AI in clinical practice.

EOS Perspective

With trust in AI amongst clinicians and patients, its adoption in healthcare diagnostics can be achieved at a more rapid pace. Lack of it breeds fear of job replacement by the technology amongst clinicians. Further, scarcity of awareness of AI’s true potential as well as its limitations also threatens diagnostic professionals from getting replaced by the technology. Therefore, to fully understand the capabilities of AI in healthcare diagnostics, clinicians and patients must learn about and trust the technology.

With the multitude and variety of challenges for AI implementation in healthcare diagnostics, its importance in technology becomes all the more critical. The benefits of AI are likely to accelerate the pace of adoption and thereby realize the true potential of AI in terms of saving clinicians’ time by streamlining how they operate, improving diagnosis, minimizing errors, maximizing efficacy, reducing redundancies, and delivering reliable diagnostic results. To power healthcare diagnostics with AI, it is important to view AI as an opportunity rather than a threat. This in turn will set AI in diagnostics on its path from pipe dream to reality.

China's Medtech Volume-Based Procurement Big Savings, Bigger Challenges by EOS Intelligence
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China’s Medtech Volume-Based Procurement: Big Savings, Bigger Challenges

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China’s phased rollout of Volume-Based Procurement (VBP), which started in the pharmaceutical industry in 2018, quickly expanded to the medical devices market in 2019. VBP standardizes medical device prices in China, fosters medtech innovation, makes medical consumables more accessible, and reduces healthcare expenses for both patients and the government. The program is doing this by granting high-volume sales to medical device manufacturers, offering the lowest prices across the city, province, or country level, depending on the tender type.

VBP policy follows the Healthy China strategy

In September 2021, the National Healthcare Security Administration, a governmental body responsible for funding public healthcare in China, made its 14th five-year plan (FYP), including the years from 2021 to 2025. China’s 14th FYP has laid down a Healthy China strategy that aims to improve social conditions, including healthcare in the country.

China has struggled with costly and uneven healthcare access between urban and rural areas, contributing to poverty, primarily in rural regions. Poverty due to illness affected around 20 million people, or 44.1% of the poor population in 2015, according to the National Health Commission. Other challenges include a hike in noninfectious diseases due to poor lifestyle habits and an increasingly aging population.

The 14th FYP aims to mitigate these challenges by improving the affordability and accessibility of healthcare services in China by 2025. China will achieve this through various policies, including public hospital reform and equal access to essential public healthcare services.

The Chinese government rolled out VBP, or competitive tendering of medical consumables, to achieve the 2025 target of 80% of hospitals’ expenditure to go through the provincial tendering process across several device categories.

China's Medtech Volume-Based Procurement Big Savings, Bigger Challenges by EOS Intelligence

China’s Medtech Volume-Based Procurement Big Savings, Bigger Challenges by EOS Intelligence

VBP has had a tremendous impact on many medtech players in China

Between 2019 and 2021, the top 10 producers of high-value medical consumables in the Chinese market participated in VBP tenders at the provincial level with a nearly 70% median reduction in the prices the manufacturers offer under the tender.

The average price reductions on medical devices such as coronary stents, joint replacement systems, spinal and orthopedic products, and total knee replacement systems were cut by 95%, 82%, 84%, and 84%, respectively.

With these significant price reductions, VBP rippled through the medtech sector, affecting companies in many ways and forcing them to rethink their strategies to compete more effectively in China.

Declining revenues

The introduction of VBP has adversely affected some of the leading medtech companies, resulting in a downturn in their revenues in China. These medtech companies aimed to mitigate the impact by reducing costs and discounts. The impact of VBP on the world’s largest medical device maker, Medtronic, caught the attention of the medtech community due to the company’s considerable presence in China. The company’s Q3 2022-2023 earnings call reported that sales declined drastically due to VBP. Medtronic’s most impacted business lines included the surgical division, cardiac ablation solutions, and neurovascular lines. According to estimates, VBP affected 80% of Medtronic’s product portfolio in China. As a response, the company reduced its marketing, selling, administrative costs, and discounts. However, by Q2 2023-2024, the company said it would work through the impact due to China VBP by the end of FY 2024.

VBP has also negatively affected other foreign medtech companies, such as Alcon in China. Alcon’s exposure to China is about 5% of the company’s sales, predominantly in the surgical division. Alcon is likely to witness the impact of VBP in FY2024, ending in March 2025. Since the rollout of VBP takes place on a province-by-province basis, an abrupt fall in sales is highly unlikely in Alcon’s implants segment.d

The introduction of VBP has unfavorably impacted domestic medtech companies manufacturing intraocular lenses (IOLs) in China. Local player Airui Technology decreased its price of IOLs by as much as 65%.

Pressure on resource availability

National-level VBP tenders in China are usually finalized and awarded quickly. For instance, a temporary alliance of 22 (out of 23) provinces issued a competitive tender for liver function tests (LFTs) in November 2022. This tender’s result was published on December 30, 2022.

Compared to biopharma players, an idiosyncratic challenge for medtech companies is the need for a considerable amount of resources to be readily available when tenders occur. These resources must be strategically deployed to facilitate responses to tenders that are issued on short notice and awarded quickly and frequently. This is particularly challenging when bidding for regional or provincial VBP tenders that occur more frequently than national tenders, as many provinces in the country award contracts at different times.

Market exits

Although in the minority, some companies opted for more extreme measures. A few of them decided to withdraw from the Chinese market. For example, in March 2023, US-based Zimvie disclosed its intention to withdraw its spine business from the Chinese market following the challenges caused by the VBP roll-out.

Medtech companies have adapted amidst tough market conditions

Medtech companies faced pressure to lower prices, adjust their market and segment entry strategies, and optimize their workforce. These strategic changes aimed at mitigating the impact of lower revenue and profit margins on their existing product lines.

Staffing and organizational changes

Many medical device manufacturers that have encountered significant price reductions have responded by either reducing their workforce to manage expenses or by maintaining only managerial roles to focus on distribution in markets outside of VBP. Similarly, some medtech companies that witnessed moderate price cuts streamlined their field force to better align with the future servicing needs of their customers, including hospitals.

Other staffing and organizational changes include freezing hiring, outsourcing technical service jobs to third-party providers, and consolidating multiple product-focused teams into a single team.

Business model alterations

Some MNCs, including in-vitro diagnostics (IVD) companies, have changed their business model and leveraged partnerships with local medtech players to develop products. This strategic move will likely attenuate margin pressure by utilizing the local medtech partner’s cost advantage. Another advantage is that in-licenses or combined medical device development will likely counteract revenue stream losses.

IVD players are increasingly partnering with local medtech players to minimize the risk to their business model due to VBP, increase profit margins, expand their revenue streams, and continue to have sustainable relationships with hospitals. For example, Roche Diagnostics partnered with Fapon Biotech in November 2022 to improve its cost advantage by outsourcing its non-core reagent materials. Similarly, Danaher partnered with China Resources to outsource portfolios to national distributors or contract sales organizations in 2022.

VBP brought a mixed bag of consequences to other medtech industry stakeholders

Impact on the Chinese government spending

The Chinese government made considerable savings through the VBP program, thanks to curbing certain healthcare costs, and could potentially shift these savings to the sector’s other segments. The estimated annual savings based on the intended purchase volume was 10.9 billion yuan (US$1.6 billion) for coronary stents, 16 billion yuan (US$2.3 billion) for artificial hip and knee joints, and 26 billion yuan (USD$3.7 billion) for spinal and orthopedic products.

To put these numbers into perspective, the total savings from these three categories alone make up nearly 2.2% of China’s total public medical insurance spending of US$372.6 billion in 2021. These savings stem from VBP’s aim to reduce healthcare expenditures for the Chinese government by providing reasonably priced medical devices and implementing standardized pricing nationwide.

Impact on medtech distributors

One of the primary reasons for the high costs of medical devices for hospitals and patients in China is the unreasonably elevated profit margins of medtech distributors. The introduction of VBP has negatively impacted these margins.

At the same time, medtech companies are likely to pivot from a distributor-driven model to a direct distribution strategy to regain their own margins lost due to the increasing price pressures imposed by VBP. This transition is likely to limit the role of distributors to logistics functions, as seen in many other markets. At the same time, medtech companies will take ownership of commercial responsibilities and execute them through various channels.

The focus of VBP has expanded to specialized medical device categories

While the initial focus of VBP was on commoditized products with strong local alternatives, VBP has now ventured into medical device categories earlier perceived as not feasible for VBP tenders, such as electrophysiology for cardiology and immunoassays for IVD.

With VBP causing a radical change in commoditized products, medtech companies must now speed up registration and commercialization of products from specialized (non-commoditized) medical device categories that are in the pipeline. Pharmaceutical companies have already embraced this shift in strategy, while the change is gradually gaining steam among medtech players.

EOS Perspective

VBP is not a win-win strategy for all medtech stakeholders. Clear winners of VBP are patients and the Chinese healthcare system, while medtech companies, both domestic and foreign, and medtech distributors might get the shorter end of the stick.

VBP has made it difficult for all medtech companies operating in China to earn profits as high as in the past and has forced them to navigate in a more challenging environment.

At the same time, VBP is not entirely synonymous with foreign medtech players not succeeding in China. Chinese patients tend to prefer medical devices made by Western producers over those from domestic companies, provided that the imported devices are available at affordable prices. This preference is mainly due to the perception that foreign products are of higher quality than local options.

VBP will likely foster innovation in technology as companies will need to develop and design the best quality products to have an edge over their competition in tenders. Due to lowered prices, the bargaining power of medtech companies has decreased. Therefore, to differentiate themselves from their competition, they will need to prioritize innovation.

Although VBP has increased headwinds on the prices of medical devices, it has fueled strategic partnerships of MNCs with local medtech players. Local partnerships are likely a good move for all involved stakeholders, potentially also driving the overall growth of the medtech industry in China.

With China’s intention to pay 80% of its medtech expenditure through VBP by 2025, it will not be surprising to see VBP’s rollout in new categories of medical devices in the country.

The introduction of VBP will also have global repercussions, including a decline in small to medium medtech players’ interest in entering the Chinese market. However, the undeniable advantage of VBP’s introduction is that medtech companies will strive to innovate at lower costs, which will be a long-term driver for the market.

 

Recall Aftermath Who is Gaining Share in the Sleep Apnea Devices by EOS Intelligence
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Recall Aftermath: Who is Gaining Share in the Sleep Apnea Devices and Ventilators Market?

In recent years, the number of ventilator recalls has increased considerably, primarily due to product quality issues, software malfunction, and manufacturing defects. This affected manufacturers such as Philips, Medtronic, and Vyaire Medical, leading to brand damage, financial losses, and a shift in the market competition. Existing players and new entrants such as Getinge and Nihon Kohden are stepping in to fill the gap with innovative and non-invasive products. The recalls caused challenges for manufacturers and patients, highlighting the need for strong quality control and regulatory oversight.

Recalls of its sleep apnea devices and ventilators hit Philips the hardest

The medical device industry has recently experienced many product recalls, particularly in the ventilators segment, impacting major market players such as Philips, Medtronic, Baxter, GE Healthcare, Hamilton Medical, and Vyaire Medical.

Philips (Philips Respironics) faced a series of class I respiratory product recalls, including CPAP and BiPAP machines, and ventilators, due to health risks caused by the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown in the devices. Industry experts consider Philips’ sleep apnea devices and ventilator recalls among the most significant since 2021. As of January 2024, the company experienced a recall of over 15 million sleep apnea devices and ventilators, and reportedly hundreds of deaths. The recall seriously hurt the company’s reputation, weakened its position in the market, and caused significant financial problems.

The recalls led to a decline in the company’s share price by 60-70% in 2021, and it is still about 50% lower than its peak in April 2021 (US$ 53.45). Comparable sales of the connected care segment, including sleep apnea devices and ventilators, declined by about 19% in 2021 in comparison to 2020. This happened primarily due to sleep apnea devices and ventilators recalls, and the normalization of demand for hospital ventilators and monitoring systems following the COVID-19 surge. Recalls continued to drive down ventilator and sleep apnea device sales in 2022 and 2023.

The considerable impact on sleep apnea devices and ventilator sales resulted in a decline in Philip’s share in the sleep apnea device market, dropping to an estimated 20% between 2021-2023 from over 30% before the recall. The company also experienced a notable decline in market share in the ventilators market. Despite the decline in market share, Philips maintained its position as one of the leading players in both the sleep apnea devices and ventilators market.

However, in January 2024, Philips agreed to halt the sales of 19 sleep and respiratory products in the USA as a part of the consent decree with the US Department of Justice (DOJ). These products included hospital ventilation, certain home ventilation, sleep diagnostic devices, and portable and stationary oxygen concentrators. This affected the company’s brand image greatly and resulted in a further loss of market share in both ventilators and sleep apnea devices markets. Since the company will continue to sell consumables and accessories, including masks, it is anticipated to maintain a portion of its market share in both segments.

In April 2024, the company agreed to pay US$1.1 billion in legal settlement to resolve injury-related cases caused by sleep apnea devices and ventilators in the USA. Overall, sleep apnea device recalls cost the company over US$5 billion, likely including charges such as provisions for Philips Respironics-related litigation, consent decree, remediation costs, legal settlements, workforce restructuring, and quality remediation action. In addition, Philips cut 6,600 jobs by 2023 and is likely to reduce its workforce by a total of 10,000 by 2025.

Several companies bore the brunt of their own ventilator recall setbacks

Other prominent manufacturers such as Drägerwerk (Draeger), Medtronic, Vyaire Medical, Hamilton Medical, and Baxter also experienced various ventilator recalls due to manufacturing and quality defects. Although the FDA classified these recalls as serious, these companies did not face the same severe consequences as Philips, as these recalls did not result in major injuries.

All these manufacturers also witnessed a drop in ventilator sales largely due to the stabilization of demand for ventilators following the COVID-19 surge, with product recalls also contributing to the downturn.

In February 2024, Medtronic completely exited the ventilator market due to unprofitability. Similarly, in June 2024, Vyaire Medical filed for bankruptcy and was subsequently acquired in October 2024 by Zoll, an Asahi Kasei company engaged in the manufacturing of medical devices and related software solutions. This caused a profound impact on the ventilators market.

Market players are introducing products with advanced features to gain market share

The ventilator market encountered a radical shift in competition due to numerous product recalls. The suspension of sleep and respiratory product sales cost Philips its leading market position in sleep apnea devices and ventilators (except for certain home ventilators). It remains unclear when or if Philips will be able to resume sales of these devices. However, the company is unlikely to leave its presence in the sleep apnea devices and ventilators market entirely due to its commitment to service and supply of parts of ventilators in use, as well as its decision to continue the sale of consumables and accessories.

Existing market players such as Getinge, Hamilton Medical, Drägerwerk (Draeger), ResMed, and GE Healthcare, and newer entrants such as Nihon Kohden, are likely to fill in the gap left by Philips, Medtronic, and Vyaire Medical in the USA.

Market players such as Getinge, Drägerwerk (Draeger), and Nihon Kohden are focusing on introducing technologically advanced ventilators with features such as enhanced patient comfort, advanced monitoring capabilities, portability, and adaptive ventilation modes, to grab a slice of the pie. They are also increasingly focusing on expanding their portfolio of non-invasive ventilators with different interfaces, including face masks, nasal masks, helmets, and mouthpieces.

For instance, in October 2024, Nihon Kohden introduced a new ventilator system that combines invasive and non-invasive ventilation and high-flow oxygen therapy in one device, offering adaptability and eliminating the need to switch between machines. It also features a customizable, app-based touchscreen interface with advanced monitoring capabilities. Similarly, in January 2024, Getinge introduced ‘Servo-air Lite’, a non-invasive ventilator with high-flow therapy that offers optimal respiratory support, enhanced patient comfort, and ease of use for clinicians.

ResMed, a leading player in both the sleep apnea devices and ventilators market, is estimated to have grabbed over 10% of Philips’ market share in the sleep apnea devices market in the USA. ResMed witnessed a substantial increase in demand for its sleep and respiratory care products, including sleep apnea devices and ventilators, for various reasons, including Philips’ product recalls. The demand for its sleep and respiratory care products in the USA, Canada, and Latin America increased by 16%, 25%, and 10% in 2022, 2023, and 2024, respectively.

Companies engaging in sleep apnea devices and ventilator rentals, sales, and distribution, such as Trace Medical, also started adding brands from different companies to their product mix to meet the demand for these devices.

Patients experience delays in treatment and struggle to switch to other brands

Philips’ foam degradation issue has exposed patients to severe health risks, leading to respiratory complications and even cancer. Recalls of many ventilators and sleep apnea devices have left hospitals struggling to replace them, causing delays in patient treatment.

Patients relying on a specific brand faced reduced treatment options. Many patients found it difficult to switch to other brands due to cost and differences in machine settings or interfaces. With Philips halting sales of various sleep apnea devices and ventilators, patients have no choice but to switch to other brands.

The recall of various products from different companies has created significant demand and supply chain pressures for existing companies. These pressures will likely drive up ventilator and sleep apnea device prices, further burdening patients.

EOS Perspective

Product recalls in the sleep apnea devices and ventilator segment brought quality issues to the limelight. This highlights the need for stronger quality control processes and technologically advanced sleep apnea devices and ventilators incorporating virtual monitoring and AI integration, which can help detect defects earlier.

While the FDA received complaints about Philips’ degradation of the sound abatement foam in the sleep apnea devices and ventilators before the recall initiation, decisive action to force correction was not taken immediately. Also, despite knowing that Philips had been aware of the foam degradation issue for many years, the FDA did not take stronger enforcement measures against the company sooner. This situation highlights the importance of assessing and enhancing the FDA’s oversight process to ensure timely response to medical device complaints.

Philips suffered lasting brand damage due to the recalls. Although the company is trying to regain shareholder and consumer trust after settling US claims for an amount much lower than anticipated (US$2-5 billion) by analysts and the public, it faces a long road ahead.

Regarding market competition, ResMed is estimated to continue to lead and strengthen its dominant position in the sleep apnea devices market. The exit of well-established players from the ventilator market will intensify competition among existing companies and new entrants seeking to capture market share. However, it will be a gradual process as customers slowly transition from existing products to new brand ones. On top of that, the new entrants are likely to face stricter regulatory norms and product approval processes aimed at reducing the number of product recalls and enhancing patients’ safety.

Continuous Glucose Monitoring Devices Overcoming Barriers in LMICs by EOS Intelligence
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Continuous Glucose Monitoring Devices: Overcoming Barriers in LMICs

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The rising prevalence of diabetes in low- and middle-income countries (LMICs) underscores the need for advanced diabetes management solutions. Continuous glucose monitoring (CGM) systems are highly valuable but face limited adoption in LMICs due to high costs, infrastructure inadequacies, issues with accessibility, affordability, and limited insurance coverage. On the other hand, these countries offer opportunities to develop scalable CGM solutions tailored to the needs of LMICs and to penetrate these markets.

Over the past decade, the global prevalence of diabetes has surged, with a notable concentration in LMICs, particularly across India, China, the Middle East, and Southeast Asia. The LMICs now host the majority of nearly 540 million people living with diabetes.

Read our related Perspective:
  The Future of Diabetes Care: Key Innovations in Continuous Glucose Monitoring

Effectively managing diabetes in LMICs is crucial and requires advanced solutions for precise and consistent monitoring of blood glucose levels. However, the CGM adoption rate remains low in developing and underdeveloped countries. As LMICs seek to incorporate these advanced solutions into their healthcare systems, they face numerous challenges.

Why is CGM adoption and acceptance lagging in emerging economies?

CGM systems are a revolutionary diabetes management tool. Despite the critical role it plays in advancing diabetes care, the high cost, uneven distribution, and inadequate infrastructure severely restrict their access, particularly in LMICs.

High costs hinder CGM adoption

A substantial barrier to adopting CGM systems in LMICs is their prohibitive cost. The average cost of CGM systems can be between US$120 and US$300 per month, placing them predominantly within the realm of those who can pay out of pocket.

For instance, the Dexcom G6 system, which includes sensors and transmitters, costs approximately US$300-US$350 per month. This price makes it out of reach for most individuals in LMICs, where average incomes are significantly lower.

As highlighted by a 2023 report by FIND, while an estimated 55,000 individuals live with type 1 diabetes in Kenya and South Africa, only about 10% are currently utilizing CGM systems. Many LMICs do not have subsidized healthcare or insurance coverage systems, which makes the situation worse. Consequently, the high cost of these devices creates a significant affordability gap, further entrenching healthcare inequalities.

In countries such as Iran, Lebanon, and Pakistan, the absence of governmental support and the unavailability of CGM technology highlight a broader issue. In many of these countries, private sector’s efforts are underway to bring diabetes-related innovations to the market, but the high costs associated with these technologies are a major obstacle.

Continuous Glucose Monitoring Devices Overcoming Barriers in LMICs by EOS Intelligence

Continuous Glucose Monitoring Devices Overcoming Barriers in LMICs by EOS Intelligence

Limited availability of CGM systems impedes diabetes management

In addition to high costs, the availability of CGM systems is another pressing issue. In many LMICs, including countries such as Turkey, Uganda, and Malawi, CGM solutions are either scarce or completely unavailable. This lack of availability limits access to advanced diabetes management technologies, crucial to improving health outcomes.

Similarly, In Egypt, where diabetes prevalence is notably high at 18.4% of the total adult population, the situation is equally challenging. The country lacks access to the latest innovations, while healthcare professionals need training in using CGM.

In LMICs, inadequate infrastructure poses a significant barrier to the widespread adoption of CGM devices. These tools rely on consistent power and internet connectivity to function optimally. However, frequent power outages, a common issue in many LMICs, can disrupt the continuous monitoring process, leading to data gaps and potential risks for patients who depend on CGM alerts for their health management.

Moreover, limited internet access, especially in rural areas, can severely impact the real-time data-sharing capabilities of CGM systems. This is particularly evident in African nations such as Niger, Nigeria, Chad, and South Africa, where infrastructure challenges are more pronounced.

For instance, South Sudan, with one of the lowest Infrastructure Index ratings in the region, faces critical limitations in accessing reliable power and internet services. These infrastructural deficits highlight the urgent need for targeted investments and solutions to bridge the infrastructure gap and enhance diabetes care in these regions.

Insurance coverage gaps stifle CGM access

The accessibility of diabetes management technologies, particularly CGM systems, is significantly hindered by inadequate insurance coverage and reimbursement policies.

This gap is especially noticeable in Asian LMICs such as the Philippines, where the healthcare system often does not include comprehensive coverage for these critical tools, placing a substantial financial burden on patients. In Vietnam, the National Health Insurance (NHI) scheme covers essential treatments such as oral antidiabetic medicines and insulin. However, it does not extend to glucose monitoring products. This lack of coverage forces patients to pay out-of-pocket for CGM, making it challenging for many to access.

What lies ahead for CGM in LMICs?

As diabetes increasingly poses a global health challenge, LMICs are ramping up efforts to enhance diabetes care. Progressive government policies, innovative programs, and manufacturers expanding reach across LMICs support this shift.

Government policies facilitating CGM integration with diabetes management

In many LMICs, government agencies and organizations are slowly working towards integrating advanced diabetes management solutions into healthcare infrastructure. This is visible through various initiatives undertaken that highlight the growing importance of CGM technologies.

For instance, the Chinese government demonstrated its commitment to standardizing CGM practices by issuing the Chinese Clinical Guidelines for CGM in 2009, with subsequent updates in 2012 and 2017. These guidelines establish clear protocols for device operation, data interpretation, and patient management. The guidelines also support training of healthcare professionals, improving quality assurance, and facilitating CGM integration into the national healthcare system. In several Chinese hospitals, the implantation, operation, and daily management of CGM systems are already handled by trained nurses and head nurses within the endocrinology departments.

India has also made significant strides, particularly in 2021, with the establishment of guidelines for optimizing diabetes management through CGM. The Indian government has introduced several initiatives to foster digital health advancements, including the National Digital Health Mission.

Advancing diabetes care, the ‘Access to CGMs for Equity in Diabetes Management’ initiative, a collaboration between the International Diabetes Federation and FIND, aims to integrate CGM solutions into African healthcare systems. This initiative seeks to double the number of CGM users in Kenya and South Africa by 2025, potentially impacting 21.5 million individuals with type 2 diabetes and 213,000 individuals with type 1 diabetes in Southern and Eastern Africa.

Government support for such initiatives is pivotal, as it can significantly enhance market access and ensure that CGM technologies reach underserved populations. These collaborative efforts and governmental actions are likely to drive extensive market reach and foster a more effective response to the global diabetes epidemic.

Manufacturers driving adoption by introducing affordable CGM solutions

Customizing CGM to meet the needs of LMICs offers manufacturers an opportunity to expand device access and adoption within these markets.

Medtronic is taking the lead by customizing its CGM solutions to reduce production and distribution costs specifically for LMIC markets. By optimizing its technology to be more cost-effective, Medtronic aims to increase the accessibility of its CGM systems in regions where diabetes management tools are often limited.

Similarly, emerging startups such as Diabetes Cloud (Aidex) and Meiqi are making strides in expanding CGM availability in South Africa. These companies are introducing more affordable CGM devices designed to meet the needs of local populations, thereby broadening access to critical diabetes management tools.

Manufacturers’ strategic initiatives accelerating CGM access

Manufacturers recognize the urgent need for effective diabetes care solutions in LMICs and the significant growth potential in the underpenetrated CGM market. To capitalize on this opportunity, they are focusing on expanding their product portfolios in these regions.

Additionally, Dexcom is planning to introduce the Dexcom ONE+ across the Middle East and Africa in the near future. This advanced CGM system can be worn in three locations on the body, enhancing comfort and usability. By accommodating individual preferences and needs, Dexcom aims to improve user experience. This strategic launch underscores Dexcom’s commitment to broadening its market presence and advancing its footprint in emerging regions.

Manufacturers are also supporting research initiatives across Africa. For instance, Abbott has donated its FreeStyle Libre Pro CGM devices for research in Uganda. The research’s favorable reviews and positive outcomes reflect a notable interest in and demand for sophisticated diabetes management technologies in these regions.

Moreover, strategic partnerships amongst manufacturers highlight a broader commitment to enhance the accessibility of CGM systems by leveraging combined expertise and innovative technologies. In January 2024, Trinity Biotech and Bayer partnered to introduce a CGM biosensor device in China and India. The collaboration is poised to leverage Bayer’s expertise and Trinity Biotech’s technological advancements to enhance diabetes care in these rapidly growing markets.

These strategic initiatives will likely impact the CGM market positively in emerging economies. Increased availability of CGM systems in LMICs will to drive higher adoption of glucose monitoring technologies and stimulate further investment in diabetes care.

EOS Perspective

Despite the challenges, the CGM market in LMICs presents a compelling growth opportunity for manufacturers. With diabetes cases on the rise, there is an increasing demand for CGM systems that offer real-time glucose data to improve patient outcomes. This demand, combined with progressive government initiatives and heightened awareness of diabetes care, creates a fertile ground for market development.

Manufacturers have a significant opportunity to capitalize on this emerging market by addressing the distinct regional needs. One of the primary challenges is the high cost of CGM systems, which limits their adoption. Hence, there’s a need to develop more affordable, scalable solutions tailored to the economic realities of LMICs. By focusing on local manufacturing and distribution strategies, healthcare companies can provide cost-effective solutions that meet the needs of underserved populations.

The shortage of trained healthcare professionals further complicates the widespread use of CGM. Manufacturers can address this by implementing comprehensive training programs for healthcare providers, equipping them with the skills needed to support patients in using CGM systems effectively.

This investment could foster greater acceptance of the technology. Non-profit organizations such as Medtronic LABS have made significant contributions, impacting over 1 million individuals with diabetes and training more than 3,000 healthcare workers across Kenya, Tanzania, Rwanda, Ghana, Sierra Leone, and India since 2013. The organization educates on diabetes management, equipping healthcare workers with skills to utilize CGM systems effectively. By enhancing the knowledge and capabilities of these health workers, Medtronic LABS ensures that communities receive better support in managing diabetes, ultimately leading to improved patient outcomes and CGM adoption.

Strategic partnerships with local entities, governments, NGOs, and international organizations can further enhance market reach. Collaborations can help manufacturers navigate the complexities of the market, overcome logistical challenges, and strengthen distribution networks. Partnering with organizations with established connections and regional expertise can facilitate more effective market entry and expansion.

For instance, organizations such as FIND, the International Diabetes Federation, and the Helmsley Charitable Trust are working to create business opportunities for CGM manufacturers. They specifically target manufacturers whose CGM products are unavailable in markets such as Kenya and South Africa to improve access in these regions.

Further, programs such as the Access to CGMs for Equity in Diabetes Management and national health guidelines in countries such as China and India are laying the groundwork for improved diabetes care. By integrating CGM solutions into national healthcare plans and providing necessary training to healthcare professionals, these initiatives aim to establish a sustainable model for diabetes management. Other developing regions should replicate this approach.

In the future, sustained emphasis on innovation, affordability, and strategic collaborations are poised to transform the CGM landscape in LMICs, ensuring that these advancements are more accessible to all. As this gains traction, access to advanced diabetes management technologies is expected to improve, offering a promising outlook for millions of individuals living with diabetes.

The Future of Diabetes Care Key Innovations in the Continuous Glucose Monitoring by EOS Intelligence
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The Future of Diabetes Care: Key Innovations in the Continuous Glucose Monitoring

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Continuous glucose monitors (CGM) represent a disruptive innovation that has transformed the diabetes management landscape. In recent years, the CGM market has seen remarkable growth, becoming an integral part of diabetes care with the potential to supplement or even replace traditional blood glucose monitoring methods. Opportunities in the CGM sector are endless, as the market remains under-penetrated. Market leaders such as Dexcom and Abbott leverage this potential to establish their foothold while continuously innovating their offerings.

CGMs provide accurate readings that can be used for insulin dosing decisions, eliminating the need for traditional fingerstick tests. The devices offer high ease of use and convenience, with many integrating seamlessly with smart devices. Additionally, the increasing use of AI and machine learning has led to the development of algorithms that customize health-related data for users.

Read our related Perspective:
Continuous Glucose Monitoring Devices: Overcoming Barriers in LMICs 

As we expect the next generation of CGMs, revolutionary advancements promise to transform diabetes management with these devices. The ongoing innovations aim to enhance precision and accuracy, offer predictive analytics, provide continuous monitoring beyond glucose, and enable the integration of other health parameters into the CGMs.

Precision and accuracy

Building on the success of current CGMs, the next-generation devices are likely to offer unprecedented precision and accuracy. Upcoming CGMs will use next-generation sensor technologies, including advanced nanomaterials and multi-enzymatic systems, to detect glucose levels with higher sensitivity and specificity.

Sophisticated AI and machine learning will support the prediction of glucose trends and real-time data processing to increase accuracy. To further improve accuracy across diverse populations and glucose ranges, emerging CGMs will leverage personalized calibration algorithms that adapt to individual metabolic variations.

Integration with broader health ecosystems and cloud-based analytics will be industry players’ key focus, ensuring improvement through real-world data feedback. Clinical validation and regulatory supervision will ascertain that CGMs adhere to all safety and health standards.

Overall, players will aim to provide reliable glucose data to empower users with actionable insights for effective diabetes management. Leading industry players, such as Abbott and Dexcom, prioritize data accuracy and ensure that their devices track glucose trends accurately with minimal error. For instance, Abbott’s Freestyle Libre uses advanced sensor technology to maintain accurate glucose readings over a 14-day wear period. On the other hand, Dexcom’s G7 utilizes advanced algorithms to continuously calibrate and refine glucose readings based on real-time data and historical trends, eliminating the need for fingerstick calibrations. Both devices provide real-time alerts on glucose levels to help users take action.

The Future of Diabetes Care Key Innovations in the Continuous Glucose Monitoring Market by EOS Intelligence

The Future of Diabetes Care Key Innovations in the Continuous Glucose Monitoring Market by EOS Intelligence

Integration with smart devices

Anticipated advancements include seamless connection with smartphones, smartwatches, and other wearable devices for uninterrupted glucose monitoring. Such integration will not only elevate user experience but also allow real-time updates, such as alerts for glucose fluctuations, viewing historical trends, and sharing data with healthcare providers, thus facilitating proactive management of user’s condition.

In advanced CGMs linked with mobile applications, predictive algorithms will be able to foresee glucose levels, offering tailored suggestions and insights based on individual patterns. Recently, in June 2024, Dexcom enabled a direct-to-watch feature, allowing its G7 users to monitor real-time blood sugar data from an Apple watch, regardless of whether they are carrying their phone.

In the future, this synergy between CGMs and smart devices will not only improve the accuracy and accessibility of glucose monitoring but also empower users to make quick, informed decisions regarding their health and improve overall well-being.

Predictive analytics

The real-time and historical analysis of glucose data equips CGMs to predict blood glucose levels several hours ahead, notifying users about impending hypoglycemia or hyperglycemia before they occur. This proactive approach allows for timely interventions, such as regulating insulin dosage or dietary modifications to maintain optimal glucose level.

Predictive analytics integrated with CGMs is revolutionizing the diabetes care market, and key market players are increasingly prioritizing its incorporation into their devices to gain a competitive edge. Roche is gearing up to compete with Abbott and Dexcom with its Accu-Chek Smartguide, which will soon be launched in the European market following its approval in July 2024. The company is betting on robust predictive analytics to differentiate its product from competitors. The device aims to enhance glucose monitoring by employing predictive AI to forecast glucose levels up to two hours ahead, identify the risk of low blood glucose within 30 minutes, and detect nocturnal hypoglycemia.

Over the years, as predictive algorithms improve, CGMs will become increasingly suitable for mitigating risks, reducing glucose spikes in patients, and equipping patients to manage diabetes better and improve quality of life. In the future, enhanced personalization and seamless integration of CGMs with broader health ecosystems can transform diabetes management by providing more precise and accessible real-time insights and recommendations tailored to individual metabolic responses, lifestyle patterns, and environmental influences. It is likely that the next generation of CGMs will also predict and adapt to potential disruptions caused by stress, illness, or diet changes.

Product diversification

The evolution of CGMs is expected to go beyond glucose monitoring, embracing a holistic approach focused on personalized and preventive healthcare. Companies are conducting research to integrate CGM readings with health metrics such as ketone levels, hydration status, and early indicators of other health conditions.

Industry players are also developing targeted solutions for various customer segments. For instance, they are focusing on pediatric and geriatric populations by creating CGMs customized to meet these segments’ unique physiological and lifestyle needs. Another area of focus is developing CGMs to support gestational diabetes, helping pregnant women better manage maternal and fetal health.

Currently, companies such as Medtronic and Abbott have partnered to integrate Medtronic’s automated insulin delivery systems with Abbott’s CGM to create closed-loop systems. This system automatically adjusts insulin delivery based on real-time glucose readings, which helps patients improve glycemic index.

EOS Perspective

The next generation of CGMs is poised to help manage chronic diseases beyond diabetes. With key players such as Dexcom and Abbott maneuvering the industry, the future promises unprecedented advancements through the fusion of technology and healthcare. The impact on patient outcomes and the broader healthcare landscape will lead to a more personalized, proactive, and interconnected approach to care.

There is a significant opportunity for industry players across major markets such as the USA, where CGM adoption remains low, with about 90% of people with diabetes still not using these devices. To penetrate key markets including the USA and Europe, CGM companies need to develop effective go-to-market strategies to increase adoption rates. They should focus on patient segmentation, exploring multiple distribution channels, and forming alliances with key stakeholders.

Patient segmentation

Sales strategy and product offerings could be tailored around specific patient groups, i.e., Type 1 versus Type 2 diabetes or various income levels. For example, Abbott has strategically developed different CGMs to target varied patient groups. Its FreeStyle Libre is designed for users with Type 2 diabetes, while Lingo, a consumer wearable, is ideal for consumers trying to improve overall health and well-being.

Diversifying distribution channels

The CGM players must diversify their distribution channels, particularly by utilizing digital marketing and social media to reach a broader audience and increase awareness. Digital marketing can also serve as a crucial tool for connecting with diabetes online communities and educating patients.

Abbott and Dexcom are looking to explore new distribution avenues. In H2 2024, both companies rolled out their competing products (Abbott’s Lingo and Dexcom’s Stelo) over-the-counter in the USA, selling through their websites, with an aim to expand the reach and enhance market penetration. Expanding sales through the online channel also makes it simpler for consumers to purchase CGMs directly from producers simpler for consumers.

Partnerships

Forging strong alliances with key stakeholders can create improved and integrated diabetes management systems. Strategic partnerships with technology companies can help CGM players enhance products, expand market reach, and improve patient outcomes. On the other hand, partnering with insulin pump and insulin pen companies can streamline diabetes care by combining real-time glucose monitoring with automated insulin delivery.

Both Abbott and Dexcom have partnered with Tandem Diabetes Care to integrate FreeStyle Libre CGM and G6 CGM, respectively, with Tandem insulin pumps. These systems use real-time glucose readings to automatically adjust insulin dosing, improving diabetes management.

The opportunities in the CGM market are vast and continually expanding. As technology advances, CGMs will become more accurate, user-friendly, and integrated with other health management tools. Moreover, with the growing prevalence of diabetes worldwide, the demand for efficient and effective glucose monitoring solutions will only grow in the future, making the CGM market an attractive segment for continued investment and development.

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