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Metal’s New Rival Why PEEK Knee Implants Have Big Players on Edge by EOS Intelligence
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Metal’s New Rival: Why PEEK Knee Implants Have Big Players on Edge

Healthcare providers performed around 3.6 million knee replacement procedures globally in 2023, according to LSI’s Global Procedure Volumes Database, which covers 37 countries. This substantial volume highlights the massive clinical demand and shows a strong opportunity to innovate beyond traditional metal-on-polymer implant technologies. As more people age and joint problems from lifestyle become more common, the orthopedic field is turning to new, improved solutions that better meet what patients and healthcare systems need today. Will all-polymer implant technology drive the next breakthrough in total knee arthroplasty (TKA)?

Breaking the mold: Is metal-on-polymer TKA still the best we can do?

Healthcare community widely regards metal-on-polymer implants as the gold standard in TKA as these implants effectively handle the knee joint’s high load-bearing demands. Compared to all-polymer alternatives, metal-on-polymer designs provide greater mechanical strength, enabling them to withstand daily use and maintain long-term joint stability. According to the American Academy of Orthopaedic Surgeons, ~90% of total knee replacements continue to function effectively 15 years after surgery.

Maxx Orthopedics and Invibio (a Victrex PLC company) are set out to challenge this conventional view with the Freedom Total Knee System using PEEK-OPTIMA femoral component (PEEK standing for Polyether Ether Ketone).

In 2025, a research study (Cowie et al., Bioengineering 2025, 12(3):261) reported that PEEK-OPTIMA polymer-on-UHMWPE (Ultra-High-Molecular-Weight Polyethylene) knee implants showed UHMWPE wear comparable to metal-on-UHMWPE. Researchers based this conclusion on their evaluation of PEEK-OPTIMA and cobalt-chrome femoral components paired with polyethylene lower knee component in a knee simulator mimicking real walking and movement. Findings from this study address the key concern that all-polymer knee implants might wear out too fast.

Another research paper (ORS 2025 Annual Meeting Paper No.275) concluded that the wear behavior (including wear factor, rate, and volume) of PEEK-on-UHMWPE was comparable to cobalt-chrome-on-UHMWPE and met ASTM (Advancing Standards Transforming Markets) wear standards.

Overall, the collective evidence demonstrates that all-polymer PEEK implants could match the wear performance of metal-on-UHMWPE systems over millions of cycles, alleviating concerns about rapid degradation. Further research and clinical trials must still confirm real-world durability.

Beyond metal: could PEEK be the future of knee implants?

PEEK’s practical advantages are vast and include faster manufacturing, onsite customization, lower allergy risk, clearer imaging, and better bone compatibility. This could address longstanding issues with metal-based knee implants and reshape the TKA landscape, potentially becoming the new benchmark for knee implant materials.

Faster, lower-cost production

Studies show that manufacturers can injection-mold PEEK components in about three minutes and can have them ready for use within a week, in contrast to custom cobalt-chrome pieces, which often require months to finish. This rapid production cuts manufacturing costs and reduces hospital inventory requirements, making implants more affordable and improving access for patients facing long waitlists. Surgical centers can also benefit from greater flexibility to adjust designs quickly.

If PEEK adoption grows, patients, healthcare providers, payers, and PEEK producers will surely benefit. However, traditional metal-implant makers would face major disruption, forcing them to adapt or partner with polymer experts to stay relevant.

On-site 3D printing and customization

PEEK’s compatibility with high-temperature 3D printing allows hospitals to create patient-specific implants on demand. Such implants can fit the anatomy more precisely, potentially improving recovery and function. On-site implant printing also eliminates shipping delays and the need for large warehouses for hospitals and solution providers.

However, acquiring industrial-grade PEEK printers and training staff require significant investment, which will likely act as a factor slowing adoption. On the supply side, implant makers will be challenged with additive manufacturing (which they will likely have to bring in-house) and the need to forge partnerships with 3D-printing players. All players, whether established or start-ups, will have to navigate strict and demanding regulatory approval before hospitals adopt these materials.

Minimizing metal-related risks

As PEEK does not release metal ions into surrounding tissue, it eliminates the risks of irritation or hypersensitivity that affect up to 25% of patients with implants. This is a considerable benefit for patients with metal allergies. Hospitals may see fewer allergy-related follow-ups, fewer revision surgeries, and lower long-term costs. This is again challenging metal-implant makers, who will have to address this shift by developing hypoallergenic alternatives or risk losing market share as patients and healthcare professionals move to polymer-based options.

Enhanced imaging transparency

PEEK’s radiolucency produces clear standard imaging (X-rays, CT scans, and MRIs) without metal artifacts, enabling earlier detection of misalignment, loosening, or infection. This means a reduced need for specialized scans, lowers costs and radiation exposure. Change in implant materials will affect radiology solutions vendors, as they may have to adjust protocols to optimize scans for polymer implants.

Bone-friendly mechanics

PEEK is isoelastic and mimics the mechanical properties of natural bone, spreading pressure more naturally through the bone around it. This reduces stress shielding that can cause bone loss around stiffer metal implants. Patients may experience fewer long-term complications and easier revision procedures if needed.

Those bone-friendly mechanics offer a great benefit for several hospitals and payers, thanks to lower costs of managing bone-loss issues. Implant developers must consider whether newer low-modulus metal alloys can match PEEK’s bone-preserving properties at all, as polymer-based solutions can redefine TKA standards.

Considering these benefits, PEEK presents a compelling alternative to metal-based knee implants. Each benefit comes with practical considerations, including upfront equipment costs, regulatory challenges, and strategic shifts for established manufacturers. As clinical trials progress and real-world data accumulate, stakeholders across orthopedics will need to monitor the impact PEEK will have on reshaping the implant market.

Is all-polymer TKA entering the home stretch?

FDA Investigational Device Exemption (IDE) approval, global feasibility trials, and dedicated research funding signal that PEEK-based knee implants are on the verge of commercialization.

FDA approval accelerates clinical testing

In September 2024, the FDA granted an IDA for the Freedom Total Knee System using Invibio’s PEEK-OPTIMA femoral component in partnership with Maxx Orthopedics. This authorization clears the way for systematic safety and efficacy data collection under controlled conditions. IDA gives legitimacy to the solution, and hospitals and surgeons can begin preparing for a polymer-based alternative entering mainstream in the future.

Decades of collaboration accompany ready manufacturing

Invibio recognized PEEK’s medical potential in the early 2000s, and by 2024, over 15 million PEEK-OPTIMA devices were implanted worldwide. Since 2012, Invibio and Maxx Orthopedics have co-developed an all-PEEK femoral component paired with a UHMWPE tibial insert. Invibio can probably consider scaling its existing PEEK production facilities (although it already maintains large-scale PEEK-OPTIMA manufacturing facilities). Similarly, other PEEK producers might follow suit to offer reliable availability and cost predictability once approvals are in place. Incumbent metal-implant manufacturers may need to forge similar partnerships or invest in polymer capabilities to avoid losing market share.

Early trial results build confidence

Feasibility studies in India, Belgium, and Italy, ongoing since 2021, have shown no device-related adverse events with the PEEK-OPTIMA component in small patient cohorts. This suggests strong biocompatibility and mechanical resilience. Healthcare providers will continue watching further study results and might alter their component purchasing decisions. Established TKA suppliers will face renewed pressure to rethink their own implant solutions if studies show continued positive results.

India leads the commercial charge

Maxx Orthopedics plans to file for regulatory approval in India with a 2025 commercial launch target. India’s large patient base and growing demand for joint replacements create an ideal environment for initial commercialization. For players, early market entry here could build clinical experience and generate real-world data to support subsequent approvals in Europe and the USA.

Academic funding fuels long-term validation

In 2023, Invibio and academic partners, including the University of Leeds, secured a £1.7 million UK EPSRC grant for TKA patient outcome research. This funding will support ongoing research into wear patterns, revision rates, and other outcomes. Robust academic data will likely affect clinical decisions and payer coverage, while boosting evidence for PEEK implant solutions makers.

The momentum around all-polymer TKA continues to grow, thanks to regulatory milestones, scientific studies, strategic manufacturing alliances, and academic validation.

EOS Perspective

The ongoing developments from Invibio and Maxx Orthopedics mark a potentially transformative era in TKA, moving beyond conventional metal-on-polymer implants. However, all-polymer implants have yet to reach a point where they can directly compete with metal implants, which have demonstrated reliable durability over five decades. Although PEEK shows promise as a metal-free alternative, additional real-world studies are needed to validate its long-term effectiveness.

Nevertheless, the emergence of all-polymer knee implants will likely prompt a counter-response from incumbent players, further accelerating innovation in the field. The stakes are high, as LSI’s Global Market Analysis & Projections database shows that Zimmer Biomet, Stryker, and DePuy Synthes still dominated the TKA market in 2023, collectively accounting for about 80% of the overall market.

Zimmer Biomet, for instance, in March 2025 secured FDA clearance of Persona Revision SoluTion Femur, a revision knee implant component made of Tivanium (Ti-6Al-4V) alloy, offering an alternative for patients with metal sensitivities. This development reflects their strategic effort to address concerns around metal allergies and to strengthen their trusted metal implant offerings to stay competitive.

Most established market players have the know-how and infrastructure to drive R&D in all-polymer implants for TKA, given their experience with implant polymer technologies and the inclusion of PEEK-based implants within their broader portfolios and other applications. For instance, both Zimmer Biomet and Stryker successfully commercialized customized solutions for PEEK-based cranial implants. Their existing R&D pipelines and clinics networks position them to act fast. With this, they might be able to considerably stifle disruption from startups or niche players. The challenge for these large companies will likely be the execution.

Smaller competitors often innovate faster, while established players can be slowed by internal processes or reliance on existing metal implant revenue streams and supply chains. How they handle this transition will shape the future of knee replacements, either reinforcing their market leadership or allowing newer companies to gain a foothold.

Metaverse Meets Medicine: Spatial Computing's Game-Changing Potential by EOS Intelligence
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Metaverse Meets Medicine: Spatial Computing’s Game-Changing Potential

Spatial computing, sometimes called the metaverse, will revolutionize healthcare by seamlessly merging the digital and physical worlds. Leveraging technologies such as augmented reality (AR) and virtual reality (VR), it offers exciting transformative possibilities, from enhanced surgical training and improved diagnostics to personalized treatment plans and remote care solutions. As the technology matures, it presents both opportunities and challenges for technology solution providers.

AR, VR, and Extended Reality solutions offer an immersive healthcare experience

Spatial computing uses technologies such as virtual, augmented, and mixed reality to interact with digital information in 3D space, fundamentally changing how healthcare is delivered. It is gradually finding applications across the industry. For example, surgeons can practice complex procedures in realistic, risk-free VR environments, improving their skills and preparedness. Doctors can visualize medical images in 3D for more accurate diagnoses.

Patients also become more engaged in their care through interactive tools that explain their conditions and treatment options. Holographic images expand the scope of remote care, providing patients with a stronger sense of connection to their doctors. VR can even be used for immersive therapy sessions, helping patients manage anxiety or PTSD in a safe, controlled setting.

The potential applications are vast. AR solutions can overlay medical imaging data (CT scans, MRIs) onto a patient’s body for improved diagnosis. Virtual patient models can simulate treatment scenarios for optimized treatment planning. Tools such as EnVisio provide continuous 3D surgical awareness, enabling surgeons to plan approaches from any angle for increased precision.

Virtual clinics promise to reshape care delivery models, while live surgeries can also benefit from this technology. Within six months of Apple Vision Pro’s launch in February 2024, surgeons at UC San Diego Health successfully performed minimally invasive operations using Apple Vision Pro headsets, which offered significant cost advantages over traditional surgical monitoring systems.

Surgery-specific applications and AI integration drive innovation

The field is attracting significant innovation. Companies such as Medivis and Osso VR are pioneering the development of spatial computing solutions for surgical planning and medical training. There are several solutions (such as Medivis’s Surgical AR and Surgical Theater) available that use real-time camera images to project 3D models in a surgeon’s headset for both surgical planning and rehearsal before the procedure. Other solutions include AR and VR to help surgeons and health professionals in their medical training.

Since the launch of Apple Vision Pro, several large solution providers and startups started developing software solutions that leverage Apple’s advanced capabilities, specifically for applications in the healthcare sector. Siemens Healthineers developed its ‘Cinematic Reality’ app in March 2024, which offers advanced imaging and visualization solutions, including 3D reconstruction and VR tools for surgical planning.

Several large surgical players are also developing solutions that help optimize the processes, making surgeries more efficient and cost-effective. For example, Stryker‘s Mako SmartRobotics app for Apple Vision Pro (launched in March 2024) enables surgeons to review and visualize patients’ surgical plans. Zeiss‘s Surgery Optimizer (launched in April 2024), an AI-powered app for cataract surgery preparation using the Artevo 850 microscope and Apple Vision Pro, is another example of this trend.

Epic‘s Spatial Computing Concept for Apple Vision Pro aims to streamline charting, lab review, and secure communication for physicians. This also enables real-time updating of patient information on the hospital’s EHR systems. Integration of AI with spatial computing is a likely next step, promising optimized procedures with spatial computing overlays. AI is also likely to aid in better processing and analysis of spatial data.

Growth in spatial computing is also likely to bring in further investments from venture capital and existing healthcare giants. Spatial computing startup XRHealth raised US$6 million in funding in January 2024, while Medivis raised US$20 million in Series A funding that would enable it to develop advanced surgical solutions that integrate AR technology.

Apple Vision Pro is a key enabler for startups to develop healthcare solutions

The competitive landscape is dynamic, with various players vying for market share. Established medical technology giants such as Siemens Healthineers, GE Healthcare, and Philips are integrating spatial computing into their existing platforms. Meanwhile, startups such as Osso VR, Surgical Theater, and Medivis are disrupting the market with innovative solutions.

Software and hardware specialists, including Microsoft (HoloLens) and Apple (Vision Pro), are crucial enablers. While Apple Vision Pro is currently prominent, other hardware and platform developers are likely to emerge.

We can anticipate mergers and acquisitions as larger companies acquire promising startups. There is an increasing focus on user experience and integration with existing healthcare systems. Apple’s launch of the Vision Pro has spurred interest in spatial computing, with startups developing for the mixed reality environment offered by AR/VR headsets such as the Vision Pro and Meta Quest.

Dependence on limited hardware ecosystems is a key challenge for developers

Solution developers face several key challenges. Dependence on hardware companies, including Apple and Meta, creates vulnerabilities. These companies have their own ecosystems for developing supported applications that limit the possibilities and options for startups.

Data privacy and security, particularly compliance with regulations such as HIPAA and GDPR, are paramount, especially as AI integration becomes more prevalent. Compatibility with legacy systems, including imaging systems and EHRs, is also essential to be successful.

Maintaining cost-effectiveness is crucial, as the high prices of devices like the Vision Pro and HoloLens pose a barrier. Funding, particularly for startups, remains a challenge, although recent successful funding rounds offer encouragement.

EOS Perspective

The spatial computing market in healthcare is poised for substantial growth, driven by the increasing demand for immersive technologies, the rise of AR/VR in medical training, and the growing need for remote healthcare solutions.

Spatial computing advancements are transforming areas such as clinical education, surgical planning, training, medical imaging, and behavioral health. We can expect even more applications to emerge, improving care delivery and surgical outcomes. Imaging data will become more interactive, detailed, and accessible. Increased deployment in surgical settings will drive further growth in the development of supporting software and hardware. We may also witness an increase in hardware companies developing spatial computing systems suitable for application in the healthcare sector.

As the technology matures and costs decrease, spatial computing is expected to become an integral part of the healthcare ecosystem, transforming patient care and revolutionizing how medical professionals work.

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.

Mind over Matter How Non-invasive Neuromodulation Is Becoming the Future of Pain Management by EOS Intelligence
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Mind over Matter: How Non-invasive Neuromodulation Is Becoming the Future of Pain Management and Beyond

Scientists have been researching the possibility of using electrical impulses to treat many health conditions. The starting point was the introduction of the first TENS (transcutaneous electrical nerve stimulation) device in the 1970s in the USA. Its goal was to test the tolerance of chronic pain patients to electrical stimulation. In recent years, non-invasive neuromodulation has emerged as a promising field for treating various neurological disorders. This field will likely experience significant growth in the coming decade, thanks to technological advancements, such as AI-powered sophisticated wearables.

Non-invasive neuromodulation is emerging as a novel treatment for several diseases

Non-invasive neuromodulation is a technique that uses external devices to apply electromagnetic fields, electrical currents, or other forms of stimulation to the brain to enable targeted modulation of neural activity.

The technique is effective in treating a range of conditions. Currently, several devices are available in the market for treating illnesses, including chronic pain, tinnitus, diabetic neuropathy, and functional disorders such as bladder and bowel control.

The non-invasive neuromodulation market encompasses a diverse array of devices that can modify neural activity without the need for invasive procedures. This includes transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and TENS.

TMS therapy sessions typically require the presence of a physician. An example is MagVenture Pain Therapy, a TMS device developed by a Denmark-based company, MagVenture, for treating chronic pain.

TENS and tDCS devices are portable and, hence, suitable for at-home treatments. The FDA has not yet approved tDCS in the USA for medical use. However, its use falls under the Investigational Device Exception (IDA) regulations. Though it is marketed for non-medical uses in the USA, it is used for medical treatment in regions such as the EU, Singapore, and Israel.

TENS devices are small, battery-powered devices that consist of leads that connect to electrodes, sticky pads placed on the skin in the area that needs stimulation. An example is Cefaly, an FDA-approved TENS device developed by the US-based Cefaly Technology for pain management. This device works by stimulating and desensitizing the primary source of migraine pain, the trigeminal nerve, using a precise electrical impulse.

Mind over Matter How Non-invasive Neuromodulation Is Becoming the Future by EOS Intelligence

Mind over Matter How Non-invasive Neuromodulation Is Becoming the Future by EOS Intelligence

The non-invasive neuromodulation market is showing rapid growth

The global non-invasive neuromodulation devices market for neurological and psychiatric disorders was approximately US$1.2 billion in 2022. According to a 2023 report by Report Prime, an India-based market research firm, the market is projected to grow at a CAGR of 7.2% from 2023 to 2030, reaching US$2.1 billion by 2030.

Several reasons fuel this rapid growth in recent years, including the increasing prevalence of chronic pain and other neurological conditions (especially in older patients), the numerous advantages this technique has over invasive neuromodulation, breakthroughs in non-invasive technology, and a surge in investments.

Increasing incidence of neurological disorders is a major driver

The increasing incidence of debilitating disorders such as chronic pain, Parkinson’s disease, diabetic neuropathy, etc., is creating a pressing need for new and efficient treatments to address these conditions. A 2023 study by the CDC indicated that 20.9% of American adults suffered from chronic pain, and 6.9% experienced chronic pain that significantly limited their daily activities.

Similarly, Parkinson’s disease affects nearly 1 million people in the USA as of 2023, with this number expected to rise to 1.2 million by 2030. These statistics indicate a rising trend of neurological disease burden in the USA.

One major issue that many patients and physicians face is that the current treatments for many of these conditions fall short, leaving a significant gap in the care of patients. Typically, doctors treat people suffering from chronic pain, including that of diabetic neuropathy, using painkillers. Most patients develop medicine tolerance, experience drug-wearing-off effects, or suffer from severe side effects, diminishing the overall treatment effectiveness.

Some patients may even consider drastic and irreversible surgical procedures, such as nerve amputation, due to inadequate treatment results. However, even these may not always provide the desired relief. This indicates the need for a reliable and effective solution for managing the pain, discomfort, and other neurological symptoms associated with the primary disease.

As non-invasive neuromodulation stimulates the brain areas responsible for pain processing, it alters the patient’s perception of pain. With the growing incidence of neurological disorders, this desired neuromodulation effect will continue to be in high demand, contributing to the growth of the non-invasive neuromodulation devices market.

Non-invasive treatments offer advantages over other techniques

Typically, conditions such as chronic pain are treated using a combination of prescription medicines. However, these medications, including NSAIDs, opioids, etc., come with a variety of side effects, such as digestive issues, ulcers, drowsiness, etc. Long-term use of opioids can lead to a range of negative consequences, including the development of tolerance, physical dependence, and opioid use disorder, increasing the risk of overdose and death. Conventional treatment methods also need frequent hospital visits.

Invasive neuromodulation is an effective treatment option for various neurological conditions. However, it also carries significant risks, such as site infections, perioperative and postoperative complications, blood clots, and device malfunctions. Additionally, these techniques often require multiple hospital visits.

In contrast, non-invasive neuromodulation offers several advantages over invasive methods. These wearable devices provide drug-free treatments that do not require surgery or complex installation. As a result, they are easy for patients and physicians to use.

A comprehensive study about the efficacy of various non-invasive devices is not yet available. However, controlled individual studies by companies and developers have shown promising efficiency in treating various diseases.

Moreover, a 2019 report published in BMJ, a peer-reviewed medical journal, indicated that non-invasive neuromodulation offers a potential solution for patients who are sensitive to traditional treatments. This includes patient groups such as pregnant women, adolescents, and those who experience poor tolerability or lack of efficacy from pharmacological treatment therapies.

The need to treat health conditions of these patient groups may drive the use of non-invasive devices to treat health conditions.

Scientific advancements help improve efficacy and expand applications

The non-invasive neuromodulation field has seen several breakthroughs in recent years, showing promise for accelerated R&D and new and improved devices potentially entering the market in the future.

One example is the proprietary magnetic peripheral nerve stimulation (mPNS), marketed as Axon Therapy, developed in 2023 by US-based Neuralace Medical for managing painful diabetic neuropathy.

Another example is vibrotactile stimulation (VTS), currently under development by an interdisciplinary research team from the University of Minnesota as a treatment for spasmodic torticollis or cervical dystonia. This is a painful neurological condition that affects the neck. Though the product is not yet marketable, the clinical trials are showing significant promise.

VTS devices are also being developed for conditions other than pain. An example is the VTS glove, a wearable device developed by researchers at Stanford University and the Georgia Institute of Technology in 2024. The device applies high-frequency vibrations to the hands and fingers to relieve uncontrollable arm and hand spasms. In clinical trials, patients who used the device experienced significant improvements in symptoms, with some even reporting a reduction in their use of oral medications. The team is now working to develop the device further and make it available to patients as a publicly available therapy.

Furthermore, a new treatment for tinnitus, known as bimodal neuromodulation, which involves stimulating two sensory pathways in the brain, has been developed. Ireland-based company Neuromod offers the Lenire device, which combines headphones and a mouthpiece to deliver auditory and tactile stimuli to alleviate symptoms. Patients wear the device for an hour daily, for at least six weeks, to stimulate the tongue with electrical impulses while listening to tones.

These new developments are likely to give momentum to the ongoing R&D in the sector.

Increased investment signals growing market potential

The sector has also seen an uptick in investments. For example, Nalu Medical, a US-based company, secured US$65 million in funding in 2024 to advance its neurostimulation technology for treating chronic pain.

Similarly, Avation Medical, a US-based company focusing on treating bladder issues, raised over US$22 million in 2024 to launch the Vivally System. This wearable device treats patients with urge urinary incontinence (UUI) and overactive bladder (OAB) syndrome.

Massachusetts–based Cognito Therapeutics, a company focused on developing a new therapy for Alzheimer’s disease, raised around US$73 million in 2023.

This increasing trend in R&D investments shows investors’ rising interest in the field of non-invasive neuromodulation, indicating promising market prospects.

Integration with AI is expected to pave the way for future developments

Non-invasive neuromodulation is seeing considerable success in developing closed-loop systems that leverage artificial intelligence (AI) and machine learning (ML) to give customized therapeutic output. This trend is likely to see more growth, especially with the rapid advancements in the field of AI.

An example is Avation Medical’s Vivally System, a wearable neuromodulation device that uses closed-loop, autonomously adjusted electrical stimulation to treat patients with UUI and OAB syndrome. The device uses a smartphone app to calibrate itself for each patient and then delivers a constant current of electrical stimulation through a wearable garment. It also uses an advanced AI-powered closed-loop algorithm and electromyography (a medical test that measures the electrical signals sent by nerves to muscles and received back from them) to enable continuous real-time monitoring and therapy adjustment, ensuring uniformity and safety.

Non-invasive neuromodulation device companies are forming partnerships with research institutes to develop safe ways to treat various disorders using generative AI neuromodulation.

One such collaboration started in June 2024 between US-Swiss generative neuromodulation firm, Dandelion Science and Geneva-based research institute Wyss Center for Bio and Neuroengineering. The goal is to develop a generative AI neuromodulation platform for treating neurodegenerative and neuropsychiatric disorders.

Similar collaborations are likely to commence in the future, as it is clear that the combination of neuromodulation and AI is set to impact various treatment fields significantly.

Expansion of insurance coverage could boost treatment accessibility

Conventionally, chronic pain treatment involves a combination of drugs and physical therapy. The US patient usually pays 20% of their Medicare-approved amount. People with severe pain spend about US$7,700 on annual healthcare expenditures, and with insurance, they have to spend around US$1,600 annually. For the management of pain conditions such as migraine, the out-of-pocket expense can increase to 30% of their Medicare-approved amount.

Non-invasive neuromodulation treatment has proved to be more cost-effective than conventional treatments. Although many non-invasive pain management devices are not covered by insurance, some are eligible for reimbursement.

For instance, Nerivio, a wearable device for treating migraine, is covered by Medicaid and Highmark Insurance. Moreover, Theranica, Nerivio’s Israel-based parent company, introduced the Nerivio Savings Program in October 2020 to help US patients access the device. It is a reimbursement plan that allows patients to receive their first device for a copay of up to US$49 (for 18 treatments), depending on their insurance coverage. The refill costs US$89 for those without insurance.

Additionally, patients may be able to use Health Savings Accounts (HSAs) or Flexible Spending Accounts (FSAs) to pay for specific approved devices. An example is Cefaly, for which, though not covered by insurance in the USA, consumers can use HSA and FSA funds or finance their purchase with Affirm (a US-based financial technology company that offers flexible payment options) for US$36 per month upon qualifying. Without insurance or other financial aid, the upfront cost varies from US$330 to US$430, and an additional US$25 for three reusable electrodes, each usable up to 20 times each.

Non-invasive neuromodulation devices’ high upfront cost remains the key barrier to broader adoption 

Overall, non-invasive neuromodulation devices offer a more cost-effective option than other treatments. The most significant barrier for patients opting for non-invasive neuromodulation is the high upfront cost, especially with no insurance coverage.

For example, Israel-based Zida Therapeutics’ Zida Control Sock, a device to treat urinary incontinence, comes with an upfront cost of US$750. Without insurance, many people may find it challenging to cover this cost. This is particularly true for older adults whom conditions such as chronic pain and urinary incontinence affect the most. According to 2023 data released by the US Census Bureau, 14.1% of Americans aged 65 and older live in poverty, making these devices less accessible to them without insurance coverage.

However, this situation may improve as several companies are now in talks to receive insurance coverage for their devices. With an increase in R&D, companies can also offer robust evidence to demonstrate the effectiveness and long-term safety of the devices, prompting insurance companies to provide coverage.

With reimbursement available for companies such as Theranica and Zida, and with several other companies such as Neurovalens planning to enter discussions with insurance providers to achieve reimbursement status, the accessibility has a chance to improve in the near future. This will likely drive adoption in the coming years.

EOS Perspective

Adopting non-invasive devices will likely increase as a standalone treatment and adjunct therapy. While non-invasive treatments currently focus on conditions such as chronic pain, tinnitus, urinary incontinence, etc., experts believe that this will soon expand into other neurological conditions, including ALS, and Parkinson’s disease.

Currently, there are only seven FDA-approved drugs for ALS treatment, all of them with limited effectiveness. The significant unmet need in this field presents a compelling opportunity for non-invasive neuromodulation companies. PathMaker Neurosystems is among the few companies conducting feasibility studies and developing non-invasive neuromodulation treatment options for ALS patients.

Research is also underway to develop a non-invasive treatment for Parkinson’s disease, which was previously treated using invasive techniques. Czech Republic-based STIMVIA has reported promising results from its initial pilot study of a new treatment for patients with Parkinson’s disease as an add-on therapy.

Several new non-invasive devices are also in the development pipeline, and their clinical trials are promising. An example that has shown positive results in a pivotal trial is a treatment for improving upper limb function by Netherlands-based ONWARD Medicals.

Non-invasive neuromodulation has the potential to revolutionize the treatment of chronic pain and other neurological disorders. As the field continues to evolve, with advancements in AI-powered wearables and increased investment in R&D, we can expect to see even more innovative solutions emerge in the coming years.

New Directions in Alzheimer’s Diagnostics Will Blood Tests Replace CSF and PET by EOS Intelligence
by EOS Intelligence EOS Intelligence No Comments

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.

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