ARTICLE SUMMARY:
Point-of-care testing (POCT) is rapidly growing, driven by rising demand for fast diagnostics and strategic industry investments. The global market is projected to nearly double by 2033, highlighting its expanding role in healthcare. By Gina Bransley, Client Executive at Medidata.
Medidata
Medidata, part of Dassault Systèmes, offers industry-leading expertise and analytics-powered insights in clinical trials, supporting 34,000+ trials, 10 million patients, and the world’s largest patient-level clinical trial data set.
The Growth of Point-of-Care Testing
The rapid rise of point-of-care testing (POCT), largely propelled by the COVID-19 pandemic, continues to exhibit strong growth as companies intensify efforts to make diagnostic testing more accessible and user-friendly. One industry projection indicates that the global POCT market is expected to almost double to $80.75 billion by 2033 (BioSpace, 2024). This growth trajectory is evidenced by the recent surge in investments and collaborations within the sector.
Industry Momentum and Market Projections
Several notable recent developments underscore the industry’s momentum. Roche recently gained Emergency Use Authorization (EUA) from the FDA for its multiplex SARS-CoV-2 and influenza A/B molecular test on the cobas® liat system (Roche, 2024). Meanwhile, Bosch and Randox Laboratories have entered a strategic partnership where they will commit a combined $162 million investment towards developing a PCR test for sepsis (Randox, 2024). In another significant move, Salignostics, a company specializing in saliva-based diagnostics, announced its partnership with ARC Innovation, focusing on early detection of oral cavity cancer (HIT Consultant, 2024).
These exciting advancements, among numerous others, demonstrate that POCT has become a major priority for diagnostic companies as they actively pursue fast-track approvals for new tests and indications. The shift in patient preferences towards avoiding unnecessary doctor’s office or hospital visits, coupled with increased use of telehealth services, has dramatically boosted the demand for POCTs. This trend reflects a broader transformation in healthcare delivery, emphasizing convenience and rapid results without compromising diagnostic accuracy.
Expansion of POCT into Specialized Diagnostic Areas
POCT is broadening its applications to include specialized diagnostics in areas such as oncology, infectious disease, and chronic condition management, driven by demand for fast, accurate, and accessible testing options. This shift has heightened the sector’s relevance in oncology, where early detection and continuous monitoring are pivotal. Salignostics' saliva-based diagnostic partnership for early oral cancer detection exemplifies this trend. Expanding POCT's utility beyond primary care to specialized clinical settings has become a primary growth driver, reshaping the landscape of diagnostics.
Role of Regulatory Frameworks in Shaping POCT Growth
The surge in diagnostic innovation has prompted updates to regulatory frameworks to manage risks and ensure quality control. Recent FDA guidelines on laboratory-developed tests (LDTs) illustrate the increased scrutiny POCTs face, especially as companies seek rapid market entry. Fast-track approvals, CLIA waivers, and EUAs are now key regulatory strategies, but they require companies to navigate a complex environment. This regulatory momentum will shape future POCT products as manufacturers work to balance innovation and compliance. Consequently, clinical trials for POCT devices are also becoming more rigorous and multifaceted, addressing real-world testing environments and integrating multi-phase testing to meet regulatory standards.
Clinical Trials and POCT: Decentralized Approaches to Diagnostics
The integration of POCT within decentralized clinical trials (DCTs) has been a game-changer, enhancing accessibility and enabling rapid data collection at patient-friendly locations, including patients’ homes. DCTs leverage POCT devices to collect real-time data remotely, reducing the burden on both patients and clinical sites—a model that has grown increasingly popular post-pandemic. Remote trials using POCT facilitate more inclusive patient participation, especially benefiting those who face logistical challenges with traditional trial setups. As POCT devices become more sophisticated, the clinical trial landscape is expected to incorporate AI-driven diagnostic tools that analyze test results instantly, streamlining clinical workflows and improving participant retention and engagement.
Integration of Digital Health Technologies: A Catalyst for POCT Expansion
With smartphone connectivity, telemedicine platforms, and wearable devices increasingly incorporated into POCT, diagnostics are evolving into a more user-centric, proactive model of care. For example, integrating POCT with digital health platforms allows patients to share real-time test results with their healthcare providers, promoting faster clinical decision-making. This digitalization enhances patient engagement and supports broader adoption of home-based testing solutions. The approach is especially promising for chronic condition management, where continuous monitoring is key. Companies like Roche and Randox are pioneering such advancements, aiming to drive patient convenience and improve health outcomes.
Risks and Challenges in POCT Development
Despite its promise, the race for new POCTs does not come without risks. For instance, San Diego-based Cue Health, which gained prominence during the early stages of the COVID-19 pandemic, shuttered operations and filed for bankruptcy following a tumultuous year marked by layoffs and an FDA warning letter advising against the use of its COVID-19 tests. This case serves as a sobering reminder of the risks associated with developing novel POCTs, emphasizing the importance of regulatory compliance and ensuring product reliability. As companies strive to meet growing demand, potential regulatory scrutiny—especially with updated LDT regulations—poses a challenge for new entrants.
Emerging Players and Market Disruption in the Diagnostic Sector
The diagnostic segment is witnessing a growing influx of start-ups and new entrants who are introducing fresh perspectives and technologies to the POCT market. Leveraging niche innovations, these companies often collaborate with larger players for R&D and distribution support. Strategic partnerships and acquisitions have become essential for sustaining innovation, as demonstrated by Bosch and Randox Laboratories’ substantial sepsis PCR test investment. Additionally, advancements in miniaturization and microfluidics are further lowering costs and simplifying POCT devices, making them accessible in diverse settings globally. This influx of new players and disruptive technologies is accelerating product diversity and enhancing competition in the sector.
Strategic Collaborations Driving Diagnostic Innovation
Collaborations across academia, healthcare, and industry are proving instrumental in addressing regulatory, technical, and operational challenges associated with POCT. ARC Innovation's partnership with Salignostics exemplifies how joint initiatives target underserved areas in diagnostics, such as saliva-based testing for early cancer detection. Through partnerships, companies share expertise, regulatory insights, and R&D capabilities, essential for developing robust POCT solutions that can withstand rigorous testing and regulatory scrutiny. Increasing collaborations promise sustainable growth in diagnostics, as these alliances expedite development cycles and foster innovation.
Future Landscape of POCT
As healthcare evolves, characterized by technological advancements and personalized care demand, POCT’s growing importance is underscored. The integration of AI/ML algorithms into POCT devices promises to enhance diagnostic accuracy and speed, further improving patient outcomes. Moreover, the shift towards home-based testing kits, enabled by smartphone connectivity and remote monitoring, is opening new avenues for patient engagement and proactive health management. These developments ensure POCT’s role as a mainstay in clinical trials, supporting both on-site testing and decentralized clinical trials (DCTs), bringing diagnostics closer to patients.
Summary
In summary, the POCT sector, spurred by the COVID-19 pandemic, has transformed diagnostic testing, making it more accessible and efficient for patients worldwide. Substantial investments and collaborations are driving innovation in the field, signaling a promising future for POCT. However, the industry faces ongoing challenges, including navigating complex regulatory landscapes and ensuring new tests’ reliability. Despite these hurdles, continued commitment from both established players and emerging companies sets the POCT sector on a path to launch numerous new products and clinical initiatives in the coming years, showing no signs of slowing down.
Gina Bransley is a Client Executive at Medidata, which provides customized clinical trial solutions. Learn more about the company at medidata.com. Follow Medidata on LinkedIn and X.
References
BioSpace. (2024). Point Of Care Diagnostics Market Size to Increase USD 80.75 Bn by 2033. Available at:https://www.biospace.com/article/point-of-care-diagnostics-market-size-to-increase-usd-80-75-bn-by-2033/
FDA. (2024). FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests. Available at:https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests
HIT Consultant. (2024). Sheba Medical Center & Salignostics to Develop Saliva Test for Early Oral Cancer Detection. Available at:https://hitconsultant.net/2024/05/28/sheba-medical-center-salignostics-to-develop-saliva-test-for-early-oral-cancer-detection/
Roche. (2024). Roche Molecular Respiratory Virus Panel Receives FDA Emergency Use Authorization. Available at: https://diagnostics.roche.com/us/en/news-listing/2024/roche-four-in-one-molecular-test-for-sars-cov-2-influenza-a-b-viruses-and-rsv-receives-us-fda-emergency-use-authorization.html
Randox. (2024). Bosch and Randox Invest Heavily In the Vivalytic Analysis Platform. Available at:https://www.randox.com/growth-through-medical-technology-randox-and-bosch-invest-heavily-in-the-vivalytic-analysis-platform/
Medidata, part of Dassault Systèmes, offers industry-leading expertise and analytics-powered insights in clinical trials, supporting 34,000+ trials, 10 million patients, and the world’s largest patient-level clinical trial data set.
Learn more at Medidata