The U.S. point-of-care diagnostics (POCD) market is anticipated to grow at a compound annual growth rate (CAGR) of 5.00% from 2024 to 2031. Valued at USD 17.47 billion in 2023, the market is expected to reach USD 25.81 billion by 2031. This growth is driven by rising cases of infectious diseases, increased awareness of early diagnosis, preference for portable diagnostic tools, technological innovation, and greater investments from both public and private sectors.
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Post-Pandemic Growth & Innovation
The COVID-19 pandemic underscored the importance of rapid, reliable testing—especially in remote or underserved areas. In response, the healthcare landscape has shifted toward more accessible and decentralized diagnostics. Innovations involving AI, nanotechnology, biosensors, and smartphone integration have improved the accuracy and speed of point-of-care testing. The integration with electronic health records (EHR) and the expansion of CLIA-waived tests are transforming how care is delivered across the country.
In June 2024, for instance, Co-Diagnostics Inc. submitted a pre-market approval (PMA) application for its Co-Dx PCR Pro—a miniaturized, smartphone-controlled device that aims to bring gold-standard PCR testing beyond complex labs to more accessible settings. This marks a significant step in democratizing infectious disease diagnostics.
Technology Enhancing Accessibility and Accuracy
Technology continues to shape the POCD landscape, with portable devices like handheld analyzers and mobile labs enabling real-time decision-making in non-traditional care environments. In June 2024, Cepheid Inc. gained FDA approval for its Xpert HCV test and GeneXpert Xpress System—bringing advanced hepatitis C diagnostics to point-of-care settings.
AI is also playing a crucial role in diagnostics by interpreting test results, identifying patterns, and predicting health outcomes. In October 2024, HueDx Inc. introduced a paper-based, smartphone-powered platform capable of producing accurate colorimetric results without needing extra hardware—a breakthrough for portable, affordable diagnostics.
Rising Infectious Diseases Drive Demand
The increasing prevalence of infectious diseases—due to factors such as global travel, urbanization, antibiotic resistance, and aging populations—continues to fuel demand for quick and accessible diagnostics. The CDC aims to reduce new HIV infections from 32,800 (2022) to 9,300 by 2025 and 3,000 by 2030, emphasizing the need for early detection tools.
To meet this demand, companies are stepping up innovation. For example, in April 2024, Cepheid Inc. received WHO prequalification for its Xpert HIV-1 Qual XC, a point-of-care diagnostic test for HIV-1 detection in blood samples.
Funding Fuels Innovation and Market Expansion
Increased investment from government bodies and private firms is another key driver. Financial support is enabling the development of more efficient, portable diagnostic solutions that are widely accessible.
In April 2024, Binx Health Inc. raised $65 million in Series F funding to expand its diagnostic platform. Its FDA-approved Binx io device delivers chlamydia and gonorrhea test results in just 30 minutes—significantly reducing the time from diagnosis to treatment.
Dominance of the Glucose Monitoring Segment
Among various diagnostic segments, glucose monitoring holds the largest market share due to the widespread prevalence of diabetes in the U.S. The popularity of user-friendly devices, including continuous glucose monitors and smartphone-compatible systems, is fueling growth in this space.
In August 2024, DexCom Inc. launched the Stelo—the first over-the-counter glucose biosensor in the U.S., designed for Type 2 diabetics and prediabetics. Worn on the upper arm, it provides real-time insights and enhances self-management.
Market Outlook (2024–2031)
The future of point-of-care diagnostics in the U.S. looks promising, driven by:
- AI and Machine Learning: Enhancing test accuracy and efficiency.
- Telehealth Integration: Rising demand for rapid, remote diagnostic tools.
- Growing Investments and Awareness: Supporting innovation and broader adoption.
For instance, in April 2024, CARB-X awarded $1 million to Scout Health Inc. to develop a 30-minute STI test capable of distinguishing between Neisseria gonorrhoeae and Chlamydia trachomatis—another move toward faster, affordable diagnostics.
Report Scope
The report, “United States Point-of-Care Diagnostics Market Assessment, Opportunities and Forecast, 2017–2031F”, offers a detailed analysis of market trends, size, growth drivers, challenges, and forecasts. It also provides insights into competitive dynamics and profiles key industry players, helping stakeholders make informed decisions in a rapidly evolving market.
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