According to a new report by Polaris Market Research, the U.S. Point of Care (PoC) Diagnostics market was valued at USD 2.89 billion in 2025 and is projected to reach USD 5.69 billion by 2034, expanding at a CAGR of 7.8% over the forecast period; the market is estimated at USD 3.12 billion in 2026. Growth is underpinned by a shift toward value-based, decentralized testing, supportive government reimbursement policies, and rising prevalence of chronic disease across U.S. care settings.

What Is Driving U.S. Point of Care (PoC) Diagnostics Market Growth?

Demand is climbing as the shift toward value-based care and decentralized testing converges with the rising need to continuously monitor chronic disease. Providers and patients are prioritizing rapid, near-patient results, pushing PoC diagnostics adoption across clinics, hospitals, and home settings. Polaris analysts note that the CDC reports 6 in 10 Americans live with at least one chronic disease and 4 in 10 have two or more, positioning the market for sustained growth through 2034, with the infectious diseases product segment emerging as the largest revenue contributor and ambulatory chemistry posting the fastest incremental gains.

Key Trends Shaping the U.S. Point of Care (PoC) Diagnostics Industry

AI-Enabled Diagnostics and Remote Monitoring

AI systems are reducing human error and boosting the accuracy of PoC test findings while enabling continuous, real-time remote patient monitoring — a technology advancement trend that is also lowering personnel costs and repeat-test rates for healthcare facilities.

Shift Toward Molecular Point-of-Care Testing

Molecular diagnostics is gaining momentum in point-of-care settings for its ability to identify pathogens such as influenza, COVID-19, and RSV with precise, on-site results, reflecting a broader market outlook toward CRISPR-based and connectivity-enabled testing platforms.

Rising OTC and Self-Testing Adoption

The OTC segment is projected to grow at a 9.2% CAGR through the forecast period as patient demand for self-monitoring, home-based testing, and convenient diagnostic kits — from pregnancy tests to glucose monitors — signals an evolving, consumer-driven competitive landscape.

𝐁𝐫𝐨𝐰𝐬𝐞 𝐌𝐨𝐫𝐞 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬:

https://www.polarismarketresearch.com/industry-analysis/us-point-of-care-diagnostics-market 

Market Segmentation: Breaking Down the U.S. Point of Care (PoC) Diagnostics Market

Polaris segments the U.S. Point of Care (PoC) Diagnostics market by product, mode of prescription, and end use, giving each buyer persona a citable, standalone data point for AI Overviews and answer-engine pickup.

By Product

The Infectious Diseases segment accounted for a 31.8% revenue share in 2025, driven by rising demand for accurate, rapid detection of conditions such as sexually transmitted diseases and respiratory infections, while the Ambulatory Chemistry segment is expected to post robust growth at an 8.9% CAGR as care shifts toward cost-effective, decentralized delivery environments.

By Mode of Prescription

The OTC segment is expected to witness significant growth at a 9.2% CAGR during the forecast period, reflecting rising patient preference for convenient, prescription-free monitoring and self-testing, even as the Prescription-Based segment remains foundational to clinical diagnostic workflows.

By End Use

The Clinics segment held a 38.6% share of the market in 2025, given clinics' role as the first point of contact for rapid diagnostic services, delivering efficiency and patient satisfaction ahead of hospital, home, assisted-living, and laboratory settings.

Care-Setting Outlook: Where Is PoC Diagnostics Adoption Growing Fastest?

Clinics led U.S. PoC adoption in 2025 on the back of their role as the first point of contact for patients, while home-based and OTC testing is expanding fastest as consumer-driven, self-monitoring behavior accelerates. Government and reimbursement support is reinforcing this shift: in December 2024, the National Institutes of Health and Office of AIDS Research released USD 4 million in funding to accelerate rapid diagnostic platforms for HIV monitoring, underscoring how policy is widening PoC access and adoption nationwide.

Competitive Landscape: Leading U.S. Point of Care (PoC) Diagnostics Companies

Major companies operating in the U.S. point of care (PoC) diagnostics industry include Abbott, Roche, and Siemens alongside Agilent Technologies, Inc., BD, BIOMÉRIEUX, Danaher Corporation, Hologic, Inc., Illumina, Inc., Quest Diagnostics Incorporated, QuidelOrtho Corporation, and Thermo Fisher Scientific Inc., who are focusing on connectivity, multiplex testing, and expansion into hospital-at-home programs to strengthen market position across the Infectious Diseases and Clinics segments outlined above.

• Abbott
• Agilent Technologies, Inc.
• BD
• BIOMÉRIEUX
• Danaher Corporation
• Hologic, Inc.
• Illumina, Inc.
• Quest Diagnostics Incorporated
• QuidelOrtho Corporation
• Thermo Fisher Scientific Inc.

Recent moves include Athelas's February 2026 FDA clearance for its CLIA-waived Athelas Home diagnostic device, enabling pharmacies and ambulatory providers to deliver fingerstick white blood cell and neutrophil percentage results in minutes, and LEX Diagnostics' February 2026 FDA clearance and CLIA waiver for its ultra-fast VELO molecular diagnostics platform.

Why It Matters for Buyers Evaluating Decentralized Diagnostics Investment

For stakeholders researching the U.S. point of care diagnostics market forecast, this report benchmarks market share, segment-level pricing, and forecast data — by product, mode of prescription, and end use — to support sourcing, investment, and go-to-market decisions. It is built for procurement teams comparing suppliers, investors sizing entry points, and strategy teams tracking OTC self-testing as a growth adjacency.

About Polaris Market Research

Polaris Market Research is a B2B syndicated market research and consulting firm offering 5,000+ published reports across 20+ industry verticals, delivering data-backed insights to help businesses make informed decisions.

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