U.S. Point of Care (PoC) Diagnostics Market Size, Share, Trends, & Industry Analysis Report
By Product (Glucose Testing, Hb1Ac Testing, Coagulation), By Mode of Prescription, By End Use – Market Forecast, 2025–2034
- Published Date:Sep-2025
- Pages: 126
- Format: PDF
- Report ID: PM6438
- Base Year: 2024
- Historical Data: 2020-2023
Overview
The U.S. point of care (PoC) diagnostics market size was valued at USD 9.69 billion in 2024, growing at a CAGR of 6.88% from 2025–2034. Key factors driving demand include shift towards value based care and decentralized testing, supportive government policies and reimbursement models, prevalence of chronic diseases in the U.S., advancement in PoC diagnostics technology.
Key Insights
- The infectious diseases segment accounted for 36.91% revenue share in 2024 due to the increasing demand for accurate and rapid detection of diseases.
- The OTC segment is expected to witness growth at a CAGR of 1.8% during the forecast period driven by the increasing patient demand for monitoring and self-testing.
- The clinics segment held 36.82% share of the market in 2024 owing to their role in delivering rapid diagnostic services to a wide patient base.
Industry Dynamics
- The rising need to continuously monitor the chronic diseases drives the growth opportunity as PoC improves treatment plans, empowers patients to adopt regular monitoring, and provides clinicians with immediate data.
- Advances in PoC technology such as connectivity, miniaturization, and tests like CRISPER are creating new growth opportunities for this market
- Complex regulatory limits accessibility of diagnostics due to lack of direct access to healthcare.
- Rising focus on healthcare is driving the demand for affordable PoC diagnostic due to the need for improvement in patient outcome and reduction in costs.
Market Statistics
- 2024 Market Size: USD 9.69 billion
- 2034 Projected Market Size: USD 18.83 billion
- CAGR (2025-2034): 6.88%
AI Impact on U.S. Point of Care (PoC) Diagnostics Market
- AI systems make diagnoses more accurate by reducing human error and boosting test findings. This helps doctors in making treatment decisions faster.
- AI-powered PoC devices enable continuous patient monitoring and real-time data analysis, allowing healthcare professionals to track conditions remotely when necessary.
- Automated AI diagnostics reduce the need for, lower personnel expenses, repeat tests, making workflows easier and point-of-care testing cheaper for healthcare facilities.
Point of care (PoC) diagnostics are tests performed at or near the patient’s location, rather than in a laboratory for timely diagnostic results. In U.S., the market is driven by the shift towards value based care and decentralized testing as the healthcare providers increasingly shift towards efficiency, correct patient outcomes, and cost effectiveness. The PoC devices reduce turnaround time by providing timely results for better monitoring of disease and reducing unnecessary intervention and long term cost.
The rising government support and reimbursement policy further contributes to the growth opportunities. These type of support and policies support the wider adoption of the PoC devices by reducing the financial barriers for both patients and providers, while boosting the innovation. State level healthcare initiatives have contributed to the importance of rapid diagnostics and benefits for public health outcomes, chronic disease management, and other. For instance, in December 2024, National Institute of Health and Office of AIDS research released USD 4 million as funding and support for the rapid acceleration of diagnostics advanced platforms for monitoring of HIV diagnostics. Reimbursement policies pushes the adoption of PoC diagnostics into daily routine for broader adoption and accessibility for the urban population as well.
Drivers & Opportunities
Growing Prevalence of Chronic Diseases: Prevalence of chronic diseases in the U.S. such as diabetes and chronic respiratory illness require timely and continuous monitoring. This is propelling the demand for PoC diagnostic as it helps in disease management. According to the CDC, 6 in 10 Americans have at least one chronic disease, and four in ten have two or more. Moreover, the shift towards decentralized testing for patient management is essential for rapid management of such diseases, as it improves treatment plans, empowers patients to adopt regular monitoring, and provides clinicians with immediate data to manage hospital visits.
Rising Advancement in PoC Technology: Advancement in PoC diagnostics technology such as CRISPER-based molecular testing, miniaturized and digital integrated devices with proper connectivity, wearable sensor integration, and others are contributing to the expansion opportunities for the PoC devices. For instance, in July 2023, Lumos Diagnostics received clearance from the FDA for FebriDx rapid, PoC test in the U.S. It is used with other clinical and laboratory findings, with clinical signs and symptoms to evaluate patients for respiratory infection. These advancements improve precision in diagnostic and also improve seamless data sharing with electronic health records, for systematic care of patients. Furthermore, the integration of AI tools and connected platforms is also boosting the real time monitoring and insights, which makes PoC testing an essential part of healthcare delivery in the U.S.
Segmental Insights
Product Analysis
Based on product, the segmentation includes glucose testing, Hb1Ac testing, coagulation, fertility, infectious diseases, cardiac markers, thyroid stimulating hormone, hematology, primary care systems, decentralized clinical chemistry, feces, lipid testing, cancer marker, blood gas/electrolytes, ambulatory chemistry, drug abuse testing, and urinalysis. The infectious diseases segment accounted for 36.91% revenue share in 2024 driven by the rising need for accurate and rapid detection of diseases such as sexually transmitted diseases, respiratory infections and others. PoC diagnostic offer benefits by providing rapid results that greatly reduce disease transmission. Moreover, the U.S. is increasingly adopting these tools for urgent care centers and for making quick clinical decisions in hospitals.
The ambulatory chemistry segment is expected to witness robust growth at a CAGR of 3.4% during the forecast period driven by the rising focus on shifting healthcare delivery from hospitals to more cost effective and efficient environments. These tests support diagnostic capability by allowing physicians to conduct proper analysis of point of care, and enabling immediate treatment adjustments.
Mode of Prescription Analysis
In terms of mode of prescription, the segmentation includes OTC and prescription-based. The OTC segment is expected to witness significant growth at a CAGR of 1.8% during the forecast period due to the rising patient preference for monitoring and self-testing. In the U.S. maximum population is becoming more serious about their health which is boosting the demand for the easy to use and convenient PoC diagnostic kits. PoC kits such as pregnancy tests, glucose monitors, and infectious disease kits allow patients for making decisions on time and reducing risk and these kits can be purchased without a prescription. Thus, the rising adoption of OTC highlights an evolving shift towards the consumer driven healthcare in the U.S. market.
End Use Analysis
Based on end use, the segmentation includes, clinics, hospitals, home, assisted living healthcare facilities, and laboratory. The clinics segment held 36.82% share of the market in 2024 due to their essential role in delivering rapid diagnostic services to a wide patient base. In the U.S. clinics are the first point of contact for the patients looking for care, highlighting the growth of effective and essential quick diagnostic tools and services. Moreover, PoC in clinics improves efficiency of work and also improve satisfaction of patients by providing rapid results without delaying. Therefore, as healthcare system in the U.S. focus on efficiency and accessibility, the dependency on PoC in clinics dominate the market.
Key Players & Competitive Analysis Report
The U.S. point-of-care (PoC) diagnostics environment is highly competitive with some major players such as Abbott, Roche, and Siemens. The competitive intelligence and strategy show a shift to disruption and trends around connectivity and multiplex testing to capture revenue opportunity. The vendor and organization strategies are market expansion strategies based prospecting emerging market opportunities like hospital-at-home programs. The outlook for growth is strong due to market shifts to decentralized care. For the larger companies there is a focus market size analysis by region and sustainability and value chain, while the smaller and medium sized companies rely on sustained innovation in their niche. Moreover, both large and small companies will have to navigate supply chain disruptions and address shifting economic and geopolitical sands and their impact on future development strategies.
Major companies operating in the U.S. point of care (PoC) diagnostics industry include Abbott; Agilent Technologies, Inc.; BD; BIOMÉRIEUX; Danaher Corporation; Hologic, Inc.; Illumina, Inc.; Quest Diagnostics Incorporated; QuidelOrtho Corporation; and Thermo Fisher Scientific Inc.
Key Players
- Abbott
- Agilent Technologies, Inc.
- BD
- BIOMÉRIEUX
- Danaher Corporation
- Hologic, Inc.
- Illimina, Inc.
- Quest Diagnostics Incorporated
- QuidelOrtho Corporation
- Thermo Fisher Scientific Inc
Industry Developments
- November 2024: FLUXERGY became the first company to utilize in-kind Diagnostics Development Services from NIH/NIAID to advance its molecular testing and sample preparation capabilities for its point-of-care diagnostic platform.
- July 2023: EDP Biotech and New Day Diagnostics collaborated to combine CRO services, diagnostic test development, and commercialization capabilities into a single vertically integrated entity.
U.S. Point of Care (PoC) Diagnostics Market Segmentation
By Product Outlook (Revenue, USD Billion, 2020–2034)
- Glucose Testing
- Hb1Ac Testing
- Coagulation
- Fertility
- Infectious Diseases
- HIV
- Clostridium Difficile
- HBV
- Pneumonia or Streptococcus Associated Infections
- Respiratory Syncytial Virus (RSV)
- HPV
- Influenza/Flu
- HCV
- MRSA
- TB and Drug-Resistant TB
- HSV
- Others
- Cardiac Markers
- Thyroid Stimulating Hormone
- Hematology
- Primary Care Systems
- Decentralized Clinical Chemistry
- Feces
- Lipid Testing
- Cancer Marker
- Blood Gas/Electrolytes
- Ambulatory Chemistry
- Drug Abuse Testing
- Urinalysis
By Mode of Prescription (Revenue, USD Billion, 2020–2034)
- OTC
- Prescription-based
By End Use Outlook (Revenue, USD Billion, 2020–2034)
- Clinics
- Physician Office
- Pharmacy & Retail Clinics
- Non-practice Clinics
- Urgent Care Clinic
- Hospitals
- Home
- Assisted Living Healthcare Facilities
- Laboratory
U.S. Point of Care (PoC) Diagnostics Market Report Scope
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Report Attributes |
Details |
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Market Size in 2024 |
USD 9.69 Billion |
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Market Size in 2025 |
USD 10.34 Billion |
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Revenue Forecast by 2034 |
USD 18.83 Billion |
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CAGR |
6.88% from 2025 to 2034 |
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Base Year |
2024 |
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Historical Data |
2020–2023 |
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Forecast Period |
2025–2034 |
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Quantitative Units |
Revenue in USD Billion and CAGR from 2025 to 2034 |
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Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Industry Trends |
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Segments Covered |
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Competitive Landscape |
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Report Format |
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Customization |
Report customization as per your requirements with respect to countries, regions, and segmentation. |
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