U.S. Point of Care (PoC) Diagnostics Market Growth Opportunities, Industry Revenue, 2026-2034
REPORT DETAILS
U.S. Point of Care (PoC) Diagnostics Market Summary
The U.S. point of care (PoC) diagnostics market size was valued at USD 2.89 billion in 2025. The market is projected to grow at a CAGR of 7.8% from 2026 to 2034. Key factors driving demand include a shift towards value-based care and decentralized testing, and supportive government policies and reimbursement models. The market also benefits from the prevalence of chronic diseases in the U.S. and advancements in PoC diagnostics technology.
Market Statistics
Key Takeaways
- The infectious diseases segment accounted for 31.8% revenue share in 2025. This is due to the increasing demand for accurate and rapid detection of infectious diseases, supported by growing testing volumes in hospitals, clinics, and decentralized healthcare settings.
- The OTC (over-the-counter) segment is expected to witness rapid growth at a 9.2% CAGR during the forecast period. The segment’s growth is driven by increasing patient demand for self-monitoring, home-based testing, and convenient diagnostic solutions.
- The clinics segment held 38.6% of the market share in 2025. This is owing to their role in delivering rapid diagnostic services to a wide patient base while reducing the burden on hospitals.
- The ambulatory chemistry segment is expected to witness robust growth at a 8.9% CAGR. The segment’s growth is attributed to the rising focus on shifting healthcare delivery from hospitals to more cost-effective, decentralized, and efficient care environments..
Note: Figures and projections outlined in this report are the result of Polaris Market Research’s proprietary analytical processes, grounded in the latest available datasets and market observations.
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.
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.
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Source: Polaris Market Research Analysis
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.
PoC Testing vs Traditional Laboratory Testing
| Factor | PoC Testing | Laboratory Testing |
| Results | Gives results within minutes | Takes hours to days |
| Accessibility | Easy accessibility | Not easily accessible |
| Convenience | Convenient | Moderately convenient |
| Test Costs | Lower than laboratory tests | May be higher due to the complexity involved |
| Number of Tests | Small batches or single test | High-volume processing |
| Applications | Rapid diagnosis and testing | More extensive diagnostic testing |
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.
Shift Toward Molecular Point-of-Care Testing
The field of molecular diagnostics is gaining momentum in point-of-care testing due to its ability to produce precise results on-site. Such tests assist health practitioners in diagnosing pathogens and genetic biomarkers to determine whether a patient has an infection. Molecular point-of-care tests can effectively identify infections such as influenza, COVID-19, and RSV, among others, owing to their ability to deliver precise results quickly. As demand for quick, effective diagnosis and treatment continues to rise, the use of molecular point-of-care testing will grow.
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Source: Polaris Market Research Analysis
Regulatory Framework in U.S. Diagnostics
The United States regulatory environment provides important guidelines that help in the provision of safe, reliable, and accurate point-of-care diagnostics systems. Regulatory agencies play an essential role in setting quality standards for diagnostic products and evaluating them before they are introduced to the market. Through this practice, there is assurance of the consistent performance of the products, which increases confidence among consumers and manufacturers. As the point-of-care testing technologies advance, the need for proper regulations becomes increasingly essential.
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 31.8% revenue share in 2025 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 8.9% 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 9.2% 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 38.6% share of the market in 2025 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.
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Source: Polaris Market Research Analysis
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
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February 2026: Athelas announced receiving FDA clearance for its CLIA-waived Athelas Home diagnostic device for use in PoC settings. The company stated that the clearance will enable pharmacies and ambulatory providers to deliver clinically validated white blood cell (WBC) and neutrophil percentage (NEUT%) results from a fingerstick in just a few minutes. (source: athelas.com)
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February 2026: LEX Diagnostics announced receiving FDA clearance and CLIA waived status for its ultra-fast PoC molecular diagnostics platform, VELO system. According to LEX Diagnostics, the clearance marks a major step in its strategy and highlights its commitment to advancing PoC. (source: lexdiagnostics.com)
U.S. Point of Care (PoC) Diagnostics Market Segmentation
By Product Outlook (Revenue, USD Billion, 2021–2034)
- 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, 2021–2034)
- OTC
- Prescription-based
By End Use Outlook (Revenue, USD Billion, 2021–2034)
- 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
| Report Attributes | Details |
| Market Size in 2025 | USD 2.89 Billion |
| Market Size in 2026 | USD 3.12 Billion |
| Revenue Forecast by 2034 | USD 5.69Billion |
| CAGR | 7.8% from 2026 to 2034 |
| Base Year | 2025 |
| Historical Data | 2021–2024 |
| Forecast Period | 2026–2034 |
| Quantitative Units | Revenue in USD Billion and CAGR from 2026 to 2034 |
| Report Coverage | Revenue Forecast, Competitive Landscape, Growth Factors, and Industry Trends |
| 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. |
Source: Polaris Market Research Analysis
U.S. Point of Care (PoC) Diagnostics Market FAQ's
The market size was valued at USD 2.89 billion in 2025 and is projected to grow to USD 18.83 billion by 2034.
The market is projected to register a CAGR of 7.8% during the forecast period.
A few of the key players in the market are include Abbott; Agilent Technologies, Inc.; BD; BIOMÉRIEUX; Danaher Corporation; Hologic, Inc.; Illumina, Inc.; Quest Diagnostics Incorporated; QuidelOrtho Corporation; and Thermo Fisher Scientific Inc.
The infectious diseases segment accounted for 31.8% revenue share in 2025.
The OTC segment is expected to witness significant growth at a CAGR of 9.2% during the forecast period.
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