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.
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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.
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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.
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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
|
Report Attributes |
Details |
|
Market Size in 2024 |
USD 9.69 Billion |
|
Market Size in 2025 |
USD 10.34 Billion |
|
Revenue Forecast by 2034 |
USD 18.83 Billion |
|
CAGR |
6.88% from 2025 to 2034 |
|
Base Year |
2024 |
|
Historical Data |
2020–2023 |
|
Forecast Period |
2025–2034 |
|
Quantitative Units |
Revenue in USD Billion and CAGR from 2025 to 2034 |
|
Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Industry Trends |
|
Segments Covered |
|
|
Competitive Landscape |
|
|
Report Format |
|
|
Customization |
Report customization as per your requirements with respect to countries, regions, and segmentation. |
FAQ's
The market size was valued at USD 9.69 billion in 2024 and is projected to grow to USD 18.83 billion by 2034.
The market is projected to register a CAGR of 6.88% 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 36.91% revenue share in 2024.
The OTC segment is expected to witness significant growth at a CAGR of 1.8% during the forecast period.
Page last updated on:
Sep-2025
Research Methodology
A robust system of research, verification, and forecasting designed to ensure reliable and actionable market insights.
Polaris Market Research uses a clear and structured approach to deliver insights that clients can rely on. The process combines detailed primary and secondary research, including direct communication with industry experts. The detailed information helps build a complete picture of market trends and developments. Secondary data is gathered from credible sources such as industry reports, company filings, government source links, and trusted organization databases. It is then cross-checked through discussions with key stakeholders across the value chain. Market size and forecasts are developed using both bottom-up and top-down methods to ensure accuracy and consistency in the final results.
Project Setup
Step 1 & 2:
- We start every project by clearly understanding the client’s objective or goal, then defining the market scope, and aligning regions, segments, and timelines.
- Once the foundation is set, we collect data from all-around of sources, including company reports, government databases, and paid industry platforms.
- Our research is based on secondary data, which helps us build a strong understanding of the market across regions and industries. Then we validate this information through primary research by speaking directly with industry experts, companies, and stakeholders.
- By combining secondary and primary research, we ensure that our market insights are accurate, practical, and closely aligned with real market conditions.
Data Collection
We gather information from both public and verified sources:
Data Structuring
Step 3:
- All collected data is organized into a consistent format to ensure accurate analysis. Since inputs come from multiple sources, they are standardized and aligned before use.
- The data is segmented by product, application, and region, and mapped across a defined historical period (2020–2024). All values are converted into common units (USD Mn/Bn), and volume and pricing are aligned where required to estimate revenue.
- Any overlaps or inconsistencies are reviewed and adjusted to maintain accuracy (<5% variance threshold).
- The result is a structured dataset that allows for clear comparison across regions and supports reliable analysis and forecasting.
Structured Market Dataset, USD Mn/Bn
4. Data Structuring
Step 4: TOP-DOWN APPROACH
- We start with the overall market size at a global or macro level.
- The market is then narrowed down based on scope and industry relevance.
- We apply penetration rates and split the data by region and segment.
- This helps us estimate the market size for specific segments.
- The numbers are validated through cross-checks to ensure accuracy.
Step 5: BOTTOM-UP APPROACH
- We begin by analyzing data from leading companies in the market.
- Revenue data is collected and mapped across different segments.
- The data is then aggregated to estimate the total market size.
- To fill in any gaps, adjustments are made based on industry standards.
- Validation checks make sure that the results are correct.
5. Data Structuring
Step 6:
At Polaris Market Research, we employ a methodical forecasting strategy. This approach blends the analysis of historical data with real-time market validation. To forecast future trends with precision, we examine past patterns, pricing fluctuations, and the interplay of supply and demand. To ensure our conclusions reflect the present market landscape, we actively seek input from industry experts and key stakeholders.
To refine our predictions, we carefully consider critical elements such as market drivers and restraints, fluctuations in raw material costs, emerging technologies, and the production capabilities of various regions. Furthermore, we assess regulatory frameworks and potential policy shifts to gauge their potential impact on market expansion.
All this information is synthesized to generate precise forecasts for each segment and region. These forecasts illuminate the current state of the market and highlight forthcoming opportunities.
6. Data Structuring
Step 7:
In the final stage, we validate all our estimates using a triangulation method, where data is cross-checked from multiple reliable sources, like company data, primary interviews, and secondary research. This helps us make sure that our numbers are correct and fit with the rest of the market.
This process involves verifying data consistency across various segments and geographic areas. It also requires comparing historical trends with the assumptions support the forecast. Any discrepancies involve adjustments to ensure everything remains aligned and dependable.
Once the data is finalized, we prepare the final outputs, including market size estimates, segment-wise breakdowns, and growth metrics. These are delivered in structured formats such as tables, charts, and data files for easy analysis and use.
We collaborate closely with clients, ensuring the final products align with their requirements. This includes offering tailored adjustments, supplementary data analyses, and continuous assistance. Furthermore, we monitor market trends post-delivery, providing updates and refinements to maintain the insights' relevance as time passes.
Post-delivery, we continue to monitor market shifts, offering updates and adjustments to ensure the insights remain relevant over time.
Validation
Triangulation Framework
- Company-level data
- Primary inputs from industry participants
- Secondary benchmarks and published data
- Variance maintained within ±5-10%
- Adjustments applied to align estimates
- Segment values validated against overall market structure
Quality Check
Data Consistency & Integrity
- Segment totals validated to 100%
- Regional estimates aligned with global market size
- Historical trends compared against forecast outputs
- Assumptions reviewed for cross-segment and regional alignment
Output & Delivery
Final Outputs
- Market size estimates (USD Mn/Bn)
- Segment-wise distribution (%)
- Growth metrics (CAGR %)
- Structured tables and charts
- Segment-level datasets
- Excel-based data files for further analysis
Client Alignment & Support
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- Custom data cuts and segment splits are incorporated as required
- Post-delivery queries are addressed through analyst interactions
- Additional clarifications and data support are provided upon request
Client Continuity & Updates
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- Updated data and revisions are provided based on new market inputs
- Additional refinements and data cuts are shared as required
- Continued analyst engagement supports evolving client requirements
