US Point of Care Diagnostics Market
US Point of Care Diagnostics Market by Product [Glucose, Infectious Disease (TB, HAI, STD), Pregnancy], Purchase Mode (Rx, OTC), Technology [Biochemistry, MDx (RT-PCR, INAAT)], Sample (Blood, Urine), End User (Home Care, Hospitals) - Forecast to 2031
OVERVIEW
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
The US point of care diagnostics market is expected to grow from USD 6.8 billion in 2026 to USD 10.6 billion by 2031, at a CAGR of 9.2% during this period. The primary factor driving the growth of the US point of care diagnostics market is the increasing demand for fast and reliable testing solutions to address the rising incidence of lifestyle and infectious diseases. Additionally, advancements in healthcare infrastructure, greater investments in decentralized diagnostic solutions, and the growing adoption of CLIA-waived point-of-care diagnostic tests in various healthcare settings are further fueling this market growth. The heightened emphasis on timely disease detection, the increasing trend of self-testing, and the expanding availability of point-of-care diagnostic solutions also contribute significantly to the growth of the US point of care diagnostics market.
KEY TAKEAWAYS
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BY PRODUCTBy product, the infectious disease diagnostics segment is expected to register the highest CAGR of 11.9% during the forecast period.
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BY PURCHASE MODEBy purchase mode, the prescription-based testing segment registers the highest CAGR of 10.0% during the forecast period.
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BY TECHNOLOGYBy technology, the biochemistry segment accounted for the largest market share of 54.7% in 2025.
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BY SAMPLE TYPEBy sample type, the blood samples segment accounted for the largest share of the market in 2025.
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BY END USERBy end user, the home care settings & self-testing segment is expected to be the fastest-growing segment.
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COMPETITIVE LANDSCAPEAbbott (US), F. Hoffmann-La Roche (Switzerland), Siemens (Germany), QuidelOrtho (US), and Danaher Corporation (US) were identified as star players in the US point of care diagnostics market, which is supported by their strong market presence and extensive product portfolios.
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COMPETITIVE LANDSCAPEModitech Med (Korea) and Response Biomedical (Canada) have distinguished themselves among startups and SMEs by securing strong footholds in specialized niche areas.
The US point of care diagnostics market is driven by several key factors. One major factor is the increasing trend toward a decentralized healthcare system, which emphasizes the need for quick clinical decision-making at the point of patient care. The growing demand for timely diagnoses is further promoting the adoption of point-of-care diagnostics. Additionally, a favorable regulatory environment, including the expansion of CLIA-waived testing, is facilitating the use of point-of-care diagnostics outside traditional laboratory settings. Advancements in technology are improving the accuracy and usability of point-of-care tests, as well as enhancing connectivity to electronic health records, making it easier to implement these diagnostics. Moreover, the emphasis on cost containment and the shift of patient care responsibilities from hospitals are also contributing to the rising adoption of point-of-care diagnostic solutions in the US.
TRENDS & DISRUPTIONS IMPACTING CUSTOMERS' CUSTOMERS
The US point of care diagnostics market is steadily growing as the healthcare community focuses on making clinical decisions faster and more accessible. Current trends in the US PoC diagnostics market include the increasing integration of these tests into hospitals, office practices, retail clinics, and home care settings to enable rapid diagnosis and immediate treatment. The adoption of CLIA-waived and digitally-enabled point-of-care tests, along with the expansion of decentralized testing models, is transforming the way testing is conducted. Moreover, advancements in compact, user-friendly, and connected point-of-care devices are making it possible to use these tools in emergency care, urgent care, and home-based settings.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
MARKET DYNAMICS
Level
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Growing incidence of infectious diseases
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Increasing prevalence of chronic diseases
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Pricing pressure on manufacturers
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Stringent regulatory approval process for product commercialization
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Rising healthcare expenditure in US
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Rising inclination toward decentralized healthcare system
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Inadequate standardization with centralized lab methods
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Premium pricing of novel platforms
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Driver: Growing incidence of infectious diseases
The increasing prevalence of infectious diseases is a major factor driving the growth of the US point of care diagnostics market. Conditions such as sexually transmitted diseases (STDs), respiratory illnesses, and viral infections have heightened the demand for rapid, accurate, and decentralized testing solutions. Point-of-care diagnostics provide quick results at the site of care, enabling timely clinical decisions and reducing reliance on centralized laboratories. This approach is crucial in helping to control the spread of diseases. In the US, the widespread adoption of POC diagnostics in healthcare practices is significantly enhancing the management of infectious diseases.
Restraint: Pricing pressure on manufacturers
The US point of care diagnostics market faces significant challenges due to several restraining factors. These include cuts in reimbursement, tight healthcare budgets, and stringent cost-containment measures. Reduced insurance coverage and increased pricing scrutiny, especially in outpatient and home care settings, make it difficult for manufacturers to set high prices. Additionally, manufacturers must navigate the challenge of maintaining profit margins while complying with regulatory requirements, managing innovation expenses, and providing cost-effective point-of-care solutions.
Opportunity: Rising inclination toward decentralized healthcare system
The rising demand for transitioning to decentralized models of healthcare delivery creates a significant opportunity for the US point of care diagnostics market. With the increasing focus of healthcare providers on extending their services beyond the boundaries of hospitals to other locations such as clinics, pharmacies, and home settings, the need for convenient and portable diagnostic solutions is increasing. Point-of-care testing helps in making informed decisions, which increases the efficiency of healthcare.
Challenge: Inadequate standardization with centralized lab methods
One of the primary challenges facing the point-of-care diagnostics industry is the lack of sufficient standardization in comparison to centralized laboratory procedures. Differences in test methods, variations in the execution of tests, and inconsistencies in testing protocols can lead to varying results. Unlike centralized laboratories, which operate in strictly controlled environments, point-of-care testing is often conducted by individuals who may not have a background in laboratory work. This increases the likelihood of errors and variations in quality. Such issues can hinder the adoption of point-of-care diagnostics, particularly for complex and highly sensitive tests.
US POINT OF CARE DIAGNOSTICS MARKET: COMMERCIAL USE CASES ACROSS INDUSTRIES
| COMPANY | USE CASE DESCRIPTION | BENEFITS |
|---|---|---|
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Abbott provides a broad portfolio of point-of-care diagnostic solutions, including rapid infectious disease testing, cardiac marker testing, glucose monitoring, and molecular testing platforms used across hospitals, physicians’ offices, retail clinics, and home settings. | Enables rapid turnaround times, supports decentralized testing, improves chronic disease management, and enhances the efficiency of clinical decision-making across diverse care environments. |
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Siemens Healthineers offers point-of-care analyzers for blood gas, cardiac biomarkers, coagulation, and infectious disease testing, widely deployed in emergency departments, critical care units, and outpatient settings across the US. | Facilitates real-time clinical insights, improves workflow efficiency in acute care settings, reduces laboratory burden, and supports timely treatment interventions. |
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Roche delivers integrated point-of-care solutions, including cobas-based near-patient testing, glucose monitoring, and molecular diagnostic platforms used in hospitals, clinics, and decentralized care environments. | Enhances diagnostic accuracy, enables connectivity with digital healthcare systems, supports chronic disease monitoring, and improves patient management outcomes. |
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QuidelOrtho provides rapid antigen and immunoassay-based point-of-care testing solutions for respiratory infections, cardiometabolic markers, and reproductive health applications used in clinics, urgent care centers, and physicians’ offices. | Supports high-throughput rapid screening, improves accessibility to infectious disease testing, enables early detection, and strengthens outbreak management capabilities. |
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Through subsidiaries such as Cepheid and Beckman Coulter, Danaher offers molecular and immunoassay-based point-of-care diagnostic platforms used for infectious disease detection, hospital screening, and decentralized laboratory workflows. | Delivers highly sensitive, rapid molecular results, enhances infection control strategies, supports scalable decentralized testing, and improves overall healthcare system responsiveness. |
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET ECOSYSTEM
The US point of care diagnostics market includes key players throughout the entire value chain. This encompasses manufacturers of point-of-care tests and devices, distributors, retail markets, and research & development partners. The end users—such as hospitals, physician practices, urgent care and retail clinics, home care settings, and diagnostic laboratories—utilize point-of-care tests and devices to perform rapid and decentralized testing.
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET SEGMENTS
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
US Point of Care Diagnostics Market, Byby Product
The US point of care diagnostics market includes several product categories: glucose monitoring, cardiometabolic testing, infectious disease testing, coagulation tests, pregnancy and fertility tests, cancer markers, urinalysis, cholesterol testing, hematology, drug abuse testing, thyroid-stimulating hormone tests, fecal occult blood tests, and other diagnostic tests. In 2025, glucose monitoring products are expected to lead the market due to the high number of people with diabetes, advancements in glucose monitoring technology, and the increasing popularity of self-testing solutions in the US.
US Point of Care Diagnostics Market, by Purchase Mode
The US point of care diagnostics market is categorized based on the mode of purchase into two segments: over-the-counter testing products and prescription-based testing products. In 2025, prescription-based tests accounted for a larger share of the market. This is primarily due to the strict regulatory standards that ensure the quality of these tests. They are commonly utilized in hospitals, physician offices, and diagnostic laboratories. Additionally, FDA approval has significantly boosted physicians' confidence in these tests.
US Point of Care Diagnostics Market, by Technology
On the basis of technology, the US point of care diagnostics market is divided into biochemistry, immunoassays, and molecular diagnostics. In 2025, biochemistry technologies accounted for the largest market share of the US point of care diagnostics market. This is because they are widely used in fast and inexpensive testing for diabetes, cardiovascular diseases, and kidney diseases. Biochemistry-based point-of-care tests, such as glucose meters and lipid profile analyzers, provide instant results and are easy to use. They are also suitable for home-care, emergency care, and outpatient care. The ability of biochemistry-based tests to provide accurate results without the need for laboratory infrastructure has been a major factor in their adoption in the US healthcare system.
US Point of Care Diagnostics Market, by Sample
On the basis of sample type, the US point of care diagnostics market is divided into blood samples, urine samples, nasal and oropharyngeal swabs, and other sample types. In 2025, blood sample tests accounted for the largest market share. This is because blood samples can be used for a variety of point-of-care tests. Additionally, blood samples are commonly used for monitoring chronic diseases such as diabetes and cardiovascular diseases. The ease of blood sample collection, such as fingerstick blood collection, makes it a popular choice for point-of-care testing in the US.
US Point of Care Diagnostics Market, by End User
On the basis of end user, the US point of care diagnostics market is divided into clinical laboratories, ambulatory care facilities and physician offices, hospitals, critical care centers, and urgent care centers, home care settings and self-testing, and other end users. In 2025, home care settings and self-testing accounted for the largest market share. This is due to the increasing preference of consumers for convenient, private, and rapid testing solutions that do not require visits to traditional healthcare settings. The rising incidence of chronic diseases such as diabetes and cardiovascular diseases, along with the development of easy-to-use, accurate, and affordable point-of-care devices, continues to fuel the adoption of home-based diagnostics in the US.
US POINT OF CARE DIAGNOSTICS MARKET: COMPANY EVALUATION MATRIX
Abbott (star) is a major player in the US point of care (POC) diagnostics market, with a strong portfolio of popular POC platforms and continuous innovation in rapid testing technology. The company has an extensive test menu, scalable systems, and a strong installed base, which creates steady demand for its consumables. Additionally, Siemens focuses on clinical performance, ease of use and regulatory requirements, which helps the company sustain a strong market position in a variety of POC segments in the US.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
KEY MARKET PLAYERS
MARKET SCOPE
| REPORT METRIC | DETAILS |
|---|---|
| Market Size in 2025 (Value) | USD 6.8 Billion |
| Market Forecast in 2031 (Value) | USD 10.6 Billion |
| Growth Rate | CAGR of 9.2% from 2026–2031 |
| Years Considered | 2024–2031 |
| Base Year | 2024 |
| Forecast Period | 2026–2031 |
| Units Considered | Value (USD Million/Billion) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments Covered |
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| Countries Covered | US |
WHAT IS IN IT FOR YOU: US POINT OF CARE DIAGNOSTICS MARKET REPORT CONTENT GUIDE
RECENT DEVELOPMENTS
- June 2024 : Abbott announced that the US FDA has approved over-the-counter (OTC) versions of its two new continuous glucose monitoring systems: Lingo and Libre Rio. Both systems are based on Abbott's Libre technology. Lingo is designed for general wellness purposes, while Libre Rio is intended for adults with Type 2 diabetes who do not use insulin.
- December 1015 : Roche received FDA approval and a CLIA waiver for its first point-of-care (PoC) test for diagnosing Bordetella infections, including whooping cough. The new test is based on the cobas Liat system and provides results in approximately 15 minutes. This product further expands Roche’s point-of-care business.
Table of Contents
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Methodology
The study involved major activities in estimating the current market size for the US point of care diagnostics market. Exhaustive secondary research was done to collect information on the US point of care diagnostics industry. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain using primary research. Different approaches, such as top-down and bottom-up, were employed to estimate the total market size. After that, the market breakup and data triangulation procedures were used to estimate the market size of the segments and subsegments of the US point of care diagnostics market.
The four steps involved in estimating the market size are:
Secondary Research
In the secondary research process, various secondary sources, such as company annual reports, press releases, and investor presentations, white papers, certified publications, articles by recognized authors, gold-standard and silver-standard websites, regulatory bodies, and databases (such as D&B Hoovers, Bloomberg Business, and Factiva), were referred to identify and collect information for this study.
Primary Research
In the primary research process, various supply and demand sources were interviewed to obtain qualitative and quantitative information for this report. Primary sources were mainly industry experts from the core and related industries and preferred suppliers, manufacturers, distributors, service providers, technology developers, researchers, and organizations related to all segments of this industry’s value chain. In-depth interviews were conducted with primary respondents, including key industry participants, subject-matter experts, C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information and assess prospects.
To know about the assumptions considered for the study, download the pdf brochure
| COMPANY NAME | DESIGNATION |
|---|---|
| PTS Diagnostics | Regional Sales Manager |
| EKF Diagnostics Holdings plc | Product Manager |
Market Size Estimation
Both top-down and bottom-up approaches were used to estimate and validate the total size of the US point of care diagnostics market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:
- The key players in the industry have been identified through extensive secondary research
- Primary and secondary research has determined the revenues of leading players operating in the US point of care diagnostics market.
- All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.
The research methodology used to estimate the market size includes the following:
Data Triangulation
After arriving at the overall market size by applying the abovementioned process, the total market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.
Market Definition
Point of care testing (POCT) includes tests designed to be used at or near the patient's site (such as at home, in an ambulance, at a physician’s office, and other locations). POCT allows rapid & reliable diagnostic testing to obtain outcomes instantly, helping physicians/patients make care decisions remotely and rapidly.
Stakeholders
- Senior Management
- End User
- Finance/Procurement Department
- R&D Department
Report Objectives
- To define, describe, segment, and forecast the US point of care diagnostics market based on product, technology, end user, and country
- To provide detailed information regarding the major factors influencing market growth (such as drivers, restraints, opportunities, and challenges) in the Europe point of care diagnostics market
- To analyze the micromarkets with respect to individual growth trends, prospects, and contributions to the US point of care diagnostics market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players in the Europe point of care diagnostics market
- To profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies in the Europe point of care diagnostics market
- To track and analyze company developments such as product launches & approvals, partnerships, acquisitions, agreements, and other developments in the Europe point of care diagnostics market
- To benchmark players within the market using the proprietary Company Evaluation Matrix framework, which analyzes market players on various parameters within the broad categories of business & product excellence Europe point of care diagnostics market
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Growth opportunities and latent adjacency in US Point of Care Diagnostics Market