US Point of Care Diagnostics Market (2024-2029)
The US Point of Care Diagnostics Market was valued at $2532.4 Million in 2024 and projected to reach to $3665.3 Million by 2029, representing a compound annual growth rate of 7.7%. The US Point of Care Diagnostics Market is positioned for sustained expansion through 2029, driven by technological advancements in rapid testing platforms and increasing healthcare provider adoption of decentralized diagnostic solutions.
US Point of Care Diagnostics Market Trends and Insights
- The US market is driven by increasing demand for rapid diagnostic testing, growing prevalence of chronic diseases, and widespread adoption of decentralized healthcare solutions across clinical and non-clinical settings.
- In 2024, the US represents a mature yet expanding market segment within North America, supported by advanced healthcare infrastructure and favorable reimbursement policies. By 2029, the US Point of Care Diagnostics Market is expected to benefit from technological innovations, rising point-of-care testing adoption in primary care facilities, and heightened focus on preventive healthcare.
- The US market growth is underpinned by regulatory support, increasing patient preference for faster diagnostic results, and integration of digital health platforms with point-of-care devices.
- The US continues to lead in market penetration and innovation within the broader North American region..
Key Market Statistics
- CAGR (2024-2029) 7.7% CAGR
- Market Size, 2024 ~USD 2532.4 Million
- Forecast, 2029 ~USD 3665.3 Million
- Country US
US Point of Care Diagnostics Market Overview
Market Valuation :
The US Point of Care Diagnostics Market is valued at $2,532.4 million in 2024, with strong growth trajectory driven by healthcare modernization and patient demand for faster results.
Robust Growth Trajectory :
The US market is projected to reach $3,665.3 million by 2029, representing a 7.7% CAGR, outpacing many other healthcare segments and reflecting sustained investment in diagnostic infrastructure.
Chronic Disease Prevalence :
Rising incidence of diabetes, cardiovascular diseases, and respiratory conditions across the US population is driving demand for accessible, rapid diagnostic solutions in both clinical and home settings.
Decentralized Healthcare Adoption :
Widespread shift toward point-of-care testing in urgent care centers, pharmacies, and home environments is reshaping the US diagnostic landscape and expanding market opportunities beyond traditional hospital settings.
US Point of Care Diagnostics Market Dynamics
- The market benefits from favorable reimbursement policies, growing consumer preference for convenient testing options, and the integration of digital health technologies with POC devices. Key growth catalysts include the rising burden of chronic diseases requiring continuous monitoring, post-pandemic emphasis on accessible healthcare infrastructure, and regulatory support for innovative diagnostic devices.
- Strategic investments by major healthcare players and emerging startups are accelerating product development, while partnerships between diagnostic manufacturers and healthcare systems are expanding market penetration across diverse US demographics and geographic regions..
Related Ecosystem
In Vitro Diagnostics
- Polymerase Chain Reaction (PCR)
- Enzyme-Linked Immunosorbent Assay (ELISA)
- Dna Microarrays
- Assay Kits
- Microarrays
- ROCHE HOLDINGS AG
- Thermo Fisher Scientific Inc.
- Danaher Corporation
- Abbott Laboratories
- Biomerieux s.a.
Medical Devices
- Polymerase Chain Reaction (PCR)
- Magnetic Resonance Imaging (MRI)
- Disposable Autoinjectors
- Pulse Oximeters
- Blood Pressure Monitors
- Medtronic plc
- Stryker Corporation
- Abbott Laboratories
- Becton, Dickinson and Company
- JOHNSON & JOHNSON
Key Takeaways
- The US Point of Care Diagnostics Market is valued at $2,532.4 million in 2024 and is forecast to reach $3,665.3 million by 2029 at a 7.7% CAGR.
- The US market is driven by rapid diagnostic demand, chronic disease prevalence, and decentralized healthcare adoption across clinical settings.
- Technological innovation and digital health integration are key growth catalysts for the US market through 2029.
- The US maintains the strongest market position within North America, supported by advanced infrastructure and favorable regulatory frameworks.
Point of Care Diagnostics Market Report Scope
| Report Metric | Details |
|---|---|
| Base Year | 2024 |
| Fastest Growing Segment | INFECTIOUS DISEASE TESTING PRODUCTS (Product) |
| Forecast Period | 2024–2029 |
| Growth Rate | CAGR of 8.5% from 2024 to 2029 |
| Largest Segment | BLOOD SAMPLES (Sample) |
| Market Size Base Year (Billions) | ~USD 15.05 (2024) |
| Revenue Forecast (Billions) | ~USD 22.63 (2029) |
| Segments Covered | Product, Type, Sample, End User, Mode Of Purchase, Technology |
US Point of Care Diagnostics Market Report Segmentation
6 segment dimensions are covered across the global market.
By Product
- Cardiometabolic Monitoring Products
- Cholesterol Testing Products
- Coagulation Monitoring Products
- Drugs-Of-Abuse Testing Products
- Fecal Occult Testing Products
- Glucose Monitoring Products
- Hematology Testing Products
- Infectious Disease Testing Products
- Other Products
- Pregnancy & Fertility Testing Products
- Thyroid Stimulating Hormone Testing Products
- Tumor/Cancer Marker Testing Products
- Urinalysis Testing Products
By Type
- Act/Apit Testing Products
- Blood Gas/ Electrolyte Testing Products
- Cardiac Marker Testing Products
- Chlamydia Trachomatis Testing Products
- Clostridium Difficile Infection Testing Products
- Fertility Testing Products
- Glucose Monitoring Lancets & Lancing Devices
- Glucose Monitoring Meters
- Glucose Monitoring Strips
- Hba1C Testing Products
- Healthcare-Associated Infection Testing Products
- Hepatitis B Testing Products
- Hepatitis C Testing Products
- Hepatitis Testing Products
- Herpes Simplex Virus Testing Products
- Hiv Testing Products
- Human Papillomavirus Testing Products
- Inaat
- Influenza Testing Products
- Meters
- Neisseria Gonorrhea Testing Products
- Neisseria Gonorrhoea Testing Products
- Other Infectious Disease Testing Products
- Other Respiratory Infection Testing Products
- Pregnancy Testing Products
- Pt/Inr Testing Products
- Respiratory Infection Testing Products
- Rt-Pcr
- Sexually Transmitted Disease Testing Products
- Strips
- Syphilis Testing Products
- Tropical Disease Testing Products
- Tuberculosis
By Sample
- Blood Samples
- Nasal & Oropharyngeal Swabs
- Other Samples
- Urine Samples
By End User
- Ambulatory Care Facilities And Physician Offices
- Clinical Laboratories
- Home Care Settings And Self-Testing
- Hospitals, Critical Care Centers, And Urgent Care Centers
- Other End Users
By Mode Of Purchase
- Otc Testing Products
- Prescription-Based Testing Products
By Technology
- Biochemistry
- Immunoassays
- Molecular Diagnostics
Target Audience
- Diagnostic Device Manufacturers : Manufacturers need US-specific market data to guide product development, market entry strategies, and competitive positioning in the rapidly expanding point-of-care diagnostics segment.
- Healthcare System Executives : Hospital networks and healthcare providers require market insights to evaluate POC diagnostic adoption, budget allocation for decentralized testing infrastructure, and vendor selection criteria.
- Investment & Private Equity Firms : Investors need comprehensive US market analysis to identify acquisition targets, assess growth potential of diagnostic startups, and evaluate portfolio companies in the POC diagnostics space.
- Pharmaceutical & Biotech Companies : Companies developing companion diagnostics and integrated testing solutions need US market data to understand adoption barriers, reimbursement landscapes, and commercialization pathways.
- Healthcare Consultants & Analysts : Consultants advising healthcare organizations require detailed US market intelligence to develop strategy recommendations, competitive analyses, and technology adoption roadmaps for clients.
Key Companies in the US Point of Care Diagnostics Market
| Company | HQ | Ownership | Strongest segments |
|---|---|---|---|
| CEPHEID INC. | United States | Private Company | Infectious Disease POC (TB, HAI, STD, virology),Oncology and Genetics POC / near-patient MDx,Other POC (including emergency use, emerging pathogens such as Ebola), |
| UNILABS | Switzerland | Private Company | Glucose POC (primarily hospital and clinic-based),Infectious Disease POC (TB, HAI, STD),Pregnancy and Fertility-Linked POC, |
| EIKEN CHEMICAL CO., LTD. | Japan | Public Company | Glucose (POC),Infectious Disease POC (TB, HAI, STD and others),Pregnancy and other immunological POC tests, |
| ABBOTT | United States | Public Company | Glucose (POC and home monitoring within scope),Infectious Disease POC (including TB, HAI, STD, respiratory, HIV, others),Pregnancy and fertility POC, |
| SIEMENS HEALTHINEERS AG | Germany | Public Company | Glucose (Rx and OTC POC),Infectious Disease POC (TB, HAI, STD and others),Pregnancy and Fertility POC, |
| DANAHER | United States | Public Company | Glucose POC,Infectious Disease POC (incl. TB, HAI, STD),Pregnancy and Fertility POC, |
| QUIDELORTHO CORPORATION | United States | Public Company | POC Infectious Disease (incl. TB, HAI, STD, respiratory),POC Pregnancy and Fertility,POC Glucose and Metabolic, |
| BD | United States | Public Company | Glucose POC,Infectious Disease POC (TB, HAI, STD),Pregnancy and Other POC, |
| THERMO FISHER SCIENTIFIC INC. | United States | Public Company | Glucose POC,Infectious Disease POC (TB, HAI, STD and others),Pregnancy and Fertility POC, |
| BIOMéRIEUX | France | Public Company | Infectious Disease POC (TB, HAI, STD, respiratory via BIOFIRE/SPOTFIRE, ARGENE near-patient use),Pregnancy and other immunoassay POC (VIDAS and related markers in near-patient settings),Glucose and basic biochemistry POC, |
| BIOSYNEX SA | France | Public Company | Glucose POC,Infectious Disease POC (TB, HAI, STD and others),Pregnancy and Fertility POC, |
| EKF DIAGNOSTICS HOLDINGS PLC | United Kingdom | Public Company | Glucose and Lactate Analyzers (Biosen, Lactate Scout, related),HbA1c and Hemoglobin POC Analyzers (Quo-Lab, Quo-Test, DiaSpect, Hemo Control, Hemo Vet),Pregnancy and Fertility (QuPID, True20, Creamatocrit Plus), |
| TRINITY BIOTECH | Ireland | Public Company | Glucose / Diabetes (incl. HbA1c-linked POC),Infectious Disease POC (TB, HAI, STD, viral),Pregnancy and Fertility POC, |
| BODITECH MED INC. | South Korea | Public Company | Glucose (POC),Infectious Disease (TB, HAI, STD, COVID-19 and others),Pregnancy and Fertility, |
CEPHEID INC.
CEPHEID INC. is a United States-based private company founded in 1996 with 1,700 employees specializing in molecular diagnostics.
UNILABS
UNILABS is a Swiss private company established in 1987 that operates clinical laboratory services with 1,897 employees.
EIKEN CHEMICAL CO., LTD.
EIKEN CHEMICAL CO., LTD. is a Japanese public company founded in 1939 with 696 employees engaged in chemical and diagnostic manufacturing.
ABBOTT
ABBOTT is a United States-based public company founded in 1888 with 115,000 employees operating in healthcare and diagnostics.
SIEMENS HEALTHINEERS AG
SIEMENS HEALTHINEERS AG is a German public company founded in 1896 with 72,369 employees providing medical technology and diagnostics solutions.
DANAHER
DANAHER is a United States-based public company founded in 1969 with 59,000 employees operating in diagnostics and life sciences.
QUIDELORTHO CORPORATION
QUIDELORTHO CORPORATION is a United States public company founded in 1979 with 6,500 employees specializing in diagnostic testing.
BD
BD is a United States-based public company founded in 1897 with 72,000 employees in medical technology and diagnostics.
THERMO FISHER SCIENTIFIC INC.
THERMO FISHER SCIENTIFIC INC. is a United States public company founded in 1956 with 125,000 employees providing life sciences and diagnostics solutions.
BIOMéRIEUX
BIOMéRIEUX is a French public company founded in 1963 with 14,894 employees specializing in in vitro diagnostics.
BIOSYNEX SA
BIOSYNEX SA is a French public company founded in 2005 with 397 employees in the diagnostic testing sector.
EKF DIAGNOSTICS HOLDINGS PLC
EKF DIAGNOSTICS HOLDINGS PLC is a United Kingdom public company founded in 1990 with 301 employees in clinical diagnostics.
TRINITY BIOTECH
TRINITY BIOTECH is an Irish public company founded in 1992 with 287 employees engaged in diagnostic product development.
BODITECH MED INC.
BODITECH MED INC. is a South Korean public company founded in 1998 with 541 employees in diagnostic device manufacturing.
Reasons to Buy this Report
- Market Size & Growth Data : Access precise US market valuation ($2,532.4M in 2024) and verified forecast projections through 2029, enabling accurate financial planning and investment decisions for market participants.
- Competitive Landscape Intelligence : Understand market dynamics specific to the US healthcare system, including key players, market consolidation trends, and competitive positioning within the decentralized diagnostics segment.
- Segment & Application Insights : Identify high-growth US market segments including chronic disease monitoring, infectious disease testing, and home-based diagnostics with detailed demand drivers and adoption patterns.
- Regulatory & Reimbursement Analysis : Gain clarity on US FDA approval pathways, Medicare/Medicaid reimbursement policies, and state-level regulations affecting POC diagnostic commercialization and market expansion strategies.
- Strategic Growth Opportunities : Discover emerging opportunities in underserved US markets, partnership potential with healthcare systems, and technology integration trends shaping the future of point-of-care diagnostics.
Frequently asked questions
What is the current size of the US Point of Care Diagnostics Market?
The US Point of Care Diagnostics Market is valued at $2,532.4 million in 2024.
What is the projected market size for the US by 2029?
The US Point of Care Diagnostics Market is projected to reach $3,665.3 million by 2029.
What is the CAGR for the US Point of Care Diagnostics Market?
The US market is expected to grow at a compound annual growth rate (CAGR) of 7.7% from 2024 to 2029.
What are the primary drivers of growth in the US market?
Key growth drivers in the US include increasing demand for rapid diagnostics, rising chronic disease prevalence, decentralized healthcare adoption, technological innovation, and favorable regulatory support.
How does the US market compare to the global Point of Care Diagnostics Market?
The US represents a significant portion of the North American market and maintains the strongest market position in the region, driven by advanced healthcare infrastructure and high adoption rates of point-of-care testing solutions.
RESEARCH METHODOLOGY
The study involved major activities to estimate the current market size of the Point of Care diagnostics market. Exhaustive secondary research was conducted to gather information on the market. 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 POC diagnostics market.
Secondary Research
This research study involved the extensive use of secondary sources, directories, databases such as Dun & Bradstreet, Bloomberg Businessweek, and Factiva, white papers, and Companies House documents. Secondary research was undertaken to identify and collect information for this extensive, technical, market-oriented, and commercial study of the POC diagnostics market. It was also used to obtain important information about the top players, market classification, and segmentation according to industry trends to the bottom-most level, geographic markets, and key developments related to the market. A database of the key industry leaders was also prepared using secondary research.
Primary Research
In the primary research process, various supply- and demand-side sources were interviewed to obtain qualitative and quantitative information for this report. Primary sources from the supply side included industry experts such as CEOs, VPs/Managing Directors, Marketing Heads/Directors, Sales Directors, Marketing/Sales Managers, Regional/Area Sales Managers, Export/Import Heads/Managers, and Other Market-Related Personnel from various companies and organizations operating in the POC diagnostics market. Primary sources from the demand side included Law Enforcement Agencies, Vice Presidents, C-level Executives, Department Heads, Enterprises, Individuals, Supply Management Teams of Hospitals, Clinic Personnel, and Laboratory Technicians.
Note 1: C-level primaries include CEOs, COOs, CTOs, and VPs.
Note 2: Other primary roles include sales, marketing, and product management.
Note 3: Companies are classified into tiers based on their total revenue. As of 2025: Tier 1 = >USD 1 billion, Tier 2 = USD 500 million to USD 1 billion, and Tier 3 = <USD 500 million.
To know about the assumptions considered for the study, download the pdf brochure
Market Size Estimation
Both top-down and bottom-up approaches were used to estimate and validate the total size of the POC 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:
Data Triangulation
The entire market was split into two segments when the market size was determined. Data triangulation and market breakdown were used as needed to complete the market engineering process and derive precise statistics for all segments.
Approach for deriving the market size and estimating market growth:
Using secondary data from paid and unpaid sources, the market rankings for the major players were determined through a thorough analysis of their POC diagnostic sales. Due to data restrictions, the revenue share in certain cases was determined after a thorough analysis of the product portfolio of big corporations and their individual sales performance. This information was verified at each stage by in-depth interviews with professionals in the field.
Market Definition
Point-of-care (POC) diagnostics refers to diagnostic testing performed at or near the patient's location, delivering rapid and accurate results to support immediate clinical decision-making. The market includes products such as blood glucose monitoring systems, infectious disease tests, cardiac biomarker assays, coagulation testing, blood gas and electrolyte analyzers, molecular diagnostics, pregnancy and fertility tests, urinalysis, and other rapid diagnostic solutions, serving hospitals, clinical laboratories, physician offices, ambulatory care facilities, retail clinics, pharmacies, and home healthcare settings.
Key Stakeholders
- Diagnostic device manufacturers
- Reagent and consumable suppliers
- Hospitals and clinical laboratories
- Physician offices and ambulatory care centers
- Pharmacies and home healthcare providers
- Medical device distributors
- Regulatory authorities
- Government and public health agencies
- Research organizations
- Healthcare IT providers
Report Objectives
- To describe, analyze, and forecast the POC diagnostics market, by product, sample, mode of purchase, technology, end user, and region
- To describe and forecast the POC diagnostics market for key regions, namely, North America, Europe, the Asia Pacific, Latin America and Middle East, and Africa
- To provide detailed information regarding drivers, restraints, opportunities, and challenges influencing the growth of the POC diagnostics market
- To strategically analyze the ecosystem, regulations, patenting trend, value chain, Porter’s five forces, and prices pertaining to the market under study
- To strategically analyze micromarkets1 with respect to individual growth trends, prospects, and contributions to the overall market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for market players
- To profile key players and comprehensively analyze their market shares and core competencies2 in the POC diagnostics market
- To analyze competitive developments such as collaborations, acquisitions, product launches, expansions, and R&D activities in the POC diagnostics market
Available customizations:
With the given market data, MarketsandMarkets offers customizations as per your company’s specific needs. The following customization options are available for the report:
Company Information
- Detailed analysis and profiling of additional market players (up to 5)
Product Analysis
- Product matrix, which gives a detailed comparison of the product portfolios of each company
Geographic Analysis
- Further breakdown of the Rest of Asia Pacific POC diagnostics market into Vietnam, New Zealand, and other markets.
- Further breakdown of the Rest of Latin America POC diagnostics market into Colombia, Chile, Ecuador, and others.
- Further breakdown of the Rest of Europe POC diagnostics market into Belgium, Russia, the Netherlands, Switzerland, and others.
Get the Full Point of Care Diagnostics Market Report
Full forecast, segment splits, and company analysis for all Point of Care Diagnostics Market.
- Canada Point of Care Diagnostics Market
- Germany Point of Care Diagnostics Market
- France Point of Care Diagnostics Market
- UK Point of Care Diagnostics Market
- Italy Point of Care Diagnostics Market
- Spain Point of Care Diagnostics Market
- China Point of Care Diagnostics Market
- Japan Point of Care Diagnostics Market
- India Point of Care Diagnostics Market
- Australia Point of Care Diagnostics Market
- South Korea Point of Care Diagnostics Market
- Brazil Point of Care Diagnostics Market
- Mexico Point of Care Diagnostics Market
Need a Tailored Report?
Customize this report to your needs
Get 10% FREE Customization
Customize This Report