Market Scenario 

Point-of-care testing market was valued at US$ 46.48 million in 2024 and is projected to hit the market valuation of US$ 85.55 million by 2033 at a CAGR of 7.33% during the forecast period 2025–2033.

The point-of-care testing market is experiencing unprecedented growth, fundamentally reshaping healthcare delivery through decentralization. This expansion is primarily fueled by the increasing prevalence of chronic diseases requiring constant monitoring and the pressing need for rapid diagnostics in managing infectious diseases. A key indicator of this shift is the dramatic increase in adoption, with 68,000 healthcare facilities globally implementing POCT programs in 2024, a significant jump from 42,000 in 2020. This move away from traditional, centralized laboratories is empowering clinicians with immediate, actionable data, which is crucial for conditions like diabetes, where millions of patients rely on daily POCT, and for the rapid triage of cardiac events. The market's strong foundation is built on improving patient access and speeding up critical care decisions.

Fueling the expansion of the point-of-care testing market is a wave of technological innovation and regulatory support. In 2024 alone, the FDA cleared 67 new point-of-care devices, signaling a robust pipeline of new technologies. These advancements are not just incremental; they include AI-integrated devices for enhanced data analysis and a significant push towards connectivity with Electronic Health Records (EHRs) to streamline clinical workflows. This technological surge is extending the reach of POCT beyond hospitals into more accessible settings like community pharmacies and rural clinics. Furthermore, the development of multiplex assays, which can detect multiple pathogens from a single sample, is revolutionizing infectious disease diagnostics by providing comprehensive results with the speed of a single test.

Looking ahead, the outlook for the point-of-care testing market remains exceptionally strong, with projections valuing it at US$ 85.55 billion in 2033. This continued momentum is driven by tangible benefits: faster diagnosis for influenza and other respiratory illnesses, reduced turnaround times in emergency departments, and improved management of chronic conditions in remote and home-care settings. The convergence of rising patient demand, continuous technological advancement, and a favorable regulatory landscape ensures that point-of-care testing will become an even more integral component of the global healthcare ecosystem, ultimately leading to more efficient, accessible, and effective patient care. 

To Get more Insights,  Request A Free Sample 

Market Dynamics 

Top Test Categories Gaining Momentum in the Point-Of-Care Testing Market:

• Use of point of care testing for COVID-19 Testing (2024): Approximately 60% of COVID-19 testing performed in non-hospital settings is expected to be POCT.
• Point of Care Testing for Influenza Diagnosis: Expected to be used in over 80% of suspected cases for faster diagnosis.
• Rapid Strep Tests Usage: Anticipated to exceed 50 million tests annually.
• Cardiac Marker Point Of Care Testing Usage: The use of cardiac marker point of care tests in ambulances will increase by 15%.
• Point of Care Testing for Glucose Monitoring: Over 35 million patients with diabetes will regularly monitor their glucose levels using POCT devices.

Top Technological Advancements Shaping Growth of the Point-Of-Care Testing Market

• Adoption of Connected Point Of Care Testing Devices (2024): The integration of devices with electronic health records (EHRs) will rise by 20%.
• Number of Point Of Care Testing Devices with Smartphone Connectivity: Expected to increase by 30%.
• Increase in Multiplex POCT assays: The availability of tests capable of detecting multiple analytes simultaneously will increase by 25%.
• Artificial intelligence integration: Number of POCT devices using AI to analyze results and provide clinical decision support will increase by 10%.
• Cloud-based data sharing for POCT results: Usage of cloud based data sharing for POCT results will increase by 35%.

Titans Clash and Innovators Rise: The New Competitive Era of Point-of-Care Testing

The competitive landscape for the point-of-care testing market in 2025 is intensely dynamic, characterized by aggressive strategic maneuvers, technological disruption, and the opening of entirely new market fronts. Large, established players are actively reshaping the industry through major acquisitions to consolidate power and fill technological gaps. This is evidenced by Roche's acquisition of LumiraDx's POCT platform for approximately $295 million. This trend of consolidation is complemented by sharp strategic pivots, such as QuidelOrtho's decision to discontinue its Savanna platform in favor of acquiring LEX Diagnostics, highlighting how companies are making decisive moves to back the most competitive and high-performing technologies in a crowded field.

The battle for market share in the point-of-care testing is increasingly being fought on new technological and consumer-facing fronts. The traditional clinical setting is no longer the sole focus, as companies race to innovate in several key areas:

• The "At-Home" Revolution: A major disruptive force is the direct-to-consumer market, which is projected to grow from approximately $7.8 billion in 2025 to over $11.8 billion by 2035. The FDA's clearance of the first over-the-counter dual test for influenza and COVID-19 in February 2025 has intensified competition in this lucrative space.
• AI and Digital Pathology: Artificial intelligence is emerging as a critical competitive differentiator. Roche’s receipt of an FDA Breakthrough Device Designation in April 2025 for its AI-driven pathology diagnostic illustrates how advanced data analysis is becoming a new frontier for accuracy and innovation.
• Rapid Molecular Diagnostics: The demand for lab-quality accuracy at the point of care is driving significant growth in molecular POCT, with projections suggesting a CAGR of 27%. Companies are launching rapid PCR systems, such as Nuclein's Dash which delivers results in 15 minutes, to capture this high-growth segment.
• Miniaturization for Critical Care: Competition is also extending to portable, high-acuity diagnostics. Siemens Healthineers' showcase of its Somatom On.site mobile CT scanner in 2025 for in-ambulance stroke diagnosis underscores the push to bring sophisticated testing directly to the patient in emergency situations.

Segmental Analysis 

Testing Kits & Consumables to Continue Leading the Market With over 65.55% Market Share

Testing kits and consumables dominate the global point-of-care testing market due to their recurring purchase nature and essential role in diagnostic procedures, with each test requiring fresh supplies regardless of equipment availability. The most prominent consumables include glucose test strips, generating US$ 12.8 billion in annual revenue, lateral flow immunoassay cartridges worth US$ 8.4 billion, and blood gas analysis cartridges commanding US$ 3.2 billion globally. Coagulation monitoring strips, pregnancy test kits, and cardiac marker cassettes collectively contribute another US$ 9.7 billion to the consumables segment. Unlike equipment that requires one-time capital investment lasting 5-7 years, consumables generate continuous revenue streams as healthcare facilities perform millions of tests daily. Major hospitals report spending US$ 2.4 million annually on consumables versus US$ 800,000 on equipment amortized over multiple years.

The consumables segment benefits from technological innovations that enhance test accuracy while reducing costs, making them increasingly accessible across healthcare settings. Advanced manufacturing processes have reduced production costs by US$ 0.82 per unit since 2020, enabling broader market penetration. In the global point-of-care testing market, consumables maintain higher profit margins, with manufacturers reporting 4.2 times greater returns compared to equipment sales The shift toward value-based healthcare models drives consumables adoption, as providers seek cost-effective solutions for routine testing. Strategic partnerships between manufacturers and healthcare systems ensure steady consumables supply, with long-term contracts worth US$ 18.3 billion signed in 2024 alone. This dominance reflects the fundamental healthcare reality that while equipment provides the platform, consumables deliver the actual diagnostic capability required for patient care.

Immunological PoC Tests Market Leadership to Continue Contributing Over 41.41% Market Revenue 

Immunological point-of-care tests command significant market share in the global point-of-care testing market by addressing critical diagnostic needs across infectious diseases, cardiac conditions, and pregnancy monitoring with rapid, accurate results Major immunological tests include rapid HIV antibody tests processing 89 million samples annually, hepatitis screening assays conducting 67 million tests, and COVID-19 antigen tests performing over 1.2 billion analyses worldwide. Cardiac troponin tests, utilized in 45 million emergency department visits yearly, enable immediate heart attack diagnosis, while pregnancy tests remain the highest volume consumer application with 380 million units sold annually. These tests leverage antibody-antigen interactions to deliver results within 15 minutes, eliminating laboratory delays that could compromise patient outcomes. The technology's versatility allows adaptation across multiple disease states, creating economies of scale that reduce per-test costs to US$ 2.85 compared to US$ 18.50 for laboratory equivalents.

Key end-users driving immunological test demand include emergency departments performing 127 million annual tests, primary care clinics conducting 203 million screenings, and community health centers processing 94 million tests in underserved areas. The global point-of-care testing market benefits from immunological tests' simplicity, requiring minimal training for healthcare workers to achieve laboratory-comparable accuracy Regulatory approvals accelerate market growth, with 234 new immunological tests receiving clearance in 2024 across major markets. Investment in immunological test development reached US$ 4.7 billion in 2024, focusing on multiplex panels that simultaneously detect multiple pathogens. Healthcare systems report US$ 156 average savings per patient through immunological point-of-care testing, combining reduced laboratory costs, faster treatment initiation, and decreased hospital stays, solidifying these tests' position as essential diagnostic tools.

Infectious Diseases Indication Dominance to Stay Leading with Over 31.30% Market Share

Infectious diseases represent the largest indication in the global point-of-care testing market due to their acute nature requiring immediate diagnosis and treatment initiation to prevent transmission and complications. Global infectious disease burden remains substantial, with 1.6 billion respiratory infections, 296 million hepatitis B cases, 58 million hepatitis C infections, and 38.4 million HIV cases driving continuous testing demand. Annual testing volumes reach staggering numbers: 2.8 billion tests for respiratory pathogens, 890 million sexually transmitted infection screenings, and 1.4 billion gastrointestinal pathogen tests performed worldwide. The COVID-19 pandemic fundamentally transformed infectious disease testing paradigms, establishing decentralized diagnostics as standard practice rather than emergency response. Healthcare systems now maintain permanent point-of-care testing infrastructure, with US$ 23.7 billion invested in infectious disease diagnostic capacity during 2023-2024.

The segment's dominance stems from multiple factors including disease transmissibility, public health mandates, and treatment urgency that cannot accommodate traditional laboratory turnaround times. Rapid identification enables immediate isolation protocols, targeted therapy, and contact tracing, particularly critical in densely populated areas where 4.4 billion people face elevated transmission risks. In the global point-of-care testing market, infectious disease applications benefit from continuous innovation, with molecular diagnostics reducing detection times from days to 20 minutes Government funding programs allocate US$ 31.2 billion globally for infectious disease surveillance and testing, ensuring sustainable market growth. Emerging infectious disease threats, antimicrobial resistance patterns requiring 156 million susceptibility tests annually, and seasonal epidemics affecting 1 billion people maintain constant demand. This combination of high disease prevalence, public health imperatives, and technological advancement cements infectious diseases' position as the dominant point-of-care testing indication.

Prescription-Based Testing Control the Largest 53.25% Market Share

Prescription-based testing maintains dominance in the global point-of-care testing market through regulatory requirements ensuring appropriate test utilization and clinical oversight for complex diagnostic procedures Major prescription-based tests include hemoglobin A1c monitoring for 537 million diabetics worldwide, generating US$ 8.9 billion annually; anticoagulation monitoring through PT/INR testing for 42 million patients, worth US$ 3.4 billion; and comprehensive metabolic panels performed 267 million times yearly, representing US$ 5.8 billion in market value. Cardiac biomarker panels, thyroid function tests, and specialized infectious disease confirmatory assays collectively add US$ 11.2 billion to prescription-based revenues. Healthcare systems mandate physician authorization to prevent inappropriate testing, ensure proper result interpretation, and maintain quality standards that protect patient safety while optimizing resource utilization.

The prescription model's dominance reflects healthcare's professional oversight requirements and reimbursement structures that tie payment to physician orders. Insurance providers processed US$ 28.7 billion in prescription-based point-of-care test claims during 2024, while denying 3.8 million unauthorized test reimbursements. Clinical guidelines from 47 major medical societies specify prescription requirements for diagnostic tests affecting treatment decisions. In the global point-of-care testing market, prescription-based testing benefits from integrated electronic health records that streamline ordering, result reporting, and clinical decision support. Regulatory frameworks in 82 countries mandate prescription requirements for tests with significant clinical implications, reinforcing market dynamics. The model ensures continuity of care, with 94 million test results automatically transmitted to ordering physicians for interpretation and follow-up, maintaining healthcare quality standards while supporting the growing demand for decentralized diagnostics.

 To Understand More About this Research:  Request A Free Sample 

Regional Analysis 

North America: The Largest Point-of-Care Testing Market

North America dominates the global point-of-care testing market with revenues exceeding US$ 18,648.82 million in 2024, driven by advanced healthcare infrastructure, high per-capita healthcare spending of US$ 12,914 annually, and widespread insurance coverage affecting 287 million individuals. The region benefits from robust regulatory frameworks facilitating rapid product approvals, with the FDA clearing 67 new point-of-care devices in 2024 alone. Major healthcare systems including Mayo Clinic, Cleveland Clinic, and Johns Hopkins have invested US$ 3.8 billion collectively in point-of-care infrastructure, establishing 45,000 testing sites across hospitals, clinics, and pharmacies. The presence of leading manufacturers such as Abbott, Danaher, and Thermo Fisher Scientific, headquartered in the region, creates innovation ecosystems generating 234 patents annually. Additionally, government initiatives allocating US$ 8.7 billion for diagnostic preparedness and Medicare reimbursements covering 42 million beneficiaries ensure sustained market growth.

United States: The Largest Single Country Market

The United States represents the largest single-country global point-of-care testing market by performing 1.8 billion tests annually across 6,090 hospitals and 238,000 physician offices. American healthcare's unique dynamics, including immediate diagnostic expectations and litigation concerns driving defensive medicine practices, result in 3.2 tests per capita annually compared to 1.7 in other developed nations. The country's investment in diagnostic innovation reaches US$ 5.4 billion yearly, with Silicon Valley and Boston emerging as diagnostic technology hubs housing 312 point-of-care startups. Major retail pharmacy chains CVS, Walgreens, and Walmart operate 21,000 locations offering point-of-care services, democratizing access for 198 million Americans. Federal programs including BARDA provide US$ 2.1 billion in funding for next-generation diagnostic development, maintaining technological leadership.

Asia Pacific: The Fastest Growing Regional Market

Asia Pacific emerges as the fastest-growing region in the global point-of-care testing market at a CAGR of 8.27%, with investments reaching US$ 5 billion in 2024 as countries modernize healthcare infrastructure to serve 4.6 billion residents China leads regional expansion with 34,000 new primary care centers implementing point-of-care diagnostics, while India's Ayushman Bharat program covers 500 million citizens requiring accessible testing. Japan's aging society of 36 million elderly drives sophisticated home-testing adoption worth US$ 3.2 billion annually. Southeast Asian nations collectively invested US$ 6.7 billion in diagnostic capabilities, with Indonesia, Thailand, and Vietnam establishing 12,000 rural testing facilities. The region benefits from local manufacturing reducing costs by US$ 4.30 per test, technology transfer agreements worth US$ 2.8 billion, and government mandates requiring point-of-care capabilities in 156,000 healthcare facilities, positioning Asia Pacific to surpass North America by 2033.

Key Developments in Point-of-Care Testing (2024-2025)

Mergers & Acquisitions:

• Roche Acquires LumiraDx's POC Platform: In a significant move, Roche completed its acquisition of LumiraDx's point-of-care technology platform in July 2024 for $295 million, with an additional $55 million in development funding. This acquisition is set to enhance Roche's diagnostic offerings across various fields.
• Clearbridge Health to Acquire Elpis Biopharmaceuticals: Singapore-based Clearbridge Health has entered into a binding agreement to acquire Elpis Biopharmaceuticals for $330 million. The deal is anticipated to close in 2025 and will integrate Elpis's cancer therapies into Clearbridge's portfolio.

Significant Funding Rounds:

• AMDI's NIH Grant: Autonomous Medical Devices Incorporated (AMDI) secured a $5.3 million grant from the National Institutes of Health (NIH) in February 2024. This funding is aimed at advancing their rapid PCR point-of-care system for viral testing.
• Binx Health's Series F: Diagnostics company Binx Health raised $65 million in a Series F financing round in April 2024 to fuel the growth of its point-of-care testing solutions.
• CARB-X Funds Scout: The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) awarded up to $1 million to Scout in April 2024. The funding will support the development of a low-cost, rapid point-of-care test for gonorrhea.
• Cubit Diagnostics' NIH Funding: In December 2024, Cubit Diagnostics received $2.6 million from the NIH's RADx® Tech program to finalize the development of its Covid/Flu A/Flu B test for clinical trials.
• Exo's Series C and D Funding: Exo raised $43.9 million in a Series D funding round in June 2025. This follows a significant $220 million Series C round to commercialize its handheld ultrasound device and Exo Works platform. There are also reports of a potential new funding round of up to $100 million with Samsung's involvement.
• Tethis's Private Equity Round: In January 2025, Tethis, a cancer diagnostics company, secured €15 million ($15.3 million) in a private equity funding round.

Government & Institutional Initiatives:

• Australian Government's STI Testing Rebate: In July 2024, the Australian government announced ongoing funding to support a Medicare rebate for molecular point-of-care testing for sexually transmissible infections (STIs) in remote Aboriginal and Torres Strait Islander communities.
• European Union's Tender for Antimicrobial Susceptibility Testing: The European Health and Digital Executive Agency (HaDEA) has announced a call for tenders in March 2025 with a budget of approximately €12.86 million. The aim is to fast-track the development of a rapid point-of-care diagnostic device for antimicrobial susceptibility testing.

Top Companies in the Point of Care Testing Market

• Abbott Laboratories
• F. Hoffmann-La Roche Ltd
• Danaher Corporation
• Becton, Dickinson and Company (BD)
• bioMérieux SA
• Bio-Rad Laboratories, Inc.
• Other Prominent Players

Market Segmentation Overview

By Product

• Devices & Instruments
  • Diagnostic Analyzers & Testing Devices
    • Blood Gas & Electrolyte Analyzers
    • Cardiac Biomarker Analyzers
    • Glucose Monitoring Devices
    • Coagulation Testing Analyzers
    • Urinalysis Analyzers
    • Routine Clinical Chemistry Analyzers
    • Others
  • Monitoring Devices
    • Blood Pressure Monitors
    • Thermometers
    • Pulse Oximeters
    • Others
• Testing Kits & Consumables
  • Blood Gas & Electrolyte Test Kits
  • Cardiac Biomarker Test Kits
  • Routine Clinical Chemistry Test Kits
  • Hematology Test Kits Coagulation Testing Kits
  • Urinalysis Test Strips & Kits
  • Cholesterol Test Strips
  • Drugs Abuse Testing Kits
  • Pregnancy And Fertility Testing Kits
  • Others

By Test Type

• Immunological PoC Tests
• Nucleic Acid-Based PoC Tests
• Biomarker-Based PoC Tests

 By Indication

• Infectious Diseases
  • HIV
  • COVID-19
  • Others
• Oncology
• Cardiovascular Diseases
• Metabolic Disorders
• Respiratory Diseases
• Neurological Disorders
• Gastrointestinal Disorders
• Others

By Technology

• Biosensor Technology
• Microfluidic Lab-On-A-Chip Technology
• Molecular Diagnostics
• Immunoassays
• Others

By Sample Type

• Blood
• Urine
• Saliva
• Others

By Mode Of Purchase

• Prescription-based Testing
• Over the Counter (OTC) Testing

By End User

• Hospitals & Clinics
• Diagnostic Centers
• Homecare Settings
• Research Laboratories
• Others

By Distribution Channel

• Direct Distribution
• Retail Pharmacies
• Online Pharmacies
• Others

By Region

• North America
  • The U.S.
  • Canada
  • Mexico
• Europe
  • Western Europe
    • The UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Western Europe
  • Eastern Europe
    • Poland
    • Russia
    • Hungary
    • Rest of Eastern Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Australia & New Zealand
  • ASEAN
  • Rest of Asia Pacific
• Middle East
  • UAE
  • Saudi Arabia
  • Bahrain
  • Kuwait
  • Qatar
  • Rest of Middle East
• Africa
  • Morocco
  • Egypt
  • Nigeria
  • South Africa
  • Rest of Africa
• South America
  • Argentina
  • Brazil
  • Rest of South America