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    US Point of Care Diagnostics Testing Market

    ID: MRFR/HC/13100-HCR
    100 Pages
    MRFR Team
    October 2025

    United States Point of Care Diagnostics Testing Market Research Report to 2032

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    US Point of Care Diagnostics Testing Market Infographic
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    US Point of Care Diagnostics Testing Market Summary

    As per MRFR analysis, the US point of-care-diagnostics-testing market Size was estimated at 15.5 USD Billion in 2024. The US point of-care-diagnostics-testing market is projected to grow from 16.99 USD Billion in 2025 to 42.5 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 9.6% during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The US point-of-care diagnostics testing market is poised for substantial growth driven by technological advancements and increasing consumer demand.

    • Technological advancements are enhancing the accuracy and speed of point-of-care diagnostics, making them more accessible.
    • The largest segment in the market is the infectious disease testing segment, which continues to dominate due to ongoing health concerns.
    • The fastest-growing segment is the chronic disease testing segment, reflecting a shift towards early detection and management.
    • Rising prevalence of chronic diseases and increased focus on preventive healthcare are key drivers propelling market expansion.

    Market Size & Forecast

    2024 Market Size 15.5 (USD Billion)
    2035 Market Size 42.5 (USD Billion)

    Major Players

    Abbott Laboratories (US), Roche Diagnostics (CH), Siemens Healthineers (DE), Danaher Corporation (US), Thermo Fisher Scientific (US), Becton Dickinson and Company (US), Cepheid (US), Quidel Corporation (US), Hologic Inc. (US)

    US Point of Care Diagnostics Testing Market Trends

    The point of-care-diagnostics-testing market is currently experiencing notable growth, driven by advancements in technology and an increasing demand for rapid testing solutions. This market encompasses a variety of diagnostic tests that can be performed at or near the site of patient care, allowing for immediate results. The convenience and speed of these tests are appealing to both healthcare providers and patients, as they facilitate timely decision-making and treatment. Furthermore, the ongoing emphasis on personalized medicine and patient-centered care is likely to enhance the adoption of point-of-care diagnostics, as these tests can be tailored to individual patient needs. In addition, regulatory support and innovation in test development are contributing to the expansion of the point of-care-diagnostics-testing market. The U.S. Food and Drug Administration (FDA) has been actively streamlining the approval process for new diagnostic devices, which encourages manufacturers to invest in research and development. As a result, a diverse range of tests, including those for infectious diseases, chronic conditions, and genetic disorders, are becoming available. This trend suggests a promising future for the market, as stakeholders continue to seek efficient and effective diagnostic solutions that enhance patient outcomes.

    Technological Advancements

    Recent innovations in technology are transforming the point of-care-diagnostics-testing market. The integration of artificial intelligence and machine learning into diagnostic devices is enhancing accuracy and efficiency. These advancements enable healthcare professionals to obtain reliable results quickly, which is crucial for effective patient management.

    Regulatory Support

    Regulatory bodies are playing a pivotal role in the growth of the point of-care-diagnostics-testing market. Streamlined approval processes by the FDA are encouraging the introduction of new diagnostic tests. This support fosters innovation and allows for a wider array of testing options to be available to healthcare providers.

    Increased Demand for Rapid Testing

    There is a growing demand for rapid testing solutions within the point of-care-diagnostics-testing market. Patients and healthcare providers are increasingly prioritizing quick results to facilitate timely treatment decisions. This trend is likely to drive further investment in the development of efficient diagnostic tools.

    US Point of Care Diagnostics Testing Market Drivers

    Shift Towards Home Healthcare

    The shift towards home healthcare is transforming the landscape of the point of-care-diagnostics-testing market. With an increasing number of patients preferring to receive care in the comfort of their homes, there is a growing demand for portable and user-friendly diagnostic devices. This trend is supported by advancements in technology that enable accurate testing outside traditional clinical settings. The US home healthcare market is projected to grow at a CAGR of 8% from 2025 to 2030, indicating a robust demand for point-of-care testing solutions. As patients seek convenience and efficiency, healthcare providers are likely to adopt these technologies to facilitate remote monitoring and management of health conditions. This evolution not only enhances patient satisfaction but also drives the expansion of the point of-care-diagnostics-testing market, as more individuals gain access to timely and effective diagnostic services.

    Rising Prevalence of Chronic Diseases

    The increasing incidence of chronic diseases in the US is a pivotal driver for the point of-care-diagnostics-testing market. Conditions such as diabetes, cardiovascular diseases, and respiratory disorders necessitate regular monitoring and timely interventions. According to the Centers for Disease Control and Prevention (CDC), chronic diseases account for approximately 7 out of 10 deaths each year, highlighting the urgent need for effective diagnostic solutions. The demand for point-of-care testing is likely to surge as healthcare providers seek to offer immediate results and personalized care. This trend not only enhances patient outcomes but also reduces the burden on healthcare facilities, thereby propelling the growth of the point of-care-diagnostics-testing market. As the population ages and the prevalence of these diseases rises, the market is expected to expand significantly, potentially reaching a valuation of $50 billion by 2027.

    Increased Focus on Preventive Healthcare

    The growing emphasis on preventive healthcare is a significant driver for the point of-care-diagnostics-testing market. As healthcare systems in the US shift from reactive to proactive approaches, there is a heightened demand for early detection and monitoring of diseases. Preventive measures can lead to better health outcomes and reduced healthcare costs. The US healthcare expenditure on preventive services is expected to rise, with estimates suggesting an increase of 5% annually over the next five years. This trend encourages the adoption of point-of-care testing, as it allows for immediate results and timely interventions. By facilitating early diagnosis, these tests can potentially reduce the incidence of severe health complications, thereby driving the growth of the point of-care-diagnostics-testing market. The integration of these services into routine healthcare practices is likely to become more prevalent, further enhancing market dynamics.

    Rising Consumer Awareness and Engagement

    The rising consumer awareness regarding health and wellness is a notable driver for the point of-care-diagnostics-testing market. As individuals become more informed about their health, there is a growing demand for accessible and reliable diagnostic solutions. This trend is reflected in the increasing popularity of health apps and wearable devices that facilitate self-monitoring. According to a recent survey, approximately 60% of US consumers express interest in using point-of-care testing for routine health checks. This heightened engagement encourages healthcare providers to incorporate point-of-care diagnostics into their services, thereby enhancing patient access to timely testing. The point-of-care diagnostics testing market is likely to benefit from this trend, as more consumers seek convenient and efficient ways to manage their health. The potential for increased patient participation in their healthcare journey may lead to improved health outcomes and a more proactive approach to health management.

    Technological Integration in Healthcare Systems

    The integration of advanced technologies into healthcare systems is a crucial driver for the point of-care-diagnostics-testing market. Innovations such as artificial intelligence, machine learning, and telemedicine are reshaping how diagnostic tests are conducted and interpreted. These technologies enhance the accuracy and efficiency of point-of-care testing, enabling healthcare providers to make informed decisions rapidly. The US healthcare technology market is projected to reach $500 billion by 2026, indicating a robust investment in innovative solutions. As healthcare providers increasingly adopt these technologies, the demand for point-of-care diagnostics is likely to grow. This integration not only streamlines workflows but also improves patient engagement and satisfaction, thereby propelling the expansion of the point-of-care diagnostics testing market. The potential for real-time data analysis and remote monitoring further underscores the importance of technological advancements in this sector.

    Market Segment Insights

    By Product: Glucose Monitoring (Largest) vs. Infectious Disease Testing (Fastest-Growing)

    The product segment of the US point-of-care diagnostics testing market is characterized by a diverse range of testing solutions. Glucose Monitoring holds the largest market share among these products, driven by the rising prevalence of diabetes and the increasing demand for self-monitoring blood glucose devices. Other significant contributors include Cardiometabolic Monitoring and Coagulation Monitoring, reflecting growing awareness regarding cardiovascular health and the importance of monitoring blood clotting, respectively. Meanwhile, Infectious Disease Testing, which traditionally has a smaller share, showcases considerable growth due to the heightened focus on rapid testing solutions during health crises and the ongoing need for accurate disease detection. The growth trends within this segment are spurred by advancements in technology, enhancing the accuracy and speed of tests. The surge in chronic conditions has fostered an environment where consumers seek accessible and efficient diagnostics. Innovations in mobile health applications and connected devices are further catalyzing demand, particularly among tech-savvy populations. Additionally, regulatory support and increased investments by healthcare providers to expand testing capabilities are set to drive significant growth in the US point-of-care diagnostics testing market, especially for emerging products like Infectious Disease Testing.

    Glucose Monitoring (Dominant) vs. Infectious Disease Testing (Emerging)

    Glucose Monitoring has established itself as the dominant player in the US point-of-care diagnostics testing market, primarily due to the escalating incidence of diabetes and the increasing recognition of the importance of regular monitoring. This segment encompasses various devices like glucometers and continuous glucose monitors, which allow patients to manage their condition effectively. On the other hand, Infectious Disease Testing is an emerging sector, driven by the urgent need for quick diagnostic solutions, particularly in the wake of public health emergencies. This category includes tests for pathogens such as viruses and bacteria, positioned for rapid results. The contrast between these segments highlights the balancing act of addressing chronic conditions versus emerging public health challenges.

    By End User: Hospitals & Clinics (Largest) vs. Homecare/Self Testing (Fastest-Growing)

    In the US point of-care-diagnostics-testing market, Hospitals & Clinics dominate the segment with the largest market share, driven by the increasing need for rapid testing solutions in emergency situations and routine screenings. Diagnostic Centers follow, catering to a growing patient base that seeks specialized testing services. Homecare/Self Testing is gaining traction, appealing to health-conscious consumers preferring convenience and privacy in managing their health. Growth trends in this segment are fueled by advancements in technology, particularly the rise of telehealth and mobile health applications. The COVID-19 pandemic has significantly accelerated the adoption of Homecare/Self Testing, as more individuals opt for at-home testing kits. Moreover, the increasing prevalence of chronic diseases and the emphasis on preventive healthcare are also contributing to the growth of this segment, enhancing its overall appeal to both consumers and providers.

    Hospitals & Clinics (Dominant) vs. Homecare/Self Testing (Emerging)

    The Hospitals & Clinics segment remains dominant in the US point of-care-diagnostics-testing market, primarily due to their established infrastructures and the ability to handle a high volume of patients requiring immediate diagnostic services. These facilities are equipped with advanced testing technologies and trained professionals who ensure quality care. In contrast, Homecare/Self Testing is an emerging segment that offers significant growth potential, driven by consumer demand for convenience and autonomy in health management. This segment includes various products catering to self-diagnosis and monitoring, enabling patients to take proactive health measures in the comfort of their homes. As product innovations and regulatory approvals progress, Homecare/Self Testing is poised to reshape patient engagement in healthcare.

    By Mode of Purchase: OTC Testing Products (Largest) vs. Prescription-based Testing Products (Fastest-Growing)

    In the US point of-care-diagnostics-testing market, OTC testing products hold a significant portion of the market share, reflecting a strong preference among consumers for convenient and accessible testing options. These products allow end-users to take control of their health monitoring without the need for prescriptions, making them prevalent in various health scenarios, from glucose tracking to pregnancy tests. On the other hand, prescription-based testing products are emerging as the fastest-growing segment, driven by increasing healthcare provider recommendations and advancements in technology. The shift towards personalized medicine and the growing focus on preventive healthcare are key trends fueling the demand for these testing products. As patients and providers recognize the benefits of accurate testing facilitated by prescriptions, this segment is expected to experience substantial growth in the coming years.

    OTC Testing Products (Dominant) vs. Prescription-based Testing Products (Emerging)

    OTC testing products dominate the US point of-care-diagnostics-testing market due to their user-friendly nature and immediate availability at retail outlets, reducing barriers to access. Consumers favor these products for their convenience, affordability, and the ability to conduct tests in privacy. In contrast, prescription-based testing products represent an emerging trend, gaining traction as they offer more precise and comprehensive testing solutions tailored by healthcare professionals. The increasing integration of digital health technologies within these products enhances their market presence, with greater focus on accuracy and reliability. As healthcare systems advocate for early detection and intervention, prescription-based testing is positioned to become an integral component of patient care.

    By Platform: Immunoassays (Largest) vs. Molecular Diagnostics (Fastest-Growing)

    In the US point of-care-diagnostics-testing market, the distribution of market share among various platform segment values highlights the dominance of immunoassays, which maintain the largest portion due to their extensive use in various healthcare settings. Molecular diagnostics, while currently smaller in market share, are rapidly gaining traction and generating significant interest among practitioners and patients alike due to their precise and rapid results. Growth trends in this segment are primarily driven by technological advancements, with molecular diagnostics emerging as a key player offering rapid testing capabilities that are essential in urgent clinical situations. The COVID-19 pandemic has further accelerated the adoption of these advanced diagnostic tools, along with a rising demand for personalized medicine, pushing the market towards innovative and efficient testing solutions.

    Technology: Immunoassays (Dominant) vs. Molecular Diagnostics (Emerging)

    Immunoassays have remained the dominant technology within the US point of-care-diagnostics-testing market, primarily attributed to their ability to provide accurate and quick results for a wide range of tests, including infectious diseases and chronic conditions. These assays are widely recognized for their reliability and ease of use, making them favorable in emergency settings. In contrast, molecular diagnostics are emerging as a significant force, promising enhanced accuracy and the capability to detect pathogens at a genetic level. This advancement positions molecular diagnostics as a future leader in the market, appealing particularly to a growing demographic that prioritizes precision in healthcare interventions.

    Get more detailed insights about US Point of Care Diagnostics Testing Market

    Key Players and Competitive Insights

    The point-of-care diagnostics testing market is characterized by a dynamic competitive landscape, driven by technological advancements, increasing demand for rapid testing solutions, and a growing emphasis on personalized medicine. Major players such as Abbott Laboratories (US), Roche Diagnostics (CH), and Siemens Healthineers (DE) are strategically positioned to leverage these trends. Abbott Laboratories (US) focuses on innovation in its product offerings, particularly in the development of portable testing devices that enhance accessibility. Roche Diagnostics (CH) emphasizes partnerships with healthcare providers to expand its market reach, while Siemens Healthineers (DE) invests heavily in digital transformation initiatives to streamline operations and improve patient outcomes. Collectively, these strategies contribute to a competitive environment that is increasingly centered around technological innovation and strategic collaborations.

    Key business tactics within the market include localizing manufacturing to reduce costs and optimize supply chains, which is particularly relevant in the context of fluctuating global trade dynamics. The market structure appears moderately fragmented, with several key players holding substantial market shares. This fragmentation allows for a diverse range of products and services, fostering competition that drives innovation and enhances customer choice.

    In October 2025, Abbott Laboratories (US) announced the launch of a new rapid diagnostic test for infectious diseases, which is expected to significantly reduce the time required for results. This strategic move not only reinforces Abbott's commitment to innovation but also positions the company to capture a larger share of the growing demand for rapid testing solutions. The introduction of this product is likely to enhance Abbott's competitive edge in the market.

    In September 2025, Roche Diagnostics (CH) expanded its collaboration with a leading telehealth provider to integrate its point-of-care testing solutions into remote patient monitoring systems. This partnership is strategically important as it aligns with the increasing trend towards telehealth and remote diagnostics, potentially broadening Roche's customer base and enhancing patient access to testing services.

    In August 2025, Siemens Healthineers (DE) unveiled a new AI-driven analytics platform designed to optimize laboratory workflows and improve diagnostic accuracy. This initiative reflects Siemens' focus on digitalization and the integration of advanced technologies into its product offerings. By enhancing operational efficiency and diagnostic precision, Siemens is likely to strengthen its market position and appeal to healthcare providers seeking innovative solutions.

    As of November 2025, current competitive trends in the point-of-care diagnostics testing market include a pronounced shift towards digitalization, sustainability, and the integration of artificial intelligence. Strategic alliances are increasingly shaping the landscape, enabling companies to pool resources and expertise to drive innovation. Looking ahead, competitive differentiation is expected to evolve, with a greater emphasis on technological advancements and supply chain reliability rather than solely on price. This shift suggests that companies that prioritize innovation and adaptability will likely emerge as leaders in the market.

    Key Companies in the US Point of Care Diagnostics Testing Market market include

    Future Outlook

    US Point of Care Diagnostics Testing Market Future Outlook

    The point-of-care diagnostics testing market is projected to grow at a 9.6% CAGR from 2024 to 2035, driven by technological advancements, increasing demand for rapid testing, and a shift towards decentralized healthcare.

    New opportunities lie in:

    • Development of portable diagnostic devices for remote patient monitoring.
    • Integration of AI-driven analytics for enhanced test accuracy and efficiency.
    • Expansion of telehealth services incorporating point-of-care testing solutions.

    By 2035, the market is expected to achieve substantial growth, driven by innovation and evolving healthcare needs.

    Market Segmentation

    US Point of Care Diagnostics Testing Market Product Outlook

    • Glucose Monitoring
    • Cardiometabolic Monitoring
    • Infectious Disease Testing
    • Coagulation Monitoring
    • Pregnancy & Fertility Testing
    • Hematology Testing
    • Cancer/Tumor Marker Testing
    • Urinalysis Testing
    • Cholesterol
    • Drugs-of-Abuse Testing

    US Point of Care Diagnostics Testing Market End User Outlook

    • Hospitals & Clinics
    • Diagnostic Centers
    • Homecare/Self Testing

    US Point of Care Diagnostics Testing Market Platform Outlook

    • Immunoassays
    • Molecular Diagnostics
    • Dipsticks

    US Point of Care Diagnostics Testing Market Mode of Purchase Outlook

    • OTC Testing Products
    • Prescription-based testing products

    Report Scope

    MARKET SIZE 2024 15.5(USD Billion)
    MARKET SIZE 2025 16.99(USD Billion)
    MARKET SIZE 2035 42.5(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR) 9.6% (2024 - 2035)
    REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR 2024
    Market Forecast Period 2025 - 2035
    Historical Data 2019 - 2024
    Market Forecast Units USD Billion
    Key Companies Profiled Abbott Laboratories (US), Roche Diagnostics (CH), Siemens Healthineers (DE), Danaher Corporation (US), Thermo Fisher Scientific (US), Becton Dickinson and Company (US), Cepheid (US), Quidel Corporation (US), Hologic Inc. (US)
    Segments Covered Product, End User, Mode of Purchase, Platform
    Key Market Opportunities Integration of advanced digital technologies enhances efficiency in the point of-care-diagnostics-testing market.
    Key Market Dynamics Technological advancements drive rapid growth in point-of-care diagnostics, enhancing accessibility and efficiency in healthcare delivery.
    Countries Covered US

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