Canada and U.S. Point of Care Testing Market Size, Share and Trends Analysis Report – Industry Overview and Forecast to 2032

Canada and U.S. Point of Care Testing Market Size

• The Canada and U.S. point of care testing market was valued at USD 15.25 billion in 2024 and is expected to reach USD 31.72 billion by 2032
• During the forecast period of 2025 to 2032 the market is likely to grow at a CAGR of 9.6%, primarily driven by the rising prevalence of chronic and infectious diseases
• This growth is driven by factors such as the increasing demand for rapid diagnosis in emergency and outpatient settings

Canada and U.S. Point of Care Testing Market Analysis

• Canada and U.S. point of care testing market is driven by the rising prevalence of chronic conditions such as diabetes and cardiovascular diseases, along with the growing burden of infectious diseases that demand rapid and accurate diagnostic solutions. The COVID-19 pandemic significantly accelerated adoption of both molecular and rapid POC tests, while ongoing demand for respiratory, gastrointestinal, sexually transmitted, and bloodstream infection panels continues to expand the market. Increasing preference for decentralized and home-based healthcare, supported by the widespread availability of self-testing kits and retail pharmacy-based diagnostics, further fuels growth
• Technological advancements in molecular assays, microfluidics, and smartphone-connected POCT devices are enhancing test accuracy and accessibility, while healthcare systems adopt these solutions to reduce costs and improve patient turnaround times. Additionally, supportive government policies, regulatory approvals, and reimbursement frameworks in Canada and U.S. are encouraging broader adoption of POCT across clinical, retail, and homecare settings
• Healthcare providers and policymakers in both Canada and U.S. are increasingly recognizing the value of POCT in addressing the growing disease burden, especially in community health centers, urgent care settings, and remote regions where access to centralized labs is limited. This rising demand is driving public and private investments in advanced diagnostic platforms that support rapid clinical decision-making
• The COVID-19 pandemic catalyzed widespread adoption of decentralized testing solutions, accelerating the deployment of POCT technologies across hospitals, pharmacies, and other healthcare facilities throughout North America. As health systems continue to focus on accessibility, early detection, and value-based care, the need for efficient, near-patient diagnostics is expected to remain a key growth driver in the market
• U.S. is expected to dominate the Canada and U.S. point of care testing market with the market share of 88.56% due to the presence of advanced healthcare infrastructure, high adoption of rapid diagnostic technologies, strong government support, and a large patient population driving demand for efficient and accurate testing solutions

Report Scope and Canada and U.S. Point of Care Testing Market Segmentation 

Canada and U.S. Point of Care Testing Market Trends

Rising prevalence of chronic and infectious diseases increasing demand for rapid, decentralized diagnostics

• The rising prevalence of chronic and infectious diseases in Canada and U.S. is creating an urgent need for rapid, decentralized diagnostic solutions that enable timely detection and effective disease management
• Healthcare providers and policymakers in both Canada and U.S. are increasingly recognizing the value of POCT in addressing the growing disease burden, especially in community health centers, urgent care settings, and remote regions where access to centralized labs is limited
• For instance, in May 2025, Renyun (Hunan) Busbar Co., Ltd. recently hosted a valued customer at its headquarters, marking another milestone in the company’s commitment to building strong, long-term partnerships. The visit included a guided tour of Renyun’s state-of-the-art manufacturing facilities, where the customer observed advanced production processes, rigorous quality testing, and innovative product designs
• Data centers, where uptime is non-negotiable, Canada and U.S. point of care testing are being integrated to provide streamlined and reconfigurable power delivery, allowing operators to scale infrastructure without extended downtime. Their plug-and-play nature has been valued for enabling quick rack power connections and supporting dynamic load shifts—needs that have become common in both hyperscale and edge computing scenarios
• The World Bank’s energy development programs further highlight how electrification is being linked with sustainable industrial growth in emerging economies. In smart industrial zones and government-led infrastructure corridors, Canada and U.S. point of care testing are being considered as part of low-voltage distribution strategies—particularly where speed, flexibility, and long-term safety are required

Canada and U.S. Point of Care Testing Market Dynamics

Driver

Advanced Healthcare Infrastructure and Strong Mobile/Wearable Adoption in Canada and U.S.

• One of the key trends propelling the Canada and U.S. point of care testing market is the rapid diagnostic workflows, real-time data sharing, and streamlined clinical decision-making, which together enhance patient outcomes
• Alongside this infrastructure, strong consumer adoption of mobile and wearable health technologies in Canada and U.S. is driving the demand for connected and user-friendly POCT devices
• For instance, in August 2025, Canada Health Infoway launched the Connected Care Clinical Student Scholarship, offering up to USD 3,000 per student to support clinical learners pursuing digital health education programs at accredited Canadian post-secondary institutions
• This initiative, part of the Centre for Clinical Innovation in Digital Health (CIDH), aims to advance interoperability and connected care by empowering students with knowledge in areas such as electronic health records, AI in healthcare, and healthcare data analytics. The scholarship aligns with Infoway’s Shared Pan-Canadian Interoperability Roadmap and supports the development of decentralized diagnostic capabilities and digital health solutions
• Wearables and mobile health apps empower patients to monitor their health continuously, creating a data-rich environment that POCT solutions can leverage to provide timely and personalized diagnostics
• The convergence of these technologies facilitates remote patient monitoring, chronic disease management, and preventive care, reducing hospital visits and easing the burden on healthcare systems. As mobile and wearable adoption continues to grow, it will increasingly support the expansion and acceptance of POCT as a key component of modern healthcare delivery

Opportunity

Increasing Use in Drug Abuse, Infectious Disease, and Oncology Screening, Driving Market Diversification

• The landscape of healthcare in Canada and U.S. is undergoing a significant transformation, driven by the increasing adoption of Point-of-Care Testing (POCT). This shift is particularly evident in the diversification of its applications, moving beyond traditional diagnostics into new, high-growth areas
• The expansion of POCT into fields like drug abuse, infectious disease, and oncology screening is creating a new paradigm for timely and accessible patient care. This evolution is driven by the demand for faster results, which can lead to more rapid treatment decisions and improved patient outcomes
• For instance, in August 2025, according to Canada and U.S.'s Drug Agency, the onset of the COVID-19 pandemic spurred substantial uptake of POCT, leading to greater awareness of how these tests can be applied across different aspects of medicine, with examples including HIV rapid diagnostic tests and biomarker-based tests for mild traumatic brain injuries
• The ability to perform these tests outside of a centralized laboratory setting, such as in clinics, pharmacies, and even remote locations, is a key enabler of this trend. As technology becomes more sophisticated and user-friendly, the range of conditions that can be screened for at the point of care continues to grow, offering new opportunities for healthcare providers and patients alike. This diversification not only addresses long-standing challenges in healthcare access but also promises to streamline clinical workflows and reduce the burden on traditional laboratory infrastructure
• The U.S. POCT landscape is increasingly embracing diverse screening applications from drug-of-abuse panels to infectious disease detection and oncology biomarkers, broadening its impact across healthcare domains. For instance, home-based infectious disease tests such as SARS-CoV-2 antigen kits have demonstrated substantial cost savings of approximately USD 12.5 million over 60 days—highlighting demand for decentralized testing. Concurrently, advances in oncology diagnostics, for instance, machine learning enhanced blood tests capable of detecting early-stage ovarian cancer with around 92% accuracy, portend a similar expansion in cancer screening via POCT

Restraint/Challenge

High Costs for Advanced POCT Devices and Reagents

• The adoption of advanced Point of Care Testing (POCT) devices in Canada and U.S. is often hindered by the substantial costs involved. These technologies typically feature sophisticated components and require specialized reagents, leading to higher manufacturing and purchase expenses
• The recurring expenses related to consumables, maintenance, and device calibration further increase the overall financial burden. In many cases, healthcare organizations must carefully evaluate the cost-benefit ratio before investing in advanced POCT systems, which may lead to delayed adoption or selective usage of these technologies
• For instance, in June, 2025, a study published in Applied Sciences explored the integration of point-of-care testing (POCT) for cancer and chronic disease management in workplace settings. The study highlighted that the variability in performance and quality among different POCT devices from various manufacturers poses significant challenges to standardization efforts
• This inconsistency complicates the establishment of uniform testing protocols and quality assurance measures, leading to difficulties in clinical adoption and integration into routine healthcare practices. The lack of standardized devices and procedures can result in discrepancies in test results, impacting patient care and hindering the widespread implementation of POCT solutions
• Addressing this cost-related restraint will be critical for market growth. It may require innovations to reduce production costs, economies of scale, and potential financial support from the government or private sectors to improve affordability and accessibility across diverse healthcare settings
• The high costs associated with advanced POCT devices and reagents remain a significant barrier to their widespread adoption in Canada and U.S.. Overcoming this financial challenge through cost reduction strategies, increased production efficiencies, and supportive funding mechanisms will be essential to making these technologies more accessible across diverse healthcare settings and driving market growth

Canada and U.S. Point of Care Testing Market Scope

The Canada and U.S. point of care testing market is segmented into six segments based on product/disease, method/technology, panel type, testing location, end user and distribution channel

• By Product/Disease

On the basis of product/disease, the Canada and U.S. point of care testing market is segmented into respiratory infections, gastroenteric infections, Sexually Transmitted Disease (STD), hepatitis, Bloodstream Infections (BSI), Blood Yeast Infections (Fungal BSI), and others. In 2025, the respiratory infections segment is expected to dominate the market with a market share of 48.15% and 34.50% in U.S. and Canada respectively, due to their high prevalence, rapid transmission, and the clinical need for timely diagnosis. The COVID-19 pandemic demonstrated the critical importance of decentralized and rapid molecular testing, significantly accelerating investment in point-of-care platforms.

The Sexually Transmitted Disease (STD) segment is anticipated to gain traction with a CAGR of 10.1% in the U.S. and 9.4% in Canada during the forecast period of 2025 to 2032, driven by the rising prevalence of STDs, growing demand for rapid and confidential testing, continuous product innovations, and increasing adoption of at-home and clinic-based point-of-care diagnostic solutions.

• By Method/Technology

On the basis of method/technology, the Canada and U.S. point of care testing market is segmented into NAAT (Nucleic Acid Amplification Tests), LAMP (Loop-Mediated Isothermal Amplification), microfluidics / lab-on-a-chip, and others. In 2025, the NAAT (Nucleic Acid Amplification Tests) segment is expected to dominate the market with a market share of 55.27% and 55.58% in U.S. and Canada respectively, owing to PCR-based rapid tests became essential for large-scale screening and rapid clinical decision-making. Beyond COVID-19, NAATs are increasingly applied in detecting respiratory pathogens, Sexually Transmitted Infections (STIs), gastrointestinal infections, and bloodstream infections, supporting faster diagnosis compared to conventional laboratory PCR tests.

The LAMP (Loop-Mediated Isothermal Amplification) segment is anticipated to gain traction with a CAGR of 10.2% in the U.S. and 9.5% in Canada during the forecast period of 2025 to 2032, driven by its high sensitivity and rapid detection capabilities, increasing adoption in infectious disease diagnostics, continuous product innovations, and growing demand for cost-effective molecular testing solutions in both clinical and home care settings.

• By Panel Type

On the basis of panel type, the Canada and U.S. point of care testing market is segmented into simplex assay, multiplex panel (syndromic testing), duplex assay, and triplex assay. In 2025, the simplex assay segment is projected to dominate the market with a market share of 52.50% and 52.38% in U.S. and Canada respectively, because they are cost-effective, easy to use, and widely adopted across routine diagnostic applications. These assays are designed to detect a single analyte or pathogen per test, making them particularly suitable for high-volume needs such as blood glucose monitoring, pregnancy and fertility testing, infectious disease screening (like HIV and COVID-19 rapid antigen tests), and cardiac markers.

The multiplex panel (syndromic testing) segment is anticipated to gain traction with a CAGR of 10.1% in the U.S. and 9.3% in Canada during the forecast period of 2025 to 2032, driven by rising demand for rapid and comprehensive diagnostic solutions, continuous product innovations, growing adoption in clinical and near-patient settings, and the need for accurate detection of multiple pathogens in a single test.

• By Testing Location

On the basis of testing location, the Canada and U.S. point of care testing market is segmented into Laboratory based Point-of-Care-Testing (POCT) and At-Home Point-of-Care-Testing (POCT). In 2025, the Laboratory based Point-of-Care-Testing (POCT) segment is expected to dominate the market with a market share of 60.13% and 59.87% in U.S. and Canada respectively, due to higher accuracy, reliability, and integration into hospital and clinical workflows compared to at-home testing. These tests are typically conducted within healthcare facilities such as hospitals, diagnostic laboratories, and urgent care centers, where trained professionals can ensure proper sample handling, quality control, and interpretation of results.

The At-Home Point-of-Care Testing (POCT) segment is anticipated to gain traction with a CAGR of 9.9% in the U.S. and 9.2% in Canada during the forecast period of 2025 to 2032, driven by increasing adoption of self-testing kits, growing product innovations, wider availability through online and retail channels, and rising patient preference for convenient and rapid diagnostic solutions.

• By End User

On the basis of end user, the Canada and U.S. point of care testing market is segmented into hospitals, home care, clinics, laboratories, ambulatory surgery centers, elderly care centers, and others. In 2025, the hospitals segment is expected to hold the largest share of 42.86% and 43.28% in U.S. and Canada respectively owing to high patient volumes, advanced infrastructure, and strong integration of rapid diagnostics into clinical workflows. POCT is widely adopted in hospital settings for emergency care, intensive care units, operating rooms, and inpatient monitoring, where timely results are critical for treatment decisions. Hospitals also utilize a broad range of POCT applications, including blood glucose monitoring, cardiac marker testing, coagulation tests, and infectious disease diagnostics, particularly syndromic panels for respiratory and bloodstream infections.

The home care segment is anticipated to gain traction with a CAGR of 10.1% in the U.S., while the hospital segment is expected to grow at a CAGR of 9.6% in Canada during the forecast period of 2025 to 2032, driven by rising demand for rapid diagnostics, increasing availability of innovative POCT devices, patient preference for at-home monitoring, and the growing need for faster decision-making in clinical settings.

• By Distribution Channel

On the basis of distribution channel, the Canada and U.S. point of care testing market is segmented into direct tender, retail sales, online sales, and others. In 2025, the direct tender segment is expected to dominate the market with a market share of 44.13% and 43.74% in U.S. and Canada respectively, owing to the primary procurement method for large-scale healthcare institutions such as hospitals, diagnostic laboratories, and government-funded healthcare facilities. Through direct tenders, bulk purchasing agreements are established between healthcare providers and manufacturers or authorized distributors, ensuring lower costs per unit, stable supply, and standardized product availability.

The online sales segment in the POCT market is anticipated to gain traction with a CAGR of 10.3% in the U.S. and 9.6% in Canada during the forecast period of 2025 to 2032, driven by increasing adoption of digital health platforms, growing availability of diagnostic devices through e-commerce channels, rising patient preference for at-home testing, and the convenience of direct-to-consumer delivery models.

The Major Market Leaders Operating in the Market Are:

• Danaher Corporation (U.S.)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Siemens Healthineers AG (Germany)
• BD (Becton, Dickinson and Company) (U.S.)
• Abbott Laboratories (U.S.)
• Cardinal Health (U.S.)
• Agilent Technologies, Inc. (U.S.)
• Medline Industries, LP (U.S.)
• Trinity Biotech (Ireland)
• OraSure Technologies Inc (U.S.)
• Bio-Rad Laboratories, Inc. (U.S.)
• BIOMÉRIEUX (France)
• QIAGEN (Germany)
• Thermo Fisher Scientific Inc. (U.S.)
• QuidelOrtho Corporation (U.S.)
• Trimedic Inc (Canada)
• Abaxis, Inc. (U.S.)
• Sysmex Corporation (Japan)
• NIPRO (Japan)
• SEKISUI Diagnostics (U.S.)
• SANNER (Germany)
• PTS Diagnostics (U.S.)
• The Stevens Company Limited (Canada)
• QuantuMDx Group Ltd. (U.K.)
• EKF Diagnostics Holdings plc (U.K.)
• Creative Diagnostics (U.S.)
• Hipro Biotechnology Co., Ltd. (China)
• Canadian Hospital Specialties Limited (Canada)
• Radiometer Medical ApS (Denmark)
• Meridian Bioscience, Inc. (U.S.)
• Henry Schein, Inc. (U.S.)
• Nova Biomedical (U.S.)
• binx health, inc. (U.S.)
• Sanguina (U.S.)

Latest Developments in Canada and U.S. Point of Care Testing Market

• In February 2025, Thermo Fisher Scientific acquired Solventum’s Purification and Filtration business for USD 4.1 billion, strengthening its bioprocessing capabilities. The acquisition enhances Thermo Fisher's portfolio of filtration and purification technologies, which utilize advanced surface analysis techniques to optimize material interactions in both biologics and industrial applications
• In July 2025, OraSure, through its subsidiary DNA Genotek, launched the HEMAcollect PROTEIN blood collection tube, a new device for proteomic research. The product is an evacuated tube with a proprietary stabilizing liquid designed to preserve and stabilize plasma proteins in whole blood for up to seven days at ambient temperatures. This eliminates the need for immediate processing or cold-chain shipping, making sample collection and transport more efficient and cost-effective. Powered by ProteoPrecision technology, it minimizes hemolysis and platelet activation, ensuring the collected sample accurately reflects the body's in vivo state, leading to higher-quality research data for applications in oncology, neurology, and cardiology
• In July 2025, according to Time Magazine, Microsoft's MAI DxO system demonstrated significantly higher diagnostic accuracy than human doctors-around 85% vs 20%-and reduced patient testing costs by 20%
• In August 2025, according to Reuters, a U.S.-based team developed an AI-enabled blood test that detects early-stage ovarian cancer with over 90% accuracy, opening new avenues for POC diagnostics in oncology
• In August 2025, according to a report by the National Collaborating Centre for Infectious Diseases, POCT can provide accessible testing for individuals facing barriers to conventional services, improving access in remote or resource-limited areas

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