According to DataM Intelligence, the North America Point-of-Care Diagnostics Market size reached US$6.74 billion in 2024 and is expected to reach US$13.25 billion by 2033, growing at a CAGR of 7.9% during the forecast period 2025-2033. Point-of-care diagnostics enable medical testing near or at the patient’s location, facilitating faster clinical decisions and improved patient outcomes across a range of conditions including diabetes, cardiovascular diseases, and infectious diseases. This market growth is supported by rising chronic disease prevalence, technological innovations such as portable and miniaturized diagnostic devices, and increasing adoption of home-based and outpatient testing solutions. The demand for rapid, reliable diagnostics in emergency and routine care settings fuels the expanding use of point-of-care tools, particularly in hospital and ambulatory environments.

North America remains a dominant market driven by the United States’ strong healthcare infrastructure, robust research and development ecosystem, and presence of major industry players like Abbott Laboratories, BD, and Siemens Healthineers. Canada is also witnessing rapid growth, propelled by demographic shifts such as an aging population that increases the need for accessible chronic disease monitoring. The integration of digital health technologies and artificial intelligence enhances the usability and accuracy of these diagnostic devices, contributing further to market expansion. Government initiatives, rising healthcare expenditure, and an ongoing rise in infectious diseases additionally underpin the steady rise of the North American point-of-care diagnostics market through 2033.

𝗚𝗲𝘁 𝗮 𝗦𝗮𝗺𝗽𝗹𝗲 𝗣𝗗𝗙 𝗕𝗿𝗼𝗰𝗵𝘂𝗿𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗥𝗲𝗽𝗼𝗿𝘁 (𝗨𝘀𝗲 𝗖𝗼𝗿𝗽𝗼𝗿𝗮𝘁𝗲 𝗘𝗺𝗮𝗶𝗹 𝗜𝗗 𝗳𝗼𝗿 𝗮 𝗤𝘂𝗶𝗰𝗸 𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗲): https://www.datamintelligence.com/download-sample/north-america-point-of-care-diagnostics-market

Market Segmentation

By Product (Infectious Disease Testing Products, Blood Glucose Products, Blood Gas & Electrolyte Products, Hematology Testing Products, Urinalysis Products, Pregnancy and Fertility Testing Products, Tumor/Cancer Profiling Products, Drug-of-Abuse Products, Others)
By Technology (Lateral Flow Assays, Immunoassays, Molecular Diagnostics, Microfluidics, Others)
By Application (Infectious Diseases, Hematology, Cardiology, Endocrinology, Oncology, Drug Testing, Neurology, Others)
By End-User (Hospitals & Clinics, Diagnostic Laboratories, Home Care Settings, Ambulatory Surgery Centers (ASCs))

Market Drivers

The North America POC diagnostics market growth is fueled by multiple key drivers:

• The rising prevalence of chronic diseases such as diabetes, cardiovascular disorders, respiratory illnesses, and cancer demands frequent monitoring and early diagnosis, significantly supporting the POC diagnostics adoption.
• Growing infectious disease burden including COVID-19, influenza, and other regional infections has heightened the need for rapid, decentralized testing solutions.
• Technological innovations including miniaturized, wireless, and portable diagnostic devices enhance clinical workflow efficiency, enable bedside testing, and reduce dependency on centralized laboratories.
• Increasing consumer focus on self-testing and home care diagnostics, facilitated by user-friendly and reliable OTC products, expands the market footprint beyond traditional care settings.
• The integration of artificial intelligence (AI) and data analytics optimizes diagnostic accuracy, speeds up results, and supports personalized medicine approaches.
• Supportive government policies, research funding, and partnerships between healthcare institutions and diagnostic device manufacturers accelerate market development and product approvals.

Market Share

North America dominates the global POC diagnostics market, accounting for about 35%-45% of global revenue share depending on sources, with the United States as the major contributor due to its advanced healthcare infrastructure and strong presence of market leaders such as Abbott Laboratories, BIOMERIEUX, BD, Siemens Healthineers AG, QIAGEN, Quidel, and Quest Diagnostics. Canada is the fastest-growing country in the region, attributed to its aging population projected to have one-fifth over 65 years old by 2036 boosting demand for chronic disease management diagnostics. Hospital settings in metropolitan regions lead market consumption, reflecting priorities on rapid diagnostic turnaround and patient care efficiency.

Key Players

Major companies shaping the North America POC diagnostics market include:

• Abbott Laboratories
• BIOMERIEUX
• BD (Becton Dickinson)
• Siemens Healthineers AG
• QIAGEN N.V.
• Quidel Corporation
• Quest Diagnostics
• Roche Diagnostics
• Alere Inc.
• Nova Biomedical

These companies invest heavily in product innovation, regulatory compliance, and strategic partnerships to expand their portfolio and market reach.

Recent Developments in 2025

In January 2025, Roche Diagnostics obtained FDA clearance with a CLIA waiver for its cobas Liat molecular tests meant for rapid diagnosis of sexually transmitted infections at point of care, expanding use across healthcare settings and reinforcing regulatory confidence in molecular POC tests.

Sense Biodetection partnered with Bio Nuclear Diagnostics in 2025 to distribute an instrument-free molecular COVID-19 test, accelerating access to rapid testing solutions in Canada’s decentralized regions.

Conclusion

The North American point-of-care diagnostics market is poised for steady growth driven by increasing chronic and infectious disease prevalence, technological advancements, and evolving healthcare delivery models emphasizing rapid, accurate on-site testing. The United States remains the largest market, supported by innovation-led companies and a mature healthcare infrastructure, whereas Canada shows the fastest expansion due to demographic shifts. With rising consumer acceptance of home-based diagnostics and the integration of AI technologies, POC diagnostics will continue redefining healthcare accessibility and patient management across North America through 2032 and beyond.

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