North America Point of Care Testing Market By Product Type (Infectious Diseases Testing, Blood Glucose Monitoring, Cardiac Testing, Coagulation Testing, Fertility Testing, Drug Abuse Testing, Respiratory Testing, Others), By Sample Type (Blood Samples, Respiratory Samples, Urine Samples, Saliva Samples, Fecal Samples, Tissue Samples, Other), By Technology (Immunoassays, Molecular Diagnostics, Electrochemical Detection, Optical Detection, Bio Sensors, Microfluidics, Imaging Technology, Wearable Technology, Others), Market Size, Segmental analysis, Country Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The North America Point of Care Testing market accounted for USD 15.4 Billion in 2024 and is expected to reach USD 30.5 Billion by 2035, growing at a CAGR of around 6.4% between 2025 and 2035. The North American Point of Care Testing (POCT) market encompasses diagnostic tests conducted at or near the patient’s location, rather than in a laboratory. This market is proliferating, primarily because of the increasing demand for prompt diagnostic solutions, the prevalence of chronic diseases, and population aging. General devices for POCT include blood glucose monitors, pregnancy tests, and infectious disease tests. Advances in technology, including mobile health apps, continue to fuel this market. Regulation continues to play a prominent role in shaping the market, with oversight from the FDA among others. As with many promising markets reimbursement and test accuracy are among the important issues to grasp. In general, POCT will remain a critical component for improving patient care through the rapid availability of testing capabilities.

Report Scope:

Market Dynamics

The Importance of Point of Care Testing in Emergency and Acute Care Settings

The North America Point of Care Testing (POCT) market is driven by several key factors, particularly its critical role in emergency and acute care settings. Amongst the major drivers is a higher requirement for rapid diagnostic outcomes because it may significantly alter patient results. Timely diagnosis can be proved to reduce mortality by as much as 50% in acute conditions such as myocardial infarction and sepsis, states the CDC. There is also a growing trend of chronic conditions, among which diabetes and cardiovascular diseases prevail, thus requiring constant monitoring and driving the demand for POCT.
For instance, over 37 million Americans suffer from diabetes, thus requiring an increased need for simple testing solutions, and technological developments have further maximized the accuracy, ease of use, and accessibility of POCT devices in the multifaceted spectrum of healthcare services. With these, hospitals and clinics use more of these devices as it helps in smoothing up the processes of working and treatment practices. According to conclusions developed from the National Institutes of Health, in which POCT reduced hospital stay by 25% for it accelerates clinical decision-making.

Innovations Enhancing Usability and Reliability in Point of Care Testing Devices

Innovations in technology are a significant driver of the North American point of Care Testing (POCT) market, enhancing both the usability and reliability of testing devices. Advances such as miniaturization, improved biosensors, and connectivity features have made POCT devices more user-friendly and accurate. For instance, the FDA reports that modern POCT devices can achieve diagnostic accuracy rates exceeding 90%, comparable to traditional lab testing.

Also, mobile technology has turned the tide of the way data is looked at, therefore giving healthcare providers the ability to monitor patient results in real-time. According to the Journal of Medical Internet Research, 70% of healthcare professionals state that mobile connectivity improves patient outcomes through quicker clinical decisions. As more and more healthcare settings look at achieving efficiency and putting patients at the center, such innovations are of paramount importance in urging the use of POCT devices in various healthcare setups.

Financial Barriers to Adopting Advanced Point of Care Testing in Smaller Clinics

Financial barriers are a significant restraint on the adoption of advanced point of care testing (POCT) in smaller clinics throughout North America. Many such clinics exist on razor-thin margins and cannot afford new technologies. As per the American Hospital Association, almost 30% of rural hospitals are running in the red, and that is a serious area of financial constraint that restricts capital for advanced POCT systems.
Added to these are the reimbursement issues, which make it much more difficult. For instance, on the rate of reimbursement, POCT might even prove to be less expensive than sending it to a traditional laboratory, where bigger clinics are not as likely to make such investments. According to a study by the National Rural Health Association, low reimbursement leads to inadequate adoption of new testing methods, further jeopardizing the quality of care. This does not favor the small clinics, because it is hard for them to acquire the new POCT technologies available in the market. As a result, they cannot provide clients with up-to-date and timely treatment services.

Unlocking Market Potential with Opportunities in Specialized Point of Care Testing for Targeted Health Conditions

The North American point-of-care testing (POCT) market has immense potential for niche testing that focuses on specific health conditions. With the prevalence of chronic diseases like diabetes, cardiovascular disorders, and infectious diseases on the rise, there is an increasing demand for POCT solutions specific to their type. According to the Centers for Disease Control and Prevention, more than 34 million Americans have diabetes a significant number of monitoring solution requirements.

Advances in technology have enabled the devising of specialist POCT devices that can be engineered specifically for focused applications within diagnostic testing for specific health-related conditions yet deliver results that are at once rapid and accurate. In a report on Research and Markets concerning the infectious disease POCT market, a reflective upwardly trending market for such targeted solutions in testing was also indicated. This growth affords manufacturers the possibility of innovation and expanding their product lines in markets catering to high-demand areas for healthcare providers. This will open significant market potential while improving the quality of care and outcomes for patients.

The Vital Role of Point of Care Testing in Early Disease Detection and Preventive Healthcare

North America Point of Care Testing Point of Care Testing in North America provides an important opportunity for early disease detection and preventive healthcare. POCT enables fast diagnosis that can in most cases result in the identification of infections, diabetes, and cardiovascular diseases at onset. According to the CDC, the earlier a disease is detected, the better it can be managed as a chronic disease and subsequently lower healthcare costs while also improving outcomes for patients.

Additionally, preventive care is an area that is gaining increasing importance, and thus investments in POCT are increasingly being undertaken in healthcare systems to make regular screenings easier. The US Preventive Services Task Force advises routine screening for several health conditions, thereby also confirming the requirement for these testing procedures that are easily accessible and efficient. Integration of POCT within preventive health approaches allows providers to improve patient outreach while lessening the workload on general laboratory services, thus providing huge market potential in this regard.

Industry Experts Opinion

“With an increased national incidence of syphilis and other STIs, having a quick and easy way to test in various healthcare settings is essential,”

• Lily Li, Senior Director, Medical Scientific & Clinical Affairs, Quidel Corporation

Segment Analysis

Based on product type, the North American Point of Care Testing market is further segmented into Infectious Diseases Testing, Blood Glucose Monitoring, Cardiac Testing, Coagulation Testing, Fertility Testing, Drug Abuse Testing, Respiratory Testing, and Others. Blood Glucose Monitoring is the leading segment in the Point of Care Testing market due to the rising prevalence of diabetes and the need for frequent, convenient testing. Portable glucose meters allow patients to easily monitor their levels at home, while advancements in technology have enhanced accuracy and usability, driving widespread adoption.

Based on sample type, the North America Point of Care Testing market is categorized into several key groups, including Blood Samples, Respiratory Samples, Urine Samples, Saliva Samples, Fecal Samples, Tissue Samples, and other samples. Blood Samples are the leading segment, as they are widely used for a variety of diagnostic tests, providing critical insights into numerous health conditions and enabling timely clinical decisions.

Regional Analysis

The United States regional landscape of the Point of Care Testing market is characterized by significant variation across different areas, driven by healthcare access, demographics, and disease prevalence. Major metropolitan regions such as New York, Los Angeles, and Chicago tend to exhibit the highest uptake because of their more developed health infrastructure and higher medical facilities. For instance, 34.2 million adults in the United States have diabetes, a considerable demand for Blood Glucose Monitoring. The Northeast and West Coast are highly strong, highlighting innovation and an emphasis on rapid point of care diagnostics. Rural areas, however, are experiencing a continually increasing demand for POCT by healthcare providers to increase accessibility and efficiency. In addition, the implementation of telehealth services is making it easier to integrate POC tests in both urban and remote settings, which will further increase patient coverage. Continued chronic illness management focus, coupled with the desire for infectious disease testing, which has grown lately, exceeding 2 million Americans affected with STI yearly, will further propel the growth of this market in the United States. With altering healthcare trends and requirements, it appears as though the U.S. will also continue on its trend ofin being a market leader for Point of Care Testing.

The Point of Care Testing market in Canada is one of the fastest growing sectors in healthcare, exhibiting a diverse landscape shaped by both urban and rural healthcare dynamics. In major urban centers such as Toronto, Vancouver, and Montreal, there is significant adoption of POCT due to advanced medical infrastructure and a concentration of healthcare facilities. With approximately 3.4 million Canadians diagnosed with diabetes, the demand for Blood Glucose Monitoring solutions is particularly strong. Asthma, affecting over 3.8 million Canadians many of whom remain undiagnosed highlights the critical need for accessible testing options, especially given Canada’s high asthma rates. Moreover, around 2 million Canadians aged 35 and older are living with chronic obstructive pulmonary disease (COPD), with overall prevalence on the rise despite fewer new cases. The Canadian government’s initiatives to enhance healthcare access are fostering investments in telehealth and POCT technologies, particularly in remote areas. As innovations in diagnostic tools continue to emerge, Canada is well-positioned for sustained growth in the Point of Care Testing market.

Competitive Landscape

The competitive landscape of the North American Point of Care Testing market is characterized by a few key players, Abbott Laboratories, BD (Becton, Dickinson, and Company), Quidel Corporation, and Roche Diagnostics, who continuously innovate and expand their product offerings to keep their edge over one another. For instance, Abbott has introduced the Afinion 2 Analyzer, which allows testing for multiple conditions in a single device within a short period. The persistent demand has also enriched BD's portfolio with new quick solutions for COVID-19 testing. Quidel added the Sofia 2 SARS Antigen FIA to its product line and strengthened itself as a competitor in infectious disease testing. From there, research and development from these companies will likely continue to drive the North American diagnostic market forward, experiencing steady progressions in technology and fuelling competition while improving patient care.

North America Point of Care Testing Market, Company Shares Analysis, 2024

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Recent Developments:

• In July 2024, Thermo Fisher Scientific Inc. has showcase its innovations at the Association for Diagnostics & Laboratory Medicine Conference (ADLM) in Chicago, Illinois, featuring a “Story Tunnel” booth to highlight advancements in diagnostics and Point of Care Testing across various healthcare fields.
• In April 2024, Quidel Ortho Corporation received FDA 510(k) clearance for its QuickVue COVID-19 test, enabling its use in home and medical facility settings with CLIA certificates of waiver, demonstrating the company’s commitment to effective testing solutions and innovation in the diagnostics market.

Report Coverage:

By Product Type

• Infectious Diseases Testing
• Blood Glucose Monitoring
• Cardiac Testing, Coagulation Testing
• Fertility Testing
• Drug Abuse Testing
• Respiratory Testing
• Others

By Sample Type

• Blood Samples
• Respiratory Samples
• Urine Samples
• Saliva Samples
• Fecal Samples
• Tissue Samples
• Other

By Technology

• Immunoassays
• Molecular Diagnostics
• Electrochemical Detection
• Optical Detection
• Bio Sensors
• Microfluidics
• Imaging Technology
• Wearable Technology
• Others

By Region

North America

• U.S.
• Canada

List of Companies:

• Abbott Laboratories
• BD (Becton, Dickinson and Company)
• Thermo Fisher Scientific
• Roche Diagnostics
• Quidel Corporation
• Cepheid
• PerkinElmer
• Hologic
• Bio-Rad Laboratories
• Luminex Corporation
• OraSure Technologies
• Acon Laboratories
• AccuMedical
• MedMira
• HCA Healthcare

Frequently Asked Questions (FAQs)

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