North America Point-of-Care Diagnostics Market - 2025-2033

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 refers to a medical diagnostic testing process that takes place at or near the site of patient care rather than in a centralized laboratory or hospital setting. These tests are designed to deliver rapid and reliable results that help healthcare providers make quick, informed decisions regarding patient diagnosis and treatment. The goal is to enable immediate decision-making without the need for a patient to wait for results or travel to another location for testing.

The point-of-care diagnostics market in North America is experiencing significant growth due to increasing demand for accessible, efficient, and cost-effective diagnostic solutions. Technological advancements, an aging population, rising incidences of chronic diseases, and the growing adoption of home-based testing drive the market's expansion. With rapid innovations in mobile health integration, artificial intelligence (AI), and digital diagnostics, the market is evolving to meet the needs of healthcare providers and patients for faster, more reliable diagnostics at the point of care.

Market Dynamics: Drivers & Restraints

Rising advancements in point-of-care diagnostics are significantly driving the market growth.

New technologies like molecular diagnostics, microfluidics, and biosensors have improved the accuracy and speed of point-of-care diagnostic devices. These advancements allow tests to be performed rapidly at a low cost, often in less than 30 minutes.

For instance, in January 2024, 3EO Health received FDA Emergency Use Authorization (EUA) for its COVID-19 test utilizing 3TR technology. 3TR technology eliminates the need for sample preparation, expensive consumables, and complex equipment, creating a new category of "high efficiency" point-of-care molecular testing. High efficiency is defined as low-cost, easy-to-use molecular testing under $20 per test with no sample preparation required.

Artificial Intelligence (AI) is playing an increasing role in the interpretation of test results, offering quicker and more accurate decision-making. AI-powered point-of-care diagnostics can analyze diagnostic data and help clinicians make faster, more accurate diagnoses at low costs.

For instance, in February 2025, Avitia launched an AI-powered platform for rapid & point-of-care cancer testing. With Avitia's platform, laboratories and clinicians now have access to advanced molecular testing. This technology will allow a healthcare team to accurately obtain cancer insights and begin treating patients faster, all at reduced costs.

Connectivity & data integration issues hampering market growth.

One of the primary barriers to the widespread adoption of point-of-care diagnostic technologies is the lack of interoperability between devices, healthcare IT systems, and electronic health records. In many healthcare environments, diagnostic devices, electronic health systems and patient data platforms are not integrated, making it difficult to consolidate and access patient data in real-time.

As point-of-care diagnostic devices often transmit sensitive health data, maintaining the security and privacy of this information is critical. Poor data integration can expose patient information to unauthorized access, making it difficult for healthcare providers to ensure compliance with data protection regulations (such as HIPAA in the U.S.).

For instance, according to the HIPAA Journal, in August 2023, 23 million breached healthcare records were reported. Over the past 12 months, an average of 9,989,003 healthcare records were breached each month. In the year to August 31, 2024, there have been 491 data breaches of 500 or more records, and at least 58,668,002 records are known to have been breached.

The issues related to connectivity and data integration, such as interoperability challenges, data security concerns, manual data entry, and cloud storage inefficiencies, are significant barriers to the growth of the market.

Segment Analysis

The North American point-of-care diagnostics market is segmented based on product, technology, application, and end-user.

Product:

The infectious disease testing products from the product segment are expected to dominate the point-of-care diagnostics market with the highest market share.

Infectious disease test products are diagnostic tools used to detect pathogens like bacteria or viruses in the body. They are crucial in identifying and controlling the spread of infectious diseases. Manufacturers offer various types of products, each tailored to detect specific pathogens or markers associated with specific diseases. Rapid tests provide quick results, often within minutes, and are commonly used for point-of-care testing.

Moreover, diagnostic testing capabilities for infectious diseases like influenza, SARS-CoV-2, Clostridium difficile, HIV, Group A streptococcus, STIs, and Lyme disease have significantly improved over the past few years due to significant launches, product innovations, and other various factors.

For instance, in January 2023, BARDA's Division of Research, Innovation, and Ventures (DRIVe) and the Detection, Diagnostics, and Devices Infrastructure (DDDI) Division are partnering with multiple industry and academic partners to develop next-generation home-based, over-the-counter diagnostic technologies for the detection of SARS-CoV-2, influenza, and future pandemic preparedness.

Additionally, the growing need for rapid and accurate diagnostics of infectious diseases, driven by early detection, decentralized testing, and antimicrobial resistance, is expanding. Government initiatives to improve diagnostic capabilities, especially in low- and middle-income countries, further support market expansion.

Competitive Landscape

Top companies in the North America point-of-care diagnostics market include BD, QuidelOrtho Corporation, QIAGEN, Trinity Biotech plc, BioMerieux SA, F. Hoffmann-La Roche Ltd, Siemens Healthineers AG, Abbott, Danaher Corporation, and Nova Biomedical, among others.

Key Developments

• In February 2025, Avitia launched an AI-powered platform for rapid & point-of-care cancer testing. With Avitia's platform, laboratories and clinicians now have access to advanced molecular testing. This technology will allow a healthcare team to accurately obtain cancer insights and begin treating patients faster, all at reduced costs.
• In January 2025, Roche announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels at the point of care. These panels, including tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea, and Mycoplasma genitalium (CT/NG/MG), enable clinicians to diagnose and differentiate between multiple STIs with a single sample.
• In January 2024, 3EO Health received FDA Emergency Use Authorization (EUA) for its COVID-19 test utilizing 3TR technology. 3TR technology eliminates the need for sample preparation, expensive consumables, and complex equipment, creating a new category of "high efficiency" point-of-care molecular testing. High efficiency is defined as low-cost, easy-to-use molecular testing under $20 per test with no sample preparation required.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyze product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: This covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyze competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The North America point-of-care diagnostics market report delivers a detailed analysis with 42 key tables, more than 45 visually impactful figures, and 198 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.