Global Point of Care Diagnostics Market 2025-2033

Market Size

The Global Point-of-Care Diagnostics Market reached US$ 15.46 billion in 2024 and is expected to reach US$ 32.63 billion by 2033, growing at a CAGR of 8.7 % during the forecast period of 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.

Point-of-care diagnostics is a rapidly advancing field that enables healthcare professionals and patients to perform diagnostic tests at or near the site of care. With growing adoption and innovations, point-of-care diagnostics is transforming healthcare delivery by making diagnostics faster, more accessible and more efficient.

Market Dynamics: Drivers & Restraints

Rising Advancements in Point-of-Care Diagnostics

Rising advancements in point-of-care (POC) diagnostics are a key driver of the global POC diagnostics market. 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, often in less than 30 minutes at a low cost.

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.

Also, in May 2024, MolBio announced that it is working on many pathbreaking point-of-care technologies in the areas of hematology, cancer, anti-microbial resistance (AMR), next-generation sequencing (NGS), syndromic testing, etc. The company is developing artificial intelligence (AI)-enabled point-of-care test TruSight for various hematology applications, including complete blood count (CBC). This platform could also be eventually used for PAP smears, malaria parasites, sperm counting, sickle cell disease, thalassemia, etc.

Connectivity & Data Integration Issues

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. or GDPR in Europe).

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.

Market Segment Analysis

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

Product:

The infectious disease testing products segment in the product is expected to dominate the global 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 February 2023, Thermo Fisher Scientific announced that its Applied Biosystems TaqPath PCR products for infectious diseases like MTB MDR, MT B, HBV, HCV, HIV, and HLA B27 have received licensing rights from the Central Drugs Standard Control Organization (CDSCO). The products will be manufactured in India in association with Mylab Discove1Y Solutions.

Also, growth 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. These factors have solidified the segment's position in the global point of care diagnostics market.

Market Geographical Share

North America is expected to hold a significant position in the global point of care diagnostics market with the highest market share

North America, particularly the United States and Canada, holds a dominant position in the global POC diagnostics market. This market includes a wide range of diagnostic products such as blood glucose monitors, cardiac markers, pregnancy tests, infectious disease testing, and cholesterol testing.

The North American market is well-established with a high demand for diagnostic testing across various healthcare settings, including hospitals, clinics, urgent care centers, and even homecare environments. The increasing incidence of chronic diseases such as diabetes, cardiovascular diseases, respiratory disorders, and cancer is one of the primary drivers of the POC diagnostics market in North America. These conditions require regular monitoring and testing, which is facilitated by POC devices.

Key players in the region are receiving regulatory approvals and launching their products in the region. For instance, in January 2025, Roche received FDA clearance with a CLIA waiver for its cobas Liat molecular tests designed to diagnose sexually transmitted infections (STIs) at the point of care. Roche's cobas Liat molecular tests have met the regulatory standards for safety and effectiveness in the U.S. market. This is a significant milestone, as it ensures that the tests can be used legally and widely in healthcare settings. Thus, the above factors are consolidating the region's position as a dominant force in the global point of care diagnostics market.

Major Global Players

The major global players in the point of care diagnostics market include BD, QuidelOrtho Corporation, QIAGEN, Trinity Biotech plc., BioMérieux SA, F. Hoffmann-La Roche Ltd, Siemens Healthineers AG, Abbott Laboratories, Danaher Corporation, and SEKISUI MEDICAL CO., LTD. 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 May 2024, MolBio announced that it is working on many pathbreaking point-of-care technologies in hematology, cancer, anti-microbial resistance (AMR), next-generation sequencing (NGS), syndromic testing, etc. The company is developing artificial intelligence (AI)-enabled point-of-care test TruSight for various hematology applications, including complete blood count (CBC). This platform could also be used for PAP smears, malaria parasites, sperm counting, sickle cell disease, thalassemia, etc.

• 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.

• In April 2024, Roche Diagnostics India announced the launch of its point-of-care NT-proBNP test for screening diabetes patients who are at risk of cardiovascular diseases (CVD) such as heart failure (HF). This breakthrough innovation is designed to bring testing closer to clinics and revolutionize patient care. The claim extension of the NT-proBNP biomarker, available exclusively on the cobas h 232 system, aims to provide faster, more efficient diagnosis and management of HF in patients with type 2 diabetes (T2D).

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials and product pipelines and forecasts upcoming advancements in medical devices and pharmaceuticals.

• Product Performance & Market Positioning: Analyzed 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.

• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.

• 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 global point of care diagnostics market report delivers a detailed analysis with 70+ key tables, more than 70+ visually impactful figures, and 176 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.