United States Point-of-Care Testing Devices Market 2025 | Growth Drivers, Trends & Market Forecast, Competitive Landscape & Investment Opportunities

Market Size and Growth

The Global Point-of-Care Testing Devices Market reached US$49.73 billion in 2024 and is expected to reach US$101.51 billion by 2033, growing at a CAGR of 8.6% during the forecast period 2025-2033, according to DataM Intelligence report.

Key Development:

United States: Recent Industry Developments

✅ In September 2025, Exact Sciences launched Cancerguard, the first multi-cancer early detection blood test commercially available that analyzes multiple biomarker classes to help detect a wide range of cancers, including those that often go undiagnosed until later stages when treatment options are limited.

✅ In May 2025, molecular diagnostics company Roche received FDA clearance and CLIA waiver for its cobas® liat CTNG & CTNG/MG, expanding the NAT POCT segment beyond respiratory infections.

Japan: Recent Industry Developments

✅ In August 2025, Olympus partnered with a domestic AI software startup to co-develop next-generation Software as a Medical Device (SaMD) solutions for endoscopy diagnostics, enhancing algorithm accuracy and regulatory compliance.

✅ In February 2025, Japan's digital health landscape evolved to include expanded remote medical consultations, the proliferation of health-related mobile apps, and a heightened focus on the secure and effective use of healthcare data.

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Point-of-Care Testing Devices are medical diagnostic tools that allow rapid testing and analysis near the patient, rather than in centralized laboratories. They provide timely results for conditions like infections, blood glucose levels, and cardiac markers, enabling immediate clinical decisions, improved patient outcomes, and enhanced healthcare efficiency.

Recent Mergers and Acquisitions:

United States: Recent M&A Activity in POCT Devices

✅ In August 2025, Glooko, a leader in digital health solutions, acquired Monarch Medical Technologies, a company specializing in diabetes management. This strategic move aims to enhance Glooko's offerings in diabetes care and expand its presence in the point-of-care testing market.

✅ In July 2025, Innovaccer, a health data platform company, completed the acquisition of Humbi AI, a startup focused on artificial intelligence for healthcare. This acquisition is expected to bolster Innovaccer's capabilities in patient experience and automation within the POCT sector.

✅ In May 2025, Commure, a health software company, announced the acquisition of Memora Health, a care coordination platform. This move is part of Commure's strategy to enhance its digital health solutions, including point-of-care testing capabilities.

Japan: Recent M&A Activity in POCT Devices

✅ In June 2025, Olympus Corporation, a leading medical technology company, acquired a domestic AI software startup specializing in endoscopy diagnostics. This acquisition aims to integrate advanced AI technologies into Olympus's point-of-care testing devices, enhancing diagnostic accuracy and efficiency.

✅ In May 2025, a Japanese digital health company partnered with a local AI firm to co-develop next-generation Software as a Medical Device (SaMD) solutions. This collaboration focuses on integrating AI-driven diagnostics into point-of-care testing platforms, aiming to improve patient outcomes.

✅ In April 2025, a Japanese healthcare conglomerate expanded its point-of-care diagnostics portfolio through the acquisition of a molecular diagnostics company. This strategic move is intended to strengthen its position in the growing POCT market and diversify its product offerings.

Key Players:

Abbott, F. Hoffmann-La Roche, BD, Siemens Healthcare Private Limited, Bio-Rad Laboratories, Inc., Danaher Corporation, SEKISUI Diagnostics, Trinity Biotech, Beckman Coulter, Inc., Nova Biomedical among others.

Growth Forecast Projected:

The Global Point-of-Care Testing Devices Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2033. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Point-of-Care Testing Devices Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

➥ By Product: Glucose Monitoring Products, Infectious Disease Testing Products, Pregnancy and Fertility Testing Products, Tumor/Cancer Marker Testing Products, Hematology Testing Products, Others

➥ By Application: Blood Transfusion, Cardiac Monitoring, Blood Glucose, Hematology, Non-Invasive SPO2 and CO2 Monitoring, Others

➥ By Testing Type: Immunoassays, Cell-Based Assays, Nucleic Acid Amplification Testing, Clinical Chemistry Assays, Hematology, Others

➥ By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies

Regional Analysis for Point-of-Care Testing Devices Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Point-of-Care Testing Devices producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Point-of-Care Testing Devices revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ

What is the current size of the Point-of-Care Testing Devices Market?

A: In 2024, the Point-of-Care Testing Devices Market was valued at US$49.73 billion , reflecting its strong industry presence.

Q2: How large is the Point-of-Care Testing Devices Market expected to be by 2033?

A: By 2033, industry forecasts suggest the Point-of-Care Testing Devices Market will grow to around US$101.51 billion, demonstrating significant expansion.

Q3: What is the growth rate of the Point-of-Care Testing Devices Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 8.6% during the forecast period from 2025 to 2033.

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