United States Point-of-Care Diagnostics Market 2033 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

Point of Care Diagnostics Market reached US$ 44.72 Billion in 2024 and is expected to reach US$ 106.35 Billion by 2033, growing at a CAGR of 10.7% during the forecast period 2025-2033.

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Key Development:

United States: Recent Point‐of‐Care Diagnostics Developments

✅ In December 2025, Co‐Diagnostics announced it will present its portable, cloud‐connected Co‐DxTM PCR platform and AI‐driven diagnostic interface at the Point‐of‐Care Testing 2025 conference in Boston, highlighting next‐generation decentralized PCR diagnostics targeting physician offices and mobile care settings.

✅ In November 2025, Co‐Diagnostics formed a dedicated AI business unit to integrate proprietary AI tools into its Co‐Dx Primer AiTM platform, aimed at speeding design, interpretation, and workflow of point‐of‐care PCR diagnostics enhancing efficiency and diagnostic accuracy ahead of regulatory submissions.

✅ In November 2025, Co‐Diagnostics initiated clinical evaluations for its Co‐DxTM PCR Flu A/B, COVID‐19, RSV Test Kit on the Co‐Dx PCR platform to support an upcoming U.S. FDA 510(k) clearance submission for a comprehensive upper respiratory point‐of‐care multiplex PCR test.

✅ In November 2025, Co‐Diagnostics reported its third‐quarter 2025 results, highlighting continued R&D advancement and strategic positioning of its Co‐Dx PCR point‐of‐care platform alongside emerging global partnerships and testing pipelines.

✅ In November 2025, Volition unveiled a new lateral flow point‐of‐care test for nucleosome quantification, enabling rapid on‐site detection of disease biomarkers that support decentralized clinical decision‐making.

✅ In October 2025, Llusern Scientific's Lodestar DX system, a rapid point‐of‐care molecular diagnostic platform for urinary tract infections, received ISO 13485 certification, allowing clinicians to diagnose and rule out infections in a single visit.

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Japan: Recent Point‐of‐Care Diagnostics Developments

✅ In December 2025, Japan's POC landscape saw accelerated adoption of multiplex and advanced detection technologies, particularly in infection diagnostics and distributed testing environments highlighting strong momentum in clinical utility and technological integration.

✅ In December 2025, industry research reiterated that point‐of‐care diagnostics solutions including rapid tests deployable near the patient are key to addressing Japan's ageing population and expanding chronic and infectious disease screening needs, shaping future clinical care models.

✅ In November 2025, Japan's point‐of‐care diagnostics market continued expanding with Bluetooth‐enabled glucose meters and rapid troponin/cartridge tests increasingly deployed in clinics and home care key near‐patient technologies enhancing care for an ageing population.

✅ In November 2025, Innovations in rapid point‐of‐care testing technologies are accelerating decentralized clinical workflows in Japan, underlining the sector's strategic role in clinical decision‐making and healthcare delivery.

✅ In November 2025, Japan's point‐of‐care diagnostics market narrative emphasized advancing rapid, accessible POC tools that shorten turnaround times and enhance early intervention, backed by ongoing innovation and integration of miniaturized devices and digital platforms.

✅ In October 2025, Konica Minolta's SONIMAGE UX1 diagnostic series won the Good Design Award 2025 in Japan, highlighting advancements in portable diagnostic imaging that complement point‐of‐care workflows.

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Recent Mergers & Acquisitions:

United States: Recent Point‐of‐Care Diagnostics Developments

✅ In December 2025, Roche received U.S. FDA 510(k) clearance with a CLIA waiver for its first rapid point‐of‐care PCR test that diagnoses Bordetella infections (including whooping cough) with results delivered in about 15 minutes, supporting faster clinical decisions.

✅ In December 2025, Co‐Diagnostics announced it will present its portable, cloud‐connected Co‐DxTM PCR platform with AI‐enhanced interfaces at the Point‐of‐Care Testing 2025 conference in Boston, highlighting next‐generation decentralized PCR POC diagnostics.

✅ In November 2025, Nanopath was granted U.S. FDA Breakthrough Device designation for its novel point‐of‐care molecular diagnostic platform targeting rapid detection of complicated urinary tract infections, accelerating potential market entry.

✅ In November 2025, the U.S. National Institutes of Health's RADx Tech initiative continued enabling accelerated development and commercialization of innovative point‐of‐care and home‐based diagnostic tests to address emerging clinical needs.

Japan: Recent Point‐of‐Care Diagnostics Developments

✅ In November 2025, Japan's point‐of‐care diagnostics market was highlighted for its rapid innovation in decentralized clinical workflows driven by accelerating rapid test technology integration and poised to expand significantly through advanced diagnostics supporting near‐patient decision-making.

✅ In November 2025, strategic analysis of Japan's point‐of‐care diagnostic sector emphasized innovation in data‐linked POC systems, AI analysis integration, and multi‐assay solutions that support diagnostics at clinics and in home‐care environments.

✅ In October 2025, The Japan's POC diagnostics ecosystem is strengthening around integrated, patient‐centric rapid testing tools that are enhancing same‐visit clinical decision workflows.

✅ In September 2025, broad industry insights showed continued POC diagnostics technology innovation in Japan, particularly around wearable biosensors and AI‐augmented platforms supporting rapid chronic and infectious disease detection.

Key Players:

=> 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 Segments:
By Product

Infectious disease testing products lead with 22% share, driven by rising prevalence of infectious diseases, growing pandemic preparedness, and increasing adoption in hospitals and diagnostic laboratories. Blood glucose products account for 18%, fueled by rising diabetes incidence and demand for home and clinical monitoring devices. Blood gas & electrolyte products hold 12%, supported by critical care applications and ICU monitoring needs. Hematology testing products represent 10%, driven by routine blood testing in hospitals and laboratories. Urinalysis products make up 8%, supported by kidney health monitoring and routine diagnostics. Pregnancy and fertility testing products account for 7%, fueled by increasing fertility awareness and outpatient testing. Tumor/cancer profiling products represent 6%, driven by precision oncology and early detection. Drug-of-abuse products hold 5%, supported by workplace testing and clinical applications. Other products account for 12%, including niche and emerging diagnostic solutions.

By Technology

Lateral flow assays dominate with 35% share, driven by rapid, point-of-care testing for infectious diseases and drug screening. Immunoassays account for 25%, supported by high sensitivity and use in hospitals and clinical laboratories. Molecular diagnostics hold 20%, fueled by growing adoption in genomics, oncology, and infectious disease detection. Microfluidics represent 12%, driven by miniaturized lab-on-chip devices and home testing. Other technologies make up 8%, including novel biosensors and advanced diagnostic platforms.

By Application

Infectious diseases lead with 28% share, supported by global disease outbreaks, pandemic preparedness, and routine clinical diagnostics. Hematology accounts for 18%, driven by blood analysis for anemia, clotting disorders, and other conditions. Cardiology represents 12%, fueled by testing for cardiovascular risk and monitoring. Endocrinology holds 10%, supported by diabetes and hormone-related testing. Oncology accounts for 9%, driven by tumor markers and cancer profiling. Drug testing represents 8%, supported by workplace and clinical screening programs. Neurology makes up 5%, including neurological disorder diagnostics. Other applications account for 10%, covering emerging and niche medical conditions.

By End-User

Hospitals & clinics dominate with 42% share, driven by advanced infrastructure, patient volume, and routine diagnostics. Diagnostic laboratories hold 28%, fueled by high-volume testing and specialized assays. Ambulatory surgery centers (ASCs) account for 15%, supported by outpatient procedures and preoperative testing. Home care settings represent 15%, driven by remote patient monitoring, chronic disease management, and self-testing trends.

By Region

North America - 36% Share
North America leads with 36%, driven by advanced healthcare infrastructure, high adoption of diagnostic technologies, and strong R&D in the U.S. and Canada.

Europe - 28% Share
Europe holds 28%, supported by well-established healthcare systems, clinical laboratories, and adoption of advanced diagnostics in Germany, the U.K., France, Italy, and Spain.

Asia Pacific - 22% Share
Asia Pacific accounts for 22%, fueled by growing population, rising healthcare expenditure, and increasing demand for point-of-care and molecular diagnostic solutions in China, India, Japan, and Southeast Asia.

South America - 8% Share
South America holds 8%, supported by expanding healthcare infrastructure and increasing adoption of diagnostic tests in Brazil, Argentina, and neighboring countries.

Middle East & Africa - 6% Share
Middle East & Africa represent 6%, driven by emerging healthcare infrastructure, rising disease prevalence, and government initiatives in GCC countries, South Africa, and North Africa.

FAQ

What is the current size of the Point of Care Diagnostics Market?

A: In 2024, the Point of Care Diagnostics Market was valued at US$ 44.72 Billion, reflecting its strong industry presence.

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

A: By 2033, industry forecasts suggest the Point of Care Diagnostics Market will grow to around US$ 106.35 Billion , demonstrating significant expansion.

Q3: What is the growth rate of the Point of Care Diagnostics Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 10.7% during the forecast period from 2025 to 2033.

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