Point of care testing is one of the fastest-growing segments within the U.S. in vitro diagnostics industry. Rather than sending a patient sample to a central laboratory and waiting hours for results, POC diagnostics delivers answers in minutes — right where the patient is.
That speed has real clinical consequences. From emergency rooms managing cardiac events to intensive care units tracking oxygen and acid-base balance, the ability to act on real-time diagnostic data is directly tied to patient outcomes. The shift toward decentralized, faster healthcare is making point-of-care testing a priority across hospitals, urgent care centers, and ambulatory settings alike.
The overall U.S. in vitro diagnostics market was valued at $23.9 billion in 2025, with a forecast to reach $31.8 billion at a CAGR of 4.2%. Point-of-care testing is a key and growing segment within that market, spanning blood gas, blood glucose, immunochemistry, and urinalysis applications.
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Table of Contents
➜ What Is Point-of-Care Testing?
➜ How Big Is the U.S. POC Diagnostics Market in 2025?
➜ What Is Driving Point-of-Care Testing Growth in the U.S.?
➜ What Are the Biggest Point-of-Care Testing Segments in the U.S.?
➜ Who Are the Top Companies in U.S. POC Diagnostics?
➜ What Does the Future of Point-of-Care Testing Look Like?
➜ Point-of-Care Testing FAQ 2025
Key Takeaways
- The U.S. in vitro diagnostics market was valued at $23.9 billion in 2025 and is forecast to reach $31.8 billion at a 4.2% CAGR
- POC immunochemistry is the largest point-of-care testing segment reviewed, reaching $1.43 billion in 2025 with 3.4% growth
- POC blood gas diagnostics totaled $424.3 million in 2025, with reagents accounting for the majority of market value at $334.0 million
- POC blood glucose test strips topped $276.6 million in 2025, with over 515 million strips sold across hospital settings
- Abbott, Nova Biomedical, Radiometer America, Siemens Healthineers, and Roche Diagnostics are the dominant players across the U.S. POC diagnostics market
What Is Point of Care Testing?
Point-of-care testing refers to diagnostic testing performed at or near the site of patient care. That could mean a bedside in an ICU, an examination room in a primary care clinic, a trauma bay in an emergency department, or an ambulance in transit.
The defining feature of point-of-care testing is speed. Results are typically available within minutes, compared to the hours required for centralized laboratory processing. By eliminating sample transport time, POC diagnostics also reduces preanalytical errors — changes to a sample that can occur between collection and analysis, such as clotting or metabolic shifts.
Depending on the device, POC analyzers can measure a broad range of parameters: blood gas levels (oxygen, carbon dioxide, pH), electrolytes (sodium, potassium, ionized calcium, chloride), metabolites (lactate, glucose, BUN, creatinine), hematocrit, and more. Many modern point-of-care testing systems also connect directly to electronic medical records (EMRs) via Wi-Fi or Bluetooth, reducing manual documentation and supporting audit-ready data management.
POC diagnostics in this context refers primarily to clinical and hospital-based testing, not consumer self-testing at home. The majority of point-of-care testing volume in the U.S. originates from hospital departments including emergency rooms, intensive care units, operating rooms, and neonatal intensive care units. The U.S. Food and Drug Administration (FDA) provides regulatory guidance on in vitro diagnostic devices, including the requirements that govern POC device clearance and approval.
How Big Is the U.S. POC Diagnostics Market in 2025?
The U.S. in vitro diagnostics market was valued at $23.9 billion in 2025, according to iData Research, with growth expected to reach $31.8 billion over the forecast period at a CAGR of 4.2%. Point-of-care testing is one of the most active and commercially significant segments within that broader market.
Across four major POC diagnostics sub-segments tracked by iData Research in 2025, total market value breaks down as follows:
- POC immunochemistry: $1.43 billion
- POC blood gas: $424.3 million
- POC urinalysis: $172.3 million
- POC blood glucose (analyzers and test strips combined): approximately $285 million
Reagents and consumables consistently account for the majority of revenue within each point-of-care testing segment. This is largely driven by the reagent rental contracts common across the industry. Under these agreements, manufacturers reduce analyzer prices substantially in exchange for long-term, minimum-volume reagent purchasing commitments. The more tests a facility runs, the more favorable the contract terms — giving large hospital systems and group purchasing organizations significant pricing leverage.
What Is Driving Point of Care Testing Growth in the U.S.?
Several structural factors are pushing POC diagnostics adoption higher, and most of them are long-term in nature.
The growing burden of chronic disease is one of the most significant drivers. Diabetes, cardiovascular disease, respiratory illness, and sepsis all require frequent monitoring and rapid diagnostic results to guide immediate treatment decisions. As the number of Americans living with one or more chronic conditions continues to rise, so does the demand for faster, more accessible point-of-care testing. According to iData Research data, approximately 28 million Americans had diagnosed diabetes as of 2024 — a population that creates sustained demand for bedside glucose monitoring across hospital settings.
The shift toward decentralized care is another major factor. Urgent care clinics, retail health settings, and ambulatory surgery centers are expanding their diagnostic capabilities. These environments rely on POC diagnostics because they lack the staffing and infrastructure of centralized laboratories. The ability to receive results within the same clinical visit improves both patient satisfaction and clinical throughput.
In critical care environments specifically, speed is not a convenience — it is a clinical necessity. For patients in emergency departments or ICUs, delayed test results directly delay treatment decisions. A peer-reviewed study published in Diagnostics (NIH/NCBI, November 2025) found that point-of-care testing supports faster clinical decisions and helps link real-time bedside data to broader care coordination, particularly in time-sensitive infectious disease scenarios.
Finally, the integration of POC diagnostics with digital health infrastructure has made institutional adoption easier to justify. Analyzers that connect wirelessly to hospital EMR systems, support remote quality control checks, and generate compliance-ready records are displacing older standalone devices. Connectivity is now a baseline expectation, not a premium feature.
What Are the Biggest Point of Care Testing Segments in the U.S.?
POC Blood Gas Testing
POC blood gas analyzers provide immediate measurement of oxygen and carbon dioxide levels, pH, electrolytes, metabolites, and hematocrit from a small blood sample. They are indispensable in settings where respiratory and metabolic status must be assessed quickly — including emergency rooms, ICUs, operating rooms, NICUs, and air and ground transport.
According to iData Research, the U.S. POC blood gas market reached $424.3 million in 2025, growing 1.6% year over year. Reagents drove the majority of market value at $334.0 million (1.0% growth), while analyzers accounted for $90.3 million (3.9% growth).
Within the analyzer segment, handheld devices held the larger share at $51.6 million in 2025, compared to $38.7 million for decentralized benchtop systems. However, compact standalone systems are expected to gain ground over time as high-volume hospital settings and GPOs consolidate point-of-care testing at centralized unit locations — a trend that lowers per-test costs and improves contract leverage.
On the reagent side, multi-test formats led with $194.6 million in 2025, followed by single-use reagents at $113.8 million and other packaged reagents and electrodes at $25.6 million.
POC Blood Glucose Monitoring
Hospital-based POC blood glucose monitoring has evolved well beyond basic bedside tracking. Modern hospital glucometers are designed for accuracy across critically ill patient populations, with features including wireless EMR data transfer, barcoded patient and operator identification, and performance validated for ICU, NICU, and emergency settings.
The analyzer market reached $8.9 million in 2025 (4.2% growth), with 13,132 units sold at an average selling price of $681. The test strip market is significantly larger, reaching $276.6 million in 2025 (4.6% growth), with over 515 million strips sold at an average of $0.54 per strip.
As with POC blood gas, analyzer pricing is typically bundled into consumable contracts, making test strip volume the primary commercial driver. The rise in critical care monitoring requirements and expanded glycemic management protocols in hospital settings continues to push test strip volumes higher.
For a broader look at glucose monitoring and diabetes care technology in the U.S., see iData Research’s overview of the U.S. Diabetes Market.
POC Immunochemistry
The POC immunochemistry segment covers both immunoassay and clinical chemistry devices used in decentralized point-of-care testing environments. These devices support rapid, actionable results in emergency departments and primary care settings without requiring full laboratory infrastructure.
According to iData Research, the POC immunochemistry market reached $1.43 billion in 2025 (3.4% growth), making it the largest of the four point-of-care testing segments covered here. Both immunoassay and clinical chemistry device categories hold significant shares of the market, and both are expected to continue growing.
The expansion of this segment reflects a broader shift in care delivery: providers increasingly want POC diagnostics solutions that are faster, more portable, and integrated with digital health platforms. As devices in this category become more accurate and more connected, their adoption across a wider range of care settings is expected to accelerate.
POC Urinalysis
POC urinalysis devices provide fast diagnostic results at or near the patient, reducing the time between sample collection and clinical decision-making. They are widely used in primary care, urgent care, and outpatient environments where turnaround time is a priority.
The POC urinalysis market reached $172.3 million in 2025, though it recorded a slight decline of 1.8% during the year. Analyzers represented the majority of that value at $141.1 million, while test strips accounted for $31.2 million.
The segment’s limited growth reflects the long lifespan of urinalysis devices combined with budget constraints at smaller care settings, which reduce the pace of new analyzer purchases. Going forward, the test strip market is expected to be the primary area of value growth within POC urinalysis point-of-care testing, as volume continues to rise even while capital equipment spending remains conservative.
Who Are the Top Companies in U.S. POC Diagnostics?
The point-of-care testing market is led by a concentrated group of large medical device companies with established product lines, broad reagent portfolios, and deep hospital contracting relationships.
In POC blood gas, Abbott held the leading position in 2025, driven by the i-STAT device line. The i-STAT Alinity — the most advanced version — offers a more intuitive interface, faster processing speeds, and improved EMR connectivity compared to earlier generations. Abbott’s associated reagent cartridges, including the CG8+, CG4+, and CHEM8+, support comprehensive blood chemistry and electrolyte testing at the bedside.
Radiometer America ranked second in POC blood gas, led by its ABL90 FLEX PLUS analyzer, which delivers results for 17 to 19 parameters in approximately 35 seconds from a small sample. Its ABL9 analyzer offers a simplified design suited to acute point-of-care testing environments.
Siemens Healthineers ranked third in blood gas, with a portfolio that spans handheld devices — including the epoc Blood Analysis system — and benchtop platforms such as the RAPIDPoint 500e and RAPIDLab 1200.
In POC blood glucose, Nova Biomedical led the market in 2025. Its StatStrip Glucose Hospital Meter is the only glucose meter FDA-cleared for critically ill patients across all hospital settings, delivering lab-quality accuracy in six seconds. Abbott ranked second with its FreeStyle Precision Pro system, which supports wireless EMR transfer and ketone testing alongside glucose monitoring. Roche Diagnostics ranked third, with the long-established ACCU-CHEK Inform II and the newer cobas pulse system, featuring a smartphone-like interface and infection control-grade durability.
What Does the Future of Point-of-Care Testing Look Like?
The structural forces driving POC diagnostics adoption are not short-term. Chronic disease prevalence, aging demographics, and the ongoing shift toward decentralized care all create sustained and growing demand for faster, more accessible diagnostic testing.
Within the analyzer segment, compact standalone systems are expected to grow at the expense of handheld devices over the longer term. As larger hospital systems consolidate point-of-care testing volumes into specific care units, the economics favor benchtop platforms that offer lower per-test costs and higher throughput. This shift is also expected to maintain downward pressure on average selling prices for analyzers across segments.
Connectivity and integration will remain key differentiators. POC diagnostics platforms that support wireless EMR transfer, remote quality control, and compliance reporting are already displacing devices without these capabilities. As hospitals continue investing in digital health infrastructure, seamless data flow from point-of-care testing into hospital information systems will become a non-negotiable requirement.
Reagents and consumables will continue to represent the majority of commercial value across all POC diagnostics segments. For manufacturers with established volume contracts at major health systems, this creates a recurring revenue base that is relatively resilient through capital spending cycles.
The overall U.S. IVD market is projected to grow from $23.9 billion in 2025 to $31.8 billion at a CAGR of 4.2%, according to iData Research. Point-of-care testing is positioned to remain one of the most active contributors to that growth — and one of the most strategically important categories for diagnostics companies, investors, and hospital systems to monitor.
To understand how remote monitoring and connected diagnostics are reshaping patient care delivery, see iData Research’s coverage of the Remote Patient Monitoring Market.
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Frequently Asked Questions
What is point-of-care testing used for?
Point-of-care testing is used to perform diagnostic tests at or near the patient’s location — typically in hospital departments, urgent care clinics, or ambulances. Common applications include monitoring blood glucose in critically ill or diabetic patients, measuring blood gas levels in ICU and emergency settings, assessing electrolytes and metabolites, and running rapid immunoassays in primary care environments.
How big is the POC diagnostics market in the U.S.?
The U.S. in vitro diagnostics market was valued at $23.9 billion in 2025, according to iData Research. Within that total, POC immunochemistry alone reached $1.43 billion, POC blood gas totaled $424.3 million, POC urinalysis reached $172.3 million, and POC blood glucose test strips exceeded $276 million in 2025.
What is the difference between handheld and decentralized POC analyzers?
Handheld POC analyzers are small, portable devices designed for bedside or prehospital point-of-care testing with minimal sample volumes. Decentralized analyzers are compact benchtop systems placed within a specific hospital unit — such as an ICU or emergency department — rather than a central laboratory. Handheld devices prioritize portability; decentralized systems offer higher throughput and lower per-test costs for moderate to high volume settings.
Who leads the U.S. POC diagnostics market?
Abbott leads POC blood gas testing with its i-STAT device line. Nova Biomedical leads POC blood glucose with its StatStrip Glucose Hospital Meter. Radiometer America and Siemens Healthineers hold the second and third positions in blood gas, respectively. Roche Diagnostics rounds out the top three in POC blood glucose with the ACCU-CHEK Inform II and cobas pulse systems.
Why is point-of-care testing growing in the U.S.?
The primary drivers are the rising prevalence of chronic diseases such as diabetes and cardiovascular conditions, the expansion of decentralized care settings such as urgent care clinics and ambulatory centers, and the clinical demand for fast results in emergency and critical care environments. Improved connectivity with hospital EMR systems has also significantly reduced the administrative and operational barriers to adopting point-of-care testing.
How does reagent contracting affect the POC diagnostics market?
In the POC diagnostics industry, manufacturers typically offer analyzers at significantly reduced prices in exchange for binding long-term reagent purchasing agreements. The revenue from reagents — not the analyzer hardware — is the primary commercial driver for most point-of-care testing companies. Higher testing volumes lead to more favorable pricing, which is why large hospital systems and group purchasing organizations hold significant leverage in contract negotiations.
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