U.S. Gastrointestinal Point of Care Testing Market Innovations Driving Growth, Notes Persistence Market Research

The U.S. gastrointestinal point of care testing (POCT) market is undergoing a period of rapid evolution, driven by increasing demand for swift, accurate, and accessible diagnostics. According to a recent report published by Persistence Market Research, the market is projected to grow from US$ 926.0 million in 2025 to US$ 1,850.9 million by 2032, registering a robust CAGR of 10.4% during the forecast period. The market is being driven primarily by a growing burden of gastrointestinal (GI) diseases such as Clostridioides difficile infections, norovirus outbreaks, and colorectal cancer, all of which require timely diagnosis for effective treatment and management.

From emergency departments to home-based care, point of care diagnostics are transforming how GI conditions are detected and managed. The shift toward decentralized, patient-centric healthcare, coupled with technological innovation in immunoassays and molecular diagnostics, has made POCT an indispensable tool in modern healthcare delivery. Among various product types, assay kits are the leading segment, accounting for the largest market share due to their broad application scope and reliability. Geographically, the Western U.S. leads the market, largely owing to advanced healthcare infrastructure, higher adoption of innovative technologies, and proactive health screening policies.

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✅Key Highlights from the Report:

➤ The U.S. gastrointestinal POCT market is expected to reach US$ 1,850.9 Mn by 2032.
➤ Assay kits dominate the product segment with over 41.4% market share in 2025.
➤ Norovirus causes 19-21 million illnesses annually in the U.S., boosting POCT demand.
➤ CDC and FDA initiatives are pushing home-based screening and early diagnosis tools.
➤ Dipsticks are emerging as the fastest-growing product for fecal occult blood testing.
➤ Technological advances in smartphone-enabled POCT are unlocking new home-use potential.

Market Segmentation: Product & Indication Insights

The U.S. gastrointestinal POCT market is segmented by product type, including assay kits, dipsticks, and cassette-based tests. Assay kits lead the category, favored for their accuracy, rapid results, and broad use in clinical and home environments. These kits are essential in detecting bacterial, viral, and parasitic pathogens such as H. pylori and C. difficile. Dipsticks, mainly used for fecal occult blood testing (FOBT), are gaining popularity for colorectal cancer screening due to their affordability and ease of use. On the other hand, cassette-based tests, which utilize lateral flow assay technology, are growing steadily thanks to their minimal sample preparation and user-friendly design, making them ideal for use in urgent care and physician offices.

Based on indications, the market is segmented into bacterial, viral, parasitic infections, and colorectal cancer screening. Bacterial infections, including Salmonella and Clostridioides difficile, account for the largest share of diagnostic demand, due to their frequency and risk of complications. Norovirus and rotavirus lead the viral infection segment and are particularly impactful in communal living environments like nursing homes and schools. Parasitic infections remain relevant in immunocompromised and traveling populations. Fecal immunochemical tests (FIT) are witnessing increasing adoption for non-invasive colorectal cancer screening, reinforcing POCT's role in both diagnosis and preventive care.

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✅Regional Insights

The Western U.S. dominates the gastrointestinal POCT market due to higher healthcare spending, early technology adoption, and robust screening programs. States like California and Washington have a high prevalence of GI diseases, and health systems there are leveraging POCT to improve outcomes and minimize hospital stays.

Meanwhile, the Southeastern U.S. is emerging as a high-growth region. Factors such as increased incidence of colorectal cancer, growing awareness, and government-supported screening programs are driving adoption. These regions benefit from targeted outreach initiatives and increased deployment of POCT in community health centers.

✅Market Drivers

One of the major drivers of the U.S. gastrointestinal POCT market is the growing prevalence of GI disorders and the urgent need for rapid diagnostics. According to CDC data, over 179 million cases of acute gastroenteritis occur annually in the U.S., and Clostridioides difficile infections alone lead to nearly 223,900 hospitalizations each year. These alarming statistics have heightened demand for point-of-care tools that offer on-the-spot results, enabling quicker treatment and isolation measures in healthcare settings.

Further, the transition to decentralized healthcare has significantly influenced POCT adoption. As more patients receive care in home settings, outpatient clinics, and urgent care centers, there's growing reliance on diagnostics that are portable, efficient, and easy to use. Technological innovations, particularly in molecular diagnostics and immunoassays, have also contributed to improved sensitivity and specificity, making POCT more reliable and applicable across clinical scenarios.

✅Market Restraints

Despite strong growth drivers, the U.S. gastrointestinal POCT market faces several hurdles. One of the main concerns is the variability in test accuracy, especially in sensitivity and specificity. Some rapid tests may result in false positives or negatives, leading to delayed or inappropriate treatments. This is a significant limitation, particularly in critical care environments where diagnostic certainty is essential.

In addition, regulatory and reimbursement challenges restrict broader adoption. The FDA's rigorous approval process for new POCT technologies can be time-consuming and costly. Furthermore, inconsistent reimbursement policies across private insurers and Medicare create financial uncertainty for providers looking to adopt new POCT platforms. Smaller practices and rural facilities often lack the capital and infrastructure to implement advanced diagnostic systems, which slows overall market penetration.

✅Market Opportunities

Despite the constraints, the U.S. gastrointestinal POCT market is ripe with opportunities. One promising area is the development of smartphone-compatible POCT solutions that can be used at home and transmit real-time results to physicians. These tools are highly relevant in today's telehealth-driven landscape, allowing seamless integration between diagnostics and virtual care.

Preventive care initiatives and public awareness campaigns, particularly around colorectal cancer, are creating fertile ground for market growth. The increasing use of FIT tests for early cancer detection, backed by FDA approvals for over-the-counter availability, reflects a growing consumer preference for non-invasive and accessible diagnostics. Additionally, expanding POCT services into rural and underserved communities, where access to centralized labs is limited, represents a valuable growth frontier.

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✅Reasons to Buy the Report:

✔ Get a comprehensive analysis of a market projected to grow at 10.4% CAGR through 2032.
✔ Understand current trends, innovations, and strategic moves of key market players.
✔ Identify high-growth segments such as assay kits and dipsticks across diverse indications.
✔ Explore untapped regional markets with rising demand for GI POCT.
✔ Leverage insights to align your strategy with evolving patient care models and preventive diagnostics.

✅Frequently Asked Questions (FAQs):

How Big is the U.S. Gastrointestinal Point of Care Testing Market in 2025?
Who are the Key Players in the U.S. Gastrointestinal Point of Care Testing Market?
What is the Projected Growth Rate of the U.S. Gastrointestinal POCT Market?
What is the Market Forecast for Gastrointestinal POCT through 2032?
Which Region is Estimated to Dominate the Industry through the Forecast Period?

Company Insights

Leading players in the U.S. gastrointestinal point of care testing market include:

✦ Abbott
✦ QuidelOrtho Corporation
✦ Thermo Fisher Scientific Inc.
✦ Bio-Rad Laboratories, Inc.
✦ Siemens Healthineers
✦ BD
✦ Roche Diagnostics
✦ Preventis GmbH
✦ BIOMÉRIEUX
✦ Epitope Diagnostics, Inc.
✦ Luminex Corporation
✦ Prometheus Bio Inc.
✦ Guardant Health
✦ Cardinal Health
✦ DiaSorin S.p.A.
✦ KAINOS Laboratories, Inc.
✦ Hangzhou AllTest Biotech CO., LTD
✦ Aidian
✦ Selinion
✦ Molbio Diagnostics Limited

Recent Developments:

✦ MP Biomedicals launched a new line of immunochromatographic in vitro diagnostic kits in August 2024, targeting pathogens like H. pylori and Salmonella typhi.
✦ Reese Pharmaceutical introduced ColoTest, an FDA-approved OTC fecal immunochemical test (FIT) in February 2024, enabling early at-home colorectal cancer screening.

Conclusion

The U.S. gastrointestinal point of care testing market is well-positioned for sustained growth, backed by rising disease burden, increasing decentralization of healthcare, and continued technological innovation. As healthcare providers and consumers seek faster, more reliable diagnostics, POCT offers a critical solution. With significant support from public health agencies like the CDC and FDA, and a growing trend toward at-home and remote testing, the market is set to play an essential role in the future of gastrointestinal disease management and prevention.

For investors, medical device companies, and healthcare providers, this market represents a high-potential space with opportunities for innovation, expansion, and improved patient outcomes. The strategic insights provided by Persistence Market Research offer valuable guidance to capitalize on this momentum and align with the evolving healthcare landscape.

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