Summary

Persistence Market Research has recently released a comprehensive report on the U.S. gastrointestinal point of care (POC) testing market. The report offers a thorough assessment of crucial market dynamics, including drivers, trends, opportunities, and challenges, providing detailed insights into the market structure. This research publication presents exclusive data and statistics outlining the anticipated growth trajectory of the U.S. gastrointestinal POC testing market from 2025 to 2032.

Key Insights:

• U.S. Gastrointestinal POC Testing Market Size (2025E): USD 926.0 Million
• Projected Market Value (2032F): USD 1,850.9 Million
• U.S. Market Growth Rate (CAGR 2025 to 2032): 10.4%

U.S. Gastrointestinal POC Testing Market – Report Scope:

Gastrointestinal point of care testing provides rapid diagnostic solutions for the detection of various gastrointestinal disorders, including infections, inflammation, and bleeding, at or near the patient site. These tests are crucial for timely diagnosis and treatment initiation, particularly in emergency settings, primary care clinics, and ambulatory surgical centers. The U.S. gastrointestinal POC testing market encompasses a range of test types, such as stool tests for infections, fecal occult blood tests (FOBT), and inflammatory markers like calprotectin. Market growth is fueled by increasing prevalence of gastrointestinal diseases, technological advancements in diagnostic platforms, and the shift toward decentralized healthcare delivery models.

Market Growth Drivers:

The U.S. gastrointestinal POC testing market is propelled by several key factors, including the rising incidence of gastrointestinal infections, inflammatory bowel disease (IBD), and colorectal cancer. Growing patient demand for rapid, accurate diagnostic solutions outside traditional hospital settings drives the adoption of POC tests. Technological innovations, such as multiplex molecular assays and smartphone-integrated test devices, enhance diagnostic accuracy and user convenience, accelerating market penetration. Additionally, increased awareness about early diagnosis and preventive healthcare initiatives further bolster the demand for gastrointestinal POC testing.

Market Restraints:

Despite a promising growth outlook, the U.S. gastrointestinal POC testing market faces challenges related to regulatory approvals, reimbursement issues, and limitations in test accuracy compared to laboratory-based methods. Stringent FDA regulations for POC diagnostics can delay product launches and increase compliance costs for manufacturers. Furthermore, inadequate insurance coverage and reimbursement for certain gastrointestinal POC tests limit their adoption, particularly in cost-sensitive healthcare settings. Concerns regarding variability in test performance and false negatives or positives necessitate continued investment in product validation and clinician education.

Market Opportunities:

The U.S. gastrointestinal POC testing market presents significant growth opportunities driven by advancements in portable diagnostics, miniaturization of testing devices, and integration with telehealth platforms. The growing preference for at-home testing solutions among patients offers new revenue streams for companies developing user-friendly POC kits. Expansion into the early detection of colorectal cancer through non-invasive fecal tests represents a major growth area. Strategic collaborations between diagnostic companies, healthcare providers, and digital health innovators will further expand market access and enhance the scope of gastrointestinal point of care diagnostics.

Key Questions Answered in the Report:

• What are the key drivers propelling the growth of the U.S. gastrointestinal POC testing market?
• Which gastrointestinal conditions are driving demand for rapid diagnostic tests in different healthcare settings?
• How are technological advancements reshaping the future of gastrointestinal POC testing?
• Who are the leading players in the U.S. gastrointestinal POC testing market, and what strategies are they adopting to gain a competitive advantage?
• What are the emerging trends and future prospects in the U.S. gastrointestinal POC testing landscape?

Competitive Intelligence and Business Strategy:

Leading players in the U.S. gastrointestinal POC testing market, including Abbott Laboratories, QuidelOrtho Corporation, and BIOMÉRIEUX, focus on expanding their product portfolios with rapid, highly sensitive tests and integrated digital reporting solutions. These companies invest in R&D to develop multiplexed platforms capable of detecting multiple pathogens or biomarkers simultaneously. Strategic mergers, acquisitions, and partnerships with healthcare institutions and retail clinics enable broader market penetration. Emphasis on regulatory compliance, clinical validation, and patient-centric innovation strengthens their competitive positioning in the rapidly evolving gastrointestinal POC testing sector.

Key Companies Profiled:

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

Market Segmentation

By Product

• Assay Kits
• Dipsticks
• Cassette
• Others

By Test Type

• Occult Blood Tests
• H. pylori Test
• Calprotectin Test
• C. difficile Assays
• Others

By Indication

• Bacterial Infection
• Viral Infection
• Parasitic Infection
• Colorectal Cancer

By Sample Type

• Stool
• Blood
• Others

By End-user

• Hospitals and Clinics
• Diagnostic Laboratories
• Ambulatory Surgical Centers
• Urgent Care Centers
• Home Care Settings
• Others

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Table of Contents

1. Executive Summary
1.1. U.S. Gastrointestinal Point-of-Testing Market Snapshot, 2025 and 2032
1.2. Market Opportunity Assessment, 2025-2032, US$ Mn
1.3. Key Market Trends
1.4. Future Market Projections
1.5. Premium Market Insights
1.6. Industry Developments and Key Market Events
1.7. PMR Analysis and Recommendations
2. Market Overview
2.1. Market Scope and Definition
2.2. Market Dynamics
2.2.1. Drivers
2.2.2. Restraints
2.2.3. Opportunity
2.2.4. Challenges
2.2.5. Key Trends
2.3. Macro-Economic Factors
2.3.1. U.S. Sectorial Outlook
2.4. COVID-19 Impact Analysis
2.5. Forecast Factors - Relevance and Impact
3. Value Added Insights
3.1. Regulatory Landscape
3.2. Product Type Adoption Analysis
3.3. Diseases Epidemiology
3.4. Value Chain Analysis
3.5. Key Deals and Mergers
3.6. PESTLE Analysis
3.7. Porter’s Five Force Analysis
4. U.S. Gastrointestinal Point-of-Testing Market Outlook:
4.1. Key Highlights
4.1.1. Market Size (US$ Mn) and Y-o-Y Growth
4.1.2. Absolute $ Opportunity
4.2. Market Size (US$ Mn) Analysis and Forecast
4.2.1. Historical Market Size (US$ Mn) Analysis, 2019-2024
4.2.2. Market Size (US$ Mn) Analysis and Forecast, 2025-2032
4.3. U.S. Gastrointestinal Point-of-Testing Market Outlook: Product Type
4.3.1. Introduction / Key Findings
4.3.2. Historical Market Size (US$ Mn) Analysis, By Product Type, 2019-2024
4.3.3. Market Size (US$ Mn) Analysis and Forecast, By Product Type, 2025-2032
4.3.3.1. Assay Kits
4.3.3.2. Dipsticks
4.3.3.3. Cassette
4.3.3.4. Others
4.3.4. Market Attractiveness Analysis: Product Type
4.4. U.S. Gastrointestinal Point-of-Testing Market Outlook: Test Type
4.4.1. Introduction / Key Findings
4.4.2. Historical Market Size (US$ Mn) Analysis, By Test Type, 2019-2024
4.4.3. Market Size (US$ Mn) Analysis and Forecast, By Test Type, 2025-2032
4.4.3.1. Occult Blood Tests
4.4.3.2. H. pylori Test
4.4.3.3. Calprotectin Test
4.4.3.4. C. difficile Assays
4.4.3.5. Others
4.4.4. Market Attractiveness Analysis: Test Type
4.5. U.S. Gastrointestinal Point-of-Testing Market Outlook: Indication
4.5.1. Introduction / Key Findings
4.5.2. Historical Market Size (US$ Mn) Analysis, By Indication, 2019-2024
4.5.3. Market Size (US$ Mn) Analysis and Forecast, By Indication, 2025-2032
4.5.3.1. Bacterial Infection
4.5.3.2. Viral Infection
4.5.3.3. Parasitic Infection
4.5.3.4. Colorectal Cancer
4.5.4. Market Attractiveness Analysis: Indication
4.6. U.S. Gastrointestinal Point-of-Testing Market Outlook: Sample Type
4.6.1. Introduction / Key Findings
4.6.2. Historical Market Size (US$ Mn) Analysis, By Sample Type, 2019-2024
4.6.3. Market Size (US$ Mn) Analysis and Forecast, By Sample Type, 2025-2032
4.6.3.1. Stool
4.6.3.2. Blood
4.6.3.3. Others
4.6.4. Market Attractiveness Analysis: Sample Type
4.7. U.S. Gastrointestinal Point-of-Testing Market Outlook: End User
4.7.1. Introduction / Key Findings
4.7.2. Historical Market Size (US$ Mn) Analysis, By End User, 2019-2024
4.7.3. Market Size (US$ Mn) Analysis and Forecast, By End User, 2025-2032
4.7.3.1. Hospitals and Clinics
4.7.3.2. Diagnostic Laboratories
4.7.3.3. Ambulatory Surgical Centers
4.7.3.4. Urgent Care Centers
4.7.3.5. Home Care Settings
4.7.3.6. Others
4.7.4. Market Attractiveness Analysis: End User
5. U.S. Gastrointestinal Point-of-Testing Market Outlook: Zone
5.1. Key Highlights
5.2. Historical Market Size (US$ Mn) Analysis, By Zone, 2019-2024
5.3. Market Size (US$ Mn) Analysis and Forecast, By Zone, 2025-2032
5.3.1. West U.S.
5.3.2. Midwest U.S.
5.3.3. Southwest U.S.
5.3.4. Southeast U.S.
5.3.5. Northeast U.S.
5.4. Market Attractiveness Analysis: Zone
6. Competition Landscape
6.1. Market Share Analysis, 2024
6.2. Market Structure
6.2.1. Competition Intensity Mapping by Market
6.2.2. Competition Dashboard
6.3. Company Profiles (Details - Overview, Financials, Strategy, Recent Developments)
6.3.1. Preventis GmbH
6.3.1.1. Overview
6.3.1.2. Segments and Product Types
6.3.1.3. Key Financials
6.3.1.4. Market Developments
6.3.1.5. Market Strategy
6.3.2. Selinion
6.3.3. BIOMÉRIEUX
6.3.4. Hangzhou AllTest Biotech CO., LTD.
6.3.5. Molbio Diagnostics Limited
6.3.6. KAINOS Laboratories, Inc.
6.3.7. Epitope Diagnostics, Inc.
6.3.8. Abbott
6.3.9. F. Hoffmann-La Roche Ltd
6.3.10. QuidelOrtho Corporation
6.3.11. BD
6.3.12. SEKISUI Diagnostics
6.3.13. Thermo Fisher Scientific Inc.
6.3.14. Siemens Healthineers
6.3.15. Bio-Rad Laboratories, Inc.
6.3.16. Luminex Corporation
6.3.17. Cardinal Health
6.3.18. Prometheus Bio Inc.
6.3.19. DiaSorin S.p.A.
6.3.20. Guardant Health
6.3.21. Aidian
6.3.22. Others
7. Appendix
7.1. Research Methodology
7.2. Research Assumptions
7.3. Acronyms and Abbreviations