Gastrointestinal Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test Type (Endoscopy, Blood Test, H. pylori Test, Calprotectin Test, Immunoglobulin A Test, and Others), By Technology (ELISA, PCR, Microbiology, and Others), By Application (Infection, Inflammatory Bowel Disease, Gastroesophageal Reflux Disease, Cancer, and Others), By Test Location (Central laboratories and Point-of-Care), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 5.58 Billion
CAGR (2026-2031)	4.65%
Fastest Growing Segment	Endoscopy
Largest Market	North America
Market Size (2031)	USD 7.33 Billion

Market Overview

The Global Gastrointestinal Diagnostics Market will grow from USD 5.58 Billion in 2025 to USD 7.33 Billion by 2031 at a 4.65% CAGR. Gastrointestinal diagnostics encompass a specialized category of medical testing platforms, imaging technologies, and assay kits designed to identify pathological conditions within the digestive tract, including the esophagus, stomach, and intestines. The market is fundamentally supported by the escalating prevalence of gastrointestinal malignancies and functional disorders, combined with a global demographic shift toward an aging population that requires frequent clinical screening. These primary drivers are distinct from temporary industry trends, as they represent a sustained structural increase in demand for early detection and disease monitoring capabilities.

According to the American Cancer Society, in 2024, an estimated 152,810 new cases of colorectal cancer were expected to be diagnosed in the United States. This high disease burden underscores the critical necessity for accurate diagnostic tools. However, a significant challenge impeding broader market expansion is the substantial capital expense associated with advanced endoscopic systems and molecular testing equipment, which restricts accessibility in cost-sensitive healthcare environments.

Key Market Drivers

The rising prevalence of gastrointestinal cancers and chronic digestive disorders serves as the foundational catalyst for the Global Gastrointestinal Diagnostics Market. As the incidence of malignancies such as pancreatic, colorectal, and gastric cancers accelerates, healthcare systems are compelled to prioritize early detection capabilities to mitigate high mortality rates. This escalating disease burden directly translates into sustained demand for established endoscopic hardware and advanced imaging modalities required for definitive diagnosis. For instance, according to the American Cancer Society, January 2024, in 'Cancer Facts & Figures 2024', pancreatic cancer remains particularly lethal, with approximately 51,750 deaths expected to occur in the United States alone during the year. Consequently, major medical technology entities continue to report robust sales in this sector; according to Olympus Corporation, May 2024, in the 'Consolidated Financial Results for the Fiscal Year Ended March 31, 2024', revenue for the Endoscopic Solutions Division reached 586.6 billion JPY, reflecting the critical ongoing reliance on invasive diagnostic tools.

Simultaneously, the market is experiencing a transformative shift driven by the rising demand for point-of-care and at-home diagnostic solutions. Patients and payers are increasingly favoring non-invasive screening methods, such as stool-based DNA tests, which offer superior convenience and compliance compared to traditional colonoscopies. This preference is expanding the diagnostic pool to include under-screened populations, thereby generating new revenue streams outside the traditional hospital setting. The commercial impact of this trend is evident in the performance of market leaders in non-invasive screening. According to Exact Sciences Corp., February 2024, in the 'Fourth Quarter 2023 Results', screening revenue, which primarily includes laboratory service revenue from Cologuard tests, generated 1.87 billion USD for the full year 2023, representing a 31 percent increase compared to the previous year.

Download Free Sample Report

Key Market Challenges

The substantial capital expense required for advanced endoscopic systems and molecular testing equipment constitutes a primary restraint on the expansion of the gastrointestinal diagnostics market. Healthcare facilities, particularly community hospitals and outpatient clinics in cost-sensitive regions, often operate with restricted budgets that cannot accommodate the high upfront procurement costs of these diagnostic platforms. This financial barrier necessitates the prolonged use of legacy instrumentation and delays the adoption of higher-throughput technologies. Consequently, the market experiences a structural deceleration in volume growth as the cycle for replacing and upgrading essential equipment is extended significantly beyond optimal clinical timelines.

This economic pressure is further exacerbated by contracting reimbursement environments that diminish the return on investment for expensive diagnostic assets. According to the American College of Gastroenterology, in 2025, the finalized Medicare Physician Fee Schedule implemented a payment conversion factor reduction of 2.83 percent. Such reductions in reimbursement rates directly erode the operating margins of gastroenterology practices, substantially limiting their financial capacity to invest in high-cost diagnostic capital equipment and thereby hampering the broader market's growth trajectory.

Key Market Trends

The integration of artificial intelligence into endoscopic imaging systems is fundamentally altering detection standards for gastrointestinal pathologies. Computer-aided detection systems utilize deep learning algorithms to analyze video feeds in real-time, identifying polyps and lesions that might otherwise be missed by the human eye during colonoscopies. This technological capability addresses the critical clinical variable of adenoma detection rates, directly improving patient outcomes by facilitating early intervention. The superior clinical efficacy of these automated tools is driving recent regulatory clearances and market adoption; according to Fujifilm Healthcare Americas Corporation, March 2024, in the announcement 'Fujifilm Receives 510(k) Clearance for CAD EYE', the newly cleared AI system demonstrated a 17 percent higher adenoma per colonoscopy rate compared to conventional high-definition colonoscopy.

Simultaneously, the market is transitioning toward single-use disposable endoscopes to mitigate cross-contamination risks and eliminate complex reprocessing workflows. Hospitals are adopting these sterile, one-time-use devices for high-risk procedures to ensure patient safety and reduce the operational overhead associated with cleaning capital-intensive reusable equipment. This shift is particularly evident in the rapid commercial expansion of disposable platforms across gastroenterology departments that require efficient infection control solutions. This adoption momentum is quantifiable; according to Ambu A/S, November 2024, in the 'Annual Report 2023/24', organic revenue for the Endoscopy Solutions division increased by 19.7 percent for the financial year, reflecting the accelerating integration of disposable scopes into standard clinical practice.

Segmental Insights

The endoscopy segment is projected to witness the fastest growth within the global gastrointestinal diagnostics market due to a rising preference for minimally invasive procedures that reduce patient recovery time. This expansion is further driven by the increasing prevalence of gastrointestinal disorders which require frequent internal visualization for accurate diagnosis. Additionally, consistent product clearances by regulatory authorities such as the U.S. FDA facilitate the widespread adoption of new endoscopic technologies. These factors collectively encourage healthcare providers to utilize endoscopic solutions for early disease detection, thereby sustaining the rapid development of this segment.

Regional Insights

North America maintains a leading position in the global gastrointestinal diagnostics market, driven by the increasing prevalence of chronic digestive disorders and widely accessible healthcare services. This dominance is significantly reinforced by substantial investments in medical research and the strategic presence of key industry manufacturers. Furthermore, supportive regulatory frameworks established by the U.S. Food and Drug Administration facilitate timely product launches. The adoption of these diagnostic tests is also bolstered by favorable reimbursement coverage provided by the Centers for Medicare & Medicaid Services, ensuring broad patient access to essential screening procedures.

Recent Developments

• In January 2025, RNT Health Insights announced that it had received a second Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its artificial intelligence-driven esophageal cancer detection tool. This innovative diagnostic technology was developed to assist gastroenterologists in the real-time identification of early-stage and advanced esophageal cancers during standard upper gastrointestinal endoscopy procedures. The solution specifically targets the detection of adenocarcinoma and dysplasia associated with Barrett's esophagus. This designation acknowledged the device's potential to significantly enhance diagnostic accuracy and improve patient survival rates by reducing the incidence of missed pathologies during routine examinations.
• In October 2024, Exact Sciences Corp. announced that the U.S. Food and Drug Administration (FDA) granted approval for the Cologuard Plus test, the company's next-generation multitarget stool DNA test. This advanced diagnostic product was approved for screening adults aged 45 years and older who are at average risk for colorectal cancer. The regulatory decision was based on findings from the pivotal BLUE-C study, which demonstrated that the test achieved 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions with high specificity. The company highlighted that this non-invasive screening tool significantly reduced false positives compared to the previous version and planned for a commercial launch in 2025.
• In July 2024, Guardant Health, Inc. secured U.S. Food and Drug Administration (FDA) approval for its Shield blood test, establishing it as a primary screening option for colorectal cancer. This regulatory milestone allowed the test to be used for average-risk adults aged 45 and older, making it the first blood test to receive such authorization for this indication. The approval was supported by results from the ECLIPSE study, which indicated an 83% sensitivity for detecting colorectal cancer. Furthermore, the test became the first blood-based screening method to meet the specific performance requirements necessary for Medicare coverage eligibility, aiming to improve screening compliance rates.
• In May 2024, Geneoscopy, Inc. received U.S. Food and Drug Administration (FDA) approval for ColoSense, a noninvasive multi-target stool RNA screening test designed for colorectal cancer detection. This diagnostic test was indicated for adults aged 45 and older who are at average risk of developing the disease. The approval was supported by data from the CRC-PREVENT trial, in which the test demonstrated a 93% sensitivity for colorectal cancer and a 45% sensitivity for advanced adenomas. The company also noted a strategic collaboration with Labcorp to support the effective commercial distribution and accessibility of this new screening option for patients nationwide.

Key Market Players

• bioMérieux S.A.
• F. Hoffmann-La Roche Ltd.
• Abbott Laboratories, Inc.
• Beckman Coulter, Inc.
• DiaSorin S.p.A
• Siemens Healthineers AG
• QIAGEN N.V.
• Meridian Bioscience, Inc.
• Hologic, Inc.
• Epitope Diagnostics Inc.

By Test Type	By Technology	By Application	By Test Location	By Region
Endoscopy Blood Test H. pylori Test Calprotectin Test Immunoglobulin A Test and Others	ELISA PCR Microbiology and Others	Infection Inflammatory Bowel Disease Gastroesophageal Reflux Disease Cancer and Others	Central laboratories and Point-of-Care	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Gastrointestinal Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Gastrointestinal Diagnostics Market, By Test Type:

• Endoscopy
• Blood Test
• H. pylori Test
• Calprotectin Test
• Immunoglobulin A Test
• and Others

• Gastrointestinal Diagnostics Market, By Technology:

• ELISA
• PCR
• Microbiology
• and Others

• Gastrointestinal Diagnostics Market, By Application:

• Infection
• Inflammatory Bowel Disease
• Gastroesophageal Reflux Disease
• Cancer
• and Others

• Gastrointestinal Diagnostics Market, By Test Location:

• Central laboratories and Point-of-Care

• Gastrointestinal Diagnostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE