Enteric Disease Testing Market Size Analysis:

The Enteric Disease Testing Market size was valued at USD 3.80 billion in 2023 and is expected to reach USD 5.25 billion by 2032, growing at a CAGR of 3.70% from 2024-2032.

Our Enteric Disease Testing Market Report provides insights with profound incidence and prevalence analysis, quantifying the worldwide and regional distribution of bacterial, viral, and parasitic diseases. The report contains testing volume trends by geography, illustrating changes in diagnostic adoption among hospitals, laboratories, and research institutions. The report has a market share breakdown by test category, including molecular, immunoassay, and chromatography-based diagnostics. Moreover, we provide comprehensive healthcare expenditure insights region-wise, divided into government, commercial, private, and out-of-pocket expenses. Finally, our study includes regulatory and technology developments such as IVDR compliance, laboratory automation, and AI-based diagnostic advancements.

The U.S. Enteric Disease Testing Market size was USD 1 billion in 2023 and is expected to reach USD 1.38 billion by 2032, growing at a CAGR of 3.69% over the forecast period of 2024-2032.

The market is driven by the increasing incidence of foodborne and waterborne illnesses, rising demand for rapid diagnostic solutions, and advancements in molecular testing technologies. Growing awareness of gastrointestinal infections and their impact on public health has led to higher adoption of enteric disease testing. Additionally, government initiatives to improve food and water safety regulations are further propelling market growth.

Enteric Disease Testing Market Dynamics

Drivers

• Rising Incidence of Enteric Diseases and Growing Need for Early Diagnosis is accelerating the market growth.

The growing global enteric disease burden, comprising bacterial infections such as Salmonella and Clostridium difficile, viral pathogens such as Norovirus and Rotavirus, and parasitic infections such as Giardia and Cryptosporidium, is a major factor in the enteric disease testing market. Foodborne illnesses claim 48 million people every year in the U.S., as stated by the CDC, triggering more demand for fast and precise diagnostic solutions. Furthermore, food- and waterborne outbreaks have compelled governments to fortify disease surveillance programs. In 2023, the WHO emphasized an upsurge in antimicrobial-resistant (AMR) enteric pathogens, which further boosted demand for molecular diagnostic testing. Vendors such as Cepheid and Roche have broadened their PCR-based panels to promote early and accurate disease detection, fueling market growth.

• Advancements in Molecular Diagnostics and Automation in Laboratories are propelling the market to grow.

The transition towards molecular and automation-based diagnostic solutions is transforming enteric disease testing. PCR-based tests, next-generation sequencing (NGS), and multiplex panels offer quicker and more accurate detection than traditional culture techniques. Multiple syndromic panels for the detection of gastrointestinal pathogens have recently been approved by the FDA, boosting the usage of molecular testing in hospitals and diagnostic laboratories. Thermo Fisher Scientific introduced a sophisticated TaqMan Pathogen Detection Kit in 2023, which strengthens real-time PCR capabilities. Diagnostic workflows are also being shortened by automation, decreasing turnaround time and human errors, and increasing efficiency. Greater use of AI-powered diagnostics and automated sample preparation is further simplifying high-throughput enteric disease testing, making it scalable and cost-effective, particularly in areas where disease prevalence is high.                                                     

Restraint

• High Cost of Advanced Diagnostic Tests and Limited Accessibility in Low-Income Regions are restraining the market from growing.

One of the major constraints in the Enteric Disease Testing Market is the exorbitant price of sophisticated molecular diagnostic tests, which restricts their uptake, especially in low- and middle-income nations (LMICs). Molecular tests like PCR-based assays and next-generation sequencing (NGS) are costly, ranging from USD 50 to USD 300 per test, rendering them less affordable for general disease screening. Furthermore, most of the diagnostic laboratories in developing countries also lack the necessary infrastructure as well as personnel for introducing and sustaining sophisticated diagnostic technologies. A WHO report in 2023 emphasized unequal distribution in enteric disease diagnostics, with low-resource settings continuing to use older culture-based techniques that take longer and are less sensitive compared to newer methods. These barriers to cost and access hamper early diagnosis and control of outbreaks, especially in countries with high disease burden.

Opportunities

• The increasing need for quick, convenient, and affordable diagnostic tools is a huge opportunity in the Enteric Disease Testing Market.

Point-of-care (POC) and home-based diagnostic kits enable quicker identification of enteric pathogens without the need for laboratory facilities. Abbott and Meridian Bioscience have launched rapid immunoassay-based stool tests that deliver results in minutes, enhancing early diagnosis and patient care. Further, the growth in telemedicine and online healthcare platforms is fueling the use of at-home testing kits, especially in rural and underserved areas. Decentralized testing will grow substantially by 2030 due to the initiatives of government policies supporting self-testing solutions. The growth of affordable, mobile, and AI-enabled diagnostic tools further supports this market opportunity for industry players.

Challenges

• Variability in regulatory standards across regions is challenging the market growth.

One of the significant issues in the Enteric Disease Testing Market is that there are no similar regulatory norms across countries, resulting in time lags for product approvals and market entry obstacles. The European Union's In Vitro Diagnostic Regulation (IVDR 2017/746) replaced earlier directives and has created tighter compliance demands, which hamper manufacturers' launches of new diagnostic products in Europe. The U.S. FDA has rigorous clearance procedures, especially for molecular-based tests, that enhance time-to-market and compliance expenses. Conversely, most developing countries do not have standardized regulations, leading to quality inconsistencies and restricted market reach. The necessity of harmonized global regulatory schemes is still an issue, given that firms will have to deal with complicated approval procedures, affecting innovation and market extension activities in enteric disease diagnosis.

Enteric Disease Testing Market Segmentation Analysis

By Disease

The Bacterial Enteric Disease segment dominated the enteric disease testing market with around 54.31% market share in 2023, as a result of the high incidence and extensive outbreaks of bacterial infections like Salmonella, Clostridium difficile, Escherichia coli (E. coli), and Campylobacter. Based on the CDC, Salmonella alone infects around 1.35 million people every year in the U.S., making it a reason for high demand for quick diagnosis testing. Also, HAIs caused by Clostridium difficile (C. difficile) have been on the rise, pushing molecular and immunoassay-based testing solutions. Global governments and healthcare organizations have introduced stringent food safety measures and monitoring initiatives, boosting the uptake of bacterial enteric disease diagnostic tests. The increasing demand for multiplex PCR panels and automated systems from market leaders such as BD, bioMérieux, and Roche has further driven dominance in the segment.

By Test Type

The Immunoassay segment dominated the enteric disease testing market with around 46.32% market share in 2023 because of its prevalence, affordability, and quick turnaround time relative to molecular and traditional diagnostic techniques. Immunoassays, such as enzyme-linked immunosorbent assays (ELISA) and lateral flow assays (LFAs), are used extensively in clinical labs, hospitals, and point-of-care facilities for the detection of enteric pathogens like Salmonella, Clostridium difficile, E. coli, and Rotavirus. Their capacity to provide results in minutes to a few hours makes them crucial for the timely diagnosis and control of outbreaks. Additionally, the increased uptake of immunoassay-based rapid test kits in developing countries, where access to sophisticated molecular diagnostics is constrained, has driven this segment substantially. Organizations such as bioMérieux, Meridian Bioscience, and Abbott have continued to advance highly sensitive immunoassay-based diagnostic products, further establishing the dominance of this test type in 2023.

By End-Use

The Hospitals segment dominated the enteric disease testing market with a 42.11% market share in 2023 because of the large number of patient admissions, sophisticated diagnostic facilities, and growing demand for precise and timely testing. Hospitals are central health facilities for the diagnosis and management of acute gastrointestinal infections, foodborne infections, and hospital-acquired infections (HAIs) like Clostridium difficile (C. difficile). The presence of sophisticated laboratory equipment, skilled personnel, and automated diagnostic platforms in hospitals has fueled the use of enteric disease testing on a large scale, especially molecular diagnostics and immunoassays.

Also, the increase in hospitalization rates of cases due to foodborne outbreaks and infectious diarrhea, along with government efforts for enhancing infection control and patient safety, has further contributed to the growth of hospital-based diagnostic testing. Top players like Roche, Cepheid, and BD have kept expanding hospital-centric diagnostic solutions, confirming the stronghold of the segment in 2023.

Enteric Disease Testing Market Regional Insights

North America dominated the Enteric Disease Testing Market with around 38.42% market share in 2023, mostly because it has a well-developed healthcare infrastructure, high disease incidence, and a robust regulatory system. According to the CDC, foodborne illness strikes 48 million Americans every year, fueling demand for fast and reliable diagnostic solutions. The area boasts a strong adoption of molecular diagnostics and automation-driven laboratory processes, with prominent companies such as Cepheid, Roche, and Abbott continually developing next-generation PCR-based and syndromic panel tests. Furthermore, government policies and funding initiatives, including the FDA's antimicrobial resistance (AMR) surveillance efforts and the U.S. Food Safety Modernization Act (FSMA), have fortified the area's diagnostic infrastructure. The availability of major biotechnology companies and reference labs, as well as extensive insurance coverage for diagnostic procedures, further cements North America's leadership in this market.

Asia Pacific is the fastest-growing region in the enteric disease testing market with a 4.25% CAGR throughout the forecast period, fueled by growing disease incidence, urbanization, and enhanced accessibility to healthcare. India, China, and Indonesia have a high rate of bacterial and viral enteric infections because of poor sanitation, dirty water sources, and weak food safety control. The WHO approximates that more than 220 million children are affected by diarrheal diseases every year in Asia, and this demonstrates the need for effective diagnostic products. Furthermore, efforts by the government to enhance infectious disease surveillance, coupled with increasing investments in healthcare infrastructure and growing diagnostic laboratory networks, are driving market growth. The rising use of point-of-care and low-cost rapid test kits, backed by local players and multinational corporations, further enhances the region's diagnostic testing growth and accessibility.

Enteric Disease Testing Market Key Players

• Abbott Laboratories (RealTime PCR Assays, Immunoassay Kits)

• Becton, Dickinson and Company (BD) (BD MAX Enteric Bacterial Panel, BD Veritor System)

• Biomerica, Inc. (EZ Detect Stool Blood Test, H. pylori Test)

• bioMérieux SA (VIDAS Enteric Panel, GENE-UP Pathogen Detection)

• Bio-Rad Laboratories, Inc. (iQ-Check Real-Time PCR Kits, Bio-Plex Multiplex Immunoassays)

• Cepheid (Danaher Corporation) (Xpert C. difficile, Xpert Norovirus)

• Coris BioConcept (Gastro Viruses Respi-Strip, H. pylori Antigen Test)

• DiaSorin S.p.A. (LIAISON Enteric Pathogen Panel, Simplexa C. difficile Direct)

• Meridian Bioscience, Inc. (ImmunoCard STAT! EHEC, Premier C. difficile GDH)

• Quest Diagnostics (GI Pathogen Panel, H. pylori Urea Breath Test)

• Trinity Biotech (Uni-Gold H. pylori, EntericBio Multiplex PCR)

• Thermo Fisher Scientific (TaqMan Pathogen Detection Kits, SureTect PCR Assays)

• Quansys Biosciences Inc. (Q-Plex Human Environmental Enteric Dysfunction Panel, Q-Plex Multiplex ELISA Kits)

• SGS (Microbiological Testing Services, Pathogen Detection Assays)

• Merck (Singlepath Listeria, Singlepath Salmonella)

• Roche Diagnostics (LightCycler PCR Systems, cobas Cdiff Test)

• GenMark Diagnostics (ePlex Gastrointestinal Pathogen Panel, eSensor Respiratory Viral Panel)

• Luminex Corporation (VERIGENE Enteric Pathogens Test, xTAG Gastrointestinal Pathogen Panel)

• Hologic, Inc. (Aptima GI Assays, Panther Fusion GI Panel)

• Siemens Healthineers (IMMULITE 2000 Immunoassay System, VERSANT kPCR Molecular System)

Suppliers (These suppliers commonly provide essential reagents and consumables, such as enzymes, nucleotides, and buffers, which are crucial for developing and performing diagnostic assays used in enteric disease testing). In the enteric disease testing market.

• Thermo Fisher Scientific​

• Bio-Rad Laboratories​

• Merck KGaA​

• Qiagen N.V.​

• PerkinElmer Inc.​

• Agilent Technologies​

• Promega Corporation​

• Takara Bio Inc.​

• New England Biolabs​

• Integrated DNA Technologies (IDT)​

Recent Development in the Enteric Disease Testing Market

• In Feb. 2025 – Biomerica, Inc., a leading international company for medical diagnostic products, has issued a statement stating that its products for food intolerance used for the diagnosis of Crohn's Disease and Ulcerative Colitis have been certified CE-mark as per the European Union's revised In Vitro Diagnostic Medical Devices Regulation (IVDR – 2017/746).

• In April 2023, Danaher-owned Cepheid is soon to launch several new infectious disease diagnostic tests, including those for tuberculosis and respiratory viruses, as part of its long-term commitment to molecular diagnostics innovation.