Global Enteric Disease Testing Market: Information by Product Type (Reagents and Consumables, Equipment), Technique (Molecular Diagnostics, Immunodiagnostics), Disease Type (Bacterial Enteric Diseases, Viral Enteric Diseases, Parasitic Enteric Diseases), End-User (Academic and Research Institutes, Hospital Laboratories, Pharmaceutical and Biotechnology Companies), and Region—Forecast Till 2032

Market Overview

The global enteric disease testing market size was valued at USD 3.9 billion in 2023 and is projected to reach USD 5.4 billion by 2032, registering a CAGR of 3.6% during the forecast period (2024-2032). The growing number of patients suffering from target illnesses drives the global demand for enteric disease testing.

Enteric disease testing diagnoses infections and diseases that affect the gastrointestinal tract, specifically the stomach and intestines. These diseases are typically caused by various pathogens, including bacteria, viruses, and parasites, and can result in symptoms such as diarrhea, vomiting, stomach pain, and fever. Enteric disease testing is critical for identifying the causative agents of gastrointestinal infections, making informed treatment decisions, and implementing public health measures to prevent the spread of infectious diseases.

Furthermore, the rising incidence rates of shigellosis, Clostridium difficile (C. difficile), campylobacteriosis, cholera, Escherichia coli (E. coli), salmonellosis, and cholera, all of which can cause severe diarrhea or death, are driving the growth of the enteric disease testing market share.

Moreover, the untapped enteric disease testing market in developing countries provides a significant opportunity for healthcare companies to create innovative and cost-effective testing solutions to meet the population's unmet needs. Furthermore, the rise in the trend of enteric disease testing, the increase in awareness of enteric disease testing diagnosis in developing countries such as China and India, the increase in disposable income, the increase in funding, and the rise in the discovery and development of effective enteric disease testing products all contribute to the growth of the enteric disease testing industry.

Highlights

• Reagents and Consumables hold the significant market share by product type.
• Immunodiagnostics dominates the market by technique.
• Bacterial Enteric Diseases led the market by disease type.
• Hospital Laboratories is a significant contributor to the market by end-users.

Market Dynamics

Global Enteric Disease Testing Market Drivers

Increasing Incidence of Enteric Infections

The rising global prevalence of enteric infections significantly drives demand for enteric disease testing. Population growth, urbanization, globalization, and shifts in food production and consumption patterns help spread enteric pathogens. As a result, there is an increasing demand for diagnostic tests to detect and identify the causative agents of gastrointestinal infections, such as bacteria, viruses, and parasites.

According to the World Health Organization (WHO), enteric infections are a primary global health concern, especially in low- and middle-income countries with limited access to safe water, sanitation, and hygiene (WASH). Diarrheal diseases, primarily caused by enteric pathogens, are a significant cause of morbidity and mortality, particularly among children under the age of five. The World Health Organization (WHO) reported 135 deaths from acute watery diarrhea (AWD) or cholera between January 1 and September 15, 2023. These deaths were reported by eight member states, including Afghanistan, Iraq, Lebanon, and Pakistan.

Furthermore, according to the CDC, FoodNet reported more infections from Shiga toxin-producing Escherichia coli (ETEC), Yersinia, Vibrio, and Cyclospora in 2022 than in 2016-2018. In 2023, the Republic of Congo's Ministry of Health and Population declared a suspected triple typhoid fever, shigellosis, and cholera outbreak. The outbreak has resulted in an overflow of healthcare facilities and a large number of patients requiring surgical intervention for intestinal perforation. 

Moreover, the rising incidence of enteric infections, as evidenced by outbreaks and epidemiological data, emphasizes the critical need for reliable enteric disease testing capabilities. Rapid and accurate diagnostic testing is essential to identifying enteric pathogens, making treatment decisions, and implementing public health interventions to prevent and control the spread of infectious diseases. 

Global Enteric Disease Testing Market Restraints

Limited Access to Healthcare Services

Many regions, deficient- and middle-income countries, may have limited access to healthcare services and diagnostic facilities. Lack of healthcare infrastructure, trained personnel, and diagnostic equipment can impede timely diagnosis and management of enteric infections, resulting in underreporting cases and insufficient disease surveillance. Due to resource and personnel constraints, diagnostic methods for enteric diseases are scarce in African countries. Even though polymerase chain reaction (PCR) has been used to diagnose chronic carrier status, stool culture remains the preferred investigation for typhoid fever. Many centers rely on clinical diagnosis and serodiagnosis with the Widal test. 

According to a 2023 report by the World Health Organization (WHO) and the World Bank, 4.5 billion people, or half of the global population, do not have access to essential health services. This includes 2 billion people experiencing severe financial hardship. Furthermore, South Sudan has the world's worst healthcare system, scoring 13.1 in 2023. The LPI also ranks South Sudan as the world's second unhealthiest country, trailing only the Central African Republic (31.95 out of 100).

Furthermore, data from the United Nations Children's Fund (UNICEF) show that access to healthcare services varies significantly by region, with rural populations frequently facing the most difficult challenges. Many low- and middle-income countries' rural areas need more healthcare infrastructure, trained healthcare workers, and diagnostic capabilities, making it difficult for people to receive timely and appropriate medical care, including enteric disease testing.

Global Enteric Disease Testing Market Opportunity

Expansion of Point-of-Care-Testing (POCT)

There is an increasing demand for rapid, decentralized testing solutions for enteric diseases, particularly in resource-constrained settings, remote areas, and outbreaks. Point-of-care testing (POCT) technologies, including rapid diagnostic tests (RDTs), portable molecular assays, and lab-on-a-chip devices, have the potential to improve access to timely diagnosis and treatment, shorten turnaround times, and improve patient management in a variety of healthcare settings.

Additionally, access to centralized laboratory facilities for enteric disease testing is limited in remote and underserved areas of sub-Saharan Africa. As a result, people with gastrointestinal infections may experience delays in diagnosis and treatment, resulting in a more prolonged illness and a higher risk of complications. To address this issue, healthcare organizations and non-governmental organizations (NGOs) have launched point-of-care testing (POCT) initiatives that use portable diagnostic devices capable of rapidly detecting enteric pathogens.

A 2020 study discovered that Juba, South Sudan, has an enteric fever coincidence rate of 30/100 person-years, with a cumulative incidence of 74% over four years. One method for estimating enteric fever coincidence in South Sudan is to test previously collected blood samples. In June 2023, the CDC launched FETP-Intermediate, the second tier of the FETP program. The CDC and its partners use this program to improve South Sudan's ability to respond to outbreaks. 

Furthermore, World Health Organization (WHO) data show that implementing POCT for enteric diseases has been linked to better patient outcomes, higher treatment compliance, and lower healthcare costs in low-resource settings. In a systematic review of POCT interventions for diarrheal diseases, the WHO found that POCT devices, such as rapid diagnostic tests (RDTs) for bacterial and viral pathogens, had high sensitivity and specificity for enteric pathogen detection, with turnaround times ranging from minutes to hours. 

Regional Analysis

The global enteric disease testing market share is bifurcated into North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global enteric disease testing market shareholder and is estimated to grow at a CAGR of 3.3% over the forecast period. The presence of several important players in the region, including Abbott Laboratories, Becton Dickinson & Company, Biomerica, Inc., Bio-Rad Laboratories, Inc., Meridian Bioscience, Inc., and Quest Diagnostics, as well as advancements in manufacturing technology for enteric disease testing products, drive market growth. This is primarily due to the increased number of patients suffering from enteric diseases, increased government funding for research into enteric disease diagnosis, and a significant increase in capital income in developed countries.

Furthermore, a sophisticated reimbursement structure aimed at lowering expenditure levels fuels enteric disease testing market growth. Thus, such factors drive market growth. Moreover, the United States is expected to contribute a significant share of the regional market and drive the development of the enteric disease testing market over the forecast period. The well-established healthcare infrastructure, high purchasing power, and increased adoption of enteric disease testing are expected to drive market growth. 

Europe is anticipated to exhibit a CAGR of 3.0% over the forecast period, accounting for the second-largest revenue share at 30%. Germany dominates the European market, owing to its large senior population. According to United Nations population data, one in every 20 people in Germany is over 80, expected to rise to one in every six by 2050. People over the age of 65 represented 22.4% of the total population. In 2019, 90.4 million people over 65 lived in Europe. Problems with the growing senior population include an increased risk of enteric diseases caused by senescence and decreased immunity levels. Rapid diagnostic techniques like point-of-care diagnostic devices can benefit this population. Key manufacturers, including Roche and Bio-Rad, are expanding their operations in Germany, which is expected to boost the enteric disease testing industry.

Asia-Pacific is expected to grow at the fastest CAGR over the forecast period as people become more aware of the importance of testing and the increase in infections. Attractive market regions are located in developing nations such as China and India, resulting in Asia Pacific's fastest growth. Enteric diseases are more prevalent in Asian countries. For example, Bangladesh has the highest typhoid case rate, with 252 cases per 100,000 people. 

Latin America is expected to experience moderate growth over the forecast period. Brazil is expected to provide significant opportunities for market growth. Brazil has experienced positive economic growth due to increased financial and political stability. Healthcare reforms, such as the Unified Health System (SUS), offer free healthcare services to people of all income levels without charging additional fees. The SUS consists of public, private, and supplemental healthcare services.

Additionally, government initiatives, such as collaboration between the United States and Brazil on biomedical research to accelerate R&D in diagnosing and treating infectious diseases, are also boosting the market. However, access to advanced diagnostics in Brazil is currently restricted to urban areas due to a need for more infrastructure in rural areas, which may slow market growth.

Segmental Analysis

The global enteric disease testing market is segmented based on product type, technique, disease type, and end-user.

The market is further segmented by product type into Reagents, Consumables, and Equipment.

The reagents and consumables segment accounted for most of the enteric disease testing market share in 2023, owing to the high adoption of reagents and consumables, increased availability of reagents and consumables, and companies experiencing high reagent and consumable sales. Enteric disease testing procedures require reagents and consumables to prepare samples, perform assays, and generate test results. These include the chemicals, buffers, enzymes, antibodies, and other biochemical substances needed for sample processing, nucleic acid extraction, amplification, and detection of enteric pathogens. Reagents and consumables are typically tailored to specific testing methods, such as molecular diagnostics, immunoassays, and culture-based techniques. 

The equipment segment is expected to grow fastest during the forecast period, owing to the short testing time, the ability to run multiple samples simultaneously, increased accuracy, and the high demand for automation for enteric disease testing. Enteric disease testing laboratories use equipment to perform diagnostic assays, analyze samples, and generate test results. This includes laboratory instruments like PCR machines, real-time PCR systems, microplate readers, automated liquid handling systems, incubators, centrifuges, and specialized diagnostic platforms for detecting enteric pathogens. 

Based on technique, the market is fragmented into Molecular Diagnostics and immunodiagnostics.

The immunodiagnostics segment generated the most revenue in 2023, owing to increased adoption of immunodiagnostic techniques and advancements in immunodiagnostic technology. Immunodiagnostics is a technique in enteric disease testing that detects and measures immune responses to enteric pathogens. This method employs antibodies, antigens, and immunological assays such as enzyme-linked immunosorbent assays (ELISAs), lateral flow assays, and immunofluorescence assays to detect specific antigens or antibodies associated with enteric infections. 

The molecular diagnostics segment is expected to grow at the fastest CAGR during the forecast period, owing to increased demand for molecular diagnostics products, increased use of molecular diagnostics techniques in research, and increased availability of molecular diagnostics equipment. Immunodiagnostics is a technique in enteric disease testing that detects and measures immune responses to enteric pathogens. 

The market can be further bifurcated by disease type into Bacterial Enteric Diseases, Viral Enteric Diseases, and Parasitic Enteric Diseases.

The bacterial enteric disease segment had the highest market share in 2023, owing to the large number of people suffering from Clostridium difficile (C. difficile), campylobacteriosis, cholera, Escherichia coli (E. coli), Helicobacter pylori (H. pylori), salmonellosis, and the widespread use of enteric disease testing products for the diagnosis of bacterial enteric diseases. The same segment is expected to grow at the fastest CAGR during the forecast period, owing to increased awareness about bacterial enteric disease diagnosis and prevalence worldwide.

Additionally, these pathogens can spread through contaminated food and water, person-to-person, or animal contact. Bacterial enteric diseases pose significant public health challenges worldwide, frequently linked to foodborne illness, waterborne outbreaks, and inadequate sanitation.

Viral enteric diseases are caused by viruses that infect the gastrointestinal tract, resulting in symptoms like diarrhea, vomiting, abdominal cramps, and fever. Norovirus, rotavirus, adenovirus, astrovirus, and enteric viruses like hepatitis A and E are among the most common viral enteric pathogens. Viral enteric diseases are highly contagious and spread quickly via fecal-oral transmission, contaminated food and water, and person-to-person contact. 

Based on end-users, the market is fragmented into Academic and Research Institutes, Hospital Laboratories, and Pharmaceutical and Biotechnology Companies.

The hospital laboratories segment generated the most revenue in 2023, thanks to increased health coverage for hospital-based treatment, hospital admissions, and a greater preference for hospital laboratories. The same segment is expected to grow at the fastest CAGR during the forecast period, owing to an increase in the diagnosis of enteric diseases in hospital laboratories and an increase in awareness of routine body checkups.

Moreover, bacterial culture, molecular assays, antigen detection tests, and serological testing are among the diagnostic tests for enteric pathogens performed by hospital laboratories. These laboratories play an important role in patient care by providing timely and accurate test results, guiding treatment decisions, and facilitating infection prevention measures. 

Pharmaceutical and biotechnology companies are responsible for developing, manufacturing, and commercializing enteric disease testing products such as reagents, consumables, equipment, and diagnostic assays. These companies invest in R&D to create new diagnostic technologies, improve assay performance, and broaden the number of enteric pathogens detected. 

Recent Developments

• April 2024- Abbott received FDA clearance for a whole blood rapid test to help with the assessment of concussion at the patient's bedside.
• March 2024- Diasorin submitted the LIAISON PLEX® Yeast Blood Culture Assay for the LIAISON PLEX® system to the US FDA.
• January 2024- Trinity Biotech announced the acquisition of Waveform Technologies, Inc.'s CGM assets.