Global Hepatitis E Diagnostic Tests Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In November 2023, F. Hoffmann-La Roche Ltd launched automated serology hepatitis E virus tests named Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays.

• In November 2023, WHO included HEV tests, such as the Altona assay, in their Essential Diagnostics List (EDL).

The global hepatitis E diagnostic tests market is segmented by test type, including polymerase chain reaction (PCR) tests, enzyme-linked immunosorbent assay (ELISA) tests, and others. PCR tests dominate the market due to their high sensitivity and specificity, making them the gold standard for detecting hepatitis E virus (HEV) RNA in clinical samples. These tests are crucial for early diagnosis and management of the disease, particularly in regions with high HEV prevalence. ELISA tests, which detect antibodies against HEV, are also widely used due to their cost-effectiveness and ease of use, making them suitable for large-scale screening programs and epidemiological studies.

The Global Hepatitis E Diagnostic Tests Market has been segmented by sample type into Blood and Stool, each providing unique insights into the presence of the hepatitis E virus (HEV). Blood samples are the most commonly used for detecting hepatitis E, as they allow for the identification of antibodies and viral antigens associated with the infection.Stool samples are also an important diagnostic tool for hepatitis E, particularly for detecting viral RNA in the early stages of infection or during outbreaks. Since HEV is primarily transmitted through the fecal-oral route, stool samples can provide a direct indication of the virus’s presence in the gastrointestinal system.Geographically, the market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Asia-Pacific holds the largest market share, driven by the high incidence of hepatitis E in countries like India and China, coupled with increasing awareness and government initiatives to control the disease. North America and Europe also represent significant markets due to the presence of advanced healthcare infrastructure and a growing focus on infectious disease diagnostics. In contrast, Latin America and the Middle East & Africa are emerging markets with potential growth opportunities, supported by improving healthcare systems and increasing access to diagnostic facilities.

The end-user segment of the hepatitis E diagnostic tests market includes hospitals, diagnostic laboratories, and academic and research institutes. Hospitals and diagnostic laboratories constitute the largest end-user segment, as they are primary centers for disease diagnosis and management. These facilities are equipped with advanced diagnostic tools and trained personnel, ensuring accurate and timely detection of hepatitis E. Academic and research institutes also play a vital role, focusing on the development of novel diagnostic methods and conducting epidemiological research to better understand the disease and its transmission dynamics. This segmentation underscores the diverse applications and critical importance of hepatitis E diagnostics across different healthcare settings.

Global Hepatitis E Diagnostic Tests Segment Analysis

In this report, the Global Hepatitis E Diagnostic Tests Market has been segmented by Test Type, Sample Type, End User and Geography.

Global Hepatitis E Diagnostic Tests Market, Segmentation by Test Type

The Global Hepatitis E Diagnostic Tests Market has been segmented by Test Type into ELISA HEV IgM Test kits, ELISA HEV IgG Test kits, RT-PCR Test kits and Others.

The global hepatitis E diagnostic tests market is segmented by test type, with enzyme-linked immunosorbent assay (ELISA) tests being one of the primary segments. ELISA tests are widely used due to their high sensitivity, specificity, and ability to detect both acute and chronic infections. These tests work by detecting antibodies (IgM and IgG) or antigens in the blood, providing crucial information for the diagnosis and management of hepatitis E. The reliability and ease of use of ELISA tests have made them a standard choice in clinical settings, contributing to their dominant market share.

Another significant segment within the hepatitis E diagnostic tests market is the polymerase chain reaction (PCR) tests. PCR tests are highly valued for their ability to detect viral RNA, allowing for the early detection of hepatitis E infection even before the appearance of symptoms or antibodies. This molecular diagnostic technique is particularly useful in identifying acute infections and in cases where rapid diagnosis is essential. The precision and speed of PCR tests make them indispensable in both research and clinical diagnostics, especially in regions with high hepatitis E prevalence.

Rapid diagnostic tests (RDTs) represent a growing segment in the hepatitis E diagnostic market. These tests offer the advantage of quick results, typically within minutes, making them suitable for point-of-care settings and in-field testing during outbreaks. RDTs are designed to be user-friendly and do not require specialized laboratory equipment, which enhances their accessibility, especially in resource-limited areas. The convenience and rapid turnaround time of RDTs are driving their adoption, providing a critical tool for timely diagnosis and intervention in managing hepatitis E outbreaks.

Global Hepatitis E Diagnostic Tests Market, Segmentation by Sample Type

The Global Hepatitis E Diagnostic Tests Market has been segmented by Sample Type into Blood and Stool.

The Global Hepatitis E Diagnostic Tests Market has been segmented by sample type into Blood and Stool, each providing unique insights into the presence of the hepatitis E virus (HEV). Blood samples are the most commonly used for detecting hepatitis E, as they allow for the identification of antibodies and viral antigens associated with the infection. Blood-based tests, such as enzyme-linked immunosorbent assays (ELISA) and PCR, are widely used to detect HEV-specific immunoglobulins (IgM and IgG) or viral RNA, offering highly sensitive and accurate results. These tests are critical in diagnosing active infections and monitoring disease progression, particularly in symptomatic or at-risk patients.

Stool samples are also an important diagnostic tool for hepatitis E, particularly for detecting viral RNA in the early stages of infection or during outbreaks. Since HEV is primarily transmitted through the fecal-oral route, stool samples can provide a direct indication of the virus’s presence in the gastrointestinal system. Testing stool samples is often used in epidemiological studies and during outbreaks to track the spread of the virus and identify asymptomatic carriers or individuals at higher risk of transmission. The use of both blood and stool samples in diagnosing hepatitis E ensures a comprehensive approach to detecting the virus, allowing for accurate, early detection, and better disease management across various healthcare settings.

Global Hepatitis E Diagnostic Tests Market, Segmentation by End User

The Global Hepatitis E Diagnostic Tests Market has been segmented by End User into Hospitals, Research Centers, Diagnostic Laboratories and Point of Care.

In the global hepatitis E diagnostic tests market, segmentation by end user highlights distinct groups, each with specific needs and usage patterns. Hospitals and diagnostic laboratories represent a significant segment, where the demand for hepatitis E diagnostic tests is driven by the need for accurate and rapid diagnosis of infections. These facilities rely on advanced diagnostic tools to identify hepatitis E virus (HEV) infections swiftly, enabling timely intervention and treatment. The high throughput of these institutions necessitates robust, reliable testing equipment capable of handling large volumes of samples efficiently.

Another crucial segment consists of public health and research organizations. These entities use hepatitis E diagnostic tests for epidemiological studies and public health surveillance. Their focus is on understanding the prevalence and spread of the virus within populations, which aids in developing effective public health strategies and vaccination programs. In this segment, there is a strong emphasis on the accuracy and sensitivity of diagnostic tests, as these factors are vital for tracking outbreaks and informing policy decisions.

Point-of-care (POC) testing facilities and home care settings are becoming increasingly important end users. The demand for rapid, user-friendly diagnostic tests that can be administered outside traditional clinical environments is growing. These tests provide immediate results, facilitating prompt medical decisions and reducing the burden on healthcare facilities. The convenience and accessibility of POC and home-based tests make them particularly valuable in remote or underserved areas, where access to conventional diagnostic labs might be limited. This segment underscores the trend towards decentralization of healthcare, enabling broader and more equitable access to diagnostic services.

Global Hepatitis E Diagnostic Tests Market, Segmentation by Geography

In this report, the Global Hepatitis E Diagnostic Tests Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Hepatitis E Diagnostic Tests Market Share (%), by Geographical Region, 2024

The global Hepatitis E diagnostic tests market is witnessing varied growth patterns across different geographical regions. In North America, the market is experiencing steady expansion due to advanced healthcare infrastructure and increased awareness about Hepatitis E. The presence of major diagnostic companies and continuous investment in research and development contribute significantly to the market's growth in this region. Additionally, government initiatives aimed at controlling the spread of infectious diseases and the adoption of advanced diagnostic technologies are further propelling the market forward.

In contrast, the Asia-Pacific region is poised for substantial growth driven by the high prevalence of Hepatitis E in countries like India and China. The increasing incidence of the disease, coupled with a rising demand for accurate and early diagnosis, is fueling market expansion. Improvements in healthcare facilities, growing public awareness, and supportive government policies are also playing crucial roles. Furthermore, the region's large population base and improving economic conditions are leading to higher healthcare spending, which supports the adoption of Hepatitis E diagnostic tests.

Meanwhile, in Europe, the market for Hepatitis E diagnostic tests is marked by significant advancements in diagnostic technologies and a strong focus on public health. Countries such as Germany, France, and the United Kingdom are at the forefront due to their robust healthcare systems and extensive research activities. The European market benefits from stringent regulatory standards that ensure high-quality diagnostic procedures and the availability of innovative testing solutions. Additionally, collaborations between healthcare providers and diagnostic companies are enhancing the accessibility and efficiency of Hepatitis E testing across the continent.

This report provides an in depth analysis of various factors that impact the dynamics of Global Hepatitis E Diagnostic Tests Market. These factors include; Market Drivers, Restraints and Opportunities Analysis..

Drivers, Restraints and Opportunity Analysis

Key players in Global Hepatitis E Diagnostic Tests Market include:

• Beijing Wantai Biological Pharmacy Enterprise Co. Ltd
• Biokit S.A.
• Dia.Pro - Diagnostic Bioprobes s.r.l
• F. Hoffmann-La Roche Ltd.
• Fast-track diagnostics Ltd
• Fortress Diagnostics Limited
• Mikrogen GmBH
• MP Biomedicals.

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis