Global Hepatitis E Diagnostic Tests Market 2023-2030

Global Hepatitis E Diagnostic Tests Market 2023-2030

Global Hepatitis E Diagnostic Tests Market Size, Share & Trends Analysis Report by Disease Type (Serology Tests, Molecular Tests, Immunoassays, and Point-of-Care Tests), by Technology (Enzyme-Linked Immunosorbent Assay, Rapid Diagnostic Tests, Next-Generation Sequencing, and Nucleic Acid Amplification Tests) and by End User (Hospitals and Clinics, Diagnostic Laboratories, and Public Health Agencies and Research Institutions), Forecast Period (2024-2031)

The global hepatitis e diagnostic tests market is anticipated to grow at a CAGR of 7.40% during the forecast period (2024-2031). The market’s growth is attributed to the demand for global health concern. The global prevalence and significance of Hepatitis E as a major public health concern motivate continued growth and acceptance of diagnostic tests to effectively manage and minimize the disease's impact on public health. According to the National Institute of Health (gov.) in May 2023, the hepatitis E is a liver inflammation caused by the hepatitis E virus (HEV), that is commonly transmitted through contaminated water or the consumption of undercooked animal meat, particularly pork. According to the World Health Organization (WHO), there are approximately 20 million HEV infections annually, resulting in 3.3 million symptomatic cases and 44,000 deaths. This accounts for 3.3% of viral hepatitis-related mortalities. While hepatitis E is prevalent globally.

Segmental Outlook

The global hepatitis E diagnostic tests market is segmented on the product type, animal type, application, and end user. Based on the product type, the market is sub-segmented into stationary multi-slice CT scanner, and portable CT scanner. Based on the animal type, the market is sub-segmented into companion animal, livestock animal, others. Based on the application, the market is sub-segmented into neurology, oncology, cardiology, nephrology, gastroenterology, and others. Furthermore, on the basis of end-user, the market is sub-segmented into veterinary clinics and hospitals, research institutes, and others. The enzyme-linked immunosorbent assay (ELISA) subcategory is expected to capture a significant portion of the market share within the technology segment. The growth can be attributed to the widespread adoption of the procedure to diagnose hepatitis in hospitals.

The Serology Tests Sub-Segment is Anticipated to Hold a Considerable Share of the global Hepatitis E Diagnostic Tests Market

Among the disease type, the serology tests sub-segment is expected to hold a considerable share of the global Hepatitis E Diagnostic Tests market. The segmental growth is attributed to the advancement in serological testing. The introduction of Enzyme Immunoassay (EIA) testing, specifically passive EIA techniques capable of identifying IgM and IgG anti-HEV antibodies, emphasizes technological advances in serology tests for Hepatitis E diagnosis. The division between IgM and IgG antibodies aids in the identification of modern or previous diseases. According to the MDPI, in January 2021, serological tests used to detect HEV infection include enzyme immunoassay (EIA) tests. Indirect EIA assays are capable of detecting IgM and IgG anti-HEV antibodies. IgM anti-HEV antibodies are the first to appear, indicating an acute or recent infection, while IgG anti-HEV antibodies persist for years, suggesting a recent or past infection. However, the sensitivity and specificity of these assays can vary, and there is a potential for cross-reactivity with other viruses such as CMV and EBV. The Wantai test is the most commonly used commercial ELISA test for IgM detection, known for its high sensitivity and specificity among EIA tests.

Regional Outlook

The global hepatitis E diagnostic tests market is further segmented based on geography including North America (the US, and Canada), Europe (UK, Italy, Spain, Germany, France, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia), and the Rest of the World (the Middle East & Africa, and Latin America). Among these, Asia-Pacific is anticipated to hold a prominent share of the market across the globe, owing to the growing healthcare facilities, a significant amount of applicable manufacturer and rise in government involvement and proficient communities.

The North America Region is Expected to Grow at a Significant CAGR in the global Hepatitis E Diagnostic Tests Market

Among all regions, the North America regions is anticipated to grow at a considerable CAGR over the forecast period. Regional growth is attributed to the diagnostic test development across the region. Insights from such studies motivate the development of diagnostic tests capable of identifying numerous markers of Hepatitis E infection, such as antibodies and viral RNA, in order to provide a more complete diagnostic picture and aid in understanding disease dynamics. According to the MDPI, in October 2023, the prevalence of anti-HEV IgG and IgM antibodies, as well as viral RNA, was analyzed in 1002 donor sera in Estonia. Out of these, 48 sera (4.8%) tested positive for anti-HEV antibodies, with 40 (4%) containing anti-HEV IgG and 15 (1.5%) containing anti-HEV IgM. Additionally, 7 donors had antibodies of both classes simultaneously. However, no HEV RNA was detected in any of the blood serum samples. However for a higher incidence of anti-HEV IgG carriers with age, statistical analysis identified no statistically significant associations between infection risk variables and the prevalence of anti-HEV antibodies.

Market Players Outlook

The major companies serving the hepatitis E diagnostic tests market includes Bio-Rad Laboratories, Inc., Danaher Corp., Diasorin S.p.A., EKF Diagnostics Holdings plc, ELITech Group, and others. The market players are considerably contributing to the market growth by the adoption of various strategies including mergers and acquisitions, partnerships, collaborations, funding, and new product launches, to stay competitive in the market. For instance, in September 2022,Gilead Sciences, Inc. collaborated with Brigham and Women's Hospital, Harvard Medical School and Beth Israel Deaconess Medical Center. This multi-year program comprises a staged approach to addressing barriers to viral hepatitis diagnosis and management in basic healthcare authorities in Vietnam and the Philippines, two countries with significant hepatitis B and C prevalence.

The Report Covers

Market value data analysis of 2022 and forecast to 2030.

Annualized market revenues ($ million) for each market segment.

Country-wise analysis of major geographical regions.

Key companies operating in the global hepatitis E diagnostic tests market. Based on the availability of data, information related to new product launches, and relevant news is also available in the report.

Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.

Analysis of market-entry and market expansion strategies. Competitive strategies by identifying ‘who-stands-where’ in the market.