San Francisco, 24 September 2025, – The global hepatitis E diagnostic tests market size is anticipated to reach USD 75.6 million by 2030 and is expected to expand at a CAGR of 4.8% during the forecast period, according to a new report by Grand View Research, Inc. The market is fueled by the rising incidence of hepatitis E infections worldwide, particularly in regions with inadequate sanitation and limited access to clean water. As the hepatitis E virus (HEV) continues to pose a significant public health challenge, especially in developing countries, the demand for accurate and timely diagnostic solutions has surged. This has prompted healthcare systems and governments to invest in screening programs and awareness campaigns aimed at early detection and containment of outbreaks.

Technological advancements in diagnostic methods have also played a pivotal role in driving market expansion. Innovations in molecular diagnostics, such as polymerase chain reaction (PCR) and enzyme-linked immunosorbent assays (ELISA), have significantly improved the sensitivity, specificity, and speed of hepatitis E detection. These tools enable clinicians to diagnose infections more reliably, facilitating prompt treatment and reducing the risk of complications. Additionally, the development of point-of-care testing devices has made diagnostics more accessible in remote and underserved areas, further broadening the market’s reach.

The increasing emphasis on public health surveillance and integrating hepatitis E testing into routine diagnostic panels further contributes to market growth. Hospitals and diagnostic laboratories are adopting these tests at a steady pace, supported by government-backed initiatives and international health organizations. As awareness rises and diagnostic technologies become more refined and affordable, the market is expected to grow.

The market players are focusing on various strategic initiatives such as mergers, acquisitions, and collaborations. For instance, in November 2023, Roche unveiled the Elecsys Anti-HEV IgM and IgG immunoassays for identifying hepatitis E in CE-mark countries. These automated serology tests, including one for acute HEV, are recommended in the 2023 WHO Essential Diagnostics List.

Order a free sample PDF of the Hepatitis E Diagnostic Tests Market Intelligence Study, published by Grand View Research.

Further key findings from the report suggest:

  • By type, the ELISA HEV IgM tests segment captured the largest revenue share of 50.2% in 2024, owing to its high sensitivity, ease of use, and cost-effectiveness. 
  • By end use, the hospitals segment generated the largest revenue share of 38.9% in 2024, attributed to the increasing occurrence of hepatitis E infections, especially in regions with poor sanitation.
  • Asia Pacific hepatitis E diagnostic tests market dominated with the largest revenue share of 36.9% in 2024.
  • North America hepatitis E diagnostic tests market is anticipated to witness the fastest CAGR of 3.5% over the forecast period.

List of Key Players in the Hepatitis E Diagnostic Tests Market

  • Wantai BioPharm
  • MP Biomedicals LLP
  • PerkinElmer, Inc
  • Dia.Pro Diagnostic Bioprobes srl
  • ELITechGroup
  • Primerdesign Ltd
  • F. Hoffmann-La Roche Ltd
  • Mikrogen GmbH
  • Altona Diagnostics
  • Fortress Diagnostics

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