Hepatitis E Diagnostic Tests Market Overview
The global hepatitis E diagnostic tests market reached a value of approximately USD 68.34 billion in 2024 and is projected to grow at a CAGR of 4.40% between 2025 and 2034, expected to attain a market value of USD 105.12 billion by 2034. The rising prevalence of hepatitis E virus (HEV) infections globally, especially in developing countries with poor sanitation and contaminated water supplies, is fueling demand for accurate and timely diagnostic testing.
Market Segmentation by Test Type
ELISA HEV IgM Test: Dominates the market due to its high sensitivity and reliability in detecting recent HEV infections. It is widely used in hospitals and diagnostic labs for early detection.
ELISA HEV IgG Test: Used to identify past infections and immunity status, significant for epidemiological studies and blood donor screening.
RT-PCR Test: Molecular-based test enabling highly sensitive and specific detection of HEV RNA, useful especially in acute infections and immunocompromised patients.
Market Segmentation by End-Use
Hospitals: Leading users, employing a wide range of diagnostic tests for patient screening and outbreak management.
Diagnostic Centres: Contribute significantly by providing specialized testing services with quick turnaround times.
Others: Include blood banks, research institutes, and public health laboratories where HEV testing is critical for blood safety and surveillance.
Regional Market Insights
North America: Focus on improving blood safety, advanced healthcare infrastructure, and adoption of molecular diagnostics support strong market demand.
Europe: Growing emphasis on HEV screening in blood donations and organ transplants, combined with government-backed public health programs.
Asia Pacific: Largest burden of HEV infections with expanding healthcare access contributes to rapid market growth.
Latin America and Middle East & Africa: Emerging regions showing increasing investments in healthcare infrastructure and infectious disease diagnostics.
Market Drivers and Growth Catalysts
Rising HEV incidence due to inadequate sanitation, increasing urbanization, and global travel.
Heightened public health awareness and government initiatives promoting HEV testing in endemic regions.
Technological advancements leading to the development of highly sensitive, rapid, and easy-to-use diagnostic kits including point-of-care solutions.
Increasing demand for screening in blood banks and organ transplantation to prevent transmission.
Expansion of molecular testing technologies such as real-time PCR improving detection accuracy and speed.
Challenges Facing the Market
Limited awareness and underdiagnosis, especially in non-endemic regions where HEV is often confused with other hepatitis types or viral illnesses.
High investment requirements and infrastructure needs for advanced molecular diagnostic setups limit penetration in resource-poor areas.
Variability in regulatory and reimbursement frameworks across countries.
Lack of standardized screening protocols and low adoption of HEV testing in routine clinical diagnostics.
Leading Companies in Hepatitis E Diagnostic Tests Market
MP Biomedicals, LLC
F. Hoffmann-La Roche Ltd
Altona Diagnostics GmbH
AccuBioTech Co., Ltd.
Dia.Pro Diagnostic Bioprobes s.r.l
Beijing Wantai
Fortress Diagnostics
Mikrogen GmbH
Primerdesign Ltd
Gold Standard Diagnostics
These players focus on continuous innovation, expanding product portfolios, strategic partnerships, and geographic expansion to strengthen their hold in the diagnostic testing landscape.
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