Hepatitis E Diagnostic Tests Market Size, Share & Trends Analysis Report By Type (ELISA HEV IgM Test, Rapid Diagnostics Test), By End Use (Hospitals, Blood Banks), By Region, And Segment Forecasts, 2024 - 2030

Hepatitis E Diagnostic Tests Market Trends

The global hepatitis E diagnostic tests market size was estimated at USD 54.75 million in 2023 and is projected to grow at a CAGR of 4.77% from 2024 to 2030. This growth is attributed to the rising incidences of hepatitis E, increased awareness about the need for early detection, and advancement in diagnostic technologies. According to the World Health Organization (WHO), approximately 20 million people worldwide are infected with the hepatitis E virus (HEV) each year, leading to approximately 3.3 million cases of symptomatic hepatitis E.

The global market has witnessed significant technological advancements in recent years, driving improvements in the accuracy, efficiency, and accessibility of diagnostic solutions. For Instance, in June 2021, DiaSorin introduced the fully automated high-throughput CLIA solution for diagnosis, available in countries that accept the CE market. DiaSorin's new offering represents a significant advancement in hepatitis E diagnostics. The fully automated CLIA (Chemiluminescence Immunoassay) platform enables high-throughput testing, allowing healthcare providers to screen and diagnose many patients efficiently. This is particularly important in regions with a high prevalence of hepatitis E, where the ability to identify infected individuals rapidly is crucial for effective disease management and prevention. The availability of such advanced diagnostic platforms aligns with the growing demand for accurate and efficient hepatitis E testing solutions.

Efforts to raise awareness among healthcare providers, at-risk populations, and the general public are also significant in driving market growth. Greater awareness about the risks and consequences of hepatitis E, such as the higher mortality rates in pregnant women, is fueling the demand for accurate diagnostic tests. The inclusion of hepatitis E tests in the WHO's 2023 Essential Diagnostics List reflects the increasing global recognition of the importance of early detection and management of hepatitis E.

Governments and healthcare systems recognize the need for improved surveillance and outbreak management, leading to increased procurement of HEV diagnostic kits. Patients and clinicians also seek better access to hepatitis E tests to enable early diagnosis and timely treatment, further boosting market growth. For instance, the Government of India comprehensive National Viral Hepatitis Control Program aims to address the burden of all forms of viral hepatitis, including Hepatitis E, through a multi-pronged approach focused on prevention, diagnosis, and treatment. The program involves significant government funding and a decentralized implementation strategy to strengthen the healthcare system's capacity to manage viral hepatitis effectively.

The increasing healthcare expenditure, particularly in emerging markets, is supporting the market growth. The growing emphasis on early detection and effective disease management is driving the demand for diagnostic tests. As awareness about the disease increases, there is a greater focus on implementing preventive measures such as personal hygiene, safe water sources, proper sanitation, and food safety to curb the spread of the virus.

Type Insights

Based on type, the ELISA HEV IgM test segment led the market with the largest revenue share of 50.12% in 2023. This is attributed to the importance of detecting IgM-class antibodies to the HEV for identifying acute or recent (<6 months) hepatitis E infections. Detecting the presence of IgM antibodies is the primary test for diagnosing acute hepatitis E, confirmed by follow-up RNA testing. The high sensitivity and specificity of ELISA-based IgM tests make them the preferred choice for initial HEV screening. For Instance, Dia.Pro provides the HEV-IgM ELISA test kit, which is designed for the detection of IgM antibodies against HEV in human serum or plasma. The rising incidence of hep E infections worldwide, particularly in developing regions with poor sanitation and hygiene practices, has fueled the demand for efficient diagnostic tools such as the ELISA HEV IgM test.

The rapid diagnostics test segment is projected to grow at a significant CAGR of 5.98% over the forecast period. This is attributed to the increasing demand for quick and accurate diagnostic solutions, especially in regions with limited access to healthcare facilities. Rapid diagnostic tests offer the advantage of providing results within a short period, enabling prompt treatment and management of infections. For Instance, the Wantai HEV-IgM Rapid Test allows for the qualitative detection of IgM antibodies against HEV in human serum or plasma within 10 minutes. In addition, the ease of use and portability of these tests make them particularly suitable for point-of-care testing in remote or resource-limited settings.

End Use Insights

Based on end use, the hospital segment led the market with the largest revenue share of 39.10% in 2023. This is primarily driven by the high prevalence of Hepatitis E cases being diagnosed and treated in hospitals worldwide. Hospitals have advanced diagnostic facilities, a wide range of healthcare professionals, and infrastructure to diagnose and manage cases efficiently. In addition, hospitals often serve as referral centers for complex cases, further contributing to their significant revenue share in the global market.

The diagnostics laboratories segment is anticipated to witness at a lucrative CAGR over the forecast period. As it is a viral infection that can lead to acute liver disease, timely and precise diagnosis is crucial for effective management and treatment. Diagnostics laboratories are vital in providing these diagnostic services to healthcare providers and patients. The growing awareness about the importance of early detection and screening has encouraged individuals to seek testing services from diagnostics laboratories.

Regional Insights

The hepatitis E diagnostic tests market in North America accounted for a significant share in 2023. The well-established healthcare infrastructure in North America, including hospitals, diagnostic laboratories, and research centers, supports the market's growth by providing a platform for adopting diagnostic tests. Government initiatives and funding for research and development in the field of infectious disease diagnostics contribute to the market growth by supporting the development of new diagnostic solutions and their adoption in the region. For Instance, in April 2024, Dr. Susan Hafenstein of The Hormel Institute, University of Minnesota, has been awarded an $85,000 NIH-funded grant from Nationwide Children’s Hospital. This funding supports her cryoEM research into the HEV aiming to create new treatments and prevention strategies for HEV hepatitis.

U.S. Hepatitis E Diagnostic Tests Market Trends

The hepatitis E diagnostic tests market in the U.S. is expected to grow at a substantial CAGR over the forecast period. There is increasing awareness among healthcare professionals and the public about hepatitis E and its potential complications, particularly neurological disorders. For Instance, in December 2023, a professor at the Virginia-Maryland College of Veterinary Medicine was awarded a $2 million grant from the National Institutes of Health (NIH) to study the neurological disorders associated with the infection. This research grant highlights the growing concern over HEV infections in the U.S. and the need for improved diagnostic capabilities.

Asia Pacific Hepatitis E Diagnostic Tests Market Trends

Asia Pacific dominated the hepatitis E diagnostic tests market with a revenue share of 36.58% in 2023 and is anticipated to witness at the fastest CAGR over the forecast period. This is attributed to the rising prevalence in the region with limited access to clean water and sanitation. According to the National Institute of Health (NIH), HEV infection is widespread in East and Southeast Asia, with seroprevalence rates between 17-42%. Specifically, more than 30% of adults in countries such India, Bangladesh, China, and Malaysia have been exposed to the Hepatitis E virus. The region's rapidly improving healthcare infrastructure and the increasing investments in the pharmaceutical and biotechnology industries further fuel the market's expansion.

Europe Hepatitis E Diagnostic Tests Market Trends

The hepatitis E diagnostic tests market in Europe is expected to witness at a lucrative CAGR over the forecast period. The region's comprehensive healthcare policies support widespread access to diagnostic services, including those for Hepatitis E. According to the European Centre for Disease Prevention and Control (ECDC), over the past decade, there has been a rise in reported cases among humans in Europe, where genotype 3 of the virus (HEV-3) is prevalent and primarily accountable for the infections. In Europe, pigs and wild boars serve as the main carriers of the HEV. The ECDC has been instrumental in establishing HEV diagnosis guidelines and encouraging consistent testing practices.

Key Hepatitis E Diagnostic Tests Company Insights

Key players operating in the global market aim to drive innovation, expand market reach, and strengthen their competitive position. The players are seeking regulatory approvals, such as FDA and CE-IVD, for their Hepatitis E diagnostic products to ensure compliance and expand their market access.

Recent Developments

• In November 2023, Roche launched two automated immunoassays, the Elecsys Anti-HEV IgG and the Elecsys Anti-HEV IgM, to detect hepatitis E virus infections. These tests are accessible in nations that accept the CE mark, such as European Union member countries

• In November 2023, the WHO added HEV tests, including the Altona RealStar HEV RT-PCR assay, to their Essential Diagnostics List (EDL) 2023. The assay is categorized as the most sensitive among the three PCR assays compared in a publication by Vollmer et al

• In April 2023, Altona Diagnostics, a leading provider of molecular diagnostic solutions, announced the integration of Velsera’s automated analysis solution into its AltoStar Molecular Diagnostics Workflow. This collaboration aims to enhance the efficiency and accuracy of molecular diagnostic testing processes, ultimately benefiting healthcare professionals and patients alike

Hepatitis E Diagnostic Tests Market Report Scope

Global Hepatitis E Diagnostic Tests Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global hepatitis E diagnostic tests market report based on type, end use, and region.

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • ELISA HEV IgM Test

  • ELISA HEV IgG Test

  • Rapid Diagnostics Test

  • Polymerase Chain Reaction (PCR)

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospital

  • Diagnostics Laboratories

  • Blood Banks

  • Other End User 

• Regional Outlook (Revenue in USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait