PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1584113
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1584113
Hepatitis E Diagnostic Tests Market size was valued at USD 53.52 Million in 2023, expanding at a CAGR of 4.80% from 2024 to 2032.
Hepatitis E diagnostic tests are medical assays designed to detect the presence of the Hepatitis E virus (HEV), which causes liver inflammation. These tests typically utilize serological methods to identify antibodies (anti-HEV IgM and IgG) or molecular techniques such as PCR polymerase chain reaction (PCR) to detect viral RNA. Early and accurate diagnosis is crucial for managing hepatitis E, especially in pregnant women and individuals with compromised liver function, as the infection can result in severe complications. Hepatitis E diagnostics play a vital role in public health monitoring and controlling outbreaks, particularly in regions where the virus is endemic.
Hepatitis E Diagnostic Tests Market- Market Dynamics
Increasing need of early diagnosis and timely treatment to propel market demand
The global market for hepatitis E diagnostics has experienced significant technological advancements in recent years, enhancing the accuracy, efficiency, and accessibility of diagnostic solutions. For instance, in June 2021, DiaSorin launched fully automated high-throughput CLIA solution for the hepatitis E diagnosis, available in countries that accept the CE mark. This new offering represents a important improvement in hepatitis E diagnostics, allowing healthcare providers to conduct high-throughput testing efficiently. This capability is particularly important in regions with high hepatitis E prevalence, where rapid identification of infected individuals is essential for effective disease management and prevention. The introduction of such advanced diagnostic platforms meets the growing demand for accurate and efficient testing solutions. Efforts to raise awareness among healthcare providers, at-risk populations, and the general public are also crucial in driving market growth. Increased awareness of the risks and consequences of hepatitis E, including higher mortality rates in pregnant women, is fueling demand for accurate diagnostic tests. The inclusion of hepatitis E tests in the WHO's 2023 Essential Diagnostics List highlights the global recognition of the importance of early detection and management of the disease. Governments and healthcare systems are increasingly acknowledging the need for improved surveillance and outbreak management, leading to greater procurement of HEV diagnostic kits. Additionally, patients and clinicians are seeking better access to hepatitis E tests to enable early diagnosis and timely treatment, further boosting market growth. For example, the Government of India's 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. This program involves significant government funding and a decentralized implementation strategy to enhance the healthcare system's capacity to manage viral hepatitis effectively. Increasing healthcare expenditure, particularly in emerging markets, is also supporting market growth. The emphasis on early detection and effective disease management is driving demand for diagnostic tests. As awareness about hepatitis E grows, there is a heightened focus on implementing preventive measures, including personal hygiene, safe water sources, proper sanitation, and food safety, to mitigate the virus's spread.
Hepatitis E Diagnostic Tests Market- Key Insights
As per the analysis shared by our research analyst, the global market is estimated to grow annually at a CAGR of around 4.80% over the forecast period (2024-2032)
Based on Product Type segmentation, ELISA HEV IgM test was predicted to show maximum market share in the year 2023
Based on End-use segmentation, the hospital was the leading type in 2023
On the basis of region, North America was the leading revenue generator in 2023
The Global Hepatitis E Diagnostic Tests Market is segmented on the basis of Product Type, End-use, and Region.
The market is divided into four categories based on product type: ELISA HEV IgM Test, ELISA HEV IgG Test, Rapid Diagnostics Test and Polymerase Chain Reaction (PCR). Based on type, the ELISA HEV IgM test segment led the hepatitis E diagnostic tests market with the largest revenue share in 2023. This dominance is primarily due to the critical role of detecting IgM-class antibodies to the hepatitis E virus (HEV) for identifying acute or recent infections (less than six months). The presence of IgM antibodies is essential for diagnosing acute hepatitis E, typically confirmed by follow-up RNA testing. The high sensitivity and specificity of ELISA-based IgM tests make them the preferred option for initial HEV screening. For example, Dia.Pro offers the HEV-IgM ELISA test kit, specifically designed to detect IgM antibodies against HEV in human serum or plasma. The increasing incidence of hepatitis E infections, especially in developing regions with inadequate sanitation and hygiene practices, has significantly boosted the demand for effective diagnostic tools like the ELISA HEV IgM test.
The market is divided into four categories based on End use: Hospital, Blood Banks, Diagnostics Laboratories, and Other End User. In terms of end use, the hospital segment was leading the market with the largest revenue share in 2023. This trend is primarily driven by the high prevalence of hepatitis E cases being diagnosed and treated in hospitals globally. Hospitals are equipped with advanced diagnostic facilities, a diverse range of healthcare professionals, and the necessary infrastructure to efficiently diagnose and manage hepatitis E cases. Moreover, hospitals often act as referral centers for more complex cases, further enhancing their significant revenue share in the global market.
Hepatitis E Diagnostic Tests Market- Geographical Insights
This market caters to a geographically scattered customer base, spanning North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. Participating nations within these regions create sub-segments within the market. The hepatitis E diagnostic tests market in North America accounted for a significant share in 2023. The region's well-established healthcare infrastructure, comprising hospitals, diagnostic laboratories, and research centers, supports market growth by providing a conducive environment for the adoption of diagnostic tests. Additionally, government initiatives and funding for research and development in infectious disease diagnostics contribute to market growth by facilitating the development and adoption of new diagnostic solutions. For instance, in April 2024, Dr. Susan Hafenstein of The Hormel Institute at the University of Minnesota received an $85,000 NIH-funded grant from Nationwide Children's Hospital to support her cryoEM research into HEV, with the goal of creating new treatments and prevention strategies for hepatitis E.
Companies in the hepatitis E diagnostic tests market employ various strategies to enhance competitiveness and expand their market reach. Emphasizing research and development is crucial, with efforts focused on improving test sensitivity and specificity, as well as creating rapid and point-of-care testing solutions. Strategic collaborations with healthcare institutions and laboratories help facilitate clinical validation and promote the widespread adoption of new tests. Marketing strategies highlight the importance of early detection in preventing complications, specifically targeting healthcare providers and public health agencies. Additionally, companies frequently engage in educational initiatives to raise awareness about the risks of hepatitis E and the availability of testing, ensuring that diagnostics become an integral part of liver health management.
In November 2023, Roche introduced two automated immunoassays, the Elecsys Anti-HEV IgG and the Elecsys Anti-HEV IgM, designed to detect hepatitis E virus infections. These tests are available in countries that recognize the CE mark, including members of the European Union.