Hepatitis E Diagnostic Tests Market Size, Share, Growth, Trends, and Global Industry Analysis: By Type (ELISA HEV IgM Tests, ELISA HEV IgG Tests, Rapid Diagnostics Tests, Polymerase Chain Reaction (PCR), By End Use (Hospitals, Diagnostics Laboratories, Blood Banks, Others) and Region Forecast 2020-2031

Hepatitis E Diagnostic Tests Market size was valued at US$ 82.3 million in 2024 and is expected to reach US$ 112.0 million by 2031, growing at a significant CAGR of 4.5% from 2025-2031. Moreover, the U.S. Hepatitis E Diagnostic Tests Market is projected to grow at 4.3% over the forecast period. The market refers to the global industry focused on the development, production, and distribution of diagnostic tools used to detect Hepatitis E virus (HEV) infection in humans. These diagnostic methods include enzyme-linked immunosorbent assays (ELISA), polymerase chain reaction (PCR) tests, and rapid diagnostic kits that identify HEV antigens or antibodies in blood, serum, or stool samples. The market serves hospitals, diagnostic laboratories, public health institutions, and research centers to support early detection, disease surveillance, and outbreak control of Hepatitis E, which is primarily transmitted through contaminated food and water sources.

The market is witnessing steady growth due to the increasing prevalence of Hepatitis E infections, particularly in developing regions with poor sanitation and water quality. Rising awareness of foodborne and waterborne viral diseases, along with government-led health screening initiatives, is further driving demand for accurate and rapid testing solutions. Technological advancements such as molecular assays and automated diagnostic platforms are improving test sensitivity and turnaround times. Additionally, global health organizations like the WHO are emphasizing early diagnosis to reduce mortality in vulnerable populations, including pregnant women and immunocompromised individuals. As a result, the market is poised for continuous expansion, supported by improvements in healthcare infrastructure and the growing adoption of point-of-care testing in endemic regions.

Facts & Figures

• The World Health Organization (WHO) estimates that in 2021 there were approximately 19.47 million incident cases of acute hepatitis E globally.
• As per WHO data, HEV genotypes 1 and 2 alone were estimated to have caused roughly 70,000 deaths annually worldwide, and about 20.1 million infections in certain high-burden regions in a given year.
• A meta-analysis in Europe showed wide variation in seroprevalence of anti-HEV IgG, with reported rates ranging from 0.6% up to 52.5%, depending on assay used, country and age group — showing assay sensitivity strongly impacts observed prevalence.

Key Developments:

• In October 2023, The World Health Organization (WHO) published its 2023 Essential Diagnostics List (EDL) which, for the first time, includes three tests for Hepatitis E virus (HEV) including a rapid diagnostic test to aid in diagnosis and surveillance of HEV infection.
• In November 2023, Roche Diagnostics launched its automated serology immunoassays the Elecsys Anti-HEV IgM and IgG tests — for detection of acute and past HEV infections in CE-marked countries. These assays helped complete Roche’s viral hepatitis panel and aligned with WHO’s EDL inclusion of HEV testing.

Hepatitis E Diagnostic Tests Market Segmentation:

Based on the type:

• ELISA HEV IgM Tests
• ELISA HEV IgG Tests
• Rapid Diagnostics Tests
• Polymerase Chain Reaction (PCR)

Among the different types, ELISA HEV IgM tests are anticipated to lead the market due to their high sensitivity, cost-effectiveness, and suitability for large-scale screening. Enzyme-linked immunosorbent assay (ELISA) remains the preferred diagnostic tool for detecting acute HEV infections, as the presence of IgM antibodies indicates recent exposure to the virus. This method is widely adopted in hospitals, diagnostic centers, and research laboratories because it allows simultaneous testing of multiple samples, making it ideal for outbreak surveillance and epidemiological studies. According to WHO and CDC data, Hepatitis E causes millions of infections each year, particularly in Asia and Africa, where ELISA kits are the most accessible diagnostic option. Continuous advancements in assay design and automation are further enhancing accuracy and reducing false positives.

Moreover, the low cost and ease of standardization of ELISA platforms make them vital for national health programs and routine diagnostic use, thereby sustaining their dominance in the market.

Based on the end-use:

• Hospitals
• Diagnostics Laboratories
• Blood Banks
• Others

Diagnostic laboratories are projected to lead the market owing to their central role in large-scale testing, outbreak investigation, and disease surveillance. These laboratories are equipped with advanced testing platforms such as ELISA and PCR, which enable accurate detection of HEV IgM and RNA in clinical samples. Given that Hepatitis E infections often present with symptoms similar to other hepatic diseases, laboratory confirmation remains essential for differential diagnosis and patient management. In endemic regions across Asia and Africa, public health diagnostic laboratories perform most of the routine and emergency testing during outbreaks, supported by WHO-led surveillance initiatives.

Furthermore, private laboratories in developed regions such as Europe and North America are expanding their viral hepatitis panels to include HEV screening, driven by increased recognition of zoonotic and transfusion-related cases. The combination of technological sophistication, skilled personnel, and testing throughput positions diagnostic laboratories as the leading end-use segment in the Hepatitis E diagnostic landscape.