The Hepatitis E Diagnostic Tests Market represents the global landscape of laboratory tests and diagnostic solutions used to detect Hepatitis E virus (HEV) infection. Hepatitis E is a significant cause of acute viral hepatitis worldwide, particularly in developing regions with limited access to clean water and sanitation. However, growing awareness, improved surveillance, and rising cases in developed economies have brought hepatitis E diagnostics into sharper focus.

In 2025, the hepatitis E diagnostic tests market reached a value of USD 71.35 billion. Supported by increasing disease prevalence, improved diagnostic infrastructure, and advancements in molecular testing technologies, the market is projected to grow at a CAGR of 4.40% from 2026 to 2035, reaching USD 109.75 billion by 2035. As early and accurate diagnosis becomes critical for disease management and outbreak control, demand for hepatitis E diagnostic tests continues to rise globally.

Why Is the Hepatitis E Diagnostic Tests Market Growing Steadily?

 

The steady growth of the hepatitis E diagnostic tests market is driven by a combination of epidemiological, technological, and public health factors. Hepatitis E is increasingly recognized as a global health concern, affecting both developing and developed countries.

Key growth drivers include:

  • Rising incidence of hepatitis E infections globally

  • Increased awareness of HEV among healthcare professionals

  • Improved access to diagnostic facilities

  • Growing use of molecular diagnostics such as RT-PCR

  • Expansion of surveillance and screening programs

Additionally, outbreaks linked to contaminated water supplies and zoonotic transmission have increased the need for rapid and reliable diagnostic solutions, further supporting market growth.

How Important Is Early Diagnosis in Hepatitis E Management?

 

Early diagnosis of hepatitis E plays a critical role in disease control, patient management, and prevention of severe complications. While many HEV infections are self-limiting, certain populations—such as pregnant women, immunocompromised individuals, and patients with chronic liver disease—face a higher risk of severe outcomes.

Accurate diagnostic testing enables:

  • Timely identification of acute and past infections

  • Effective patient monitoring and supportive care

  • Prevention of disease transmission

  • Better outbreak management and epidemiological tracking

As a result, healthcare systems worldwide are placing greater emphasis on reliable hepatitis E diagnostic testing.

What Are the Major Test Types in the Hepatitis E Diagnostic Tests Market?

 

Based on test type, the market is segmented into ELISA HEV IgM tests, ELISA HEV IgG tests, and RT-PCR tests.

ELISA HEV IgM tests are widely used for detecting acute hepatitis E infections. These tests identify IgM antibodies, which appear early during infection and indicate recent exposure to the virus. Their cost-effectiveness and ease of use make them common in routine diagnostics.

ELISA HEV IgG tests detect IgG antibodies, which indicate past exposure or immunity to hepatitis E. These tests are particularly useful for epidemiological studies and seroprevalence surveys.

RT-PCR tests are considered the gold standard for detecting active HEV infection. By identifying viral RNA, RT-PCR provides high sensitivity and specificity, making it essential for early diagnosis, confirmation of infection, and monitoring viral load, especially in immunocompromised patients.

Why Is RT-PCR Gaining Traction in the Market?

 

RT-PCR testing is gaining significant traction in the hepatitis E diagnostic tests market due to its superior accuracy and ability to detect active infection even before antibody formation. This is especially important in early-stage infections and in patients with weakened immune systems who may not produce detectable antibody levels.

Key advantages of RT-PCR include:

  • High sensitivity and specificity

  • Early detection of infection

  • Ability to confirm active viral replication

  • Improved clinical decision-making

As molecular diagnostic infrastructure expands globally, RT-PCR tests are expected to witness strong demand growth.

How Does End-Use Segmentation Influence Market Demand?

 

By end use, the hepatitis E diagnostic tests market is segmented into hospitals, diagnostic centres, and others.

Hospitals represent a major end-user segment due to the high volume of patients presenting with liver-related symptoms and the availability of advanced diagnostic laboratories. Hospitals play a crucial role in managing acute hepatitis cases and severe infections.

Diagnostic centres are experiencing rapid growth as they offer specialized testing services, faster turnaround times, and cost-effective diagnostic solutions. These centres are increasingly preferred for routine screening and confirmatory testing.

The others category includes research laboratories and public health institutions involved in surveillance, outbreak investigation, and epidemiological studies, contributing to overall market demand.

What Is the Regional Outlook for the Hepatitis E Diagnostic Tests Market?

 

Geographically, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

Asia Pacific holds a significant share of the hepatitis E diagnostic tests market due to the high prevalence of HEV infections in countries such as India, China, and Southeast Asian nations. Poor sanitation in certain regions and frequent outbreaks drive strong demand for diagnostic testing.

North America is witnessing growing awareness of hepatitis E as an emerging infection, particularly among immunocompromised individuals and transplant recipients. Improved surveillance and availability of advanced diagnostics support market growth.

Europe shows steady growth due to rising zoonotic transmission, increased testing among high-risk populations, and strong laboratory infrastructure.

Latin America and the Middle East and Africa represent emerging markets, where improving healthcare access and increasing focus on infectious disease diagnostics are creating new growth opportunities.

How Are Public Health Initiatives Supporting Market Expansion?

 

Government-led public health initiatives play a critical role in driving the hepatitis E diagnostic tests market. Surveillance programs, outbreak monitoring, and infectious disease control strategies require reliable diagnostic tools to identify and manage HEV cases effectively.

Key initiatives supporting market growth include:

  • National hepatitis surveillance programs

  • Improved reporting and disease tracking systems

  • Investments in diagnostic laboratory infrastructure

  • Awareness campaigns targeting healthcare professionals

These efforts are particularly impactful in regions with high disease burden, reinforcing the need for accessible and accurate diagnostic testing.

What Technological Trends Are Shaping the Hepatitis E Diagnostic Tests Market?

 

Technological innovation is transforming hepatitis E diagnostics by improving accuracy, speed, and accessibility. Key trends include:

  • Development of highly sensitive ELISA kits

  • Advancements in real-time PCR technologies

  • Automation of diagnostic workflows

  • Multiplex testing platforms for viral hepatitis

These innovations help laboratories improve efficiency and deliver faster, more reliable results, enhancing patient care and disease management.

Who Are the Key Players in the Hepatitis E Diagnostic Tests Market?

 

The market is moderately competitive, with key players focusing on product development, regulatory approvals, and geographic expansion. Major companies operating in the market include:

  • 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 companies invest in research and development to enhance test sensitivity, expand product portfolios, and address unmet diagnostic needs.

What Challenges Could Limit Market Growth?

 

Despite favorable growth prospects, the hepatitis E diagnostic tests market faces challenges such as underdiagnosis in low-resource settings, limited awareness in certain regions, and variability in testing standards. Additionally, the asymptomatic nature of many HEV infections can reduce testing rates.

However, increasing awareness and expanding diagnostic capabilities are expected to mitigate these challenges over the forecast period.

What Is the Future Outlook for the Hepatitis E Diagnostic Tests Market?

 

The future outlook for the hepatitis E diagnostic tests market remains positive. Rising global awareness, expanding surveillance programs, and growing adoption of molecular diagnostics will continue to drive market growth. As healthcare systems prioritize early detection and infectious disease preparedness, the demand for reliable hepatitis E diagnostic tests is expected to increase steadily through 2035.

FAQs

 

What is the Hepatitis E Diagnostic Tests Market?

The Hepatitis E Diagnostic Tests Market includes laboratory tests used to detect acute and past hepatitis E virus infections.

Why is the Hepatitis E Diagnostic Tests Market growing?

Growth is driven by rising hepatitis E cases, increased awareness, and wider adoption of advanced diagnostic technologies.

Which test type is most commonly used?

ELISA-based tests are widely used, while RT-PCR is preferred for confirmatory and early-stage diagnosis.

Which region has the highest market share?

Asia Pacific holds a major share due to high disease prevalence and frequent outbreaks.

What is the projected market value by 2035?

The market is expected to reach USD 109.75 billion by 2035, growing at a CAGR of 4.40%.