Hepatitis E Diagnostic Tests Market Size, Share, Growth and Industry Analysis, By Types (ELISA HEV IgM Test kits, ELISA HEV IgG Test Kits, RT-PCR Test Kits), By Applications (Hospitals, Diagnostic Laboratories, Research Centers, Point of Care), Regional Insights and Forecast to 2034

Hepatitis E Diagnostic Tests Market Size

The Global Hepatitis E Diagnostic Tests Market size was USD 42.92 Million in 2024 and is projected to touch USD 43.87 Million in 2025, USD 44.83 Million in 2026, and reach USD 53.36 Million by 2034, exhibiting a CAGR of 2.2% during the forecast period (2025–2034). The market growth is supported by 45% dominance of ELISA IgM test kits, 35% contribution from IgG kits, and 19.5% share from RT-PCR diagnostics. Hospitals account for 50% of application use, while diagnostic laboratories cover 28% and research centers 12%, reflecting strong global adoption patterns.

The US Hepatitis E Diagnostic Tests Market is expanding steadily, representing over 60% of the North America share. With 55% of hospital-based adoption and 25% contribution from diagnostic laboratories, the country remains the leader in clinical utilization. Around 22% of innovation projects are concentrated in the US, where strong R&D frameworks and diagnostic awareness programs drive adoption, particularly in advanced hospital systems and research-focused institutions.

Key Findings

• Market Size: Valued at USD 42.92 Million in 2024, projected to touch USD 43.87 Million in 2025 to USD 53.36 Million by 2034 at a CAGR of 2.2%.
• Growth Drivers: 45% adoption in hospitals, 30% increase in awareness programs, and 25% rise in point-of-care testing initiatives.
• Trends: 35% growth in molecular testing, 28% expansion in ELISA kits, and 22% focus on portable point-of-care devices.
• Key Players: Wantai Biological, Roche, Biokit, Mikrogen, MP Biomedicals & more.
• Regional Insights: Asia-Pacific holds 42% share, led by high infection rates and hospital testing. North America captures 28% with strong labs. Europe accounts for 20% driven by research. Middle East & Africa represents 10% through selective screening programs.
• Challenges: 35% rural inaccessibility, 28% quality variation issues, and 22% limited standardization in emerging markets.
• Industry Impact: 40% driven by hospital testing, 30% through labs, and 20% growth from awareness campaigns and government-backed initiatives.
• Recent Developments: 25% product expansions, 32% new ELISA innovations, and 20% increase in multiplex molecular diagnostic launches.

The Hepatitis E Diagnostic Tests Market is shaped by a combination of strong hospital demand, rapid laboratory expansions, and rising point-of-care adoption. With Asia-Pacific leading at 42% share, global strategies emphasize accessibility, product innovation, and integration of advanced molecular diagnostic platforms for sustainable growth.

Hepatitis E Diagnostic Tests Market Trends

The Hepatitis E diagnostic tests market is witnessing strong adoption with significant regional and technological shifts. Around 42% of the demand is concentrated in Asia-Pacific, driven by high prevalence rates and large-scale screening initiatives. North America accounts for 28%, supported by advanced healthcare infrastructure and growing awareness campaigns. Europe represents nearly 20% of the market, with increased focus on preventive diagnostics and hospital-based testing. Rapid advancements in molecular diagnostics contribute to more than 35% of the market share, while immunoassays hold approximately 45%. Point-of-care testing solutions are gaining momentum, representing over 18% of new installations globally. The shift towards early detection and improved clinical outcomes continues to shape market dynamics with increasing adoption across hospitals, laboratories, and research institutions.

Hepatitis E Diagnostic Tests Market Dynamics

OPPORTUNITY

Expanding Point-of-Care Testing

Point-of-care diagnostic solutions are expanding rapidly, accounting for nearly 22% of overall usage. Adoption in rural and semi-urban areas is driving accessibility, with 30% of primary care facilities integrating these tests. Enhanced accuracy levels above 90% have further increased demand, creating new opportunities for suppliers and healthcare providers worldwide.

DRIVERS

Rising Prevalence and Awareness

Globally, over 20 million Hepatitis E infections occur annually, with diagnostic awareness campaigns covering nearly 40% of high-risk populations. Hospital-based adoption has grown by 25% in the last few years, while laboratory-based tests dominate with over 55% share, driving sustained growth across multiple regions.

RESTRAINTS

"Limited Accessibility in Rural Areas"

Despite advancements, around 35% of rural healthcare centers lack access to Hepatitis E diagnostic tests. High costs of advanced molecular diagnostics restrict their adoption, with 27% of small clinics unable to integrate such systems. Moreover, 18% of laboratories report shortages of skilled personnel, slowing down diagnostic capacity expansion globally.

CHALLENGE

"Quality Standardization Issues"

Standardization of Hepatitis E diagnostic tests remains a challenge, with 28% of laboratories citing variations in accuracy across different test kits. Inconsistent regulatory frameworks affect nearly 22% of emerging markets. Additionally, over 30% of diagnostic centers face challenges in maintaining sensitivity levels above 85%, impacting reliability and trust in results.

Segmentation Analysis

The Global Hepatitis E Diagnostic Tests Market size was USD 42.92 Million in 2024 and is projected to reach USD 43.87 Million in 2025 before declining to USD 53.36 Million by 2034, registering a CAGR of 2.2% during the forecast period (2025–2034). Market segmentation highlights the dominance of immunoassay-based kits and growing adoption of molecular diagnostics. ELISA HEV IgM and IgG tests remain critical for serological screenings, while RT-PCR is gaining traction for its higher accuracy and sensitivity. Each type contributes differently in terms of share, growth rate, and regional adoption patterns.

By Type

ELISA HEV IgM Test Kits

ELISA HEV IgM test kits are widely used for early detection, particularly in outbreak-prone regions, accounting for a large portion of demand in both hospitals and diagnostic laboratories. With over 45% share of the diagnostic market, these kits remain the frontline choice in acute infection testing and large-scale screening initiatives.

ELISA HEV IgM Test Kits held the largest share in the Hepatitis E Diagnostic Tests market, accounting for USD 49.21 Million in 2025, representing 45.5% of the total market. This segment is expected to grow at a CAGR of 2.4% from 2025 to 2034, driven by rising outbreak cases, hospital testing demand, and increasing adoption in public health programs.

Top 3 Major Dominant Countries in the ELISA HEV IgM Test Kits Segment

• China led the ELISA HEV IgM Test Kits segment with a market size of USD 15.67 Million in 2025, holding a 31.8% share and expected to grow at a CAGR of 2.6% due to large population base and higher testing volume.
• India recorded USD 11.84 Million in 2025, holding a 24% share, projected to grow at a CAGR of 2.5% due to government-supported screening campaigns.
• Brazil achieved USD 7.38 Million in 2025, accounting for a 15% share, expected to grow at a CAGR of 2.2% supported by improved healthcare infrastructure.

ELISA HEV IgG Test Kits

ELISA HEV IgG test kits are utilized for determining past exposure and immunity status, especially in epidemiological surveys. With over 35% market share, their demand is steadily increasing due to research applications and use in population-level studies. These tests provide critical insights into long-term infection prevalence and immunity profiling.

ELISA HEV IgG Test Kits accounted for USD 37.81 Million in 2025, representing 35% of the market. This segment is expected to grow at a CAGR of 2.1% from 2025 to 2034, driven by demand in academic research, public health surveillance, and clinical follow-ups.

Top 3 Major Dominant Countries in the ELISA HEV IgG Test Kits Segment

• Germany led the ELISA HEV IgG Test Kits segment with USD 9.82 Million in 2025, holding a 26% share and expected to grow at a CAGR of 2.3% due to strong diagnostic adoption in healthcare systems.
• United States reached USD 8.71 Million in 2025, capturing 23% of the share, with a projected CAGR of 2.2% supported by clinical studies and advanced laboratory networks.
• Japan achieved USD 7.56 Million in 2025, holding 20% of the market, growing at a CAGR of 2.1% due to rising academic research funding.

RT-PCR Test Kits

RT-PCR test kits are highly accurate and sensitive, becoming the preferred option for confirmatory testing in critical cases. Representing about 19.5% of the market, these kits are widely adopted in urban hospitals, specialized laboratories, and research centers, though cost remains a restraint for mass-scale implementation.

RT-PCR Test Kits were valued at USD 21.01 Million in 2025, representing 19.5% of the Hepatitis E Diagnostic Tests Market. This segment is expected to grow at a CAGR of 2% from 2025 to 2034, fueled by rising demand for precise molecular diagnostics and integration into advanced laboratory infrastructure.

Top 3 Major Dominant Countries in the RT-PCR Test Kits Segment

• United States led the RT-PCR Test Kits segment with USD 6.92 Million in 2025, holding a 33% share and expected to grow at a CAGR of 2.3% due to advanced healthcare networks and strong R&D investments.
• China recorded USD 5.25 Million in 2025, holding a 25% share, projected to grow at a CAGR of 2.2% due to adoption in national surveillance programs.
• United Kingdom achieved USD 3.78 Million in 2025, accounting for 18% share, expected to grow at a CAGR of 2% due to increasing hospital-based molecular testing.

By Application

Hospitals

Hospitals dominate the Hepatitis E diagnostic tests market, accounting for the highest adoption due to large patient inflow, emergency testing needs, and integrated laboratory facilities. Over 50% of total testing is carried out within hospitals, reflecting their central role in patient diagnosis and care delivery.

Hospitals held the largest share in the Hepatitis E Diagnostic Tests Market, accounting for USD 54.02 Million in 2025, representing 50% of the total market. This segment is expected to grow at a CAGR of 2.3% from 2025 to 2034, driven by rapid patient screening, advanced infrastructure, and increasing global awareness.

Top 3 Major Dominant Countries in the Hospitals Segment

• United States led the Hospitals segment with a market size of USD 17.28 Million in 2025, holding a 32% share and expected to grow at a CAGR of 2.4% due to strong healthcare systems and high diagnostic budgets.
• China recorded USD 14.05 Million in 2025, holding 26% share, projected to grow at a CAGR of 2.3% due to large-scale hospital networks and epidemic surveillance programs.
• India achieved USD 10.26 Million in 2025, accounting for 19% share, expected to grow at a CAGR of 2.2% supported by growing hospital diagnostic infrastructure.

Diagnostic Laboratories

Diagnostic laboratories are critical for specialized Hepatitis E testing, holding a significant portion of the market with nearly 28% share. Their demand is driven by advanced test accuracy, outsourcing of diagnostic services, and growing requirement for confirmatory testing across healthcare systems.

Diagnostic Laboratories accounted for USD 30.25 Million in 2025, representing 28% of the Hepatitis E Diagnostic Tests Market. This segment is projected to grow at a CAGR of 2.1% from 2025 to 2034, supported by increased outsourcing, partnerships with hospitals, and expansion of private diagnostic chains.

Top 3 Major Dominant Countries in the Diagnostic Laboratories Segment

• Germany led the Diagnostic Laboratories segment with USD 9.37 Million in 2025, holding 31% share and expected to grow at a CAGR of 2.2% due to strong diagnostic service infrastructure.
• United States reached USD 8.46 Million in 2025, capturing 28% share, with a CAGR of 2.1% supported by private lab expansions.
• Japan achieved USD 5.14 Million in 2025, accounting for 17% share, expected to grow at a CAGR of 2% due to high demand for confirmatory molecular testing.

Research Centers

Research centers play an important role in Hepatitis E diagnostics by contributing to test development and population-level studies. With around 12% market share, their use is increasing due to higher funding in viral diagnostics and expanded collaboration with academic and pharmaceutical institutions.

Research Centers represented USD 12.96 Million in 2025, accounting for 12% of the Hepatitis E Diagnostic Tests Market. This segment is expected to grow at a CAGR of 2% from 2025 to 2034, driven by R&D programs, epidemiological studies, and government-supported research grants.

Top 3 Major Dominant Countries in the Research Centers Segment

• United Kingdom led the Research Centers segment with USD 4.01 Million in 2025, holding 31% share and expected to grow at a CAGR of 2.1% due to strong academic and healthcare collaborations.
• France reached USD 3.37 Million in 2025, holding 26% share, projected to grow at a CAGR of 2% due to investments in public health research.
• United States recorded USD 2.98 Million in 2025, holding 23% share, expected to grow at a CAGR of 2% supported by robust clinical trial activity.

Point of Care

Point-of-care testing is emerging as a fast-growing application in the Hepatitis E diagnostic tests market, covering nearly 10% of global share. Adoption is particularly increasing in rural and semi-urban regions due to portable devices, rapid results, and ease of use by healthcare workers.

Point of Care testing accounted for USD 10.80 Million in 2025, representing 10% of the Hepatitis E Diagnostic Tests Market. This segment is projected to grow at a CAGR of 2.4% from 2025 to 2034, driven by rural healthcare demand, decentralization of diagnostics, and rising preference for portable test kits.

Top 3 Major Dominant Countries in the Point of Care Segment

• India led the Point of Care segment with USD 3.35 Million in 2025, holding 31% share and expected to grow at a CAGR of 2.5% due to rural adoption and healthcare outreach programs.
• China recorded USD 2.81 Million in 2025, holding 26% share, projected to grow at a CAGR of 2.4% due to portable diagnostic deployments.
• Nigeria achieved USD 2.05 Million in 2025, accounting for 19% share, expected to grow at a CAGR of 2.3% supported by government-funded rural initiatives.

Hepatitis E Diagnostic Tests Market Regional Outlook

The Global Hepatitis E Diagnostic Tests Market was valued at USD 42.92 Million in 2024 and is projected to reach USD 43.87 Million in 2025 before declining to USD 53.36 Million by 2034, exhibiting a CAGR of 2.2% during the forecast period. Regional distribution highlights Asia-Pacific as the leading market with 42% share, followed by North America with 28%, Europe with 20%, and the Middle East & Africa representing 10%. Each region demonstrates unique growth drivers, healthcare infrastructure capabilities, and adoption levels of Hepatitis E diagnostic tests across hospitals, laboratories, and point-of-care applications.

North America

North America demonstrates significant adoption of Hepatitis E diagnostic tests, driven by strong healthcare infrastructure, high diagnostic awareness, and well-established laboratories. The region accounts for 28% of the global share, with widespread adoption of ELISA kits and growing integration of molecular diagnostics in advanced hospitals.

North America accounted for USD 30.25 Million in 2025, representing 28% of the Hepatitis E Diagnostic Tests Market. This region is expected to grow steadily during the forecast period, driven by early detection programs, hospital testing capabilities, and private laboratory expansions.

North America - Major Dominant Countries in the Hepatitis E Diagnostic Tests Market

• United States led North America with USD 18.15 Million in 2025, holding a 60% share and expected to grow further due to advanced laboratory networks and screening programs.
• Canada recorded USD 7.26 Million in 2025, representing 24% share, with growth supported by increased diagnostic adoption in hospitals and government initiatives.
• Mexico reached USD 4.84 Million in 2025, holding 16% share, driven by expanding private diagnostic labs and improved healthcare infrastructure.

Europe

Europe accounts for 20% of the global Hepatitis E diagnostic tests market, with increasing adoption of IgG test kits for immunity profiling and large-scale epidemiological studies. Strong healthcare systems and robust research collaborations fuel demand, particularly in Germany, France, and the UK.

Europe held USD 21.61 Million in 2025, representing 20% of the total market. Growth in this region is supported by advanced hospital networks, increased laboratory-based testing, and higher investment in public health programs.

Europe - Major Dominant Countries in the Hepatitis E Diagnostic Tests Market

• Germany led Europe with USD 7.35 Million in 2025, holding 34% share, driven by strong diagnostic infrastructure and high adoption of ELISA test kits.
• France accounted for USD 6.04 Million in 2025, representing 28% share, supported by research-focused programs and public health surveillance.
• United Kingdom achieved USD 5.18 Million in 2025, capturing 24% share, fueled by advanced laboratories and clinical trial adoption.

Asia-Pacific

Asia-Pacific dominates the Hepatitis E diagnostic tests market with 42% share, driven by high infection prevalence, large-scale hospital testing, and rising adoption of point-of-care solutions in rural areas. The region has the fastest expansion of diagnostic infrastructure and accounts for the majority of new ELISA and RT-PCR kit sales.

Asia-Pacific held USD 45.37 Million in 2025, representing 42% of the Hepatitis E Diagnostic Tests Market. Growth is supported by government-backed health programs, population-scale screening initiatives, and rapid expansion of both public and private laboratories.

Asia-Pacific - Major Dominant Countries in the Hepatitis E Diagnostic Tests Market

• China led Asia-Pacific with USD 16.33 Million in 2025, holding 36% share, driven by government-funded epidemic control and expanded hospital networks.
• India recorded USD 14.07 Million in 2025, representing 31% share, supported by rural adoption of point-of-care diagnostics and large-scale awareness campaigns.
• Japan reached USD 9.52 Million in 2025, holding 21% share, with growth supported by advanced research institutions and academic collaborations.

Middle East & Africa

The Middle East & Africa account for 10% of the Hepatitis E diagnostic tests market, with adoption largely focused on urban hospitals and selective government screening programs. Growing prevalence and increasing diagnostic capacity are creating opportunities, particularly in Gulf countries and parts of Sub-Saharan Africa.

Middle East & Africa held USD 10.80 Million in 2025, representing 10% of the Hepatitis E Diagnostic Tests Market. Expansion in this region is supported by rising awareness campaigns, government healthcare investments, and gradual adoption of point-of-care testing solutions.

Middle East & Africa - Major Dominant Countries in the Hepatitis E Diagnostic Tests Market

• Saudi Arabia led Middle East & Africa with USD 3.56 Million in 2025, holding 33% share, supported by improved hospital diagnostic capabilities and government-backed health initiatives.
• United Arab Emirates recorded USD 3.13 Million in 2025, representing 29% share, driven by private healthcare expansion and adoption of advanced diagnostic technologies.
• South Africa achieved USD 2.59 Million in 2025, capturing 24% share, with growth supported by increasing demand for rural testing and diagnostic outreach programs.

List of Key Hepatitis E Diagnostic Tests Market Companies Profiled

Investment Analysis and Opportunities in Hepatitis E Diagnostic Tests Market

Investment activity in the Hepatitis E diagnostic tests market is intensifying, with over 40% of funding directed toward molecular diagnostics and high-sensitivity PCR kits. Around 35% of investors are focusing on point-of-care testing devices to meet rural demand. Strategic partnerships between hospitals and diagnostic manufacturers account for 28% of the total collaborations, aimed at expanding access and lowering testing costs. Venture capital funding is contributing nearly 22% of all market developments, with strong interest in portable kits and high-throughput systems. Growth opportunities lie in public health programs, where government-driven investments represent nearly 30% of total new deployments globally.

New Products Development

New product development in the Hepatitis E diagnostic tests market is accelerating, with nearly 32% of innovations focused on next-generation ELISA kits offering improved sensitivity above 90%. Around 25% of new product launches are molecular-based, integrating automation features to enhance laboratory efficiency. Portable and point-of-care kits make up 20% of product pipelines, enabling rapid detection in low-resource settings. Collaborations between global diagnostic companies and regional healthcare providers account for 27% of innovation projects. Additionally, 18% of new developments emphasize multiplex testing solutions, allowing simultaneous screening of multiple hepatitis strains and reducing testing turnaround times across laboratories and hospitals.

Developments

• Wantai Biological: In 2024, Wantai expanded its ELISA HEV test kit production capacity by 25%, ensuring better global distribution. The company also achieved 92% sensitivity rates, improving trust in large-scale testing campaigns.
• Roche: Roche introduced an advanced molecular-based HEV PCR kit in 2024, with over 95% accuracy. The launch increased hospital adoption by 18% across North America and Europe, strengthening its diagnostic presence.
• Biokit: Biokit developed a new rapid diagnostic HEV test in 2024 that reduced testing time by 30%. The product gained approval in 40% of European hospitals within its first six months.
• Fast-track Diagnostics: In 2024, Fast-track Diagnostics launched a multiplex test for simultaneous screening of hepatitis A, C, and E. This innovation captured 20% of laboratory-based installations across Asia-Pacific.
• Fortress Diagnostics: Fortress Diagnostics enhanced its immunoassay platform in 2024, offering an improved 90% accuracy rate. Adoption rose by 15% in Middle East & Africa due to strong partnerships with government hospitals.

Report Coverage

The Hepatitis E Diagnostic Tests Market report provides an in-depth analysis of market dynamics, segmentation, regional outlook, and competitive landscape, offering valuable insights into emerging opportunities and restraints. The study covers global market size of USD 42.92 Million in 2024, projected to reach USD 43.87 Million in 2025 and decline to USD 53.36 Million by 2034, with a CAGR of 2.2% during 2025–2034. Segmentation highlights key types such as ELISA IgM, ELISA IgG, and RT-PCR kits, where ELISA IgM holds 45.5% share and RT-PCR represents 19.5%. By application, hospitals dominate with 50% share, followed by diagnostic laboratories at 28%. Regional analysis reveals Asia-Pacific leading with 42% share, North America at 28%, Europe at 20%, and Middle East & Africa contributing 10%. The report also profiles nine leading companies, with Wantai Biological holding 22% and Roche capturing 19% of the market. Investment analysis indicates 40% of funds directed toward molecular diagnostics, while 35% focus on point-of-care innovation. New product developments are shaping the competitive environment, with 32% aimed at improving ELISA kits and 25% targeting molecular tests. This comprehensive coverage ensures stakeholders gain clarity on opportunities, market trends, and competitive strategies.