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Hepatitis E Diagnostic Tests - Global Strategic Business Report

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    Report

  • 285 Pages
  • June 2025
  • Region: Global
  • Global Industry Analysts, Inc
  • ID: 6070490
The global market for Hepatitis E Diagnostic Tests was estimated at US$55.4 Million in 2024 and is projected to reach US$67.8 Million by 2030, growing at a CAGR of 3.4% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the Hepatitis E Diagnostic Tests market.

Global Hepatitis E Diagnostic Tests Market - Key Trends & Drivers Summarized

Why Is Hepatitis E Diagnosis Gaining Global Attention?

Hepatitis E, a liver infection caused by the hepatitis E virus (HEV), is becoming an increasing public health concern, particularly in developing regions with limited access to clean water and sanitation. The disease primarily spreads through contaminated water sources, making it a significant challenge in countries with poor infrastructure. Diagnostic tests play a crucial role in detecting HEV infections, facilitating timely treatment, and preventing outbreaks. The growing prevalence of hepatitis E in both endemic and non-endemic regions has heightened the demand for accurate and rapid diagnostic solutions. Governments and healthcare organizations are investing in screening programs to mitigate the spread of HEV, driving the expansion of the hepatitis E diagnostic tests market.

How Are Technological Innovations Improving Hepatitis E Diagnostics?

The hepatitis E diagnostic market is witnessing rapid technological advancements, with improvements in serological assays, polymerase chain reaction (PCR) techniques, and point-of-care testing solutions. The development of enzyme-linked immunosorbent assays (ELISA) has enhanced the accuracy and efficiency of detecting HEV antibodies, allowing for early diagnosis and disease monitoring. Additionally, the introduction of molecular diagnostic techniques, such as real-time PCR, has enabled precise identification of HEV RNA, aiding in the differentiation of acute and chronic infections. The emergence of rapid test kits is further improving access to hepatitis E diagnostics, particularly in resource-limited settings. These innovations are enhancing the reliability and accessibility of hepatitis E testing, contributing to improved disease control efforts.

Why Is the Demand for Hepatitis E Diagnostic Tests Increasing?

The rising incidence of hepatitis E infections, increasing global travel, and growing awareness about viral hepatitis have fueled the demand for hepatitis E diagnostic tests. Governments and healthcare agencies are implementing screening programs in high-risk populations, such as pregnant women and immunocompromised individuals, to prevent complications associated with HEV infections. The expansion of point-of-care diagnostics in rural areas has also contributed to improved disease detection and management. Additionally, advancements in diagnostic automation are reducing turnaround times, enabling faster decision-making in clinical settings. As global health organizations prioritize hepatitis prevention and control, the demand for HEV diagnostic solutions is expected to grow significantly.

What Are the Key Factors Driving the Growth of the Hepatitis E Diagnostic Tests Market?

The growth in the hepatitis E diagnostic tests market is driven by increasing disease prevalence, advancements in diagnostic technologies, and government initiatives aimed at improving viral hepatitis surveillance. The expansion of healthcare infrastructure in developing countries is also facilitating greater access to hepatitis testing. Additionally, the rising investment in research and development for faster and more accurate diagnostic solutions is contributing to market growth. As public health strategies focus on early detection and prevention of viral hepatitis, the hepatitis E diagnostic tests market is poised for substantial expansion.

Scope of Study:

The report analyzes the Hepatitis E Diagnostic Tests market in terms of units by the following Segments, and Geographic Regions/Countries:
  • Segments: Type (ELISA HEV IGM Tests Type, ELISA HEV IGG Tests Type, Rapid Diagnostics Tests Type, Polymerase Chain Reaction Type); End-Use (Hospitals End-Use, Diagnostics Laboratories End-Use, Blood Banks End-Use, Other End-Uses)
  • Geographic Regions/Countries: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Key Insights:

  • Market Growth: Understand the significant growth trajectory of the ELISA HEV IGM Tests Type segment, which is expected to reach US$29.6 Million by 2030 with a CAGR of a 4.8%. The ELISA HEV IGG Tests Type segment is also set to grow at 2.1% CAGR over the analysis period.
  • Regional Analysis: Gain insights into the U.S. market, estimated at $15.1 Million in 2024, and China, forecasted to grow at an impressive 6.6% CAGR to reach $13.7 Million by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Why You Should Buy This Report:

  • Detailed Market Analysis: Access a thorough analysis of the Global Hepatitis E Diagnostic Tests Market, covering all major geographic regions and market segments.
  • Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
  • Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global Hepatitis E Diagnostic Tests Market.
  • Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.

Key Questions Answered:

  • How is the Global Hepatitis E Diagnostic Tests Market expected to evolve by 2030?
  • What are the main drivers and restraints affecting the market?
  • Which market segments will grow the most over the forecast period?
  • How will market shares for different regions and segments change by 2030?
  • Who are the leading players in the market, and what are their prospects?

Report Features:

  • Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
  • In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
  • Company Profiles: Coverage of players such as Altona Diagnostics GmbH, Beijing Beier Bioengineering Co., Ltd., Beijing Zhongjian Antai Diagnosis Technology Co., Ltd., CTK Biotech, Inc., Dia.Pro Diagnostic Bioprobes s.r.l and more.
  • Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Some of the 42 companies featured in this Hepatitis E Diagnostic Tests market report include:

  • Altona Diagnostics GmbH
  • Beijing Beier Bioengineering Co., Ltd.
  • Beijing Zhongjian Antai Diagnosis Technology Co., Ltd.
  • CTK Biotech, Inc.
  • Dia.Pro Diagnostic Bioprobes s.r.l
  • DiaSorin S.p.A.
  • ELITechGroup
  • Eurofins Viracor
  • F. Hoffmann-La Roche Ltd
  • Fortress Diagnostics
  • GenScript Biotech Corporation
  • Guangzhou Wondfo Biotech Co., Ltd.
  • Healgen Scientific
  • Jiangsu Macro micro-test Medical Technology
  • Medsource Ozone Biomedicals Pvt. Ltd.
  • Mikrogen GmbH
  • MP Biomedicals
  • PerkinElmer, Inc.
  • Primerdesign Ltd
  • Wantai BioPharm

This edition integrates the latest global trade and economic shifts as of June 2025 into comprehensive market analysis. Key updates include:

  • Tariff and Trade Impact: Insights into global tariff negotiations across 180+ countries, with analysis of supply chain turbulence, sourcing disruptions, and geographic realignment. Special focus on 2025 as a pivotal year for trade tensions, including updated perspectives on the Trump-era tariffs.
  • Adjusted Forecasts and Analytics: Revised global and regional market forecasts through 2030, incorporating tariff effects, economic uncertainty, and structural changes in globalization. Includes segmentation by product, technology, type, material, distribution channel, application, and end-use, with historical analysis since 2015.
  • Strategic Market Dynamics: Evaluation of revised market prospects, regional outlooks, and key economic indicators such as population and urbanization trends.
  • Innovation & Technology Trends: Latest developments in product and process innovation, emerging technologies, and key industry drivers shaping the competitive landscape.
  • Competitive Intelligence: Updated global market share estimates for 2025, competitive positioning of major players (Strong/Active/Niche/Trivial), and refined focus on leading global brands and core players.
  • Expert Insight & Commentary: Strategic analysis from economists, trade experts, and domain specialists to contextualize market shifts and identify emerging opportunities.
  • Complimentary Update: Buyers receive a free July 2025 update with finalized tariff impacts, new trade agreement effects, revised projections, and expanded country-level coverage.

Table of Contents

I. METHODOLOGYII. EXECUTIVE SUMMARY
1. MARKET OVERVIEW
Influencer Market Insights
Tariff Impact on Global Supply Chain Patterns
Hepatitis E Diagnostic Tests - Global Key Competitors Percentage Market Share in 2025 (E)
Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2025 (E)
2. FOCUS ON SELECT PLAYERS
3. MARKET TRENDS & DRIVERS
Rising Incidence of Hepatitis E in Developing Regions Drives Demand for Diagnostic Tests
Technological Advancements in Molecular Diagnostics Strengthen the Business Case for Hepatitis E Testing
Increased Focus on Early Diagnosis of Hepatitis E to Prevent Outbreaks Spurs Growth in Diagnostic Market
Emergence of Rapid Testing Solutions Expands Addressable Market Opportunity for Hepatitis E Diagnostics
Regulatory Support for Hepatitis E Testing in Public Health Programs Accelerates Market Adoption
Growing Awareness About Hepatitis E in High-Risk Populations Drives Demand for Diagnostic Tools
Expansion of Hepatitis E Screening Programs in Endemic Regions Promotes Adoption of Diagnostic Tests
Integration of Hepatitis E Diagnostic Tests into Routine Healthcare Practices Generates Demand for Reliable Solutions
Healthcare Infrastructure Development in Emerging Markets Expands Market Opportunity for Hepatitis E Diagnostics
Increased Investment in Infectious Disease Diagnostics Spurs Growth in Hepatitis E Testing Solutions
The Shift Toward Point-of-Care Testing Solutions Drives Market Growth for Hepatitis E Diagnostics
Rising Government and NGO Efforts to Combat Hepatitis E Promote Widespread Use of Diagnostic Tests
Advances in Immunoassay Technology Propel Innovation in Hepatitis E Diagnostic Testing
Growing Importance of Hepatitis E Diagnosis in Pregnancy and Transfusion Medicine Generates Market Opportunities
Improvement in Test Sensitivity and Specificity Strengthens the Case for Hepatitis E Diagnostic Kits
Integration of Hepatitis E Diagnostic Solutions with Digital Health Platforms Expands Adoption Across Healthcare Systems
The Emergence of Next-Generation Sequencing Technologies Spurs Growth in Molecular Hepatitis E Diagnostics
Collaborations Between Pharmaceutical Companies and Diagnostic Providers Strengthen Hepatitis E Test Market
Expanding Global Travel and Migration Trends Heighten the Need for Hepatitis E Screening and Diagnostics
The Push Toward Universal Health Coverage and Preventative Healthcare Drives Demand for Hepatitis E Testing
Rising Environmental and Sanitation Concerns Contribute to Increased Testing for Hepatitis E in Vulnerable Regions
The Development of Combination Diagnostic Panels for Hepatitis E and Other Hepatitis Viruses Promotes Market Expansion
Improved Government Funding and Initiatives to Combat Hepatitis E Accelerates Diagnostic Solutions Adoption
Enhanced Global Surveillance Systems for Hepatitis E Drives Innovation and Investment in Diagnostic Solutions
Growing Number of Hepatitis E Outbreaks Due to Climate Change Prompts Accelerated Demand for Diagnostic Tests
4. GLOBAL MARKET PERSPECTIVE
TABLE 1: World Hepatitis E Diagnostic Tests Market Analysis of Annual Sales in US$ for Years 2015 through 2030
TABLE 2: World Recent Past, Current & Future Analysis for Hepatitis E Diagnostic Tests by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
TABLE 3: World Historic Review for Hepatitis E Diagnostic Tests by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2015 through 2023 and % CAGR
TABLE 4: World 15-Year Perspective for Hepatitis E Diagnostic Tests by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets for Years 2015, 2025 & 2030
TABLE 5: World Recent Past, Current & Future Analysis for ELISA HEV IGM Tests Type by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
TABLE 6: World Historic Review for ELISA HEV IGM Tests Type by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2015 through 2023 and % CAGR
TABLE 7: World 15-Year Perspective for ELISA HEV IGM Tests Type by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
TABLE 8: World Recent Past, Current & Future Analysis for ELISA HEV IGG Tests Type by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
TABLE 9: World Historic Review for ELISA HEV IGG Tests Type by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2015 through 2023 and % CAGR
TABLE 10: World 15-Year Perspective for ELISA HEV IGG Tests Type by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
TABLE 11: World Recent Past, Current & Future Analysis for Rapid Diagnostics Tests Type by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
TABLE 12: World Historic Review for Rapid Diagnostics Tests Type by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2015 through 2023 and % CAGR
TABLE 13: World 15-Year Perspective for Rapid Diagnostics Tests Type by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
TABLE 14: World Recent Past, Current & Future Analysis for Polymerase Chain Reaction Type by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
TABLE 15: World Historic Review for Polymerase Chain Reaction Type by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2015 through 2023 and % CAGR
TABLE 16: World 15-Year Perspective for Polymerase Chain Reaction Type by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
TABLE 17: World Recent Past, Current & Future Analysis for Hospitals End-Use by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
TABLE 18: World Historic Review for Hospitals End-Use by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2015 through 2023 and % CAGR
TABLE 19: World 15-Year Perspective for Hospitals End-Use by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
TABLE 20: World Recent Past, Current & Future Analysis for Diagnostics Laboratories End-Use by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
TABLE 21: World Historic Review for Diagnostics Laboratories End-Use by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2015 through 2023 and % CAGR
TABLE 22: World 15-Year Perspective for Diagnostics Laboratories End-Use by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
TABLE 23: World Recent Past, Current & Future Analysis for Blood Banks End-Use by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
TABLE 24: World Historic Review for Blood Banks End-Use by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2015 through 2023 and % CAGR
TABLE 25: World 15-Year Perspective for Blood Banks End-Use by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
TABLE 26: World Recent Past, Current & Future Analysis for Other End-Uses by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2024 through 2030 and % CAGR
TABLE 27: World Historic Review for Other End-Uses by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ for Years 2015 through 2023 and % CAGR
TABLE 28: World 15-Year Perspective for Other End-Uses by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2015, 2025 & 2030
III. MARKET ANALYSIS
UNITED STATES
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United States for 2025 (E)
CANADA
JAPAN
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Japan for 2025 (E)
CHINA
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in China for 2025 (E)
EUROPE
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Europe for 2025 (E)
FRANCE
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in France for 2025 (E)
GERMANY
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Germany for 2025 (E)
ITALY
UNITED KINGDOM
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United Kingdom for 2025 (E)
SPAIN
RUSSIA
REST OF EUROPE
ASIA-PACIFIC
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Asia-Pacific for 2025 (E)
AUSTRALIA
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Australia for 2025 (E)
INDIA
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in India for 2025 (E)
SOUTH KOREA
REST OF ASIA-PACIFIC
LATIN AMERICA
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Latin America for 2025 (E)
ARGENTINA
BRAZIL
MEXICO
REST OF LATIN AMERICA
MIDDLE EAST
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Middle East for 2025 (E)
IRAN
ISRAEL
SAUDI ARABIA
UNITED ARAB EMIRATES
REST OF MIDDLE EAST
AFRICA
Hepatitis E Diagnostic Tests Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Africa for 2025 (E)
IV. COMPETITION

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Altona Diagnostics GmbH
  • Beijing Beier Bioengineering Co., Ltd.
  • Beijing Zhongjian Antai Diagnosis Technology Co., Ltd.
  • CTK Biotech, Inc.
  • Dia.Pro Diagnostic Bioprobes s.r.l
  • DiaSorin S.p.A.
  • ELITechGroup
  • Eurofins Viracor
  • F. Hoffmann-La Roche Ltd
  • Fortress Diagnostics
  • GenScript Biotech Corporation
  • Guangzhou Wondfo Biotech Co., Ltd.
  • Healgen Scientific
  • Jiangsu Macro micro-test Medical Technology
  • Medsource Ozone Biomedicals Pvt. Ltd.
  • Mikrogen GmbH
  • MP Biomedicals
  • PerkinElmer, Inc.
  • Primerdesign Ltd
  • Wantai BioPharm

Table Information