The Global Hepatitis Testing/Diagnosis Market, valued at approximately USD 4.07 billion in 2024, is projected to grow at a promising CAGR of 6.50% during the forecast period 2025-2035. Hepatitis, a major public health challenge affecting millions globally, demands precise diagnostic solutions to curb its long-term health implications, such as liver cirrhosis and hepatocellular carcinoma. Testing methods-ranging from advanced molecular assays to rapid diagnostic kits-have evolved into indispensable tools for early detection, disease monitoring, and guiding therapeutic interventions. The surge in market demand is being propelled by rising infection rates, heightened public awareness, and the adoption of modern, highly sensitive technologies like polymerase chain reaction (PCR) and next-generation ELISA platforms. Governments, healthcare organizations, and private providers are increasingly prioritizing early detection strategies, while industry players are channeling investments into innovative, point-of-care solutions that ensure accessibility even in remote or resource-limited settings.
The momentum in this market is further reinforced by global health initiatives targeting hepatitis elimination, alongside the mounting integration of hepatitis testing into routine health check-ups, antenatal care, and blood bank screening protocols. According to WHO estimates, more than 350 million people live with chronic hepatitis B or C, and most remain undiagnosed, underscoring the critical need for scalable diagnostic infrastructure. The proliferation of rapid diagnostic tests and portable imaging systems has significantly improved screening penetration rates in developing regions, while high-income countries are focusing on advanced, lab-based PCR assays to refine accuracy and reduce turnaround times. However, the high cost of certain advanced diagnostic platforms, disparities in healthcare access, and the absence of robust screening policies in some nations continue to impede optimal market expansion.
North America currently leads the global hepatitis testing/diagnosis market, supported by comprehensive screening guidelines, strong insurance coverage, and a technologically advanced healthcare ecosystem. The U.S., in particular, benefits from continuous innovation, with biotech companies launching new-generation diagnostic assays to detect viral genotypes and quantify viral loads. Europe follows closely, driven by large-scale public health programs and cross-country collaborations to achieve WHO hepatitis elimination targets by 2030. Meanwhile, Asia Pacific is set to witness the fastest growth over the forecast period, fuelled by high disease prevalence in countries like China and India, expanding healthcare infrastructure, and intensified government-backed awareness campaigns. Latin America and the Middle East & Africa are also emerging as important growth corridors, propelled by donor-funded healthcare initiatives, increased diagnostic capacity, and international partnerships aimed at strengthening hepatitis control strategies.
Major market player included in this report are:
Abbott Laboratories
Siemens Healthineers AG
Danaher Corporation
F. Hoffmann-La Roche Ltd
Bio-Rad Laboratories, Inc.
Thermo Fisher Scientific Inc.
QIAGEN N.V.
Hologic, Inc.
Quest Diagnostics Incorporated
Ortho Clinical Diagnostics
Sysmex Corporation
Grifols, S.A.
Becton, Dickinson and Company
bioMerieux SA
Cepheid, Inc.
Global Hepatitis Testing/Diagnosis Market Report Scope:
Historical Data - 2023, 2024
Base Year for Estimation - 2024
Forecast period - 2025-2035
Report Coverage - Revenue forecast, Company Ranking, Competitive Landscape, Growth factors, and Trends
Regional Scope - North America; Europe; Asia Pacific; Latin America; Middle East & Africa
Customization Scope - Free report customization (equivalent up to 8 analysts' working hours) with purchase. Addition or alteration to country, regional & segment scope*
The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values for the coming years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within the countries involved in the study. The report also provides detailed information about crucial aspects, such as driving factors and challenges, which will define the future growth of the market. Additionally, it incorporates potential opportunities in micro-markets for stakeholders to invest, along with a detailed analysis of the competitive landscape and product offerings of key players. The detailed segments and sub-segments of the market are explained below:
By Test:
Blood Test
Imaging Tests
Liver Biopsy
By Technology:
ELISA
Rapid Diagnostic Test
PCR
By End-use:
Hospitals
Diagnostic Laboratories
Others
By Region:
North America
U.S.
Canada
Europe
UK
Germany
France
Spain
Italy
Rest of Europe (ROE)
Asia Pacific
China
India
Japan
Australia
South Korea
Rest of Asia Pacific (RoAPAC)
Latin America
Brazil
Mexico
Middle East & Africa
UAE
Saudi Arabia
South Africa
Rest of Middle East & Africa
Key Takeaways:
Market Estimates & Forecast for 10 years from 2025 to 2035.
Annualized revenues and regional level analysis for each market segment.
Detailed analysis of geographical landscape with Country level analysis of major regions.
Competitive landscape with information on major players in the market.
Analysis of key business strategies and recommendations on future market approach.
Analysis of competitive structure of the market.
Demand side and supply side analysis of the market.
Table of Contents
Chapter 1. Global Hepatitis Testing/Diagnosis Market Report Scope & Methodology
1.1. Research Objective
1.2. Research Methodology
1.2.1. Forecast Model
1.2.2. Desk Research
1.2.3. Top Down and Bottom-Up Approach
1.3. Research Attributes
1.4. Scope of the Study
1.4.1. Market Definition
1.4.2. Market Segmentation
1.5. Research Assumption
1.5.1. Inclusion & Exclusion
1.5.2. Limitations
1.5.3. Years Considered for the Study
Chapter 2. Executive Summary
2.1. CEO/CXO Standpoint
2.2. Strategic Insights
2.3. ESG Analysis
2.4. Key Findings
Chapter 3. Global Hepatitis Testing/Diagnosis Market Forces Analysis
3.1. Market Forces Shaping The Global Hepatitis Testing/Diagnosis Market (2024-2035)
3.2. Drivers
3.2.1. Rising prevalence of hepatitis infections and increased screening initiatives (Key Driver)
3.2.2. Adoption of advanced molecular diagnostics and point-of-care rapid tests (Key Driver)
3.3. Restraints
3.3.1. High capital and per-test costs of advanced diagnostic platforms (Key Restraint)
3.3.2. Uneven access to diagnostic infrastructure in emerging and low-income regions (Key Restraint)
3.4. Opportunities
3.4.1. Expansion of decentralized testing and rapid diagnostics in APAC and Africa (Key Opportunity)
3.4.2. Integration of multiplex assays, AI-driven interpretation and public-private screening programs (Key Opportunity)
Chapter 4. Global Hepatitis Testing/Diagnosis Industry Analysis
4.1. Porter's 5 Forces Model
4.1.1. Bargaining Power of Buyer
4.1.2. Bargaining Power of Supplier
4.1.3. Threat of New Entrants
4.1.4. Threat of Substitutes
4.1.5. Competitive Rivalry
4.2. Porter's 5 Force Forecast Model (2024-2035)
4.3. PESTEL Analysis
4.3.1. Political
4.3.2. Economical
4.3.3. Social
4.3.4. Technological
4.3.5. Environmental
4.3.6. Legal
4.4. Top Investment Opportunities
4.5. Top Winning Strategies (2025)
4.6. Market Share Analysis (2024-2025)
4.7. Global Pricing Analysis And Trends 2025
4.8. Analyst Recommendation & Conclusion
Chapter 5. Global Hepatitis Testing/Diagnosis Market Size & Forecasts by Test 2025-2035
5.1. Market Overview
5.2. Global Hepatitis Testing/Diagnosis Market Performance - Potential Analysis (2025)
5.3. Blood Test
5.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
5.3.2. Market size analysis, by region, 2025-2035
5.4. Imaging Tests
5.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
5.4.2. Market size analysis, by region, 2025-2035
5.5. Liver Biopsy
5.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
5.5.2. Market size analysis, by region, 2025-2035
Chapter 6. Global Hepatitis Testing/Diagnosis Market Size & Forecasts by Technology 2025-2035
6.1. Market Overview
6.2. Global Hepatitis Testing/Diagnosis Market Performance - Potential Analysis (2025)
6.3. ELISA
6.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
6.3.2. Market size analysis, by region, 2025-2035
6.4. Rapid Diagnostic Test (RDT)
6.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
6.4.2. Market size analysis, by region, 2025-2035
6.5. PCR
6.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
6.5.2. Market size analysis, by region, 2025-2035
Chapter 7. Global Hepatitis Testing/Diagnosis Market Size & Forecasts by Region 2025-2035