Comprehensive Market Report: Global Hepatitis Diagnostics Market
Executive Summary
The global Hepatitis Diagnostics market is a critical and evolving segment within the infectious disease diagnostics and public health landscape. Encompassing the detection and monitoring of Hepatitis A, B, C, D, and E viruses, this market is essential for disease screening, diagnosis, treatment initiation, and monitoring of cure. The market, valued at an estimated USD XX billion in 2025, is projected to reach approximately USD YY billion by 2036, growing at a steady Compound Annual Growth Rate (CAGR) of Z% from 2026 to 2036. This growth is fueled by high global disease burden, World Health Organization (WHO) elimination targets (particularly for HCV), increasing blood donation screening, rising awareness, and technological advancements enabling point-of-care (POC) and molecular testing. This report provides a strategic analysis of the testing cascade, technological platforms, and regional elimination initiatives.
1. Segments Analysis
By Test Type & Technology Platform:
-
Immunoassays & Serology Tests (Largest Segment):
-
Rapid Diagnostic Tests (RDTs)/Point-of-Care (POC) Tests: For screening and initial diagnosis (e.g., HBsAg, HCV antibody). Crucial for outreach in resource-limited settings.
-
Enzyme-Linked Immunosorbent Assay (ELISA): Laboratory-based standard for detecting antigens and antibodies (e.g., anti-HBc, anti-HAV).
-
Chemiluminescence Immunoassay (CLIA): Higher-throughput, automated platform used in centralized labs, offering improved sensitivity.
-
-
Molecular Diagnostics (Nucleic Acid Testing - NAT) (Fastest-Growing Segment):
-
Polymerase Chain Reaction (PCR): Gold standard for confirming active infection, determining viral load (HCV RNA, HBV DNA), and monitoring treatment response. Includes real-time PCR.
-
Transcription-Mediated Amplification (TMA): High-sensitivity alternative to PCR, widely used for blood screening.
-
-
Other Tests:
-
Liver Function Tests (LFTs) & Biomarkers: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin. Used for assessing liver damage.
-
Genotyping & Resistance Testing: For HCV and HBV to guide personalized therapy.
-
Liver Biopsy & Non-Invasive Tests (NITs): FibroScan (transient elastography), serum fibrosis markers (e.g., APRI, FIB-4) to stage liver fibrosis/cirrhosis, replacing biopsy in many cases.
-
By Disease Type:
-
Hepatitis C Virus (HCV) Diagnostics: The most dynamic segment due to global elimination efforts. High demand for screening antibody tests, confirmatory RNA tests, and genotyping.
-
Hepatitis B Virus (HBV) Diagnostics: Large volume segment driven by chronic infection management requiring lifelong monitoring of viral load (DNA) and antigens (HBsAg, HBeAg).
-
Hepatitis A (HAV) & Hepatitis E (HEV) Diagnostics: Primarily serology-based for outbreak investigation and travel medicine.
-
Hepatitis D Virus (HDV) Diagnostics: Niche but critical segment, as HDV requires HBV co-infection. Testing is underutilized but growing.
By End-User:
-
Hospital & Clinical Laboratories: Core users for comprehensive diagnostic workups, including molecular testing and fibrosis assessment.
-
Diagnostic & Reference Laboratories: High-volume testing centers for screening and specialized assays.
-
Blood Banks & Blood Donation Centers: Mandatory screening of all donated blood for HBV, HCV, and HIV using highly sensitive serology and NAT.
-
Public Health Laboratories & Outreach Programs: Utilize POC/RDTs for mass screening campaigns.
-
Academic & Research Institutes: For epidemiological studies and clinical trials.
2. Key Players
The market is dominated by global in vitro diagnostics (IVD) giants.
Leading Companies:
-
Abbott Laboratories
-
F. Hoffmann-La Roche Ltd. (Cobas® systems for serology and molecular testing)
-
Siemens Healthineers AG
-
Danaher Corporation (Via Beckman Coulter, Cepheid)
-
Bio-Rad Laboratories, Inc.
-
Grifols, S.A. (Blood screening)
-
Qiagen N.V. (Sample prep and PCR technologies)
-
Hologic, Inc. (Via its Panther® system for molecular testing)
-
DiaSorin S.p.A. (Leader in immunodiagnostics)
-
Ortho Clinical Diagnostics (A part of QuidelOrtho)
-
bioMérieux SA (Via its VIDAS® immunoassay systems)
-
Sysmex Corporation
-
Becton, Dickinson and Company (BD) (Specimen collection, microbiology)
-
Meridian Bioscience, Inc.
-
Chembio Diagnostic Systems, Inc. (Specialized in POC RDTs)
3. Regional Analysis
-
North America: A mature, high-value market. Driven by advanced healthcare infrastructure, routine screening recommendations, high treatment rates (HCV), and sophisticated laboratory testing. The US dominates.
-
Europe: Similar to North America, with strong screening programs and high adoption of automated systems. Eastern Europe has a higher disease burden, driving diagnostic demand.
-
Asia-Pacific: The largest and fastest-growing market by volume. Home to over 70% of global HBV and HCV cases (China, India, Pakistan). Growth is driven by massive government-led screening initiatives, improving healthcare access, and rising awareness. A key market for both high-volume lab systems and low-cost POC tests.
-
Latin America, Middle East & Africa: High-burden regions with significant unmet needs. Growth is fueled by donor-funded elimination programs (e.g., via WHO, Gavi, The Global Fund), focusing on scaling up POC screening and affordable confirmatory testing. South Africa, Brazil, and Egypt are key countries.
4. Porter’s Five Forces Analysis
-
Competitive Rivalry (High): The market is highly concentrated among a few large IVD companies that compete on assay menu, automation, throughput, and installed instrument base. Competition is intense, especially for high-value molecular systems in core labs.
-
Bargaining Power of Suppliers (Low to Moderate): Suppliers provide biological reagents (antigens, antibodies, enzymes), plastics, and electronic components. For proprietary enzymes and specialized biochemicals, power is moderate. Large IVD firms often produce key components in-house.
-
Bargaining Power of Buyers (High): Buyers are large hospital networks, national health systems, and group purchasing organizations (GPOs). They wield significant power in negotiating pricing, especially for high-volume commodity tests (e.g., HBsAg ELISA). Blood banks also purchase in bulk.
-
Threat of New Entrants (Low): Barriers are very high due to stringent regulatory requirements (FDA, CE-IVD), need for extensive clinical validation, complex manufacturing, and established customer loyalty to integrated instrument platforms ("razor-razorblade" model).
-
Threat of Substitutes (Low): There are no substitutes for specific viral diagnostics. However, competition exists between technology platforms (e.g., POC vs. lab-based, different molecular methods) and between test strategies (e.g., reflex testing algorithms).
5. SWOT Analysis
-
Strengths: Essential for public health and clinical management; aligned with global health priorities (HCV elimination); strong recurring revenue from consumables; continuous innovation in sensitivity, speed, and ease of use.
-
Weaknesses: Price sensitivity in high-burden, low-resource regions; regulatory hurdles for new assays; complexity of the diagnostic cascade requiring multiple tests; dependency on healthcare funding and policy.
-
Opportunities: Massive scale-up of screening in APAC and Africa; development of multi-parameter POC tests (e.g., HCV antibody/antigen combo); integration of diagnostics with telehealth for remote management; under-diagnosis of HDV creating a new market.
-
Threats: Funding uncertainties for global health elimination programs; competition from extremely low-cost generic test manufacturers; potential decline in HCV testing volume in regions nearing elimination targets.
6. Trend Analysis, Drivers & Challenges
Key Trends:
-
Decentralization & Point-of-Care (POC) Testing: Shift towards POC molecular tests (e.g., GeneXpert HCV Viral Load) enabling test-and-treat models in community settings, critical for elimination.
-
Automation & High-Throughput Systems: Consolidation of testing in core labs driving demand for fully automated, walk-away systems for serology and molecular testing.
-
Multiplexing & Combination Assays: Tests that screen for multiple hepatitis viruses (or HIV/syphilis) simultaneously, improving efficiency for blood screening and high-risk populations.
-
Dried Blood Spot (DBS) Sampling: Enables easy sample collection and transport from remote areas to central labs for molecular testing, expanding access.
Primary Drivers:
-
Global Hepatitis Elimination Goals: WHO targets to eliminate HCV by 2030 and reduce HBV drive massive government and donor-funded screening campaigns.
-
High Global Disease Burden: Persistent prevalence of HBV and HCV, with millions undiagnosed.
-
Advancements in Treatment: Highly effective direct-acting antivirals (DAAs) for HCV create a direct need for diagnostics to find and cure patients.
-
Mandatory Blood Screening: Stringent regulations worldwide ensuring safety of blood supply.
Critical Challenges:
-
Access & Equity in Low-Resource Settings: High cost and infrastructure requirements for confirmatory molecular tests remain a major barrier to elimination.
-
Linkage to Care: Ensuring individuals who screen positive receive confirmatory testing and treatment.
-
Complex Diagnostic Pathways: Especially for HBV (requiring multiple serology markers and DNA) and HCV (antibody screening followed by RNA confirmation).
-
Under-Diagnosis: Stigma, lack of symptoms, and poor awareness keep diagnosis rates low in many regions.
7. Value Chain Analysis
-
R&D & Assay Development: Designing antigens/antibodies, primer/probe sets, and optimizing assay chemistry.
-
Reagent & Instrument Manufacturing: Producing test kits, calibrators, controls, and diagnostic instruments/analyzers.
-
Regulatory Affairs & Clinical Trials: Securing approvals from health authorities (FDA, EMA, NMPA, WHO PQ) with clinical performance data.
-
Sales, Marketing & Distribution: Through direct salesforces and distributors. Key to placing instruments (often at low cost) to lock in recurring consumable sales.
-
Laboratory Testing & Service: The value-adding step where the test is performed, either in a central lab, hospital, or at the POC.
-
Result Reporting & Clinical Decision Support: Integration with laboratory information systems (LIS) and providing interpretive guidance.
-
Public Health Surveillance & Data Management: Aggregating data for monitoring disease prevalence and program effectiveness.
Value is concentrated in proprietary assay chemistry and instrument platforms that create a "closed system" with high-margin consumable sales. Companies that also provide data management solutions and program support for elimination campaigns capture additional value.
8. Quick Recommendations for Stakeholders
-
For IVD Market Leaders (Roche, Abbott, Siemens): Develop integrated, scalable solutions for elimination programs. Offer bundled POC screening + confirmatory molecular systems with connectivity for data tracking. Invest in high-throughput, low-cost-per-test NAT systems for emerging market labs. Expand HBV and HDV assay menus as management becomes more sophisticated.
-
For Public Health Agencies & Donors (WHO, Governments, The Global Fund): Procure diagnostics based on total program cost and impact, not just unit test cost. Invest in strengthening lab networks and sample referral systems alongside POC tests. Standardize testing algorithms and data reporting across programs to track progress.
-
For Laboratories & Healthcare Providers: For high-volume settings, invest in automated platforms that reduce hands-on time and human error. Implement efficient reflex testing algorithms (e.g., automatic RNA testing on positive antibody screens) to improve linkage. Adopt non-invasive tests (FibroScan) for staging to replace biopsy.
-
For New Entrants & Specialized Players: Focus on addressing critical gaps: ultra-low-cost POC tests for mass screening, simple, instrument-free molecular confirmatory tests, or multi-disease syndromic panels for high-risk populations. Partner with NGOs and governments for pilot programs.
-
For Investors: Focus on companies with strong portfolios in molecular diagnostics and POC, as these are the growth engines for elimination. Companies with a significant presence in high-burden Asia-Pacific markets and those providing end-to-end program support (not just kits) are well-positioned. Monitor adoption curves of new POC molecular platforms in public health programs.
Report Basis: History Years: 2020-2024; Base Year: 2025; Forecast Period: 2026-2036.
Note: All market values (XX, YY) and CAGR (Z%) are illustrative placeholders. This analysis reflects the critical role of diagnostics in public health initiatives. Customized data, including disease-specific test volume forecasts, pricing analysis by region, and detailed competitive landscape, is available per client specifications.
Table of Contents
Global Hepatitis Diagnostic Test global market
1 Industry Overview of Hepatitis Diagnostic Test
1.1 Hepatitis Diagnostic Test Market Overview
1.1.1 Hepatitis Diagnostic Test Product Scope
1.1.2 Market Status and Outlook
1.2 Global Hepatitis Diagnostic Test Market Size and Analysis by Regions ()
1.2.1 United States
1.2.2 Europe
1.2.3 China
1.2.4 Japan
1.2.5 Southeast Asia
1.2.6 India
1.3 Hepatitis Diagnostic Test Market by Type
1.3.1 Blood tests
1.3.2 Imaging Tests
1.3.3 Liver Biopsy
1.4 Hepatitis Diagnostic Test Market by End Users/Application
1.4.1 Hospital
1.4.2 Clinic
1.4.3 Research Institute
1.4.4 Laboratories
2 Global Hepatitis Diagnostic Test Competition Analysis by Players
2.1 Hepatitis Diagnostic Test Market Size (Value) by Players ()
2.2 Competitive Status and Trend
2.2.1 Market Concentration Rate
2.2.2 Product/Service Differences
2.2.3 New Entrants
2.2.4 The Technology Trends in Future
3 Company (Top Players) Profiles
3.1 Abbott Laboratories
3.1.1 Company Profile
3.1.2 Main Business/Business Overview
3.1.3 Products, Services and Solutions
3.1.4 Hepatitis Diagnostic Test Revenue (Million USD) ()
3.2 Danaher Corporation
3.2.1 Company Profile
3.2.2 Main Business/Business Overview
3.2.3 Products, Services and Solutions
3.2.4 Hepatitis Diagnostic Test Revenue (Million USD) ()
3.3 F. Hoffmann Roche
3.3.1 Company Profile
3.3.2 Main Business/Business Overview
3.3.3 Products, Services and Solutions
3.3.4 Hepatitis Diagnostic Test Revenue (Million USD) ()
3.4 DiaSorin S.p.A
3.4.1 Company Profile
3.4.2 Main Business/Business Overview
3.4.3 Products, Services and Solutions
3.4.4 Hepatitis Diagnostic Test Revenue (Million USD) ()
3.5 MedMira, Inc.
3.5.1 Company Profile
3.5.2 Main Business/Business Overview
3.5.3 Products, Services and Solutions
3.5.4 Hepatitis Diagnostic Test Revenue (Million USD) ()
3.6 Siemens AG
3.6.1 Company Profile
3.6.2 Main Business/Business Overview
3.6.3 Products, Services and Solutions
3.6.4 Hepatitis Diagnostic Test Revenue (Million USD) ()
3.7 Hologic, Inc.
3.7.1 Company Profile
3.7.2 Main Business/Business Overview
3.7.3 Products, Services and Solutions
3.7.4 Hepatitis Diagnostic Test Revenue (Million USD) ()
3.8 Bio Rad Laboratories
3.8.1 Company Profile
3.8.2 Main Business/Business Overview
3.8.3 Products, Services and Solutions
3.8.4 Hepatitis Diagnostic Test Revenue (Million USD) ()
3.9 bioMeriuex
3.9.1 Company Profile
3.9.2 Main Business/Business Overview
3.9.3 Products, Services and Solutions
3.9.4 Hepatitis Diagnostic Test Revenue (Million USD) ()
4 Global Hepatitis Diagnostic Test Market Size by Type and Application ()
4.1 Global Hepatitis Diagnostic Test Market Size by Type ()
4.2 Global Hepatitis Diagnostic Test Market Size by Application ()
4.3 Potential Application of Hepatitis Diagnostic Test in Future
4.4 Top Consumer/End Users of Hepatitis Diagnostic Test
5 United States Hepatitis Diagnostic Test Development Status and Outlook
5.1 United States Hepatitis Diagnostic Test Market Size ()
5.2 United States Hepatitis Diagnostic Test Market Size and Market Share by Players ()
5.3 United States Hepatitis Diagnostic Test Market Size by Application ()
6 Europe Hepatitis Diagnostic Test Development Status and Outlook
6.1 Europe Hepatitis Diagnostic Test Market Size ()
6.2 Europe Hepatitis Diagnostic Test Market Size and Market Share by Players ()
6.3 Europe Hepatitis Diagnostic Test Market Size by Application ()
7 China Hepatitis Diagnostic Test Development Status and Outlook
7.1 China Hepatitis Diagnostic Test Market Size ()
7.2 China Hepatitis Diagnostic Test Market Size and Market Share by Players ()
7.3 China Hepatitis Diagnostic Test Market Size by Application ()
8 Japan Hepatitis Diagnostic Test Development Status and Outlook
8.1 Japan Hepatitis Diagnostic Test Market Size ()
8.2 Japan Hepatitis Diagnostic Test Market Size and Market Share by Players ()
8.3 Japan Hepatitis Diagnostic Test Market Size by Application ()
9 Southeast Asia Hepatitis Diagnostic Test Development Status and Outlook
9.1 Southeast Asia Hepatitis Diagnostic Test Market Size ()
9.2 Southeast Asia Hepatitis Diagnostic Test Market Size and Market Share by Players ()
9.3 Southeast Asia Hepatitis Diagnostic Test Market Size by Application ()
10 India Hepatitis Diagnostic Test Development Status and Outlook
10.1 India Hepatitis Diagnostic Test Market Size ()
10.2 India Hepatitis Diagnostic Test Market Size and Market Share by Players ()
10.3 India Hepatitis Diagnostic Test Market Size by Application ()
11 Market Forecast by Regions, Type and Application ()
11.1 Global Hepatitis Diagnostic Test Market Size (Value) by Regions ()
11.1.1 United States Hepatitis Diagnostic Test Revenue and Growth Rate ()
11.1.2 Europe Hepatitis Diagnostic Test Revenue and Growth Rate ()
11.1.3 China Hepatitis Diagnostic Test Revenue and Growth Rate ()
11.1.4 Japan Hepatitis Diagnostic Test Revenue and Growth Rate ()
11.1.5 Southeast Asia Hepatitis Diagnostic Test Revenue and Growth Rate ()
11.1.6 India Hepatitis Diagnostic Test Revenue and Growth Rate ()
11.2 Global Hepatitis Diagnostic Test Market Size (Value) by Type ()
11.3 Global Hepatitis Diagnostic Test Market Size by Application ()
12 Hepatitis Diagnostic Test Market Dynamics
12.1 Hepatitis Diagnostic Test Market Opportunities
12.2 Hepatitis Diagnostic Test Challenge and Risk
12.2.1 Competition from Opponents
12.2.2 Downside Risks of Economy
12.3 Hepatitis Diagnostic Test Market Constraints and Threat
12.3.1 Threat from Substitute
12.3.2 Government Policy
12.3.3 Technology Risks
12.4 Hepatitis Diagnostic Test Market Driving Force
12.4.1 Growing Demand from Emerging Markets
12.4.2 Potential Application
13 Market Effect Factors Analysis
13.1 Technology Progress/Risk
13.1.1 Substitutes
13.1.2 Technology Progress in Related Industry
13.2 Consumer Needs Trend/Customer Preference
13.3 External Environmental Change
13.3.1 Economic Fluctuations
13.3.2 Other Risk Factors
14 Research Finding/Conclusion
15 Appendix
Methodology
Analyst Introduction
Data Source
List of Tables and Figures
Figure Global Hepatitis Diagnostic Test Market Size (Million USD) Status and Outlook ()
Table Global Hepatitis Diagnostic Test Revenue (Million USD) Comparison by Regions ()
Figure Global Hepatitis Diagnostic Test Market Share by Regions ()
Figure United States Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate by Regions ()
Figure Europe Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate by Regions ()
Figure China Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate by Regions ()
Figure Japan Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate by Regions ()
Figure Southeast Asia Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate by Regions ()
Figure India Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate by Regions ()
Table Global Hepatitis Diagnostic Test Revenue (Million USD) and Growth Rate (%) Comparison by Product ()
Figure Global Hepatitis Diagnostic Test Revenue Market Share by Type in 2017
Figure Blood tests Market Size (Million USD) and Growth Rate ()
Figure Imaging Tests Market Size (Million USD) and Growth Rate ()
Figure Liver Biopsy Market Size (Million USD) and Growth Rate ()
Figure Global Hepatitis Diagnostic Test Market Share by Application in 2017
Figure Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate in Hospital ()
Figure Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate in Clinic ()
Figure Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate in Research Institute ()
Figure Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate in Laboratories ()
Table Hepatitis Diagnostic Test Market Size (Million USD) by Players ()
Figure Hepatitis Diagnostic Test Market Size Share by Players in 2013
Figure Hepatitis Diagnostic Test Market Size Share by Players in 2017
Table Abbott Laboratories Basic Information List
Table Hepatitis Diagnostic Test Business Revenue (Million USD) of Abbott Laboratories ()
Figure Abbott Laboratories Hepatitis Diagnostic Test Business Revenue Market Share ()
Table Danaher Corporation Basic Information List
Table Hepatitis Diagnostic Test Business Revenue (Million USD) of Danaher Corporation ()
Figure Danaher Corporation Hepatitis Diagnostic Test Business Revenue Market Share ()
Table F. Hoffmann Roche Basic Information List
Table Hepatitis Diagnostic Test Business Revenue (Million USD) of F. Hoffmann Roche ()
Figure F. Hoffmann Roche Hepatitis Diagnostic Test Business Revenue Market Share ()
Table DiaSorin S.p.A Basic Information List
Table Hepatitis Diagnostic Test Business Revenue (Million USD) of DiaSorin S.p.A ()
Figure DiaSorin S.p.A Hepatitis Diagnostic Test Business Revenue Market Share ()
Table MedMira, Inc. Basic Information List
Table Hepatitis Diagnostic Test Business Revenue (Million USD) of MedMira, Inc. ()
Figure MedMira, Inc. Hepatitis Diagnostic Test Business Revenue Market Share ()
Table Siemens AG Basic Information List
Table Hepatitis Diagnostic Test Business Revenue (Million USD) of Siemens AG ()
Figure Siemens AG Hepatitis Diagnostic Test Business Revenue Market Share ()
Table Hologic, Inc. Basic Information List
Table Hepatitis Diagnostic Test Business Revenue (Million USD) of Hologic, Inc. ()
Figure Hologic, Inc. Hepatitis Diagnostic Test Business Revenue Market Share ()
Table Bio Rad Laboratories Basic Information List
Table Hepatitis Diagnostic Test Business Revenue (Million USD) of Bio Rad Laboratories ()
Figure Bio Rad Laboratories Hepatitis Diagnostic Test Business Revenue Market Share ()
Table bioMeriuex Basic Information List
Table Hepatitis Diagnostic Test Business Revenue (Million USD) of bioMeriuex ()
Figure bioMeriuex Hepatitis Diagnostic Test Business Revenue Market Share ()
Table Global Hepatitis Diagnostic Test Market Size (Million USD) by Product ()
Figure Global Hepatitis Diagnostic Test Revenue Market Share (%) by Product ()
Figure Global Hepatitis Diagnostic Test Market Share by Product in 2017
Table Global Hepatitis Diagnostic Test Market Size by Application ()
Figure Global Hepatitis Diagnostic Test Revenue Market Share (%) by Application in 2017
Table Top Consumer/End Users of Hepatitis Diagnostic Test
Figure United States Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate ()
Table United States Hepatitis Diagnostic Test Market Size (Million USD) by Players ()
Figure United States Hepatitis Diagnostic Test Market Size Share by Players in 2013
Figure United States Hepatitis Diagnostic Test Market Size Share by Players in 2017
Table United States Hepatitis Diagnostic Test Market Size by Application ()
Figure United States Hepatitis Diagnostic Test Revenue Market Share (%) by Application ()
Figure United States Hepatitis Diagnostic Test Market Size Share by Application in 2017
Figure Europe Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate ()
Table Europe Hepatitis Diagnostic Test Market Size (Million USD) by Players ()
Figure Europe Hepatitis Diagnostic Test Market Size Share by Players in 2013
Figure Europe Hepatitis Diagnostic Test Market Size Share by Players in 2017
Table Europe Hepatitis Diagnostic Test Market Size by Application ()
Figure Europe Hepatitis Diagnostic Test Revenue Market Share (%) by Application ()
Figure Europe Hepatitis Diagnostic Test Market Size Share by Application in 2017
Figure China Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate ()
Table China Hepatitis Diagnostic Test Market Size (Million USD) by Players ()
Figure China Hepatitis Diagnostic Test Market Size Share by Players in 2013
Figure China Hepatitis Diagnostic Test Market Size Share by Players in 2017
Table China Hepatitis Diagnostic Test Market Size by Application ()
Figure China Hepatitis Diagnostic Test Revenue Market Share (%) by Application ()
Figure China Hepatitis Diagnostic Test Market Size Share by Application in 2017
Figure Japan Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate ()
Table Japan Hepatitis Diagnostic Test Market Size (Million USD) by Players ()
Figure Japan Hepatitis Diagnostic Test Market Size Share by Players in 2013
Figure Japan Hepatitis Diagnostic Test Market Size Share by Players in 2017
Table Japan Hepatitis Diagnostic Test Market Size by Application ()
Figure Japan Hepatitis Diagnostic Test Revenue Market Share (%) by Application ()
Figure Japan Hepatitis Diagnostic Test Market Size Share by Application in 2017
Figure Southeast Asia Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate ()
Table Southeast Asia Hepatitis Diagnostic Test Market Size (Million USD) by Players ()
Figure Southeast Asia Hepatitis Diagnostic Test Market Size Share by Players in 2013
Figure Southeast Asia Hepatitis Diagnostic Test Market Size Share by Players in 2017
Table Southeast Asia Hepatitis Diagnostic Test Market Size by Application ()
Figure Southeast Asia Hepatitis Diagnostic Test Revenue Market Share (%) by Application ()
Figure Southeast Asia Hepatitis Diagnostic Test Market Size Share by Application in 2017
Figure India Hepatitis Diagnostic Test Market Size (Million USD) and Growth Rate ()
Table India Hepatitis Diagnostic Test Market Size (Million USD) by Players ()
Figure India Hepatitis Diagnostic Test Market Size Share by Players in 2013
Figure India Hepatitis Diagnostic Test Market Size Share by Players in 2017
Table India Hepatitis Diagnostic Test Market Size by Application ()
Figure India Hepatitis Diagnostic Test Revenue Market Share (%) by Application ()
Figure India Hepatitis Diagnostic Test Market Size Share by Application in 2017
Figure Global Hepatitis Diagnostic Test Market Size and Growth Rate ()
Table Global Hepatitis Diagnostic Test Market Size (Million USD) by Regions ()
Figure Global Hepatitis Diagnostic Test Market Size Share ()
Figure Global Hepatitis Diagnostic Test Market Size Share by Regions in 2025
Figure United States Hepatitis Diagnostic Test Revenue (Million USD) and Growth Rate ()
Figure Europe Hepatitis Diagnostic Test Revenue (Million USD) and Growth Rate ()
Figure China Hepatitis Diagnostic Test Revenue (Million USD) and Growth Rate ()
Figure Japan Hepatitis Diagnostic Test Revenue (Million USD) and Growth Rate ()
Figure Southeast Asia Hepatitis Diagnostic Test Revenue (Million USD) and Growth Rate ()
Figure India Hepatitis Diagnostic Test Revenue (Million USD) and Growth Rate ()
Table Global Hepatitis Diagnostic Test Market Size (Million USD) by Type ()
Figure Global Hepatitis Diagnostic Test Market Size Share by Type in 2018
Figure Global Hepatitis Diagnostic Test Market Size Share by Type in 2025
Table Global Hepatitis Diagnostic Test Market Size (Million USD) by Application ()
Figure Global Hepatitis Diagnostic Test Market Size (Million USD) by Application in 2018
1. Segments Analysis
By Test Type & Technology Platform:
-
Immunoassays & Serology Tests (Largest Segment):
-
Rapid Diagnostic Tests (RDTs)/Point-of-Care (POC) Tests: For screening and initial diagnosis (e.g., HBsAg, HCV antibody). Crucial for outreach in resource-limited settings.
-
Enzyme-Linked Immunosorbent Assay (ELISA): Laboratory-based standard for detecting antigens and antibodies (e.g., anti-HBc, anti-HAV).
-
Chemiluminescence Immunoassay (CLIA): Higher-throughput, automated platform used in centralized labs, offering improved sensitivity.
-
-
Molecular Diagnostics (Nucleic Acid Testing - NAT) (Fastest-Growing Segment):
-
Polymerase Chain Reaction (PCR): Gold standard for confirming active infection, determining viral load (HCV RNA, HBV DNA), and monitoring treatment response. Includes real-time PCR.
-
Transcription-Mediated Amplification (TMA): High-sensitivity alternative to PCR, widely used for blood screening.
-
-
Other Tests:
-
Liver Function Tests (LFTs) & Biomarkers: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin. Used for assessing liver damage.
-
Genotyping & Resistance Testing: For HCV and HBV to guide personalized therapy.
-
Liver Biopsy & Non-Invasive Tests (NITs): FibroScan (transient elastography), serum fibrosis markers (e.g., APRI, FIB-4) to stage liver fibrosis/cirrhosis, replacing biopsy in many cases.
-
By Disease Type:
-
Hepatitis C Virus (HCV) Diagnostics: The most dynamic segment due to global elimination efforts. High demand for screening antibody tests, confirmatory RNA tests, and genotyping.
-
Hepatitis B Virus (HBV) Diagnostics: Large volume segment driven by chronic infection management requiring lifelong monitoring of viral load (DNA) and antigens (HBsAg, HBeAg).
-
Hepatitis A (HAV) & Hepatitis E (HEV) Diagnostics: Primarily serology-based for outbreak investigation and travel medicine.
-
Hepatitis D Virus (HDV) Diagnostics: Niche but critical segment, as HDV requires HBV co-infection. Testing is underutilized but growing.
By End-User:
-
Hospital & Clinical Laboratories: Core users for comprehensive diagnostic workups, including molecular testing and fibrosis assessment.
-
Diagnostic & Reference Laboratories: High-volume testing centers for screening and specialized assays.
-
Blood Banks & Blood Donation Centers: Mandatory screening of all donated blood for HBV, HCV, and HIV using highly sensitive serology and NAT.
-
Public Health Laboratories & Outreach Programs: Utilize POC/RDTs for mass screening campaigns.
-
Academic & Research Institutes: For epidemiological studies and clinical trials.
2. Key Players
The market is dominated by global in vitro diagnostics (IVD) giants.
Leading Companies:
-
Abbott Laboratories
-
F. Hoffmann-La Roche Ltd. (Cobas® systems for serology and molecular testing)
-
Siemens Healthineers AG
-
Danaher Corporation (Via Beckman Coulter, Cepheid)
-
Bio-Rad Laboratories, Inc.
-
Grifols, S.A. (Blood screening)
-
Qiagen N.V. (Sample prep and PCR technologies)
-
Hologic, Inc. (Via its Panther® system for molecular testing)
-
DiaSorin S.p.A. (Leader in immunodiagnostics)
-
Ortho Clinical Diagnostics (A part of QuidelOrtho)
-
bioMérieux SA (Via its VIDAS® immunoassay systems)
-
Sysmex Corporation
-
Becton, Dickinson and Company (BD) (Specimen collection, microbiology)
-
Meridian Bioscience, Inc.
-
Chembio Diagnostic Systems, Inc. (Specialized in POC RDTs)
