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Hepatitis Test Solution/Diagnosis Market - Global Forecast 2025-2032

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    Report

  • 198 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 4904514
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The hepatitis test solution/diagnosis market is undergoing significant advancement as diagnostic technologies expand, regulatory landscapes shift, and care settings diversify. For senior decision-makers, understanding these evolving market dynamics is essential for staying competitive and ensuring operational resilience.

Market Snapshot: Hepatitis Test Solution/Diagnosis Market

The hepatitis test solution/diagnosis market grew from USD 3.71 billion in 2024 to USD 3.92 billion in 2025, with further expansion forecasted at a CAGR of 5.71% to reach USD 5.79 billion by 2032. This growth reflects the combined impact of new molecular and diagnostic innovations, the transition to more decentralized screening models, and proactive supply chain realignment strategies. Stakeholders are capitalizing on these dynamics to respond to emerging needs in both high-resource and resource-limited regions, reinforcing the sector’s long-term sustainability.

Scope & Segmentation

  • Technology: The market covers chromatography technologies such as fluorescence immunoassays and high-performance liquid chromatography, along with immunoassays including chemiluminescent immunoassays, enzyme-linked immunosorbent assays, and rapid immunoassays. Molecular diagnostics span isothermal amplification, PCR, and real-time PCR platforms, reflecting the growing adoption of genetic and molecular approaches.
  • Product Type: Segmented by instruments (bench-top and high-throughput systems), it also includes a range of kits and reagents (chromatography, immunoassay, and molecular assay kits) as well as specialized software and service offerings relevant for deploying and maintaining testing capabilities.
  • End User: Key customer segments are blood banks, clinics, diagnostic laboratories (hospital-based and independent), home care settings, and hospitals (general and specialized), each representing different adoption patterns and care delivery needs.
  • Test Type: Encompasses confirmatory tests such as ELISA and PCR confirmatory assays, as well as screening tests utilized in clinical and public health contexts to support early detection and patient management.
  • Application: Covers clinical diagnostics for hepatitis identification and management, as well as research-oriented applications supporting innovation and therapeutic development.
  • Geography: Analysis includes the Americas (United States, Canada, Mexico, Brazil, Argentina, Chile, Colombia, Peru), Europe, Middle East & Africa (including United Kingdom, Germany, France, Russia, Italy, Spain, Netherlands, Sweden, Poland, Switzerland, United Arab Emirates, Saudi Arabia, Qatar, Turkey, Israel, South Africa, Nigeria, Egypt, Kenya), and Asia-Pacific (China, India, Japan, Australia, South Korea, Indonesia, Thailand, Malaysia, Singapore, Taiwan), highlighting diverse market trends and expansion drivers.
  • Company Coverage: Leading participants include Abbott Laboratories, AbbVie Inc., Avantor Inc., Beckman Coulter, Inc., Bio-Rad Laboratories Inc., bioMérieux SA, Cepheid, Creative Diagnostics, DiaSorin S.p.A., Epitope Diagnostics, Inc., Everlywell, Inc., F. Hoffmann-La Roche AG, FUJIREBIO Inc., GenMark Diagnostics, Inc., Grifols S.A., Hologic, Inc., Laboratory Corporation of America Holdings, MedMira Inc., Merck & Co., Inc, Meridian Bioscience, Inc.

Key Takeaways: Strategic Insights for the Hepatitis Test Solution/Diagnosis Market

  • Rapid immunoassays and advanced molecular platforms provide real-time monitoring and broaden access across both centralized hospitals and remote healthcare environments, supporting responsive disease management.
  • Point-of-care and self-testing technologies are becoming more prevalent, facilitating greater diagnostic flexibility and enabling home-based testing, especially relevant for under-resourced or remote regions.
  • The integration of machine learning algorithms holds promise for more personalized diagnosis and care through refined genotype analysis and predictive resistance profiling, adding value for providers seeking precision healthcare solutions.
  • Coordinated regulatory frameworks and enhanced public-private cooperation are streamlining the approval process for new diagnostic assays and enabling more rapid market deployment of advanced technologies.
  • Distinct regional strategies are evident: the Americas emphasize robust laboratory infrastructure and digital system integration, while Asia-Pacific markets experience rising growth fuelled by economic development, public health screening initiatives, and regional manufacturing investments.
  • Service models offering bundled solutions—such as fixed-fee maintenance and reagent agreements—are helping laboratories and hospitals manage costs and support consistent diagnostic service delivery.

Tariff Impact: Supply Chain and Affordability Trends

United States tariff policies instituted in 2025 have led to increased manufacturing costs for imported hepatitis testing products, particularly reagents, kits, and instruments. Market participants are responding by diversifying their supplier networks and establishing local production arrangements. These adaptations are designed to manage procurement risks, contain price volatility, and encourage investment in domestic manufacturing—all of which are crucial for ensuring steady supply of precision diagnostic components.

Methodology & Data Sources

This report is based on structured interviews with industry stakeholders for primary data, as well as a comprehensive review of peer-reviewed journals, regulatory records, and respected market databases. Insights have been strengthened through data triangulation and expert validation workshops, ensuring an accurate and multidimensional perspective on the hepatitis test solution/diagnosis market.

Why This Report Matters for Decision Makers

  • Delivers actionable guidance on technology adoption, market trends, and segmentation, enabling leaders to make informed strategic decisions.
  • Enhances procurement planning by analyzing supply chain risks and regulatory shifts, supporting judicious investment and vendor selection.
  • Equips executives with in-depth intelligence for aligning diagnostic offerings to current and emerging clinical needs across diverse global markets.

Conclusion

Successfully navigating the hepatitis test solution/diagnosis market requires forward-thinking strategies and the capacity to adapt to technological, regulatory, and operational shifts. Informed stakeholders are best positioned to advance care delivery and optimize market opportunities.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Integration of point-of-care NAT testing devices with cloud-based patient data management platforms for hepatitis diagnosis
5.2. Adoption of multiplexed rapid diagnostic test panels enabling simultaneous detection of hepatitis B, C and E antigens in resource-limited settings
5.3. Development of digital immunoassay platforms leveraging smartphone readouts for quantitative monitoring of hepatitis B surface antigen levels
5.4. Growing use of CRISPR-based molecular diagnostics for ultra-sensitive detection of hepatitis C viral RNA at the point of care
5.5. Rising investments in microfluidic lab-on-a-chip devices for portable, low-cost hepatitis serological testing in rural clinics
5.6. Expansion of hepatitis screening initiatives through at-home self-collection kits with telehealth integration for underserved populations
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Hepatitis Test Solution/Diagnosis Market, by Technology
8.1. Chromatography
8.1.1. Fia
8.1.2. Hplc
8.2. Immunoassay
8.2.1. Chemiluminescent Immunoassays
8.2.2. Elisa
8.2.3. Rapid Immunoassays
8.3. Molecular Diagnostics
8.3.1. Isothermal Amplification
8.3.2. Pcr
8.3.3. Real-Time Pcr
9. Hepatitis Test Solution/Diagnosis Market, by Product Type
9.1. Instruments
9.1.1. Bench-Top Instruments
9.1.2. High-Throughput Instruments
9.2. Kits & Reagents
9.2.1. Chromatography Kits
9.2.2. Immunoassay Kits
9.2.3. Molecular Assay Kits
9.3. Software & Services
10. Hepatitis Test Solution/Diagnosis Market, by End User
10.1. Blood Banks
10.2. Clinics
10.3. Diagnostic Laboratories
10.3.1. Hospital-Based Laboratories
10.3.2. Independent Laboratories
10.4. Home Care Settings
10.5. Hospitals
10.5.1. General Hospitals
10.5.2. Specialized Hospitals
11. Hepatitis Test Solution/Diagnosis Market, by Test Type
11.1. Confirmatory Tests
11.1.1. Elisa Confirmatory
11.1.2. Pcr Confirmatory
11.2. Screening Tests
12. Hepatitis Test Solution/Diagnosis Market, by Application
12.1. Clinical Diagnostics
12.2. Research
13. Hepatitis Test Solution/Diagnosis Market, by Region
13.1. Americas
13.1.1. North America
13.1.2. Latin America
13.2. Europe, Middle East & Africa
13.2.1. Europe
13.2.2. Middle East
13.2.3. Africa
13.3. Asia-Pacific
14. Hepatitis Test Solution/Diagnosis Market, by Group
14.1. ASEAN
14.2. GCC
14.3. European Union
14.4. BRICS
14.5. G7
14.6. NATO
15. Hepatitis Test Solution/Diagnosis Market, by Country
15.1. United States
15.2. Canada
15.3. Mexico
15.4. Brazil
15.5. United Kingdom
15.6. Germany
15.7. France
15.8. Russia
15.9. Italy
15.10. Spain
15.11. China
15.12. India
15.13. Japan
15.14. Australia
15.15. South Korea
16. Competitive Landscape
16.1. Market Share Analysis, 2024
16.2. FPNV Positioning Matrix, 2024
16.3. Competitive Analysis
16.3.1. Abbott Laboratories
16.3.2. AbbVie Inc.
16.3.3. Avantor Inc.
16.3.4. Beckman Coulter, Inc.
16.3.5. Bio-Rad Laboratories Inc.
16.3.6. bioMérieux SA
16.3.7. Cepheid
16.3.8. Creative Diagnostics
16.3.9. DiaSorin S.p.A.
16.3.10. Epitope Diagnostics, Inc.
16.3.11. Everlywell, Inc.
16.3.12. F. Hoffmann-La Roche AG
16.3.13. FUJIREBIO Inc.
16.3.14. GenMark Diagnostics, Inc.
16.3.15. Grifols S.A.
16.3.16. Hologic, Inc.
16.3.17. Laboratory Corporation of America Holdings
16.3.18. MedMira Inc.
16.3.19. Merck & Co., Inc
16.3.20. Meridian Bioscience, Inc.
List of Tables
List of Figures

Samples

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Companies Mentioned

The key companies profiled in this Hepatitis Test Solution/Diagnosis market report include:
  • Abbott Laboratories
  • AbbVie Inc.
  • Avantor Inc.
  • Beckman Coulter, Inc.
  • Bio-Rad Laboratories Inc.
  • bioMérieux SA
  • Cepheid
  • Creative Diagnostics
  • DiaSorin S.p.A.
  • Epitope Diagnostics, Inc.
  • Everlywell, Inc.
  • F. Hoffmann-La Roche AG
  • FUJIREBIO Inc.
  • GenMark Diagnostics, Inc.
  • Grifols S.A.
  • Hologic, Inc.
  • Laboratory Corporation of America Holdings
  • MedMira Inc.
  • Merck & Co., Inc
  • Meridian Bioscience, Inc.

Table Information