간염 진단 검사 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, hepatitis diagnostic test market size in 2026 is estimated at USD 4.98 billion, growing from 2025 value of USD 4.73 billion with 2031 projections showing USD 6.46 billion, growing at 5.32% CAGR over 2026-2031.

This report is Segmented by Product Type (Reagents & Kits and More), Disease Type (Hepatitis B and More), Technology (Serology Tests and More), Sample Type (Blood and More), Test Setting (Hospital Laboratories and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Hepatitis Diagnostic Test Market Trends and Insights

Escalating Global HBV & HCV Prevalence

More than 254 million people live with chronic hepatitis B and 50 million with hepatitis C, with Asia-Pacific bearing 75% of chronic HBV cases. Rising incidence keeps diagnostic demand high, particularly in China where new HCV infections are projected to reach 17.92 per 100,000 by 2030. Regional disparities linger-southern Korea still reports elevated HCV prevalence despite national declines. Uncommon genotypes such as HCV 1c dominate among chronic kidney-disease patients in West Bengal, India, underscoring the need for robust genotyping. Combined, these patterns ensure a sustained base of at-risk patients requiring accurate and repeat testing.

Migration from Serology to High-Sensitivity Molecular Platforms

Targeted next-generation sequencing (NGS) now detects hepatitis viruses, even in extrahepatic tissue, where classical assays fail. High-throughput sequencing also tracks resistance-associated variants such as A1343V in hepatitis E during treatment. Artificial intelligence tools enable high-accuracy liver disease diagnosis with faster turnaround times and lower costs. Regulatory support accelerates adoption: the FDA reclassified HBV assays from Class III to Class II, streamlining the 510(k) pathway. As platforms migrate to clinics and community settings, the hepatitis diagnostic test market experiences a notable increase.

High Per-Test Cost of Molecular Assays in Low-Income Settings

Surveys across 23 low- and middle-income countries confirm that many programs still limit hepatitis testing to blood donors because virological assays remain unaffordable. Complex confirmation algorithms push per-patient costs well beyond those of single-step serology. Product developers face an innovation-to-access gap, as environmental factors and regulatory fragmentation raise validation expenses. Until tiered pricing, pooled procurement or subsidy models expand, penetration of advanced platforms will lag in high-burden but cash-strapped markets.

Other drivers and restraints analyzed in the detailed report include:

1. Government-Funded Screening & Vaccination Programs
2. Emergence of Microfluidic Point-of-Care Viral-Load Analyzers
3. Weak Cold-Chain Logistics for Sample Transport in Remote Areas

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Reagents and kits generated the largest slice of the hepatitis diagnostic test market size in 2025 with 62.05% revenue, underscoring the recurrent-consumables model that underpins laboratory workflows. Instruments benefited from miniaturization trends such as palm-sized elastography, yet capital budgets remained cyclical. Software and services, though still a smaller base, are on track for a 6.21% CAGR to 2031 as laboratories embed AI engines that streamline interpretation and automate reporting. Vendors that link cloud-based analytics to their reagent franchises lock-in customers while creating incremental subscription income.

The reagents segment faces mounting price transparency and generics, but demand persists through continuous innovation in lyophilized molecular master mixes and multiplex point-of-care kits. Instrument vendors increasingly bundle connectivity and decision-support dashboards, transforming once-stand-alone analyzers into networked devices. BioMerieux's January 2025 purchase of SpinChip Diagnostics for EUR 111 million illustrates the race to secure ultra-fast sample-to-answer platforms that fit primary-care settings. As software layers expand, service models shift toward outcome-based contracts, giving the hepatitis diagnostic test market a new revenue vector tied to digital performance.

Hepatitis B dominated 2025 revenue with a 48.40% of the hepatitis diagnostic test market share in 2025, mirroring its 254 million-patient prevalence. Testing panels remain complex-pregnant women require HBsAg, anti-HBc and anti-HBs screening every pregnancy under CDC guidance. Hepatitis C volumes are scaling quickly as elimination programs simplify algorithms; the Cepheid finger-stick RNA test enables single-visit diagnosis in primary care. "Other hepatitis" (A, E, D) is the fastest-growing group at 6.33% CAGR, propelled by increasing HAV and HEV outbreaks and new sequencing data confirming wider geographic spread.

Emerging data link specific HAV genotype IIIA and HEV-1 strains to more severe outcomes, pressuring hospitals to upgrade to molecular assays and genotyping. In parallel, hepatitis C elimination funding in the U.S. supports universal screening, driving consistent reagent pull-through. As novel therapies for hepatitis D roll out, demand for HDV reflex testing is likely to rise. This mix of chronic HBV burden, HCV elimination acceleration and broader recognition of other viral hepatitides secures long-term breadth for the hepatitis diagnostic test market.

Complete Report Scope:

• By Product Type
  • Reagents & Kits
  • Instruments & Analyzers
  • Software & Services
• By Disease Type
  • Hepatitis B
  • Hepatitis C
  • Other Hepatitis
• By Technology
  • Serology Tests
  • Rapid Diagnostic Tests
  • Molecular Tests
  • Next-Gen Sequencing Panels
• By Sample Type
  • Blood
  • Saliva / Oral Fluid
  • Urine
• By Test Setting
  • Hospital Laboratories
  • Reference Laboratories
  • Blood Banks
  • Point-of-Care / Physician Offices
  • Home Testing & Self-Collection
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 39.88% of the global hepatitis diagnostic test market share in 2025 due to structured government screening and early adoption of molecular platforms. U.S. policy momentum, including the proposed USD 12.3 billion hepatitis C elimination budget, ensures a steady 4.84% CAGR for the regional hepatitis diagnostic test market. FDA approvals, such as Cepheid's HCV point-of-care RNA test, accelerate decentralized uptake. Laboratory networks integrate AI-enhanced interpretation pathways like iLFT to boost chronic liver-disease detection, demonstrating a mature ecosystem that rapidly scales innovation.

Europe posts a 5.17% CAGR as harmonized regulations and robust clinical guidelines sustain investment. EASL's updated hepatitis B management protocol mandates advanced diagnostics, reinforcing demand for molecular panels. Roche's 18-minute Elecsys PRO-C3 fibrosis test exemplifies the region's appetite for rapid, non-invasive tools. Yet, care gaps remain, with only 70% of Spanish hospitals performing reflex tests for HBV and under 50% for HDV, spotlighting workflow opportunities. Innovation in wearable ultrasound monitoring further differentiates European offerings.

Asia-Pacific is the fastest-expanding territory at 6.23% CAGR to 2031, fueled by its disproportionate hepatitis burden and rising healthcare investment. China, Japan, and South Korea host half of all chronic HBV patients, creating unparalleled testing demand. China's HCV incidence is projected to reach 17.92 per 100,000 by 2030, urging an upgrade to high-throughput diagnostics. Japan's reimbursement for the Enhanced Liver Fibrosis score underscores policy support for advanced tools. Sophisticated genotyping needs are rising in India due to uncommon subtypes like HCV 1c. Regulatory collaboration across ASEAN and East-Asia regulators is improving device approval timelines, fostering broader market access.

1. Abbott Laboratories
2. Avantor
3. Beckton Dickinson
4. bioMerieux
5. Bio-Rad Laboratories
6. Danaher
7. DiaSorin
8. Roche
9. Fujirebio Inc.
10. Grifols
11. Helena Laboratories
12. Hologic
13. Orasure Technologies
14. Ortho Clinical Diagnostics
15. QIAGEN
16. Revvity Inc.
17. Siemens Healthineers
18. Sysmex
19. Thermo Fisher Scientific
20. Trinity Biotech plc

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Escalating Global HBV & HCV Prevalence
  • 4.2.2 Rapid Migration from Serology to High-Sensitivity Molecular Platforms
  • 4.2.3 Expansion of Government-Funded Screening & Vaccination Programs
  • 4.2.4 Emergence of Microfluidic POC Viral-Load Analyzers
  • 4.2.5 AI-Assisted Elastography Improving Non-Invasive Liver Assessment
  • 4.2.6 Adoption of Self-Collection Dried-Blood-Spot Kits for Remote Testing
• 4.3 Market Restraints
  • 4.3.1 High Per-Test Cost of Molecular Assays in Low-Income Settings
  • 4.3.2 Regulatory Ambiguity Around Direct-To-Consumer Viral-Load Kits
  • 4.3.3 Undetected Occult Infections Causing False-Negatives in Immunocompromised Patients
  • 4.3.4 Weak Cold-Chain Logistics for Sample Transport in Remote Areas
• 4.4 Supply Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value)

• 5.1 By Product Type
  • 5.1.1 Reagents & Kits
  • 5.1.2 Instruments & Analyzers
  • 5.1.3 Software & Services
• 5.2 By Disease Type
  • 5.2.1 Hepatitis B
  • 5.2.2 Hepatitis C
  • 5.2.3 Other Hepatitis
• 5.3 By Technology
  • 5.3.1 Serology Tests
  • 5.3.2 Rapid Diagnostic Tests
  • 5.3.3 Molecular Tests
  • 5.3.4 Next-Gen Sequencing Panels
• 5.4 By Sample Type
  • 5.4.1 Blood
  • 5.4.2 Saliva / Oral Fluid
  • 5.4.3 Urine
• 5.5 By Test Setting
  • 5.5.1 Hospital Laboratories
  • 5.5.2 Reference Laboratories
  • 5.5.3 Blood Banks
  • 5.5.4 Point-of-Care / Physician Offices
  • 5.5.5 Home Testing & Self-Collection
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Competitive Benchmarking
• 6.3 Market Share Analysis
• 6.4 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.4.1 Abbott Laboratories
  • 6.4.2 Avantor, Inc.
  • 6.4.3 Becton Dickinson and Company
  • 6.4.4 bioMerieux SA
  • 6.4.5 Bio-Rad Laboratories
  • 6.4.6 Danaher Corporation
  • 6.4.7 DiaSorin SpA
  • 6.4.8 F. Hoffmann-La Roche AG
  • 6.4.9 Fujirebio Inc.
  • 6.4.10 Grifols, S.A.
  • 6.4.11 Helena Laboratories Corporation
  • 6.4.12 Hologic Inc.
  • 6.4.13 OraSure Technologies Inc.
  • 6.4.14 Ortho Clinical Diagnostics
  • 6.4.15 QIAGEN N.V.
  • 6.4.16 Revvity Inc.
  • 6.4.17 Siemens Healthineers
  • 6.4.18 Sysmex Corporation
  • 6.4.19 Thermo Fisher Scientific, Inc.
  • 6.4.20 Trinity Biotech plc

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment