HBsAg 검사 시장 : 규모, 점유율, 성장, 업계 분석, 유형별, 용도별, 지역별 인사이트, 예측(2026-2034년)

Growth Factors of HBsAg testing Market

The global HBsAg testing market was valued at USD 1.44 billion in 2025 and is projected to grow to USD 1.53 billion in 2026, reaching USD 2.44 billion by 2034, exhibiting a CAGR of 6.07% during 2026-2034. North America dominated the market with a 38.89% share in 2025, supported by advanced diagnostic infrastructure and strong screening initiatives.

HBsAg (Hepatitis B Surface Antigen) testing plays a critical role in diagnosing hepatitis B infection by detecting viral antigens in the bloodstream. The growing global burden of hepatitis B, along with rising awareness and screening programs, is significantly boosting market demand.

Market Drivers

Rising Burden of Hepatitis B

The increasing prevalence of hepatitis B is a major factor driving demand for HBsAg testing. According to global health estimates, millions of people continue to live with chronic hepatitis B infections, creating a strong need for early diagnosis and monitoring. Increased transmission risks in healthcare settings and developing regions further accelerate testing demand.

Government Initiatives & Screening Programs

Governments and health organizations are actively promoting hepatitis B screening. Guidelines recommending routine testing-especially among pregnant women and adults-are increasing the number of tests conducted annually. Global elimination programs targeting hepatitis B by 2030 are further strengthening market growth.

Market Trends

Growing Adoption of Advanced Diagnostic Technologies

There is a rising demand for advanced testing techniques such as chemiluminescence immunoassays and rapid diagnostic tests. These technologies offer higher sensitivity, faster results, and improved efficiency, making them preferable in both laboratory and point-of-care settings.

Expansion of Point-of-Care Testing

The market is witnessing a shift toward point-of-care (POC) testing, enabling faster diagnosis in remote and low-resource settings. Additionally, digital health integration and home-based testing solutions are gaining traction, improving accessibility and convenience.

Market Restraints

Accuracy Limitations and False Results

HBsAg tests may sometimes produce false positives or false negatives due to sensitivity limitations or environmental conditions. These inaccuracies can affect diagnosis reliability and hinder widespread adoption.

Availability of Alternative Tests

The presence of alternative diagnostic methods such as anti-HBs and IgM anti-HBc tests may reduce reliance on HBsAg testing, thereby restraining market growth.

Market Opportunities

Increasing R&D for Innovative Testing Solutions

Market players and research institutions are investing heavily in developing advanced diagnostic tools, including self-testing kits and rapid assays. These innovations aim to improve early detection and expand testing accessibility globally.

Expansion in Emerging Markets

Developing regions present significant growth opportunities due to rising awareness, improving healthcare infrastructure, and increasing government initiatives for disease control.

Segmentation Analysis

By Type

The qualitative segment dominated the market with a 93.6% share in 2026, driven by its widespread use in initial screening and diagnosis. The quantitative segment is expected to grow steadily due to increasing chronic disease monitoring.

By Technique

The chemiluminescence immunoassay segment led with a 48.28% share in 2026, owing to its high sensitivity and efficiency. ELISA remains a strong alternative due to cost-effectiveness.

By Setting

The laboratory-based segment dominated with a 97.24% share in 2026, supported by the increasing number of diagnostic laboratories. However, point-of-care testing is expected to grow at a faster rate.

By Sample Type

The blood sample segment held 91.62% share in 2026, as blood testing remains the standard for hepatitis B diagnosis.

By End-user

Clinical laboratories led the market due to high testing volumes, while hospitals and clinics are expected to grow steadily.

Regional Insights

• North America: Valued at USD 0.56 billion in 2025 and USD 0.59 billion in 2026, driven by strong healthcare systems and government funding.
• Europe: Reached USD 0.45 billion in 2025 and USD 0.47 billion in 2026, supported by increasing screening programs.
• Asia Pacific: Valued at USD 0.17 billion in 2025 and USD 0.19 billion in 2026, expected to grow fastest due to high disease prevalence in countries like China and India.
• Latin America & Middle East & Africa: Showing steady growth due to improving healthcare access and awareness initiatives.

Competitive Landscape

Key players such as Siemens Healthineers AG, F. Hoffmann-La Roche Ltd., and Abbott dominate the market. These companies focus on partnerships, acquisitions, and product innovation to strengthen their market position. Emerging players are also investing in rapid diagnostic technologies to expand their presence.

Conclusion

The HBsAg testing market is set for steady growth, increasing from USD 1.44 billion in 2025 to USD 2.44 billion by 2034, driven by the rising global burden of hepatitis B and strong government screening initiatives. Technological advancements, particularly in rapid and point-of-care testing, are reshaping the diagnostic landscape. However, challenges such as test inaccuracies and limited access in low-resource regions persist. Overall, with continuous innovation, expanding healthcare infrastructure, and global disease elimination efforts, the market is expected to witness sustained growth throughout the forecast period.

Segmentation By Type

• Qualitative
• Quantitative

By Technique

• Enzyme-linked immunosorbent Assay
• Chemiluminescence Immunoassay
• Chromatographic Immunoassay

By Setting

• Point of Care
• Laboratory-based

By Sample Type

• Blood
• Plasma
• Others

By End-user

• Hospitals & Clinics
• Clinical Laboratories
• Others

By Region

• North America (By Type, Technique, Setting, Sample Type, End-user, and Country)
  • U.S.
  • Canada
• Europe (By Type, Technique, Setting, Sample Type, End-user, and Country/Sub-region)
  • U.K.
  • Germany
  • France
  • Spain
  • Italy
  • Sweden
  • Scandinavia
  • Rest of Europe
• Asia Pacific (By Type, Technique, Setting, Sample Type, End-user, and Country/Sub-region)
  • Japan
  • China
  • Australia
  • India
  • New Zealand
  • Taiwan
  • South Korea
  • Singapore
  • Hong Kong
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America (By Type, Technique, Setting, Sample Type, End-user, and Country/Sub-region)
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa (By Type, Technique, Setting, Sample Type, End-user, and Country/Sub-region)
  • South Africa
  • GCC
  • Rest of the Middle East & Africa

Table of Content

1. Introduction

• 1.1. Research Scope
• 1.2. Market Segmentation
• 1.3. Research Methodology
• 1.4. Definitions and Assumptions

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Market Trends

4. Key Insights

• 4.1. Incidence of Hepatitis B - by Key Countries, 2025
• 4.2. Pricing Analysis - By Key Countries, 2025
• 4.3. New Product Launches - by Key Players
• 4.4. Key Industry Development (Mergers, Acquisitions, and Partnerships)
• 4.5. Impact of COVID-19 on the Market

5. Global HBsAg Testing Market Analysis, Insights and Forecast, 2021-2034

• 5.1. Market Analysis, Insights and Forecast - By Type
  • 5.1.1. Qualitative
  • 5.1.2. Quantitative
• 5.2. Market Analysis, Insights and Forecast - By Technique
  • 5.2.1. Chromatographic Immunoassay
  • 5.2.2. Chemiluminescence Immunoassay
  • 5.2.3. Enzyme-linked Immunosorbent Assay (ELISA)
• 5.3. Market Analysis, Insights and Forecast - By Setting
  • 5.3.1. Point of Care
  • 5.3.2. Laboratory-based
• 5.4. Market Analysis, Insights and Forecast - By Sample Type
  • 5.4.1. Blood
  • 5.4.2. Plasma
  • 5.4.3. Others
• 5.5. Market Analysis, Insights and Forecast - By End-user
  • 5.5.1. Hospitals & Clinics
  • 5.5.2. Clinical Laboratories
  • 5.5.3. Others
• 5.6. Market Analysis, Insights and Forecast - Region
  • 5.6.1. North America
  • 5.6.2. Europe
  • 5.6.3. Asia Pacific
  • 5.6.4. Latin America
  • 5.6.5. Middle East & Africa

6. North America HBsAg Testing Market Analysis, Insights and Forecast, 2021-2034

• 6.1. Market Analysis, Insights and Forecast - By Type
  • 6.1.1. Qualitative
  • 6.1.2. Quantitative
• 6.2. Market Analysis, Insights and Forecast - By Technique
  • 6.2.1. Chromatographic Immunoassay
  • 6.2.2. Chemiluminescence Immunoassay
  • 6.2.3. Enzyme-linked Immunosorbent Assay (ELISA)
• 6.3. Market Analysis, Insights and Forecast - By Setting
  • 6.3.1. Point of Care
  • 6.3.2. Laboratory-based
• 6.4. Market Analysis, Insights and Forecast - By Sample Type
  • 6.4.1. Blood
  • 6.4.2. Plasma
  • 6.4.3. Others
• 6.5. Market Analysis, Insights and Forecast - By End-user
  • 6.5.1. Hospitals & Clinics
  • 6.5.2. Clinical Laboratories
  • 6.5.3. Others
• 6.6. Market Analysis, Insights and Forecast - By Country
  • 6.6.1. U.S.
  • 6.6.2. Canada

7. Europe HBsAg Testing Market Analysis, Insights and Forecast, 2021-2034

• 7.1. Market Analysis, Insights and Forecast - By Type
  • 7.1.1. Qualitative
  • 7.1.2. Quantitative
• 7.2. Market Analysis, Insights and Forecast - By Technique
  • 7.2.1. Chromatographic Immunoassay
  • 7.2.2. Chemiluminescence Immunoassay
  • 7.2.3. Enzyme-linked Immunosorbent Assay (ELISA)
• 7.3. Market Analysis, Insights and Forecast - By Setting
  • 7.3.1. Point of Care
  • 7.3.2. Laboratory-based
• 7.4. Market Analysis, Insights and Forecast - By Sample Type
  • 7.4.1. Blood
  • 7.4.2. Plasma
  • 7.4.3. Others
• 7.5. Market Analysis, Insights and Forecast - By End-user
  • 7.5.1. Hospitals & Clinics
  • 7.5.2. Clinical Laboratories
  • 7.5.3. Others
• 7.6. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 7.6.1. U.K.
  • 7.6.2. Germany
  • 7.6.3. France
  • 7.6.4. Italy
  • 7.6.5. Spain
  • 7.6.6. Sweden
  • 7.6.7. Scandinavia
  • 7.6.8. Rest of Europe

8. Asia Pacific HBsAg Testing Market Analysis, Insights and Forecast, 2021-2034

• 8.1. Market Analysis, Insights and Forecast - By Type
  • 8.1.1. Qualitative
  • 8.1.2. Quantitative
• 8.2. Market Analysis, Insights and Forecast - By Technique
  • 8.2.1. Chromatographic Immunoassay
  • 8.2.2. Chemiluminescence Immunoassay
  • 8.2.3. Enzyme-linked Immunosorbent Assay (ELISA)
• 8.3. Market Analysis, Insights and Forecast - By Setting
  • 8.3.1. Point of Care
  • 8.3.2. Laboratory-based
• 8.4. Market Analysis, Insights and Forecast - By Sample Type
  • 8.4.1. Blood
  • 8.4.2. Plasma
  • 8.4.3. Others
• 8.5. Market Analysis, Insights and Forecast - By End-user
  • 8.5.1. Hospitals & Clinics
  • 8.5.2. Clinical Laboratories
  • 8.5.3. Others
• 8.6. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 8.6.1. Japan
  • 8.6.2. China
  • 8.6.3. India
  • 8.6.4. Australia
  • 8.6.5. New Zealand
  • 8.6.6. Taiwan
  • 8.6.7. South Korea
  • 8.6.8. Singapore
  • 8.6.9. Hong Kong
  • 8.6.10. Southeast Asia
  • 8.6.11. Rest of Asia Pacific

9. Latin America HBsAg Testing Market Analysis, Insights and Forecast, 2021-2034

• 9.1. Market Analysis, Insights and Forecast - By Type
  • 9.1.1. Qualitative
  • 9.1.2. Quantitative
• 9.2. Market Analysis, Insights and Forecast - By Technique
  • 9.2.1. Chromatographic Immunoassay
  • 9.2.2. Chemiluminescence Immunoassay
  • 9.2.3. Enzyme-linked Immunosorbent Assay (ELISA)
• 9.3. Market Analysis, Insights and Forecast - By Setting
  • 9.3.1. Point of Care
  • 9.3.2. Laboratory-based
• 9.4. Market Analysis, Insights and Forecast - By Sample Type
  • 9.4.1. Blood
  • 9.4.2. Plasma
  • 9.4.3. Others
• 9.5. Market Analysis, Insights and Forecast - By End-user
  • 9.5.1. Hospitals & Clinics
  • 9.5.2. Clinical Laboratories
  • 9.5.3. Others
• 9.6. Market Analysis, Insights and Forecast - By Country/Sub-region
  • 9.6.1. Brazil
  • 9.6.2. Mexico
  • 9.6.3. Rest of Latin America

10. Middle East & Africa HBsAg Testing Market Analysis, Insights and Forecast, 2021-2034

• 10.1. Market Analysis, Insights and Forecast - By Type
  • 10.1.1. Qualitative
  • 10.1.2. Quantitative
• 10.2. Market Analysis, Insights and Forecast - By Technique
  • 10.2.1. Chromatographic Immunoassay
  • 10.2.2. Chemiluminescence Immunoassay
  • 10.2.3. Enzyme-linked Immunosorbent Assay (ELISA)
• 10.3. Market Analysis, Insights and Forecast - By Setting
  • 10.3.1. Point of Care
  • 10.3.2. Laboratory-based
• 10.4. Market Analysis, Insights and Forecast - By Sample Type
  • 10.4.1. Blood
  • 10.4.2. Plasma
  • 10.4.3. Others
• 10.5. Market Analysis, Insights and Forecast - By End-user
  • 10.5.1. Hospitals & Clinics
  • 10.5.2. Clinical Laboratories
  • 10.5.3. Others
• 10.6. Market Analysis, Insights and Forecast - By Country/Sub-region
  • 10.6.1. South Africa
  • 10.6.2. GCC
  • 10.6.3. Rest of Middle East & Africa

11. Competitive Analysis

• 11.1. Global Market Share Analysis (2025)
• 11.2. Company Profiles
  • 11.2.1. CTK Biotech, Inc.
    • 11.2.1.1. Overview
    • 11.2.1.2. Products
    • 11.2.1.3. SWOT Analysis
    • 11.2.1.4. Recent Developments
    • 11.2.1.5. Strategies
    • 11.2.1.6. Financials (Based on Availability)
  • 11.2.2. Biopanda Reagents Ltd
    • 11.2.2.1. Overview
    • 11.2.2.2. Products
    • 11.2.2.3. SWOT Analysis
    • 11.2.2.4. Recent Developments
    • 11.2.2.5. Strategies
    • 11.2.2.6. Financials (Based on Availability)
  • 11.2.3. Avecon Healthcare Pvt. Ltd.
    • 11.2.3.1. Overview
    • 11.2.3.2. Products
    • 11.2.3.3. SWOT Analysis
    • 11.2.3.4. Recent Developments
    • 11.2.3.5. Strategies
    • 11.2.3.6. Financials (Based on Availability)
  • 11.2.4. Abbott
    • 11.2.4.1. Overview
    • 11.2.4.2. Products
    • 11.2.4.3. SWOT Analysis
    • 11.2.4.4. Recent Developments
    • 11.2.4.5. Strategies
    • 11.2.4.6. Financials (Based on Availability)
  • 11.2.5. Bio-Rad Laboratories, Inc.
    • 11.2.5.1. Overview
    • 11.2.5.2. Products
    • 11.2.5.3. SWOT Analysis
    • 11.2.5.4. Recent Developments
    • 11.2.5.5. Strategies
    • 11.2.5.6. Financials (Based on Availability)
  • 11.2.6. Siemens Healthcare Private Limited
    • 11.2.6.1. Overview
    • 11.2.6.2. Products
    • 11.2.6.3. SWOT Analysis
    • 11.2.6.4. Recent Developments
    • 11.2.6.5. Strategies
    • 11.2.6.6. Financials (Based on Availability)
  • 11.2.7. F. Hoffmann-La Roche Ltd
    • 11.2.7.1. Overview
    • 11.2.7.2. Products
    • 11.2.7.3. SWOT Analysis
    • 11.2.7.4. Recent Developments
    • 11.2.7.5. Strategies
    • 11.2.7.6. Financials (Based on Availability)
  • 11.2.8. Elabscience Bionovation Inc.
    • 11.2.8.1. Overview
    • 11.2.8.2. Products
    • 11.2.8.3. SWOT Analysis
    • 11.2.8.4. Recent Developments
    • 11.2.8.5. Strategies
    • 11.2.8.6. Financials (Based on Availability)