혈청학적 검사 시장 - 예측(2026-2031년)

The serological testing market is expected to grow at a 6.11% CAGR, achieving USD 8.727 billion in 2031 from USD 6.114 billion in 2025.

The serological testing market is a critical component of modern diagnostic medicine, providing essential insights into immune response through the analysis of blood samples for specific antibodies, antigens, and other immunological markers. These tests are indispensable for a wide range of applications, including the diagnosis of infectious diseases, assessment of immune status (post-vaccination or post-infection), autoimmune disease detection, and monitoring of chronic conditions. The industry serves a broad network of end-users, primarily hospitals, clinical laboratories, blood banks, and public health agencies, all of which rely on the accuracy and reliability of serological assays for patient management, blood safety, and epidemiological surveillance. Market growth is fueled by enduring structural trends within the global healthcare landscape.

Primary Market Growth Drivers

Market expansion is underpinned by several powerful and sustained drivers. A fundamental catalyst is the ongoing global expansion and strengthening of healthcare infrastructure, particularly the establishment of new hospitals and diagnostic laboratories. As healthcare networks grow to serve larger populations, the volume of diagnostic testing inherently increases. Serological tests are a staple in hospital laboratories for diagnosing conditions like hepatitis, HIV, Lyme disease, and rubella, as well as for pre-operative screenings and general health assessments. This infrastructure growth directly translates to higher demand for reliable testing reagents, instruments, and platforms.

Closely linked is the strategic expansion and modernization of blood bank services. Serological testing is a non-negotiable pillar of blood safety, mandated for screening all donated blood for transfusion-transmissible infections such as HIV, hepatitis B and C, and syphilis. The global emphasis on ensuring a safe blood supply, driven by both regulatory mandates and public health priorities, creates a consistent, high-volume demand for serological screening assays. Initiatives to increase voluntary blood donations and establish regional blood processing centers further bolster this demand.

Furthermore, the increase in public health initiatives and epidemiological surveillance programs is a significant growth vector. Governments and international health organizations increasingly utilize serological testing for population-level studies to monitor disease prevalence, assess herd immunity, guide vaccination campaigns, and manage outbreak responses. The ability of serology to identify past infections makes it a powerful tool for public health planning and resource allocation, driving procurement of tests for large-scale screening efforts.

Geographical Outlook: Asia-Pacific Dominance

The Asia-Pacific region is estimated to dominate the global serological testing market. This projected leadership is attributed to the region's massive and growing population, coupled with rapid and large-scale investments in healthcare infrastructure. Many countries in the region are actively expanding their hospital networks, upgrading laboratory capabilities, and implementing national health programs that include widespread diagnostic screening. Government-led initiatives aimed at improving public health outcomes, controlling infectious diseases, and ensuring blood safety are creating a sustained and high-volume demand for diagnostic tests, positioning Asia-Pacific as the primary engine for market growth.

Key Market Restraint

A significant restraint on broader and more equitable market access is the high cost associated with advanced serological testing. This includes expenses related to automated analyzers, proprietary reagent kits, and sophisticated multiplex assays. In resource-constrained settings, including developing regions and underfunded healthcare systems, these costs can be prohibitive. High test costs can limit routine use, restrict access to the latest testing technologies, and create disparities in diagnostic capabilities. This economic barrier challenges market penetration in price-sensitive segments and necessitates the development of more cost-effective solutions without compromising essential accuracy.

Competitive Landscape and Strategic Dynamics

The market is characterized by the presence of large, multinational in-vitro diagnostics (IVD) corporations that offer comprehensive portfolios of instruments, reagents, and software. Key players compete on the basis of assay accuracy, sensitivity and specificity, test menu breadth, automation capabilities, and integration into laboratory information systems. The competitive landscape emphasizes continuous innovation in assay formats, including the development of high-throughput automated systems for core laboratory use and rapid point-of-care tests for decentralized settings.

Strategic focus areas for industry participants include expanding test menus to cover emerging and re-emerging pathogens, improving automation to enhance laboratory efficiency and reduce human error, and developing multiplex assays that can detect multiple analytes from a single sample to conserve time and resources. Success depends on securing regulatory approvals across key markets, establishing strong distributor networks, and providing robust technical support to laboratory customers.

Future Trajectory and Strategic Considerations

The serological testing market is poised for sustained growth, driven by the non-cyclical needs of healthcare infrastructure, blood safety, and public health. Future developments will likely be influenced by trends toward more personalized medicine, the need for rapid response to emerging infectious disease threats, and the integration of serological data with other diagnostic modalities for a more holistic patient assessment.

For industry leaders, strategic priorities will include navigating complex and evolving regulatory pathways, developing tiered product portfolios to serve both high-throughput reference labs and low-resource settings, and investing in research to translate new biomarker discoveries into clinically validated assays. As a fundamental tool for diagnosis, screening, and surveillance, serological testing will remain an indispensable element of clinical and public health practice, with its market growth inextricably linked to the global commitment to expanding and improving healthcare delivery.

Key Benefits of this Report:

• Insightful Analysis: Gain detailed market insights covering major as well as emerging geographical regions, focusing on customer segments, government policies and socio-economic factors, consumer preferences, industry verticals, and other sub-segments.
• Competitive Landscape: Understand the strategic maneuvers employed by key players globally to understand possible market penetration with the correct strategy.
• Market Drivers & Future Trends: Explore the dynamic factors and pivotal market trends and how they will shape future market developments.
• Actionable Recommendations: Utilize the insights to exercise strategic decisions to uncover new business streams and revenues in a dynamic environment.
• Caters to a Wide Audience: Beneficial and cost-effective for startups, research institutions, consultants, SMEs, and large enterprises.

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Industry and Market Insights, Opportunity Assessment, Product Demand Forecasting, Market Entry Strategy, Geographical Expansion, Capital Investment Decisions, Regulatory Framework & Implications, New Product Development, Competitive Intelligence

Report Coverage:

• Historical data from 2021 to 2025 & forecast data from 2026 to 2031
• Growth Opportunities, Challenges, Supply Chain Outlook, Regulatory Framework, and Trend Analysis
• Competitive Positioning, Strategies, and Market Share Analysis
• Revenue Growth and Forecast Assessment of segments and regions including countries
• Company Profiling (Strategies, Products, Financial Information, and Key Developments among others.)

Serological Testing Market Segmentation

• By Test Type
• Primary Serological Tests
• Enzyme Linked Immunosorbent Assay (ELISA)
• Immunofluorescent Antibody Technique (IFAT)
• Radio Immunoassay (RIA)
• Secondary Serological Tests
• Agglutination Tests
• Complement Fixation Tests (CFT)
• Precipitation Tests
• Serum Neutralization Tests (SNT)
• Toxin-antitoxin Tests
• Tertiary Binding Tests
• By Application
• Rotavirus
• Hepatitis
• HIV
• Endotoxins
• Therapeutic Drug Monitoring
• Other Infectious Diseases
• By End-User
• Hospitals and Clinics
• Diagnostic Laboratories
• Blood Banks
• Others
• By Geography
• North America
• USA
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• Germany
• France
• United Kingdom
• Spain
• Others
• Middle East and Africa
• Saudi Arabia
• UAE
• Others
• Asia Pacific
• China
• India
• Japan
• South Korea
• Indonesia
• Thailand
• Others

TABLE OF CONTENTS

1. EXECUTIVE SUMMARY

2. MARKET SNAPSHOT

• 2.1. Market Overview
• 2.2. Market Definition
• 2.3. Scope of the Study
• 2.4. Market Segmentation

3. BUSINESS LANDSCAPE

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Porter's Five Forces Analysis
• 3.5. Industry Value Chain Analysis
• 3.6. Policies and Regulations
• 3.7. Strategic Recommendations

4. TECHNOLOGICAL OUTLOOK

5. SEROLOGICAL TESTING MARKET BY TEST TYPE

• 5.1. Introduction
• 5.2. Primary Serological Tests
  • 5.2.1. Enzyme Linked Immunosorbent Assay (ELISA)
  • 5.2.2. Immunofluorescent Antibody Technique (IFAT)
  • 5.2.3. Radio Immunoassay (RIA)
• 5.3. Secondary Serological Tests
  • 5.3.1. Agglutination Tests
  • 5.3.2. Complement Fixation Tests (CFT)
  • 5.3.3. Precipitation Tests
• 5.4. Serum Neutralization Tests (SNT)
  • 5.4.1. Toxin-antitoxin Tests
  • 5.4.2. Tertiary Binding Tests

6. SEROLOGICAL TESTING MARKET BY APPLICATION

• 6.1. Introduction
• 6.2. Rotavirus
• 6.3. Hepatitis
• 6.4. HIV
• 6.5. Endotoxins
• 6.6. Therapeutic Drug Monitoring
• 6.7. Other Infectious Diseases

7. SEROLOGICAL TESTING MARKET BY END-USER

• 7.1. Introduction
• 7.2. Hospitals and Clinics
• 7.3. Diagnostic Laboratories
• 7.4. Blood Banks
• 7.5. Others

8. SEROLOGICAL TESTING MARKET BY GEOGRAPHY

• 8.1. Introduction
• 8.2. North America
  • 8.2.1. USA
  • 8.2.2. Canada
  • 8.2.3. Mexico
• 8.3. South America
  • 8.3.1. Brazil
  • 8.3.2. Argentina
  • 8.3.3. Others
• 8.4. Europe
  • 8.4.1. Germany
  • 8.4.2. France
  • 8.4.3. United Kingdom
  • 8.4.4. Spain
  • 8.4.5. Others
• 8.5. Middle East and Africa
  • 8.5.1. Saudi Arabia
  • 8.5.2. UAE
  • 8.5.3. Others
• 8.6. Asia Pacific
  • 8.6.1. China
  • 8.6.2. India
  • 8.6.3. Japan
  • 8.6.4. South Korea
  • 8.6.5. Indonesia
  • 8.6.6. Thailand
  • 8.6.7. Others

9. COMPETITIVE ENVIRONMENT AND ANALYSIS

• 9.1. Major Players and Strategy Analysis
• 9.2. Market Share Analysis
• 9.3. Mergers, Acquisitions, Agreements, and Collaborations
• 9.4. Competitive Dashboard

10. COMPANY PROFILES

• 10.1. Serological Research Institute (SERI) (U.K.)
• 10.2. Chembio Diagnostics, Inc (U.S.)
• 10.3. Cellex (U.S.)
• 10.4. Randox Laboratories Ltd (U.K.)
• 10.5. Abbott (U.S.)
• 10.6. Bio-Rad Laboratories Inc. (U.S.)
• 10.7. BD (U.S.)
• 10.8. Thermo Fisher Scientific Inc. (U.S.)
• 10.9. Ortho Clinical Diagnostics (U.S.)
• 10.10. Quest Diagnostics Incorporated (U.S.)

11. APPENDIX

• 11.1. Currency
• 11.2. Assumptions
• 11.3. Base and Forecast Years Timeline
• 11.4. Key Benefits for the Stakeholders
• 11.5. Research Methodology
• 11.6. Abbreviations