자가면역질환 검사 시장 - 예측(2026-2031년)

The autoimmune disease testing market is projected to expand at a 7.32% CAGR, attaining USD 8.929 billion in 2031 from USD 5.843 billion in 2025.

The autoimmune disease testing market is experiencing significant growth, driven by increasing disease prevalence and advancements in diagnostic capabilities. Autoimmune diseases, characterized by an aberrant immune response against the body's own tissues, disrupt normal immunological homeostasis and are typically marked by inflammation, autoantibodies, and self-reactive T cells. The complexity of these conditions, for which no single definitive laboratory test exists, necessitates a sophisticated diagnostic approach to aid in patient management, prognosis, and assessment of organ involvement.

A primary catalyst for market expansion is the rising global prevalence of autoimmune disorders. The increasing incidence of conditions such as type 1 diabetes in pediatric populations and rheumatoid arthritis (RA) in the growing geriatric demographic is creating a substantial and sustained demand for diagnostic solutions. This trend is compounded by a global aging population, which presents a larger patient base for age-related autoimmune conditions like RA, thereby directly fueling the need for testing.

Concurrently, heightened awareness of autoimmune diseases among both the public and healthcare professionals is bolstering market growth. Initiatives such as dedicated awareness months and patient-focused education campaigns are improving recognition of disease symptoms and underscoring the importance of early diagnosis. This growing emphasis on early detection is critical for improving patient outcomes and is a key factor propelling the demand for diagnostic testing.

The market is further segmented by test type and disease focus, with specific areas demonstrating pronounced growth potential. The antinuclear antibody (ANA) test is anticipated to be a high-growth segment due to its utility in early disease detection, often before clinical symptoms manifest. The test's procedural simplicity and accuracy compared to older methods make it a widely adopted first-line tool, directly contributing to market expansion. Similarly, the segment for Systemic Lupus Erythematosus (SLE) testing is expected to hold a significant market share. The drive to diagnose complex systemic autoimmune disorders has prompted diagnostic companies to develop and launch specialized assays, thereby enriching the product landscape and accelerating market growth.

The broader global immune diagnostics market, encompassing hospitals, diagnostic facilities, and research organizations, provides a robust infrastructure for autoimmune testing. Hospitals remain the dominant end-user setting, favored for their comprehensive care models that integrate advanced diagnostics with treatment. The continuous adoption of cutting-edge procedures and medical equipment within these institutions, often supported by public and private funding, elevates the standard of care and sustains a high volume of testing.

Geographically, the Asia-Pacific region is anticipated to dominate the autoimmune disease testing market. This leadership is attributed to a high and growing prevalence of specific autoimmune conditions, such as systemic lupus erythematosus, within the region. Strategic initiatives by market participants, ongoing research investments, and the continuous development of healthcare infrastructure are key factors consolidating the region's substantial market share.

The competitive landscape is relatively concentrated and features established global players such as Abbott Laboratories, BioMerieux, and Thermo Fisher Scientific. These companies maintain their market leadership through sustained investment in research and development and strategic expansion efforts. A notable trend involves diagnostic firms forming strategic alliances with hospital networks to address high patient volumes and diverse testing needs across different geographies, a strategy expected to persist and shape the market's trajectory. This focus on innovation and collaboration underscores a dynamic and responsive market poised for continued expansion.

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.

Autoimmune Disease Testing Market Segmentation:

• By Product Type
• Instruments
• Analyzers
• Flow Cytometers
• Others
• Reagents & Consumables
• By Test Type
• Antinuclear Antibody (ANA) Test
• C-Reactive Protein Test
• Rheumatoid Factor
• Anti-CCP Test
• Others
• By Disease Type
• Rheumatoid Arthritis
• Lupus
• Scleroderma
• Vasculitis
• Inflammatory Bowel Disease
• Others
• By End-User
• Hospitals & Clinics
• Diagnostic Centers
• Others
• By Geography
• North America
• USA
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• Germany
• France
• United Kingdom
• Spain
• Italy
• Others
• Middle East and Africa
• Saudi Arabia
• UAE
• Israel
• 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. AUTOIMMUNE DISEASE TESTING MARKET BY PRODUCT TYPE

• 5.1. Introduction
• 5.2. Instruments
  • 5.2.1. Analyzers
  • 5.2.2. Flow Crytometers
  • 5.2.3. Others
• 5.3. Reagents & Consumables

6. AUTOIMMUNE DISEASE TESTING MARKET BY TEST TYPE

• 6.1. Introduction
• 6.2. Antinuclear Antibody (ANA) Test
• 6.3. C-Reactive Protein Test
• 6.4. Rheumatoid Factor
• 6.5. Anti-CCP Test
• 6.6. Others

7. AUTOIMMUNE DISEASE TESTING MARKET BY DISEASE TYPE

• 7.1. Introduction
• 7.2. Rheumatoid Arthritis
• 7.3. Lupus
• 7.4. Scleroderma
• 7.5. Vasculitis
• 7.6. Inflammatory Bowel Disease
• 7.7. Others

8. AUTOIMMUNE DISEASE TESTING MARKET BY END-USER

• 8.1. Introduction
• 8.2. Hospitals & Clinics
• 8.3. Diagnostic Centers
• 8.4. Others

9. AUTOIMMUNE DISEASE TESTING MARKET BY GEOGRAPHY

• 9.1. Introduction
• 9.2. North America
  • 9.2.1. USA
  • 9.2.2. Canada
  • 9.2.3. Mexico
• 9.3. South America
  • 9.3.1. Brazil
  • 9.3.2. Argentina
  • 9.3.3. Others
• 9.4. Europe
  • 9.4.1. Germany
  • 9.4.2. France
  • 9.4.3. United Kingdom
  • 9.4.4. Spain
  • 9.4.5. Italy
  • 9.4.6. Others
• 9.5. Middle East and Africa
  • 9.5.1. Saudi Arabia
  • 9.5.2. UAE
  • 9.5.3. Israel
  • 9.5.4. Others
• 9.6. Asia Pacific
  • 9.6.1. China
  • 9.6.2. India
  • 9.6.3. Japan
  • 9.6.4. South Korea
  • 9.6.5. Indonesia
  • 9.6.6. Thailand
  • 9.6.7. Others

10. COMPETITIVE ENVIRONMENT AND ANALYSIS

• 10.1. Major Players and Strategy Analysis
• 10.2. Market Share Analysis
• 10.3. Mergers, Acquisitions, Agreements, and Collaborations
• 10.4. Competitive Dashboard

11. COMPANY PROFILES

• 11.1. F. Hoffmann-La Roche Ltd
• 11.2. Siemens Healthcare GmbH
• 11.3. Thermo Fisher Scientific Inc.
• 11.4. Quest Diagnostics Incorporated
• 11.5. Abbott
• 11.6. Werfen
• 11.7. Trinity Biotech Plc
• 11.8. Bio-Rad Laboratories, Inc.
• 11.9. Danaher Corporation
• 11.10. Exagen Inc

12. APPENDIX

• 12.1. Currency
• 12.2. Assumptions
• 12.3. Base and Forecast Years Timeline
• 12.4. Key Benefits for the Stakeholders
• 12.5. Research Methodology
• 12.6. Abbreviations