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Autoimmune Disease Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F

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  • 186 Pages
  • August 2025
  • Region: Global
  • TechSci Research
  • ID: 5022636
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The Autoimmune Disease Diagnostics Market was valued at USD 5.74 Billion in 2024, and is expected to reach USD 9.64 Billion by 2030, rising at a CAGR of 9.03%. The Global Autoimmune Disease Diagnostics Market refers to the worldwide industry focused on the diagnosis and testing of autoimmune diseases. Autoimmune diseases are a group of disorders in which the immune system mistakenly attacks the body's own healthy tissues, leading to various health problems. The market for autoimmune disease diagnostics encompasses a wide range of products, services, and technologies aimed at identifying and monitoring these conditions. Autoimmune diseases are a group of more than 100 chronic, debilitating conditions that affect approximately 3% of the US population, or about 10 million people. Some of the most common autoimmune diseases include obesity, cardiovascular diseases, type 2 diabetes mellitus, and all cancers.

Key Market Drivers

Rising Prevalence of Autoimmune Diseases

Autoimmune diseases have become a growing global health concern, affecting millions of people worldwide. These conditions occur when the body's immune system mistakenly targets its own tissues, leading to chronic inflammation and a wide range of health issues. As the prevalence of autoimmune diseases continues to rise, the Global Autoimmune Disease Diagnostics Market is experiencing significant growth. Autoimmune diseases are no longer considered rare. They have reached epidemic proportions, with millions of people across the globe suffering from various autoimmune conditions.

Common autoimmune diseases include rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, Crohn's disease, and type 1 diabetes. The sheer volume of patients seeking diagnosis and treatment has boosted the demand for autoimmune disease diagnostics. Early diagnosis is crucial for managing autoimmune diseases effectively. Many of these conditions exhibit subtle symptoms in their early stages, making accurate and timely diagnosis challenging. However, as awareness about autoimmune diseases increases, individuals are more likely to seek medical attention when experiencing symptoms, driving the need for diagnostic tests that can confirm or rule out these conditions.

Moreover, the rising prevalence of autoimmune diseases has coincided with significant technological advancements in healthcare. Diagnostic tools and techniques have evolved rapidly, providing healthcare professionals with more accurate and efficient ways to detect autoimmune diseases. These advancements include serology tests, genetic testing, imaging modalities, and biomarker-based assays. Such innovations enhance the diagnostic capabilities and contribute to early intervention. The growth of the autoimmune disease diagnostics market is also linked to the trend of personalized medicine. Tailoring treatments based on an individual's unique genetic and immunological profile is gaining prominence.

To prescribe personalized therapies effectively, precise diagnostics are required to identify the specific autoimmune disease and its severity, enabling clinicians to choose the most suitable treatment options. For instance, a study published in the American Journal of Managed Care (AJMC) in May 2021 reported an estimated prevalence of 276 cases per million adults for scleroderma in the U.S. A recent study found that autoimmune disorders now affect about one in ten individuals, with 80-100 known autoimmune diseases affecting more than 14 million Americans.

Key Market Challenges

Complexity of Autoimmune Diseases

One of the fundamental challenges in autoimmune disease diagnostics is the sheer complexity of these conditions. Autoimmune diseases can present with a wide array of symptoms, and their underlying mechanisms are often intricate and multifaceted. This complexity makes it challenging to develop diagnostic tests that are both accurate and comprehensive.

Key Market Trends

Advances in Biomarker Discovery

Biomarkers play a crucial role in autoimmune disease diagnostics. Ongoing research is leading to the discovery of novel biomarkers that can improve diagnostic accuracy. These biomarkers are expected to become integral in identifying autoimmune diseases at earlier stages and monitoring disease progression more effectively.

Key Market Players

  • Abbott Laboratories
  • Siemens Healthineers AG
  • Roche Diagnostics Corp
  • Beckman Coulter Inc
  • SQI Diagnostics Inc
  • EUROIMMUN Medizinische Labordiagnostika AG
  • Aesku Diagnostics GmbH & Co KG
  • INOVA Diagnostics Inc
  • Crescendo Bioscience LLC
  • bioMerieux SA

Report Scope:

In this report, the Global Autoimmune Disease Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Autoimmune Disease Diagnostics Market, By Component:

  • Instruments
  • Reagents
  • Consumables

Autoimmune Disease Diagnostics Market, By Test Type:

  • Routine Laboratory Tests
  • Inflammatory Markers
  • Antibodies & Immunologic Tests
  • Others

Autoimmune Disease Diagnostics Market, By Disease Type:

  • Systemic Autoimmune Disease Diagnostics
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Systemic Lupus Erythematosus
  • Others
  • Localized Autoimmune Disease Diagnostics
  • Multiple Sclerosis
  • Type 1 Diabetes
  • Hashimoto’s Thyroiditis
  • Others

Autoimmune Disease Diagnostics Market, By End User:

  • Hospitals & Clinics
  • Diagnostic Centers
  • Others

Autoimmune Disease Diagnostics Market, By Region:

  • North America
  • United States
  • Canada
  • Mexico
  • Europe
  • Germany
  • United Kingdom
  • France
  • Italy
  • Spain
  • Asia-Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • South America
  • Brazil
  • Argentina
  • Colombia
  • Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Autoimmune Disease Diagnostics Market.

Available Customizations:

With the given market data, the publisher offers customizations according to a company's specific needs. The following customization options are available for the report.

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Autoimmune Disease Diagnostics Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Component (Instruments, Reagents, Consumables)
5.2.2. By Test Type (Routine Laboratory Tests, Inflammatory Markers, Antibodies & Immunologic Tests, Others)
5.2.3. By Disease Type (Systemic Autoimmune Disease Diagnostics, Localized Autoimmune Disease Diagnostics)
5.2.3.1. By Systemic Autoimmune Diseases (Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus, Others)
5.2.3.2. By Localized Autoimmune Diseases (Multiple Sclerosis, Type 1 Diabetes, Hashimoto’s Thyroiditis, Others)
5.2.4. By End User (Hospitals & Clinics, Diagnostic Centers, Others)
5.2.5. By Region
5.2.6. By Company (2024)
5.3. Product Market Map
5.3.1. By Component
5.3.2. By Test Type
5.3.3. By Disease Type
5.3.4. By End User
5.3.5. By Region
6. North America Autoimmune Disease Diagnostics Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Component (Instruments, Reagents, Consumables)
6.2.2. By Test Type (Routine Laboratory Tests, Inflammatory Markers, Antibodies & Immunologic Tests, Others)
6.2.3. By Disease Type (Systemic Autoimmune Disease Diagnostics, Localized Autoimmune Disease Diagnostics)
6.2.3.1. By Systemic Autoimmune Diseases (Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus, Others)
6.2.3.2. By Localized Autoimmune Diseases (Multiple Sclerosis, Type 1 Diabetes, Hashimoto’s Thyroiditis, Others)
6.2.4. By End User (Hospitals & Clinics, Diagnostic Centers, Others)
6.2.5. By Country
6.3. North America: Country Analysis
6.3.1. United States Autoimmune Disease Diagnostics Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Component
6.3.1.2.2. By Test Type
6.3.1.2.3. By Disease Type
6.3.1.2.3.1. By Systemic Autoimmune Diseases
6.3.1.2.3.2. By Localized Autoimmune Diseases
6.3.1.2.4. By End User
6.3.2. Canada Autoimmune Disease Diagnostics Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Component
6.3.2.2.2. By Test Type
6.3.2.2.3. By Disease Type
6.3.2.2.3.1. By Systemic Autoimmune Diseases
6.3.2.2.3.2. By Localized Autoimmune Diseases
6.3.2.2.4. By End User
6.3.3. Mexico Autoimmune Disease Diagnostics Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Component
6.3.3.2.2. By Test Type
6.3.3.2.3. By Disease Type
6.3.3.2.3.1. By Systemic Autoimmune Diseases
6.3.3.2.3.2. By Localized Autoimmune Diseases
6.3.3.2.4. By End User
7. Europe Autoimmune Disease Diagnostics Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Component (Instruments, Reagents, Consumables)
7.2.2. By Test Type (Routine Laboratory Tests, Inflammatory Markers, Antibodies & Immunologic Tests, Others)
7.2.3. By Disease Type (Systemic Autoimmune Disease Diagnostics, Localized Autoimmune Disease Diagnostics)
7.2.3.1. By Systemic Autoimmune Diseases (Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus, Others)
7.2.3.2. By Localized Autoimmune Diseases (Multiple Sclerosis, Type 1 Diabetes, Hashimoto’s Thyroiditis, Others)
7.2.4. By End User (Hospitals & Clinics, Diagnostic Centers, Others)
7.2.5. By Country
7.3. Europe: Country Analysis
7.3.1. Germany Autoimmune Disease Diagnostics Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Component
7.3.1.2.2. By Test Type
7.3.1.2.3. By Disease Type
7.3.1.2.3.1. By Systemic Autoimmune Diseases
7.3.1.2.3.2. By Localized Autoimmune Diseases
7.3.1.2.4. By End User
7.3.2. United Kingdom Autoimmune Disease Diagnostics Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Component
7.3.2.2.2. By Test Type
7.3.2.2.3. By Disease Type
7.3.2.2.3.1. By Systemic Autoimmune Diseases
7.3.2.2.3.2. By Localized Autoimmune Diseases
7.3.2.2.4. By End User
7.3.3. France Autoimmune Disease Diagnostics Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Component
7.3.3.2.2. By Test Type
7.3.3.2.3. By Disease Type
7.3.3.2.3.1. By Systemic Autoimmune Diseases
7.3.3.2.3.2. By Localized Autoimmune Diseases
7.3.3.2.4. By End User
7.3.4. Italy Autoimmune Disease Diagnostics Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Component
7.3.4.2.2. By Test Type
7.3.4.2.3. By Disease Type
7.3.4.2.3.1. By Systemic Autoimmune Diseases
7.3.4.2.3.2. By Localized Autoimmune Diseases
7.3.4.2.4. By End User
7.3.5. Spain Autoimmune Disease Diagnostics Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Component
7.3.5.2.2. By Test Type
7.3.5.2.3. By Disease Type
7.3.5.2.3.1. By Systemic Autoimmune Diseases
7.3.5.2.3.2. By Localized Autoimmune Diseases
7.3.5.2.4. By End User
8. Asia-Pacific Autoimmune Disease Diagnostics Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Component (Instruments, Reagents, Consumables)
8.2.2. By Test Type (Routine Laboratory Tests, Inflammatory Markers, Antibodies & Immunologic Tests, Others)
8.2.3. By Disease Type (Systemic Autoimmune Disease Diagnostics, Localized Autoimmune Disease Diagnostics)
8.2.3.1. By Systemic Autoimmune Diseases (Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus, Others)
8.2.3.2. By Localized Autoimmune Diseases (Multiple Sclerosis, Type 1 Diabetes, Hashimoto’s Thyroiditis, Others)
8.2.4. By End User (Hospitals & Clinics, Diagnostic Centers, Others)
8.2.5. By Country
8.3. Asia-Pacific: Country Analysis
8.3.1. China Autoimmune Disease Diagnostics Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Component
8.3.1.2.2. By Test Type
8.3.1.2.3. By Disease Type
8.3.1.2.3.1. By Systemic Autoimmune Diseases
8.3.1.2.3.2. By Localized Autoimmune Diseases
8.3.1.2.4. By End User
8.3.2. Japan Autoimmune Disease Diagnostics Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Component
8.3.2.2.2. By Test Type
8.3.2.2.3. By Disease Type
8.3.2.2.3.1. By Systemic Autoimmune Diseases
8.3.2.2.3.2. By Localized Autoimmune Diseases
8.3.2.2.4. By End User
8.3.3. India Autoimmune Disease Diagnostics Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Component
8.3.3.2.2. By Test Type
8.3.3.2.3. By Disease Type
8.3.3.2.3.1. By Systemic Autoimmune Diseases
8.3.3.2.3.2. By Localized Autoimmune Diseases
8.3.3.2.4. By End User
8.3.4. Australia Autoimmune Disease Diagnostics Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Type
8.3.5. South Korea Autoimmune Disease Diagnostics Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Component
8.3.5.2.2. By Test Type
8.3.5.2.3. By Disease Type
8.3.5.2.3.1. By Systemic Autoimmune Diseases
8.3.5.2.3.2. By Localized Autoimmune Diseases
8.3.5.2.4. By End User
9. South America Autoimmune Disease Diagnostics Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Component (Instruments, Reagents, Consumables)
9.2.2. By Test Type (Routine Laboratory Tests, Inflammatory Markers, Antibodies & Immunologic Tests, Others)
9.2.3. By Disease Type (Systemic Autoimmune Disease Diagnostics, Localized Autoimmune Disease Diagnostics)
9.2.3.1. By Systemic Autoimmune Diseases (Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus, Others)
9.2.3.2. By Localized Autoimmune Diseases (Multiple Sclerosis, Type 1 Diabetes, Hashimoto’s Thyroiditis, Others)
9.2.4. By End User (Hospitals & Clinics, Diagnostic Centers, Others)
9.2.5. By Country
9.3. South America: Country Analysis
9.3.1. Brazil Autoimmune Disease Diagnostics Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Component
9.3.1.2.2. By Test Type
9.3.1.2.3. By Disease Type
9.3.1.2.3.1. By Systemic Autoimmune Diseases
9.3.1.2.3.2. By Localized Autoimmune Diseases
9.3.1.2.4. By End User
9.3.2. Argentina Autoimmune Disease Diagnostics Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Component
9.3.2.2.2. By Test Type
9.3.2.2.3. By Disease Type
9.3.2.2.3.1. By Systemic Autoimmune Diseases
9.3.2.2.3.2. By Localized Autoimmune Diseases
9.3.2.2.4. By End User
9.3.3. Colombia Autoimmune Disease Diagnostics Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Component
9.3.3.2.2. By Test Type
9.3.3.2.3. By Disease Type
9.3.3.2.3.1. By Systemic Autoimmune Diseases
9.3.3.2.3.2. By Localized Autoimmune Diseases
9.3.3.2.4. By End User
10. Middle East and Africa Autoimmune Disease Diagnostics Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Component (Instruments, Reagents, Consumables)
10.2.2. By Test Type (Routine Laboratory Tests, Inflammatory Markers, Antibodies & Immunologic Tests, Others)
10.2.3. By Disease Type (Systemic Autoimmune Disease Diagnostics, Localized Autoimmune Disease Diagnostics)
10.2.3.1. By Systemic Autoimmune Diseases (Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus, Others)
10.2.3.2. By Localized Autoimmune Diseases (Multiple Sclerosis, Type 1 Diabetes, Hashimoto’s Thyroiditis, Others)
10.2.4. By End User (Hospitals & Clinics, Diagnostic Centers, Others)
10.2.5. By Country
10.3. MEA: Country Analysis
10.3.1. South Africa Autoimmune Disease Diagnostics Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Component
10.3.1.2.2. By Test Type
10.3.1.2.3. By Disease Type
10.3.1.2.3.1. By Systemic Autoimmune Diseases
10.3.1.2.3.2. By Localized Autoimmune Diseases
10.3.1.2.4. By End User
10.3.2. Saudi Arabia Autoimmune Disease Diagnostics Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Component
10.3.2.2.2. By Test Type
10.3.2.2.3. By Disease Type
10.3.2.2.3.1. By Systemic Autoimmune Diseases
10.3.2.2.3.2. By Localized Autoimmune Diseases
10.3.2.2.4. By End User
10.3.3. UAE Autoimmune Disease Diagnostics Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Component
10.3.3.2.2. By Test Type
10.3.3.2.3. By Disease Type
10.3.3.2.3.1. By Systemic Autoimmune Diseases
10.3.3.2.3.2. By Localized Autoimmune Diseases
10.3.3.2.4. By End User
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Recent Development
12.2. Mergers & Acquisitions
12.3. Product Launches
13. Porter’s Five Forces Analysis
13.1. Competition in the Industry
13.2. Potential of New Entrants
13.3. Power of Suppliers
13.4. Power of Customers
13.5. Threat of Substitute Products
14. Autoimmune Disease Diagnostics Market: SWOT Analysis
15. Competitive Landscape
15.1. Abbott Laboratories
15.1.1. Business Overview
15.1.2. Company Snapshot
15.1.3. Products & Services
15.1.4. Financials (As Reported)
15.1.5. Recent Developments
15.1.6. Key Personnel Details
15.1.7. SWOT Analysis
15.2. Siemens Healthineers AG
15.3. Roche Diagnostics Corp
15.4. Beckman Coulter Inc
15.5. SQI Diagnostics Inc
15.6. EUROIMMUN Medizinische Labordiagnostika AG
15.7. Aesku Diagnostics GmbH & Co KG
15.8. INOVA Diagnostics Inc
15.9. Crescendo Bioscience LLC
15.10. bioMerieux SA
16. Strategic Recommendations17. About the Publisher & Disclaimer

Companies Mentioned

  • Abbott Laboratories
  • Siemens Healthineers AG
  • Roche Diagnostics Corp
  • Beckman Coulter Inc
  • SQI Diagnostics Inc
  • EUROIMMUN Medizinische Labordiagnostika AG
  • Aesku Diagnostics GmbH & Co KG
  • INOVA Diagnostics Inc
  • Crescendo Bioscience LLC
  • bioMerieux SA

Table Information

Report AttributeDetails
No. of Pages186
PublishedAugust 2025
Forecast Period2024 - 2030
Estimated Market Value ( USD ) in 2024 $ 5.74 Billion
Forecasted Market Value ( USD ) by 2030 $ 9.64 Billion
Compound Annual Growth Rate9.0%
Regions CoveredGlobal
No. of Companies Mentioned10

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