Product Code: 978-1-68038-292-1
Autoimmune Disease Diagnostics Market Summary
The global autoimmune disease diagnostics market size was estimated at USD 6.07 billion in 2025 and is projected to reach USD 9.58 billion by 2033, growing at a CAGR of 5.84% from 2026 to 2033. The increasing prevalence of autoimmune disorders such as type 1 diabetes in newborn babies, coupled with the demand for rapid diagnostics, is the key driver accentuating growth.
In addition, there is an increasing focus on investments and funding for research related to autoimmune diseases, which further propels market growth. Furthermore, developing countries offer untapped opportunities for market expansion, presenting significant growth prospects in the years to come.
The establishment of technological advancements and the expansion of lab automation rates are anticipated to boost market growth. Clinicians are implementing advanced technology to conduct several tests at the same time with faster and more precise results.
Autoimmune diseases are a group of more than 100 chronic, debilitating conditions that affect approximately 3% of the US population. Some of the most common autoimmune diseases include obesity, cardiovascular diseases, type 2 diabetes mellitus, and all cancers. Thus, genetic factors, environmental influences, specific hormones, and susceptibility to certain infections are key contributors to the rising prevalence of autoimmune diseases globally. According to an article published by the National Health Council in September 2024, autoimmune diseases affect approximately 50 million Americans, and women account for 80% of this number. Given the inherent complexity involved in diagnosing these conditions, this figure is likely understated. More concerning is the fact that autoimmune diseases are approaching epidemic proportions, with several studies indicating annual growth rates in the range of 3%-12%.
An increasing rate of novel technological advancements and the corresponding emergence of laboratory automation technologies significantly contribute to market expansion. This trend is driven by the growing adoption of advanced technologies among clinicians, enabling them to conduct a wide range of tests while achieving faster and more accurate results. For instance, in January 2025, Werfen received FDA clearance for Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents. These assays enhance the accuracy of antiphospholipid syndrome (APS) diagnosis, addressing a significant unmet need in the diagnosis of autoimmune diseases.
In addition, the implementation of government initiatives across economies supports market developments. Work by organizations such as the Autoimmunity Centers of Excellence (ACE), the Cooperative Study Group for Autoimmune Disease Prevention (CSGADP), and the North American Rheumatoid Arthritis Consortium (NARAC) contributes to market growth by creating awareness among patients and healthcare professionals regarding proper diagnosis and treatment protocols.
The involvement of organizations such as the Autoimmunity Centers of Excellence, Cooperative Study Group for Autoimmune Disease Prevention, and North American Rheumatoid Arthritis Consortium in educating patients and healthcare professionals about proper diagnosis and treatment is anticipated to have a positive impact on market dynamics, as it promotes awareness and early intervention in autoimmune diseases. This, in turn, is expected to drive the growth of the autoimmune disease diagnostics market. Besides, favorable government initiatives aimed at increasing access to diagnostic tests, improving disease management and reducing healthcare costs, among other factors, are also expected to boost market growth during the forecast period.
Global Autoimmune Disease Diagnostics Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global autoimmune disease diagnostics market report based on type, product, test, end use, and region.
- Type Outlook (Revenue, USD Million, 2021 - 2033)
- Systemic autoimmune disease diagnostics
- Rheumatoid arthritis
- Ankylosing spondylitis
- Systemic lupus erythematosus (SLE)
- Others
- Localized autoimmune disease diagnostics
- Multiple sclerosis
- Type 1 diabetes
- Hashimoto's Thyroiditis
- Idiopathic thrombocytopenic purpura
- Others
- Product Outlook (Revenue, USD Million, 2021 - 2033)
- Instruments
- Consumables and Assays
- Test Outlook (Revenue, USD Million, 2021 - 2033)
- Antinuclear antibody tests
- Autoantibody tests
- C-reactive Protein (CRP)
- Complete blood count (CBC)
- Urinalysis
- Others
- End Use Outlook (Revenue, USD Million, 2021 - 2033)
- Hospitals
- Diagnostic centers
- Others
- Regional Outlook (Revenue, USD Million, 2021 - 2033)
- North America
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Sweden
- Norway
- Denmark
- Asia Pacific
- Japan
- China
- India
- Australia
- Thailand
- South Korea
- Latin America
- Middle East and Africa (MEA)
- South Africa
- Saudi Arabia
- UAE
- Kuwait
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation and Scope
- 1.1.1. Segment Definitions
- 1.1.1.1. Type segment
- 1.1.1.2. Product segment
- 1.1.1.3. Test segment
- 1.1.1.4. End use segment
- 1.2. Regional Scope
- 1.3. Estimates and Forecast Timeline
- 1.4. Objectives
- 1.4.1. Objective - 1
- 1.4.2. Objective - 2
- 1.4.3. Objective - 3
- 1.5. Research Methodology
- 1.6. Information Procurement
- 1.6.1. Purchased Database
- 1.6.2. GVR's Internal Database
- 1.6.3. Secondary Sources
- 1.6.4. Primary research
- 1.7. Information or Data Analysis
- 1.7.1. Data Analysis Models
- 1.8. Market Formulation & Validation
- 1.9. Model Details
- 1.9.1. Commodity Flow Analysis
- 1.10. List of Secondary Sources
- 1.11. List of Abbreviations
Chapter 2. Executive Summary
- 2.1. Market Snapshot
- 2.2. Type and Test Snapshot
- 2.3. Product and End use Snapshot
- 2.4. Competitive Landscape Snapshot
Chapter 3. Market Variables, Trends, & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent Market Outlook
- 3.1.2. Related/Ancillary Market Outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.1.1. Presence of research funding programs
- 3.2.1.2. Presence of favorable government initiatives
- 3.2.1.3. Growing patient awareness levels
- 3.2.1.4. Technological innovation in the form of lab automation
- 3.2.2. Market Restraint Analysis
- 3.2.2.1. Slow diagnostic result turnaround times and lack of skilled healthcare practitioner
- 3.3. Industry Analysis Tools
- 3.3.1. Porter's Five Forces Analysis
- 3.3.2. PESTEL Analysis
Chapter 4. Type Business Analysis
- 4.1. Autoimmune Disease Diagnostics Market: Type Movement Analysis
- 4.2. Systemic Autoimmune Disease Diagnostics
- 4.2.1. Systemic Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 4.2.2. Rheumatoid Arthritis Diagnostics
- 4.2.2.1. Rheumatoid Arthritis Diagnostics Market, 2021 - 2033 (USD Million)
- 4.2.3. Ankylosing Spondylitis Diagnostics
- 4.2.3.1. Ankylosing Spondylitis Diagnostics Market, 2021 - 2033 (USD Million)
- 4.2.4. Systemic Lupus Erythematosus (SLE) Diagnostics
- 4.2.4.1. Systemic Lupus Erythematosus (SLE) Diagnostics Market, 2021 - 2033 (USD Million)
- 4.2.5. Other Systemic Autoimmune Disease Diagnostics
- 4.2.5.1. Other Systemic Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 4.3. Localized Disease Diagnostics
- 4.3.1. Localized Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 4.3.2. Multiple sclerosis diagnostics
- 4.3.2.1. Multiple sclerosis diagnostics Market, 2021 - 2033 (USD Million)
- 4.3.3. Type 1 Diabetes Diagnostics
- 4.3.3.1. Type 1 Diabetes Diagnostics Market, 2021 - 2033 (USD Million)
- 4.3.4. Hashimoto's Thyroiditis Diagnostics
- 4.3.4.1. Hashimoto's Thyroiditis Diagnostics Market, 2021 - 2033 (USD Million)
- 4.3.5. Idiopathic Thrombocytopenic Purpura (ITP) diagnostics
- 4.3.5.1. Idiopathic Thrombocytopenic Purpura (ITP) diagnostics Market, 2021 - 2033 (USD Million)
- 4.3.6. Other Localized Autoimmune Disease Diagnostics
- 4.3.6.1. Other Localized Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
Chapter 5. Product Business Analysis
- 5.1. Autoimmune Disease Diagnostics Market: Product Movement Analysis
- 5.2. Instruments
- 5.2.1. Instruments Market, 2021 - 2033 (USD Million)
- 5.3. Consumables and Assays
- 5.3.1. Consumables and Assays Market, 2021 - 2033 (USD Million)
Chapter 6. Test Business Analysis
- 6.1. Autoimmune Disease Diagnostics Market: Test Movement Analysis
- 6.2. Antinuclear Antibody Tests
- 6.2.1. Antinuclear Antibody Tests Market, 2021 - 2033 (USD Million)
- 6.3. Autoantibody Tests
- 6.3.1. Autoantibody Tests Market, 2021 - 2033 (USD Million)
- 6.4. C-reactive Protein (CRP)
- 6.4.1. C-Reactive Protein (CRP) Market, 2021 - 2033 (USD Million)
- 6.5. Complete Blood Count (CBC)
- 6.5.1. Complete Blood Count (CBC) Market, 2021 - 2033 (USD Million)
- 6.6. Urinalysis
- 6.6.1. Urinalysis Market, 2021 - 2033 (USD Million)
- 6.7. Others
- 6.7.1. Others Market, 2021 - 2033 (USD Million)
Chapter 7. End Use Business Analysis
- 7.1. Autoimmune Disease Diagnostics Market: End Use Movement Analysis
- 7.2. Hospitals
- 7.2.1. Hospitals Market, 2021 - 2033 (USD Million)
- 7.3. Diagnostic Centers
- 7.3.1. Diagnostic Centers Market, 2021 - 2033 (USD Million)
- 7.4. Others
- 7.4.1. Others Market, 2021 - 2033 (USD Million)
Chapter 8. Regional Business Analysis
- 8.1. Autoimmune Disease Diagnostics Market Share By Region, 2024 & 2030
- 8.2. North America
- 8.2.1. SWOT Analysis
- 8.2.2. North America Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.2.3. U.S.
- 8.2.3.1. Key Country Dynamics
- 8.2.3.2. Target Disease Prevalence
- 8.2.3.3. Competitive Scenario
- 8.2.3.4. Regulatory Framework
- 8.2.3.5. U.S. Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.2.4. Canada
- 8.2.4.1. Key Country Dynamics
- 8.2.4.2. Target Disease Prevalence
- 8.2.4.3. Competitive Scenario
- 8.2.4.4. Regulatory Framework
- 8.2.4.5. Canada Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.2.5. Mexico
- 8.2.5.1. Key Country Dynamics
- 8.2.5.2. Target Disease Prevalence
- 8.2.5.3. Competitive Scenario
- 8.2.5.4. Regulatory Framework
- 8.2.5.5. Mexico Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.3. Europe
- 8.3.1. SWOT Analysis
- 8.3.2. Europe Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.3.3. UK
- 8.3.3.1. Key Country Dynamics
- 8.3.3.2. Target Disease Prevalence
- 8.3.3.3. Competitive Scenario
- 8.3.3.4. Regulatory Framework
- 8.3.3.5. UK Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.3.4. Germany
- 8.3.4.1. Key Country Dynamics
- 8.3.4.2. Target Disease Prevalence
- 8.3.4.3. Competitive Scenario
- 8.3.4.4. Regulatory Framework
- 8.3.4.5. Germany Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.3.5. France
- 8.3.5.1. Key Country Dynamics
- 8.3.5.2. Target Disease Prevalence
- 8.3.5.3. Competitive Scenario
- 8.3.5.4. Regulatory Framework
- 8.3.5.5. France Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.3.6. Italy
- 8.3.6.1. Key Country Dynamics
- 8.3.6.2. Target Disease Prevalence
- 8.3.6.3. Competitive Scenario
- 8.3.6.4. Regulatory Framework
- 8.3.6.5. Italy Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.3.7. Spain
- 8.3.7.1. Key Country Dynamics
- 8.3.7.2. Target Disease Prevalence
- 8.3.7.3. Competitive Scenario
- 8.3.7.4. Regulatory Framework
- 8.3.7.5. Spain Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.3.8. Sweden
- 8.3.8.1. Key Country Dynamics
- 8.3.8.2. Target Disease Prevalence
- 8.3.8.3. Competitive Scenario
- 8.3.8.4. Regulatory Framework
- 8.3.8.5. Sweden Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.3.9. Norway
- 8.3.9.1. Key Country Dynamics
- 8.3.9.2. Target Disease Prevalence
- 8.3.9.3. Competitive Scenario
- 8.3.9.4. Regulatory Framework
- 8.3.9.5. Norway Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.3.10. Denmark
- 8.3.10.1. Key Country Dynamics
- 8.3.10.2. Target Disease Prevalence
- 8.3.10.3. Competitive Scenario
- 8.3.10.4. Regulatory Framework
- 8.3.10.5. Denmark Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.4. Asia Pacific
- 8.4.1. SWOT Analysis
- 8.4.2. Asia Pacific Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.4.3. Japan
- 8.4.3.1. Key Country Dynamics
- 8.4.3.2. Target Disease Prevalence
- 8.4.3.3. Competitive Scenario
- 8.4.3.4. Regulatory Framework
- 8.4.3.5. Japan Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.4.4. China
- 8.4.4.1. Key Country Dynamics
- 8.4.4.2. Target Disease Prevalence
- 8.4.4.3. Competitive Scenario
- 8.4.4.4. Regulatory Framework
- 8.4.4.5. China Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.4.5. India
- 8.4.5.1. Key Country Dynamics
- 8.4.5.2. Target Disease Prevalence
- 8.4.5.3. Competitive Scenario
- 8.4.5.4. Regulatory Framework
- 8.4.5.5. India Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.4.6. Australia
- 8.4.6.1. Key Country Dynamics
- 8.4.6.2. Target Disease Prevalence
- 8.4.6.3. Competitive Scenario
- 8.4.6.4. Regulatory Framework
- 8.4.6.5. Australia Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.4.7. Thailand
- 8.4.7.1. Key Country Dynamics
- 8.4.7.2. Target Disease Prevalence
- 8.4.7.3. Competitive Scenario
- 8.4.7.4. Regulatory Framework
- 8.4.7.5. Thailand Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.4.8. South Korea
- 8.4.8.1. Key Country Dynamics
- 8.4.8.2. Target Disease Prevalence
- 8.4.8.3. Competitive Scenario
- 8.4.8.4. Regulatory Framework
- 8.4.8.5. South Korea Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.5. Latin America
- 8.5.1. SWOT Analysis
- 8.5.2. Latin America Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.5.3. Brazil
- 8.5.3.1. Key Country Dynamics
- 8.5.3.2. Target Disease Prevalence
- 8.5.3.3. Competitive Scenario
- 8.5.3.4. Regulatory Framework
- 8.5.3.5. Brazil Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.5.4. Argentina
- 8.5.4.1. Key Country Dynamics
- 8.5.4.2. Target Disease Prevalence
- 8.5.4.3. Competitive Scenario
- 8.5.4.4. Regulatory Framework
- 8.5.4.5. Argentina Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.6. Middle East and Africa
- 8.6.1. SWOT Analysis
- 8.6.2. Middle East and Africa Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.6.3. South Africa
- 8.6.3.1. Key Country Dynamics
- 8.6.3.2. Target Disease Prevalence
- 8.6.3.3. Competitive Scenario
- 8.6.3.4. Regulatory Framework
- 8.6.3.5. South Africa Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.6.4. Saudi Arabia
- 8.6.4.1. Key Country Dynamics
- 8.6.4.2. Target Disease Prevalence
- 8.6.4.3. Competitive Scenario
- 8.6.4.4. Regulatory Framework
- 8.6.4.5. Saudi Arabia Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.6.5. UAE
- 8.6.5.1. Key Country Dynamics
- 8.6.5.2. Target Disease Prevalence
- 8.6.5.3. Competitive Scenario
- 8.6.5.4. Regulatory Framework
- 8.6.5.5. UAE Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
- 8.6.6. Kuwait
- 8.6.6.1. Key Country Dynamics
- 8.6.6.2. Target Disease Prevalence
- 8.6.6.3. Competitive Scenario
- 8.6.6.4. Regulatory Framework
- 8.6.6.5. Kuwait Autoimmune Disease Diagnostics Market, 2021 - 2033 (USD Million)
Chapter 9. Competitive Landscape
- 9.1. Company Categorization
- 9.2. Strategy Mapping
- 9.3. Company Market Share Analysis, 2024
- 9.4. Company Profiles/Listing
- 9.4.1. F. Hoffmann-La Roche Ltd
- 9.4.1.1. Overview
- 9.4.1.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.4.1.3. Product Benchmarking
- 9.4.1.4. Strategic Initiatives
- 9.4.2. Siemens Healthineers AG
- 9.4.2.1. Overview
- 9.4.2.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.4.2.3. Product Benchmarking
- 9.4.2.4. Strategic Initiatives
- 9.4.3. Abbott
- 9.4.3.1. Overview
- 9.4.3.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.4.3.3. Product Benchmarking
- 9.4.3.4. Strategic Initiatives
- 9.4.4. Beckman Coulter, Inc.
- 9.4.4.1. Overview
- 9.4.4.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.4.4.3. Product Benchmarking
- 9.4.4.4. Strategic Initiatives
- 9.4.5. Danaher Corporation
- 9.4.5.1. Overview
- 9.4.5.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.4.5.3. Product Benchmarking
- 9.4.5.4. Strategic Initiatives
- 9.4.6. Quest Diagnostics
- 9.4.6.1. Overview
- 9.4.6.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.4.6.3. Product Benchmarking
- 9.4.6.4. Strategic Initiatives
- 9.4.7. EUROIMMUN Medizinische Labordiagnostika AG
- 9.4.7.1. Overview
- 9.4.7.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.4.7.3. Product Benchmarking
- 9.4.7.4. Strategic Initiatives
- 9.4.8. Nova Diagnostics Pte Ltd.
- 9.4.8.1. Overview
- 9.4.8.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.4.8.3. Product Benchmarking
- 9.4.8.4. Strategic Initiatives
- 9.4.9. BIOMERIEUX
- 9.4.9.1. Overview
- 9.4.9.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.4.9.3. Product Benchmarking
- 9.4.9.4. Strategic Initiatives
- 9.4.10. Hemagen Diagnostics, Inc.
- 9.4.10.1. Overview
- 9.4.10.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
- 9.4.10.3. Product Benchmarking
- 9.4.10.4. Strategic Initiatives