Autoimmune Disease Diagnostics Market (By Disease Segment, Test Types, Country Analysis), Company Profiles, Financial Insights, Strategy and Recent Developments - Global Forecast to 2030

The global autoimmune disease diagnostics market was valued at USD 6,583 Million in 2024, and the market is projected to reach USD 10,423 Million by 2030. Autoimmune diseases are characterized by an abnormal immune response in which the body produces antibodies that mistakenly attack its own cells and tissues, leading to the deterioration and destruction of healthy tissue. There are more than 80 known types of autoimmune diseases worldwide, including well-known conditions such as systemic lupus erythematosus (SLE) and rheumatoid arthritis. Autoimmune diseases can be divided into two general groups: Organ specific, where the autoantibodies attack a specific organ, and Non-organ specific (or systemic), where the autoantibodies attack multiple organ systems. For example, in Hashimoto’s thyroiditis, autoantibodies specifically target and damage the thyroid gland. In contrast, systemic autoimmune diseases involve multiple organ systems. A classic example is systemic lupus erythematosus (SLE), in which autoantibodies can affect a wide range of tissues and organs throughout the body.

The increasing incidence of conditions like rheumatoid arthritis and Hashimoto’s thyroiditis, coupled with supportive government policies, is expected to significantly influence the growth of the autoimmune disease diagnostics market. According to the American Autoimmune Related Diseases Association, more than 50 million people in the United States are currently affected by autoimmune disorders. This number is projected to rise in the coming years. Consequently, the growing need for accurate and advanced diagnostic techniques, alongside the rising prevalence of these diseases, is anticipated to propel market expansion over the forecast period.

Recent Developments

In April 2025, Predicta Biosciences, a precision oncology company developing novel diagnostic and therapeutic products, launched its first molecular diagnostic product to optimize the prognosis of multiple myeloma.

In February 2025, Biocon Biologics, a subsidiary of Biocon, launched YESINTEK (ustekinumab-kfce), a biosimilar option to Stelara (ustekinumab) in the US market. YESINTEK is approved for Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, offering a cost-effective treatment for chronic autoimmune diseases.

In December 2024, Quest Diagnostics introduced a revolutionary autoimmune disease diagnostic service that uses AI algorithms to analyze test results in real time, providing clinicians with instant feedback on patient status.

Key Highlights of the Report

On the basis of disease, Localized autoimmune disease segment accounted for largest market share in 2024 and is likely to dominate the market over the forecast timeframe. The prevalence of localized autoimmune disorders that includes Hashimoto's thyroiditis and type 1 diabetes is steadily increasing.

Multiple sclerosis accounted for highest share of the global localized autoimmune disease diagnostics market in 2024. Multiple sclerosis (MS) is a chronic disease that affects the central nervous system (CNS). It causes inflammation and the destruction of myelin. MS affects approximately 1 million individuals in the US and 2.8 million worldwide.

Systemic autoimmune diseases are a broad range of related diseases characterized by dysregulation of immune system which give rise to activation of immune cells to attack autoantigens and resulted in inappropriate inflammation and multi-tissue damages. They are a fascinating but poorly understood group of diseases, ranging from the commonly seen rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) to the relatively rare systemic sclerosis.

Rheumatoid Arthritis accounted for over 50% share of the global systemic autoimmune disease diagnostics market in 2024. Rheumatoid arthritis (RA) is an autoimmune disease characterized by inflammation of the joints, bone and cartilage erosion, and joint deformity.

Based on test types, Autoantibody test captured highest share of the overall autoimmune disease diagnostics market in 2024. Autoantibody tests are used to help diagnose autoimmune disorders.

Antinuclear antibody (ANA) testing is an important tool to diagnose and manage autoimmune diseases such as Systemic Lupus Erythematosus (SLE) and rheumatoid arthritis, at both the subspecialty settings and primary care. The extension of ANA from a test for SLE to a test for any autoimmune diseases has boosted the usage of antinuclear antibody (ANA) testing.

Complete blood count test is an important tool to diagnose and manage autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Idiopathic Thrombocytopenic Purpura and Multiple Sclerosis.

North America dominated the global autoimmune disease diagnostics market in 2024, and the region is likely to maintain its dominant position over the forecast period.

The European region is the second-largest autoimmune disease diagnostics market. European countries are being confronted with an increase in the occurrence of most autoimmune disorders. It is estimated that the prevalence rate of multiple sclerosis in Europe is 83 out of 100,000.

Asia-Pacific is expected to be the fastest-growing autoimmune disease diagnostics market over the forecast period owing to the rising population, increasing prevalence of autoimmune disorders, and increasing private-public partnerships for improvement of healthcare sector.

Apelo Consulting report titled “Autoimmune Disease Diagnostics Market (By Disease Segment, Test Types, Country Analysis), Company Profiles, Financial Insights, Strategy and Recent Developments - Global Forecast to 2030” provides a complete assessment of the fast–evolving, high–growth Global Autoimmune Disease Diagnostic Market landscape.

This 125 Pages report with 52 Figures and 18 Tables has been analyzed from 8 View Points:

1) Global Autoimmune Disease Diagnostics Market and Forecast (2021 - 2030)

2) Global Autoimmune Disease Diagnostics Market Share and Forecast (2021 - 2030)

3) By Disease - Global Autoimmune Disease Diagnostics Market and Forecast (2021 - 2030)

4) By Test Type - Global Autoimmune Disease Diagnostics Market and Forecast (2021 - 2030)

5) By Region - Autoimmune Disease Diagnostics Market and Forecast (2021 - 2030)

6) Autoimmune Disease Diagnostics Market - Company Profiles

7) Global Autoimmune Disease Diagnostics Market - Recent Developments

8) Global Autoimmune Disease Diagnostics Market - Growth Drivers & Challenges

By Disease - Global Autoimmune Disease Diagnostics Market and Forecast

Systemic Autoimmune Disease Diagnostics Market

Rheumatoid Arthritis

Ankylosing Spondylitis

Systemic Lupus Erythematosus

Others Systemic Autoimmune Disease

Localized Autoimmune Disease Diagnostics Market

Inflammatory Bowel Disease

Multiple Sclerosis

Type 1 Diabetes

Hashimoto's Thyroiditis

Others Localized Autoimmune Disease

By Test Type - Global Autoimmune Disease Diagnostics Market and Forecast

Autoantibody Tests

Antinuclear Antibody (ANA) Tests

Complete Blood Count Tests

Erythrocyte Sedimentation Rate Tests

C- Reactive Protein (CRP) Tests

Urinalysis Tests

Comprehensive Metabolic Panel Tests

Others Tests

By Region - Autoimmune Disease Diagnostics Market and Forecast

1. North America

United States

Canada

Mexico

2. Europe

Germany

United Kingdom

France

Italy

Spain

Rest of Europe

3. Asia Pacific

Japan

China

India

South Korea

Australia

Rest of Asia Pacific

4. South America

Brazil

Argentina

Rest of South America

5. Middle East & Africa

Saudi Arabia

United Arab Emirates

South Africa

Rest of Middle East & Africa

Autoimmune Disease Diagnostics Market – Key Company Profiles

1. Abbott Laboratories

2. Siemens Healthineers

3. Roche Diagnostics

4. bioMerieux SA

5. EUROIMMUN AG

6. Bio-Rad Laboratories

7. Quest Diagnostics

8. Thermo Fischer Scientific Inc.

9. Danaher Corporation

Data Source

Apelo Consulting employs comprehensive primary and secondary research techniques in developing distinctive data sets and research material for business reports. This report is built by using data and information sourced from Proprietary Information Database, Primary and Secondary Research Methodologies, and In house analysis by Apelo Consulting dedicated team of qualified professionals with deep industry experience and expertise. Show more