Autoimmune Disease Testing Market Size, Share, Opportunities, And Trends By Product Type (Instruments, Reagents & Consumables), By Disease Type (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Scleroderma, Vasculitis, Inflammatory Bowel Disease, Others), By Test Type (Antinuclear Autoantibody (ANA), Rheumatoid Factor (RF), C-Reactive Protein (CRP), Anti-Thyroglobulin Antibody (ATA), Others), By End-User (Hospitals & Clinics, Diagnostic Centers, Others) And By Geography - Forecasts From 2025 To 2030
- Published: July 2025
- Report Code: KSI061615574
- Pages: 148
Autoimmune Disease Testing Market Size:
The autoimmune disease testing market is projected to expand at a 7.55% CAGR, attaining USD 8.407 billion by 2030 from USD 5.843 billion in 2025.
Due to the organism's aberrant response against its tissue, autoimmune disease results in the breakdown of normal immunological homeostasis. Inflammation, autoantibodies, and self-reactive T cells are typically impacted by autoimmune disorders. Potential autoimmune illnesses are difficult to diagnose since no one laboratory test can provide an accurate diagnosis of the condition. The diagnosis can aid with the treatment of autoimmune disease patients and can help with prognosis or identifying the degree of organ involvement or damage.
Autoimmune Disease Testing Market Drivers:
- Growth in autoimmune disease prevalence is bolstering the market growth.
The main factor accelerating autoimmune disease testing market growth is the rising frequency of autoimmune diseases like type 1 diabetes in newborn infants together with the desire for quick diagnoses. Research and diagnostics organizations throughout the world are launching projects following governmental organizations due to the increased incidence of autoimmune illnesses and the resulting increase in healthcare costs.
- Growing awareness regarding the autoimmune disease.
The prevalence of autoimmune disorders is increasing globally, and there is a growing awareness of health issues and diseases, which increases the need for diagnostics for early disease diagnosis thereby propelling the autoimmune disease testing market's expansion. The American Autoimmune Related Disease Association (AARDA), for instance, marks the month of March each year as Autoimmune Disease Awareness Month (ADAM). In February 2021, the American Kidney Fund (AKF) introduced a new patient-focused education and awareness campaign on the kidney disease lupus nephritis which is a type of autoimmune disease.
- Increasing patients with rheumatoid arthritis
An autoimmune condition called rheumatoid arthritis (RA) primarily targets the synovial tissues in the joints. Most of the disease's victims are older people. The prevalence of rheumatoid arthritis among the old population has increased along with the growth of the geriatric population, which is what is driving the autoimmune disease testing market's growth. For instance, as per the World Population Prospect, in 2022 there were 771 million people worldwide who were 65 or older, and that number would rise to 994 million by 2030 and 1.6 billion by 2050.
- Antinuclear antibody test to show steady growth
During the projected period, the antinuclear antibody test is anticipated to expand at the quickest rate. The autoimmune disease-causing antibodies are generated in the blood well before an individual has symptoms of the disease; this permits early identification of the condition, which lowers morbidity and mortality from the condition. The test for antinuclear antibodies is straightforward and more accurate than previous techniques. As a result, the autoimmune disease testing market growth is driven by the rising frequency of autoimmune illnesses, the need for early disease detection, and the simplicity and speed of the ANA test.
- Systemic Lupus Erythematosus is expected to show significant growth.
Systemic Lupus Erythematosus is anticipated to have a significant market share over the forecast period. Multiple organs or systems are affected by systemic autoimmune disorders. Companies in the autoimmune disease testing industry have introduced tests for identifying systemic autoimmune disorders as a result of the increased frequency of systemic autoimmune diseases. For instance, Thermo Fisher Scientific Inc. (U.S.) debuted EliA RNA Pol III and EliA Rib-P assays in June 2022 after receiving FDA approval. Systemic sclerosis (SSS) and systemic lupus erythematosus (SLE) are both diagnosed using these assays. The expansion of the autoimmune disease testing market is therefore driven by the rising number of businesses releasing diagnostics for systemic autoimmune disorders.
- The global immune diagnostics market is increasing
Hospitals, diagnostic facilities, and academic & research organizations make up the worldwide autoimmune disease diagnostics market. Major factors influencing the autoimmune disease diagnostics market growth include the expansion of diagnostic capabilities across all hospitals and the high level of patient choice for hospitals that offer full care, including diagnostics, procedures or treatments, and physiotherapy. Hospitals remain the preferred location for medical treatment as they offer the most cutting-edge equipment for precise diagnosis and treatment. The significant use of cutting-edge procedures, tests, and medical equipment, sponsored by public and private financing, raises the level of care offered by hospitals.
Autoimmune Disease Testing Market Geographical Outlook:
- Asia Pacific is anticipated to dominate the autoimmune disease testing market
Asia-Pacific is predicted to account for a significant market share of the autoimmune disease testing market over the forecast period due to the growing prevalence of autoimmune illnesses and increased knowledge of their diagnosis. The regional market is also expanding as a result of the strategic actions undertaken by market participants, more research, and growing healthcare infrastructure.
In addition to having the greatest frequency of systemic lupus erythematosus (SLE) in China and Southeast Asia, the area already has the largest impact on chronic obstructive pulmonary disease (COPD) in the whole globe.
Key manufacturers are focusing on product innovation:
The autoimmune disease testing market growth is relatively competitive. The market has sizeable market participants, and these participants are concentrating on R&D efforts and successful expansion strategies. A few diagnostic businesses recently formed strategic alliances with hospitals. To address the significant amount of patient demands across various locations, this trend is anticipated to continue throughout the forecast period. Abbott Laboratories, Biomérieux, Trinity Biotech, Bio-rad Laboratories, and Thermo Fisher Scientific are just a few of the businesses now ruling the autoimmune disease testing industry.
Segmentation:
- By Product Type
- Instruments
- Reagents & Consumables
- By Disease Type
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
- Scleroderma
- Vasculitis
- Inflammatory Bowel Disease
- Others
- By Test Type
- Antinuclear Autoantibody (ANA)
- Rheumatoid Factor (RF)
- C-Reactive Protein (CRP)
- Anti-Thyroglobulin Antibody (ATA)
- Others
- By End-User
- Hospitals & Clinics
- Diagnostic Centers
- Others
- By Geography
- North America
- United States
- Canada
- Mexico
- South America
- Brazil
- Argentina
- Others
- Europe
- United Kingdom
- Germany
- France
- Spain
- Others
- Middle East and Africa
- Saudi Arabia
- UAE
- Israel
- Others
- Asia Pacific
- Japan
- China
- India
- South Korea
- Indonesia
- Thailand
- Others
- North America
Frequently Asked Questions (FAQs)
The autoimmune disease testing market is expected to reach a total market size of USD 8.407 billion by 2030.
Autoimmune Disease Testing Market is valued at USD 5.843 billion in 2025.
The autoimmune disease testing market is expected to grow at a CAGR of 7.55% during the forecast period.
The major factor accelerating autoimmune disease testing market growth is the rising frequency of autoimmune diseases like type 1 diabetes in newborn infants together with the desire for quick diagnoses.
The Asia Pacific region is anticipated to hold a significant share of the autoimmune disease testing market.
1. INTRODUCTION
1.1. Market Overview
1.2. Market Definition
1.3. Scope of the Study
1.4. Market Segmentation
1.5. Currency
1.6. Assumptions
1.7. Base, and Forecast Years Timeline
2. RESEARCH METHODOLOGY
2.1. Research Data
2.2. Research Process
3. EXECUTIVE SUMMARY
3.1. Research Highlights
4. MARKET DYNAMICS
4.1. Market Drivers
4.2. Market Restraints
4.3. Market Opportunities
4.4. Porter’s Five Force Analysis
4.4.1. Bargaining Power of Suppliers
4.4.2. Bargaining Power of Buyers
4.4.3. Threat of New Entrants
4.4.4. Threat of Substitutes
4.4.5. Competitive Rivalry in the Industry
4.5. Industry Value Chain Analysis
5. AUTOIMMUNE DISEASE TESTING MARKET BY PRODUCT TYPE
5.1. Introduction
5.2. Instruments
5.3. Reagents & Consumables
6. AUTOIMMUNE DISEASE TESTING MARKET BY DISEASE TYPE
6.1. Introduction
6.2. Rheumatoid Arthritis
6.3. Systemic Lupus Erythematosus
6.4. Scleroderma
6.5. Vasculitis
6.6. Inflammatory Bowel Disease
6.7. Others
7. AUTOIMMUNE DISEASE TESTING MARKET BY TEST TYPE
7.1. Introduction
7.2. Antinuclear Autoantibody (ANA)
7.3. Rheumatoid Factor (RF)
7.4. C-Reactive Protein (CRP)
7.5. Anti-Thyroglobulin Antibody (ATA)
7.6. 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. United States
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. United Kingdom
9.4.2. Germany
9.4.3. France
9.4.4. Spain
9.4.5. 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. Japan
9.6.2. China
9.6.3. India
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
11. COMPANY PROFILES
11.1. F.Hoffman-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
11.8. Bio-Rad Laboratries, Inc.
F.Hoffman-La Roche Ltd
Siemens Healthcare GmbH
Thermo Fisher Scientific Inc.
Quest Diagnostics Incorporated
Abbott
Trinity Biotech
Bio-Rad Laboratries, Inc.
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