The autoimmune disease diagnostics market is expected to reach $9.84 billion by 2030, at a CAGR of 7.2% from 2023 to 2030.
With extensive primary and secondary research and in-depth analysis of the market scenario, the report studies the key industry drivers, restraints, challenges, and opportunities. The growth of the autoimmune disease diagnostics market is attributed to the increasing prevalence of autoimmune disorders, the growing emphasis on early diagnosis, and the rising awareness regarding autoimmune diseases. However, difficulties in diagnosing autoimmune diseases restrain the growth of this market. Emerging economies and increasing investments & funding in the autoimmune diseases space are expected to generate growth opportunities for the players in this market. Moreover, the unfavorable reimbursement scenario and high rate of delayed diagnosis or misdiagnosis are major challenges for market growth.
Based on product type, the autoimmune disease diagnostics market is segmented into reagents, assays & kits, and instruments. The reagents, assays & kits segment is expected to grow at the fastest CAGR during the forecast period. The growing prevalence of autoimmune diseases, recurrent use of reagents, assays & kits, and their increasing number of launches for autoimmune diseases by major market players are the major factors responsible for the segment growth.
The growing prevalence of autoimmune diseases has prompted major players operating in the autoimmune disease diagnostics market to focus on developing, approving, and launching kits & assays for monitoring and diagnosing autoimmune diseases, further driving their adoption. For instance, in 2022, Thermo Fisher Scientific Inc. (U.S.) launched EliA RNA Pol III and EliA Rib-P blood tests for the diagnosis of Systemic Sclerosis (SSc; scleroderma) and Systemic Lupus Erythematosus (SLE). This test further expands the company's product offerings for autoimmune disease diagnostics.
Based on test type, the autoimmune disease diagnostics market is segmented into antinuclear antibodies test (ANA), C-reactive protein test (CRP), erythrocyte sedimentation rate test, rheumatoid factor test, immunoglobulins test, routine blood tests, and other test types. In 2023, the antinuclear antibodies test (ANA) segment is expected to account for the largest share of the market. This segment's large market share is attributed to the increasing prevalence of autoimmune diseases and the widespread use of the ANA test for diagnosing autoimmune diseases due to its affordability, ease of administration, and heightened sensitivity & specificity.
According to the National Stem Cells Foundation, over 80 autoimmune diseases affect nearly 4% of the global population. The high burden of autoimmune diseases leads to the adoption of the antinuclear antibodies test, which is used as a primary test for several autoimmune diseases.
Based on disease type, the autoimmune disease diagnostics market is segmented into systemic autoimmune diseases and organ-specific autoimmune diseases. In 2023, the systemic autoimmune diseases segment is expected to account for the largest share of the market. The large market share of this segment is attributed to the higher prevalence of systemic autoimmune diseases compared to organ-specific conditions, increasing initiatives to raise awareness about these diseases, and the continuous growth in research activities related to autoimmune conditions. The Arthritis Foundation (AF) estimates that the global prevalence of RA is 0.5 to 1% in developed countries. A 2020 review found that the prevalence of RA in the Middle East and Africa ranged from 0.06 to 3.4%. Rheumatoid arthritis requires long-term monitoring and management.
Based on end user, the autoimmune disease diagnostics market is segmented into hospitals & clinics, diagnostic laboratories, and academic & research institutes. In 2023, the diagnostic laboratories segment is expected to account for the largest share of the market. Diagnostic laboratories receive samples from various healthcare centers, including hospitals and clinics. Diagnostics laboratories are crucial in providing accurate diagnostic results and managing disease management. Diagnostic laboratories process more samples in less time due to the well-equipped systems and the presence of skilled professionals. These factors contribute to the large market share of this segment in the autoimmune diseases diagnostics market.
An in-depth analysis of the geographical scenario of the autoimmune disease diagnostics market provides detailed qualitative and quantitative insights into five major geographies: North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa, along with the coverage of major countries in each region. Asia-Pacific is slated to register the highest CAGR during the forecast period. The market growth in this region is attributed to the growing prevalence and incidence of celiac diseases & rheumatoid arthritis, unhealthy lifestyle, government initiatives supporting research in autoimmune diseases, and increasing expenditure on the research of autoimmune diseases.
Some of the key players operating in the global autoimmune disease diagnostics market are Thermo Fisher Scientific Inc. (U.S.), Bio-Rad Laboratories, Inc. (U.S.), Beckman Coulter, Inc. (U.S.), Abbott Laboratories (U.S.), Becton, Dickinson, and Company (U.S.), PerkinElmer, Inc. (U.S.), F. Hoffmann-La Roche Ltd (Switzerland), Siemens Healthineers AG (Germany), Grifols, S.A. (Spain), and Creative Diagnostics (U.S.).
With extensive primary and secondary research and in-depth analysis of the market scenario, the report studies the key industry drivers, restraints, challenges, and opportunities. The growth of the autoimmune disease diagnostics market is attributed to the increasing prevalence of autoimmune disorders, the growing emphasis on early diagnosis, and the rising awareness regarding autoimmune diseases. However, difficulties in diagnosing autoimmune diseases restrain the growth of this market. Emerging economies and increasing investments & funding in the autoimmune diseases space are expected to generate growth opportunities for the players in this market. Moreover, the unfavorable reimbursement scenario and high rate of delayed diagnosis or misdiagnosis are major challenges for market growth.
Based on product type, the autoimmune disease diagnostics market is segmented into reagents, assays & kits, and instruments. The reagents, assays & kits segment is expected to grow at the fastest CAGR during the forecast period. The growing prevalence of autoimmune diseases, recurrent use of reagents, assays & kits, and their increasing number of launches for autoimmune diseases by major market players are the major factors responsible for the segment growth.
The growing prevalence of autoimmune diseases has prompted major players operating in the autoimmune disease diagnostics market to focus on developing, approving, and launching kits & assays for monitoring and diagnosing autoimmune diseases, further driving their adoption. For instance, in 2022, Thermo Fisher Scientific Inc. (U.S.) launched EliA RNA Pol III and EliA Rib-P blood tests for the diagnosis of Systemic Sclerosis (SSc; scleroderma) and Systemic Lupus Erythematosus (SLE). This test further expands the company's product offerings for autoimmune disease diagnostics.
Based on test type, the autoimmune disease diagnostics market is segmented into antinuclear antibodies test (ANA), C-reactive protein test (CRP), erythrocyte sedimentation rate test, rheumatoid factor test, immunoglobulins test, routine blood tests, and other test types. In 2023, the antinuclear antibodies test (ANA) segment is expected to account for the largest share of the market. This segment's large market share is attributed to the increasing prevalence of autoimmune diseases and the widespread use of the ANA test for diagnosing autoimmune diseases due to its affordability, ease of administration, and heightened sensitivity & specificity.
According to the National Stem Cells Foundation, over 80 autoimmune diseases affect nearly 4% of the global population. The high burden of autoimmune diseases leads to the adoption of the antinuclear antibodies test, which is used as a primary test for several autoimmune diseases.
Based on disease type, the autoimmune disease diagnostics market is segmented into systemic autoimmune diseases and organ-specific autoimmune diseases. In 2023, the systemic autoimmune diseases segment is expected to account for the largest share of the market. The large market share of this segment is attributed to the higher prevalence of systemic autoimmune diseases compared to organ-specific conditions, increasing initiatives to raise awareness about these diseases, and the continuous growth in research activities related to autoimmune conditions. The Arthritis Foundation (AF) estimates that the global prevalence of RA is 0.5 to 1% in developed countries. A 2020 review found that the prevalence of RA in the Middle East and Africa ranged from 0.06 to 3.4%. Rheumatoid arthritis requires long-term monitoring and management.
Based on end user, the autoimmune disease diagnostics market is segmented into hospitals & clinics, diagnostic laboratories, and academic & research institutes. In 2023, the diagnostic laboratories segment is expected to account for the largest share of the market. Diagnostic laboratories receive samples from various healthcare centers, including hospitals and clinics. Diagnostics laboratories are crucial in providing accurate diagnostic results and managing disease management. Diagnostic laboratories process more samples in less time due to the well-equipped systems and the presence of skilled professionals. These factors contribute to the large market share of this segment in the autoimmune diseases diagnostics market.
An in-depth analysis of the geographical scenario of the autoimmune disease diagnostics market provides detailed qualitative and quantitative insights into five major geographies: North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa, along with the coverage of major countries in each region. Asia-Pacific is slated to register the highest CAGR during the forecast period. The market growth in this region is attributed to the growing prevalence and incidence of celiac diseases & rheumatoid arthritis, unhealthy lifestyle, government initiatives supporting research in autoimmune diseases, and increasing expenditure on the research of autoimmune diseases.
Some of the key players operating in the global autoimmune disease diagnostics market are Thermo Fisher Scientific Inc. (U.S.), Bio-Rad Laboratories, Inc. (U.S.), Beckman Coulter, Inc. (U.S.), Abbott Laboratories (U.S.), Becton, Dickinson, and Company (U.S.), PerkinElmer, Inc. (U.S.), F. Hoffmann-La Roche Ltd (Switzerland), Siemens Healthineers AG (Germany), Grifols, S.A. (Spain), and Creative Diagnostics (U.S.).
Scope of the Report
Autoimmune Disease Diagnostics Market, by Product Type
- Reagents, Assays, and Kits
- Instruments
- Software & Services
Autoimmune Disease Diagnostics Market, by Test Type
- Antinuclear Antibodies (ANA) Test
- Rheumatoid Factor Test
- Immunoglobulins Test
- Routine Blood Tests Test
- C-reactive Protein (CRP) Test
- Erythrocyte Sedimentation Rate (ESR) Test
- Other Test Types
Autoimmune Disease Diagnostics Market, by Disease Type
- Systemic Autoimmune Diseases
- Rheumatoid Arthritis
- Psoriasis
- Systemic Lupus Erythematosus
- Multiple Sclerosis
- Other Systemic Autoimmune Diseases
- Organ-specific Autoimmune Diseases
- Type-1 Diabetes
- Celiac Diseases
- Inflammatory Bowel Disease
- Other Organ-Specific Diseases
Autoimmune Disease Diagnostics Market, by End User
- Hospitals & Clinics
- Diagnostic Laboratories
- Academic & Research Institutes
Autoimmune Disease Diagnostics Market, by Geography
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- U.K.
- Italy
- Spain
- Rest of Europe (RoE)
- Asia-Pacific (APAC)
- Japan
- China
- India
- Rest of APAC (RoAPAC)
- Latin America
- Middle East & Africa
Table of Contents
1. Introduction
2. Research Methodology
4. Market Insights
5. Autoimmune Disease Diagnostics Market Assessment - by Product Type
6. Autoimmune Disease Diagnostics Market Assessment - by Test Type
7. Global Autoimmune Disease Diagnostics Market - by Disease Type
8. Autoimmune Disease Diagnostics Market Assessment - by End User
9. Autoimmune Disease Diagnostics Market Assessment - by Geography
10. Competition Analysis
11. Company Profiles (Company Overview, Financial Overview, Product Portfolio, and Strategic Developments)
12. Appendix
List of Tables
List of Figures
Companies Mentioned
- Thermo Fisher Scientific Inc. (U.S.)
- Bio-Rad Laboratories Inc. (U.S.)
- Beckman Coulter Inc. (U.S.)
- Abbott Laboratories (U.S.)
- Becton Dickinson and Company (U.S.)
- PerkinElmer Inc. (U.S.)
- F. Hoffmann-La Roche Ltd (Switzerland)
- Siemens Healthineers AG (Germany)
- Grifols S.A. (Spain)
- Creative Diagnostics (U.S.).
