Autoimmune Disease Diagnostics Market by Product (Reagents, Kits, Assays, Instruments), Test Type (ANA, CRP, ESR, Rheumatoid Factor, Routine Test), Disease Type (Systemic, Localized), End User (Hospital, Diagnostic Lab, Research)—Global Forecast to 2030

Autoimmune Disease Diagnostics Market by Product (Reagents, Kits, Assays, Instruments), Test Type (ANA, CRP, ESR, Rheumatoid Factor, Routine Test), Disease Type (Systemic, Localized), End User (Hospital, Diagnostic Lab, Research)—Global Forecast to 2030

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.).

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

(Note – Other test types include (Anti-double stranded DNA, Extractable nuclear antigen, Anti-signal recognition particle tests, Ferritin, and Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibodies)

Autoimmune Disease Diagnostics Market, by Disease Type

Systemic Autoimmune Diseases
Rheumatoid Arthritis
Psoriasis
Systemic Lupus Erythematosus
Multiple Sclerosis
Other Systemic Autoimmune Diseases(Other systemic autoimmune diseases include systemic scleroderma, dermatomyositis, Sjögren's syndrome, mixed connective tissue disease, Behçet syndrome, sarcoidosis, and myasthenia gravies, among others)
Organ-specific Autoimmune Diseases
Type-1 Diabetes
Celiac Diseases
Inflammatory Bowel Disease
Other Organ-Specific Diseases(Other organ-specific autoimmune diseases include Addison’s disease, Grave’s disease, Guillain-Barre syndrome, Hashimoto’s thyroiditis, and Sclerosing cholangitis, among others)

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

Autoimmune Disease Diagnostics Market - Report Summary

Report Metrics	Details
Years Considered	2021 - 2030
Base Year	2022
Forecast Period	2023-2030
Page Count	261
Units Referenced	Value (USD Million)
Segments/Key Topics	Market by Product Type, Test Type, Disease Type, and End User
Regions Covered	North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa
Key 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), and Creative Diagnostics (U.S.).

FAQs About the Report

What is the scope of the autoimmune disease diagnostics market study?

The autoimmune disease diagnostics market report covers the market sizes & forecasts based on product, test type, disease type, end user, and geography. This report involves the value analysis of various segments and subsegments of the autoimmune disease diagnostics market at the regional and country levels.

What is the revenue generated from autoimmune disease diagnostics across the globe? At what rate is their demand expected to grow for the next 5–7 years?

The autoimmune disease diagnostics market is projected to reach $9.84 billion by 2030, at a CAGR of 7.2% during the forecast period of 2023–2030.

What are the various products in the autoimmune disease diagnostics market, and which product holds the major share?

Based on the product, the autoimmune disease diagnostics market is segmented into reagents, assays, kits, instruments, and software & services. In 2023, the reagents, assays, and kits segment is expected to account for the largest share of the autoimmune disease diagnostics market due to the large market share of this segment is attributed to the frequent use of kits, assays, and reagents during the diagnosis of a wide range of autoimmune diseases. Furthermore, the growing prevalence of autoimmune diseases, especially among the geriatric population, and the increasing launches of kits and assays for autoimmune diseases by major market players contribute to the segment's growth.

What are the various test types in the autoimmune disease diagnostics market, and which test type holds the major share?

Based on test type, the autoimmune disease diagnostics market is segmented into antinuclear antibodies (ANA), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), rheumatoid factor, immunoglobulins, routine blood tests, and other test types. In 2023, the antinuclear antibody (ANA) segment is expected to account for the largest share of the autoimmune disease diagnostics market due 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.

What are the types of diseases in the autoimmune disease diagnostics market, and which disease type holds the major share?

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 autoimmune disease diagnostics market.

What end users are involved in the autoimmune disease diagnostics market, and which end user holds the major share?

Based on end user, the autoimmune disease diagnostics market is segmented into hospitals & clinics, diagnostic laboratories, and academic & research institutes. In 2023, the hospitals & clinics segment is estimated to account for the largest share of the Autoimmune Disease Diagnostics market.

What are the key factors supporting the growth of this market? What are the major opportunities for the market players in the autoimmune disease diagnostics market?

The growth of the autoimmune disease diagnostics market is driven by the increasing prevalence of autoimmune disorders, the growing emphasis on early diagnosis, and the rising awareness regarding autoimmune diseases. Moreover, emerging economies and increasing investments & funding in the autoimmune diseases space are expected to generate growth opportunities for the players in this market.

Who are the major players operating in the autoimmune disease diagnostics market?

The key players operating in the 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.).

Which regions/countries are expected to offer significant growth opportunities for the vendors operating in the Autoimmune Disease Diagnostics market?

The Asia-Pacific region is slated to witness the highest growth rate during the forecast period and offers significant growth opportunities for the players in this market. The fast market growth in Asia-Pacific is attributed to factors such as the growing prevalence and incidence of celiac diseases & rheumatoid arthritis, unhealthy lifestyle, government initiatives regarding autoimmune diseases, and increasing expenditure on the research of autoimmune diseases.