Autoimmune Disease Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The Autoimmune Disease Diagnostics Market is Segmented by Disease Type ( Systemic Autoimmune Disease ( Rheumatoid Arthritis, Psoriasis, Systemic Lupus Erythematosus (SLE), Multiple Sclerosis, Other Systemic Autoimmune Diseases) and Localized Autoimmune Disease (Inflammatory Bowel Disease, Type 1 Diabetes, Thyroid, and Other Localized Autoimmune Diseases), Diagnosis Type (Antinuclear Antibody Tests, Autoantibody Tests, Complete Blood Count (CBC), C-reactive Protein (CRP), Urinalysis, Others tests), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

autoimmune disease diagnostics market
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: 6.8 %

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Market Overview

The autoimmune disease diagnostics market was valued at USD 4,253.30 million in 2021 and is projected to reach USD 6,298.98 million by 2027 registering a CAGR of nearly 6.8% during the forecast period.

The first wave of the COVID-19 pandemic has disrupted almost all areas of health care services to some extent throughout the world. The negative impact of COVID-19 on patients with autoimmune diseases has also been recognized. According to an article titled "The impact of the COVID-19 pandemic on autoimmune diagnostics in Europe: A lesson to be learned," published in October 2021, a decrease in the number of autoantibody tests was observed in all European countries in the year 2020 compared to 2019. All autoantibody tests saw a 13% decrease, ranging from 1.4% in Switzerland to 25.5% in the United States (Greece). The decrease was most pronounced in all countries during the first wave of the pandemic (March-May 2020), with an overall decrease of 45.2% in those three months. The decrease was less pronounced(6.8%) in the second wave of the pandemic (October-December 2020).

The rising autoimmune diseases are the primary factor behind the market growth. According to scientists at the National Institutes of Health and their collaborators, autoimmunity, a condition in which the body’s immune system reacts with components of its cells, appears to be increasing in the United States. Also, according to the article published in January 2022, Autoimmune diseases are becoming more prevalent worldwide. The global spread of Western diets is linked to higher levels of autoimmune disease. As per the same source, Tens of millions of people develop autoimmune diseases in the US alone, and the number of cases has been increasing in recent decades. Thus, the increasing number of autoimmune diseases is driving the market growth.

The rising awareness about autoimmune diseases through research, education, support, and advocacy programs is a keycrucialctor boosting the usage rates of autoimmune disease diagnostics globally. Government organizations and NGOs aim to increase awareness about the socioeconomic impact of autoimmunity through fostering and facilitating collaboration in education, public awareness, research, and patient services in a practical, ethical, and efficient manner. The other factors, such as improved laboratory automation, partnerships with physicians and clinical laboratories, and technological advancements, are driving the autoimmune disease diagnostics market. However, the slow turnaround time of the diagnosis and high frequency of false results are hindering the growth of the autoimmune disease diagnostics market.

Scope of the Report

As per the report's scope, autoimmunity involves the loss of normal immune homeostasis, as the organism produces an abnormal response to its tissue. Autoimmune diseases generally affect the presence of self-reactive T cells, autoantibodies, and inflammation. Diagnosis of potential autoimmune disorders is challenging because not one laboratory test alone can produce the diagnosis results of the illness. The diagnosis can be helpful in the management of patients suffering from autoimmune diseases and help in providing a prognosis or indicating the severity of organ involvement or damage. Disease Type segments the Autoimmune Disease Diagnostics Market ( Systemic Autoimmune Disease​ ( Rheumatoid Arthritis, Psoriasis, Systemic Lupus Erythematosus (SLE), Multiple Sclerosis, Other Systemic Autoimmune Diseases) and Localized Autoimmune Disease (Inflammatory Bowel Disease, Type 1 Diabetes, Thyroid, and Other Localized Autoimmune Diseases​), Diagnosis Type (Antinuclear Antibody Tests​, Autoantibody Tests​, Complete Blood Count (CBC)​, C-reactive Protein (CRP)​, Urinalysis​, Others tests), and Geography (North America, Europe, Asia-Pacific, Middle East, and Africa, and South America). The report offers the value (USD million) for the above segments.

Disease Type
Systemic Autoimmune Disease
Rheumatoid Arthritis
Systemic Lupus Erythematosus (SLE)
Multiple Sclerosis
Other Systemic Autoimmune Diseases
Localized Autoimmune Disease
Inflammatory Bowel Disease
Type 1 Diabetes
Other Localized Autoimmune Diseases
By Diagnosis
Antinuclear Antibody Tests​
Autoantibody Tests​
Complete Blood Count (CBC)​
C-reactive Protein (CRP)​
Others tests
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle-East and Africa
South Africa
Rest of Middle-East and Africa
South America
Rest of South America

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Key Market Trends

Rheumatoid Arthritis Segment is Expected to Hold a Major Market Share in the Autoimmune Disease Diagnostics Market

Early detection of autoimmune rheumatic diseases (ARDs) is critical for effective treatment and a better prognosis. On a global scale, the coronavirus disease 2019 (COVID-19) pandemic has significantly changed clinical practice. According to an article published in February 2022 titled "Impact of the COVID-19 Pandemic on the Appropriateness of Diagnostic Pathways of Autoimmune Rheumatic Diseases," the volume of autoimmunity laboratory tests in 2020 was significantly lower than in 2019. There was also a significant reduction in the number of first rheumatological visits and diagnoses.

Additionally, according to medical records and laboratory data collected from San Carlo Hospital in Basilicata, Italy, between January and December 2020 and compared to the same period in 2019, there was a significant decrease in autoimmunity tests during the pandemic period when compared to the previous year (9912 vs. 14100, respectively). General practitioners (GPs) ordered 70% of trials in 2020, followed by other specialists (20%) and rheumatologists (10%). Antinuclear antibodies (ANA), anti-extractable nuclear antigen (anti-ENA), anti-double-stranded DNA (anti-dsDNA), rheumatoid factor (RF), and anti-neutrophil cytoplasmic antibody all had 1.5 times fewer samples. Compared to the pre-pandemic period (1272 vs. 2336), rheumatological visits decreased by 48 % in 2020, with the most significant drops occurring in March, April, and May.

Rheumatoid arthritis (RA) is an autoimmune disease that mainly attacks the synovial tissues within the joints. The disease predominantly affects elderly patients. The aging population and technological advancements in immunofluorescence and proteomics technologies will further enhance the rheumatoid arthritis diagnosis influencing the segment growth.

The rising prevalence of diseases such as rheumatoid arthritis and Hashimoto’s thyroiditis and the presence of favorable government regulations will significantly impact the autoimmune disease diagnostics market growth. As per the Global RA Network, 2021, More than 350 million people have arthritis globally. The demand for better and more precise diagnostic methods, along with the increasing prevalence, is expected to increase over the forecast period.

 autoimmune disease diagnostics market size

Asia-Pacific is the Fastest Growing Region in the Autoimmune Disease Diagnostics Market

The COVID-19 pandemic significantly impacted the diagnosis of autoimmune diseases and clinical laboratory operations far beyond shortages of reagents and supplies. The increased workload forced laboratories to mobilize personnel and resources to support SARS-CoV-2 testing, affecting diagnostic testing of autoimmune diseases. Besides, people were also reluctant to visit the clinics and diagnostics centers during the 1stand 2nd wave of the coronavirus pandemic.

Asia-Pacific is anticipated to exhibit extensive market growth over the forecast period, owing to rising disposable income and increasing patient pool in emerging countries. Furthermore, growing awareness regarding the benefits of early and accurate diagnosis of autoimmune diseases to seek the proper treatment, rising development of healthcare infrastructure, and increasing healthcare expenditure are likely to boost the growth of the autoimmune disease diagnostics market in the Asia-Pacific region.

According to an article published by Janssen Asia Pacific, a division of Johnson & Johnson Pte. Ltd., autoimmune, inflammatory, and pulmonary diseases, such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease, are on the rise in the Asia Pacific. The region already has the world's highest burden of chronic obstructive pulmonary disease (COPD), as well as the highest prevalence of systemic lupus erythematosus (SLE) in China and Southeast Asia. Hence, this will likely create demand for diagnostics in the coming years.

autoimmune disease diagnostics market analysis

Competitive Landscape

The Autoimmune Disease Diagnostics Market is fragmented and competitive. The market comprises significant market players, and these players are focusing on R&D activities and effective growth strategies. Recently, a few diagnostic companies entered into strategic partnerships with hospitals. This trend is expected to continue over the next few years to meet the high volume of patient needs across different regions.

Recent Development

  • In October 2021, Exagen Inc., a leading provider of autoimmune testing solutions, announced that AVISE CTD and AVISE Lupus are contracted covered services with Inland Empire Health Plan (IEHP), providing enhanced care to over 1.4 million members. The agreement also makes AVISE diagnostic testing available as an in-network benefit.
  • In January 2021, Exagen Inc., an organization dedicated to transforming the care continuum for patients suffering from autoimmune diseases, announced that all AVISE test offerings (CTD, Lupus, SLE Prognostic, SLE Monitor, APS, Vasculitis AAV, MTX, and HCQ) were now a contracted in-network service with Tufts Medical Center, an internationally-respected academic medical center.

Table of Contents


    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Growing Burden of Autoimmune Diseases and Rising Public Awareness​

      2. 4.2.2 Technological Advancements and Improved Laboratory Automation​

    3. 4.3 Market Restraints

      1. 4.3.1 Slow Turnaround Time of Results and Need for Multiple Diagnostic Tests

      2. 4.3.2 High Cost and Reimbursement Issues Coupled with Regulatory Uncertainties

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value – USD million)

    1. 5.1 Disease Type

      1. 5.1.1 Systemic Autoimmune Disease

        1. Rheumatoid Arthritis

        2. Psoriasis

        3. Systemic Lupus Erythematosus (SLE)

        4. Multiple Sclerosis

        5. Other Systemic Autoimmune Diseases

      2. 5.1.2 Localized Autoimmune Disease

        1. Inflammatory Bowel Disease

        2. Type 1 Diabetes

        3. Thyroid

        4. Other Localized Autoimmune Diseases

    2. 5.2 By Diagnosis

      1. 5.2.1 Antinuclear Antibody Tests​

      2. 5.2.2 Autoantibody Tests​

      3. 5.2.3 Complete Blood Count (CBC)​

      4. 5.2.4 C-reactive Protein (CRP)​

      5. 5.2.5 Urinalysis​

      6. 5.2.6 Others tests

    3. 5.3 Geography

      1. 5.3.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.3.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.3.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.3.4 Middle-East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle-East and Africa

      5. 5.3.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Abbott Laboratories

      2. 6.1.2 Biomerieux

      3. 6.1.3 Bio-rad Laboratories

      4. 6.1.4 Euroimmun AG

      5. 6.1.5 F. Hoffmann-la Roche

      6. 6.1.6 Inova Diagnostics Inc.

      7. 6.1.7 Myriad Genetics

      8. 6.1.8 Siemens Healthineers Inc.

      9. 6.1.9 Thermo Fisher Scientific

      10. 6.1.10 Trinity Biotech

      11. 6.1.11 Grifols, S.A.

      12. 6.1.12 Exagen Inc.

      13. 6.1.13 DIAsource ImmunoAssays SA

      14. 6.1.14 R-Biopharm AG

    2. *List Not Exhaustive

**Competitive Landscape Covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The Autoimmune Disease Diagnostics Market market is studied from 2019 - 2027.

The Autoimmune Disease Diagnostics Market is growing at a CAGR of 6.8% over the next 5 years.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

Abbott Laboratories, Biomérieux, Trinity Biotech, Bio-rad Laboratories, Thermo Fisher Scientific are the major companies operating in Autoimmune Disease Diagnostics Market.

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