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Autoimmune Disease Diagnostics Market - By Disease Type (Systemic Autoimmune Disease, Localized Autoimmune Disease), By Test Type (Antinuclear Antibody Tests, Autoantibody Tests, C-reactive Protein, Complete Blood Count, Urinalysis), By End-use & Forecast, 2022-2030

  • Report ID: GMI618
  • Published Date: Jul 2022
  • Report Format: PDF

Industry Autoimmune Disease Diagnostics Market Size

Autoimmune Disease Diagnostics Market size was valued at around USD 1,104 million in 2021 and is estimated to register over 6.6% CAGR between 2022 and 2030. The rising incidence of autoimmune diseases and the adoption of automation for equipment are some of the vital pointers that are propelling the global market growth.

Autoimmune Disease Diagnostics Market

To understand key trends  

Autoimmune disorders develop when the immune system attacks its own cells in the body as a result of abnormalities. The failure to detect immune cells, tissues & organs and produce autoantibodies targeting these cells causes the immune system to malfunction. Therefore, several initiatives are implemented by organizations to create awareness about autoimmune diseases and socioeconomic impact, thereby boosting the usage rates of autoimmune disease diagnostics, globally. Additionally improved laboratory automation and technological advancements in diagnostics are driving the autoimmune disease diagnostics market expansion.

Autoimmune diseases are an ailment of the immune system that attacks one or more normally functioning cells of the body owing to the asymmetry or irregularities. The malfunctioning of the immune system is mainly due to the inability of the cell to recognise tissues, immunological cells, and other organs that produce autoantibodies against these cells.

However, need for high capital investment in setting-up diagnosis centers and slow turnaround time for test results as well as need for multiple diagnostic tests can adversely affect the market growth. The diagnostics centers for autoimmune disease diagnostics are associated with stringent government regulations, and diagnostic complications that may negatively impact the business expansion. Several types of blood test such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), enzyme-linked immunosorbent assay (ELISA), rheumatoid factor (RF), etc. are done to detect the type and severity of autoimmune disease.

These tests have a long turnaround time due to several procedures to determine the positivity with accuracy. For instance, the rheumatoid factor (RF) test to determine rheumatoid arthritis take more than 2 days for the result. Similarly, the C-reactive protein (CRP) test to measure the level of CRP in blood takes over 3 days for the test results. As a result, the slow turnaround time associated with the use of standard disease diagnostic techniques, as well as the presence of fewer modern testing technologies, are some of the limitations further hindering the industry growth.

The COVID-19 pandemic emerged as an unprecedented global pandemic, affecting the healthcare sector by disrupting the global supply chain. During the initial phase of the outbreak, in the first half of 2020, the pandemic hampered the growth of the autoimmune disease diagnostics market. National emergencies and lockdowns were imposed in numerous countries to prevent the spread of the COVID-19 virus. The lockdown and travel restrictions had a negative influence on health systems.

The coronavirus pandemic had an impact on the autoimmune disease diagnostics business by restricting product uptake and associated procedures. It had an impact on consumer and manufacturers by significantly reducing and delaying the number of non-emergency surgical procedures conducted and patients assessed for eligibility of autoimmune disease diagnostics.

According to the reports of the National Center of Biotechnology Information (NCBI), in 2021, the patients suffering from the rheumatoid arthritis (RA) had a high risk of developing COVID-19. This led in more stringent operational procedures, that elevated the product demand. The combined efforts of certain regulatory authorities and market players contributed to reducing the impact of the pandemic. Furthermore, autoimmune disease diagnostics reached pre-pandemic diagnostic volume in 2021. Thus, the COVID-19 pandemic delayed industry growth marginally; however, restoring surgical volume would help market expansion in the near future.

Surging prevalence of autoimmune disease is expected to fuel the business landscape

Substantial surge in the number of patients affected with autoimmune diseases is amongst the major factors propelling the market growth in the foreseeable future. Type 1 diabetes, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease among others are some of the most common diseases that require autoimmune diagnostics and treatment.

Type 1 diabetes is a chronic ailment that is generally caused when the immune system attacks and destroys insulin-producing cells in the pancreas. This results in high blood sugar level and if left untreated may lead to multiple organ failure including heart, kidneys, nerves, etc.

For instance, according to the reports published by the International Diabetes Federation, in 2021, over 1.2 million children and adolescents below the age of 19 years are infected with type 1 diabetes and the numbers are growing at a steady pace. Moreover, according to the America Diabetes Association, in 2019 over 1.9 million Americans were suffering from Type 1 diabetes. Increasing prevalence of such disease promotes significant health consequences and co-morbidities that also results in substantial mortality.

As a result, with the surging patient population, the market is anticipated to foresee significant rise in the adoption of autoimmune disease diagnostics in the near future.

Autoimmune Disease Diagnostics Market Analysis

Global Autoimmune Disease Diagnostics Market Size, By Disease Type

To understand key trends  

The systemic autoimmune disease segment accounted for substantial market share in 2021 and is expected to register over 7% CAGR during the estimation timeframe. This notable market share is pertaining to rapid increase of systemic autoimmune diseases associated with increasing number of morbidity and mortality. Some of the major diseases that result in systemic autoimmune disease include rheumatoid arthritis, systemic lupus erythematosus (SLE), psoriasis, multiple sclerosis, etc. Among patients suffering from rheumatoid arthritis, the immune systems of these patients attack the synovial tissues in joints leading to redness, warmth, soreness, and stiffness in the joints.

According to the reports of the National Center of Biotechnology Information (NCBI), in the U.S. and other western nations of northern Europe, the annual incidence of rheumatoid arthritis is around 40 per 100,000 people. Additionally, over 1.5 million people in U.S. are suffering from rheumatoid arthritis and are likely to grow in the near future.

Therefore, the increasing prevalence of these systemic autoimmune disease and treatments associated with them via advanced automation technology will fuel the market demand. Further, the ongoing clinical studies & R&D efforts to assess and promote efficacy is set to proliferate the autoimmune disease diagnostics market size.

Based on test type, the autoimmune disease diagnostics market is segmented into antinuclear antibody tests, autoantibody tests, c-reactive protein (CRP), complete blood count (CBC), urinalysis and others. The antinuclear antibody tests segment was valued at over USD 479 million in 2021 and is anticipated to grow at a 6.8% CAGR from 2022-2030. This dominant market growth is majorly attributed to the high prevalence of chronic ailments and diseases that attack immune systems such as type 1 diabetes, myasthenia gravis, Addison’s disease, rheumatoid arthritis, etc.

Antinuclear antibody tests detect antinuclear antibodies in the blood. Myasthenia gravis is a genetically susceptible autoimmune disease. According to NCBI, in 2021, the prevalence rate of myasthenia gravis in the U.S. was around 20 individuals per 100,000 population and it is increasing at a steady pace. Thus, the high prevalence of genetical autoimmune diseases is expected to expedite the autoimmune disease diagnostics industry landscape in the coming years.

Global Autoimmune Disease Diagnostics Market Share, By End-use,

To understand key trends  

The hospitals segment accounted for a majority market share of more than 53% in 2021 and is expected to proliferate the market growth during the analysis period. This significant market share is owing to the surged adoption of autoimmune disease diagnostic procedures in hospitals associated to complex interventional surgeries. Hospitals consists of sophisticated technology labs, provide effective physiotherapy sessions, improved patient aid and counselling, and other services that ensure market expansion and create demand for these facilities.

Furthermore, the rise in the incidence of several chronic diseases, and neurological diseases that can result in autoimmune diseases will drive the market expansion. Increasing availability of highly skilled medical and healthcare professionals, as well as advanced facilities, are some of the key factors that contribute to segmental progression thereby leading to overall market growth.

Global Autoimmune Disease Diagnostics Market, By Region

To understand key trends  

The U.S. autoimmune disease diagnostics market is projected to reach more than USD 660 million by 2030. This dominant market share is owing to several factors such as the rising autoimmune disease burden, increasing healthcare expenditure, product launches, and presence of major players across the country. According to the National Stem Cell Foundation, approximately between 5% to 8% of the total U.S. population suffers from multiple autoimmune disorders accounting for around 1 in 15 people undergoing autoimmune disease diagnostics treatment.

Additionally, as per the reports of the National Institute of Environmental Health Sciences, in 2021, around 24 million people in the U.S. were affected with autoimmune diseases and additional 8 million people were having autoantibodies, blood molecules that might create chances to develop autoimmune disease. Further, the increasing awareness and favorable government initiatives will help to witness a lucrative market growth. Technologically advanced diagnostic centers and adoption of automation technology in diagnosis and treatment will provide ample growth opportunities. Also, the presence of major players in the country and launch of novel products is expected to fuel the regional market statistics.

Autoimmune Disease Diagnostics Market Share

Some of the major players operating in the autoimmune disease diagnostics market are

  • Abbott Laboratories
  • Bio-rad Laboratories
  • F. Hoffmann-la Roche
  • Thermo Fisher Scientific
  • EUROIMMUN Medizinische Labordiagnostika AG (Perkin Elmer)
  • Siemens Healthineers Inc.

These prominent players focus on strategic partnerships, new product launch & commercialization for business expansion. Furthermore, industry players are heavily investing in research that allows them to introduce innovative products and garner maximum revenue.

Recent industry developments:

  • In May 2022, Thermo Fisher Scientific announced the availability of the Phadia 2500+ Instrument in the U.S. for autoimmune testing. This device allows autoimmune diagnostics, aiding in the diagnosis of autoimmune diseases including celiac disease, rheumatoid arthritis, autoimmune liver disease and autoimmune thyroid disease among others. This strategic launch helped the company to gain business revenue along with enhanced customer base.

Autoimmune disease diagnostics market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2017 to 2030, for the following segments:

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By Disease Type

  • Systemic Autoimmune Disease
    • Rheumatoid Arthritis
    • Systemic Lupus Erythematosus (SLE)
    • Psoriasis
    • Multiple Sclerosis
    • Others
  • Localized Autoimmune Disease      
    • Inflammatory Bowel Disease
    • Type 1 Diabetes
    • Thyroid
    • Others

By Test Type

  • Antinuclear Antibody Tests
  • Autoantibody Tests
  • C-reactive Protein (CRP)
  • Complete Blood Count (CBC)
  • Urinalysis
  • Others

By End-use

  • Hospitals
  • Diagnostics Centers
  • Others

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Spain
    • Italy 
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • MEA
    • South Africa
    • Saudi Arabia
    • UAE


Authors: Mariam Faizullabhoy

Frequently Asked Questions (FAQ) :

The global autoimmune disease diagnostics industry size had crossed USD 1,104 million in 2021 and is poised to record a 6.6% CAGR between 2022 and 2030 owing to the rising incidence of the disease and greater adoption of automation for equipment.
The systemic autoimmune disease diagnostics market is likely to strike a 7% CAGR through 2030 due to the rapidly increasing morbidity and mortality rate of the disease.
The hospitals end-user segment held over 53% of the autoimmune disease diagnostics market share in 2021 and will expand with the rise in diagnostic procedures associated with complex interventional surgeries in these facilities.
The autoimmune disease diagnostics industry share in the U.S. is expected to exceed USD 660 million by 2030 impelled by the strong presence of major players, thriving autoimmune disease burden, and the expanding healthcare expenditure across the country.

Autoimmune Disease Diagnostics Market Scope

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Premium Report Details

  • Base Year: 2021
  • Companies covered: 12
  • Tables & Figures: 309
  • Countries covered: 18
  • Pages: 190
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