Autoimmune Disease Diagnostics Market – By Product (Reagents, Instruments), By Disease Type (Systemic, Localized), By Test Type (Antinuclear Antibody Tests, Autoantibody Tests, C-reactive Protein, Urinalysis), By End-use (Hospitals, Diagnostic Centers) – Global Forecast, 2024 – 2032

Autoimmune Disease Diagnostics Market Size

Autoimmune Disease Diagnostics Market size was valued at USD 5.3 billion in 2023 and is anticipated to witness growth at a CAGR of 5.9% between 2024 and 2032. The rising incidence of autoimmune diseases and the adoption of automation in equipment are vital factors propelling global market growth.
 

Autoimmune disorders develop when the immune system mistakenly attacks its own cells due to abnormalities. A failure to detect immune cells, tissues, and organs, coupled with the production of autoantibodies targeting these cells, causes the immune system to malfunction. Consequently, several initiatives by organizations aim to raise awareness about autoimmune diseases and their socioeconomic impact, thereby increasing the usage rates of autoimmune disease diagnostics globally. Additionally, improved laboratory automation and technological advancements in diagnostics are driving the expansion of the autoimmune disease diagnostics market.
 

Autoimmune diseases are conditions where the immune system attacks one or more normally functioning cells in the body due to asymmetry or irregularities. This malfunction is primarily caused by the immune system's inability to recognize tissues, immunological cells, and other organs, leading to the production of autoantibodies against these cells.
 

However, the need for high capital investment in setting up diagnostic centers, slow turnaround times for test results, and the requirement for multiple diagnostic tests can adversely affect market growth. Diagnostic centers for autoimmune diseases face stringent government regulations and diagnostic complications that may negatively impact business expansion. Various blood tests, such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), enzyme-linked immunosorbent assay (ELISA), and rheumatoid factor (RF), are used to detect the type and severity of autoimmune diseases.
 

Autoimmune Disease Diagnostics Market Trends

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

• Type 1 diabetes is a chronic ailment generally caused when the immune system attacks and destroys insulin-producing cells in the pancreas. This results in high blood sugar levels, which, if left untreated, may lead to multiple organ failures, including the heart, kidneys, nerves, and more.
   
• For instance, according to reports published by the International Diabetes Federation in 2021, over 1.2 million children and adolescents under the age of 19 are affected by Type 1 diabetes, and the numbers are steadily increasing. Moreover, according to the American Diabetes Association, in 2019, over 1.9 million Americans were suffering from Type 1 diabetes. The increasing prevalence of such diseases leads to significant health consequences and comorbidities, resulting in substantial mortality.
   
• As a result, with the surging patient population, the market is anticipated to see a significant rise in the adoption of autoimmune disease diagnostics soon.
   

Autoimmune Disease Diagnostics Market Analysis

The market, by product, is bifurcated into reagents and consumables, and instruments. The reagents and consumables segment dominated the market with a revenue of around USD 3.5 billion in 2023.
 

• The rising incidence of autoimmune diseases such as rheumatoid arthritis, lupus, and multiple sclerosis is driving the demand for diagnostic tests. As more patients require testing, the need for reagents and consumables also increases.
   
• Continuous advancements in diagnostic technologies, such as enzyme-linked immunosorbent assays (ELISA), polymerase chain reaction (PCR), and immunofluorescence assays, have led to a higher demand for specialized reagents and consumables. These innovations enhance the accuracy and efficiency of autoimmune disease diagnostics.
   
• Moreover, increased awareness about autoimmune diseases and the importance of early diagnosis among healthcare providers and patients has resulted in higher testing rates. Early detection often involves multiple tests, further boosting the demand for reagents and consumables.
   

The autoimmune disease diagnostics market by disease type, is bifurcated into systemic autoimmune disease and localized autoimmune disease. The localized autoimmune disease segment dominated the market with a revenue of around USD 3.7 billion in 2023 and is expected to grow at a CAGR of 5.7%.
 

• The high prevalence of localized autoimmune diseases, such as Type 1 diabetes, multiple sclerosis, and inflammatory bowel diseases (Crohn's disease and ulcerative colitis), drives the demand for diagnostic tests. These diseases often require ongoing monitoring and frequent testing.
   
• Continuous advancements in diagnostic technologies, such as molecular diagnostics, imaging techniques, and cancer biomarker discovery, are enhancing the accuracy and efficiency of diagnosing localized autoimmune diseases. Innovations like next-generation sequencing (NGS) and advanced immunoassays are crucial for early and precise diagnosis.
   
• Moreover, growing awareness about localized autoimmune diseases and the importance of early diagnosis among healthcare providers and patients has led to higher testing rates. Public health initiatives and screening programs promote early detection and intervention, further boosting the demand for diagnostic tests.
   

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 other tests. The antinuclear antibody tests segment was valued at over USD 2.3 billion in 2023 and is anticipated to grow at a 6.1% CAGR from 2024-2032.
 

• This dominant market growth is primarily attributed to the high prevalence of chronic ailments and diseases that attack the immune system, such as Type 1 diabetes, myasthenia gravis, Addison's disease, and rheumatoid arthritis.
   
• 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 genetic autoimmune diseases is expected to expedite the autoimmune disease diagnostics industry's growth in the coming years.
   

By end-use, the autoimmune disease diagnostics market is segmented into hospitals, diagnostic centers, and other end-users. The hospitals segment accounted for a majority market share of 53.5% in 2023 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 consist of sophisticated technology labs, offer effective physiotherapy sessions, provide improved patient care and counselling, and offer other services that ensure market expansion and create demand for these facilities.
   
• Furthermore, the rise in the incidence of several chronic and neurological diseases that can result in autoimmune conditions will drive market expansion. The increasing availability of highly skilled medical and healthcare professionals, along with advanced facilities, are key factors contributing to segmental progression, thereby leading to overall market growth.
   

North America autoimmune disease diagnostics market accounted for USD 1.9 billion in revenue in 2023 and is predicted to witness substantial market growth over the analysis timeline.
 

• The U.S. market is projected to exceed USD 2.9 billion by 2030. This dominant market share is attributed to several factors, including the rising autoimmune disease burden, increasing healthcare expenditure, product launches, and the presence of major players across the country.
   
• According to the National Stem Cell Foundation, approximately 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 reports from the National Institute of Environmental Health Sciences, in 2021, around 24 million people in the U.S. were affected by autoimmune diseases, with an additional 8 million people having autoantibodies—blood molecules that might increase the chances of developing autoimmune disease. Furthermore, increasing awareness and favourable government initiatives are expected to drive lucrative market growth.
   
• Technologically advanced diagnostic centers and the adoption of automation technology in diagnosis and treatment will provide ample growth opportunities. Moreover, the presence of major players in the country and the launch of novel products are expected to fuel the regional market statistics.
   

Autoimmune Disease Diagnostics Market Share

The global market is highly competitive, characterized by rapid advancements in diagnostic technologies and a growing focus on early detection. Market players are continuously innovating to improve the accuracy, efficiency, and accessibility of diagnostic tests. The landscape is shaped by frequent product launches, strategic partnerships, and mergers and acquisitions aimed at expanding market presence. Additionally, increased investment in research and development, along with rising awareness of autoimmune diseases, is driving competition. The market is also influenced by regional expansions and the adoption of automation in diagnostic processes, further intensifying the competitive environment.
 

Autoimmune Disease Diagnostics Market Companies

Some of the eminent market participants operating in the autoimmune disease diagnostics industry include:

• Abbott Laboratories
• Bio-Rad Laboratories, Inc.
• DIAsource ImmunoAssays SA
• Euroimmun AG (Perkin Elmer)
• F. Hoffmann-la Roche Ltd.
• Hemagen Diagnostics
• Myriad Genetics
• Quest Diagnostics
• Siemens Healthineers Inc
• SQI Diagnostics Inc.
• Thermo Fisher Scientific Inc.
• Trinity Biotech Plc.
   

Autoimmune Disease Diagnostics Industry News:

• In May 2022, Thermo Fisher Scientific announced the availability of the Phadia 2500+ Instrument in the U.S. for autoimmune testing. This device aids 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 gain business revenue along with an enhanced customer base.
   

The autoimmune disease diagnostics market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 to 2032 for the following segments:

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Market, By Product

• Reagents and consumables
• Instruments

Market, By Disease Type

• Systemic autoimmune disease 
  • Rheumatoid arthritis
  • Systemic lupus erythematosus (SLE)
  • Psoriasis
  • Multiple sclerosis
  • Other systemic autoimmune diseases
• Localized autoimmune disease 
  • Inflammatory bowel disease
  • Type 1 diabetes
  • Thyroid
  • Other localized autoimmune diseases

Market, By Test Type

• Antinuclear antibody tests
• Autoantibody tests
• C-reactive protein (CRP)
• Complete blood count (CBC)
• Urinalysis
• Other tests

Market, By End-use

• Hospitals
• Diagnostics centers
• Other end-users

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

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa