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Global Autoimmune Disorder Diagnostics Market $21.8 Billion by 2031

The global market for autoimmune disorder diagnostics estimated to reach $21.8 billion by 2031, growing steadily at a CAGR of 3.5% over the forecast period, driven by increasing prevalence of autoimmune diseases, and identification of number of autoantigen targets for autoantibodies.

  • With the trend of increasing incidence of autoimmune diseases, laboratories are faced with exponential growth of the requests for tests relating the diagnosis of these diseases.
    • Other market driving factors contributing growth include discovery of new autoantibodies and technical innovations in the immunoassays.
  • Factors restraining the market growth include the lack of laboratory personnel experienced in this specific discipline of laboratory diagnostic, as well as an unawareness of a method limitation often resulting in confusion for clinicians.
    • Similarly, lack of standardized reference samples of defined specificity and different sources of antigens (recombinant vs. native) are the main source of results discrepancy between different methods.
      • Standardization of autoantibody assay is critical to their use in the clinic to predict diagnosis and treat a very diverse group of autoimmune disorders.
Global Autoimmune Disorder Diagnostics Market

Autoimmune disorders (AD) occurs when the body’s immune system begins to attack its own antigens.  It has attracted much attention within the last decade.

  • The discovery of autoimmune antibodies targeting proteins in the body has been applied to the diagnosis of various autoimmune diseases.
  • Autoimmune diseases are recognized as a major health crisis in the United States.
    • According to American Autoimmune Related Diseases Association, Inc. (AARDA), 50 million Americans (80% women) suffer one or more autoimmune conditions.
  • The world incidence and prevalence of autoimmune diseases is increasing.
    • Europeans already have the same rates as Americans. People from developing nations such as in Asia and Southeast Asia are also developing the same rates of autoimmune disease as Americans.
      • Autoimmune disease is one of the top 10 leading causes of death in female children and women in all age groups up to 64 years of age.

A close genetic relationship exists among autoimmune disease, explaining clustering in individuals and families as well as a common pathway of disease. Commonly used immunosuppressant treatments lead to devastating long-term side effects.

The global autoimmune disease diagnostics market report estimates the market size ($million 2021 to 2031), market share, growth trends, forecast (CAGR% 2024 to 2031).

The global market for autoimmune disorder diagnostics segmented by diagnostic test (antinuclear antibody tests, auto-antibody tests, C-reactive protein, complete blood count, comprehensive metabolic panel, erythrocyte sedimentation rate, urinalysis, others), disease type (Graves’ disease, Hashimoto’s thyroiditis, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, type 1 diabetes, others), and geography.

  • Based on the diagnostic tests, the auto-antibody tests segment accounted for the largest share of the total autoimmune disorder diagnostics market, and also anticipated to expand at the fastest growth rate during the forecast period.
    • As highlighted in many medical reports from industrialized countries, autoimmune diseases (AIDs) are increasing in number (almost 100 distinct AIDs have been classified to date) and in epidemiology (5–10% of individuals worldwide are affected by an AID).
      • In the United States, AIDs are collectively estimated to affect from 5 to 8% of the population or 15 to 20 million individuals and are cumulatively the third cause of illness and mortality in humans.
        • Consequently, many efforts are produced by health systems for prevention, early diagnosis and treatment of autoimmune diseases.
          • Autoantibody measurements have been long-term companions to physicians involved in the management of rheumatoid arthritis (RA) patients, with increasing importance during the last decades. 
  • Different techniques have been used to develop specific tests for autoantibody detection including immunodiffusion, immunoblotting techniques, immunofluorescence, enzyme immunoassays and recently flow cytometry for multiplex bead-based assays.
    • Although some tests may be non-specific, such as the erythrocyte sedimentation rate (ESR), they are useful to assess disease activity.
      • These tests can be useful in the diagnosis and management of patients with autoimmune diseases and help in providing a prognosis, or indicate the severity of organ involvement or damage.
  • The urinalysis is commonly used to assess renal injury (glomerulonephritis, interstitial nephritis).
    • Typically, multiple laboratory tests are needed and include basic studies like a complete blood count, comprehensive metabolic panel, acute phase reactants, immunologic studies, serologies, flow cytometry, cytokine analysis, and HLA typing.

The global market for autoimmune disorder diagnostics report is further divided by geography into North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), Latin America (Brazil, Mexico, Rest of LA) and Rest of the World.

The global market research report also provides the detailed market landscape and profiles of major competitors in the global market including company overview, financial snapshot, key products, technologies and services offered, and recent acquisitions and alliances.

Major competitors operating in the global market for autoimmune disorder diagnostics and included in this report are Abbott Laboratories, Inc., bioMérieux S.A., Bio-Rad Laboratories, Inc., Danaher Corporation (Beckman Coulter, Inc.), Inova Diagnostics, Inc., Quest Diagnostics, Inc., Roche Holding AG (F. Hoffmann-La Roche AG), Siemens Healthineers AG, and SQI Diagnostics, Inc.

  • Diagnostic Test
    • Antinuclear Antibody (ANA) Tests
    • Autoantibody Tests
    • C-Reactive Protein (CRP)
    • Complete Blood Count (CBC)
    • Comprehensive Metabolic Panel
    • Erythrocyte Sedimentation Rate (ESR)
    • Urinalysis
    • Others
  • Disease Type
    • Graves’ Disease
    • Hashimoto’s Thyroiditis
    • Multiple Sclerosis (MS)
    • Rheumatoid Arthritis (RA)
    • Systemic Lupus Erythematosus (SLA)
    • Type 1 Diabetes
    • Others
  • Geography
    • North America (U.S., Canada)
    • Europe (U.K., Germany, France, Italy, Spain, Rest of EU)
    • Asia Pacific (Japan, China, India, Rest of APAC)
    • Latin America (Brazil, Mexico, Rest of LA)
    • Rest of the World
  • Company Profiles
    • Abbott Laboratories, Inc.
    • bioMérieux S.A.
    • Bio-Rad Laboratories, Inc.
    • Danaher Corporation (Beckman Coulter, Inc.)
    • Inova Diagnostics, Inc.
    • Quest Diagnostics, Inc.
    • Roche Holding AG (F. Hoffmann-La Roche AG)
    • Siemens Healthineers AG
    • SQI Diagnostics, Inc.

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