Autoimmune Disease Diagnostics Market Size, Trends, and Growth Outlook
The autoimmune disease diagnostics market was valued at USD 5235.34 million in 2024 and is projected to grow from USD 5610.71 million in 2025 to USD 9763.46 million by 2033, at a CAGR of 7.17% during 2025–2033. Autoimmune diseases occur when the body’s immune system mistakenly attacks its own cells, and diagnostics play a vital role in early detection and management.
Market Driving Factors
The increasing prevalence of autoimmune diseases and growing awareness about early diagnosis are fueling demand for better testing solutions. According to the National Stem Cell Foundation, around 4% of the global population suffers from one of more than 80 autoimmune disorders, including Crohn’s disease, scleroderma, psoriasis, type 1 diabetes, and lupus. Factors like lifestyle changes, poor diet, smoking, and irregular sleep patterns also contribute to rising cases. Aging populations and higher healthcare spending further support market growth.
Technological Advancements
Innovations such as antigen microarray, mass spectrometry, and multiplex technologies are revolutionizing diagnostics. These advancements allow simultaneous testing of multiple antibodies, improving accuracy and reducing time. Laboratory automation, including automated immunofluorescence and multiplex immunoassays, is expected to enhance efficiency and minimize errors, making diagnostic processes faster and more reliable.
Market Restraints
Despite growth prospects, challenges remain. Detecting autoimmune diseases often requires multiple diagnostic tests, which can delay results. In some cases, turnaround time may extend to several weeks. High costs, complex reimbursement policies, and a shortage of skilled professionals in developing regions also limit market expansion.
Market Opportunities
New entrants and innovative diagnostic technologies are expected to create opportunities for growth. Asia-Pacific, in particular, presents untapped potential due to its expanding patient pool and rising healthcare infrastructure. Increasing research activities, product launches, and automation adoption are paving the way for competitive pricing and better diagnostic outcomes.
Regional Insights
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North America is projected to hold the largest share, reaching USD 114.60 million by 2030 at a CAGR of 7.12%, driven by high disease prevalence, rising healthcare expenditure, and strong R&D investments.
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Europe will remain the second-largest market, led by Germany. Growing elderly populations and collaborative industry efforts are supporting expansion.
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Asia-Pacific is expected to see significant growth due to a large patient base, rising income levels, and increasing demand for advanced diagnostics.
Disease Type Insights
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Systemic Autoimmune Diseases: Includes rheumatoid arthritis, psoriasis, systemic lupus erythematosus, and multiple sclerosis. Rheumatoid arthritis dominates this segment due to its high prevalence among the elderly and availability of diagnostic tests such as ESR, CRP, ANA, and CCP tests.
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Localized Autoimmune Diseases: Includes inflammatory bowel disease, type 1 diabetes, and thyroid disorders. The thyroid subsegment is expected to show strong growth, supported by rising thyroid disease prevalence and healthcare spending.
Diagnosis Insights
Among diagnostic methods, autoantibody tests are projected to dominate, with an estimated market value of USD 2105.77 million by 2030 at a CAGR of 7.60%, thanks to their reliability and frequent use in disease detection.
Key Players
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Abbott Laboratories
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Biomerieux SA
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Bio-Rad Laboratories Inc.
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PerkinElmer Inc. (Euroimmun AG)
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Hoffmann-La Roche Ltd
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Werfen Company (Inova Diagnostics Inc.)
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Myriad Genetics Inc.
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Siemens Healthineers Inc.
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Thermo Fisher Scientific Inc.
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Trinity Biotech PLC
Recent Developments
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Aug 2022: KSL Beutner Laboratories launched a new blood test for mucous membrane pemphigoid.
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May 2022: Thermo Fisher introduced the Phadia 2500+ series for high-throughput autoimmune testing in the U.S.
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Jun 2022: PEPperPrint GmbH presented a novel biomarker for early rheumatoid arthritis diagnosis at the International Congress on Autoimmunity.
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