The U.S. autoimmune disease diagnostics market size is calculated at USD 2,337 million in 2025 and is expected to reach around USD 3,719 million by 2034, growing at a CAGR of 5.3% for the forecasted period.
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U.S. Autoimmune Disease Diagnostics Market Report Highlights
• By type, the Localized autoimmune disease diagnostics dominated the market and accounted for a share of 65.1% in 2024.
• By type, the systematic autoimmune disease diagnostics type segment is expected to grow at the fastest CAGR during the forecast period.
• By product, the consumables & assay product segment dominated the growth of the U.S. autoimmune disease diagnostics market in 2024.
• By product, the instruments product segment is expected to grow the fastest during the forecast period.
• By test, the antinuclear antibody (ANA) test segment accounted for a leading market share in 2024.
• By test, the C-reactive protein (CRP) test is expected to grow the fastest during the forecast period.
• By end-use, the hospital end-use segment accounted for the U.S. autoimmune disease diagnostics market with the largest revenue share in 2024.
• By end-use, the clinical laboratories segment is expected to be the fastest-growing during the forecast period.
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The U.S. autoimmune disease diagnostics market is driven by the growing incidence of autoimmune diseases like rheumatoid arthritis and multiple sclerosis, increases the need for early and accurate diagnostic testing.
Autoimmune diseases are a group of disorders that result from a modification of immune tolerance, distinguished by the formation of autoantibodies and the ensuing development of heterogeneous clinical manifestations. Diagnosing autoimmune diseases is generally a complicated process, and the available prognostic tools are limited. An area of intense research is defining why the immune system turns against its host. Research has greatly advanced the understanding of autoimmunity, and the scientific discovery from these investigations is assisting in producing the latest clinical laboratory studies of patients to aid in diagnoses.
• In February 2023, CerraCap Ventures disclosed a strategic investment in Predicta Med, one of the world's leading early startups, helping medical clinics and institutions identify and work up immune-related diseases earlier.
Major Trends in the U.S. Autoimmune Disease Diagnostics Market
- There is a shift towards personalized medicine which significantly shapes the importance of autoimmune disease diagnosis. This eventually has been boosted by advancements in molecular diagnostics and genomic data integration, which enable monitored treatment strategies derived on individual patient profiles.
- Innovative steps were taken which is directing the healthcare professionals to provide more precise interventions, bolstering the requirement for customized diagnostic tests in the autoimmune disease industry.
- Moreover, there is an increasing need of point-of-care testing (POCT) in autoimmune disease diagnostics. The preference for POCT devices stems from their ability to provide rapid results and convenience, allowing for diagnosis and management of autoimmune conditions at a real time.
U.S. Autoimmune Disease Diagnostics Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2024 |
USD 2,219 million |
|
Revenue forecast in 2034 |
USD 3,719 million |
|
Growth rate |
CAGR of 5.3% from 2025 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2019 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD million/billion and CAGR from 2025 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Type, test type, end-use |
|
Key companies profiled |
Abbott Laboratories; Biomerieux; Trinity Biotech; Bio-rad Laboratories; Thermo Fisher Scientific; BD Biosciences; Beckman Coulter; F. Hoffmann-La Roche Ltd.; Quest Diagnostics Inc.; Siemens Healthcare GmbH; Werfen |
Role of Artificial Intelligence in the U.S. Autoimmune Disease Diagnostics
Artificial Intelligence is being applied in the growing field of precision medicine. Precision medicine uses specific patient characteristics and health information to design treatments most likely to help that individual. Precision medicine is an increasing field in cancer treatment, where AI enables earlier diagnosis, new drug discovery, and innovation for more targeted approaches to research and care.
Machine learning allows us to determine vast amounts of data and carry out complex calculations with ease and minimal effort. For example, AI systems detect early signs of diseases such as cancer from radiographic images, often more precisely than human radiologists. AI is helping researchers and healthcare providers decipher this complexity by finding the multiple target inflammatory pathways that trigger autoimmune diseases. This will help healthcare providers better understand diagnoses, disease progression, and treatment.
Segment Insights
Type Insights
The localized autoimmune disease diagnostics segment dominated the U.S. autoimmune disease diagnostics market with the largest share in 2024. It deals with autoimmune diseases primarily affecting specific organs or tissues, like localized scleroderma or autoimmune thyroid disorders. These conditions need specific treatments involving the usage of immunosuppressants, biologics, and local intervention injections in certain cases.
- Nearly 1 million people in the United States are affected by multiple sclerosis.
The systemic autoimmune disease diagnostics segment is the fastest growing in the U.S. autoimmune disease diagnostics market during the forecast period. The increasing technological advancements, rising need for systemic autoimmune disease diagnostics, and supportive government policies. Systemic autoimmune disease diagnostics are further bifurcated into rheumatoid arthritis, systemic lupus erythematosus (SLE), etc. Many key players compete for market leaders in an extremely competitive landscape, ranging from established industry giants to innovative startups.
Test Type Insights
The antinuclear antibody tests segment dominated the U.S. autoimmune disease diagnostics market share in 2024. Antinuclear antibody tests are considered a cornerstone in the autoimmune diagnostics market in the United States, primarily due to their critical role in determining autoimmune disorders such as rheumatoid arthritis and systemic lupus erythematosus. The transformation of testing technologies that includes ELISA and immunofluorescence assays, has improved the efficiency and accuracy. Such advancements have defined laboratory workflows and enhanced diagnostic precision.
End-use Insights
The hospitals segment dominated the U.S. autoimmune disease diagnostics market in 2024. With the rise in autoimmune disorders such as rheumatoid arthritis, lupus, and multiple sclerosis, more accurate testing techniques, such as blood tests, biopsy procedures, and imaging techniques, are being used in hospitals. The need for hospitals to utilize advanced equipment in diagnosing autoimmune diseases through specialized diagnostic equipment and well-developed health infrastructure promotes the growth of autoimmune disease diagnostics.
The diagnostic centers segment is the fastest growing in the U.S. autoimmune disease diagnostics market during the forecast period. Diagnostic centers are increasingly adopting advanced imaging techniques and laboratory automation, improving the accuracy and efficiency of autoimmune disease detection. Collaborations between diagnostic centers and research institutions are expanding the range of available tests.
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Some of the prominent players in the U.S. Autoimmune Disease Diagnostics market include:
• Abbott Laboratories
• Biomerieux
• Trinity Biotech
• Bio-rad Laboratories
• Thermo Fisher Scientific
• BD Biosciences
• Beckman Coulter
• F. Hoffmann-La Roche Ltd.
• Quest Diagnostics Inc.
• Siemens Healthcare GmbH
• Werfen
Recent Developments
• In April 2023, Merck declared that the companies had entered into a specific agreement under which Merck, through a subsidiary, had agreed to obtain Prometheus for $200.00 per share in cash for a total equity value of nearly $10.8 billion..
• In February 2023, CerraCap Ventures, a Venture Capital fund, made a strategic investment in Predicta Med, a prominent early-stage startup specializing in assisting medical clinics and institutions in the early detection and management of immune-related diseases.
• In August 2022, KSL Beutner Laboratories (Beutner) introduced a blood test designed to identify an antigen associated with the autoimmune blistering condition known as mucous membrane pemphigoid (MMP), which commonly leads to painful sores in the mouth.
• In May 2022, Thermofisher launched the new Phadia 2500+ series of instruments in the U.S. for autoimmune testing, providing unmatched high throughput and reliability for both allergy diagnostics and autoimmune testing.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, statifacts, Inc. has segmented the U.S. Autoimmune Disease Diagnostics market
By Type
• Systemic Autoimmune Disease Diagnostics
• Rheumatoid Arthritis
• Ankylosing Spondylitis Diagnostics
• Systemic Lupus Erythematosus (SLE)
• Others
• Localized Autoimmune Disease Diagnostics
• Multiple Sclerosis
• Type 1 Diabetes
• Hashimoto's Thyroiditis
• Idiopathic Thrombocytopenic Purpura
• Others
By Test Type
• Antinuclear Antibody Tests
• Autoantibody Tests
• C-Reactive Protein (CRP)
• Complete Blood Count (CBC)
• Urinalysis
• Others
By End-use
• Hospitals
• Diagnostic Centers
• Others
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