United States Autoimmune Diagnostics Market Demonstrates Robust Growth, Led by Abbott, Roche, and Siemens Healthineers | DataM Intelligence

The global Autoimmune Diagnostics Market is projected to experience a high Compound Annual Growth Rate (CAGR) throughout the forecast period from 2023 to 2030, reflecting strong and sustained expansion driven by technological advancements and increasing clinical demand.

United States: Recent Industry Developments

✅ In October 2025, Abbott Laboratories received FDA clearance for a new multiplex autoimmune panel that tests for 12 different autoantibodies simultaneously.
✅ In October 2025, The American College of Rheumatology updated diagnostic guidelines, incorporating new automated testing protocols for early autoimmune disease detection.
✅ In October 2025, Quest Diagnostics launched a direct-to-consumer autoimmune screening test with telehealth consultation services.

Japan: Recent Industry Developments

✅ In October 2025, Sysmex Corporation introduced a fully automated autoimmune testing system with AI-based result interpretation.
✅ In October 2025, Japan's Ministry of Health approved a novel biomarker test for early detection of rheumatoid arthritis.
✅ In October 2025, Tosoh Corporation expanded its autoimmune diagnostics portfolio with new chemiluminescence assays for rare autoimmune disorders.

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Market Trends & Drivers

The Autoimmune Diagnostics Market is experiencing significant growth driven by increasing autoimmune disease prevalence, advancements in testing technologies, and growing awareness about early diagnosis. Key trends include the shift toward multiplex testing panels, automation in laboratory workflows, and integration of artificial intelligence for result interpretation. The rising demand for personalized medicine approaches, expansion of point-of-care testing, and improvements in assay sensitivity and specificity are significantly accelerating market expansion.

Competitive Landscape

The market is characterized by strong competition among global diagnostic companies and specialized autoimmune testing manufacturers.

Abbott Laboratories leads the market with comprehensive autoimmune testing portfolios including ARCHITECT and Alinity systems.
Roche Diagnostics maintains a strong position with its Elecsys and cobas autoimmune diagnostic assays and platforms.
Siemens Healthineers offers advanced autoimmune testing solutions through its Atellica and ADVIA platforms.
Thermo Fisher Scientific provides extensive autoimmune diagnostic reagents and kits for clinical laboratories.
Bio-Rad Laboratories specializes in autoimmune disease testing with focus on quality control and standardization.
Werfen (Instrumentation Laboratory) offers comprehensive autoimmune diagnostics through its ACL and BIO-FLASH systems.
Danaher Corporation (Beckman Coulter) provides automated autoimmune testing solutions for high-volume laboratories.
Sysmex Corporation focuses on hematology and autoimmune testing with advanced instrumentation.
QuidelOrtho Corporation offers rapid autoimmune tests and automated immunoassay systems.
DiaSorin S.p.A. specializes in infectious disease and autoimmune testing with LIAISON platforms.

Segmentation

By Diagnostic Tests (Autoantibody Tests, Complete Blood Count (CBC), Antinuclear Antibody Tests, C-reactive Protein (CRP), Rheumatoid Factor Test, Others)
By Product Type (Instruments, Assay Kits, Others)
By Disease Type (Systemic Autoimmune Disease, Localized Autoimmune Disease)
By End User (Hospitals and Clinics, Diagnostic Centers, Academic and Research Institutes, Others)

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Regional Analysis:

⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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✅ Competitive Landscape
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✅ Sustainability Impact Analysis
✅ KOL / Stakeholder Insights
✅ Consumer Behavior & Demand Analysis
✅ Import-Export Data Monitoring
✅ Live Market & Pricing Trends

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