Global ANA Testing Market to Reach US$4.9 Billion by 2032 Driven by Growing Autoimmune Burden and AI-Powered Diagnostics
Industry Experts, Inc. has unveiled a new market research report, "Anti-Nuclear Antibody (ANA) Testing - A Global Market Overview," estimating that global revenues from ANA testing are projected to climb from US$2.1 billion in 2025 to surpass US$4.9 billion by 2032, advancing at a CAGR of 12.5% during the analysis period.
The growth of the ANA testing market is being powered by rising autoimmune disease prevalence worldwide, including lupus, rheumatoid arthritis, scleroderma, and Sjogren's syndrome. Increased awareness and early screening initiatives, together with favorable reimbursement policies and government-supported diagnostic programs, are fueling test volumes. Technological innovations, such as multiplex immunoassays, automation, and AI-based interpretation, are reshaping the diagnostic landscape by improving accuracy, scalability, and clinical confidence. Furthermore, expanding applications in biomarker-based research, personalized medicine, and pharmaceutical trials are broadening the scope of ANA testing, while point-of-care and telehealth-enabled platforms are enhancing accessibility in both developed and emerging regions.

Regionally, North America remains the leading market, capturing 41.4% of global demand in 2025, supported by high autoimmune incidence, advanced healthcare infrastructure, and the presence of leading diagnostic companies like Abbott, Thermo Fisher, and Bio-Rad. Meanwhile, Asia-Pacific is forecast to be the fastest-growing region, posting a CAGR of 13.5% through 2032. Growth here is driven by rising autoimmune cases in China, India, and Japan, increasing healthcare spending, and accelerating adoption of automated and AI-based solutions.
By product, Reagents & Assay Kits lead the market with a 55.5% share in 2025, underscoring their recurring demand across ELISA, IFA, and multiplex assays. The Software & Services segment, however, will expand the quickest at 12.8% CAGR, spurred by AI-driven interpretation and cloud-based diagnostic platforms. Among techniques, the Immunofluorescence Assay (IFA) remains the gold standard with 40.7% share in 2025, while ELISA is set to grow the fastest at 13.7% CAGR due to its throughput efficiency and scalability. Application-wise, Rheumatoid Arthritis dominates with nearly 50% share in 2025, while systemic lupus erythematosus (SLE) is expected to expand the fastest at 13.2% CAGR. Hospitals continue to serve as the leading end user with 42% share in 2025, though clinical laboratories will grow most rapidly at 12.8% CAGR, fueled by outsourcing trends and specialized diagnostic services.
The report segments the global antinuclear antibody testing market by product (Reagents & Assay Kits, Systems, Software & Services), technique (ELISA, IFA, Multiplex, Others), application (Rheumatoid Arthritis, SLE, Sjogren's Syndrome, Scleroderma, Others), and end user (Hospitals, Clinical Laboratories, Research Institutes, Others). Regional coverage spans North America, Europe, Asia-Pacific, South America, and Rest of World, supplemented with in-depth analysis of 14 countries. Profiles of 14+ major companies are included, such as Abbott, Thermo Fisher Scientific, Bio-Rad, Roche, QuidelOrtho, EUROIMMUN (PerkinElmer), Grifols, and Werfen.
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