Press release
Antinuclear Antibody Test Market to Triple to USD 3.75 Billion by 2030 - North America Leads with 42% Share as Multiplex, AI-Assisted & High-Throughput Autoimmune Diagnostics Accelerate Worldwide
Leander, Texas and Paris, France - Dec 05, 2025According to DataM Intelligence, the global antinuclear antibody test market size was valued at US$1.25 billion in 2022 and is forecasted to reach US$3.75 billion by 2030, growing at a CAGR of 14.8% from 2023 to 2030. This robust growth is propelled by rising prevalence of autoimmune disorders like SLE and rheumatoid arthritis, increasing awareness campaigns by organizations such as the World Lupus Federation, technological advancements in immunofluorescence and ELISA assays, expanding geriatric population and healthcare spending, supportive reimbursement regulations, and surging demand for reliable diagnostics amid chronic disease surges.
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Report Details:
• No. of Pages: 180
• Forecast Period: 2023-2030
• Market Size (Base Year 2022): $1.25 Billion
• Market Size (Forecast Year 2030): $3.75 Billion
• Compound Annual Growth Rate: 14.8%
• Regions Covered: Global
United States Recent Developments:
✅ Thermo Fisher Scientific launched the Phadia 250 platform upgrade for high-throughput ANA testing, enhancing immunofluorescence accuracy for SLE screening and reporting 25% adoption in US rheumatology clinics
✅ Bio-Rad Laboratories introduced the BioPlex 2200 ANA panel with multiplex capabilities for autoimmune profiling, FDA-cleared for pediatric use and integrated into major hospital networks like Mayo Clinic
✅ Abbott Laboratories expanded its Alinity i system with automated ELISA kits for antinuclear antibody detection, focusing on rapid turnaround for rheumatoid arthritis diagnostics in ambulatory labs
Europe Recent Developments:
✅ Inova Diagnostics developed the QUANTA Flash ANA assay compliant with EULAR/ACR SLE criteria, rolled out in Germany and the UK for enhanced immunofluorescence on HEp-2 cells and supporting EMA approvals
✅ BioMérieux SA enhanced its VIDAS ANA II kit with improved sensitivity for multiplex screening in France and Italy, driven by rising lupus awareness and partnerships with European rheumatology societies
✅ Werfen launched the EVOLUTION analyzer with integrated ANA software for clinical labs across Scandinavia, aligning with EU IVDR standards and achieving 20% growth in autoimmune testing volumes
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Competitive Landscape
The market features strong competition between global diagnostics leaders, specialized immunoassay providers, and innovative testing tech firms.
1. Thermo Fisher Scientific maintained market leadership with 26% global market share, expanding their multiplex assay portfolio and reporting 15% revenue growth in 2024-2025 through rheumatology partnerships.
2. Bio-Rad Laboratories captured 22% market share in ELISA applications, securing contracts with clinical labs and achieving 13% growth through automated system innovations.
3. Abbott Laboratories dominated the immunofluorescence segment with 20% market share, reporting 14% growth via rapid diagnostic solutions.
4. Inova Diagnostics led European market expansion with 18% market share, achieving 12% growth through EULAR-compliant kits.
5. Werfen expanded their analyzer channels with 14% market share, focusing on high-throughput testing with 11% revenue growth.
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Segmentation Analysis
By Product
• Reagents & Assay Kits represents the largest segment with 60% revenue share in 2022, projected to grow at 15.2% CAGR, valued for high adoption in routine screening, standardized procedures for repeatability, cost-efficiency in bulk rentals, effective performance in SLE and RA diagnostics, and widespread adoption in labs requiring reliable, scalable antibody detection across global healthcare networks.Systems shows steady growth with 25% revenue share in 2022, expected to grow at 14.5% CAGR, preferred for automated integration, high-throughput capabilities, and applications in hospital settings with moderate volume requirements.
By Technique
• Immunofluorescence commands the largest share with 45% revenue share in 2022, growing at 15.0% CAGR, driven by EULAR/ACR preferences for HEp-2 cell testing, urbanization in specialty diagnostics, growing demand for pattern recognition in autoimmune profiling, essential need for high sensitivity in early detection, and rising R&D across rheumatology centers and research institutes.
• ELISA shows robust growth with 30% revenue share in 2022, expanding at 14.7% CAGR, valued for quantitative accuracy and ease of automation in multiplex assays. Multiplex Assay demonstrates significant applications with 25% revenue share in 2022 for comprehensive profiling.
By End-User
• Hospitals lead the market with 50% revenue share in 2022, growing at 15.1% CAGR, driven by integrated autoimmune screening, urbanization in chronic care facilities, growing geriatric patient volumes, essential role in confirmatory testing, and rising insurance reimbursements across public and private sectors. Clinical Laboratories shows accelerated growth with 35% revenue share in 2022, expected to grow at 14.6% CAGR, preferred for outsourced high-volume processing. Others demonstrate consistent presence with 15% revenue share in 2022.
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Regional Analysis:
» North America holds the largest market share with 42% revenue share in 2022, driven by high autoimmune disease prevalence affecting 5-8% of the population, advanced healthcare infrastructure, substantial R&D funding, and supportive FDA guidelines across the United States and Canada.
» Asia-Pacific emerges as the fastest-growing region, projected to expand at 16.0% CAGR through 2030, fueled by rising geriatric demographics, increasing awareness of lupus and RA, massive healthcare expansions, growing medical tourism, and policy support for diagnostic access across China, India, and Southeast Asian countries.
Market Trends & Drivers
The Antinuclear Antibody Test Market is experiencing robust growth driven by autoimmune disorder surges, diagnostic technology advancements, awareness campaigns, and reimbursement enhancements. Key trends include the development of multiplex immunofluorescence-ELISA hybrids, growth of point-of-care kits for rapid screening, advancement in AI-assisted pattern analysis, expansion of applications in post-COVID autoimmunity monitoring, and increasing focus on cost-effective reagent rentals and global harmonization of SLE criteria. The epidemiological evolution, innovation in assays, and screening requirements are significantly contributing to market growth.
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Contact Us:
Sai Kiran
DataM Intelligence 4 market Research LLP
Phone: +1 877-441-4866
Email: Sai.k@datamintelligence.com
About DataM Intelligence
DataM Intelligence is a renowned provider of market research, delivering deep insights through pricing analysis, market share breakdowns, and competitive intelligence. The company specialises in strategic reports that guide businesses in high-growth sectors such as diagnostics and autoimmune health innovations.
To find out more, visit https://www.datamintelligence.com/ or follow us on Twitter, LinkedIn and Facebook.
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