Autoimmune Diagnostics Market to Reach USD 9.8 Billion by 2031, Growing at a CAGR of 7.2% | Rising Prevalence of Autoimmune Diseases Drives Demand

The Global Autoimmune Diagnostics Market reached US$ 5.6 billion in 2023 and is expected to reach US$ 9.8 billion by 2031, growing at a CAGR of 7.2% during the forecast period 2024-2031. The market is expanding steadily due to the rising prevalence of autoimmune diseases such as rheumatoid arthritis, lupus, multiple sclerosis, and type 1 diabetes, along with increasing awareness and early diagnosis initiatives.

Growth is driven by advancements in diagnostic technologies including immunoassays, molecular diagnostics, and point-of-care testing, as well as improved biomarker discovery. Increasing healthcare expenditure, expanding access to diagnostic services, and growing adoption of automated and high-throughput testing platforms are further supporting market growth. As clinicians emphasize early and accurate detection to improve patient outcomes, demand for advanced autoimmune diagnostic solutions is expected to rise globally.

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The Autoimmune Diagnostics Market is the sector that provides laboratory tests, instruments, and technologies used to detect, diagnose, and monitor autoimmune diseases accurately and efficiently

Key Developments
✅ December 2025: Clinical laboratories increased adoption of advanced autoimmune diagnostic assays, including multiplex and biomarker-based tests, to enable earlier and more accurate disease detection.

✅ October 2025: Diagnostic companies launched AI-enabled autoimmune testing platforms to improve result interpretation, reduce diagnostic turnaround time, and support clinical decision-making.

✅ August 2025: Hospitals expanded use of point-of-care autoimmune diagnostic tests to accelerate diagnosis and improve patient management in rheumatology and immunology settings.

✅ June 2025: Growing prevalence of autoimmune disorders drove demand for standardized and high-throughput diagnostic solutions across reference laboratories.

✅ March 2025: Research institutions and diagnostic manufacturers intensified focus on novel autoantibody discovery to enhance test specificity and disease stratification.

Mergers & Acquisitions / Strategic Moves
✅ December 2025: A global diagnostics company acquired an autoimmune testing startup to expand its specialty diagnostics portfolio and strengthen biomarker development capabilities.

✅ October 2025: Strategic partnerships were formed between diagnostic solution providers and healthcare networks to deploy integrated autoimmune testing services.

✅ August 2025: Diagnostic manufacturers collaborated with AI technology firms to enhance data analytics and interpretation in autoimmune diagnostics.

✅ June 2025: Regional diagnostic laboratories were acquired by multinational players to expand geographic presence and improve access to advanced autoimmune tests.

✅ March 2025: Diagnostic vendors entered research collaborations with academic institutions to accelerate development of next-generation autoimmune biomarkers.

Key Players
Aurora Life Sciences | Bio-Rad Laboratories, Inc. | ZEUS Scientific, Inc. | Thermo Fisher Scientific Inc. | Scimedx Corporation | Merck KGaA | Medsource Ozone Biomedicals Pvt. Ltd. | Proteometech Inc. | ImmunoDiagnostics Limited | Cambridge Life Sciences Limited

Key Highlights
Aurora Life Sciences - 14.9%: Focuses on specialized autoimmune diagnostic kits and reagents with strong adoption in clinical and research laboratories.

Bio-Rad Laboratories, Inc. - 16.3%: Leads with a broad portfolio of immunoassay systems, autoimmune testing panels, and strong global laboratory presence.

ZEUS Scientific, Inc. - 9.8%: Known for FDA-approved autoimmune diagnostic assays and reliable ELISA-based testing solutions.

Thermo Fisher Scientific Inc. - 18.1%: Dominates through advanced diagnostic platforms, extensive autoimmune reagent offerings, and global distribution capabilities.

Scimedx Corporation - 8.7%: Provides cost-effective autoimmune testing solutions with growing penetration in hospital laboratories.

Merck KGaA - 12.4%: Strengthened by high-quality antibodies, reagents, and research-grade autoimmune diagnostic tools.

Medsource Ozone Biomedicals Pvt. Ltd. - 6.1%: Expands presence through affordable diagnostic kits and increasing adoption in emerging markets.

Proteometech Inc. - 5.4%: Specializes in proteomics-based autoimmune assays and custom diagnostic solutions.

ImmunoDiagnostics Limited - 4.3%: Focuses on niche autoimmune testing products and laboratory-developed tests.

Cambridge Life Sciences Limited - 3.0%: Supports the market with specialized reagents and autoimmune research diagnostics.

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Market Drivers
- Rising prevalence of autoimmune diseases such as rheumatoid arthritis, lupus, and multiple sclerosis.

- Growing awareness about early and accurate diagnosis of autoimmune disorders.

- Increasing adoption of advanced diagnostic technologies including immunoassays and molecular diagnostics.

- Expansion of healthcare infrastructure and access to diagnostic services globally.

- Rising demand for personalized medicine and targeted treatment approaches.

- Technological advancements improving sensitivity and specificity of autoimmune tests.

- Increasing healthcare spending and focus on chronic disease management.

Industry Developments
- Launch of advanced immunoassay-based diagnostic kits for rapid autoimmune disease detection.

- Development of multiplex testing platforms enabling simultaneous detection of multiple biomarkers.

- Expansion of automated laboratory diagnostic systems to improve throughput and accuracy.

- Growing partnerships between diagnostic companies and healthcare providers.

- Integration of AI and data analytics for improved test interpretation and disease monitoring.

- Introduction of point-of-care autoimmune diagnostic tests for faster clinical decision-making.

- Increased investment in research to identify novel autoimmune biomarkers.

Regional Insights
North America - 42% share: "Driven by high disease awareness, strong diagnostic infrastructure, and early adoption of advanced autoimmune testing technologies."

Europe - 29% share: "Supported by robust healthcare systems, increasing focus on early diagnosis, and strong presence of diagnostic manufacturers."

Asia Pacific - 24% share: "Fueled by improving healthcare access, rising prevalence of autoimmune conditions, and growing adoption of advanced diagnostic solutions."

Latin America - 3% share: "Boosted by expanding diagnostic laboratory networks, increasing disease awareness, and rising investment in healthcare diagnostics."

Middle East & Africa - 2% share: "Driven by improving healthcare infrastructure, growing focus on chronic disease diagnosis, and increasing availability of diagnostic services."

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Key Segments

➥ By Diagnostic Tests
Autoantibody Tests: Detect the presence of autoantibodies to help identify and monitor autoimmune disorders.

Complete Blood Count (CBC): Evaluates blood cell components to assess immune response, inflammation, and overall health status.

Antinuclear Antibody Tests: Used to detect antibodies that attack cell nuclei, commonly applied in diagnosing systemic autoimmune diseases.

C-reactive Protein (CRP): Measures inflammation levels in the body, supporting disease activity assessment and treatment monitoring.

Rheumatoid Factor Test: Identifies rheumatoid factor antibodies, aiding in the diagnosis of rheumatoid arthritis and related autoimmune conditions.

Others: Includes erythrocyte sedimentation rate (ESR), complement tests, and specialized biomarker assays.

➥ By Product Type
Instruments: Diagnostic analyzers and laboratory systems used to perform autoimmune testing with high accuracy and throughput.

Assay Kits: Reagent kits and test panels enabling standardized and reliable autoimmune disease diagnostics.

Others: Includes consumables, accessories, and supplementary diagnostic components.

➥ By Disease Type
Systemic Autoimmune Disease: Conditions affecting multiple organs or systems, such as systemic lupus erythematosus and rheumatoid arthritis.

Localized Autoimmune Disease: Disorders limited to specific organs or tissues, including autoimmune thyroid disease and multiple sclerosis.

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