Autoimmune Disease Diagnostics Market By Product (Consumables & Assay Kits, Instruments, Software & Services), By Test Type (Antinuclear Antibody Tests, Autoantibody Tests, C-Reactive Protein Tests, Erythrocyte Sedimentation Rate Tests, Complete Blood Count, Others), By Technology (ELISA, Radioimmunoassay, Immunofluorescence Assay, Multiplex Assays, Immuno), By Disease Type (Systemic Autoimmune Diseases {Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjögren’s Syndrome, Scleroderma}, Organ-Specific Autoimmune Diseases {Type 1 Diabetes, Hashimoto’s Thyroiditis, Graves’ Disease, Celiac Disease, Multiple Sclerosis, Others}), By End-user (Hospitals, Clinical Laboratories, Diagnostic Centers, Research Institutes).Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles, and Market Forecast, 2025 – 2035

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Industry Outlook

The Autoimmune Disease Diagnostics market accounted for USD 5.74 Billion in 2024 and is expected to reach USD 11.24 Billion by 2035, growing at a CAGR of around 6.30% between 2025 and 2035. The Autoimmune Disease Diagnostics Market represents the industry dedicated to developing and delivering diagnostic tests that identify autoimmune condition symptoms as the immune system mistakenly targets body tissues. The diagnostic process includes tests with antibodies and blood tests along with biomarker screening. The market progresses through rising disease cases as well as expanding diagnostic needs and technological innovations in the field. The product range of leading companies includes complete testing solutions, including materials used during testing and testing devices, along with software packages for accurate results. The diagnostic accuracy, together with efficiency, has been improved following innovations in AI and automation. The market exists to help doctors achieve better patient results by enabling swift disease recognition.

Report Scope:

Market Dynamics

The increasing prevalence of autoimmune diseases is driving the global diagnostic test demand growth

The Autoimmune Disease Diagnostics Market shows persistent expansion because the diagnosis rate of rheumatoid arthritis, type 1 diabetes, multiple sclerosis, and other autoimmune conditions keeps increasing. Due to genetic susceptibility environmental stimuli, and life changes worldwide, these diseases continue to expand their impact on populations. The diagnosis of autoimmune diseases increases daily, while the market demands better diagnostic tests that provide both accuracy and efficiency.

The number of ongoing autoimmune conditions has prompted healthcare systems to direct their attention toward prompt medical identification and sustained disease surveillance. The growing market demand motivates healthcare institutions to use both conventional and sophisticated diagnostic testing methods. The increased number of patients drives diagnostic laboratories, together with healthcare providers, to roll out new tests, which expands the market by reaching this patient growth.

Rising awareness among patients promotes early testing and timely autoimmune disease detection.

The Autoimmune Disease Diagnostics Market receives benefits from rising public knowledge about autoimmune diseases and their signs. Educational campaigns together with patient advocacy organizations and hospital staff members serve as important drivers of early testing promotion. Earlier patient-initiated medical interventions enable the detection of problems at an earlier stage, which leads to superior outcomes for treatment.

Early detection enables better disease management strategies alongside decreased medical expenses and reduced complications throughout treatment. An ongoing spread of knowledge among patients drives them to perform their scheduled medical check-ups, including screening tests, which results in increased demand for diagnostic tests. Proactive patient health behavior turns out to be a key market expansion factor.

The high cost of advanced diagnostic tests limits accessibility in low-income regions.

The Autoimmune Disease Diagnostics Market overcomes several obstacles to affordability, especially within low- and middle-income countries, despite technological progress. Sophisticated diagnostic technologies, including multiplex assays and immunofluorescence systems, maintain high costs that prohibit their access to underprivileged populations. Economic inequality causes delays both in identifying diseases and providing appropriate medical care.

The medical facilities in numerous low-resource jurisdictions lack the technology and trained specialists to conduct specialized autoimmune assessment services. Premature and incorrect medical diagnosis happens frequently in such regions, affecting successful patient outcomes. The diagnostic shortcomings call for cost-effective, scalable solutions that will improve diagnostic accessibility for all populations.

Expansion in emerging markets offers new opportunities for diagnostic test market growth.

Emerging economies such as India, China Brazil, and Southeast Asia have a substantial growth opportunity in the autoimmune disease diagnostics market segment. Market expansion occurs due to rising healthcare investments combined with improving medical infrastructure alongside increasing awareness among the population. The combination of governmental entities and private sector organizations is dedicated to improving diagnostic services in addition to developing affordable diagnostic programs.

The markets of emerging economies receive multinational diagnostic companies through partnership networks distribution pacts, and localized production facilities. The initiatives make costs more affordable while increasing distribution options. Emerging markets have transformed into profitable business operations that simultaneously improve diagnostic capabilities for autoimmune diseases.

Integration of AI and machine learning enhances autoimmune disease diagnostic capabilities significantly.

Modern technology represents a major shift in the way diagnostic testing occurs within the autoimmune disease diagnostics market through artificial intelligence and machine learning systems. Machine learning algorithms process large data collections, which strengthen clinical choices and minimize diagnostic timeframes, as well as cut down medical mistakes. These innovative technologies enable predictive model development, which facilitates risk evaluations and individual treatment preparation steps.
AI will continue developing, which should boost the efficiency and precision capabilities of autoimmune diagnostic procedures.

Real-time diagnostic evaluations have proven better through AI innovations that recognize intricate patterns across blood test results and antibody measurements, as well as imaging data information. AI-based systems prove beneficial for both early health condition detection and the identification of different possible diseases. Implementation has completed multiple laboratory operations while decreasing the time it takes for test results to become available. Through its remote diagnostic abilities, healthcare of quality healthcare can be delivered to areas where limited medical facilities exist. AI continues to advance through persistent developments, which will establish it as a central component of autoimmune diagnostic systems.

Industry Experts Opinion

Rapid diagnostic technology for autoimmune diseases can be used to detect autoimmune diseases such as arthritis and lupus. Developing a diagnostic tool like this is crucial to prevent diseases from progressing,"

• Solidum Jr, Secretary, Department of Science and Technology (DOST)

Segment Analysis

Based on Product, the Autoimmune Disease Diagnostics Market is classified as Consumables & Assay Kits, Instruments, and Software & Services. Consumables & assay kits currently represent the biggest segment because these products have constant applications during diagnostic testing in laboratories and hospitals. Fast and accurate test kits face stronger market demand because autoimmune diseases have become more prevalent, and doctors need early and precise diagnostic methods for these diseases. The market growth of analyzers and immunoassay systems advances because of automated technology improvements and AI system integration. Increasing digital diagnostic platform adoption, together with data management system implementation, drives the expansion of the Software & Services segment. This segment expands at a steady rate due to rising biomedical requirements for specific medical solutions, together with improved laboratory operations. The combination of modern technology innovations and increased investments in diagnostic infrastructure drives the segment toward increased growth.

Based on Test Type, the Autoimmune Disease Diagnostics Market is classified as Antinuclear Antibody Tests, Autoantibody Tests, C-reactive protein (CRP) Tests, Erythrocyte Sedimentation Rate (ESR) Tests, Complete Blood Count (CBC), and Others. Market expansion for systemic autoimmune disease diagnosis depends significantly on antinuclear antibody tests and autoantibody tests, which are commonly used for lupus and rheumatoid arthritis screening and diagnostics. Early detection and disease monitoring become possible through laboratory tests that reveal autoantibodies produced by the immune system against human tissues. Both CRP and ESR tests function as main inflammation markers which doctors use to support diagnostic assessments and monitor treatment results. Regular use of the CBC test lets doctors diagnose blood cell disorders that appear with autoimmune conditions. The sector expands because people understand autoimmune ailments better, and the disease prevalence increases along with the requirement for complete diagnostic testing protocols.

Regional Analysis

North America holds the largest share in the Autoimmune Disease Diagnostics Market, driven by the high occurrence of autoimmune diseases along with well-established medical facilities and major players consisting of Abbott, Quest Diagnostics, and Bio-Rad Laboratories. The region shows active innovation through its progress in developing both complete automated immunoassay platforms and AI-enhanced diagnostic equipment. The market keeps growing because of reimbursement benefits and increased public knowledge, and more people require quick disease discovery. The United States maintains the top position in conducting research and running clinical trials about autoimmune diseases, which result in ongoing product innovations. Diagnostic companies working with academic institutions help develop new biomarkers for the market. The strong regional ecosystem enables countries to lead the global market in marketing share.

Asia-Pacific is the fastest-growing region in the Autoimmune Disease Diagnostics Market because the area experiences increasing healthcare spending along with improving understanding of diseases and expanding patient base. Advanced diagnostic technologies experience fast implementation throughout China, India, and Japan, where manufacturing and budget-friendly solutions occupy the central focus of companies. The market has witnessed recent changes through the combination of automated diagnostic systems along AI-powered platforms that match regional demands. Market penetration accelerates because of growing private healthcare companies and government programs that support chronic disease screening. Global corporations, along with regional companies, establish collaborative partnerships that both improve availability and lower the costs of autoimmune tests. The Asian-Pacific market demonstrates dynamic growth patterns, which establish it as a crucial developing center for autoimmune diagnostics development.

Competitive Landscape

Numerous international companies active in the Autoimmune Disease Diagnostics Market concentrate on product creation and business alliances, and market portfolio increases to compete. Abbott develops immunoassay technologies while extending its autoimmune disease diagnostic product range, and bioMérieux implements AI tools that enhance diagnostic accuracy in its in-vitro platforms through automation. The company Bio-Rad Laboratories dedicates efforts to building multiplex diagnostic systems as well as developing its autoimmune testing infrastructure to meet high-volume laboratory requirements.
Siemens Healthineers AG uses its wide diagnostic infrastructure to provide complete lab solutions by introducing automated testing systems, which enhance accuracy rates.

The healthcare approach at Hoffmann-La Roche Ltd centers on personalized care, which it supports through its work on innovative biomarkers and companion diagnostics. Quest Diagnostics uses digital health formats and alliance-building strategies to grow its test offerings to enhance patients' access to autoimmune testing. The businesses use acquisitions together with research and development endeavors and merger activities to guarantee market leadership positions. The reach of their operations grows through their hospital-based research partnerships.

Autoimmune Disease Diagnostics Market, Company Shares Analysis, 2024

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Recent Developments:

• In January 2025, Exagen Inc. announced conditional approval from the New York State Department of Health for its innovative new biomarker assays designed to improve the detection of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). The new biomarker tests will be incorporated into the AVISE® CTD platform, a diagnostic tool widely used to evaluate autoimmune diseases. 

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