Autoimmune Disease Diagnostics Market Projects USD 10.5 Billion at 6.22% CAGR by 2034

The autoimmune disease diagnostics market size is calculated at USD 6.11 billion in 2025 and is expected to reach around USD 10.5 billion by 2034, growing at a CAGR of 6.22% for the forecasted period.

Ottawa, Oct. 07, 2025 (GLOBE NEWSWIRE) -- The global autoimmune disease diagnostics market size was valued at USD 5.75 billion in 2024 and is predicted to hit around USD 10.5 billion by 2034, rising at a 6.22% CAGR, a study published by Towards Healthcare a sister firm of Precedence Research.

A surge in various autoimmune disease cases and rising demand for advanced diagnostic approaches are driving the global market growth.

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Key Takeaways

The autoimmune disease diagnostics market will likely exceed USD 5.75 billion by 2024.
Valuation is projected to hit USD 10.5 billion by 2034.
Estimated to grow at a CAGR of 6.22% from 2025 to 2034.
North America held the largest revenue share of the market share by 47% in 2024.
Asia Pacific is expected to grow at the fastest CAGR during the forecast period.
By type, the localized segment was dominant in the market in 2024.
By type, the systemic disorders segment is expected to be the fastest-growing in the studied years.
By product, the consumables & assays segment dominated the autoimmune disease diagnostics market in 2024.
By product, the instruments segment is expected to witness notable growth during 2025-2034.
By test type, the antinuclear antibody tests segment led the market in 2024.
By test type, the autoantibody tests segment is expected to register the fastest expansion in the predicted timeframe.
By end use, the hospital segment registered dominance in the market in 2024.
By end use, the diagnostic centers segment is expected to grow rapidly during 2025-2034.

What are the Autoimmune Disease Diagnostics?

Diagnosis of autoimmune diseases involves an integration of medical history, physical examination, and standard laboratory tests to find abnormal immune activity. The global autoimmune disease diagnostics market is propelled by the accelerating cases of autoimmune conditions, raised awareness resulting in early diagnosis, and breakthroughs in diagnostic technologies.

It usually comprises the detection of biomarkers, particularly autoantibodies, using techniques, including immunofluorescence, ELISA, and immunoblotting. The market is stepping into a comprehensive analysis of autoantibodies and genetic markers, the use of AI for predictive modeling and image analysis, and the progress of biosensors for quicker, affordable diagnosis.

Market Scope

Metric	Details
Market Size in 2025	USD 6.11 Billion
Projected Market Size in 2034	USD 10.5 Billion
CAGR (2025 - 2034)	6.22	%
Leading Region	North America share by 47%
Market Segmentation	By Type, By Product, By Test Type, By End Use, By Region
Top Key Players	Abbott Laboratories, Thermo Fisher Scientific, Siemens AG, F. Hoffmann-La Roche Ltd, Bio-Rad Laboratories, Quest Diagnostics, Hologic, Danaher, Inova Diagnostics., EUROIMMUN Medizinische Labordiagnostika AG, Nova Diagnostics Pte Ltd., BIOMÉRIEUX, Hemagen Diagnostics, Inc.

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What are the Key Trends in the Autoimmune Disease Diagnostics Market?

A surge in the development of diverse diagnostic approaches in the expanding autoimmune disease issues, coupled with the widespread adoption of novel transforming technologies, like AI tools, is boosting the overall market growth.

In June 2025, Elucidata, a company in data-centric AI for drug discovery and translational research, and Sapien Biosciences, India's first and largest commercial biobank with 300,000+ patient samples, collaborated to convert Sapien’s extensive biobank assets into AI-ready, multimodal data products for use in drug and diagnostic development.
In April 2025, Granite Bio secured $100m in funding to advance autoimmune disease treatments.
In April 2025, Biostate AI, a leading pioneer in artificial intelligence for RNA sequencing, partnered with the Accelerated Cure Project (ACP), a nonprofit organization, to expand research and improve outcomes for people with multiple sclerosis (MS).

What is the Developing Limitation in the Market?

Arising financial hurdles in the adoption of highly sophisticated genetic testing & blood testing among the low-income population are a critical barrier to comprehensive development. Also, a shortage of globally accepted and standardized diagnostic criteria can result in variations in test results and diagnostic practices across various healthcare providers.

Regional Analysis

What Made North America Dominant in the Market in 2024?

North America’s autoimmune disease diagnostics market accounted for the biggest share by 47% in 2024. The market is fueled by the presence of a supportive healthcare infrastructure with suitable reimbursement policies and accelerated investments in healthcare research. Currently, the US is pushing a combination of traditional lab tests, such as anti-nuclear antibody (ANA) and C-reactive protein (CRP), clinical assessment, and emerging imaging techniques like PET scans for further detection of inflammation.

For instance,

In March 2025, WellStone, the largest and most comprehensive mental health provider in North Alabama, ordered 1,000 Trauma Autoimmune Indicator (TAI) tests from iXpressGenes to enhance trauma screening.

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How did the Asia Pacific Grow Significantly in the Market in 2024?

In the prospective period, the Asia Pacific is anticipated to register rapid growth in the autoimmune disease diagnostics market. ASAP countries are facing a huge burden of various autoimmune diseases, like rheumatoid arthritis, lupus, and type 1 diabetes, which further demand robust diagnostic tests. The widespread development of the healthcare system, and other effective approaches, like multiplex immunoassays, biomarker-based tests, laboratory automation platforms, and the application of biosensors, are encouraging rapid, more precise, and efficacious testing.

For this market,

In May 2025, Singapore General Hospital (SGH) was awarded a S$5.77 million IAF-PP grant from A*STAR for a project to better diagnose and treat systemic sclerosis (SSc), a life-threatening autoimmune disease.

Autoimmune Disease Diagnostics Market: Notable Steps in 2025

Country	Regulatory Body	Notable Steps
U.S.	US FDA (Food and Drug Administration)	In January 2025, Werfen received FDA clearance for its Aptiva APS IgG and IgM reagents, created to find antiphospholipid syndrome using advanced particle-based technology.
China	NMPA (National Medical Products Administration)	In June 2025, the NMPA published the revised "Catalog of In Vitro Diagnostic Reagents Exempt from Clinical Trials."
India	CDSCO (Central Drugs Standard Control Organisation)	The Indian Council of Medical Research (ICMR), in collaboration with CDSCO, evolved and released 39 standard evaluation protocols for high-risk IVD kitsMold, which was introduced at the Andhra Pradesh MedTech Zone (AMTZ) in August 2025.

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Segmental Insights

By type analysis

Which Type Dominated the Autoimmune Disease Diagnostics Market in 2024?

The localized segment captured a dominant revenue share of the market in 2024. A rise in localized autoimmune diseases, particularly Multiple Sclerosis and Inflammatory Bowel Disease, is increasingly demanding specific diagnostic tests. Alongside, the developing patient and healthcare professional awareness is fostering early diagnosis and broader adoption of advanced technologies, such as microarray and mass spectrometry. Innovations in Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) are supporting visualization of inflammation and immune cell activity.

Although the systemic disorders segment is estimated to witness rapid growth in the coming era. The global expansion of multiple organ and system affections, like rheumatoid arthritis, lupus, and multiple sclerosis, is boosting the groundbreaking solutions. In 2025, the market is highly leveraging advanced "Omics" technologies like Next Generation Sequencing and mass spectrometry for complete genetic and protein profiling, exosome analysis to recognize intercellular communication, and the detection of new disease-driving proteins like granzyme K.

By product analysis

Why did the Consumables & Assays Segment Lead the Market in 2024?

The consumables & assays segment was dominant in the autoimmune disease diagnostics market in 2024. An expanding diagnostic solution is fueling the need for advanced test kits, reagents, antibodies, and specialized assays. A prominent contribution of immunoassay kits, including ELISA and immunofluorescence assays (IFA), in the identification of specific autoantibodies in blood samples is assisting the overall development. Currently, the globe is imposing advancements aiming at multiplex platforms, like bead or laser arrays, and the development of biosensors for rapid, more affordable, and sensitive detection.

However, the instruments segment is predicted to expand at a lucrative CAGR. Inclusion of well-sophisticated automated platforms, biosensors, and imaging and genetic testing devices is supporting the segmental transformation. Traditional solutions like flow cytometry, PCR, and antigen microarrays, alongside advanced imaging techniques, particularly MRI and PET scans, are eventually revolutionizing into cytometry by time-of-flight (CyTOF) for deeper cell analysis, modified imaging contrast agents, and the integration of Artificial Intelligence (AI).

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By test type analysis

What Made the Antinuclear Antibody Tests Segment Dominant in the Market in 2024?

By capturing the largest share, the antinuclear antibody tests segment dominated the autoimmune disease diagnostics market in 2024. The widespread adoption of these types of tests in the accelerating prevalence of Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA). Recent efforts are improving automated fluorescence readers to enhance test precision and consistency, the adoption of digital imaging systems, and the emergence of new research activities in novel biomarkers, with optimized specificity of ANA tests for differentiating between diverse autoimmune diseases.

During 2025-2034, the autoantibody tests segment will expand rapidly. A wide range of benefits of these tests encompasses early intervention, reduction of misdiagnosis, as well as continuous laboratory automation solutions are impacting the overall market growth. The latest developments comprise high-throughput platforms (e.g., antigen microarrays) for simultaneous diagnosis, artificial intelligence (AI) for risk prediction, and new autoantibodies, mainly anti-cN1A, for myositis diagnosis. The incorporation of ANA, anti-dsDNA, anti-CCP, RF, and ANCA tests in the boosting instances of Lupus, Rheumatoid Arthritis, and Vasculitis is assisting the ahead progressive activities.

By end use analysis

How did the Hospital Segment Lead the Market in 2024?

In the autoimmune disease diagnostics market, the hospital segment held a major share in 2024. The rising incidences of rheumatoid arthritis, lupus, and Type I Diabetes are fostering the hospital as a primary care solution, which possesses early and accurate detection through specialized diagnostic equipment. In this era, hospitals are using highly sophisticated technologies and specialized diagnostic equipment, such as autoantibody assays, inflammation markers, and genetic tests. Hospitals are shifting towards AI/machine learning, novel biosensor technologies, and advanced proteomic techniques, especially antigen arrays for simultaneous multi-autoantibody profiling.

Whereas the diagnostic centers segment is anticipated to register rapid growth in the upcoming years. Possession of well-equipped facilities, specialized professionals, and adoption of advanced and latest diagnostic technologies are assisting the progress of these centers. Ongoing developments in nanotechnology-based contrast agents for optimized MRI and PET scans to identify inflammation, and consistent alliances are boosting patient access to these advanced services.

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Recent Developments in the Autoimmune Disease Diagnostics Market

In September 2025, Abselion, a pioneering life sciences technology company, launched its Protein G Total Antibody Quantification Kit.
In September 2025, New York University Abu Dhabi (NYUAD), Yas Clinic- Khalifa city, and Abu Dhabi Stem Cells Centre (ADSCC) collaboratively unveiled an AI-enabled MRI technique for rapid multiple sclerosis diagnosis.
In July 2025, Agilus Diagnostics, in alliance with Sebia, introduced the Anti-MCV (anti–mutated citrullinated vimentin) antibody test in India to expand the early detection of rheumatoid arthritis (RA).

Autoimmune Disease Diagnostics Market Key Players List

Abbott Laboratories
Thermo Fisher Scientific
Siemens AG
F. Hoffmann-La Roche Ltd
Bio-Rad Laboratories
Quest Diagnostics
Hologic
Danaher
Inova Diagnostics.
EUROIMMUN Medizinische Labordiagnostika AG
Nova Diagnostics Pte Ltd.
BIOMÉRIEUX
Hemagen Diagnostics, Inc.

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Segments Covered in the Report

By Type

Systemic autoimmune disease diagnostics
- Rheumatoid arthritis
- Ankylosing spondylitis
- Systemic lupus erythematosus (SLE)
- Others
Localized autoimmune disease diagnostics
- Multiple sclerosis
- Type 1 diabetes
- Hashimoto's Thyroiditis
- Idiopathic thrombocytopenic purpura
- Others

By Product

Instruments
Consumables and Assays

By Test Type

Antinuclear antibody tests
Autoantibody tests
C-reactive Protein (CRP)
Complete blood count (CBC)
Urinalysis
Others

By End Use

Hospitals
Diagnostic centers
Others

By Region

North America
- U.S.
- Canada
Asia Pacific
- China
- Japan
- India
- South Korea
- Thailand
Europe
- Germany
- UK
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
Latin America
- Brazil
- Mexico
- Argentina
Middle East and Africa (MEA)
- South Africa
- UAE
- Saudi Arabia
- Kuwait

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