Autoimmune Disease Diagnosis Market

Autoimmune Disease Diagnosis Market Overview:

The global autoimmune disease diagnosis market size reached USD 3.4 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 5.5 Billion by 2033, exhibiting a growth rate (CAGR) of 5.57% during 2025-2033. There are numerous factors that are driving the market, which include the rising focus on improving patient outcomes, advancements in diagnostic technologies, collaborations and partnerships among major players, and the need for accurate diagnostic solutions.

Autoimmune Disease Diagnosis Market Analysis:

• Major Market Drivers: The market is experiencing moderate growth, driven by the rising prevalence of autoimmune diseases among individuals and the need for personalized treatment approaches.
• Key Market Trends: The increasing focus on improving patient outcomes and advancements in diagnostic technologies are key market trends.
• Geographical Trends: North America exhibits a clear dominance, accounting for the biggest market share owing to the highly developed healthcare system.
• Competitive Landscape: Major market players in the autoimmune disease diagnosis industry are Abbott Laboratories, AESKU.GROUP, Danaher Corp., bioMérieux SA, Bio-Rad Laboratories, Inc., PerkinElmer Inc., Hemagen Diagnostics, Inc., Inova Diagnostics, Inc., Myriad Genetics, Inc., Quest Diagnostics Incorporated, Siemens Healthineers AG, SQI Diagnostics, Thermo Fisher Scientific Inc., Trinity Biotech plc., among many others.
• Challenges and Opportunities: The complexity of autoimmune diseases represents a key market challenge. Nonetheless, the expansion of biomarker discovery, along with the increasing focus on telemedicine and remote diagnostics, is anticipated to overcome these challenges and offer recent market opportunities.

Autoimmune Disease Diagnosis Market Trends:

Advancements in Diagnostic Technologies

New biomarkers like autoantibodies are discovered to diagnose specific autoimmune diseases like lupus, rheumatoid arthritis, and celiac disease. Biomarkers can provide more precise classification and early identification of autoimmune diseases. More individualized diagnostics are allowing for the discovery of distinct protein signatures or metabolic profiles linked to autoimmune disorders only because of developments in proteomics and metabolomics. Furthermore, microarray technology allows simultaneous testing of multiple biomarkers, which makes it easier to diagnose complex autoimmune diseases involving multiple genetic or protein factors. Additionally, companies are launching cutting-edge products and new technologies, which is positively influencing the autoimmune disease diagnosis market outlook. For instance, on 25 March 2024, AbbVie Inc. and Landos Biopharma, Inc. announced a definitive agreement under which AbbVie will acquire Landos, a clinical stage biopharmaceutical company focused on the development of novel and oral therapeutics for patients with autoimmune diseases. The main investigational asset of Landos is NX-13, a first-in-class, oral NLRX1 agonist with a bimodal mechanism of action (MOA).

Rising Focus on Improving Patient Outcomes

The US Food and Drug Administration (FDA) provided clearance for Werfen's Aptiva® connective tissue disease (CTD) essential reagent under 510(k) on October 16, 2023. New reagents benefit in speeding up diagnosis and enhancing patient outcomes in difficult-to-diagnose autoimmune disorders. In addition, the increasing focus on early and accurate diagnosis for better patient outcomes is catalyzing the autoimmune disease diagnosis demand. Apart from this, early diagnosis of autoimmune disorders enables medical professionals to start treatment quickly while preventing or delaying the onset of diseases including multiple sclerosis, lupus, and rheumatoid arthritis.

Collaborations and Partnerships Among Key Players

On 10 January 2023, ScipherMedicine acquired CrossBridge, a Philadelphia-based data, analytics, and software company, to enhance its data and analytics capabilities. This enables a more granular and real time understanding of patients' treatment pathway. The software as a service (SaaS) value-based care platform aid in lowering healthcare costs while enhancing patient outcomes. Through various collaborations, companies combine their expertise in immunology, molecular biology, and bioinformatics, which is supporting the autoimmune disease diagnosis market growth. A large number of pharmaceutical companies are collaborating with diagnostic companies to provide companion diagnostics tests that are intended to determine which patients will benefit the most from particular treatments. These diagnostics aid in matching patients with the best biologic therapy for autoimmune illnesses, enhancing results while decreasing treatment selection trial and error. These partnerships also involve the co-development of treatments and diagnostic tools. For instance, pharmaceutical companies might work with diagnostics firms to create tests that monitor treatment efficacy, helping doctors adjust therapies in real time to improve patient outcomes.

Autoimmune Disease Diagnosis Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2025-2033. Our report has categorized the market based on product type, disease type, test type, and end-user.

Breakup by Product Type:

• Consumables and Assay Kits
• Instruments
   

Consumables and assay kits account for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the product type. This includes consumables and assay kits and instruments. According to the report, consumables and assay kits represented the largest segment.

Diagnostic laboratories and hospitals require a continuous supply of consumables and assay kits for routine testing and monitoring of autoimmune diseases. Since autoimmune conditions often require long-term monitoring, the demand for consumables remains high. They are used in a variety of diagnostic procedures including immunohistochemistry, flow cytometry, Western blot, and enzyme-linked immunosorbent assay (ELISA). They play a vital role in identifying autoantibodies connected to celiac disease, multiple sclerosis, lupus, and rheumatoid arthritis. Assay kits and consumables have a shorter lifespan as compared to diagnostic devices.

Breakup by Disease Type:

• Systemic Autoimmune Disease
  • Rheumatoid Arthritis
  • Psoriasis
  • Systemic Lupus Erythematosus (SLE)
  • Multiple Sclerosis
  • Others
• Localized Autoimmune Disease
  • Inflammatory Bowel Disease
  • Type 1 Diabetes
  • Thyroid
  • Others
     

Localized autoimmune disease holds the largest share of the industry

A detailed breakup and analysis of the market based on the disease type have also been provided in the report. This includes systemic autoimmune disease (rheumatoid arthritis, psoriasis, systemic lupus erythematosus (SLE), multiple sclerosis, and others) and localized autoimmune disease (inflammatory bowel disease, type 1 diabetes, thyroid, and others). According to the report, localized autoimmune disease accounts for the largest market share.

Localized autoimmune diseases are far more common as compared to systemic autoimmune illnesses. Localized autoimmune disease diagnostic procedures are more precise and targeted. Additionally, companies are developing products that aid in the treatment of various illnesses. For example, on June 9, 2023, AstraZeneca and Quell Therapeutics entered in a license agreement to develop multiple engineered T-regulator (Treg) cell therapies with the potential to be curative for both type 1 diabetes (T1D) and inflammatory bowel disease (IBD) indications. Autologous multi-modular Treg cell therapy candidates for key autoimmune disease indications will be developed using Quell's patented toolbox of Treg cell engineering modules. This is expected to provide a positive autoimmune disease diagnosis market forecast.

Breakup by Test Type:

• Routine Laboratory Tests
• Inflammatory Markers
• Autoantibodies and Immunologic Tests
• Others
   

Routine laboratory tests represent the leading market segment 

The report has provided a detailed breakup and analysis of the market based on the test type. This includes routine laboratory tests, inflammatory markers, autoantibodies and immunologic tests, and others. According to the report, routine laboratory tests represent the largest segment.

Routine laboratory tests are the initial step toward the diagnosis of autoimmune disorders. These tests are important to the diagnostic procedure since they are frequently used to evaluate immune system function, general inflammation, or the existence of particular autoantibodies. These tests are the most often utilized diagnostic tools in clinical settings because they are readily available and reasonably priced. Patients with autoimmune disorders need to be closely watched in order to monitor the course of their illness, the effectiveness of their treatments, and any flare-ups. Moreover, routine tests are often employed for screening and early detection of autoimmune conditions.

Breakup by End-User:

• Clinical Laboratories
• Hospitals
• Others
   

Clinical laboratories exhibit a clear dominance in the market 

A detailed breakup and analysis of the market based on the end-user have also been provided in the report. This includes clinical laboratories, hospitals, and others. According to the report, clinical laboratories account for the largest market share.

Clinical laboratories are the primary centers for managing diagnostic tests for autoimmune diseases. They are an essential component of the diagnostic ecosystem since they provide centralized testing services capable of handling big sample quantities. Advanced diagnostic equipment, technology, and knowledge are available in clinical laboratories to conduct a broad range of tests like molecular diagnostics, autoantibody detection, and biomarker analysis. This enables them to identify a wide range of autoimmune conditions, ranging from systemic lupus erythematosus (SLE) to rheumatoid arthritis. The autoimmune disease diagnosis market value is also driven by the ability of clinical laboratories to handle larger numbers of diagnostic tests than smaller healthcare facilities, clinics, or hospitals.

Breakup by Region:

• North America
  • United States
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

North America leads the market, accounting for the largest autoimmune disease diagnosis market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for autoimmune disease diagnosis.

North America, particularly the United States, has a high prevalence of autoimmune diseases among individuals. The region benefits from a highly developed healthcare system with widespread access to advanced diagnostic technologies. Clinical laboratories, hospitals, and specialized diagnostic centers have the latest molecular diagnostics and imaging techniques, enabling efficient and accurate diagnosis of autoimmune diseases. Besides this, autoimmune disease diagnosis companies in the region are focusing on introducing solutions that provide enhanced care to individuals suffering from autoimmune diseases. For example, on 3 October 2023, WellTheory, a first-of-its-kind virtual solution for the 50 million Americans suffering with autoimmune disease, launched an enterprise solution that will enable employers and payers to offer autoimmune care through WellTheory. Through its new enterprise solution, WellTheory will be able to tackle the unseen costs and productivity impacts of untreated autoimmune diseases across the entire healthcare ecosystem.

Competitive Landscape:

• The autoimmune disease diagnosis market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the autoimmune disease diagnosis industry include Abbott Laboratories, AESKU.GROUP, Danaher Corp., bioMérieux SA, Bio-Rad Laboratories, Inc., PerkinElmer Inc., Hemagen Diagnostics, Inc., Inova Diagnostics, Inc., Myriad Genetics, Inc., Quest Diagnostics Incorporated, Siemens Healthineers AG, SQI Diagnostics, Thermo Fisher Scientific Inc., Trinity Biotech plc.
  
  (Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
   
• On 10 February 2023, CerraCap Ventures, announced a strategic investment in Predicta Med, one of the world's leading early startups that help medical clinics and institutions identify and work-up immune-related diseases earlier. Top players are forming collaborations with academic institutions, pharmaceutical companies, and tech firms to foster innovation and increase their autoimmune disease diagnosis market revenue. In addition, key players in the market are investing in research and development (R&D) activities to develop innovative diagnostic technologies. This includes advanced molecular diagnostics, autoantibody detection kits, and biomarker-based assays that offer higher accuracy and faster diagnosis of autoimmune diseases. Some companies are also integrating artificial intelligence (AI) and machine learning (ML) into diagnostic platforms to enhance the precision of diagnostics, improve the interpretation of test results, and accelerate disease detection. As a result, all these factors are providing autoimmune disease diagnosis market overview.

Autoimmune Disease Diagnosis Market News:

• 28 July 2023: Roche Diagnostics India unveiled the Elecsys® HCV Duo, India’s first commercially available fully automated immunoassay that enables simultaneous and independent determination of the hepatitis C virus (HCV) antigen and antibody status from a single human plasma or serum sample. The test can detect the early stage of infection, when the patient is recovering from the virus, or even during chronic infection.
• 20 January 2023: Perelman School of Medicine at the University of Pennsylvania conducted a preclinical study, which indicated that the revolutionary chimeric antigen receptor (CAR) T cell therapy can be reworked to treat myasthenia gravis (MG), a type of autoimmune disease.
• 1 June 2023: Revvity, Inc. declared that its EUROIMMUN business introduce the UNIQO 160 (CE-IVDR), an automated indirect immunofluorescence test (IIFT) system for autoimmune disease diagnostics.

Autoimmune Disease Diagnosis Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the autoimmune disease diagnosis market from 2019-2033.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the global market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the autoimmune disease diagnosis industry and its attractiveness.
• The competitive landscape allows stakeholders to understand their competitive environment and provides insight into the current positions of key players in the market.