Autoimmune Disease Diagnostics Market Size Worth $7,146.32 Million by 2034 | CAGR: 4.9%

Autoimmune Disease Diagnostics Market Size Worth $7,146.32 Million by 2034 | CAGR: 4.9%


The global autoimmune disease diagnostics market size is expected to reach USD 7,146.32 million by 2034, according to a new study by Polaris Market Research. The report “Autoimmune Disease Diagnostics Market Size, Share, Trends, Industry Analysis Report: By Product, Type, Test Type, End User, and Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa) – Market Forecast, 2025–2034.” gives a detailed insight into current market dynamics and provides analysis on future market growth.

The autoimmune disease diagnostics market is a sector within the healthcare and diagnostic industry. The market focuses on the identification and management of autoimmune diseases through advanced diagnostic tools and techniques. Autoimmune diseases occur when the immune system attacks the body's tissues, leading to a range of chronic and potential conditions. The market encompasses diagnostic tests and technologies used to detect these conditions, including blood tests, imaging techniques, and molecular assays.

The increasing prevalence of autoimmune diseases globally drives demand for early and accurate diagnostic tools. As awareness of these conditions grows, patients and healthcare providers seek more precise and efficient diagnostic solutions. Additionally, the rising adoption of personalized medicine and advanced treatment approaches necessitates accurate diagnostics, further boosting market growth. Government initiatives and funding for research into autoimmune diseases and diagnostics are contributing to the development of new diagnostic methods, thereby enhancing market opportunities.

In 2021, the Accelerating Medicines Partnership (AMP) program introduced the Accelerating Medicines Partnership Autoimmune and Immune-Mediated Diseases (AMP AIM) program. The AMP Autoimmune and Immune-Mediated Diseases (AMP AIM) initiative is driving the market by increasing awareness and promoting early screening for autoimmune diseases.

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The autoimmune disease diagnostics market is experiencing swift to advanced and automated diagnostic solutions that provide higher accuracy and faster results. Integration of artificial intelligence (AI) and machine learning (ML) into diagnostic platforms is transforming how autoimmune diseases are detected and monitored, improving efficiency and precision. Furthermore, there is an increasing focus on developing noninvasive diagnostic techniques, which provide a more patient-friendly alternative to traditional methods.

In July 2022, KSL Beutner Laboratories (Beutner) announced the launch of an indirect immunofluorescence (IIF) serum blood test in the US. The test effectively detects laminin 332, an antigen linked to the persistent autoimmune condition mucous membrane pemphigoid (MMP). These increasing developments in diagnostic methods drive the autoimmune disease diagnostics market growth.

Autoimmune Disease Diagnostics Market Report Highlights

  • Based on type, the systemic autoimmune disease diagnostics segment dominated the autoimmune disease diagnostics market revenue share, mainly attributed to increased awareness among healthcare providers and patients.
  • The antinuclear antibody (ANA) tests segment, by test type, is expected to register the highest CAGR during the forecast period, owing to the increasing prevalence of autoimmune diseases and advancements in diagnostic technologies.
  • North America dominated the market due to advanced healthcare infrastructure and substantial funding for medical research and development.
  • Asia Pacific is expected to register the highest CAGR during the forecast period, owing to growing healthcare sectors in countries such as China and India and the increasing prevalence of autoimmune diseases.
  • A few global key market players are Abbott; AESKU.DIAGNOSTICS; Beckman Coulter, Inc.; BIOMÉRIEUX; Bio-Rad Laboratories, Inc.; EUROIMMUN; F. Hoffmann-La Roche Ltd; Inova Diagnostics (Werfen Group); Myriad Genetics, Inc.; Quest Diagnostics; Scipher Medicine; Siemens Healthcare Private Limited; and Thermo Fisher Scientific Inc.

Polaris Market Research has segmented the autoimmune disease diagnostics market report on the basis of product, type, test type, end user, and region:

By Product Outlook (RevenueUSD Million, 2020–2034)

  • Consumables and Assay Kits
  • Instruments

By Type Outlook (Revenue – USD Million, 2020–2034)

  • 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 Test Type Outlook (Revenue – USD Million, 2020–2034)

  • Antinuclear Antibody (ANA) Tests
  • Autoantibody Tests
  • Complete Blood Count (CBC)
  • Comprehensive Metabolic Panel
  • C-Reactive Protein (CRP)
  • Others

By End User Outlook (Revenue – USD Million, 2020–2034)

  • Hospitals
  • Diagnostics Centers
  • Research Laboratories

By Regional Outlook (Revenue – USD Million, 2020–2034)

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Russia
    • Netherlands
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Indonesia
    • Australia
    • Vietnam
    • Malaysia
    • Rest of Asia Pacific
  • Latin America
    • Argentina
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • UAE
    • Saudi Arabia
    • Israel
    • South Africa
    • Rest of Middle East & Africa

Autoimmune Disease Diagnostics Market Report Scope

Report Attributes

Details

Market Size Value in 2024

USD 4,433.11 million

Market Size Value in 2025

USD 4,644.93 million

Revenue Forecast by 2034

USD 7,146.32 million

CAGR

4.9% from 2025 to 2034

Base Year

2024

Historical Data

2020–2023

Forecast Period

2025–2034

Quantitative Units

Revenue in USD million and CAGR from 2025 to 2034

Report Coverage

Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends

Segments Covered

  • By Product
  • By Type
  • By Test Type
  • By End User

Regional Scope

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

Competitive Landscape

  • Autoimmune Disease Diagnostics Industry Trends Analysis (2024)
  • Company Profiles/Industry participants profiling includes company overview, financial information, product/service benchmarking, and recent developments

Report Format

  • PDF + Excel

Customization

Report customization as per your requirements with respect to countries, regions, and segmentation.

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