Autoimmune Disease Diagnosis Market Set to Reach USD 30.0 Billion, Growing at a Notable 6.4% CAGR Till 2035

WiseGuy Reports, Today, January 2026 (Press Release) – The Autoimmune Disease Diagnosis Market Global Outlook:

Autoimmune Disease Diagnosis Market Growth Research & Trend Report By Disease Type (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Multiple Sclerosis, Type 1 Diabetes, Hashimoto's Thyroiditis), By Diagnostic Method (Immunoassays, Polymerase Chain Reaction, Western Blotting, ELISA, Lymphocyte Transformation Test), By End User (Hospitals, Diagnostic Laboratories, Research Institutes, Homecare Settings), By Test Type (Blood Tests, Urine Tests, Genetic Tests, Biopsy Tests) and Regional Insights By Size, Share, Industry Outlook - Forecast to 2035

Market Size and Market Forecast Overview

The Autoimmune Disease Diagnosis Market is experiencing sustained market growth as healthcare systems worldwide focus on early detection, accurate classification, and long-term management of autoimmune conditions. Market analysis shows that the global market size reached USD 15.3 billion in 2024, supported by increasing prevalence of autoimmune diseases such as rheumatoid arthritis, lupus, multiple sclerosis, and inflammatory bowel disease. In 2025, the market size is expected to grow to USD 16.3 billion, reflecting broader adoption of advanced diagnostic assays and increased routine screening. According to market forecast and market projections, the Autoimmune Disease Diagnosis Market is anticipated to reach USD 30.0 billion by 2035, registering a CAGR of 6.4% during 2025–2035. This expansion highlights a strong market economic outlook and a positive market global outlook driven by innovation and rising healthcare awareness.

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Competitive Landscape and Market Top Companies

The Autoimmune Disease Diagnosis Market features a competitive and technology-driven landscape with global diagnostics leaders and biopharmaceutical companies investing in high-precision testing platforms. Market research indicates that market top companies are focusing on multiplex assays, biomarker-based diagnostics, and automation to strengthen market share and diagnostic accuracy.

Market Top Companies operating in the Autoimmune Disease Diagnosis Market include:

• Siemens Healthineers
• Bio-Rad Laboratories
• Genentech
• Roche
• Fujirebio
• Ameda
• Qiagen
• Ortho Clinical Diagnostics
• Agnus Diagnostics
• BristolMyers Squibb
• Euroimmun
• Abbott
• Thermo Fisher Scientific
• Merck
• Hologic

These companies are driving market developments through continuous innovation, expanded test menus, and global laboratory partnerships.

Market Segment Analysis

Market segmentation of the Autoimmune Disease Diagnosis Market reflects the diversity of autoimmune conditions and diagnostic approaches.

By Disease Type:

• Rheumatoid arthritis
• Systemic lupus erythematosus
• Multiple sclerosis
• Type 1 diabetes
• Other autoimmune disorders

By Diagnostic Method:

• Immunoassays
• Molecular diagnostics
• Imaging-supported diagnostics

By Test Type:

• Autoantibody tests
• Inflammatory marker tests
• Genetic and biomarker-based assays

By End User:

• Hospitals
• Diagnostic laboratories
• Research institutes

Each market segment contributes to market growth dynamics by improving diagnostic confidence, enabling disease stratification, and supporting targeted therapy decisions.

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Key Market Dynamics and Business Insights

The Autoimmune Disease Diagnosis Market is driven by several interrelated growth drivers. Increasing prevalence of autoimmune diseases globally is expanding market demands for accurate and early diagnostic solutions. Advancements in diagnostic technologies, including high-sensitivity immunoassays and molecular testing, are improving detection rates and reducing diagnostic delays. Growing demand for personalized medicine is encouraging the use of biomarker-driven diagnostics to guide therapy selection. Rising awareness and education initiatives among healthcare professionals and patients are improving screening rates. Expansion of healthcare infrastructure, particularly in emerging economies, is further strengthening market business insights and reinforcing a positive long-term market forecast.

Regional Analysis and Market Regional Share

From a market region perspective, North America holds the largest market regional share in the Autoimmune Disease Diagnosis Market, driven by advanced laboratory infrastructure, strong reimbursement systems, and high disease awareness in the US and Canada. Europe represents a significant market supported by robust diagnostic adoption and public healthcare programs across Germany, the UK, France, Italy, and Spain. The Asia-Pacific region is emerging as a high-growth market region due to increasing autoimmune disease prevalence, expanding diagnostic capacity, and rising healthcare investments in China, India, Japan, and South Korea. South America and the Middle East & Africa regions are witnessing gradual market growth as diagnostic accessibility and awareness improve.

Market Opportunities and Future Outlook

The Autoimmune Disease Diagnosis Market presents strong market opportunities through adoption of advanced diagnostic technologies and expanded autoimmune test panels. Growing awareness and education initiatives are improving early diagnosis rates. Rising demand for personalized medicine is accelerating biomarker-based testing adoption. Expansion of telemedicine services is improving access to specialist diagnostics and follow-up care. These trends are expected to strengthen market projections and support sustained market growth.

Key Highlights of the Autoimmune Disease Diagnosis Market

The Autoimmune Disease Diagnosis Market is positioned for steady expansion, growing from USD 15.3 billion in 2024 to USD 30.0 billion by 2035. Strong participation from market top companies, diversified market segments, and continuous diagnostic innovation underpin a favorable market economic outlook. With rising disease prevalence and increasing emphasis on early and accurate diagnosis, the Autoimmune Disease Diagnosis Market is set to remain a critical component of global healthcare systems.

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Table of Contents

SECTION I: EXECUTIVE SUMMARY AND KEY HIGHLIGHTS

EXECUTIVE SUMMARY

Market Overview

Key Findings

Market Segmentation

Competitive Landscape

Challenges and Opportunities

Future Outlook

SECTION II: SCOPING, METHODOLOGY AND MARKET STRUCTURE

MARKET INTRODUCTION

RESEARCH METHODOLOGY

Overview

Data Mining

Secondary Research

Primary Research

Primary Interviews and Information Gathering Process

Breakdown of Primary Respondents

Forecasting Model

Market Size Estimation

Bottom-Up Approach

Top-Down Approach

Data Triangulation

Validation

SECTION III: QUALITATIVE ANALYSIS

MARKET DYNAMICS

Overview

Drivers

Restraints

Opportunities

MARKET FACTOR ANALYSIS

Value chain Analysis

Porter's Five Forces Analysis

Bargaining Power of Suppliers

Bargaining Power of Buyers

Threat of New Entrants

Threat of Substitutes

Intensity of Rivalry

COVID-19 Impact Analysis

Market Impact Analysis

Regional Impact

Opportunity and Threat Analysis

SECTION IV: QUANTITATIVE ANALYSIS…and many More

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