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Autoimmune Disease Diagnostics Market - Global Forecast 2025-2032

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    Report

  • 195 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 5014101
UP TO OFF until Jan 01st 2026
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The Autoimmune Disease Diagnostics Market is undergoing substantial change, with advanced diagnostic methods and integrated technologies shaping clinical pathways and supporting more reliable decision-making for healthcare organizations and laboratories.

Market Snapshot: Autoimmune Disease Diagnostics Market Growth

The market is projected to accelerate, expanding from USD 5.81 billion in 2024 to USD 6.23 billion in 2025, with sustained growth forecast at a CAGR of 7.42% and an anticipated market value of USD 10.30 billion by 2032. This robust upward trend reflects the increasing adoption of advanced diagnostic modalities, progress across analytical technologies, and clinical recognition of early detection needs within the global healthcare ecosystem. The introduction of enhanced multi-modal solutions has supported broad uptake among laboratories and diagnostic facilities, reinforcing steady market expansion worldwide.

Scope & Segmentation

This report presents a comprehensive analysis covering the full range of the autoimmune disease diagnostics industry. Detailed segmentation empowers executives to craft informed, flexible strategies that align with market complexity and clinical needs:

  • Product: Assay kits, reagents, and instruments comprising immunoassay analyzers and microplate readers are central to contemporary diagnostic operations, supporting accuracy and throughput in both routine and specialized testing.
  • Test Type: Autoantibodies and immunologic tests, including antinuclear antibody and disease-specific autoantibody evaluations, are foundational. Genetic testing encompasses both chromosomal and molecular tests, while imaging tests such as MRI, PET, and ultrasound supplement diagnostic workflows. Measurement of inflammatory markers like C-reactive protein and erythrocyte sedimentation rate is also integral.
  • Technology: Innovations span enzyme-linked immunosorbent assay, flow cytometry, immunofluorescence, multiplex assays, next-generation sequencing, and Western blotting, each enhancing detection capability and workflow efficiency.
  • Sample Type: Blood, saliva, and urine samples offer laboratories flexible testing and patient convenience, fitting diverse clinical contexts.
  • Indication: Testing addresses both organ-specific autoimmune conditions including Graves’ disease, Hashimoto’s thyroiditis, multiple sclerosis, and type 1 diabetes, as well as systemic disorders such as rheumatoid arthritis, systemic lupus erythematosus, and systemic sclerosis.
  • Distribution Channel: Sales are achieved through both offline and online channels, enabling tailored supply and procurement strategies across geographies.
  • End User: Primary target institutions include ambulatory care centers, diagnostic labs, hospitals, clinics, and research organizations, ensuring widespread market engagement.
  • Region: The study analyzes trends throughout the Americas (including North America and Latin America), Europe, the Middle East and Africa, and the Asia-Pacific region, spotlighting markets in China, India, Japan, Australia, and South Korea.
  • Key Companies: Leading firms such as Abbott Laboratories, Siemens Healthineers AG, Thermo Fisher Scientific Inc., and Quest Diagnostics drive technological innovation and global reach in this space.

Key Takeaways for Senior Decision-Makers

  • Technological convergence is actively supporting higher diagnostic precision and interoperability, facilitating laboratories’ adoption of multiplex assays and next-generation sequencing solutions.
  • Multi-modal diagnostic strategies now combine serology, genetics, and imaging, enhancing accuracy and more effective risk stratification for diverse autoimmune disease presentations.
  • End users across ambulatory, hospital, and research settings are prioritizing operational efficiency and simplified result interpretation, which is leading to restructured workflows and technology choices.
  • Regulatory diversity across regions requires businesses to adapt their commercialization and compliance strategies, often necessitating local partnerships or regionally tailored service agreements.
  • Trends towards value-based care are intensifying the importance of demonstrating evidence-backed clinical utility and economic benefits in next-generation diagnostics.
  • Strategic planning in procurement, with an emphasis on risk mitigation, is increasingly vital as global trade dynamics evolve and impact key supply chains.

Tariff Impact on Procurement Strategies

Recent tariff reforms have disrupted established procurement routines, causing greater supply chain unpredictability. As organizations respond, procurement managers are turning to multi-vendor sourcing, long-term contracts, and locally focused vendor networks to bolster cost stability and business continuity. These responses are also spurring renewed attention to logistics strategies, inventory monitoring, and regulatory compliance to reduce the effects of external trade fluctuations across the diagnostics market.

Methodology & Data Sources

This report leverages peer-reviewed publications, validation studies, regulatory documentation, and confidential interviews with laboratory and clinical leaders. The approach ensures each finding accounts for both published scientific advancements and current real-world practices, offering grounded insights that inform executive decision-making.

Why This Report Matters

  • Enables senior leaders to closely align innovation, procurement, and risk-management strategies throughout the autoimmune disease diagnostics sector.
  • Provides actionable guidance on regulatory currents, evolving technologies, and buyer requirements to inform market positioning and investment decisions.
  • Facilitates confident business planning by presenting a clear map of technological, regional, and customer-demand trends across the value chain.

Conclusion

For organizations navigating the autoimmune disease diagnostics market, actionable intelligence on validated technology platforms, adaptive supply solutions, and flexible commercialization is essential. This report arms stakeholders with a solid knowledge base to advance organizational outcomes in a dynamic healthcare landscape.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Rise of telemedicine enabled home based autoimmune disease testing kits integrated with smartphone connectivity features
5.2. Surge in adoption of digital health platforms for remote ordering and interpretation of autoimmune diagnostic tests
5.3. Expansion of personalized proteomic and metabolomic biomarker panels for predictive type 1 diabetes diagnostics
5.4. Implementation of liquid biopsy based cell free DNA methylation assays for monitoring multiple sclerosis treatment efficacy
5.5. Development of point of care multiplex biomarker testing devices for rapid autoimmune diagnosis in clinical settings
5.6. Integration of artificial intelligence algorithms in immunoassay analysis for improved diagnostic precision
5.7. Adoption of next generation sequencing autoantibody panels for early rheumatoid and lupus detection
5.8. Standardized ANA testing workflows adopting ICAP pattern nomenclature and reflex pathways to reduce false positives
5.9. Rising demand for celiac disease serology with biopsy-sparing pediatric algorithms accelerating tTG-IgA and DGP assay volumes
5.10. Regulatory acceptance of real-world evidence and post-market performance studies to support label expansions
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Autoimmune Disease Diagnostics Market, by Product
8.1. Assay Kits & Reagents
8.2. Instruments
8.2.1. Immunoassay Analyzers
8.2.2. Microplate Readers
9. Autoimmune Disease Diagnostics Market, by Test Type
9.1. Autoantibodies & Immunologic Test
9.1.1. Antinuclear Antibodies
9.1.2. Cyclic Citrullinated Peptide Antibodies
9.1.3. Disease-Specific Autoantibodies
9.2. Genetic Testing
9.2.1. Chromosomal Tests
9.2.2. Molecular Tests
9.3. Imaging Tests
9.3.1. Magnetic Resonance Imaging
9.3.2. Positron Emission Tomography
9.3.3. Ultrasound
9.4. Inflammatory Markers
9.4.1. C-reactive protein
9.4.2. Erythrocyte Sedimentation Rate
10. Autoimmune Disease Diagnostics Market, by Technology
10.1. Enzyme-Linked Immunosorbent Assay
10.2. Flow Cytometry
10.3. Immunofluorescence Assay
10.4. Multiplex Assays
10.5. Next-Generation Sequencing
10.6. Western Blotting
11. Autoimmune Disease Diagnostics Market, by Sample Type
11.1. Blood
11.2. Saliva
11.3. Urine
12. Autoimmune Disease Diagnostics Market, by Indication
12.1. Organ-Specific Autoimmune Disease Diagnostics
12.1.1. Graves’ Disease
12.1.2. Hashimoto’s Thyroiditis
12.1.3. Multiple Sclerosis
12.1.4. Type 1 Diabetes
12.2. Systemic Autoimmune Disease Diagnostics
12.2.1. Rheumatoid Arthritis
12.2.2. Systemic Lupus Erythematosus
12.2.3. Systemic Sclerosis
13. Autoimmune Disease Diagnostics Market, by Distribution Channel
13.1. Offline Sales
13.2. Online Sales
14. Autoimmune Disease Diagnostics Market, by End User
14.1. Ambulatory Care Centers
14.2. Diagnostic Laboratories
14.3. Hospitals & Clinics
14.4. Research Institutions
15. Autoimmune Disease Diagnostics Market, by Region
15.1. Americas
15.1.1. North America
15.1.2. Latin America
15.2. Europe, Middle East & Africa
15.2.1. Europe
15.2.2. Middle East
15.2.3. Africa
15.3. Asia-Pacific
16. Autoimmune Disease Diagnostics Market, by Group
16.1. ASEAN
16.2. GCC
16.3. European Union
16.4. BRICS
16.5. G7
16.6. NATO
17. Autoimmune Disease Diagnostics Market, by Country
17.1. United States
17.2. Canada
17.3. Mexico
17.4. Brazil
17.5. United Kingdom
17.6. Germany
17.7. France
17.8. Russia
17.9. Italy
17.10. Spain
17.11. China
17.12. India
17.13. Japan
17.14. Australia
17.15. South Korea
18. Competitive Landscape
18.1. Market Share Analysis, 2024
18.2. FPNV Positioning Matrix, 2024
18.3. Competitive Analysis
18.3.1. Abbott Laboratories
18.3.2. AbbVie Inc.
18.3.3. Beckman Coulter, Inc. by Danaher Corporation
18.3.4. Becton, Dickinson and Company
18.3.5. Bio-Rad Laboratories, Inc.
18.3.6. bioMerieux SA
18.3.7. DiaSorin S.p.A.
18.3.8. F. Hoffmann-La Roche Ltd.
18.3.9. Grifols, S.A
18.3.10. Labcorp Holdings Inc.
18.3.11. Quest Diagnostics, Inc.
18.3.12. Revvity, Inc.
18.3.13. Siemens Healthineers AG
18.3.14. Takeda Pharmaceutical Company Limited
18.3.15. Thermo Fisher Scientific Inc.
List of Tables
List of Figures

Samples

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Companies Mentioned

The key companies profiled in this Autoimmune Disease Diagnostics market report include:
  • Abbott Laboratories
  • AbbVie Inc.
  • AESKU.GROUP GmbH & Co. KG
  • Autobio Diagnostics Co., Ltd.
  • Beckman Coulter, Inc. by Danaher Corporation
  • Becton, Dickinson and Company
  • Bio-Rad Laboratories, Inc.
  • BioAgilytix Labs
  • bioMerieux SA
  • Chengdu Maccura Biotechnology Co., Ltd.
  • DiaSorin S.p.A.
  • Exagen Inc.
  • F. Hoffmann-La Roche Ltd.
  • GlaxoSmithKline plc
  • Grifols, S.A
  • Hemagen Diagnostics, Inc.
  • Labcorp Holdings Inc.
  • Medical & Biological Laboratories Co. Ltd
  • Menarini Group
  • Merck KGaA
  • Progentec Diagnostics, Inc.
  • Quest Diagnostics, Inc.
  • Revvity, Inc.
  • RSR Limited
  • Sebia S.A.
  • Shanghai Kehua Bio-Engineering Co., Ltd.
  • Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • Shenzhen YHLO Biotech Co.,Ltd.
  • Siemens Healthineers AG
  • Svar Life Science AB
  • Takeda Pharmaceutical Company Limited
  • Thermo Fisher Scientific Inc.
  • Trinity Biotech PLC
  • Werfen Group

Table Information