Autoimmune Disease Diagnostics Market Companies Analysis

The global Autoimmune Disease Diagnostics Market is entering a period of accelerated expansion. According to Renub Research, the industry is projected to grow from US$ 5.70 billion in 2024 to US$ 10.63 billion by 2033, reflecting a strong compound annual growth rate (CAGR) of 7.17% between 2025 and 2033.

This remarkable growth trajectory underscores the increasing demand for accurate, reliable, and early diagnostic solutions. Rising prevalence of autoimmune disorders, heightened awareness among healthcare providers, and continuous technological innovation are reshaping the diagnostic landscape. With a greater emphasis on improving patient outcomes and enabling personalized medicine, autoimmune disease diagnostics is becoming a cornerstone of modern healthcare systems worldwide.

Industry Overview

Autoimmune diseases occur when the immune system mistakenly attacks healthy tissues. These disorders can affect nearly every organ system and include conditions such as lupus, rheumatoid arthritis, multiple sclerosis, systemic sclerosis, and myositis. Because symptoms often overlap with other conditions, diagnosis can be complex and time-consuming.

Autoimmune disease diagnostics involve a comprehensive process that begins with detailed patient history and physical examination, followed by laboratory investigations targeting specific biomarkers. Common tests include antinuclear antibody (ANA) testing, rheumatoid factor (RF), and organ-specific autoantibody panels. Inflammatory markers and genetic analyses further enhance diagnostic precision.

Advancements in molecular diagnostics, immunoassays, and automated laboratory platforms are transforming how clinicians identify and monitor autoimmune conditions. Early and accurate diagnosis enables timely therapeutic interventions, reduces complications, and improves long-term disease management.

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Key Growth Drivers

Rising Prevalence of Autoimmune Disorders

Globally, autoimmune diseases are becoming increasingly prevalent due to genetic predispositions, environmental triggers, and lifestyle changes. Earlier detection and better awareness are contributing to rising diagnosis rates, which in turn drive demand for advanced diagnostic tools.

Technological Innovation

Automation, digital laboratory platforms, and AI-enabled analytics are enhancing test sensitivity and specificity. Molecular diagnostic techniques and high-throughput screening systems are enabling clinicians to detect complex autoimmune markers more efficiently.

Focus on Personalized Medicine

Healthcare systems are moving toward personalized treatment strategies. Precision diagnostics play a critical role in identifying specific biomarkers, guiding therapeutic decisions, and monitoring treatment response.

Strategic Collaborations and Partnerships

Industry leaders are forming strategic alliances to expand product portfolios, improve automation, and integrate next-generation technologies. These collaborations accelerate innovation and expand global market reach.

Major Players in the Autoimmune Disease Diagnostics Market

Abbott Laboratories

Founded: 1888
Headquarters: Illinois, United States
Revenue (2023): US$ 42.0 Billion

Abbott develops and markets a broad range of diagnostic systems, including core laboratory instruments, rapid diagnostics, and point-of-care testing solutions. Its global distribution network spans North America, Europe, Asia-Pacific, Latin America, and Africa. The company’s strong R&D investments support advancements in immunoassays and autoimmune testing platforms.

Bio-Rad Laboratories

Founded: 1952
Headquarters: California, United States
Revenue (2023): US$ 2.6 Billion

Bio-Rad specializes in life science research tools and clinical diagnostic solutions. Its portfolio includes autoimmune diagnostic kits, digital PCR systems, and antibody detection technologies. The company serves hospitals, research institutions, and commercial laboratories worldwide.

Roche Diagnostics

Founded: 1896
Headquarters: Rotkreuz, Switzerland

Roche Diagnostics provides in-vitro diagnostic systems, molecular diagnostic reagents, and automated workflow solutions. Its platforms are widely used in hospitals, laboratories, and research centers. Roche’s continuous innovation in molecular and immunological diagnostics strengthens its position in autoimmune disease testing.

Siemens Healthineers

Founded: 1847
Headquarters: Forchheim, Germany
Revenue (2023): US$ 24.2 Billion

Siemens Healthineers designs imaging systems, in-vitro diagnostics, and point-of-care testing instruments. The company’s integrated digital solutions enhance laboratory efficiency and diagnostic accuracy.

bioMérieux

Founded: 1963
Headquarters: Marcy l’Etoile, France
Revenue (2023): US$ 1.3 Billion

bioMérieux focuses on in-vitro diagnostic solutions, including immunoassays and molecular tests for infectious and autoimmune conditions. The company operates through direct sales and a global distributor network.

Myriad Genetics

Founded: 1991
Headquarters: Utah, United States
Revenue (2023): US$ 837.6 Million

Myriad Genetics develops molecular diagnostic tests to assess genetic risk factors and guide personalized treatment decisions. Its innovations contribute to improved autoimmune disease detection and management.

Recent Product Launches and Developments

·        In July 2025, Quest Diagnostics announced the launch of the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio test, the first FDA-cleared blood test aiding in the identification of amyloid pathology associated with Alzheimer’s disease.

·        In December 2023, Thermo Fisher Scientific signed a sole distributor agreement with Aesku.Group to distribute FDA-cleared IFA products and automated systems in the United States, strengthening its autoimmune diagnostic portfolio.

These developments highlight the industry’s focus on automation, regulatory approval, and portfolio expansion.

SWOT Analysis

EUROIMMUN – Strength

EUROIMMUN maintains a broad autoimmune testing portfolio, offering over 150 specialty tests covering more than 80 autoimmune diseases. Its clinically validated panels support screening, diagnosis, and monitoring, enhancing physician confidence and patient outcomes.

Inova Diagnostics – Strength

Inova Diagnostics, part of Werfen, provides comprehensive autoimmune testing solutions aligned with global clinical guidelines. Its extensive test portfolio supports evidence-based diagnosis and disease monitoring.

Corporate Developments

·        In July 2025, Grifols announced a EUR 160 million investment to expand plasma fractionation capacity in Europe.

·        In August 2025, Labcorp launched Test Finder, a generative AI-based tool developed with Amazon Web Services to streamline lab test selection for healthcare providers.

These initiatives illustrate ongoing digital transformation and infrastructure expansion across the diagnostics sector.

Sustainability Commitments

Trinity Biotech

Trinity Biotech integrates environmental stewardship into product development and manufacturing processes, focusing on energy efficiency, waste reduction, and sustainable innovation.

BD (Becton Dickinson)

Becton Dickinson aims to reduce Scope 1 and 2 emissions by 46% by 2030 and achieve carbon neutrality in direct operations by 2040 through its ESG strategy “Together We Advance.”

Sustainability efforts align with broader healthcare goals of reducing environmental impact while improving patient care.

Market Outlook and Forecast

Historical Trends

The autoimmune diagnostics market has expanded steadily due to improved clinical awareness, increased laboratory automation, and broader access to healthcare services.

Forecast Analysis

Renub Research forecasts the market to reach US$ 10.63 billion by 2033, driven by rising disease prevalence, technological innovation, and strategic collaborations.

Market Share and Company Analysis

Comprehensive company evaluations include:

·        Corporate overview and mission

·        Business operations and leadership

·        Recent mergers, acquisitions, and investments

·        Sustainability initiatives

·        Product portfolio and benchmarking

·        SWOT and revenue analysis

Companies covered include Abbott Laboratories, Bio-Rad Laboratories, Roche Diagnostics, Siemens Healthineers, bioMérieux, Myriad Genetics, Quest Diagnostics, Thermo Fisher Scientific, EUROIMMUN, Inova Diagnostics, Grifols, Labcorp, Revvity, Trinity Biotech, and BD.

Final Thoughts

The Autoimmune Disease Diagnostics Market is positioned for sustained and transformative growth. With projections rising from US$ 5.70 billion in 2024 to US$ 10.63 billion by 2033, the sector reflects a strong commitment to improving diagnostic precision and patient care.

Technological innovation, AI integration, strategic collaborations, and sustainability initiatives are collectively shaping the future of autoimmune testing. As healthcare systems increasingly prioritize early detection and personalized treatment, diagnostic companies that invest in advanced platforms and global partnerships will lead the next phase of industry expansion.

Ultimately, the market’s evolution is not only about financial growth—it is about delivering earlier diagnoses, better therapies, and improved quality of life for millions of patients worldwide.