Autoimmune Disease Diagnostics Market Size and Forecast 2025–2033

Accurate diagnostics are becoming the backbone of modern healthcare—especially in the fast-evolving world of autoimmune diseases. With rising cases of conditions like rheumatoid arthritis, lupus, multiple sclerosis, and celiac disease, timely diagnosis has become more crucial than ever. According to Renub Research, the global Autoimmune Disease Diagnostics Market is projected to reach US$ 10.63 billion by 2033, up from US$ 5.70 billion in 2024, growing at a CAGR of 7.17% from 2025 to 2033.

This steady rise reflects a global shift toward early detection, personalized medicine, and advanced diagnostic technologies that help clinicians identify complex diseases faster and with more accuracy.

Autoimmune Disease Diagnostics Market Overview

The autoimmune disease diagnostics market is witnessing robust expansion due to higher disease awareness, increasing disease prevalence, and ongoing advancements in technologies such as immunofluorescence, PCR, ELISA, and next-generation biomarker discovery.

Autoimmune diseases—from multiple sclerosis to type 1 diabetes—are notoriously difficult to diagnose due to overlapping symptoms. That challenge has fueled demand for precise, early testing and accelerated the adoption of multi-biomarker assays, microarray platforms, and point-of-care devices.

A growing number of global health organizations are raising awareness as well. The Autoimmune Association’s Autoimmune Disease Awareness Month held every March has brought public attention to early symptoms, disease management, and the importance of timely testing. Greater awareness naturally translates to earlier doctor visits, earlier screenings, and a growing diagnostics market.

The rise in disease prevalence is striking. According to the Multiple Sclerosis International Federation, MS cases increased from 2.3 million in 2013 to 2.8 million in 2020. WHO’s 2023 data shows over 18 million people worldwide had rheumatoid arthritis in 2019, with women representing roughly 70% of all cases.

These accelerating numbers underline the demand for dependable diagnostics—and the market is responding.

Growth Drivers for the Autoimmune Disease Diagnostics Market

1. Strong Focus on Enhancing Patient Outcomes

Healthcare systems worldwide are prioritizing earlier disease detection and improved patient outcomes. On October 16, 2023, Werfen’s Aptiva® connective tissue disease (CTD) reagent received FDA 510(k) approval, a milestone that supports faster and more accurate autoimmune screening.

The logic is simple:

Early diagnosis = early intervention = better outcomes.

For chronic, degenerative diseases like lupus, rheumatoid arthritis, and multiple sclerosis, rapid testing can help prevent serious organ damage and long-term complications. As precision medicine grows in popularity, demand for highly sensitive diagnostic tools is climbing.

2. Partnerships, Collaborations, and Strategic Acquisitions

The autoimmune diagnostics landscape is rapidly evolving thanks to strategic collaborations across pharma, biotech, and diagnostic laboratories.

One example is Scipher Medicine’s January 2023 acquisition of CrossBridge, a data and analytics firm. This move enhances real-time patient pathway insights, improves value-based care platforms, and reduces unnecessary treatments.

Partnerships between pharmaceutical companies and diagnostics firms are also boosting companion diagnostics—tests designed to identify which patients will best respond to specific therapies.

This ecosystem of collaboration:

Improves diagnostic accuracy

Reduces trial-and-error prescribing

Enhances patient outcomes

Supports precision immunology

This collaborative shift is reshaping the autoimmune diagnostics industry.

3. Rapid Developments in Diagnostic Technologies

Breakthroughs in biomarker discovery, especially in autoantibodies, are enabling earlier and more precise diagnosis of complex autoimmune disorders. Meanwhile, proteomics and metabolomics are paving the way for personalized diagnostic approaches based on unique protein or metabolic signatures.

Microarray technologies now allow clinicians to test multiple biomarkers simultaneously, improving the accuracy of diagnosing diseases with multi-factor origin.

Industry activity is also accelerating.

For example, on March 25, 2024, AbbVie announced its acquisition of Landos Biopharma, bringing in NX-13—a promising oral NLRX1 agonist designed to treat autoimmune disorders. This kind of R&D momentum fuels further advancements in diagnostics.

Challenges in the Autoimmune Disease Diagnostics Market

Despite strong growth, several hurdles remain:

• Low product penetration in developing economies

Limited epidemiological data, shortage of trained specialists, and insufficient diagnostic infrastructure restrain market growth in regions like Latin America, Africa, and parts of Asia.

• Competitive pricing pressures

Local manufacturers often offer lower-cost devices, intensifying price competition and affecting premium technology adoption.

• High costs of advanced diagnostic systems

Healthcare providers hesitate to upgrade to expensive instruments, slowing down adoption rates of state-of-the-art technologies.

Market Breakdown by Segment

1. Product Insights

Diagnostic Equipment Leads the Market

Diagnostic equipment—from analyzers to imaging systems—plays a foundational role in rapid and accurate autoimmune testing. As early intervention becomes more important, demand for automation, precision, and AI-driven diagnostic platforms continues to rise.

2. Types of Autoimmune Diseases

Systemic Autoimmune Diseases Dominate

The market is divided into:

Systemic autoimmune diseases

Localized autoimmune diseases

Systemic diseases lead due to their chronic nature, complexity, and the need for lifelong monitoring. Advances such as autoantibody assays and genetic susceptibility testing also support their dominance.

3. Indication Analysis

Among all indications, rheumatic diseases hold a major share. Rheumatoid arthritis, lupus, and related disorders affect nearly 1 in 4 adults globally, reflected in high demand for diagnostic testing.

Other indications include:

Diabetes (especially type 1)

Multiple sclerosis

Inflammatory bowel disease

Others

Early detection, personalized therapy, and expanding research in autoimmune rheumatology support strong growth.

4. End-Users

Diagnostics Centers Expected to Lead

Diagnostics centers are rapidly becoming the go-to hubs for autoimmune testing due to:

Specialized expertise

Faster turnaround times

Advanced testing platforms

Wider availability of high-complexity tests

Better digital integration and referral pathways

Value-based care models also support the shift toward affordable, high-efficiency diagnostics.

Regional Analysis

The Autoimmune Disease Diagnostics Market spans:

North America

United States

Canada

Europe

France, Germany, Italy, Spain, UK, Belgium, Netherlands, Turkey

Asia-Pacific

China, Japan, India, South Korea, Thailand, Malaysia, Indonesia, Australia, New Zealand

Latin America

Brazil, Mexico, Argentina

Middle East & Africa

Saudi Arabia, UAE, South Africa

United States

The U.S. remains the global leader due to:

High prevalence of autoimmune diseases

Advanced diagnostic infrastructure

Widespread adoption of PCR, ELISA, and immunofluorescence

Strong shift toward personalized medicine

Oxford University reported in May 2023 that 1 in 10 of 22 million global autoimmune patients reside in the U.S. This rising burden increases the need for early and advanced testing solutions.

Germany

Germany’s strong healthcare ecosystem and high disease awareness fuel demand for diagnostics. Precision diagnostics, genetic testing, and point-of-care solutions are expanding rapidly, creating opportunities for innovation.

Stringent regulations and high costs remain challenges, but steady market growth continues.

Australia

Australia faces rising cases of type 1 diabetes, lupus, and multiple sclerosis. The International Diabetes Federation reported 1,500 new type 1 diabetes cases in 2021 among children aged 0–19.

With robust healthcare policies, advances in molecular diagnostics, and growing awareness, Australia is shaping up as a high-opportunity market—despite challenges in remote regions.

United Arab Emirates

The UAE is experiencing rapid adoption of advanced testing due to:

Healthcare modernization

Rising autoimmune disease burden

Investments in ELISA, PCR, and genetic testing

Recognition of personalized medicine

Challenges include high equipment costs and specialist training gaps, but overall momentum favors strong market expansion.

Market Segmentation Summary

Product

Therapeutic & Monitoring Equipment

Diagnostics Equipment

Drugs

Types

Systemic

Localized

Indications

Rheumatic Disease

Diabetes

Multiple Sclerosis

Inflammatory Bowel Disease

Others

End-Users

Hospitals

Diagnostics Centers

Others

Key Companies Covered

Each analyzed by Overview, Recent Developments, and Revenue Analysis:

Abbott Laboratories

Bio-Rad Laboratories

Roche Diagnostics

Siemens Healthineers

BioMérieux SA

Myriad Genetics, Inc.

Quest Diagnostics Incorporated

Thermo Fisher Scientific Inc.

Final Thoughts

Autoimmune diseases are no longer rare or poorly understood—they’re a growing global challenge with increasing visibility and increasing complexity. As patients seek answers earlier, clinicians need smarter diagnostic tools that deliver clarity fast. This is where technological innovation, strategic partnerships, and precision medicine converge.

With the market expected to reach US$ 10.63 billion by 2033, the autoimmune disease diagnostics sector is entering a transformative decade. Increased awareness, better biomarkers, AI-powered testing, and personalized medicine will redefine how early—and how accurately—patients receive their diagnosis.

The future of autoimmune care starts with diagnostics. And diagnostics, as this market shows, are getting smarter every year.