The global autoimmune disease diagnostics market is poised for significant growth in the coming decade. Market forecasts indicate a surge from USD 5.75 billion in 2024 to USD 10.5 billion by 2034, growing at a CAGR of 6.22%. This growth is largely driven by increasing autoimmune disease cases, technological advancements, and heightened awareness.

Key Highlights at a Glance

• Market size projected to reach USD 10.5 billion by 2034

• CAGR of 6.22% from 2025 to 2034

• North America dominated the market with a 47% share in 2024

• Asia Pacific expected to grow at the fastest rate

• Localized autoimmune diseases held the largest market share in 2024

• Systemic disorders segment is projected to witness the fastest growth

• Consumables & assays dominated the product segment in 2024

• Instruments segment is projected to expand significantly

• Antinuclear antibody tests led in test types; autoantibody tests expected to grow fastest

• Hospitals held the largest share in end-use; diagnostic centers forecasted for rapid growth

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Understanding Autoimmune Disease Diagnostics

Autoimmune diseases occur when the body’s immune system mistakenly attacks its own healthy tissues. Diagnosing these complex conditions involves specialized tests to identify and monitor disease progression. The rising number of autoimmune cases, coupled with advances in nanotechnology, genomics, and personalized medicine, are significantly contributing to market expansion.

Emerging Market Trends

Key Collaborations and Partnerships

• Allogene Therapeutics and Foresight Diagnostics (Feb 2025): Entered a partnership to develop minimal residual disease (MRD) assays for large B-cell lymphoma patients. (Source: Finance)

• Carisma Therapeutics and Moderna (Sep 2024): Expanded partnership to develop treatments for autoimmune diseases. (Source: PR Newswire)

• Accelerating Medicines Partnership (Oct 2024): NIH, FDA, pharma companies, and non-profits collaborating to identify novel diagnostics and treatments for autoimmune diseases. (Source: NIA)

The Role of Artificial Intelligence

AI is playing a transformative role in autoimmune disease diagnostics by analyzing vast datasets, identifying complex patterns, and supporting early detection. AI algorithms enhance medical imaging analysis and clinical data interpretation, often uncovering insights that conventional methods may overlook.

For example:
In May 2025, WellTheory, a digital health company focused on autoimmune care, raised $5 million from investors like Samsung Next and Accel. The company introduced two AI-powered tools, Care Scribe and Care Hub, to streamline autoimmune patient care. (Source: MedCity News)

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Market Drivers

Rising Disease Prevalence and Technology Advancements

The global rise in autoimmune conditions like rheumatoid arthritis, lupus, and multiple sclerosis fuels the demand for precise diagnostics. Technological innovations in biomarker identification, genetic testing, and imaging continue to improve diagnostic accuracy.

Escalating Novel Technologies

Breakthroughs in omics research (genomics, proteomics, metabolomics) and nanotechnology are paving the way for next-generation diagnostics and therapies. Techniques such as biosensors and synthetic receptor-based cell therapies are creating new opportunities in the market.

Market Challenges

High Costs and Lack of Standardization

The complexity of autoimmune diseases makes diagnosis expensive, often limiting patient access to essential tests. Additionally, developing universally accepted diagnostic criteria remains a challenge due to the variability of symptoms across patients.

Segmental Insights

Dominance of Localized Autoimmune Diseases

In 2024, localized autoimmune disorders led the market, driven by rising disease prevalence, technological advancements, and growing awareness of treatment options.

Growth in Systemic Disorders

Systemic disorders are expected to witness the fastest growth due to improved understanding of complex immune responses and development of comprehensive diagnostic solutions.

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Regional Market Insights

North America Leads the Market

North America remains the largest market due to its strong R&D infrastructure, advanced healthcare systems, and significant investments in diagnostic technologies.

Asia Pacific: A Rapidly Growing Region

Asia Pacific is witnessing accelerated growth, supported by a growing population, increasing disease prevalence, and rapidly improving healthcare infrastructure.

Spotlight on Canada

Canada’s market is benefiting from rising healthcare spending and supportive government reimbursement policies that encourage diagnostic testing.

Advancements in China

China is adopting advanced technologies such as antinuclear antibody tests and autoantibody tests to meet rising demand due to increasing autoimmune disease prevalence.

Recent Developments by Industry Leaders

• Quanterix Corporation (Jan 2025): Announced acquisition of Akoya Biosciences to develop integrated solutions for ultra-sensitive biomarker detection. (Source: Businesswire)

• OMNY Health and Scipher Medicine (Jan 2025): Partnered to advance precision medicine capabilities for autoimmune conditions. (Source: Businesswire)

Latest Innovations in the Market

• Predicta Biosciences (Apr 2025): Launched molecular diagnostic product for multiple myeloma. (Source: Businesswire)

• Progentec Diagnostics (Aug 2024): Introduced CareMGMT™, a mobile app empowering patients in managing their autoimmune health. (Source: PR Newswire)

Conclusion

The autoimmune disease diagnostics market is on a promising growth trajectory, driven by rising disease prevalence, technological advancements, and the integration of AI and precision medicine. Despite facing challenges such as high costs and complex diagnostic criteria, the market is witnessing continuous innovations that are reshaping its future.

Source : https://www.towardshealthcare.com/insights/autoimmune-disease-diagnostics-market-sizing