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.
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
Invest in Our Premium Strategic Solution: https://www.towardshealthcare.com/download-databook/5723
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.
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)
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)
Get All the Details in Our Solutions – Access Report Preview: https://www.towardshealthcare.com/download-sample/5723
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.
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.
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.
In 2024, localized autoimmune disorders led the market, driven by rising disease prevalence, technological advancements, and growing awareness of treatment options.
Systemic disorders are expected to witness the fastest growth due to improved understanding of complex immune responses and development of comprehensive diagnostic solutions.
If you have any questions, please feel free to contact us at sales@towardshealthcare.com
North America remains the largest market due to its strong R&D infrastructure, advanced healthcare systems, and significant investments in diagnostic technologies.
Asia Pacific is witnessing accelerated growth, supported by a growing population, increasing disease prevalence, and rapidly improving healthcare infrastructure.
Canada’s market is benefiting from rising healthcare spending and supportive government reimbursement policies that encourage diagnostic testing.
China is adopting advanced technologies such as antinuclear antibody tests and autoantibody tests to meet rising demand due to increasing autoimmune disease prevalence.
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)
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)
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
Kedrion Biopharma has announced that its human coagulation factor X concentrate, COAGADEX®, has been granted orphan drug designation by the… Read More
enecard PBF, a pioneer in pharmacy benefit facilitation, has announced a strategic partnership with DecisionRX, Inc., a leader in medication… Read More
In a high-stakes biotech industry where drug development can span over a decade, four small but determined biotech companies are… Read More
cell-free DNA and precision medicine, has officially announced the launch of the TEODOR trial (ABCSG 61), a groundbreaking phase 2,… Read More
The global interventional radiology market is witnessing rapid expansion, driven by advancements in minimally invasive procedures, rising demand for diagnostic… Read More
The global physical therapy market is valued at USD 28.06 billion in 2024, growing to USD 29.18 billion in 2025… Read More