Autoimmune Disease Diagnostics Market Summary
As per MRFR Analysis, the Autoimmune Disease Diagnostics Market was valued at 6.36 USD Billion in 2023 and is projected to reach 12.3 USD Billion by 2035, growing at a CAGR of 5.66% from 2025 to 2035. The market is driven by the increasing prevalence of autoimmune diseases, technological advancements in diagnostic tools, and heightened awareness among patients and healthcare providers.
Key Market Trends & Highlights
Key trends driving the Autoimmune Disease Diagnostics Market include technological innovations and rising disease awareness.
- The market is expected to grow from 6.72 USD Billion in 2024 to 12.3 USD Billion by 2035.
- Serological Tests are projected to rise from 2.68 USD Billion in 2024 to 4.8 USD Billion by 2035.
- Molecular Diagnostics are anticipated to grow from 1.85 USD Billion in 2024 to 3.4 USD Billion by 2035.
- North America is expected to dominate the market with a valuation of 2.8 USD Billion in 2024.
Market Size & Forecast
2023 Market Size: USD 6.36 Billion
2024 Market Size: USD 6.72 Billion
2035 Market Size: USD 12.3 Billion
CAGR (2025-2035): 5.66%
Largest Regional Market Share in 2024: North America.
Major Players
Key players include Genentech, Abbott Laboratories, Hologic, BD, Quest Diagnostics, Thermo Fisher Scientific, ImmunoPrecise Antibodies, ArcherDX, LabCorp, Roche Diagnostics, Mayo Clinic Laboratories, Eurofins Scientific, BioRad Laboratories, Cepheid, Siemens Healthineers.
Key Autoimmune Disease Diagnostics Market Trends Highlighted
One significant trend in the global market for autoimmune disease diagnostics is the growing emphasis on cutting-edge diagnostic methods like next-generation sequencing and biomarker discovery. These methods improve the precision of autoimmune disease diagnosis, which increases demand in medical facilities.
Another important market driver is the rising incidence of autoimmune illnesses around the world. According to the World Health Organization, millions of people suffer from autoimmune disorders, and their prevalence is increasing. This underscores the pressing need for efficient diagnostic tools. There are prospects to investigate in this industry due to the growth of customized medicine.
Optimizing healthcare resources and improving patient outcomes are possible when diagnostic methods are customized to each patient's unique profile. Additionally, there is a drive to develop point-of-care testing equipment, which guarantee quick results and patient convenience, therefore attracting a market segment that prioritizes effectiveness and user-friendliness.
Additionally, recent patterns show that pharmaceutical companies and biotech companies have significantly increased their investment in autoimmune disease research and development. This tendency is crucial for fostering innovation and producing new, more dependable, and more affordable diagnostic instruments and tests.
Additionally, industry-academia cooperation are become more frequent, which promotes the creation of novel diagnostic tools. Overall, the future of diagnostics in this crucial field of healthcare is being shaped by the convergence of cutting-edge technology, rising autoimmune disease prevalence, and the expansion of point-of-care and tailored testing.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
Autoimmune Disease Diagnostics Market Drivers
Increasing Prevalence of Autoimmune Diseases
The Autoimmune Disease Diagnostics Market is significantly driven by the increasing prevalence of autoimmune diseases worldwide. According to the World Health Organization, autoimmune disorders, which include conditions like rheumatoid arthritis and systemic lupus erythematosus, affect around 5% of the global population.This translates to approximately 400 million people globally. The rising incidence of such diseases creates a pressing demand for accurate and effective diagnostic methods.
Major oncology-focused organizations like the American Autoimmune Related Diseases Association (AARDA) continuously report growing awareness and funding for autoimmune research, resulting in the availability of advanced diagnostic tools and technologies.This interplay between growing disease incidence and improved diagnostic solutions is expected to fuel the market growth significantly over the next decade, as more people seek diagnoses and treatment options.
Advancements in Diagnostic Technologies
Technological advancements in diagnostic tools are revolutionizing the Autoimmune Disease Diagnostics Market. Innovations such as next-generation sequencing and biomarker identification are leading to more precise and faster diagnostic solutions.
For instance, new molecular diagnostic methods enable the identification of specific autoimmune disorders with greater accuracy, leading to better patient outcomes. The development and incorporation of these technologies are supported by leading biotechnology firms, which have invested heavily in Research and Development initiatives.
The National Institutes of Health (NIH) data shows that funding for diagnostic technology projects has increased by over 20% in the past five years, showcasing the strong focus on improving diagnostics for autoimmune diseases. This trend is shaping the future of disease diagnostics and is a pivotal driver for the market.
Rising Healthcare Expenditure
The rise in global healthcare expenditure is another significant driver for the Autoimmune Disease Diagnostics Market. Reports indicate that healthcare spending worldwide is expected to grow at a compound annual growth rate of around 5.3%, reaching approximately 12 trillion USD by 2025.
This increase in spending is primarily fueled by the need for enhanced diagnostic tools and treatments for chronic diseases, including autoimmune disorders. Government initiatives in various countries push for improved healthcare access and quality, leading to a surge in demand for diagnostic services and medical innovations.
Organizations like the World Bank highlight the importance of strengthening healthcare systems, which in turn supports the growth of the diagnostic sector. As governments and health organizations invest more in healthcare, the market for autoimmune disease diagnostics is expected to thrive.
Growing Awareness and Educational Initiatives
Growing awareness about autoimmune diseases and targeted educational initiatives are pivotal in enhancing the Autoimmune Disease Diagnostics Market. With increased public and medical community awareness regarding the symptoms and complexities of autoimmune disorders, more individuals are seeking diagnoses and treatments. Organizations such as the Lupus Foundation of America emphasize the importance of education in recognizing symptoms early, which spurs demand for diagnostic services.
Research shows that awareness campaigns have led to a 30% increase in the number of individuals seeking testing for autoimmune diseases over the last few years. As these awareness initiatives continue to expand, they directly contribute to the market growth by prompting more patients and healthcare providers to utilize diagnostic services for timely intervention.
Autoimmune Disease Diagnostics Market Segment Insights
Autoimmune Disease Diagnostics Market Test Type Insights
The Autoimmune Disease Diagnostics Market was segmented into various test types, reflecting a significant aspect of the industry.Among these, Serological Tests held the largest share, valued at 2.4 USD Billion in 2024 and expected to grow to 4.3 USD Billion by 2035, highlighting their importance in detecting autoimmune diseases through serum analysis. This method was crucial for diagnosing conditions such as rheumatoid arthritis and lupus, as it identified specific antibodies in the patient's bloodstream, driving the demand for these tests.
Molecular Diagnostics also gained traction, with an anticipated valuation of 1.8 USD Billion in 2024, rising to 3.5 USD Billion by 2035. This segment employed advanced techniques like PCR and next-generation sequencing, allowing for precise diagnosis and the identification of genetic markers associated with autoimmune diseases, thereby showing potential for significant growth within the market.Imaging Tests, valued at 1.0 USD Billion in 2024 and expected to double to 2.0 USD Billion in 2035, played a vital role in assessing the severity and progression of autoimmune disorders, providing critical visual insights that complement laboratory results.
Lastly, Biopsies accounted for a valuation of 1.52 USD Billion in 2024, projected to reach 2.5 USD Billion by 2035. This test type was essential for obtaining tissue samples, allowing for direct examination of affected areas, thus facilitating accurate diagnosis and treatment planning.The growth of these test types was driven by increased awareness of autoimmune diseases, advancements in diagnostic technologies, and a surge in healthcare spending globally.
The demand for precise and early detection of these conditions significantly shaped the Autoimmune Disease Diagnostics Market, as these diagnostics ultimately led to better patient outcomes and tailored therapies, making continuous innovation and adaptation essential to meet the evolving needs of this vital healthcare sector.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
Autoimmune Disease Diagnostics Market Disease Type Insights
The market showcases a broad range of disease types, with notable segments including Rheumatoid Arthritis, Lupus, Multiple Sclerosis, Type 1 Diabetes, and Thyroid Disorders. Rheumatoid Arthritis remains a prominent focus due to its widespread impact on mobility and overall quality of life.Lupus is also critical, often affecting young women disproportionately, creating a pressing need for effective diagnostic tools. Multiple Sclerosis diagnostics are gaining attention as they play a crucial role in early intervention, which can greatly affect disease progression.
Type 1 Diabetes diagnostics are vital for immediate treatment, enabling better management of the disease from an early age. Additionally, Thyroid Disorders diagnostics are essential as they affect a significant portion of the global population, often going unnoticed until symptoms become severe.
The Autoimmune Disease Diagnostics Market statistics indicate that the demand for advanced and rapid diagnostic solutions is rising, propelled by increased awareness and improved healthcare access, making this sector ripe with opportunities for innovation and growth in the coming years.
Autoimmune Disease Diagnostics Market End-user Insights
The Autoimmune Disease Diagnostics Market is experiencing significant growth, driven by a rising prevalence of autoimmune diseases and advancements in diagnostic technologies. Among the key End-users, hospitals play a crucial role as they provide critical diagnostic services and patient care, significantly contributing to market growth.
Diagnostic laboratories, which specialize in conducting various tests, also hold a major stake in the market, offering precise diagnostics that are essential for effective disease management.Research institutes are increasingly important as they contribute to the development of innovative diagnostic modalities and methodologies, focusing on enhancing the accuracy and efficiency of autoimmune disease detection.
The increasing investments in healthcare infrastructure and a surge in awareness about autoimmune conditions are further propelling the Autoimmune Disease Diagnostics Market revenue. With the ongoing advancements in technology, the segmentation and service offerings in this market are expected to expand, providing opportunities for improved patient outcomes globally.An emphasis on early diagnosis and continuous monitoring will enhance the value of these end-user segments, continuing to shape the landscape of the Autoimmune Disease Diagnostics Market.
Autoimmune Disease Diagnostics Market Product Type Insights
The Autoimmune Disease Diagnostics Market is poised for growth, reflecting the increasing demand for accurate and efficient diagnostics. The Product Type segmentation of this market includes important categories such as Reagents, Instrumentations, and Software, each playing a vital role in the diagnosis and management of autoimmune diseases.
Reagents are essential for performing tests that detect various autoimmune conditions, driving the majority of the market as they facilitate diagnosis by providing necessary components for testing. Instrumentations are significant due to advancements in technology which allow for faster and more precise results, making them crucial in clinical settings.
Additionally, Software is increasingly important as it aids in data management and analysis, streamlining workflow in laboratories and enhancing diagnostic accuracy. The market is benefitting from trends such as increased awareness of autoimmune diseases and advancements in technology, although challenges such as high costs and regulatory barriers remain.The Autoimmune Disease Diagnostics Market data reveals that these trends create opportunities for innovation in all product types, which could enhance diagnostics capabilities and market growth.
Autoimmune Disease Diagnostics Market Regional Insights
The Autoimmune Disease Diagnostics Market was characterized by significant regional diversity, with North America leading the way, holding a market value of 2.67 USD Billion in 2024 and projected to grow to 4.78 USD Billion by 2035, largely due to advanced healthcare infrastructure and a high prevalence of autoimmune disorders.
Europe followed with a 2024 valuation of 1.88 USD Billion and a 2035 projection of 3.36 USD Billion, driven by increased awareness and R&D investments in diagnostic technologies. South America, valued at 0.45 USD Billion in 2024 and expected to reach 0.81 USD Billion by 2035, gradually expanded, propelled by rising healthcare access and government initiatives.
The Asia Pacific region, valued at 1.67 USD Billion in 2024 with an anticipated rise to 2.98 USD Billion by 2035, benefited from rapid urbanization and growing healthcare investments. Meanwhile, the Middle East and Africa segment, with a valuation of 0.55 USD Billion projected to increase to 1.08 USD Billion, reflected the improving healthcare environment and investments in diagnostics.
Together, these regional dynamics contributed to the overall growth and trends of the Autoimmune Disease Diagnostics Market, with varying degrees of market strength and development opportunities underpinning the different areas.
Source: Primary Research, Secondary Research, MRFR Database and Analyst Review
Autoimmune Disease Diagnostics Market Key Players and Competitive Insights
The Autoimmune Disease Diagnostics Market is characterized by intense competition and a rapidly evolving landscape, driven by the increasing prevalence of autoimmune diseases and the growing demand for accurate diagnostic solutions.This market features a diverse range of players including established corporations, specialized biotech firms, and innovative start-ups that are engaged in developing advanced diagnostic tests and technologies.
Competitive dynamics are influenced by factors such as technological advancement, regulatory changes, strategic collaborations, and the need for cost-effective solutions. Companies are striving to enhance their product offerings while also expanding their global reach through mergers, acquisitions, and partnerships that allow them to leverage synergies and shared expertise.
- HoffmannLa Roche holds a significant position in the Autoimmune Disease Diagnostics Market, leveraging its reputation for high-quality and reliable diagnostic solutions. With a well-established presence across multiple regions, the company benefits from a broad portfolio of diagnostic assays and instruments that cater to various autoimmune conditions.
The strengths of F. HoffmannLa Roche lie in its robust research and development capabilities, allowing it to continually innovate and develop new diagnostic tests that are critical for early and accurate disease detection.The company’s commitment to quality and comprehensive customer support enhances its competitive advantage, enabling healthcare professionals to rely on its products when diagnosing autoimmune diseases.
- Menarini Diagnostics has carved a niche for itself within the Autoimmune Disease Diagnostics Market through a dedicated focus on diagnostic accuracy and reliability. The company offers a range of key products and services that are specifically designed to meet the needs of healthcare providers in diagnosing autoimmune conditions.
Notably, A. Menarini Diagnostics has established a strong market presence by leveraging advanced technology to develop innovative diagnostic solutions that facilitate timely interventions. The strengths of the company include its agile approach to the market, allowing it to quickly adapt to emerging trends and shifting customer requirements.
- Menarini Diagnostics has also engaged in strategic mergers and acquisitions that bolster its product range and expand its reach, reinforcing its competitive positioning globally while ensuring compliance with regional regulations and quality standards.
Key Companies in the Autoimmune Disease Diagnostics Market Include
- HoffmannLa Roche
- Menarini Diagnostics
- Genova Diagnostics
- Novartis
- BioRad Laboratories
- Quest Diagnostics
- Thermo Fisher Scientific
- Siemens Healthineers
- Roche Diagnostics
- Hologic
- Danaher Corporation
- AbbVie
- Ortho Clinical Diagnostics
- Abbott Laboratories
- Merck KGaA
Autoimmune Disease Diagnostics Market Developments
The worldwide market for autoimmune disease diagnostics experienced a number of noteworthy developments and calculated actions from market players at the beginning of 2025. Sanofi said on March 20, 2025, that it will buy Dren Bio's immunology division, namely the DR-0201 autoimmune treatment candidate, for $600 million up front and up to $1.3 billion in milestone payments.
The agreement is anticipated to completion in Q2 2025. April 21, 2025: Immunovant, a subsidiary of Roivant Sciences, named Eric Venker as CEO and Tiago Girao as CFO. The company also focused on cutaneous lupus erythematosus and Sjögren's illness with its main diagnostic medication IMVT-1402, beginning proof-of-concept and registrational studies, respectively.
An important advancement in diagnostic-linked biologics was made in April 2025 when the FDA authorized nipocalimab (Imaavy), an FcRn blocker for generalized myasthenia gravis. Argenx strengthened its diagnostic and therapeutic integration approach in May 2025 when it got FDA clearance for Vyvgart Hytrulo at-home therapy and an EMA good opinion for subcutaneous Vyvgart.
In terms of product innovation, Progentec Diagnostics published CareMGMTTM, an app that helps patients monitor autoimmune diseases, in August 2024, while Predicta Biosciences introduced its first molecular diagnosis for multiple myeloma in June 2025.
To improve lab diagnosis, Thermo Fisher released an Autoimmune Assay Kit in May 2023, and EUROIMMUN launched an automated IIFT system (UNIQO 160) in mid-2023 (June 2023) as well. In May 2025, inverse vaccines—a new immunotolerance diagnostic-therapeutic strategy—also began clinical trials for conditions including MS and celiac disease, thanks to collaborations between Genentech and AbbVie.
Autoimmune Disease Diagnostics Market Segmentation Insights
Autoimmune Disease Diagnostics Market Test Type Outlook
- Serological Tests
- Molecular Diagnostics
- Imaging Tests
- Biopsies
Autoimmune Disease Diagnostics Market Disease Type Outlook
- Rheumatoid Arthritis
- Lupus
- Multiple Sclerosis
- Type 1 Diabetes
- Thyroid Disorders
Autoimmune Disease Diagnostics Market End-user Outlook
- Hospitals
- Diagnostic Laboratories
- Research Institutes
Autoimmune Disease Diagnostics Market Product Type Outlook
- Reagents
- Instrumentations
- Software
Autoimmune Disease Diagnostics Market Regional Outlook
- North America
- Europe
- South America
- Asia Pacific
- Middle East and Africa
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Report Attribute/Metric
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Details
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Market Size 2023
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6.36(USD Billion)
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Market Size 2024
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6.72(USD Billion)
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Market Size 2035
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12.3(USD Billion)
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Compound Annual Growth Rate (CAGR)
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5.65% (2025 - 2035)
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Report Coverage
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Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
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Base Year
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2024
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Market Forecast Period
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2025 - 2035
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Historical Data
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2019 - 2024
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Market Forecast Units
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USD Billion
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Key Companies Profiled
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F. HoffmannLa Roche, A. Menarini Diagnostics, Genova Diagnostics, Novartis, BioRad Laboratories, Quest Diagnostics, Thermo Fisher Scientific, Siemens Healthineers, Roche Diagnostics, Hologic, Danaher Corporation, AbbVie, Ortho Clinical Diagnostics, Abbott Laboratories, Merck KGaA
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Segments Covered
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Test Type, Disease Type, End-user, Product Type, Regional
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Key Market Opportunities
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Rising prevalence of autoimmune diseases, Advancements in diagnostic technologies, Increased awareness and education, Growth in personalized medicine, Expansion in point-of-care testing
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Key Market Dynamics
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Rising autoimmune disease prevalence, Advancements in diagnostic technologies, Increasing awareness and education, Growing demand for early diagnosis, Expansion of healthcare infrastructure
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Countries Covered
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North America, Europe, APAC, South America, MEA
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Autoimmune Disease Diagnostics Market Highlights:
Frequently Asked Questions (FAQ) :
By 2035, the Autoimmune Disease Diagnostics Market is expected to reach a value of 12.3 USD Billion.
The expected CAGR for the Autoimmune Disease Diagnostics Market from 2025 to 2035 is 5.65%.
In 2024, North America dominated the Autoimmune Disease Diagnostics Market with a value of 2.67 USD Billion.
The market value for Serological Tests is anticipated to reach 4.3 USD Billion by 2035.
Key players in the market include F. Hoffmann-La Roche, A. Menarini Diagnostics, Genova Diagnostics, and Novartis.
The market value for Molecular Diagnostics in 2024 was 1.8 USD Billion.
The Asia Pacific region is expected to grow to a market value of 2.98 USD Billion by 2035.
The market value for Imaging Tests by 2024 was 1.0 USD Billion.
The market faces challenges including high costs of diagnostic tests and the complexity of autoimmune diseases.
By 2035, the market size for Biopsies is expected to reach 2.5 USD Billion.
