• Cat-intel
  • MedIntelliX
  • Resources
  • About Us
  • Request Free Sample ×

    Kindly complete the form below to receive a free sample of this Report

    Leading companies partner with us for data-driven Insights

    clients tt-cursor

    Autoimmune Disease Diagnostics Market

    ID: MRFR/HC/5252-HCR
    200 Pages
    Rahul Gotadki
    September 2025

    Autoimmune Disease Diagnostics Market Research Report By Test Type (Serological Tests, Molecular Diagnostics, Imaging Tests, Biopsies), By Disease Type (Rheumatoid Arthritis, Lupus, Multiple Sclerosis, Type 1 Diabetes, Thyroid Disorders), By End-user (Hospitals, Diagnostic Laboratories, Research Institutes), By Product Type (Reagents, Instrumentations, Software), and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

    Share:
    Download PDF ×

    We do not share your information with anyone. However, we may send you emails based on your report interest from time to time. You may contact us at any time to opt-out.

    Autoimmune Disease Diagnostics Market Infographic
    Purchase Options
    $ 4,950.0
    $ 5,950.0
    $ 7,250.0

    Autoimmune Disease Diagnostics Market Summary

    As per Market Research Future 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%

    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.

    Autoimmune Disease Diagnostics Market Trends

    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.

    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.

    The increasing prevalence of autoimmune diseases, coupled with advancements in diagnostic technologies, suggests a burgeoning demand for innovative and accurate diagnostic solutions in the global market.

    U.S. National Institutes of Health (NIH)

    Autoimmune Disease Diagnostics Market Drivers

    Increased Awareness and Education

    Growing awareness regarding autoimmune diseases among healthcare professionals and the general public is driving the Global Autoimmune Disease Diagnostics Market Industry. Educational initiatives and campaigns aimed at highlighting the symptoms and implications of autoimmune disorders have led to earlier diagnosis and treatment. This heightened awareness is reflected in increased patient consultations and testing rates. As a result, the market is poised for growth, with projections indicating it could reach 12.3 USD Billion by 2035. The emphasis on education and awareness is likely to foster a more proactive approach to managing autoimmune diseases, thereby enhancing the demand for diagnostic services.

    Government Initiatives and Funding

    Government initiatives aimed at improving healthcare infrastructure and funding for autoimmune disease research are pivotal to the Global Autoimmune Disease Diagnostics Market Industry. Various countries are investing in research programs and public health campaigns to better understand autoimmune disorders and develop effective diagnostic tools. For instance, funding from national health organizations supports studies that explore the etiology and progression of these diseases. Such initiatives not only enhance research capabilities but also promote the development of innovative diagnostic solutions. As the market continues to evolve, government support is likely to remain a critical factor in driving advancements in autoimmune disease diagnostics.

    Growing Demand for Personalized Medicine

    The shift towards personalized medicine is influencing the Global Autoimmune Disease Diagnostics Market Industry significantly. Tailoring treatment plans based on individual patient profiles, including genetic and biomarker information, enhances therapeutic efficacy. This trend is particularly relevant in autoimmune diseases, where treatment responses can vary widely among patients. The demand for personalized diagnostics is expected to rise as healthcare providers seek to optimize treatment outcomes. As the market evolves, the integration of personalized medicine into diagnostic practices is likely to drive growth, aligning with the projected market expansion to 12.3 USD Billion by 2035.

    Rising Prevalence of Autoimmune Diseases

    The increasing incidence of autoimmune diseases globally is a primary driver for the Global Autoimmune Disease Diagnostics Market Industry. Conditions such as rheumatoid arthritis, lupus, and multiple sclerosis are becoming more prevalent, affecting millions worldwide. For instance, the prevalence of rheumatoid arthritis is estimated to be around 0.5 to 1 percent of the global population. This rise in cases necessitates advanced diagnostic tools and techniques, propelling market growth. As the market is projected to reach 6.72 USD Billion in 2024, the demand for accurate diagnostics is likely to escalate, influencing healthcare strategies and resource allocation.

    Technological Advancements in Diagnostic Tools

    Innovations in diagnostic technologies are significantly shaping the Global Autoimmune Disease Diagnostics Market Industry. The advent of advanced imaging techniques, biomarker identification, and genetic testing has enhanced the accuracy and speed of autoimmune disease diagnosis. For example, the use of multiplex assays allows for the simultaneous detection of multiple autoantibodies, improving diagnostic efficiency. These advancements not only facilitate early detection but also contribute to better patient outcomes. With the market expected to grow at a CAGR of 5.65% from 2025 to 2035, the integration of cutting-edge technologies is likely to play a crucial role in meeting the rising demand for effective diagnostic solutions.

    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, Market Research Future 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.

    Get more detailed insights about Autoimmune Disease Diagnostics Market Research Report - Forecast till 2035

    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.

    Autoimmune Disease Diagnostics Market Regional Insights

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    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.

    1. 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.

    1. 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.

    1. 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 market include

    Industry 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.

    Future Outlook

    Autoimmune Disease Diagnostics Market Future Outlook

    The Autoimmune Disease Diagnostics Market is projected to grow at a 5.65% CAGR from 2024 to 2035, driven by technological advancements, increasing prevalence of autoimmune diseases, and rising awareness.

    New opportunities lie in:

    • Develop AI-driven diagnostic tools for early detection of autoimmune diseases.
    • Expand telehealth services for remote autoimmune disease management.
    • Invest in personalized medicine approaches to enhance treatment efficacy.

    By 2035, the market is expected to be robust, reflecting significant advancements and increased accessibility.

    Market Segmentation

    Autoimmune Disease Diagnostics Market End-user Outlook

    • Hospitals
    • Diagnostic Laboratories
    • Research Institutes

    Autoimmune Disease Diagnostics Market Regional Outlook

    • North America
    • Europe
    • South America
    • Asia Pacific
    • Middle East and Africa

    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 Product Type Outlook

    • Reagents
    • Instrumentations
    • Software

    Report Scope

    Report Attribute/Metric

    Details

    Market Size 2023

    6.36(USD Billion)

    Market Size 2024

    6.72(USD Billion)

    Market Size 2035

    12.3(USD Billion)

    Compound Annual Growth Rate (CAGR)

    5.65% (2025 - 2035)

    Report Coverage

    Revenue Forecast, Competitive Landscape, Growth Factors, and Trends

    Base Year

    2024

    Market Forecast Period

    2025 - 2035

    Historical Data

    2019 - 2024

    Market Forecast Units

    USD Billion

    Key Companies Profiled

    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

    Segments Covered

    Test Type, Disease Type, End-user, Product Type, Regional

    Key Market Opportunities

    Rising prevalence of autoimmune diseases, Advancements in diagnostic technologies, Increased awareness and education, Growth in personalized medicine, Expansion in point-of-care testing

    Key Market Dynamics

    Rising autoimmune disease prevalence, Advancements in diagnostic technologies, Increasing awareness and education, Growing demand for early diagnosis, Expansion of healthcare infrastructure

    Countries Covered

    North America, Europe, APAC, South America, MEA

    Market Highlights

    Author
    Rahul Gotadki
    Assistant Manager

    He holds an experience of about 7+ years in Market Research and Business Consulting, working under the spectrum of Life Sciences and Healthcare domains. Rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. His expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. In addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives

    Leave a Comment

    FAQs

    What is the projected market size of the Autoimmune Disease Diagnostics Market by 2035?

    By 2035, the Autoimmune Disease Diagnostics Market is expected to reach a value of 12.3 USD Billion.

    What is the expected Compound Annual Growth Rate (CAGR) for the Autoimmune Disease Diagnostics Market from 2025 to 2035?

    The expected CAGR for the Autoimmune Disease Diagnostics Market from 2025 to 2035 is 5.65%.

    Which region dominated the Autoimmune Disease Diagnostics Market in 2024?

    In 2024, North America dominated the Autoimmune Disease Diagnostics Market with a value of 2.67 USD Billion.

    What is the anticipated market value for Serological Tests in the Autoimmune Disease Diagnostics Market by 2035?

    The market value for Serological Tests is anticipated to reach 4.3 USD Billion by 2035.

    Who are the major players in the Autoimmune Disease Diagnostics Market?

    Key players in the market include F. Hoffmann-La Roche, A. Menarini Diagnostics, Genova Diagnostics, and Novartis.

    What was the market value for Molecular Diagnostics in 2024?

    The market value for Molecular Diagnostics in 2024 was 1.8 USD Billion.

    How much is the Autoimmune Disease Diagnostics Market expected to grow in the Asia Pacific region by 2035?

    The Asia Pacific region is expected to grow to a market value of 2.98 USD Billion by 2035.

    What was the projected market value for Imaging Tests in the Autoimmune Disease Diagnostics Market by 2024?

    The market value for Imaging Tests by 2024 was 1.0 USD Billion.

    What challenges does the Autoimmune Disease Diagnostics Market currently face?

    The market faces challenges including high costs of diagnostic tests and the complexity of autoimmune diseases.

    What will be the market size for Biopsies by 2035 in the Autoimmune Disease Diagnostics Market?

    By 2035, the market size for Biopsies is expected to reach 2.5 USD Billion.

    Autoimmune Disease Diagnostics Market Research Report - Forecast till 2035 Infographic
    Free Sample Request

    Kindly complete the form below to receive a free sample of this Report

    Customer Stories

    “I am very pleased with how market segments have been defined in a relevant way for my purposes (such as "Portable Freezers & refrigerators" and "last-mile"). In general the report is well structured. Thanks very much for your efforts.”

    Victoria Milne Founder
    Case Study
    Chemicals and Materials