Autoimmune Disease Diagnostics Market Trends

ID: MRFR/HC/5252-HCR

200 Pages

Rahul Gotadki

October 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

Autoimmune Disease Diagnostics Market Infographic

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Market Trends

Key Emerging Trends in the Autoimmune Disease Diagnostics Market

Due to the rising prevalence of autoimmune issues worldwide, there is a surge in demand for autoimmune disease diagnostics. Natural variations, genetic predisposition, and lifestyle factors contribute to the increased prevalence of conditions such as lupus, multiple sclerosis, and rheumatoid arthritis. Rapid advances in demonstration technologies are shaping commercial trends. These developments contribute to improved quiet outcomes by enabling early identification and precise, recognisable proof of autoimmune conditions. Increasing awareness of the value of early detection among the general public and medical professionals is a significant industry trend. Early diagnosis of autoimmune illnesses considers focusing on the overall prognosis, preventing obstacles, and providing appropriate intervention. Modern symptomatic technologies and treatments are becoming more and more popular as a result of this move in healthcare toward proactive therapy. The market for autoimmune disease diagnostics is characterized by increased inventive work activities aimed at developing analytic methodologies and discovering new biomarkers. The course of events and the acceptance of rationale behind care evaluations for autoimmune disorders exhibit an amazing pattern. Place-of-care testing provide rapid results, considering that medical service providers must make decisions quickly. This trend is particularly significant in areas where access to the contemporary healthcare system is constrained, supporting the outcomes of the work being done on understanding. Advances in subatomic diagnostics enable the identification of specific genetic markers, facilitating the development of personalized therapy regimens tailored to each patient. This method reduces adverse effects and improves treatment adequacy. Growing awareness of autoimmune disorders, the expansion of the medical services infrastructure, and increased disposable income are all contributing to the growth of the autoimmune disease diagnostics industry in emerging nations. These areas offer unexplored opportunities for market participants to identify their areas of expertise and address the population's growing need for medical services. High costs associated with state-of-the-art therapeutic innovations may limit their uptake, especially in developing areas. For equitable access to autoimmune disease diagnostics worldwide, these issues must be resolved immediately.

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

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FAQs

What is the projected growth of the Autoimmune Disease Diagnostics market?

The Autoimmune Disease Diagnostics market is the expected increase in total market value of 11.41 USD billion over a defined forecast period 2025–2035. It is driven by factors such as demand trends, technological advances, regulatory changes, and geographic expansion.

What is the size of the Autoimmune Disease Diagnostics market?

Autoimmune Disease Diagnostics market size was valued at approximately 5.58 billion USD in 2024. This figure will reach 11.41 billion USD covering all regions (America, Europe, Asia, MEA and ROW), focusing its segments / services / distribution channels till 2035.

What is the CAGR of the Autoimmune Disease Diagnostics market?

Autoimmune Disease Diagnostics market is expected to grow at a CAGR of 6.72% between 2025 and 2035.

How much will the Autoimmune Disease Diagnostics market be worth by 2035?

Autoimmune Disease Diagnostics market is expected to be worth of 11.41 billion USD, reflecting growth driven by usage, technology and global demands by the end of 2035.

How will the Autoimmune Disease Diagnostics market perform over the next 10 years?

Over the next 10 years the Autoimmune Disease Diagnostics market is expected to shift from usd billion 5.58 to 11.41 billion USD, led by adoption of advanced tech, demographic trends, regulatory approvals, with potential headwinds from 2025 to 2035.

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.

1. Market Overview

2. Market Trends

3. Market Segment Insights

4. Key Players and Competitive Insights

5. Industry Developments

6. Market Segmentation

7. Report Scope

8. Market Highlights

9. FAQs

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Market Summary

As per Market Research Future Analysis, the Autoimmune Disease Diagnostics Market was valued at 5.58 USD Billion in 2024 and is projected to reach 11.41 USD Billion by 2035, growing at a CAGR of 6.72% 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.

Autoimmune Disease Diagnostics Market

CAGR

6.72%

Market Size & Forecast

2024 Market Size	USD 5.58 Billion
2035 Market Size	USD 11.41 Billion
CAGR (2025-2035)	6.72%
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.

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.

Autoimmune Disease Diagnostics Market 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% 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 <a href="https://www.marketresearchfuture.com/reports/rheumatoid-arthritis-market-1658">rheumatoid arthritis</a> 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.

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.

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.

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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 2025 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 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 2024	5.58 (USD Billion)
Market Size 2035	11.41 (USD Billion)
Compound Annual Growth Rate (CAGR)	6.72% (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 Size 2025	5.96 (USD Billion)