Autoimmune Disease Diagnosis Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

Autoimmune Disease Diagnosis Market Size

• The global autoimmune disease diagnosis market size was valued at USD 5.72 billion in 2024 and is expected to reach USD 10.70 billion by 2032, at a CAGR of 8.15% during the forecast period
• This growth is driven by factors such as the rising prevalence of autoimmune diseases, technological advancements in diagnostic tools and increased awareness and screening initiatives

Autoimmune Disease Diagnosis Market Analysis

• Autoimmune disease diagnostics are essential for the early detection and management of conditions where the immune system mistakenly attacks the body’s own tissues. These tests are critical for diseases such as rheumatoid arthritis, lupus, and type 1 diabetes, enabling timely interventions that can significantly improve patient outcomes.
• The demand for these diagnostics is significantly driven by the rising prevalence of autoimmune diseases, technological advancements in testing methods, and increasing awareness about the importance of early detection
• North America is expected to dominate the autoimmune disease diagnostics market, with a projected market share of 39.6%, driven by advanced healthcare infrastructure, high adoption of innovative diagnostic technologies, and the strong presence of key market players
• Asia-Pacific is expected to be the fastest growing region in the autoimmune disease diagnostics market, with a projected CAGR of 9.7%, driven by rapid expansion in healthcare infrastructure, increasing awareness about autoimmune disorders, and rising diagnostic volumes
• Rheumatoid arthritis is expected to dominate the market, with 57.8% of the share, due to its high prevalence and chronic nature. As a leading autoimmune disorder, early and accurate diagnosis is critical for effective disease management and prevention of joint damage, driving the demand for advanced diagnostic solutions

Report Scope and Autoimmune Disease Diagnosis Market Segmentation

Autoimmune Disease Diagnosis Market Trends

“Technological Advancements in Autoimmune Disease Diagnostics”

• One prominent trend in the autoimmune disease diagnostics market is the rapid advancement in diagnostic technologies, including the integration of artificial intelligence (AI), machine learning (ML), and next-generation sequencing (NGS)
• These innovations significantly improve diagnostic accuracy by enabling early detection, personalized disease profiling, and real-time monitoring of disease progression, thereby enhancing patient outcomes 
  • For instance, AI-driven platforms can analyze complex immunological data to identify disease biomarkers more precisely, while NGS technologies offer comprehensive insights into genetic predispositions, supporting early diagnosis and targeted therapies for conditions such as rheumatoid arthritis, lupus, and multiple sclerosis
• These technological advancements are transforming autoimmune disease diagnostics, improving clinical decision-making, reducing diagnostic errors, and driving the demand for innovative diagnostic solutions

Autoimmune Disease Diagnosis Market Dynamics

Driver

“Rising Prevalence of Autoimmune Diseases Globally”

• The increasing prevalence of autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), multiple sclerosis, and type 1 diabetes is significantly driving the demand for advanced diagnostic solutions
• As awareness about these chronic, often debilitating conditions grows, more patients are seeking early and accurate diagnosis to manage their symptoms and improve long-term outcomes
• In addition, autoimmune diseases are becoming more common globally, partly due to genetic factors, environmental triggers, and lifestyle changes that can disrupt immune system function

For instance,

• In 2024, a study published in the Journal of Autoimmunity reported that the global incidence of autoimmune diseases has increased by nearly 20% over the past decade, with an estimated 50 million people in the United States alone affected by these conditions. This growing patient population is driving the need for reliable, high-precision diagnostic tools 
• As a result of this increasing prevalence, there is a significant demand for innovative diagnostic tests that can detect autoimmune disorders at earlier stages, enabling more personalized and effective treatments

Opportunity

“Emerging Role of Artificial Intelligence in Autoimmune Disease Diagnosis”

• AI-powered diagnostic platforms can enhance the accuracy and speed of autoimmune disease detection, supporting personalized medicine and improving patient outcomes
• Advanced machine learning algorithms can analyze complex immunological data, identify subtle disease patterns, and predict disease progression, making them invaluable for early diagnosis
• In addition, AI systems can streamline laboratory workflows, reduce diagnostic errors, and lower costs by automating routine processes and reducing the need for repeat testing

For instance,

• In March 2025, according to a report published by MedTech Innovations, AI-driven diagnostic tools have demonstrated significant potential in early rheumatoid arthritis detection, with algorithms capable of accurately identifying biomarkers and predicting disease severity based on patient data. This can reduce diagnostic delays and improve patient outcomes through earlier, targeted interventions 
• The integration of AI in autoimmune disease diagnostics is expected to transform the market by enabling faster, more accurate diagnoses and enhancing patient management

Restraint/Challenge

“High Cost and Complexity of Advanced Diagnostic Technologies”

• The high cost of advanced diagnostic technologies, including AI-based platforms and next-generation sequencing (NGS) systems, can be a significant barrier for healthcare providers, especially in resource-limited settings
• These technologies often require substantial upfront investments, specialized infrastructure, and highly trained personnel, which can limit their widespread adoption
• Smaller clinics and diagnostic labs may struggle to afford these cutting-edge tools, leading to disparities in the availability of advanced diagnostic services

For instance,

• In February 2025, a report by the World Health Organization highlighted the financial burden of implementing advanced autoimmune diagnostic technologies, noting that many healthcare facilities in low- and middle-income countries lack the resources needed to adopt these innovations. This can hinder early diagnosis and effective disease management, particularly in regions with high disease burdens 
• As a result, the high cost and complexity of advanced diagnostic tools remain a key challenge, potentially restricting market growth and limiting patient access to state-of-the-art care

Autoimmune Disease Diagnosis Market Scope

The market is segmented on the basis of product and service, test, disease, and end user

In 2025, the rheumatoid arthritis is projected to dominate the market with a largest share in disease segment

The rheumatoid arthritis segment is expected to dominate the autoimmune disease diagnosis market with the largest share of approximately 57.8% in 2025 due to its high prevalence and chronic nature. As a leading autoimmune disorder, early and accurate diagnosis is critical for effective disease management and prevention of joint damage, driving the demand for advanced diagnostic solutions. The increasing aging population, which is more susceptible to RA, further contributes to the segment's market dominance.

The autoantibodies and immunologic tests is expected to account for the largest share during the forecast period in test market

In 2025, the autoantibodies and immunologic tests segment is expected to dominate the market with the largest share of 29.4% due to its critical role in detecting autoantibodies that target healthy cells. These tests are essential for early diagnosis, reducing morbidity and mortality by identifying autoimmune conditions before the onset of severe symptoms. The high prevalence of autoimmune diseases and the growing need for early detection further contribute to the segment's market dominance.

Autoimmune Disease Diagnosis Market Regional Analysis

“North America Holds the Largest Share in the Autoimmune Disease Diagnosis Market”

• North America dominates the autoimmune disease diagnostics market, with a projected market share of approximately 39.6%, driven by advanced healthcare infrastructure, high adoption of innovative diagnostic technologies, and the strong presence of key market players
• U.S. holds a significant share, accounting for approximately 41.1% of the global market share, due to the high prevalence of autoimmune diseases such as rheumatoid arthritis, lupus, and multiple sclerosis, along with robust investments in research and development for advanced diagnostic tools
• The availability of well-established reimbursement policies, along with a mature healthcare system, supports the widespread adoption of cutting-edge diagnostic platforms, enhancing early disease detection and patient outcomes
• In addition, the increasing focus on personalized medicine and precision diagnostics, coupled with strong collaborations between biotech companies and healthcare providers, further strengthens the market across the region

“Asia-Pacific is Projected to Register the Highest CAGR in the Autoimmune Disease Diagnosis Market”

• Asia-Pacific is expected to witness the highest growth rate in the autoimmune disease diagnostics market, with a projected CAGR of 9.7%, driven by rapid expansion in healthcare infrastructure, increasing awareness about autoimmune disorders, and rising diagnostic volumes
• Countries such as China, India, and Japan are emerging as key markets due to the growing prevalence of autoimmune diseases and expanding access to advanced diagnostic technologies
• Japan, with its advanced medical technology and increasing number of specialized diagnostic centers, remains a crucial market for autoimmune disease diagnostics. The country continues to lead in the adoption of precision diagnostic tools to enhance patient outcomes
• India is projected to register the highest CAGR in the autoimmune disease diagnostics market, driven by expanding healthcare infrastructure, increasing awareness about early disease detection, and a rising burden of autoimmune conditions

Autoimmune Disease Diagnosis Market Share

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

The Major Market Leaders Operating in the Market Are:

• Siemens (Germany)
• Abbott (U.S.)
• Thermo Fisher Scientific Inc. (U.S.)
• Danaher Corporation (U.S.)
• GRIFOLS S.A. (Spain)
• Bio-Rad Laboratories Inc. (U.S.)
• ProtaGene Group (Germany)
• HYCOR Biomedical (U.S.)
• Trinity Biotech Ireland (Ireland)
• EUROIMMUN Medizinische Labordiagnostika AG (Germany)
• Quest Diagnostics, Incorporated (U.S.)
• Hemagen Diagnostics, Inc. (U.S.)
• Crescendo Bioscience Inc. (U.S.)
• AESKU.GROUP GmbH (Germany)
• Seramun Diagnostica GmbH (Germany)
• Myriad Genetics, Inc. (U.S.)
• Omega Diagnostics Ltd (Scotland)
• ORGENTEC Diagnostika (Germany)

Latest Developments in Global Autoimmune Disease Diagnosis Market

• In January 2025, Siemens Healthineers announced the launch of its advanced autoimmune disease diagnostic platform, which incorporates cutting-edge AI-powered technology for enhanced diagnostic precision. This platform is designed to improve the early detection of autoimmune disorders, including rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE), by offering automated, high-throughput testing with reduced human error. The AI integration allows for faster and more accurate diagnosis, leading to better patient outcomes
• In October 2024, Abbott unveiled its new autoimmune disease diagnostic tool at the AACC Annual Meeting. This tool utilizes next-generation immunoassay technology to detect multiple autoantibodies simultaneously. By expanding the range of detectable autoantibodies in a single test, this innovation aims to improve diagnostic efficiency and help clinicians make more informed decisions when diagnosing autoimmune diseases such as thyroiditis and scleroderma
• In September 2024, Thermo Fisher Scientific introduced a next-gen autoimmunity test kit that can identify autoantibodies with higher sensitivity and specificity. This diagnostic kit is designed to provide clinicians with more accurate results for complex autoimmune disorders such as rheumatoid arthritis and SLE, even in the early stages of disease progression. The launch was part of their ongoing effort to expand diagnostic capabilities for autoimmune diseases, enabling earlier and more precise treatments
• In September 2024, Bio-Rad Laboratories announced the global release of its new autoimmune disease diagnostic panel, which combines multiple biomarkers to offer more comprehensive insights into the progression of autoimmune disorders. The panel leverages advanced multiplex immunoassays, offering higher throughput, improved detection sensitivity, and faster results. This launch is expected to enhance clinical decision-making and reduce the time to diagnosis for conditions such as RA and systemic lupus erythematosus (SLE)
• In December 2024, Quest Diagnostics introduced a revolutionary autoimmune disease diagnostic service that uses AI algorithms to analyze test results in real time, providing clinicians with instant feedback on patient status. This service is designed to improve the accuracy and speed of autoimmune disease diagnoses, especially for complex conditions such as SLE and scleroderma, and is expected to enhance patient outcomes by enabling earlier intervention

SKU-18817