Autoimmune Disease Diagnostics Market Size, Share & Trends Analysis Report By Type, By Product (Instruments, Consumables and Assays), By Test, By End Use, By Region, And Segment Forecasts, 2024 - 2030

Report Overview

The global autoimmune disease diagnostics market size was valued at USD 5.39 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.2% from 2024 to 2030. Unceasing growth in new cases of autoimmune disease, increasing focus of professionals and practitioners on early diagnosis to reduce the intensity of damage, increasing awareness regarding the severity of autoimmune diseases, and advancements in associated technology such as laboratory automation are key growth driving factors for this market.

An increasing rate of novel technological advancements and the corresponding emergence of laboratory automation technologies significantly contribute to market expansion. This trend is driven by the growing adoption of advanced technologies among clinicians, enabling them to conduct a wide range of tests while achieving faster and more accurate results. Furthermore, the implementation of government initiatives across economies supports market developments. Work by organizations such as the Autoimmunity Centers of Excellence (ACE), Cooperative Study Group for Autoimmune Disease Prevention (CSGADP), and North American Rheumatoid Arthritis Consortium (NARAC) contributes to market growth as it creates awareness among patients and healthcare professionals regarding proper diagnosis and treatment protocols.

Growing awareness in patients concerning autoimmune diseases has developed a trend of early-stage diagnosis. According to the National Institute of Environmental Health Sciences, nearly 50 million people in the U.S. suffer from some form of autoimmune disease, making it the third leading disease category in the country, following cancer and heart disease. Environmental infections, genetics, and other exposures are significant in increasing the prevalence of these disorders. Clinical research has shown a potential link between autoimmune diseases and a complex combination of genetic predisposition and environmental triggers of autoimmune conditions. Additionally, demographic factors such as gender, race, and ethnicity may influence susceptibility to these conditions. As a result, there is a growing demand for effective diagnostics techniques to address these disorders.

Type Insights

The localized autoimmune disease diagnostics segment dominated the market and accounted for a revenue share of 64.7% in 2023. Long procedure volumes compared to systemic diseases and high patient awareness regarding conditions such as multiple sclerosis and type 1 diabetes drive segment growth. Unlike systemic autoimmune diseases that affect the whole body, localized diseases target specific organs or tissues. This necessitates focused diagnostic tests, potentially leading to faster and more accurate diagnosis. The high prevalence of type 1 diabetes is a major factor driving developments in this diagnostics segment.

The systemic autoimmune disease diagnostics segment is expected to grow at the fastest CAGR over the forecast period. It is due to the varied symptoms presented by systemic autoimmune diseases that affect multiple organs, making the diagnosis more challenging. This drives demand for advanced diagnostic tools and tests to finish complex procedures. The growing prevalence of conditions such as rheumatoid arthritis, ankylosing spondylitis, and systemic lupus erythematosus (SLE), among others, contributes to the rising need for systemic disease diagnostics. According to the U.S. Centers for Disease Control and Prevention, more than 200,000 individuals in the U.S. are assessed to have Systemic lupus erythematosus (SLE).

Product Insights

The consumables & assays segment accounted for the largest revenue share in 2023. Every laboratory diagnostic test utilizes test kits, reagents, and antibodies. Advancements in novel biomarkers and specific assays for autoimmune diseases fuel the demand for specialized consumables. Additionally, advancements in consumable technologies have led to the emergence of cost-effective alternatives to traditional diagnostic instruments, particularly in resource-constrained settings. Furthermore, there are numerous types of autoimmune diseases, each requiring specific tests and assays. This translates to a wider range of consumables and assays needed to diagnose such conditions, leading to a higher market share of these products.

The instruments segment is expected to experience significant CAGR during the forecast period. In contrast to consumables, instruments are typically used for multiple tests and have a longer lifespan, leading to a lower need for replacements. Instruments often run various tests but may not be specific to autoimmune diseases. In addition, high-end diagnostic instruments are usually designed for long-term use with a high initial investment. With the emergence of new instrument models, the overall replacement cycle for these products is expected to remain longer compared to consumables, leading to their lower market share.

Test Insights

In terms of test type, antinuclear antibody tests (ANA) accounted for a leading market share in 2023. The growth of this segment is attributed to affordability, high sensitivity, and extensive availability. They initially serve as an important screening tool, but further testing is often necessary for establishing a conclusive diagnosis. Healthcare professionals take a small amount of blood sample from the patient’s arm via a small needle, which is then collected in a vial or test tube and tested for antinuclear antibodies. The growing prevalence of various autoimmune disorders has highlighted the importance of these tests, as they can diagnose conditions such as systemic lupus erythematosus, scleroderma, Addison Disease, and autoimmune hepatitis.

C-reactive protein (CRP) tests are expected to experience the fastest CAGR from 2024 to 2030. The growing incidence of disorders, including lupus, type 1 diabetes, and rheumatoid arthritis, is considered a major driver of this segment. Elevated CRP levels may be associated with the development of type 1 diabetes. CRP is a protein made by the liver, which causes inflammation in the body, resulting in a higher level of CRP. The CRP test is very easy to carry out, as it involves using a needle to withdraw a small volume of blood, which is evaluated; a high-test result equal to or greater than eight mg/L or ten mg/L can be considered a sign of inflammation.

End Use Insights

The hospitals segment accounted for the largest revenue share in 2023. The high share is attributed to the increased adoption of autoimmune disease diagnostic practices in hospitals for various diseases. Moreover, hospitals are generally equipped with modern and state-of-the-art labs and the latest diagnostic techniques, leading to an increasing number of people preferring to be tested for autoimmune disorders in these facilities. The presence of well-trained nurses and healthcare professionals is another key factor in this segment’s higher share, as they can efficiently and safely carry out these tests without the risk of damaging blood cells or causing other complications.

The clinical laboratories segment is expected to experience the fastest CAGR during the forecast period. It is attributed to the presence of skilled lab technicians and workforce in these facilities. The adoption of advanced technologies, increased availability and accessibility of modern diagnostic systems, and changing preferences of patients inclined towards a more personalized experience are expected to generate greater growth for this segment in the coming years. Growing laboratory automation and lower costs compared to other settings also contribute to the rising demand experienced by clinical laboratories providing numerous diagnostic services. For instance, more than 7 billion tests are performed in clinical laboratories in the U.S. every year.

Regional Insights

The North America autoimmune disease diagnostics market dominated the global industry and accounted for a revenue share of 42.8% in 2023. The growth of this market is primarily influenced by the continuous rise in autoimmune diseases in the region, strong and enhanced healthcare infrastructure in countries such as Canada and the U.S. and increasing awareness regarding the severity of autoimmune diseases. Multiple regional organizations have initiated programs and campaigns to enhance mindfulness regarding symptoms and treatments related to autoimmune diseases. For instance, the Autoimmune Association organizes the Autoimmune Community Summit every year and provides patients and professionals with access to recorded sessions from previous years' summits through its website.

U.S. Autoimmune Disease Diagnostics Market Trends

The U.S. autoimmune disease diagnostics market dominated regional industry in 2023. The Presence of many patients currently having autoimmune diseases in the country, growing awareness leading to increased diagnosis, and a vast network of clinical laboratories are expected to fuel demand for this market during forecast years. The country's advanced and technologically sophisticated infrastructure associated with diagnostics also plays a vital role in its growth. In addition, the existence of key industry participants in the U.S. has contributed to the growth experienced by this market in recent years.

Europe Autoimmune Disease Diagnostics Market Trends

Europe was identified as a lucrative region for the autoimmune disease diagnostics market in 2023. Growing awareness leading to higher diagnosis, an increasing number of newly diagnosed cases, and a strong healthcare infrastructure are expected to fuel the growth of this market. Autoimmune diseases have a higher prevalence in Northern Europe. Development of new treatments, growing newly identified cases of rare autoimmune diseases in the region, and advanced research backed by governments and organizations are anticipated to assist this market in terms of growth during the forecast period.

The Germany autoimmune disease diagnostics market held a substantial revenue share in 2023. The country has a large number of existing patients with autoimmune diseases, an increasing rate of diagnosis backed by growing awareness, and rising healthcare infrastructural advancements. These factors mainly influence this market, and progress in scientific and technological innovation is projected to drive its growth in the upcoming years.

Asia Pacific Autoimmune Disease Diagnostics Market Trends

The Asia Pacific autoimmune disease diagnostics market is anticipated to witness a fastest CAGR from 2024 to 2030. The increasing prevalence of multiple autoimmune diseases, the robust diagnostic capabilities in countries like China and Japan, the heightened awareness of the severity of autoimmune conditions and the significance of early diagnosis, as well as the participation of numerous major industry players from North America and Europe in the Asia Pacific region, are all factors contributing to the growth of the autoimmune disease diagnostics market in the Asia Pacific region. Unceasing growth in diseases such as psoriasis in the area has developed a growing demand for effective autoimmune disease diagnostic solutions in recent years.

India autoimmune disease diagnostics market is expected to experience a noteworthy growth during forecast period. This market encompasses a vast diagnostics sector that plays a vital role in the healthcare ecosystem, as well as preventive wellness testing, early disease detection, and therapeutic monitoring. The rise in awareness regarding the ill effects caused by autoimmune diseases on the human body and standard of life, increasing availability and accessibility of cost-efficient diagnostic solutions, and enhancements in the country's healthcare infrastructure are anticipated to generate an upsurge in demand for this market.

Key Companies & Market Share Insights

Some key autoimmune disease diagnostics market companies include F. Hoffmann-La Roche Ltd, Siemens Healthineers AG, EUROIMMUN Medizinische Labordiagnostika AG, Abbott, Quest Diagnostics, and others. To address growing competition and demand, the major market participants in the industry have adopted strategies such as enhanced research efforts, embracing innovation and technological advancements, collaborations and partnerships, and contributions to awareness campaigns supported by governments and related organizations.

• Siemens Healthineers provides comprehensive solutions for laboratories and healthcare facilities. It offers a variety of diagnostic instruments, including immunoassay analyzers and automation systems, used in autoimmune disease testing. It also provides a range of immunoassays specifically designed for autoimmune disease diagnostics. These assays can detect the presence of autoantibodies associated with various autoimmune conditions.

• EUROIMMUN offers test systems for diagnosing various autoimmune diseases, including Rheumatic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus), Connective tissue diseases (e.g., Sjogren's syndrome), vasculitis, autoimmune hepatitis, primary biliary cholangitis, celiac disease, autoimmune thyroid diseases.

Autoimmune Disease Diagnostics Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global autoimmune disease diagnostics market report based on type, product, test, end use, and region.

• Type Outlook (Revenue, USD Billion, 2018 - 2030)

  • Systemic autoimmune disease diagnostics

  • Rheumatoid arthritis

  • Ankylosing spondylitis

  • Systemic lupus erythematosus (SLE)

  • Others

  • Localized autoimmune disease diagnostics

  • Multiple sclerosis

  • Type 1 diabetes

  • Hashimoto's thyroiditis

  • Idiopathic thrombocytopenic purpura

  • Others

• Product Outlook (Revenue, USD Billion, 2018 - 2030)

  • Instruments

  • Consumables and Assays

• Test Outlook (Revenue, USD Billion, 2018 - 2030)

  • Antinuclear antibody tests

  • Autoantibody tests

  • C-reactive Protein (CRP)

  • Complete blood count (CBC)

  • Urinalysis

  • Others

• End Use Outlook (Revenue, USD Billion, 2018 - 2030)

  • Hospitals

  • Clinical Laboratories

  • Others

• Regional Outlook (Revenue, USD Billion, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • Saudi Arabia

    • UAE

    • South Africa

    • Kuwait