Autoimmune Disease Diagnostics Market Size & Forecast

The Autoimmune Disease Diagnostics Market is projected to reach $10.55 billion by 2031, at a CAGR of 7.2% in the forecast period of 2024–2031. The growth of the autoimmune disease diagnostics market is driven by the increasing prevalence of autoimmune disorders, the growing emphasis on early diagnosis, and the rising awareness regarding autoimmune diseases. However, difficulties in diagnosing autoimmune diseases restrain the growth of this market. Emerging economies and increasing investments & funding in the autoimmune diseases space are expected to generate growth opportunities for the players in this market. However, the unfavorable reimbursement scenario and high rate of delayed diagnosis or misdiagnosis are major challenges for market growth.

Autoimmune Disease Diagnostics Market Growth Drivers

Rising Awareness About Autoimmune Diseases

Stress, genetic mutations, unhealthy eating habits, and environmental factors are among the primary causes of autoimmune diseases. The high prevalence of these conditions worldwide has increased the demand for autoimmune disease diagnostics. For instance, the CDC's National Diabetes Statistics Report of 2020 indicates that approximately 1.4 million people in the U.S. have Type 1 diabetes, with this number projected to rise to 2.1 million by 2040.

Furthermore, growing awareness about the diagnosis and treatment of autoimmune diseases, driven by initiatives from various public and private organizations, has contributed to this demand. For example, the Autoimmune Association in the U.S. conducts events and campaigns every March to raise awareness, disseminate information, and enhance knowledge about autoimmune disorders.

Early diagnosis of autoimmune diseases is crucial for reducing disability, morbidity, and mortality, which is fueling the growth of the autoimmune disease diagnostics market.

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Autoimmune Disease Diagnostics Market Trends

Use of Biosensors for Detection of Autoimmune Diseases

Biosensors are analytical devices that utilize biological elements, measurement devices, and a transducer to detect specific substances. In the context of autoimmune diseases, biosensors are employed for diagnostic applications based on the detection of highly specific biomarkers, using antigens, peptides, and antibodies as recognition elements.

In the field of autoimmune diseases, biosensors can diagnose diseases by detecting specific biomarkers through antibodies (Abs), antigens (Ags), and peptides. Research indicates that biomarkers exhibit different specificities in autoimmune diseases; some biomarkers are associated with multiple diseases, while others are disease-specific. Among these biomarkers, autoantibodies (AAbs) are considered the most effective diagnostic biomarkers due to their significant role in the pathogenic process of disease development. AAbs are particularly valuable for diagnosis, monitoring, and assessing disease severity due to their specificity and stability during illness.

In addition to AAbs, other biomarkers such as chemokines, cytokines, and proteins are also utilized for diagnosing autoimmune diseases, offering the potential for various diagnostic applications.

Several research efforts are focused on developing biosensors for autoimmune disease diagnosis. These biosensors provide rapid, sensitive, and cost-effective diagnostic solutions, enhancing analytical performance. Commonly used biosensors for autoimmune disease diagnostics include those based on electrochemical detection, as well as piezoelectric and optical biosensors. These advancements are expected to improve the diagnostic outcomes of autoimmune diseases, paving the way for new product segments in the autoimmune disease diagnostics market in the future.

Autoimmune Disease Diagnostics Market Opportunities

Developing Countries

Developed countries have a higher market penetration rate for autoimmune disease diagnostics than developing countries, primarily due to higher diagnosis rates. According to the hygiene hypothesis, children in developed countries, who are less exposed to diverse microbial challenges compared to children from developing countries, have altered immune homeostasis, increasing their risk for several immune-mediated diseases. This hypothesis is supported by epidemiological data, especially migration studies, which show that individuals migrating from low-incidence to high-incidence countries acquire immune disorders.

In developing countries, the adoption of unhealthy lifestyles has been on the rise due to increasing urbanization, fast food consumption, reduced physical activity, stress, and other factors. These lifestyle changes are contributing to the growing incidence of autoimmune diseases in these regions. For instance, according to the National Institute of Environmental Health Sciences (U.S.), as of 2022, approximately 24 million people in the U.S. suffer from autoimmune diseases, making these conditions one of the leading causes of death and disability in the country.

Autoimmune Disease Diagnostics Market Analysis: Key Findings

By Product Type: In 2024, the Reagents, Assays, & Kits Segment is Expected to Dominate the Autoimmune Disease Diagnostics Market

Based on product type, the autoimmune disease diagnostics market is segmented into reagents, assays, & kits; software & services; and instruments. In 2024, the reagents, assays, & kits segment is expected to account for the largest share of 84.0% of the autoimmune disease diagnostics market. The large market share of this segment is attributed to factors such as the high diagnosis rate of autoimmune diseases in developed countries coupled with the recurring purchase of reagents and kits.

Similarly, the growing availability of assays and kits, convenience & ease of use, cost-effectiveness, and product launches by the players operating in the market are the factors driving the growth of the segment at the highest CAGR of 7.4% during the forecast period of 2024 to 2031.

By Test Type: In 2024, the Antinuclear Antibodies (ANA) Segment is Expected to Dominate the Autoimmune Disease Diagnostics Market

Based on test type, the autoimmune disease diagnostics market is segmented into antinuclear antibodies test (ANA), C-reactive protein test (CRP), erythrocyte sedimentation rate test, rheumatoid factor test, immunoglobulins test, routine blood tests, and other test types. In 2024, the antinuclear antibodies (ANA) segment is expected to account for the largest share of the autoimmune disease diagnostics market. Antinuclear antibodies (ANA) tests detect autoantibodies in the blood that target healthy cells. These antibodies often appear well before the onset of symptoms, enabling the early diagnosis of autoimmune diseases. Early detection through ANA tests can significantly reduce morbidity and mortality associated with these conditions. Consequently, the high prevalence of autoimmune diseases and the critical need for early diagnosis are key factors driving the significant market share of this segment.

Additionally, the antinuclear antibodies (ANA) segment is expected to register the highest CAGR of 8.3% during the forecast period. The advantages of the ANA test, including sensitivity, early detection of autoimmune disease, and the most preferred test for primary detection of autoimmune diseases, are the factors responsible for segment growth.

By Disease Type: In 2024, the Systemic Autoimmune Diseases Segment is Expected to Dominate the Autoimmune Disease Diagnostics Market

Based on disease type, the autoimmune disease diagnostics market is segmented into systemic autoimmune diseases and organ-specific autoimmune diseases. In 2024, the systemic autoimmune diseases segment is expected to account for the larger share of the autoimmune disease diagnostics market. Systemic autoimmune diseases impact multiple organs or systems, in contrast to localized autoimmune diseases, which target a specific organ or region of the body. Some of the most prevalent autoimmune diseases are systemic, such as rheumatoid arthritis, multiple sclerosis, and systemic lupus erythematosus (SLE). For example, according to the World Health Organization, approximately 14 million people worldwide had rheumatoid arthritis as of 2021. The high prevalence of systemic autoimmune diseases is a key factor contributing to the significant share of this segment.

Moreover, the systemic autoimmune diseases segment is expected to grow at the highest CAGR during the forecast period of 2024-2031. This growth is attributed to the growing prevalence of systemic autoimmune diseases and the growing availability of diagnostic tests for systemic autoimmune diseases.

By End User: In 2024, the Diagnostic Laboratories Segment is Expected to Dominate the Autoimmune Disease Diagnostics Market

Based on end user, the autoimmune disease diagnostics market is segmented into hospitals & clinics, diagnostic laboratories, and academic & research institutes. In 2024, the diagnostic laboratories segment is expected to account for the largest share of the autoimmune disease diagnostics market. The large market share of this segment is attributed to the presence of skilled professionals, the capacity to process numerous samples efficiently, and the availability of well-equipped systems and instruments in diagnostics laboratories.

Diagnostic labs are well equipped with a skilled workforce to conduct diagnostic testing. Additionally, these labs have instruments and systems required to carry out testing and can run multiple samples in a short amount of time. Therefore, patients and healthcare professionals prefer diagnostic labs, leading to a large share of the segment.

However, the hospitals & clinics segment is slated to register the highest CAGR during the forecast period of 2024-2031. The growth of this segment is attributed to the growing adoption of point-of-care testing in hospitals, initiatives undertaken by the hospitals to expand diagnostic capabilities, and rising prevalence and awareness regarding autoimmune diseases coupled with hospitals & clinics being the first point of contact for patients.

Geographical Analysis

In 2024, North America is expected to account for the largest share of 39.6% of the global autoimmune disease diagnostics market. This large share of North America is attributed to the high prevalence of autoimmune diseases, technological advancements in diagnostics, the presence of key players, and high healthcare expenditure in the region.

However, Asia-Pacific is slated to register the highest growth rate of 9.7% in the autoimmune disease diagnostics market during the forecast period. The high market growth in the Asia-Pacific region is attributed to the increasing prevalence and incidence of celiac disease and rheumatoid arthritis, unhealthy lifestyles, government initiatives addressing autoimmune diseases, and rising expenditure on autoimmune disease research. Autoimmune diseases are becoming more prevalent in the Asia-Pacific region. For example, psoriasis is one of the most common autoimmune skin conditions globally. According to the Global Psoriasis Atlas, around 3.59 million people in India have psoriasis, a number that is expected to rise.

Autoimmune Disease Diagnostics Key Companies

The report includes a competitive landscape based on an extensive assessment of product portfolio, test type, disease type, end user, geographic presence, and the key growth strategies adopted by leading market players in the industry over the past years. The key players profiled in the autoimmune disease diagnostics market are Thermo Fisher Scientific Inc. (U.S.), Bio-Rad Laboratories, Inc. (U.S.), Beckman Coulter, Inc. (U.S.), Abbott Laboratories (U.S.), Becton, Dickinson, and Company (U.S.), PerkinElmer, Inc. (U.S.), F. Hoffmann-La Roche Ltd (Switzerland), Siemens Healthineers AG (Germany), Grifols, S.A. (Spain), and Creative Diagnostics (U.S.).

Autoimmune Disease Diagnostics Market Industry Overview: Latest Developments from Key Industry Players

• In June 2023, EUROIMMUN Medizinische Labordiagnostika AG (Germany) launched a new automated indirect immunofluorescence test (IIFT) system, ‘UNIQO 160’. This system is used for the diagnosis of autoimmune diseases.
• In May 2022, Thermo Fisher Scientific, Inc. (U.S.) launched an EliA-based instrument named Phadia 2500+. This system diagnoses autoimmune diseases, including connective tissue disease, antiphospholipid syndrome, celiac disease, rheumatoid arthritis, autoimmune liver disease, and autoimmune thyroid disease.
• In December 2021, Grifols, S.A. (Spain) received its first European Union (EU) Technical Documentation Assessment and Quality Management System certificates under the In Vitro Diagnostics Medical Devices Regulation (IVDR) from EU-designated notified bodies under the new regulation. The company has received IVDR certifications for several products for immunohematology blood typing and detection of anti-erythrocyte antibodies, such as DG Gel cards, antisera, reagent red blood cells and ID HPA XT test, a human platelet antigen (HPA) genotyping assay.

Autoimmune Disease Diagnostics Market Research Summary

Key questions answered in the autoimmune disease diagnostics market report: