Market Overview –

The size of the market for autoimmune disease diagnostics was estimated at USD 4.9 billion in 2022 and is expected to increase at a compound yearly growth rate (CAGR) of 6.7% from USD 5.23 billion in 2023 to USD 8.78 billion by 2032.

The Autoimmune Disease Diagnostics Market focuses on the development and provision of diagnostic tools and tests for autoimmune diseases. Autoimmune diseases occur when the immune system mistakenly attacks the body's own tissues, leading to a range of chronic and often debilitating conditions such as rheumatoid arthritis, lupus, and multiple sclerosis.

In recent years, the autoimmune disease diagnostics market has experienced significant growth globally due to several factors. Firstly, there has been an increase in the prevalence of autoimmune diseases worldwide, driven by factors such as genetic predisposition, environmental triggers, and lifestyle changes. This rise in disease incidence has led to a greater demand for accurate and timely diagnostic tests to facilitate early detection and effective management.

The autoimmune disease diagnostics market is witnessing growth driven by advancements in the diagnosis of lupus and other autoimmune conditions. With increasing awareness and understanding of these diseases, there's a rising demand for accurate and efficient diagnostic tools. Innovations in biomarker testing and imaging techniques are enhancing early detection and personalized treatment strategies, driving market expansion.

Top Boosters and Challenges

Accelerated burden of autoimmune disorders including type 1 diabetes among newborn babies has raised the need for accurate and rapid diagnostics worldwide. Diagnostics and research institutes around the world are introducing initiatives along with government firms due to the surging cases, in line with the surge in healthcare spending. The National Institutes of Health suggests that autoimmune diseases are among the top five disorders that result in high mortality rates, especially among women.

Active involvement of various government bodies is touted to be favorable for the global industry. Organizations like Cooperative Study Group for Autoimmune Disease Prevention, North American Rheumatoid Arthritis Consortium and Autoimmunity Centers of Excellence are proactively working on educating people as well as medical professionals about effective diagnosis and treatment. Surging awareness among the mass with regard to these disorders should bolster market growth in the coming years. Besides, frequent technological advances and the surge in lab automation rates will be major trends, with clinicians now able to carry out multiple tests simultaneously at a faster rate along with more precise and successful results.

Key companies are taking up effective steps such as acquisitions, mergers, collaborations, product launches and partnerships to garner a higher ground in the global industry. To illustrate, in May 2021, LabCorp acquired Myriad Genetics' autoimmune diagnostics business for USD 150 million. This autoimmune business’ acquisition will mean that LabCorp will now own Vectra rheumatoid arthritis assay, a blood test that studies 12 biomarkers including CRP and IL-6 to provide an accurate measure of the disease activity based on a 100-point scale.

Market Segmentation

The autoimmune disease diagnostics industry can be considered for disease type, test type, and end-user.

With respect to disease type, the market caters to localized autoimmune disease as well as systemic autoimmune disease. Systemic disease types should procure the fastest growth rate in the years ahead, thanks to the supportive government initiatives, particularly the AMP RA/SLE program for those afflicted by systemic lupus erythematosus and rheumatoid arthritis. This program is expected to offer a platform for the creation of novel therapeutics as well as disease-specific databases for use in research activities in the future. However, localized autoimmune disease is the highest revenue generating segment in the global industry, given the high patient awareness and demand for more precise diagnosis methods.

The test types covered in the report are agglutination, enzyme-linked immunosorbent assay (ELISA), western blotting, dot blot, double immune diffusion, line blot, counter immune-electrophoresis, multiplex immunoassay, immunofluorescence assays (IFA), and more.

The top end-users in the industry are research laboratories, diagnostics centers, hospitals, and others. Soaring number of hospitals with modern facilities and services have led to higher number of patient visits, and therefore, the segment is touted to secure the leading position in the years to come.

Regional Study

The regional study of the autoimmune disease diagnostics market comprises Europe, Asia Pacific or APAC, the Americas and MEA or Middle East and Africa.

America is the market leader, considering the high patient awareness about the latest diagnosis techniques and the presence of modern healthcare infrastructure in the region. Escalating burden of diseases like Hashimoto’s thyroiditis and rheumatoid arthritis in the US and the government giving financial assistance to healthcare should also enhance the market size in the region. The American Autoimmune Related Diseases Association confirms that close to 60 million individuals in the United States are currently struggling with an autoimmune disease and this number is anticipated to jump rapidly in the next few years. As a result, the need for more effective and advanced autoimmune disease diagnostic tests is soaring rapidly in the region.

The European market stands second globally, primarily owing to the government support in the form of large-scale funding for the development of the healthcare sector. In addition, the surge in the number of research and development activities, emergence of the automation trend across laboratories, and aggressive strategical moves taken by leading companies in the region also add to the market value.

APAC should give a stellar performance in the years ahead and will potentially attain the fastest growth rate, on account of the rising cases of autoimmune diseases and the surging expenditure in to upgrade the healthcare infrastructure. Burgeoning elderly population along with focus on business expansion by the market leaders also add to the market value. APAC is catching up with North America in terms of growth, by increasingly producing innovative and cost-effective diagnostic tests that are not only effective but have additional features, which in turn ensures better patient care.

Key Players –

Autoimmune disease diagnostics companies include Siemens Healthcare Private Limited, bioMérieux SA, Bio-rad Laboratories, Beckman Coulter, AstraZeneca, EUROIMMUN AG, Hoffmann-la Roche, Inova Diagnostics, Myriad Genetics, Thermo Fisher Scientific, Trinity Biotech Plc., and Hemagen Diagnostics.

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