Autoimmune Diagnostics Market Size, Share, Industry, Forecast and outlook (2024-2031)

Autoimmune Diagnostics Market is segmented By Diagnostic Tests (Autoantibody Tests​, Complete Blood Count (CBC)​, Antinuclear Antibody Tests​, C-reactive Protein (CRP), Rheumatoid Factor Test, Others​), By Product Type (Instruments, Assay Kits, Others), By Disease Type (Systemic Autoimmune Disease, Localized Autoimmune Disease), By End User (Hospitals and Clinics, Diagnostic Centers, Academic and Research Institutes, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030.

Autoimmune Diagnostics Market Overview

Global Autoimmune Diagnostics Market is expected to reach at a high CAGR during the forecast period 2023-2030.

Autoimmune diseases have no cure; addressing and managing the symptoms is very important. Autoimmune disease diagnosis helps detect the illness's root cause so that the proper treatment is given to the patient to manage the disease in the coming years. Basic blood tests help in detecting the disease but with no specificity. To overcome this, specific antibody tests like autoantibody tests, anti-nuclear tests, etc. are done to identify particular conditions.

Diseases like lupus, multiple sclerosis, and rheumatoid arthritis are the most prevalent and challenging to diagnose, as they affect the entire body without sticking to a particular organ. No single test diagnoses a specific autoimmune disease; multiple tests have to be performed to confirm the condition.   

Autoimmune Diagnostics Market Scope

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Autoimmune Diagnostics Market Dynamics

Increasing Incidence of autoimmune diseases

Autoimmune diseases destroy the body's immune cells. Detection of these diseases is often difficult. There is no cure for autoimmune diseases; hence, the prevalence is higher worldwide as individuals only manage the condition but do not cure the disease. In 2023, worldwide incidence and prevalence of autoimmune diseases are 19.1% and 12.5%, respectively. According to Nature Journal, 2023, there is a 42.6% higher chance of acquiring an autoimmune condition 3–15 months after covid 19 infection compared with non-COVID-19 patients

According to the University of Oxford, in 2023, 22 million people found autoimmune disorders now affect around one in 10 individuals, with women more affected than men (13% of women and 7% of men). 

 According to National Institute of Health 2023 article, the global prevalence of Lupus has increased slightly from 60.2 in 2010 to 66.1 per 100,000 in 2021 for women and from 7.6 in 2010 to 8.8 per 100,000 in 2021 for men. According to the World Health Organisation 2023, 13 million people with rheumatoid arthritis experience severity levels of the disease.

Furthermore, rising advancements in treating autoimmune disorders, increasing research focus, and increasing drug discoveries are few factors that drive the market in the forthcoming period. 

False Positive Results

False positive tests are often the leading cause of the wrong disease diagnosis. Antinuclear antibody testing is susceptible. It lacks overall specificity to detect certain autoimmune diseases. Inaccurate results lead to further complications in the individual. According to the American College of Rheumatology, ANA assays are believed to be positive in 95–99% of patients with lupus disease; however, more than 30% of the patients were serologically negative.

Furthermore, false negative results, lack of skilled professionals are few other factors which hamper the market in the forthcoming period. 

Autoimmune Diagnostics Market Segment Analysis

The global autoimmune diagnostics are segmented based on diagnosis, product type, application, end user and region.

The Assay kits segment accounted for approximately 59.2% of the market share 

Assays Kits is expected to hold the largest share in the market. Assay kits are advanced and efficient autoimmune disease testing solutions that provide rapid results. Depending on the type of disease diagnosis, the kit varies, which gives precise and accurate results. They are portable and cost-effective for the diagnosis of any autoimmune disease.  Launch of assay kits with advanced technology provide better results for disease specific diagnosis. 

In July 2022, KSL Beutner Laboratories, a pioneer in immunological testing, introduced a serum blood test using immunofluorescence technology. This test is the first of its kind introduced in the US that detects autoimmune disorder, mucus membrane pemphigoid (MMP). 

In May 2022, ZEUS Scientific received approval from the US Food and Drug Administration for a digital immunofluorescence system for use with Hep-2 indirect antibody assay.

Autoimmune Diagnostics Market Geographical Share

North America accounted for approximately 39.7% of the market share in 2022

North America is expected to hold the largest market share due to the rising prevalence of autoimmune diseases in older people in the U.S. For instance, according to the National Institutes of Health (NIH), 2023, most autoimmune biomarkers are increasing in the United States; autoimmune diseases affect more than 23.5 million Americans in 2021. Approximately 8% of the U.S. population lives with an autoimmune disease, and nearly 80% of those with an autoimmune disease are women.

According to the National Institute of Biotechnology Information 2023, systemic autoimmune rheumatic diseases (SARDs) are significant in Canada, affecting between 2 and 5 cases per 1000 residents is observed in data given from Furthermore, Canada has the highest rates of multiple sclerosis (M.S.) globally, with an estimated more 90,000 Canadians living with the disease.

COVID-19 Impact Analysis

Covid 19 moderately impacted the autoimmune diagnostics market. Due to the implementation of lockdowns worldwide, diagnostic centers were closed. Fear of contracting COVID made people sit at home. Hence, the diagnosis of autoimmune diseases was postponed to later stages. Supply chains were severely affected due to quarantines and lockdowns. There is a shift in the research and development focus for covid 19 treatment. Covid-testing kits were massively manufactured and distributed worldwide, which slightly affected the manufacturing of autoimmune disease detection kits.

Autoimmune Diagnostics Market Companies

The major global players in the autoimmune diagnostics market include Aurora Life Sciences, Bio-Rad Laboratories, Inc., ZEUS Scientific, Inc., Thermo Fisher Scientific Inc., Scimedx Corporation, Merck KGaA, Medsource Ozone Biomedicals Pvt. Ltd., Proteometech Inc, ImmunoDiagnostics Limited., Cambridge Life Sciences Limited among others.

Key Developments

• In May 2022, the new Phadia 2500+series of instruments by Thermofisher is available for autoimmune testing in the United States. 

Why Purchase the Report?

• To visualize the global autoimmune diagnostics market segmentation based on diagnostic test, product type, disease type, end user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development. 
• Excel data sheet with numerous data points of autoimmune diagnostics market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global autoimmune diagnostics market report would provide approximately 69 tables, 70 figures, and 195 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies