The global autoimmune disease diagnostics market was valued at USD 1.3 billion in 2021 and it is anticipated to grow up to USD 3.1 billion by 2031, at a CAGR of 9.2% during the forecast period.
Autoimmune disease diagnostics is a branch of medicine that deals with the diagnosis and treatment of autoimmune diseases. Autoimmune diseases are conditions in which the body’s immune system attacks healthy tissue, mistaking it for foreign invaders. Common symptoms of autoimmune diseases include fatigue, joint pain, muscle pain, and skin rashes. There is no cure for autoimmune diseases, but early diagnosis and treatment can help to manage the symptoms and prevent the disease from progressing.
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Market Trends and Drivers
Substantial surge in the number of patients affected with autoimmune diseases is amongst the major factors propelling the market growth in the foreseeable future. Type 1 diabetes, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease among others are some of the most common diseases that require autoimmune diagnostics and treatment. Type 1 diabetes is a chronic ailment that is generally caused when the immune system attacks and destroys insulin-producing cells in the pancreas. This results in high blood sugar level and if left untreated may lead to multiple organ failure including heart, kidneys, nerves, etc. For instance, according to the reports published by the International Diabetes Federation, in 2021, over 1.2 million children and adolescents below the age of 19 years are infected with type 1 diabetes and the numbers are growing at a steady pace. Moreover, according to the America Diabetes Association, in 2019 over 1.9 million Americans were suffering from Type 1 diabetes. The increasing prevalence of such disease promotes significant health consequences and co-morbidities that also results in substantial mortality.
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Market Restraints and Challenges
The key restraints and challenges in the Autoimmune Disease Diagnostics market are the lack of awareness about autoimmune diseases and the lack of early diagnosis. Autoimmune diseases are often misdiagnosed or undiagnosed due to the lack of awareness and the lack of early diagnosis. Early diagnosis is important for the treatment of autoimmune diseases. The lack of early diagnosis leads to the progression of the disease and the development of complications.
Global Autoimmune Disease Diagnostics Market Segmental Overview
By Disease Type
- Systemic Autoimmune Disease
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus (SLE)
- Psoriasis
- Multiple Sclerosis
- Others
- Localized Autoimmune Disease
- Inflammatory Bowel Disease
- Type 1 Diabetes
- Thyroid
- Others
By Test Type
- Antinuclear Antibody Tests
- Autoantibody Tests
- C-reactive Protein (CRP)
- Complete Blood Count (CBC)
- Urinalysis
- Others
By End-user
- Hospitals
- Diagnostic Centres
- Others
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Global Autoimmune Disease Diagnostics Market by Disease Type
Based on disease type, it is segmented into systemic autoimmune disease, and localized autoimmune disease. Systemic autoimmune disease is further divided into rheumatoid arthritis, systemic lupus erythematosus (SLE), psoriasis, multiple sclerosis, and others. Besides, localized autoimmune disease is bifurcated into inflammatory bowel disease, type 1 diabetes, thyroid, and others.
The systemic autoimmune disease segment accounted for substantial market share in 2021 and is expected to register significant CAGR during the estimation timeframe. This notable market share is pertaining to rapid increase of systemic autoimmune diseases associated with increasing number of morbidity and mortality. Some of the major diseases that result in systemic autoimmune disease include rheumatoid arthritis, systemic lupus erythematosus (SLE), psoriasis, multiple sclerosis, etc. Among patients suffering from rheumatoid arthritis, the immune systems of these patients attack the synovial tissues in joints leading to redness, warmth, soreness, and stiffness in the joints. According to the reports of the National Center of Biotechnology Information (NCBI), in the U.S. and other western nations of northern Europe, the annual incidence of rheumatoid arthritis is around 40 per 100,000 people. Additionally, over 1.5 million people in U.S. are suffering from rheumatoid arthritis and are likely to grow in the near future.
Global Autoimmune Disease Diagnostics Market by Test Type
In terms of test type, the autoimmune disease diagnostics market is segregated into antinuclear antibody tests, autoantibody tests, C-reactive Protein (CRP), complete blood count (CBC), urinalysis, and others. The antinuclear antibody tests segment was valued at significant revenue size in 2021 and is anticipated to grow at a highest CAGR from 2022-2030. This dominant market growth is majorly attributed to the high prevalence of chronic ailments and diseases that attack immune systems such as type 1 diabetes, myasthenia gravis, Addison’s disease, rheumatoid arthritis, etc. Antinuclear antibody tests detect antinuclear antibodies in the blood. Myasthenia gravis is a genetically susceptible autoimmune disease. According to NCBI, in 2021, the prevalence rate of myasthenia gravis in the U.S. was around 20 individuals per 100,000 population and it is increasing at a steady pace. Thus, the high prevalence of genetical autoimmune diseases is expected to expedite the autoimmune disease diagnostics industry landscape in the coming years.
Global Autoimmune Disease Diagnostics Market by End-user
With regards to end-user, the autoimmune disease diagnostics market is divided into hospitals, diagnostic centres, and others. The hospital segment of the autoimmune disease diagnostics market held a significant CAGR and is expected to register significant growth over the forecast period. This is owing to the surged adoption of autoimmune disease diagnostic procedures in hospitals associated to complex interventional surgeries. Hospitals consists of sophisticated technology labs, provide effective physiotherapy sessions, improved patient aid and counselling, and other services that ensure market expansion and create demand for these facilities. Furthermore, the rise in the incidence of several chronic diseases, and neurological diseases that can result in autoimmune diseases will drive the market expansion. Increasing availability of highly skilled medical and healthcare professionals, as well as advanced facilities, are some of the key factors that contribute to segmental progression thereby leading to overall market growth.
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Geographical Analysis of Global Autoimmune Disease Diagnostics Market
Region-wise, it is studied across North America, Europe, Asia Pacific, and the Rest of the World. North America autoimmune disease diagnostics market revenue is poised to grow significant CAGR during the forthcoming years. This dominant market share is owing to several factors such as the rising autoimmune disease burden, increasing healthcare expenditure, product launches, and presence of major players across the region. According to the National Stem Cell Foundation, approximately 5% to 8% of the total U.S. population suffers from multiple autoimmune disorders accounting for around 1 in 15 people undergoing autoimmune disease diagnostics treatment.
Additionally, as per the reports of the National Institute of Environmental Health Sciences, in 2021, around 24 million people in the U.S. were affected with autoimmune diseases and additional 8 million people were having autoantibodies, blood molecules that might create chances to develop autoimmune disease. Further, the increasing awareness and favorable government initiatives will help to witness a lucrative market growth. Technologically advanced diagnostic centers and adoption of automation technology in diagnosis and treatment will provide ample growth opportunities. Also, the presence of major players in the country and launch of novel products is expected to fuel the regional market statistics.
Major Players in the Global Autoimmune Disease Diagnostics Market
The key players in the autoimmune disease diagnostics market are Abbott Laboratories, Bio-rad Laboratories, F. Hoffmann-la Roche, Thermo Fisher Scientific, EUROIMMUN Medizinische Labordiagnostika AG (Perkin Elmer), Siemens Healthineers Inc, Quest Diagnostics, SQI Diagnostics Inc., Trinity Biotech Plc., and Hemagen Diagnostics, among others.
COVID-19 Impact
The COVID-19 pandemic emerged as an unprecedented global pandemic, affecting the healthcare sector by disrupting the global supply chain. During the initial phase of the outbreak, in the first half of 2020, the pandemic hampered the growth of the autoimmune disease diagnostics market. National emergencies and lockdowns were imposed in numerous countries to prevent the spread of the COVID-19 virus. The lockdown and travel restrictions had a negative influence on health systems.
The coronavirus pandemic had an impact on the autoimmune disease diagnostics business by restricting product uptake and associated procedures. It had an impact on consumer and manufacturers by significantly reducing and delaying the number of non-emergency surgical procedures conducted and patients assessed for eligibility of autoimmune disease diagnostics. According to the reports of the National Center of Biotechnology Information (NCBI), in 2021, the patients suffering from the rheumatoid arthritis (RA) had a high risk of developing COVID-19. This led in more stringent operational procedures that elevated the product demand. The combined efforts of certain regulatory authorities and market players contributed to reducing the impact of the pandemic. Furthermore, autoimmune disease diagnostics reached pre-pandemic diagnostic volume in 2021. Thus, the COVID-19 pandemic delayed industry growth marginally; however, restoring surgical volume would help market expansion in the near future.
Recent Developments
- In July 2022, KSL Beutner Laboratories launched first blood test for chronic, debilitating autoimmune such as first-to-market indirect immunofluorescence (IIF) serum blood test in the U.S. that positively identifies laminin 332, an antigen associated with the chronic, debilitating autoimmune disease mucous membrane pemphigoid (MMP).
- In June 2022, Thermo Fisher Scientific Inc. has introduced the new EliA RNA Pol III and EliA Rib-P blood tests for aiding in the diagnosis of Systemic Sclerosis (SSc; scleroderma) and Systemic Lupus Erythematosus (SLE), thus further expanding its comprehensive menu of automated connective tissue disease tests.
- In June 2022, Quotient Limited and Theradiag announced partnership to advance autoimmune disease diagnostics. This partnership brings together novel technology and clinical applications expertise to produce automated, multiplexed solutions for advancing autoimmune diagnostics. Also expanded access to $2 billion autoimmune IVD specialty market with MosaiQ
- In May 2022, Thermo Fisher Scientific announced the availability of the Phadia 2500+ Instrument in the U.S. for autoimmune testing. This device allows autoimmune diagnostics, aiding in the diagnosis of autoimmune diseases including celiac disease, rheumatoid arthritis, autoimmune liver disease and autoimmune thyroid disease among others. This strategic launch helped the company to gain business revenue along with enhanced customer base.
Research Scope
- Scope – Highlights, Trends, Insights. Attractiveness, Forecast
- Market Sizing – Product Type, End User, Offering Type, Technology, Region, Country, Others
- Market Dynamics – Market Segmentation, Demand and Supply, Bargaining Power of Buyers and Sellers, Drivers, Restraints, Opportunities, Threat Analysis, Impact Analysis, Porters 5 Forces, Ansoff Analysis, Supply Chain
- Business Framework – Case Studies, Regulatory Landscape, Pricing, Policies and Regulations, New Product Launches. M&As, Recent Developments
- Competitive Landscape – Market Share Analysis, Market Leaders, Emerging Players, Vendor Benchmarking, Developmental Strategy Benchmarking, PESTLE Analysis, Value Chain Analysis
- Company Profiles – Overview, Business Segments, Business Performance, Product Offering, Key Developmental Strategies, SWOT Analysis.
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