Market Insights
"The global autoimmune disease diagnosis market size was estimated at USD 5.14 billion in 2022 and is likely to grow at a CAGR of 8.84% during 2023-2028 to reach USD 8.57 billion in 2028."

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Autoimmune diseases are diseases where the immune system (which protects the body from bacteria and viruses) mistakenly attacks the healthy cells of the body. There are over 80 types with similar symptoms, and their prevalence is increasing worldwide, affecting an estimated 8% of the population. Factors such as lifestyle changes, environmental factors, and genetic predispositions contribute to this increase. Autoimmune disease diagnosis involves identifying and confirming the presence of an autoimmune disease, which can affect any part of the body. The symptoms of autoimmune diseases can be varied and nonspecific, making diagnosis difficult. However, early diagnosis is crucial for improving patient outcomes, allowing for earlier intervention and treatment, which can help prevent or delay disease progression and manage symptoms more effectively.
Autoimmune Disease Diagnosis Market Report Overview
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Market Size in 2028
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USD 8.57 Billion
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Market Size in 2022
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USD 5.14 Billion
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Market Growth (2023-2028)
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CAGR of 8.84%
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Base Year of Study
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2022
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Trend Period
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2017-2021
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Forecast Period
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2023-2028
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Market Dynamics
Market Drivers
With increasing autoimmune diseases among the growing elderly population and mounting awareness about these diseases, development in R&D is expected to drive the global autoimmune disease diagnosis market during the forecast period. Advancements in diagnostic technology have led to more accurate, sensitive, and specific tests that can detect autoimmune diseases earlier, improving patient outcomes. The growing public and healthcare professionals' awareness of autoimmune diseases is also driving increased demand for testing and diagnosis.
Challenges
Challenges in diagnosis: Autoimmune diseases, characterized by their diverse and nonspecific symptoms, can be challenging to diagnose and treat, potentially leading to delayed diagnosis and worsened patient outcomes. Insufficiency of specific biomarkers: The absence of precise biomarkers for numerous autoimmune diseases makes it challenging to create accurate and dependable diagnostic tests.
Opportunities
Surge in prevalence of autoimmune diseases: The global increase in autoimmune diseases is leading to a surge in the demand for diagnostic tests. Development in diagnostic technology: Recent developments in diagnostic technology for autoimmune diseases have led to the development of more accurate, sensitive, and specific tests. Increasing awareness of autoimmune diseases: The increasing public and healthcare professionals' awareness of autoimmune diseases is leading to a surge in demand for testing and diagnosis.
Segments Analysis
Segmentations
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List of Sub-Segments
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Dominant and Fastest-Growing Segments
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Product-Type Analysis
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Consumables & Assay Kits, Instruments
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Consumables & assay kits are expected to remain the dominant segment during the forecast period.
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Test-Type Analysis
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Routine Laboratory Tests, Inflammatory Markers, Autoantibodies & Immunologic Tests, and Other Tests
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Autoantibodies & immunologic tests are expected to remain the dominant segment during the forecast period.
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Disease-Type Analysis
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Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren’s Syndrome, Thyroiditis, Scleroderma, and Other Diseases
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The rheumatoid arthritis segment is expected to command the market during the forecast period.
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End-User-Type Analysis
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Clinical Laboratories, Hospitals, and Others
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Clinical laboratories are expected to dominate the market during the forecast period.
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Regional Analysis
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North America, Europe, Asia-Pacific, and Rest of the World
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Europe is estimated to remain the largest market during the forecast period.
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Product Trends
"The consumables & assay kits segment accounted for the largest market share."
The market is segmented into consumables & assay kits and instruments. Consumables & assay kits are expected to remain the dominant segment during the forecast period. Their higher sensitivity as compared to conventional test kits gives accurate results even with smaller samples. In addition, development in biotechnology and cost-effectiveness of consumables & assay kits, owing to the reduced need for secondary verification, are expected to propel the growth of the segment during the forecast period.
Test Trends
"The autoantibodies & immunologic tests segment accounted for the largest market share."
The market is segmented as routine laboratory tests, inflammatory markers, autoantibodies & immunologic tests, and other tests. Autoantibodies & immunologic tests are expected to remain the dominant segment during the forecast period.
Disease Trends
"The rheumatoid arthritis segment accounted for the largest market share."
The market is segmented as rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, thyroiditis, scleroderma, and other diseases. The rheumatoid arthritis segment is expected to command the market during the forecast period. It is the most common disease that affects the wrist and hand joints among the elderly population.
End-User Trends
"The clinical laboratories segment accounted for the largest market share."
The market is segmented into clinical laboratories, hospitals, and others. Clinical laboratories are expected to dominate the market during the forecast period. Clinical laboratories’ tests are performed to aid the diagnosis of autoimmune disorders, which usually include blood test autoantibodies as well as inflammations such as CRP and ECR.
Regional Insights
"Europe accounted for the largest market share."
Europe is estimated to remain the largest market during the forecast period. The rising chronic diseases such as rheumatoid arthritis among the increasing ageing population. Autoimmune diseases affect 5-10% of the population in Europe and North America. The 3TR project (taxonomy, treatments, targets and remission) funded by the EU’s Innovative Medicines Initiative with €80 million for the next seven years to discover biomarkers that can predict which patients will respond best to the treatments for autoimmune diseases is another significant factor contributing to the growth of the region’s autoimmune disease diagnosis market.

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Key Players
The following are the key players in the autoimmune disease diagnosis market (arranged alphabetically).
Note: The above list does not necessarily include all the top players in the market.
Are you the leading player in this market? We would love to include your name. Write to us at sales@stratviewresearch.com
Report Features
This report provides market intelligence in the most comprehensive way. The report structure has been kept such that it offers maximum business value. It provides critical insights into the market dynamics and will enable strategic decision-making for the existing market players as well as those willing to enter the global autoimmune disease diagnosis market.
What Deliverables Will You Get in this Report?
Key questions this report answers
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Relevant contents in the report
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How big is the sales opportunity?
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In-depth Analysis of the Autoimmune Disease Diagnosis Market
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How lucrative is the future?
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Market forecast and trend data and emerging trends
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Which regions offer the best sales opportunities?
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Global, regional, and country-level historical data and forecasts
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Which are the most attractive market segments?
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Market Segment Analysis and Forecast
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Which are the top players and their market positioning?
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Competitive landscape analysis, Market share analysis
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How complex is the business environment?
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Porter’s five forces analysis, PEST analysis, Life cycle analysis
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What are the factors affecting the market?
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Drivers & challenges
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Will I get the information on my specific requirements?
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10% free customization
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Research Methodology
This strategic assessment report, from Stratview Research, provides a comprehensive analysis that reflects today’s autoimmune disease diagnosis market realities and future market possibilities for the forecast period. The report segments and analyzes the market in the most detailed manner in order to provide a panoramic view of the market. The vital data/information provided in the report can play a crucial role for the market participants as well as investors in the identification of the low-hanging fruits available in the market as well as to formulate the growth strategies to expedite their growth process.
This report offers high-quality insights and is the outcome of a detailed research methodology comprising extensive secondary research, rigorous primary interviews with industry stakeholders, and validation and triangulation with Stratview Research’s internal database and statistical tools. More than 1000 authenticated secondary sources, such as company annual reports, fact books, press releases, journals, investor presentations, white papers, patents, and articles, have been leveraged to gather the data. We conducted more than 15 detailed primary interviews with the market players across the value chain in all four regions and industry experts to obtain both qualitative and quantitative insights.
Customization Options
Stratview Research offers one of the following free customization options to our respectable clients:
Company Profiling
- Detailed profiling of additional market players (up to 3 players).
- SWOT analysis of key players (up to 3 players).
Competitive Benchmarking
- Benchmarking of key players on the following parameters: Product portfolio, geographical reach, regional presence, and strategic alliances.
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