The Autoimmune Disease Testing Market size was valued at USD 11.24 billion in 2023 and it is expected to be worth around USD 24.14 billion by 2031 growing at a remarkable GAGR of 10.27% over the forecast period 2024-2031.
The main factor accelerating growth is the rising prevalence of autoimmune diseases like type 1 diabetes in newborn infants, along with the demand for quick diagnoses. Due to the increased prevalence of autoimmune illnesses and the resulting increase in healthcare costs, research and diagnostics organisations around the world are launching projects in accordance with governmental organisations. These conditions are listed as one of the top ten conditions that increase the death rates of women, according to statistics from the National Institutes of Health (NIH). According to estimates, market expansion will be fuelled by the introduction of technological improvements and rising lab automation rates. Clinicians are implementing cutting-edge technology to perform many tests concurrently with faster and more accurate findings. Some of the drawbacks pushing laboratories towards automation are the lengthy turnaround times associated with the use of traditional illness diagnosis procedures and the scarcity of standardised tests for more than 80 different disease types. Furthermore, it is anticipated that the existence of beneficial government programmes will favourably influence market dynamics. The appropriate diagnosis and treatment of autoimmune diseases are aggressively promoted by groups like the North American Rheumatoid Arthritis Consortium, the Cooperative Study Group for Autoimmune Disease Prevention, and Autoimmunity Centres of Excellence.
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DRIVERS
Increased prevalence of autoimmune diseases & Technological developments in diagnostics.
Growth of the ageing population.
The demand for autoimmune disease testing is being driven by the increasing incidence and prevalence of autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, and multiple sclerosis. The autoimmune disease testing market is expanding as a result of technological developments in laboratory testing, such as the creation of new biomarkers and enhanced testing procedures. Increasing awareness and spotting diseases early: The demand for autoimmune disease testing is rising as people become more aware of these conditions and the value of early detection and treatment. Because autoimmune disorders are more common in older people, the global ageing population is a factor in the expansion of the autoimmune disease testing market.
RESTRAIN
Lack of uniform diagnostic standards & High costs and restricted access.
Strict regulatory standards.
Autoimmune disorders are complicated and may manifest clinically in a variety of ways. The market may be constrained by the absence of standardised diagnostic standards and the difficulties in correctly detecting autoimmune disorders. Testing for autoimmune diseases can be expensive, and access to specialised testing facilities and cutting-edge diagnostics may be restricted, which may impede market expansion strict regulatory standards: Testing for autoimmune diseases is subject to strict regulatory criteria and quality assurance standards, which makes it difficult to enter the market and maintain compliance.
OPPORTUNITY
Growing need for personalised medicine.
Technological advancements.
The development of tailored autoimmune disease testing procedures is made possible by developments in precision medicine and the growing emphasis on individualised treatment strategies. Growth potential for autoimmune disease testing is presented by emerging markets, where healthcare infrastructure is expanding and autoimmune disorders are becoming more common. Technological advancements: Ongoing research and development projects to enhance the sensitivity, specificity, and speed of testing for autoimmune diseases are anticipated to open up new market prospects.
CHALLENGES
Autoimmune illnesses' complexity, Reimbursement difficulties.
Diagnoses of autoimmune diseases might be difficult because of their varied and complex symptoms. It is difficult to design comprehensive testing strategies that incorporate numerous biomarkers and diagnostic modalities. Market saturation in some segments of the autoimmune disease testing market can present difficulties for new entrants due to competition. Receiving proper compensation for sophisticated testing modalities may be difficult for some market participants due to differences in reimbursement rules and coverage for autoimmune disease testing procedures.
Hospitals, laboratories, and other healthcare institutions might all be badly impacted by the fighting in the affected areas. This might affect patient access to testing services and result in a reduction in the capacity for testing autoimmune diseases. Economic instability in the region may be brought on by geopolitical tensions and the conflict's economic effects. Budget restrictions in healthcare systems can result from economic downturns, which may have an impact on investments in autoimmune disease diagnostics and associated infrastructure. The regulatory environment for medical equipment and diagnostics, especially goods for autoimmune disease testing, may be impacted by political tensions and changes in regulations brought on by the conflict. This can make it more difficult or take longer to get the required permissions or comply with regulations.
IMPACT OF ONGOING RECESSION
Economic uncertainty and financial constraints during a recession may lead people to delay or forego non-essential healthcare services, including testing for autoimmune diseases. Diagnostic laboratories and manufacturers may experience a brief drop in testing volume and revenue as a result. Healthcare priorities may change during a recession to focus on urgent care and immediate health issues. This can result in less focus being placed on diagnostic testing for autoimmune illnesses and other chronic conditions. As a result, the market for evaluating autoimmune diseases may experience a pause in growth. Effect on insurance and reimbursement Economic downturns can have an impact on the insurance and reimbursement procedures for medical services, including diagnostic testing. Accessibility may be impacted by modifications to the eligibility requirements or decreases in reimbursement rates.
By Type
Systemic autoimmune disease diagnostics
Rheumatoid arthritis
Ankylosing spondylitis
Systemic Lupus Erythematosus (SLE)
Others
Localized autoimmune disease diagnostics
Multiple sclerosis
Type 1 diabetes
Hashimoto's Thyroiditis
Idiopathic thrombocytopenic purpura
Others
By End User
Clinical laboratories
Hospitals
Other End users
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North America
USA
Canada
Mexico
Europe
Germany
UK
France
Italy
Spain
The Netherlands
Rest of Europe
Asia-Pacific
Japan
South Korea
China
India
Australia
Rest of Asia-Pacific
The Middle East & Africa
Israel
UAE
South Africa
Rest of the Middle East & Africa
Latin America
Brazil
Argentina
Rest of Latin American
North America
The Affordable Care Act, the existence of favourable laws and activities conducted by the AARDA, and high disease prevalence in the region all contributed to North America holding the greatest market share of almost 40.0% in 2015.
Nearly 50 million Americans suffer from an autoimmune condition, according to AARDA. A high prevalence of chronic ailments and rising healthcare costs have prompted the government and other business-friendly organisations to introduce beneficial measures. Through early disease diagnosis and increased patient awareness, these programmes seek to reduce healthcare spending.
Asia Pacific
Due to the region's high levels of unmet patient requirements, rising patient awareness levels, and continuously improving healthcare infrastructure, the Asia Pacific region is predicted to experience profitable growth. During the timeframe of the forecast, an increase in revenue share is anticipated. It is expected that its market share will increase from 21.0% in 2015 to over 22.0% in 2025.
The major key players are Abbott, Trinity Biotech, BIOMÉRIEUX, Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., Hoffmann-La Roche Ltd, EUROIMMUN Medizinische Labordiagnostika AG, Siemens Healthcare GmbH, Danaher Corporation, Grifols, S.A., Oncimmune, HYCOR Biomedical Corporation and others.
Thermo Fisher Scientific:
The Phadia2500+ device is now accessible in the United States, according to a May 2022 announcement from Thermo Fisher Scientific. This makes autoimmune testing possible. Diagnoses for autoimmune diseases such as celiac disease, rheumatoid arthritis, autoimmune liver disease, and autoimmune thyroid disease can be made using this device. Increased customer base, revenue, and customer happiness were the outcomes of this strategic launch.
KSL Beutner Laboratories:
KSL Beutner Laboratories introduced a blood test in August 2022 to look for an antigen that may be connected to the autoimmune blistering condition known as mucous membrane pemphigoid. The oral cavity may develop painful sores as a result of this illness.
| Report Attributes | Details |
| Market Size in 2023 | US$ 11.24 Bn |
| Market Size by 2031 | US$ 24.14 Bn |
| CAGR | CAGR of 10.27% From 2024 to 2031 |
| Base Year | 2023 |
| Forecast Period | 2024-2031 |
| Historical Data | 2020-2022 |
| Report Scope & Coverage | Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook |
| Key Segments | • By Type (Systemic autoimmune disease diagnostics, Localized autoimmune disease diagnostics) • By End User (Clinical laboratories, Hospitals, Other End users) |
| Regional Analysis/Coverage | North America (USA, Canada, Mexico), Europe (Germany, UK, France, Italy, Spain, Netherlands, Rest of Europe), Asia-Pacific (Japan, South Korea, China, India, Australia, Rest of Asia-Pacific), The Middle East & Africa (Israel, UAE, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America) |
| Company Profiles | Abbott, Trinity Biotech, BIOMÉRIEUX, Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., Hoffmann-La Roche Ltd, EUROIMMUN Medizinische Labordiagnostika AG, Siemens Healthcare GmbH, Danaher Corporation, Grifols, S.A., Oncimmune, HYCOR Biomedical Corporation |
| Key Drivers | • Increased prevalence of autoimmune diseases & Technological developments in diagnostics. • Growth of the ageing population. |
| Market Opportunities | • Growing need for personalized medicine. • Technological advancements. |
Ans: The CAGR Growth rate of Autoimmune Disease Testing Market is approx. CAGR 10.2% for the forecast period of 2023-2030.
Ans: The projected market size of Autoimmune Disease Testing Market USD 10.2 billion in 2022 and it is expected to be worth around USD 11.69 billion by 2030.
Ans: The major key players are Abbott, Trinity Biotech, BIOMÉRIEUX, Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., Hoffmann-La Roche Ltd, EUROIMMUN Medizinische Labordiagnostika AG, Siemens Healthcare GmbH, Danaher Corporation, Grifols, S.A., Oncimmune, HYCOR Biomedical Corporation and others.
Ans: A significant patient population base and an increase in the usage of technologically improved diagnostic testing are some of the reasons anticipated to propel the acceptance of these products.
Ans: In 2021, North America led the market.
Table of Contents
1. Introduction
1.1 Market Definition
1.2 Scope
1.3 Research Assumptions
2. Research Methodology
3. Market Dynamics
3.1 Drivers
3.2 Restraints
3.3 Opportunities
3.4 Challenges
4. Impact Analysis
4.1 Impact of the Ukraine- Russia war
4.2 Impact of ongoing Recession
4.2.1 Introduction
4.2.2 Impact on major economies
4.2.2.1 US
4.2.2.2 Canada
4.2.2.3 Germany
4.2.2.4 France
4.2.2.5 United Kingdom
4.2.2.6 China
4.2.2.7 Japan
4.2.2.8 South Korea
4.2.2.9 Rest of the World
5. Value Chain Analysis
6. Porter’s 5 forces model
7. PEST Analysis
8. Autoimmune Disease Testing Market, By Type
8.1 Systemic autoimmune disease diagnostics
8.2 Localized autoimmune disease diagnostics
9. Autoimmune Disease Testing Market, By End-Users
9.1 Clinical laboratories
9.2 Hospitals
9.3 Other End users
10. Regional Analysis
10.1 Introduction
10.2 North America
10.2.1 North America Autoimmune Disease Testing Market, by country
10.2.2North America Autoimmune Disease Testing MarketBy Type
10.2.3 North America Autoimmune Disease Testing Market By End-User
10.2.4 USA
10.2.4.1 USA Autoimmune Disease Testing MarketBy Type
10.2.4.2 USA Autoimmune Disease Testing Market By End-User
10.2.7 Canada
10.2.7.1 Canada Autoimmune Disease Testing MarketBy Type
10.2.7.2 Canada Autoimmune Disease Testing Market By End-User
10.2.8 Mexico
10.2.8.1 Mexico Autoimmune Disease Testing Market By Type
10.2.8.2 Mexico Autoimmune Disease Testing Market By End-User
10.3 Europe
10.3.1 Europe Autoimmune Disease Testing Market by country
1.3.3.2 Europe Autoimmune Disease Testing Market By Type
10.3.3 Europe Autoimmune Disease Testing Market By End-User
10.3.6 Germany
10.3.6.1 Germany Autoimmune Disease Testing MarketBy Type
10.3.6.2 Germany Autoimmune Disease Testing Market By End-User
10.3.7 UK
10.3.7.1 UK Autoimmune Disease Testing MarketBy Type
10.3.7.2 UK Autoimmune Disease Testing Market By End-User
10.3.8 France
10.3.8.1 France Autoimmune Disease Testing MarketBy Type
10.3.8.2 France Autoimmune Disease Testing Market By End-User
10.3.9 Italy
10.3.9.1 Italy Autoimmune Disease Testing MarketBy Type
10.3.9.2 Italy Autoimmune Disease Testing Market By End-User
10.3.10 Spain
10.3.10.1 Spain Autoimmune Disease Testing MarketBy Type
10.3.10.2 Spain Autoimmune Disease Testing Market By End-User
10.3.11 The Netherlands
10.3.11.1 Netherlands Autoimmune Disease Testing MarketBy Type
10.3.11.2 Netherlands Autoimmune Disease Testing Market By End-User
10.3.12 Rest of Europe
10.3.12.1 Rest of Europe Autoimmune Disease Testing MarketBy Type
10.3.12.2 Rest of Europe Autoimmune Disease Testing Market By End-User
10.4 Asia-Pacific
10.4.1 Asia Pacific Autoimmune Disease Testing Market by country
10.4.2 Asia Pacific Autoimmune Disease Testing MarketBy Type
10.4.3 Asia Pacific Autoimmune Disease Testing Market By End-User
10.4.6 Japan
10.4.6.1 Japan Autoimmune Disease Testing MarketBy Type
10.4.6.2 Japan Autoimmune Disease Testing Market By End-User
10.4.7 South Korea
10.4.7.1 South Korea Autoimmune Disease Testing MarketBy Type
10.4.7.2 South Korea Autoimmune Disease Testing Market By End-User
10.4.8 China
10.4.8.1 China Autoimmune Disease Testing MarketBy Type
10.4.8.2 China Autoimmune Disease Testing Market By End-User
10.4.9 India
10.4.9.1 India Autoimmune Disease Testing MarketBy Type
10.4.9.2 India Autoimmune Disease Testing Market By End-User
10.4.10 Australia
10.4.10.1 Australia Autoimmune Disease Testing MarketBy Type
10.4.10.2 Australia Autoimmune Disease Testing Market By End-User
10.4.11 Rest of Asia-Pacific
10.4.11.1 APAC Autoimmune Disease Testing MarketBy Type
10.4.11.2 APAC Autoimmune Disease Testing Market By End-User
10.5 The Middle East & Africa
10.5.1 The Middle East & Africa Autoimmune Disease Testing Market by country
10.5.2 The Middle East & Africa Autoimmune Disease Testing MarketBy Type
10.5.3 The Middle East & Africa Autoimmune Disease Testing Market By End-User
10.5.6 Israel
10.5.6.1 Israel Autoimmune Disease Testing MarketBy Type
10.5.6.2 Israel Autoimmune Disease Testing Market By End-User
10.5.7 UAE
10.5.7.1 UAE Autoimmune Disease Testing MarketBy Type
10.5.7.2 UAE Autoimmune Disease Testing Market By End-User
10.5.8 South Africa
10.5.8.1 South Africa Autoimmune Disease Testing MarketBy Type
10.5.8.2 South Africa Autoimmune Disease Testing Market By End-User
10.5.9 Rest of Middle East & Africa
10.5.9.1 Rest of Middle East & Asia Autoimmune Disease Testing MarketBy Type
10.5.9.2 Rest of Middle East & Asia Autoimmune Disease Testing Market By End-User
10.6 Latin America
10.6.1 Latin America Autoimmune Disease Testing Market by country
10.6.2 Latin America Autoimmune Disease Testing MarketBy Type
10.6.3 Latin America Autoimmune Disease Testing Market By End-User
10.6.6 Brazil
10.6.6.1 Brazil Autoimmune Disease Testing MarketBy Type
10.6.6.2 Brazil Africa Autoimmune Disease Testing Market By End-User
10.6.7 Argentina
10.6.7.1 Argentina Autoimmune Disease Testing MarketBy Type
10.6.7.2 Argentina Autoimmune Disease Testing Market By End-User
10.6.8 Rest of Latin America
10.6.8.1 Rest of Latin America Autoimmune Disease Testing MarketBy Type
10.6.8.2 Rest of Latin America Autoimmune Disease Testing Market By End-User
12 Company profile
12.1 Abbott.
12.1.1 Market Overview
12.1.2 Financials
12.1.3 Treatment/Services/Offerings
12.1.4 SWOT Analysis
12.1.5 The SNS View
12.2 Trinity Biotech
12.2.1 Market Overview
12.2.2 Financials
12.2.3 Treatment/Services/Offerings
12.2.4 SWOT Analysis
12.2.5 The SNS View
12.3 BIOMÉRIEUX.
12.3.1 Market Overview
12.3.2 Financials
12.3.3 Treatment/Services/Offerings
12.3.4 SWOT Analysis
12.3.5 The SNS View
12.4 Bio-Rad Laboratories, Inc.,
12.4.1 Market Overview
12.4.2 Financials
12.4.3 Treatment/Services/Offerings
12.4.4 SWOT Analysis
12.4.5 The SNS View
12.5 Thermo Fisher Scientific Inc.,
12.5.1 Market Overview
12.5.2 Financials
12.5.3 Treatment/Services/Offerings
12.5.4 SWOT Analysis
12.5.5 The SNS View
12.6 Hoffmann-La Roche Ltd.
12.6.1 Market Overview
12.6.2 Financials
12.6.3 Treatment/Services/Offerings
12.6.4 SWOT Analysis
12.6.5 The SNS View
12.7 Siemens Healthcare GmbH.
12.7.1 Market Overview
12.7.2 Financials
12.7.3 Treatment/Services/Offerings
12.7.4 SWOT Analysis
12.7.5 The SNS View
12.8 Danaher Corporation.
12.8.1 Market Overview
12.8.2 Financials
12.8.3 Treatment/Services/Offerings
12.8.4 SWOT Analysis
12.8.5 The SNS View
12.9 Grifols.
12.9.1 Market Overview
12.9.2 Financials
12.9.3 Treatment/Services/Offerings
12.9.4 SWOT Analysis
12.9.5 The SNS View
12.10 HYCOR Biomedical Corporation.
12.10.1 Market Overview
12.10.2 Financials
12.10.3 Treatment/Services/Offerings
12.10.4 SWOT Analysis
12.10.5 The SNS View
13. Competitive Landscape
13.1 Competitive Benchmarking
13.2 Market Share analysis
13.3 Recent Developments
14. Use Case and Best Practices
15. Conclusion
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