Autoimmunity Diagnostics Market Insights 2025, Analysis and Forecast to 2030, by Manufacturers, Regions, Technology, Application, Product Type
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Introduction
Autoimmunity diagnostics encompass sophisticated testing methodologies designed to detect and monitor autoimmune disorders, where the immune system mistakenly attacks healthy body tissues. These diagnostic systems include enzyme-linked immunosorbent assays (ELISA), immunofluorescence assays, multiplex immunoassays, and advanced molecular diagnostic platforms, serving hospitals, specialized diagnostic centers, and research institutions. The market addresses both systemic autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus, and multiple sclerosis, as well as localized autoimmune conditions including Type 1 diabetes, inflammatory bowel disease, and autoimmune thyroid disorders. Market growth is driven by increasing autoimmune disease prevalence, affecting approximately 5-8% of the global population, alongside advances in precision medicine and personalized treatment approaches requiring accurate diagnostic capabilities.
Market Size and Growth Forecast
The global autoimmunity diagnostics market is projected to reach between USD 5.0 billion and USD 7.0 billion in 2025, with a compound annual growth rate (CAGR) of 5% to 10% through 2030, reflecting growing awareness of autoimmune conditions and technological advancement in diagnostic methodologies.
Regional Analysis
North America: The United States leads with advanced diagnostic infrastructure and high healthcare expenditure, while Canada emphasizes comprehensive autoimmune disease management programs. Europe: Germany, France, and the United Kingdom dominate through strong research capabilities and established diagnostic protocols, supported by robust healthcare reimbursement systems. Asia Pacific: China and India experience rapid growth due to improving healthcare access and increasing disease awareness, while Japan focuses on technological innovation in diagnostic platforms. Rest of the World: Brazil expands diagnostic capabilities for autoimmune conditions, and Middle Eastern countries invest in advanced laboratory infrastructure and specialized testing facilities.
Application Analysis
Hospitals: Expected growth of 5.5-9.0%, driven by increasing patient volumes and comprehensive diagnostic requirements. Trends focus on point-of-care testing and integrated laboratory systems. Diagnostic Centers: Projected growth of 6.0-10.5%, linked to specialized testing capabilities and reference laboratory services. Developments emphasize high-throughput testing and rapid turnaround times. Others: Anticipated growth of 4.5-8.5%, including research institutions and physician offices. Advances prioritize accessible testing platforms and cost-effective solutions.
Type Analysis
Systemic Autoimmune Disease Diagnostics: Expected growth of 5.0-9.5%, valued for comprehensive immune system assessment. Trends focus on multiplex testing panels and biomarker discovery. Localized Autoimmune Disease Diagnostics: Projected growth of 5.5-10.0%, key for organ-specific autoimmune conditions. Advances highlight precision diagnostics and therapeutic monitoring.
Key Market Players
Leading firms include Roche, offering comprehensive diagnostic solutions; Siemens Healthcare, specializing in automated immunoassay systems; Abbott, innovating in point-of-care diagnostics; Bio-Rad Laboratories, providing quality control and testing platforms; Thermo Fisher Scientific, developing advanced molecular diagnostics; Quest Diagnostics, enhancing laboratory services; Beckman Coulter, focusing on automation technologies; EUROIMMUN, targeting autoimmune testing; Danaher Corporation, advancing diagnostic instrumentation; and BIOMÉRIEUX, improving infectious disease and autoimmune diagnostics. These companies drive market growth through technological innovation and strategic acquisitions.
Porter's Five Forces Analysis
Threat of New Entrants: Moderate, due to regulatory complexity and established market relationships, though innovation opportunities exist in emerging diagnostic technologies. Threat of Substitutes: Low, as specialized autoimmune diagnostics require specific testing methodologies with limited alternatives. Bargaining Power of Buyers: Moderate, with healthcare providers and laboratories seeking cost-effective solutions while maintaining diagnostic accuracy. Bargaining Power of Suppliers: Low, due to multiple reagent and equipment suppliers providing competitive alternatives. Competitive Rivalry: High, with firms competing on diagnostic accuracy, automation capabilities, and comprehensive testing portfolios.
Market Opportunities and Challenges
Opportunities: Increasing autoimmune disease prevalence creates substantial diagnostic testing demand globally. Growing emphasis on personalized medicine drives advanced biomarker testing requirements. Technological innovations in artificial intelligence and machine learning enhance diagnostic accuracy, while expanding healthcare infrastructure in emerging markets offers growth potential. Challenges: High testing costs limit accessibility in resource-constrained healthcare systems. Complex regulatory requirements delay new test approvals and market entry. Limited healthcare professional expertise in autoimmune diagnostics restricts market penetration, while reimbursement challenges affect testing adoption rates.
Chapter 1 Executive Summary
Chapter 2 Abbreviation and Acronyms
Chapter 3 Preface
3.1 Research Scope
3.2 Research Sources
3.2.1 Data Sources
3.2.2 Assumptions
3.3 Research Method
Chapter 4 Market Landscape
4.1 Market Overview
4.2 Classification/Types
4.3 Application/End Users
Chapter 5 Market Trend Analysis
5.1 Introduction
5.2 Drivers
5.3 Restraints
5.4 Opportunities
5.5 Threats
Chapter 6 Industry Chain Analysis
6.1 Upstream/Suppliers Analysis
6.2 Autoimmunity Diagnostics Analysis
6.2.1 Technology Analysis
6.2.2 Cost Analysis
6.2.3 Market Channel Analysis
6.3 Downstream Buyers/End Users
Chapter 7 Latest Market Dynamics
7.1 Latest News
7.2 Merger and Acquisition
7.3 Planned/Future Project
7.4 Policy Dynamics
Chapter 8 Historical and Forecast Autoimmunity Diagnostics Market in North America (2020-2030)
8.1 Autoimmunity Diagnostics Market Size
8.2 Autoimmunity Diagnostics Market by End Use
8.3 Competition by Players/Suppliers
8.4 Autoimmunity Diagnostics Market Size by Type
8.5 Key Countries Analysis
8.5.1 United States
8.5.2 Canada
8.5.3 Mexico
Chapter 9 Historical and Forecast Autoimmunity Diagnostics Market in South America (2020-2030)
9.1 Autoimmunity Diagnostics Market Size
9.2 Autoimmunity Diagnostics Market by End Use
9.3 Competition by Players/Suppliers
9.4 Autoimmunity Diagnostics Market Size by Type
9.5 Key Countries Analysis
9.5.1 Brazil
9.5.2 Argentina
9.5.3 Chile
9.5.4 Peru
Chapter 10 Historical and Forecast Autoimmunity Diagnostics Market in Asia & Pacific (2020-2030)
10.1 Autoimmunity Diagnostics Market Size
10.2 Autoimmunity Diagnostics Market by End Use
10.3 Competition by Players/Suppliers
10.4 Autoimmunity Diagnostics Market Size by Type
10.5 Key Countries Analysis
10.5.1 China
10.5.2 India
10.5.3 Japan
10.5.4 South Korea
10.5.5 Southest Asia
10.5.6 Australia
Chapter 11 Historical and Forecast Autoimmunity Diagnostics Market in Europe (2020-2030)
11.1 Autoimmunity Diagnostics Market Size
11.2 Autoimmunity Diagnostics Market by End Use
11.3 Competition by Players/Suppliers
11.4 Autoimmunity Diagnostics Market Size by Type
11.5 Key Countries Analysis
11.5.1 Germany
11.5.2 France
11.5.3 United Kingdom
11.5.4 Italy
11.5.5 Spain
11.5.6 Belgium
11.5.7 Netherlands
11.5.8 Austria
11.5.9 Poland
11.5.10 Russia
Chapter 12 Historical and Forecast Autoimmunity Diagnostics Market in MEA (2020-2030)
12.1 Autoimmunity Diagnostics Market Size
12.2 Autoimmunity Diagnostics Market by End Use
12.3 Competition by Players/Suppliers
12.4 Autoimmunity Diagnostics Market Size by Type
12.5 Key Countries Analysis
12.5.1 Egypt
12.5.2 Israel
12.5.3 South Africa
12.5.4 Gulf Cooperation Council Countries
12.5.5 Turkey
Chapter 13 Summary For Global Autoimmunity Diagnostics Market (2020-2025)
13.1 Autoimmunity Diagnostics Market Size
13.2 Autoimmunity Diagnostics Market by End Use
13.3 Competition by Players/Suppliers
13.4 Autoimmunity Diagnostics Market Size by Type
Chapter 14 Global Autoimmunity Diagnostics Market Forecast (2025-2030)
14.1 Autoimmunity Diagnostics Market Size Forecast
14.2 Autoimmunity Diagnostics Application Forecast
14.3 Competition by Players/Suppliers
14.4 Autoimmunity Diagnostics Type Forecast
Chapter 15 Analysis of Global Key Vendors
15.1 Roche
15.1.1 Company Profile
15.1.2 Main Business and Autoimmunity Diagnostics Information
15.1.3 SWOT Analysis of Roche
15.1.4 Roche Autoimmunity Diagnostics Sales, Revenue, Price and Gross Margin (2020-2025)
15.2 Siemens Healthcare
15.2.1 Company Profile
15.2.2 Main Business and Autoimmunity Diagnostics Information
15.2.3 SWOT Analysis of Siemens Healthcare
15.2.4 Siemens Healthcare Autoimmunity Diagnostics Sales, Revenue, Price and Gross Margin (2020-2025)
15.3 Abbott
15.3.1 Company Profile
15.3.2 Main Business and Autoimmunity Diagnostics Information
15.3.3 SWOT Analysis of Abbott
15.3.4 Abbott Autoimmunity Diagnostics Sales, Revenue, Price and Gross Margin (2020-2025)
15.4 Bio-Rad Laboratories
15.4.1 Company Profile
15.4.2 Main Business and Autoimmunity Diagnostics Information
15.4.3 SWOT Analysis of Bio-Rad Laboratories
15.4.4 Bio-Rad Laboratories Autoimmunity Diagnostics Sales, Revenue, Price and Gross Margin (2020-2025)
15.5 Thermo Fisher Scientific
15.5.1 Company Profile
15.5.2 Main Business and Autoimmunity Diagnostics Information
15.5.3 SWOT Analysis of Thermo Fisher Scientific
15.5.4 Thermo Fisher Scientific Autoimmunity Diagnostics Sales, Revenue, Price and Gross Margin (2020-2025)
15.6 Quest Diagnostics
15.6.1 Company Profile
15.6.2 Main Business and Autoimmunity Diagnostics Information
15.6.3 SWOT Analysis of Quest Diagnostics
15.6.4 Quest Diagnostics Autoimmunity Diagnostics Sales, Revenue, Price and Gross Margin (2020-2025)
15.7 Beckman Coulter
15.7.1 Company Profile
15.7.2 Main Business and Autoimmunity Diagnostics Information
15.7.3 SWOT Analysis of Beckman Coulter
15.7.4 Beckman Coulter Autoimmunity Diagnostics Sales, Revenue, Price and Gross Margin (2020-2025)
15.8 EUROIMMUN Medizinische Labordiagnostika
15.8.1 Company Profile
15.8.2 Main Business and Autoimmunity Diagnostics Information
15.8.3 SWOT Analysis of EUROIMMUN Medizinische Labordiagnostika
15.8.4 EUROIMMUN Medizinische Labordiagnostika Autoimmunity Diagnostics Sales, Revenue, Price and Gross Margin (2020-2025)
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Table Research Scope Of Autoimmunity Diagnostics Report
Table Data Sources Of Autoimmunity Diagnostics Report
Table Major Assumptions Of Autoimmunity Diagnostics Report
Table Autoimmunity Diagnostics Classification
Table Autoimmunity Diagnostics Applications
Table Drivers Of Autoimmunity Diagnostics Market
Table Restraints Of Autoimmunity Diagnostics Market
Table Opportunities Of Autoimmunity Diagnostics Market
Table Threats Of Autoimmunity Diagnostics Market
Table Raw Materials Suppliers
Table Different Production Methods Of Autoimmunity Diagnostics
Table Cost Structure Analysis Of Autoimmunity Diagnostics
Table Key End Users
Table Latest News Of Autoimmunity Diagnostics Market
Table Merger And Acquisition
Table Planned/Future Project Of Autoimmunity Diagnostics Market
Table Policy Of Autoimmunity Diagnostics Market
Table 2020-2030 North America Autoimmunity Diagnostics Market Size
Table 2020-2030 North America Autoimmunity Diagnostics Market Size By Application
Table 2020-2025 North America Autoimmunity Diagnostics Key Players Revenue
Table 2020-2025 North America Autoimmunity Diagnostics Key Players Market Share
Table 2020-2030 North America Autoimmunity Diagnostics Market Size By Type
Table 2020-2030 United States Autoimmunity Diagnostics Market Size
Table 2020-2030 Canada Autoimmunity Diagnostics Market Size
Table 2020-2030 Mexico Autoimmunity Diagnostics Market Size
Table 2020-2030 South America Autoimmunity Diagnostics Market Size
Table 2020-2030 South America Autoimmunity Diagnostics Market Size By Application
Table 2020-2025 South America Autoimmunity Diagnostics Key Players Revenue
Table 2020-2025 South America Autoimmunity Diagnostics Key Players Market Share
Table 2020-2030 South America Autoimmunity Diagnostics Market Size By Type
Table 2020-2030 Brazil Autoimmunity Diagnostics Market Size
Table 2020-2030 Argentina Autoimmunity Diagnostics Market Size
Table 2020-2030 Chile Autoimmunity Diagnostics Market Size
Table 2020-2030 Peru Autoimmunity Diagnostics Market Size
Table 2020-2030 Asia & Pacific Autoimmunity Diagnostics Market Size
Table 2020-2030 Asia & Pacific Autoimmunity Diagnostics Market Size By Application
Table 2020-2025 Asia & Pacific Autoimmunity Diagnostics Key Players Revenue
Table 2020-2025 Asia & Pacific Autoimmunity Diagnostics Key Players Market Share
Table 2020-2030 Asia & Pacific Autoimmunity Diagnostics Market Size By Type
Table 2020-2030 China Autoimmunity Diagnostics Market Size
Table 2020-2030 India Autoimmunity Diagnostics Market Size
Table 2020-2030 Japan Autoimmunity Diagnostics Market Size
Table 2020-2030 South Korea Autoimmunity Diagnostics Market Size
Table 2020-2030 Southeast Asia Autoimmunity Diagnostics Market Size
Table 2020-2030 Australia Autoimmunity Diagnostics Market Size
Table 2020-2030 Europe Autoimmunity Diagnostics Market Size
Table 2020-2030 Europe Autoimmunity Diagnostics Market Size By Application
Table 2020-2025 Europe Autoimmunity Diagnostics Key Players Revenue
Table 2020-2025 Europe Autoimmunity Diagnostics Key Players Market Share
Table 2020-2030 Europe Autoimmunity Diagnostics Market Size By Type
Table 2020-2030 Germany Autoimmunity Diagnostics Market Size
Table 2020-2030 France Autoimmunity Diagnostics Market Size
Table 2020-2030 United Kingdom Autoimmunity Diagnostics Market Size
Table 2020-2030 Italy Autoimmunity Diagnostics Market Size
Table 2020-2030 Spain Autoimmunity Diagnostics Market Size
Table 2020-2030 Belgium Autoimmunity Diagnostics Market Size
Table 2020-2030 Netherlands Autoimmunity Diagnostics Market Size
Table 2020-2030 Austria Autoimmunity Diagnostics Market Size
Table 2020-2030 Poland Autoimmunity Diagnostics Market Size
Table 2020-2030 Russia Autoimmunity Diagnostics Market Size
Table 2020-2030 Mea Autoimmunity Diagnostics Market Size
Table 2020-2030 Mea Autoimmunity Diagnostics Market Size By Application
Table 2020-2025 Mea Autoimmunity Diagnostics Key Players Revenue
Table 2020-2025 Mea Autoimmunity Diagnostics Key Players Market Share
Table 2020-2030 Mea Autoimmunity Diagnostics Market Size By Type
Table 2020-2030 Egypt Autoimmunity Diagnostics Market Size
Table 2020-2030 Israel Autoimmunity Diagnostics Market Size
Table 2020-2030 South Africa Autoimmunity Diagnostics Market Size
Table 2020-2030 Gulf Cooperation Council Countries Autoimmunity Diagnostics Market Size
Table 2020-2030 Turkey Autoimmunity Diagnostics Market Size
Table 2020-2025 Global Autoimmunity Diagnostics Market Size By Region
Table 2020-2025 Global Autoimmunity Diagnostics Market Size Share By Region
Table 2020-2025 Global Autoimmunity Diagnostics Market Size By Application
Table 2020-2025 Global Autoimmunity Diagnostics Market Share By Application
Table 2020-2025 Global Autoimmunity Diagnostics Key Vendors Revenue
Table 2020-2025 Global Autoimmunity Diagnostics Key Vendors Market Share
Table 2020-2025 Global Autoimmunity Diagnostics Market Size By Type
Table 2020-2025 Global Autoimmunity Diagnostics Market Share By Type
Table 2025-2030 Global Autoimmunity Diagnostics Market Size By Region
Table 2025-2030 Global Autoimmunity Diagnostics Market Size Share By Region
Table 2025-2030 Global Autoimmunity Diagnostics Market Size By Application
Table 2025-2030 Global Autoimmunity Diagnostics Market Share By Application
Table 2025-2030 Global Autoimmunity Diagnostics Key Vendors Revenue
Table 2025-2030 Global Autoimmunity Diagnostics Key Vendors Market Share
Table 2025-2030 Global Autoimmunity Diagnostics Market Size By Type
Table 2025-2030 Autoimmunity Diagnostics Global Market Share By Type
Figure Market Size Estimated Method
Figure Major Forecasting Factors
Figure Autoimmunity Diagnostics Picture
Figure 2020-2030 North America Autoimmunity Diagnostics Market Size And Cagr
Figure 2020-2030 South America Autoimmunity Diagnostics Market Size And Cagr
Figure 2020-2030 Asia & Pacific Autoimmunity Diagnostics Market Size And Cagr
Figure 2020-2030 Europe Autoimmunity Diagnostics Market Size And Cagr
Figure 2020-2030 Mea Autoimmunity Diagnostics Market Size And Cagr
Figure 2020-2025 Global Autoimmunity Diagnostics Market Size And Growth Rate
Figure 2025-2030 Global Autoimmunity Diagnostics Market Size And Growth Rate
Research Methodology
- Market Estimated Methodology:
Bottom-up & top-down approach, supply & demand approach are the most important method which is used by HDIN Research to estimate the market size.
1)Top-down & Bottom-up Approach
Top-down approach uses a general market size figure and determines the percentage that the objective market represents.
Bottom-up approach size the objective market by collecting the sub-segment information.
2)Supply & Demand Approach
Supply approach is based on assessments of the size of each competitor supplying the objective market.
Demand approach combine end-user data within a market to estimate the objective market size. It is sometimes referred to as bottom-up approach.
- Forecasting Methodology
- Numerous factors impacting the market trend are considered for forecast model:
- New technology and application in the future;
- New project planned/under contraction;
- Global and regional underlying economic growth;
- Threatens of substitute products;
- Industry expert opinion;
- Policy and Society implication.
- Analysis Tools
1)PEST Analysis
PEST Analysis is a simple and widely used tool that helps our client analyze the Political, Economic, Socio-Cultural, and Technological changes in their business environment.
- Benefits of a PEST analysis:
- It helps you to spot business opportunities, and it gives you advanced warning of significant threats.
- It reveals the direction of change within your business environment. This helps you shape what you’re doing, so that you work with change, rather than against it.
- It helps you avoid starting projects that are likely to fail, for reasons beyond your control.
- It can help you break free of unconscious assumptions when you enter a new country, region, or market; because it helps you develop an objective view of this new environment.
2)Porter’s Five Force Model Analysis
The Porter’s Five Force Model is a tool that can be used to analyze the opportunities and overall competitive advantage. The five forces that can assist in determining the competitive intensity and potential attractiveness within a specific area.
- Threat of New Entrants: Profitable industries that yield high returns will attract new firms.
- Threat of Substitutes: A substitute product uses a different technology to try to solve the same economic need.
- Bargaining Power of Customers: the ability of customers to put the firm under pressure, which also affects the customer's sensitivity to price changes.
- Bargaining Power of Suppliers: Suppliers of raw materials, components, labor, and services (such as expertise) to the firm can be a source of power over the firm when there are few substitutes.
- Competitive Rivalry: For most industries the intensity of competitive rivalry is the major determinant of the competitiveness of the industry.
3)Value Chain Analysis
Value chain analysis is a tool to identify activities, within and around the firm and relating these activities to an assessment of competitive strength. Value chain can be analyzed by primary activities and supportive activities. Primary activities include: inbound logistics, operations, outbound logistics, marketing & sales, service. Support activities include: technology development, human resource management, management, finance, legal, planning.
4)SWOT Analysis
SWOT analysis is a tool used to evaluate a company's competitive position by identifying its strengths, weaknesses, opportunities and threats. The strengths and weakness is the inner factor; the opportunities and threats are the external factor. By analyzing the inner and external factors, the analysis can provide the detail information of the position of a player and the characteristics of the industry.
- Strengths describe what the player excels at and separates it from the competition
- Weaknesses stop the player from performing at its optimum level.
- Opportunities refer to favorable external factors that the player can use to give it a competitive advantage.
- Threats refer to factors that have the potential to harm the player.
- Data Sources
Primary Sources | Secondary Sources |
---|---|
Face to face/Phone Interviews with market participants, such as: Manufactures; Distributors; End-users; Experts. Online Survey |
Government/International Organization Data: Annual Report/Presentation/Fact Book Internet Source Information Industry Association Data Free/Purchased Database Market Research Report Book/Journal/News |