The autoimmune disease diagnosis market size has grown strongly in recent years. It will grow from $6.2 billion in 2025 to $6.74 billion in 2026 at a compound annual growth rate (CAGR) of 8.8%. The growth in the historic period can be attributed to increasing prevalence of autoimmune diseases, improved availability of immunoassay technologies, expansion of clinical laboratory networks, growing physician awareness of autoimmune conditions, wider adoption of routine screening tests.
The autoimmune disease diagnosis market size is expected to see strong growth in the next few years. It will grow to $9.38 billion in 2030 at a compound annual growth rate (CAGR) of 8.6%. The growth in the forecast period can be attributed to increasing demand for early and accurate diagnosis, rising use of ai-assisted diagnostic analytics, expansion of personalized diagnostic approaches, growing investments in autoimmune research, increased integration of point-of-care testing. Major trends in the forecast period include increasing adoption of advanced immunological testing, rising use of autoantibody panels, growing integration of multiplex diagnostic platforms, expansion of laboratory automation, enhanced focus on early disease detection.
A high incidence of autoimmune diseases contributed to the growth of the autoimmune disease diagnosis market. Autoimmune diseases refer to conditions in which the body’s immune system mistakenly attacks its own healthy cells, tissues, or organs. Autoimmune diseases are rising due to increasing exposure to environmental triggers such as pollution, infections, and lifestyle changes that can disrupt immune regulation. Autoimmune disease diagnosis is used to accurately identify the specific immune disorder so that appropriate treatment can begin and disease progression can be better managed. For instance, in March 2023, according to Society for Women’s Health Research, U.S-based non-profit organisation, reported that, the autoimmune diseases are estimated to estimated that 23.5 million to 50 million. Further, the global rates of autoimmune diseases are rising by between 3-9 percent each year. Therefore, the increasing incidence of autoimmune diseases across the globe is driving the growth of the autoimmune disease diagnosis market.
Rising healthcare expenditures are anticipated to drive the growth of the autoimmune disease diagnosis market in the coming years. Healthcare expenditure refers to the total funds spent on healthcare products and services. It serves as a key indicator of a population's health and the effectiveness of a healthcare system. Higher healthcare spending enables more timely healthcare services, which contributes to improved detection, treatment, and outcomes for individuals with autoimmune diseases. For example, in May 2024, according to the Office for National Statistics, a UK-based government department, total healthcare expenditure increased by 5.6% in nominal terms from 2022 to 2023, marking a significant acceleration compared to the 0.9% growth observed in 2022. Thus, increasing healthcare expenditures are fueling the autoimmune disease diagnosis market.
Major companies in the autoimmune disease diagnosis market are concentrating on developing technological innovations, such as multiplex autoantibody assay platforms, to enable comprehensive, early, and precise detection of autoimmune disorders, thereby enhancing diagnostic accuracy and patient management. A multiplex autoantibody assay platform allows the simultaneous detection of multiple disease-specific autoantibodies in a single patient sample, improving sensitivity and specificity compared to traditional single-analyte ELISA or immunofluorescence tests, while also reducing sample volume and turnaround time. For example, in January 2025, Exagen Inc., a U.S.-based diagnostics company, introduced its AVISE CTD platform with new systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) biomarker assays. The platform identifies novel biomarkers such as TIgG, TIgM, and TC4d, enabling clinicians to more accurately differentiate overlapping autoimmune conditions and streamline patient diagnosis, while integrating smoothly with existing testing workflows.
Major companies operating in the autoimmune disease diagnosis market are Siemens Healthineers AG, Abbott Laboratories, Thermo Fisher Scientific Inc, Bio-Rad Laboratories Inc, F. Hoffmann-La Roche Ltd, Danaher Corporation, AESKU Diagnostics GmbH & Co. KG, Trinity Biotech plc, bioMérieux SA, SQI Diagnostics, Philips Healthcare India, Agappe Diagnostics Ltd, Lepu Medical Technology Company (Beijing) Co., Ltd, Shanghai Runda Medical Technology Co., Ltd, GE Healthcare China Co., Ltd, Roche Holding AG, Koninklijke Philips, Theradiag, Becton Dickinson and Company, Ortho Clinical Diagnostics.
North America was the largest region in the autoimmune disease diagnosis market in 2025. Western Europe was the second largest region in the autoimmune disease diagnosis market share. The regions covered in the autoimmune disease diagnosis market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the autoimmune disease diagnosis market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Tariffs are influencing the autoimmune disease diagnosis market by increasing costs of imported assay kits, reagents, diagnostic instruments, and laboratory automation equipment used in immunological testing. Clinical laboratories and hospitals in North America and Europe are most affected due to dependence on imported consumables, while Asia-Pacific faces higher costs for diagnostic infrastructure expansion. These tariffs are raising test prices and slowing laboratory upgrades. However, they are also encouraging domestic production of diagnostic kits, regional reagent manufacturing, and localized development of testing platforms.
The autoimmune disease diagnosis market research report is one of a series of new reports that provides autoimmune disease diagnosis market statistics, including autoimmune disease diagnosis industry global market size, regional shares, competitors with a autoimmune disease diagnosis market share, detailed autoimmune disease diagnosis market segments, market trends and opportunities, and any further data you may need to thrive in the autoimmune disease diagnosis industry. This autoimmune disease diagnosis market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
Autoimmune disease diagnosis involves identifying conditions in which the body produces antibodies that attack and destroy its own healthy cells. These conditions include Crohn's disease, rheumatoid arthritis, Hashimoto’s disease, multiple sclerosis, Grave’s disease, psoriasis, coeliac disease, type 1 diabetes, lupus, and inflammatory bowel syndrome, and are detected through immunological tests.
The primary test types for diagnosing autoimmune diseases include routine laboratory tests, autoantibody tests, immunologic tests, and other tests. Autoantibody tests help support the diagnosis of autoimmune diseases. The available products consist of consumables and assay kits, as well as instruments, and they are utilized by various sectors such as clinical laboratories, hospitals, and others.
The autoimmune disease diagnosis market includes revenue earned by diagnostic assay kits, reagents, consumables, and instruments used for the diagnosis of autoimmune diseases. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 1-3 business days.
The autoimmune disease diagnosis market size is expected to see strong growth in the next few years. It will grow to $9.38 billion in 2030 at a compound annual growth rate (CAGR) of 8.6%. The growth in the forecast period can be attributed to increasing demand for early and accurate diagnosis, rising use of ai-assisted diagnostic analytics, expansion of personalized diagnostic approaches, growing investments in autoimmune research, increased integration of point-of-care testing. Major trends in the forecast period include increasing adoption of advanced immunological testing, rising use of autoantibody panels, growing integration of multiplex diagnostic platforms, expansion of laboratory automation, enhanced focus on early disease detection.
A high incidence of autoimmune diseases contributed to the growth of the autoimmune disease diagnosis market. Autoimmune diseases refer to conditions in which the body’s immune system mistakenly attacks its own healthy cells, tissues, or organs. Autoimmune diseases are rising due to increasing exposure to environmental triggers such as pollution, infections, and lifestyle changes that can disrupt immune regulation. Autoimmune disease diagnosis is used to accurately identify the specific immune disorder so that appropriate treatment can begin and disease progression can be better managed. For instance, in March 2023, according to Society for Women’s Health Research, U.S-based non-profit organisation, reported that, the autoimmune diseases are estimated to estimated that 23.5 million to 50 million. Further, the global rates of autoimmune diseases are rising by between 3-9 percent each year. Therefore, the increasing incidence of autoimmune diseases across the globe is driving the growth of the autoimmune disease diagnosis market.
Rising healthcare expenditures are anticipated to drive the growth of the autoimmune disease diagnosis market in the coming years. Healthcare expenditure refers to the total funds spent on healthcare products and services. It serves as a key indicator of a population's health and the effectiveness of a healthcare system. Higher healthcare spending enables more timely healthcare services, which contributes to improved detection, treatment, and outcomes for individuals with autoimmune diseases. For example, in May 2024, according to the Office for National Statistics, a UK-based government department, total healthcare expenditure increased by 5.6% in nominal terms from 2022 to 2023, marking a significant acceleration compared to the 0.9% growth observed in 2022. Thus, increasing healthcare expenditures are fueling the autoimmune disease diagnosis market.
Major companies in the autoimmune disease diagnosis market are concentrating on developing technological innovations, such as multiplex autoantibody assay platforms, to enable comprehensive, early, and precise detection of autoimmune disorders, thereby enhancing diagnostic accuracy and patient management. A multiplex autoantibody assay platform allows the simultaneous detection of multiple disease-specific autoantibodies in a single patient sample, improving sensitivity and specificity compared to traditional single-analyte ELISA or immunofluorescence tests, while also reducing sample volume and turnaround time. For example, in January 2025, Exagen Inc., a U.S.-based diagnostics company, introduced its AVISE CTD platform with new systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) biomarker assays. The platform identifies novel biomarkers such as TIgG, TIgM, and TC4d, enabling clinicians to more accurately differentiate overlapping autoimmune conditions and streamline patient diagnosis, while integrating smoothly with existing testing workflows.
Major companies operating in the autoimmune disease diagnosis market are Siemens Healthineers AG, Abbott Laboratories, Thermo Fisher Scientific Inc, Bio-Rad Laboratories Inc, F. Hoffmann-La Roche Ltd, Danaher Corporation, AESKU Diagnostics GmbH & Co. KG, Trinity Biotech plc, bioMérieux SA, SQI Diagnostics, Philips Healthcare India, Agappe Diagnostics Ltd, Lepu Medical Technology Company (Beijing) Co., Ltd, Shanghai Runda Medical Technology Co., Ltd, GE Healthcare China Co., Ltd, Roche Holding AG, Koninklijke Philips, Theradiag, Becton Dickinson and Company, Ortho Clinical Diagnostics.
North America was the largest region in the autoimmune disease diagnosis market in 2025. Western Europe was the second largest region in the autoimmune disease diagnosis market share. The regions covered in the autoimmune disease diagnosis market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the autoimmune disease diagnosis market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
Tariffs are influencing the autoimmune disease diagnosis market by increasing costs of imported assay kits, reagents, diagnostic instruments, and laboratory automation equipment used in immunological testing. Clinical laboratories and hospitals in North America and Europe are most affected due to dependence on imported consumables, while Asia-Pacific faces higher costs for diagnostic infrastructure expansion. These tariffs are raising test prices and slowing laboratory upgrades. However, they are also encouraging domestic production of diagnostic kits, regional reagent manufacturing, and localized development of testing platforms.
The autoimmune disease diagnosis market research report is one of a series of new reports that provides autoimmune disease diagnosis market statistics, including autoimmune disease diagnosis industry global market size, regional shares, competitors with a autoimmune disease diagnosis market share, detailed autoimmune disease diagnosis market segments, market trends and opportunities, and any further data you may need to thrive in the autoimmune disease diagnosis industry. This autoimmune disease diagnosis market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
Autoimmune disease diagnosis involves identifying conditions in which the body produces antibodies that attack and destroy its own healthy cells. These conditions include Crohn's disease, rheumatoid arthritis, Hashimoto’s disease, multiple sclerosis, Grave’s disease, psoriasis, coeliac disease, type 1 diabetes, lupus, and inflammatory bowel syndrome, and are detected through immunological tests.
The primary test types for diagnosing autoimmune diseases include routine laboratory tests, autoantibody tests, immunologic tests, and other tests. Autoantibody tests help support the diagnosis of autoimmune diseases. The available products consist of consumables and assay kits, as well as instruments, and they are utilized by various sectors such as clinical laboratories, hospitals, and others.
The autoimmune disease diagnosis market includes revenue earned by diagnostic assay kits, reagents, consumables, and instruments used for the diagnosis of autoimmune diseases. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
This product will be delivered within 1-3 business days.
Table of Contents
1. Executive Summary
2. Autoimmune Disease Diagnosis Market Characteristics
3. Autoimmune Disease Diagnosis Market Supply Chain Analysis
4. Global Autoimmune Disease Diagnosis Market Trends and Strategies
5. Autoimmune Disease Diagnosis Market Analysis of End Use Industries
7. Global Autoimmune Disease Diagnosis Strategic Analysis Framework, Current Market Size, Market Comparisons and Growth Rate Analysis
8. Global Autoimmune Disease Diagnosis Total Addressable Market (TAM) Analysis for the Market
9. Autoimmune Disease Diagnosis Market Segmentation
10. Autoimmune Disease Diagnosis Market Regional and Country Analysis
11. Asia-Pacific Autoimmune Disease Diagnosis Market
12. China Autoimmune Disease Diagnosis Market
13. India Autoimmune Disease Diagnosis Market
14. Japan Autoimmune Disease Diagnosis Market
15. Australia Autoimmune Disease Diagnosis Market
16. Indonesia Autoimmune Disease Diagnosis Market
17. South Korea Autoimmune Disease Diagnosis Market
18. Taiwan Autoimmune Disease Diagnosis Market
19. South East Asia Autoimmune Disease Diagnosis Market
20. Western Europe Autoimmune Disease Diagnosis Market
21. UK Autoimmune Disease Diagnosis Market
22. Germany Autoimmune Disease Diagnosis Market
23. France Autoimmune Disease Diagnosis Market
24. Italy Autoimmune Disease Diagnosis Market
25. Spain Autoimmune Disease Diagnosis Market
26. Eastern Europe Autoimmune Disease Diagnosis Market
27. Russia Autoimmune Disease Diagnosis Market
28. North America Autoimmune Disease Diagnosis Market
29. USA Autoimmune Disease Diagnosis Market
30. Canada Autoimmune Disease Diagnosis Market
31. South America Autoimmune Disease Diagnosis Market
32. Brazil Autoimmune Disease Diagnosis Market
33. Middle East Autoimmune Disease Diagnosis Market
34. Africa Autoimmune Disease Diagnosis Market
36. Autoimmune Disease Diagnosis Market Competitive Landscape and Company Profiles
37. Autoimmune Disease Diagnosis Market Other Major and Innovative Companies
40. Autoimmune Disease Diagnosis Market High Potential Countries, Segments and Strategies
41. Appendix
Executive Summary
Autoimmune Disease Diagnosis Market Global Report 2026 provides strategists, marketers and senior management with the critical information they need to assess the market.This report focuses autoimmune disease diagnosis market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
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Description
Where is the largest and fastest growing market for autoimmune disease diagnosis? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The autoimmune disease diagnosis market global report answers all these questions and many more.The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
- The market characteristics section of the report defines and explains the market. This section also examines key products and services offered in the market, evaluates brand-level differentiation, compares product features, and highlights major innovation and product development trends.
- The supply chain analysis section provides an overview of the entire value chain, including key raw materials, resources, and supplier analysis. It also provides a list competitor at each level of the supply chain.
- The updated trends and strategies section analyses the shape of the market as it evolves and highlights emerging technology trends such as digital transformation, automation, sustainability initiatives, and AI-driven innovation. It suggests how companies can leverage these advancements to strengthen their market position and achieve competitive differentiation.
- The regulatory and investment landscape section provides an overview of the key regulatory frameworks, regularity bodies, associations, and government policies influencing the market. It also examines major investment flows, incentives, and funding trends shaping industry growth and innovation.
- The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
- The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.
- The total addressable market (TAM) analysis section defines and estimates the market potential compares it with the current market size, and provides strategic insights and growth opportunities based on this evaluation.
- The market attractiveness scoring section evaluates the market based on a quantitative scoring framework that considers growth potential, competitive dynamics, strategic fit, and risk profile. It also provides interpretive insights and strategic implications for decision-makers.
- Market segmentations break down the market into sub markets.
- The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth.
- Expanded geographical coverage includes Taiwan and Southeast Asia, reflecting recent supply chain realignments and manufacturing shifts in the region. This section analyzes how these markets are becoming increasingly important hubs in the global value chain.
- The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
- The company scoring matrix section evaluates and ranks leading companies based on a multi-parameter framework that includes market share or revenues, product innovation, and brand recognition.
Report Scope
Markets Covered:
1) By Product: Consumables And Assay Kits; Instruments2) By Test Type: Routine Laboratory Tests; Autoantibodies Tests; Immunologic Tests; Other Tests
3) By End User: Clinical Laboratories; Hospitals; Other End Users
Subsegments:
1) By Consumables And Assay Kits: ELISA Kits; Reagents And Test Kits; Sample Collection And Preservation Devices; Control And Calibration Materials2) By Instruments: Immunoassay Analyzers; Flow Cytometers; Luminometers; Microscopes
Companies Mentioned: Siemens Healthineers AG; Abbott Laboratories; Thermo Fisher Scientific Inc; Bio-Rad Laboratories Inc; F. Hoffmann-La Roche Ltd; Danaher Corporation; AESKU Diagnostics GmbH & Co. KG; Trinity Biotech plc; bioMérieux SA; SQI Diagnostics; Philips Healthcare India; Agappe Diagnostics Ltd; Lepu Medical Technology Company (Beijing) Co., Ltd; Shanghai Runda Medical Technology Co., Ltd; GE Healthcare China Co., Ltd; Roche Holding AG; Koninklijke Philips; Theradiag; Becton Dickinson and Company; Ortho Clinical Diagnostics
Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Taiwan; Russia; South Korea; UK; USA; Canada; Italy; Spain.
Regions: Asia-Pacific; South East Asia; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
Time Series: Five years historic and ten years forecast.
Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita.
Data Segmentation: Country and regional historic and forecast data, market share of competitors, market segments.
Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
Delivery Format: Word, PDF or Interactive Report + Excel Dashboard
Added Benefits:
- Bi-Annual Data Update
- Customisation
- Expert Consultant Support
Companies Mentioned
The companies featured in this Autoimmune Disease Diagnosis market report include:- Siemens Healthineers AG
- Abbott Laboratories
- Thermo Fisher Scientific Inc
- Bio-Rad Laboratories Inc
- F. Hoffmann-La Roche Ltd
- Danaher Corporation
- AESKU Diagnostics GmbH & Co. KG
- Trinity Biotech plc
- bioMérieux SA
- SQI Diagnostics
- Philips Healthcare India
- Agappe Diagnostics Ltd
- Lepu Medical Technology Company (Beijing) Co., Ltd
- Shanghai Runda Medical Technology Co., Ltd
- GE Healthcare China Co., Ltd
- Roche Holding AG
- Koninklijke Philips
- Theradiag
- Becton Dickinson and Company
- Ortho Clinical Diagnostics
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 250 |
| Published | February 2026 |
| Forecast Period | 2026 - 2030 |
| Estimated Market Value ( USD | $ 6.74 Billion |
| Forecasted Market Value ( USD | $ 9.38 Billion |
| Compound Annual Growth Rate | 8.6% |
| Regions Covered | Global |
| No. of Companies Mentioned | 21 |
