The Global Autoimmune Disease Diagnostics Market was valued at USD 5.7 billion in 2024 and is estimated to grow at a CAGR of 6.6% to reach USD 11 billion by 2034.
Rising incidence rates of autoimmune conditions, higher awareness about early diagnosis, ongoing screening programs, and steady advancements in diagnostic technologies are fueling market expansion. Improved healthcare spending and the introduction of innovative tools for early detection have also strengthened the demand for accurate and rapid testing. From molecular assays to immunoassays and biomarker-based detection, diagnostic capabilities are evolving to meet growing clinical needs. Patient education campaigns, led by both governments and healthcare organizations, are significantly raising testing volumes. At the same time, precision diagnostics utilizing specific biomarkers are seeing greater adoption, improving outcomes through early disease detection and patient-specific monitoring. Portable and rapid testing solutions for autoimmune disorders are also gaining popularity, offering quicker results in various care settings and further driving market momentum.
In 2024, the reagents and consumables segment held 67% share owing to their recurring use in autoimmune testing procedures. The constant need for assay kits, antibodies, and buffers across diagnostic applications is contributing to the segment’s consistent growth. As testing becomes more frequent for both diagnosis and long-term disease monitoring, the demand for these materials continues to rise. Laboratories and clinics rely heavily on consumables to perform accurate and efficient diagnostics, creating a steady revenue stream within the segment.
The localized autoimmune disease segment generated USD 4 billion in 2024 and is expected to grow at a CAGR of 6.4% through 2034. This segment includes conditions such as thyroid disorders, inflammatory bowel diseases, and Type 1 diabetes diseases targeting specific organs and increasingly being diagnosed worldwide. The rise in these organ-specific conditions fuels the need for highly sensitive and precise diagnostics tailored to localized disease detection. Continued growth in this area is supported by the need for early intervention and consistent monitoring to avoid long-term complications.
North America Autoimmune Disease Diagnostics Market held 36.6% share in 2024. The region reports one of the highest rates of autoimmune disorders globally, including multiple sclerosis, lupus, rheumatoid arthritis, and Type 1 diabetes. This growing patient population drives significant demand for advanced diagnostic testing. With a strong healthcare infrastructure and widespread screening initiatives, the region continues to support both routine and advanced autoimmune testing. The emphasis on early diagnosis and personalized care further sustains market growth.
Major players active in the Global Autoimmune Disease Diagnostics Market include Euroimmun, Thermo Fisher Scientific, Roche, Quest Diagnostics, Inova Diagnostics (Werfen), DIAsource, Trinity Biotech, Revvity, Labcorp, Siemens Healthineers, GRIFOLS, Hemagen Diagnostics, BIO-RAD, BIOMERIEUX, and Abbott. Companies in the autoimmune disease diagnostics market are expanding their portfolios through strategic collaborations, acquisitions, and investments in advanced technologies. Many are focusing on developing biomarker-based diagnostics and next-generation molecular tools to improve sensitivity and speed. Increased investment in R&D is enabling firms to introduce more precise and user-friendly diagnostic platforms, including point-of-care testing kits. Companies are also prioritizing automation to streamline lab workflows and enhance throughput.
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Rising incidence rates of autoimmune conditions, higher awareness about early diagnosis, ongoing screening programs, and steady advancements in diagnostic technologies are fueling market expansion. Improved healthcare spending and the introduction of innovative tools for early detection have also strengthened the demand for accurate and rapid testing. From molecular assays to immunoassays and biomarker-based detection, diagnostic capabilities are evolving to meet growing clinical needs. Patient education campaigns, led by both governments and healthcare organizations, are significantly raising testing volumes. At the same time, precision diagnostics utilizing specific biomarkers are seeing greater adoption, improving outcomes through early disease detection and patient-specific monitoring. Portable and rapid testing solutions for autoimmune disorders are also gaining popularity, offering quicker results in various care settings and further driving market momentum.
In 2024, the reagents and consumables segment held 67% share owing to their recurring use in autoimmune testing procedures. The constant need for assay kits, antibodies, and buffers across diagnostic applications is contributing to the segment’s consistent growth. As testing becomes more frequent for both diagnosis and long-term disease monitoring, the demand for these materials continues to rise. Laboratories and clinics rely heavily on consumables to perform accurate and efficient diagnostics, creating a steady revenue stream within the segment.
The localized autoimmune disease segment generated USD 4 billion in 2024 and is expected to grow at a CAGR of 6.4% through 2034. This segment includes conditions such as thyroid disorders, inflammatory bowel diseases, and Type 1 diabetes diseases targeting specific organs and increasingly being diagnosed worldwide. The rise in these organ-specific conditions fuels the need for highly sensitive and precise diagnostics tailored to localized disease detection. Continued growth in this area is supported by the need for early intervention and consistent monitoring to avoid long-term complications.
North America Autoimmune Disease Diagnostics Market held 36.6% share in 2024. The region reports one of the highest rates of autoimmune disorders globally, including multiple sclerosis, lupus, rheumatoid arthritis, and Type 1 diabetes. This growing patient population drives significant demand for advanced diagnostic testing. With a strong healthcare infrastructure and widespread screening initiatives, the region continues to support both routine and advanced autoimmune testing. The emphasis on early diagnosis and personalized care further sustains market growth.
Major players active in the Global Autoimmune Disease Diagnostics Market include Euroimmun, Thermo Fisher Scientific, Roche, Quest Diagnostics, Inova Diagnostics (Werfen), DIAsource, Trinity Biotech, Revvity, Labcorp, Siemens Healthineers, GRIFOLS, Hemagen Diagnostics, BIO-RAD, BIOMERIEUX, and Abbott. Companies in the autoimmune disease diagnostics market are expanding their portfolios through strategic collaborations, acquisitions, and investments in advanced technologies. Many are focusing on developing biomarker-based diagnostics and next-generation molecular tools to improve sensitivity and speed. Increased investment in R&D is enabling firms to introduce more precise and user-friendly diagnostic platforms, including point-of-care testing kits. Companies are also prioritizing automation to streamline lab workflows and enhance throughput.
Comprehensive Market Analysis and Forecast
- Industry trends, key growth drivers, challenges, future opportunities, and regulatory landscape
- Competitive landscape with Porter’s Five Forces and PESTEL analysis
- Market size, segmentation, and regional forecasts
- In-depth company profiles, business strategies, financial insights, and SWOT analysis
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Table of Contents
Chapter 1 Methodology and Scope
Chapter 2 Executive Summary
Chapter 3 Industry Insights
Chapter 4 Competitive Landscape, 2024
Chapter 5 Market Estimates and Forecast, by Product, 2021-2034 ($ Mn)
Chapter 6 Market Estimates and Forecast, by Disease Type, 2021-2034 ($ Mn)
Chapter 7 Market Estimates and Forecast, by Test Type, 2021-2034 ($ Mn)
Chapter 8 Market Estimates and Forecast, by End Use, 2021-2034 ($ Mn)
Chapter 9 Market Estimates and Forecast, by Region, 2021-2034 ($ Mn)
Chapter 10 Company Profiles
Companies Mentioned
The companies profiled in this Autoimmune Disease Diagnostics market report include:- Abbott
- BIOMERIEUX
- BIO-RAD
- DIAsource
- Euroimmun
- GRIFOLS
- Hemagen Diagnostics
- Inova Diagnostics (Werfen)
- Labcorp
- Quest Diagnostics
- Revvity
- Roche
- SIEMENS Healthineers
- Thermo Fisher Scientific
- Trinity Biotech
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 145 |
| Published | September 2025 |
| Forecast Period | 2024 - 2034 |
| Estimated Market Value ( USD | $ 5.7 Billion |
| Forecasted Market Value ( USD | $ 11 Billion |
| Compound Annual Growth Rate | 6.6% |
| Regions Covered | Global |
| No. of Companies Mentioned | 16 |
