Market Overview
| Study Period | 2020 - 2031 |
|---|---|
| Forecast Data Period | 2026 - 2031 |
| Base Year Market Size (2025) | USD 2.16 Billion |
| Market Size (2026) | USD 2.28 Billion |
| Market Size (2031) | USD 2.97 Billion |
| Growth Rate (2026 - 2031) | 5.47% CAGR |
| Market Concentration | Medium |
Major Players *Disclaimer: Major Players sorted in no particular order Image © Â鶹ÊÓƵ. Reuse requires attribution under CC BY 4.0. | |
North America Autoimmune Disease Diagnostics Market Analysis by Â鶹ÊÓƵ
The North America Autoimmune Disease Diagnostics Market size was valued at USD 2.16 billion in 2025 and estimated to grow from USD 2.28 billion in 2026 to reach USD 2.97 billion by 2031, at a CAGR of 5.47% during the forecast period (2026-2031).
The rising prevalence of autoimmune diseases and growing public awareness of autoimmune disorders are the primary factors driving the market growth. For instance, study data published by the University of Oxford in May 2023 reported that about one in 10 individuals in the United Kingdom was affected by autoimmune disorders in 2022. These autoimmune conditions include 19 diseases, including rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis. It also stated that 10% of the overall population was affected by these autoimmune diseases, a significant percentage. Hence, the high burden of autoimmune diseases is expected to increase the demand for diagnostics, boosting market growth during the forecast period.
Moreover, strategic activities such as product launches by major regional market players are expected to boost market growth, enabling patients to have diversified access to various products. For instance, in March 2024, AMPEL BioSolutions launched LuGENE, a pioneering blood test, in the United States. This test is specifically designed to predict flares in systemic lupus erythematosus (SLE) and provide detailed insights into the unique nuances of each patient's condition. This, in turn, facilitates swifter, evidence-driven treatment, which is expected to be in significant demand over the coming years. Hence, the new product launches will likely drive market growth during the forecast period.
Therefore, the factors above, such as the high prevalence of autoimmune disorders and the new product launches by major market players, are expected to boost market growth. However, the slow turnaround time for autoimmune disease diagnostic test results and the high frequency of false positive results are expected to impede the market growth during the forecast period.
Note: Market size and forecast figures in this report are generated using Â鶹ÊÓƵ’s proprietary estimation framework, updated with the latest available data and insights as of 2026.
North America Autoimmune Disease Diagnostics Market Trends and Insights
The Immunologic Assays Segment is Expected to Hold a Significant Market Share During the Forecast Period
Immunologic reactions are particular, as they can take place only in the presence of proper immunologic agents. Compared to conventional tests, immunologic assays have been proven to provide highly accurate results even with tiny samples. Factors responsible for the segment's growth include cost-effectiveness, the rising prevalence of autoimmune diseases coupled with the increasing geriatric population, growth in the biotechnology and pharmaceutical sectors, and high sensitivity and specificity of immunologic assays.
For instance, according to an article published by BMC in December 2022, immunologic assays such as indirect immunofluorescence assay using human epithelial type-2 cells (HEp-2 IFA) have high sensitivity and represent a commonly used screening assay for antinuclear antibodies, which are associated with many autoimmune diseases such as systemic lupus erythematosus (SLE), primary Sjögren's syndrome (pSS), and systemic sclerosis (SSc). Thus, the high efficiency of immunologic assays for diagnosing autoimmune diseases is expected to boost segment growth.
Also, the rising prevalence of autoimmune diseases is the primary factor driving the segment's growth. For instance, according to an article published by BMJ Journals in October 2022, a study was conducted using the last 20 years' data till 2022, which showed that the estimated pooled prevalence of systemic lupus erythematosus (SLE) was 3.66 in Canada, 6.5 in Mexico, and 12.13 in the United States in 2022. Thus, the high prevalence of autoimmune disorders such as SLE is expected to boost the adoption of immunologic assays in the region.
Moreover, according to the data published by Crohn's and Colitis Canada and Pfizer Canada in November 2022, it was estimated that over 300,000 Canadians were living with inflammatory bowel disease in 2022. This number is expected to rise to 403,000 by 2030, equivalent to 1 in 100 people. Hence, the factors above, such as the rising prevalence of autoimmune disorders and the geriatric population, are expected to increase the demand for immunologic assays, thereby boosting segment growth during the forecast period.
The United States is Expected to Hold a Significant Market Share During the Forecast Period
The United States is expected to hold a significant share of the North American autoimmune disease diagnostics market owing to the increasing developments by major market players in the country. For instance, in April 2022, Quanterix received a breakthrough device designation by the US FDA for the ultra-sensitive blood test that measures a biomarker of nerve damage in people with multiple sclerosis (MS).
Additionally, the high burden of autoimmune diseases likely drives the country's market growth. For instance, according to data updated by the National Institute of Environmental Health Sciences in May 2022, autoimmune diseases are estimated to affect more than 24 million people in the United States. Also, an additional 8 million people are said to have autoantibodies, blood molecules that indicate a person's chance of developing autoimmune disease. Thus, the rising prevalence of autoimmune disorders will boost the country's market growth.
Hence, the factors above, such as the rising prevalence of autoimmune disorders and the increasing research and development on autoimmune diseases, are expected to boost market growth in the United States during the forecast period.
Competitive Landscape
The North American autoimmune disease diagnostics market is fragmented. It comprises several major market players focusing on R&D activities and significant growth strategies. A few diagnostic companies entered into strategic partnerships with hospitals. This trend will continue over the next few years to meet the high patient needs across different regions. Some key North American autoimmune disease diagnostics market players are Abbott Laboratories, µþ¾±´Ç³¾Ã©°ù¾±±ð³Ü³æ, Bio-Rad Laboratories, Euroimmun AG, and Trinity Biotech.
North America Autoimmune Disease Diagnostics Industry Leaders
Abbott Laboratories
µþ¾±´Ç³¾Ã©°ù¾±±ð³Ü³æ
Bio-Rad Laboratories Inc.
Trinity Biotech
Thermo Fisher Scientific
- *Disclaimer: Major Players sorted in no particular order
Market Opportunities and Future Outlook
FDA clearance activity in autoimmune-relevant immunology assays, along with ongoing refreshes of high-throughput analyzer menus, is creating space for manufacturers to expand differentiated autoantibody panels and add workflow automation for routine laboratories. Siemens Healthineers clearances for ADVIA Centaur Anti-Thyroid Peroxidase II (October 2025) and ADVIA Centaur Anti-Thyroglobulin II (December 2025), plus Zeus Scientific clearances for an ANCA test system (May 2025) and the Alegria Flash SSA-60 assay for SSA-52 autoantibodies (May 2026), support broader test-menu coverage across thyroid autoimmunity, vasculitis-related markers, and Sjogren syndrome-related antibodies. That direction aligns with provider needs for faster, more standardized screening and reflex testing.
Technology and research priorities also point to opportunities in multiplexed and digitally assisted interpretation. Because autoimmune conditions span multiple organ systems and can overlap clinically, the NIH-Wide Strategic Plan for Autoimmune Disease Research (FY 2026-2030) emphasizes building research infrastructure and leveraging new technologies, which can feed into more clinically validated biomarkers and data assets for assay development and algorithm-assisted phenotype discrimination. At the same time, academic and applied innovation in biosensors and miniaturized platforms supports alternatives that can reduce turnaround-time constraints versus centralized testing, with manufacturers and health systems assessing where rapid, near-patient testing can complement core-lab immunologic assays and antibody testing.
Recent Industry Developments
- June 2026: bioMerieux submitted a Dual 510(k)/CLIA Waiver application to the US FDA for the BIOFIRE SPOTFIRE Vaginitis Panel intended for point-of-care testing. The submission supports the company's effort to extend rapid, decentralized testing on the SPOTFIRE platform, which is aimed at broader adoption of near-patient molecular workflows in North American care settings.
- January 2025: bioMerieux announced an agreement to acquire SpinChip Diagnostics ASA for a total enterprise value of EUR 138 million to strengthen its point-of-care immunoassay presence. The acquisition would expand access to immunoassay POC capabilities that can complement laboratory-based autoimmune testing pathways where rapid rule-in or rule-out decisions are clinically valuable.
- May 2024: Mayo Clinic Laboratories and Progentec Diagnostics launched systemic lupus erythematosus advanced biomarker testing services, including the DX Lupus Disease Activity Index and the DX Lupus Flare Risk Index, for Mayo Clinic Laboratories clients. The expanded services broadened availability of specialized SLE biomarker testing and support more granular disease monitoring and risk stratification within established reference-lab channels.
Research Methodology Framework and Report Scope
Market Definition and Coverage
This market counts the revenue generated from diagnostic testing used to identify and support the clinical workup of autoimmune diseases across North America. It includes common lab-based approaches like antibody tests, immunologic assays, inflammatory markers, and other routine laboratory tests that are ordered and processed in the region.
Scope exclusions: We exclude treatment drugs and long term disease management equipment, and we also exclude pure research-only testing that is not used for routine patient diagnosis.
Segmentation Overview
- By Disease Type
- Systemic Autoimmune Disease
- Rheumatoid Arthritis
- Psoriasis
- Systemic Lupus Erythematosus (SLE)
- Multiple Sclerosis
- Other Disease Types
- Localized Autoimmune Disease
- Inflammatory Bowel disease
- Type 1 Diabetes
- Thyroid
- Other Localized Autoimmune Diseases
- Systemic Autoimmune Disease
- By Diagnostic Test
- Regular Laboratory Tests
- Inflammatory Markers
- Immunologic Assays
- Antibody Tests
- Other Tests
- Geography
- United States
- Canada
- Mexico
Data Sources, Market Sizing, and Validation
Desk Research
Desk work started with building the demand context, so the model is anchored to how many autoimmune related tests can realistically be ordered and processed in the United States, Canada, and Mexico. For that, we relied on public health statistics and clinical guidance signals, such as CDC data for autoimmune linked conditions where applicable, NIH and PubMed literature on testing pathways, and health system publications that describe diagnostic workups.
To connect demand to spend, we reviewed test menus and reimbursement references where available, plus trade and customs disclosures for relevant diagnostic inputs when they were helpful as a direction check. We also used company filings, investor presentations, and trusted press to understand portfolio mix changes and platform adoption, and then supplemented gaps using paid subscriptions for company financials and patent databases. These sources are illustrative only, and many other references were used during data collection, validation, and research clarification.
Primary Interviews and Surveys
Primary work was used to pressure test the desk assumptions on testing mix and price ranges, and then to confirm what really drives ordering volumes by setting and by disease group. We spoke with a mix of diagnostic laboratory stakeholders, hospital lab leaders, and commercial teams, and the feedback was balanced across North America so differences in payer behavior and lab workflows could be captured.
Distribution of primary research fieldwork respondents
| Company type | Respondent position | Region |
|---|---|---|
| Top tier: 27% | CXOs: 17% | |
| Mid tier: 55% | Functional/Unit leaders: 29% | |
| Smaller Players: 18% | Managers: 54% |
Market-Sizing & Forecasting
Sizing was built using a top-down approach where diagnostic demand pools are reconstructed from disease prevalence signals, expected testing rates along typical workups, and how those tests split across immunologic assays, antibody tests, inflammatory markers, and routine lab tests, which are then converted into spend using practical price bands. To make sure the total stays realistic, results were cross-checked with selective bottom-up approximations such as sampled test volume times average selling price by test family, plus high level supplier revenue roll ups where public disclosures made it feasible.
Inputs that mattered most included autoimmune disease prevalence and incidence trends, test utilization patterns by disease category (systemic versus localized), shifts toward earlier screening and reflex testing, lab capacity and turnaround expectations that influence repeat testing, and pricing behavior affected by reimbursement changes and panel bundling. When bottom-up signals were patchy, gaps were filled by applying conservative penetration and replacement assumptions that were validated in interviews, and then back tested against historical growth. Forecasting leaned on scenario analysis with a light multivariate regression overlay, using drivers like diagnosed patient pool growth, testing intensity per patient, and expected price movement by test group.
Data Validation & Update Cycle
Outputs were checked in multiple steps so totals and growth rates align with external signals such as diagnostic testing utilization trends, lab service activity indicators, and announced pricing or reimbursement moves. Variance checks were run at the country level and by major test categories, and any sharp jumps were traced back to the specific driver that caused them before sign-off.
If an assumption looked sensitive, experts were re-contacted to confirm whether the change was real or just a data artifact, and then the model was adjusted with clear notes. Reports are refreshed annually, and interim updates are done when a material event shifts testing behavior, pricing, or clinical practice. Right before delivery, a final review pass is completed so clients receive the latest updated view.
Â鶹ÊÓƵ's North America Autoimmune Diagnostics Market Market Size Versus Other Published Estimates
Published sizes for North America autoimmune diagnostics can differ even when they sound similar, mainly because the counting rules for what sits inside the market are not always the same. Differences also come from how each publisher treats pricing, currency timing, and how quickly assumptions are refreshed after guideline or reimbursement changes.
The main gap comes from whether adjacent categories are added on top of diagnostic testing, where Â鶹ÊÓƵ counts only diagnostic test revenues (for example, immunologic assays and antibody tests) and leaves out drugs and broader monitoring equipment that some sources blend into the same label.
Benchmark comparison
| Source | Market Size | Gaps in Research Methodology |
|---|---|---|
| Â鶹ÊÓƵ | USD 2.16 B (2025) | |
| Industry Publisher A | USD 2.05 B (2024) | Uses a different base year and mixes in end user setting assumptions that can shift price bands, and the update timing can lag reimbursement driven pricing changes. |
| Industry Publisher B | USD 1.96 B (2024) | Includes a wider basket that appears to group diagnostics with therapeutic and monitoring equipment and drugs, which can change what is counted and how revenues are allocated. |
Across the table, the spread is mostly explained by scope and base-year differences, followed by how pricing is handled for bundled panels versus individual tests. By keeping the inputs tied to test utilization and realistic price bands, and then validating them with interviews, the final number stays traceable and easier to reproduce when assumptions are revisited.
Key Questions Answered in the Report
How big is the North America Autoimmune Disease Diagnostics Market?
The North America Autoimmune Disease Diagnostics Market size is expected to reach USD 2.28 billion in 2026 and grow at a CAGR of 5.47% to reach USD 2.97 billion by 2031.
What is the current North America Autoimmune Disease Diagnostics Market size?
In 2026, the North America Autoimmune Disease Diagnostics Market size is expected to reach USD 2.28 billion.
Who are the key players in North America Autoimmune Disease Diagnostics Market?
Abbott Laboratories, µþ¾±´Ç³¾Ã©°ù¾±±ð³Ü³æ, Bio-Rad Laboratories Inc., Trinity Biotech and Thermo Fisher Scientific are the major companies operating in the North America Autoimmune Disease Diagnostics Market.
What years does this North America Autoimmune Disease Diagnostics Market cover, and what was the market size in 2025?
In 2025, the North America Autoimmune Disease Diagnostics Market size was estimated at USD 2.28 billion. The report covers the North America Autoimmune Disease Diagnostics Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the North America Autoimmune Disease Diagnostics Market size for years: 2026, 2027, 2028, 2029, 2030 and 2031.
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