The North America Autoimmune Disease Diagnostics Market accounted for USD 1.96 billion in 2024 and is expected to grow to USD 3.5 billion by 2033 at a CAGR of 6.66% during the forecast period 2025-2033. The growth is attributed to an increase in autoimmune disease cases, awareness, the development of new diagnostic technologies, and the increase in healthcare spending in the region.
In North America, autoimmune disease diagnosis is becoming increasingly popular because of increased prevalence among women and geriatric populations. Advances in technology - autoantibody assays, enzyme-linked immunosorbent assays (ELISA), and next-generation sequencing - are improving the accuracy and efficiency of diagnosis. In addition, increased public awareness and access to healthcare and an emphasis on personalized medicine are promoting routine and early screening. Hospitals, diagnostic centers, and specialty clinics are increasingly spending on sophisticated diagnostic platforms to cater to increasing demand, and thus this segment forms a critical part of the regional healthcare landscape.
North America Autoimmune Disease Diagnostics Market Outlook
Autoimmune disease testing entails a series of laboratory assays and imaging techniques utilized to detect and track illnesses wherein the body's immune system reacts against the body's own tissue. Common diseases of autoimmunity encompass rheumatoid arthritis, lupus, multiple sclerosis, and type 1 diabetes. Tests have an integral part to play in early disease identification, proper classification of diseases, and drug monitoring, with enhancement of outcomes for patients as well as an overall quality of life.In North America, autoimmune disease diagnosis is becoming increasingly popular because of increased prevalence among women and geriatric populations. Advances in technology - autoantibody assays, enzyme-linked immunosorbent assays (ELISA), and next-generation sequencing - are improving the accuracy and efficiency of diagnosis. In addition, increased public awareness and access to healthcare and an emphasis on personalized medicine are promoting routine and early screening. Hospitals, diagnostic centers, and specialty clinics are increasingly spending on sophisticated diagnostic platforms to cater to increasing demand, and thus this segment forms a critical part of the regional healthcare landscape.
Growth Drivers in the North America Autoimmune Disease Diagnostics Market
Increased Prevalence of Autoimmune Diseases
North America has experienced a consistent rise in autoimmune conditions like rheumatoid arthritis, lupus, and type 1 diabetes. Sedentary lifestyles, environmental factors, and genetic factors are the reasons for this trend. This boom fuels demand for prompt and precise diagnostics. Medical professionals are giving precedence to early detection in order to treat chronic autoimmune diseases, increasing the use of sophisticated diagnostic tests and playing a significant role in propelling market growth. The incidence of celiac disease in the U.S. has increased five times over the last 30 years, doubling every 15 years or so.Advancements in Diagnostic Technologies
Advances in molecular diagnostics, biomarker discovery, and next-generation sequencing have transformed autoimmune disease detection. These technologies enable faster, more precise results and allow clinicians to customize treatment. North American diagnostic firms and research institutions keep pouring money into R&D, increasing access to diagnostics. Increased sensitivity and specificity of diagnostic tests are driving adoption in clinical as well as research environments. Biocon Biologics on Monday announced that it has introduced a biosimilar medicine for the treatment of some autoimmune conditions, in the US market. Feb 2025, YESINTEK (ustekinumab-kfce), indicated for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, is available in the US.Well-Established Healthcare Infrastructure and Reimbursement Policies
North America has a solid healthcare infrastructure with well-established diagnostic labs and specialist clinics. Beneficial reimbursement arrangements by public and private payers motivate patients to seek testing without substantial economic costs. Such an environment fosters early diagnosis and monitoring of disease, as well as fueling demand for autoimmune diagnostics further. Moreover, augmented government funding for chronic disease management supports market growth. April 2025, The U.S. approved a 5.06% average hike in reimbursement rates for 2026 Medicare Advantage plans operated by private insurers, well above the January proposal. This rate impacts monthly premiums, plan benefits, and insurer profits for insurers administering healthcare to individuals 65 and older or disabled.Challenges in the North America Autoimmune Disease Diagnostics Market
High Cost of Advanced Diagnostic Tests
Though advanced technologies improve diagnostic accuracy, they are expensive. The expense of laboratory infrastructure, trained staff, and sophisticated tests can be a burden to healthcare systems and patients. Affordability is still a limitation for uninsured or underinsured individuals. Rural healthcare providers with limited resources may not be able to provide advanced autoimmune testing, restricting access and hindering overall market penetration.Diagnostic Complexity and Disease Overlap
Autoimmune disorders tend to have non-specific symptoms, hence differential diagnosis is challenging. Symptom overlap between different autoimmune and non-autoimmune disorders leads to misdiagnosis or delayed diagnosis. In addition, most diagnostic biomarkers are not disease specific. These limitations make treatment planning and patient outcome more challenging. Overcoming this challenge involves increased R&D in biomarker discovery and physician education to improve diagnostic accuracy.North America Autoimmune Disease Therapeutic & Monitoring Market
The North American autoimmune disease therapy and monitoring market is increasing with an expanding patient population and increased focus on disease control. Treatment with biologic drugs and immunosuppressants is common, requiring regular monitoring. This segment gains through models of integrated care in which diagnostics, therapeutics, and patient monitoring intersect. Remote monitoring technologies and mobile health platforms are further streamlining disease management.North America Systemic Autoimmune Disease Diagnostics Market
Systemic autoimmune diseases such as systemic lupus erythematosus and multiple sclerosis demand extensive diagnostic strategies. Enhancements in awareness and early screening programs in North America have supported this market. Blood tests, autoantibody testing, and imaging studies are routine practices. Government sponsorship and academic research in systemic disease study also encourage diagnostic inventions, making patient assessment quicker and more precise.North America Localized Autoimmune Disease Diagnostics Market
Localized autoimmune diseases, including psoriasis and Hashimoto's thyroiditis, are diagnosed using tissue biopsies, hormone tests, and clinical evaluation. The North American market is helped by robust dermatology and endocrinology networks that facilitate targeted diagnostics. Increased consumer awareness and demand for specialty clinics propel this segment. Pharmaceutical firms also work with diagnostic laboratories to create companion diagnostics for localized autoimmune therapies.North America Diabetes Autoimmune Disease Diagnostics Market
Type 1 diabetes, an autoimmune type of diabetes, is on the increase among children and young adults in North America. Autoantibody diagnostic testing, insulin production, and glucose monitoring are essential. Early diagnosis avoids complications and facilitates timely insulin therapy. Public health campaigns, school health programs, and pediatric screening programs are driving market growth in this segment, especially in the United States.North America Autoimmune Rheumatic Disease Diagnostics Market
Rheumatic conditions, such as rheumatoid arthritis and scleroderma, are prevalent in North America. Diagnostic equipment like rheumatoid factor (RF), anti-CCP tests, and imaging scans is an integral part of identifying the disease. Such an exercise has a strong support base in the form of established networks of rheumatology clinics. Public awareness campaigns, patient advocacy groups, and clinical trials further drive demand for early and precise diagnostics.North America Autoimmune Disease Diagnostics Hospitals Market
Hospitals continue to be the main sites for autoimmune disease diagnosis in North America. With sophisticated laboratories, trained staff, and integrated facilities, hospitals provide complete diagnostic panels. Most are associated with research centers, providing access to clinical trials and experimental diagnostics. Since chronic autoimmune diseases need long-term management, hospital-based services are key to early detection, monitoring, and multidisciplinary care coordination.United States Autoimmune Disease Diagnostics Market
Based on the University of Oxford's study released in May 2023, autoimmune disorders impact 1 out of every 10 individuals among the population of 22 million people. Autoimmune disorders such as type 1 diabetes have enrolled to be occurring more than ever before during the recent years. The U.S. dominates the North American autoimmune disease diagnostic market because of its well-developed healthcare system and high rate of disease incidence. Public and private investments in R&D in diagnostics are substantial. Patient education, robust reimbursement policies, and the availability of large diagnostic companies like Quest Diagnostics and LabCorp fuel growth. Growth of telehealth services and preventive care programs also supports development of the market. February 2023, Venture Capital firm CerraCap Ventures made a strategic investment in early-stage startup Predicta Med, which is a leading early-stage startup that provides services in helping medical institutions and clinics in the early detection and management of immune-related disorders.Canada Autoimmune Disease Diagnostics Market
The autoimmune diagnostics market in Canada is spurred by the availability of universal coverage for healthcare, guaranteeing access to necessary diagnostic services. The nation has a well-established laboratory network and cooperative research environment. Increased incidence of autoimmune diseases and heightened public health interest in early diagnosis drive market opportunities. Encouragement of healthcare innovation by government as well as patient education also drive the use of cutting-edge diagnostics. Apr 2025, Augurex Life Sciences Corp. reported that Health Canada has authorized SPINEstat™, a first-in-class blood test for axial spondyloarthritis, as a Class II medical device.Mexico Autoimmune Disease Diagnostics Market
Mexico's autoimmune disease diagnostic market is expanding steadily because of rising awareness and access to healthcare services. Although rural areas continue to have challenges, urban hospitals and diagnostic laboratories are implementing more sophisticated technologies. Government healthcare reforms and international collaborations are enhancing diagnostic capacity. Initiatives to extend universal healthcare coverage and address chronic disease burdens will be likely to enhance future market growth.North America Autoimmune Disease Diagnostics Market Segment
Product
- Therapeutic & Monitoring Equipment
- Diagnostics Equipment
- Drugs
Type
- Systemic
- Localized
Indication
- Rheumatic Disease
- Diabetes
- Multiple Sclerosis
- Inflammatory Bowel Disease
- Others
End Users
- Hospitals
- Diagnostics Centers
- Others
Countries
- United States
- Canada
- Mexico
- Rest of North America
The key players have been analyzed by:
- Overviews
- Key Persons
- Recent Developments
- Revenue
Key Players Analysis
- Bio-Rad Laboratories
- Abbott Laboratories
- Roche Diagnostics
- Quest Diagnostics Incorporated
- Thermo Fisher Scientific Inc.
- BioMerieux SA
- Myriad Genetics, Inc.
- Siemens Healthineers
Table of Contents
1. Introduction3. Executive Summary
2. Research & Methodology
4. Market Dynamics
5. North America Autoimmune Disease Diagnostics Market
6. Market Share
7. Product
8. Type
9. Indication
10. End Users
11. Countries
12. Porter’s Five Forces Analysis
13. SWOT Analysis
14. Key Players Analysis
Companies Mentioned
- Bio-Rad Laboratories
- Abbott Laboratories
- Roche Diagnostics
- Quest Diagnostics Incorporated
- Thermo Fisher Scientific Inc.
- BioMerieux SA
- Myriad Genetics, Inc.
- Siemens Healthineers
Methodology
In this report, for analyzing the future trends for the studied market during the forecast period, the publisher has incorporated rigorous statistical and econometric methods, further scrutinized by secondary, primary sources and by in-house experts, supported through their extensive data intelligence repository. The market is studied holistically from both demand and supply-side perspectives. This is carried out to analyze both end-user and producer behavior patterns, in the review period, which affects price, demand and consumption trends. As the study demands to analyze the long-term nature of the market, the identification of factors influencing the market is based on the fundamentality of the study market.
Through secondary and primary researches, which largely include interviews with industry participants, reliable statistics, and regional intelligence, are identified and are transformed to quantitative data through data extraction, and further applied for inferential purposes. The publisher's in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. These analytical tools and models sanitize the data & statistics and enhance the accuracy of their recommendations and advice.
Primary Research
The primary purpose of this phase is to extract qualitative information regarding the market from the key industry leaders. The primary research efforts include reaching out to participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions. The publisher also established professional corporate relations with various companies that allow us greater flexibility for reaching out to industry participants and commentators for interviews and discussions, fulfilling the following functions:
- Validates and improves the data quality and strengthens research proceeds
- Further develop the analyst team’s market understanding and expertise
- Supplies authentic information about market size, share, growth, and forecast
The researcher's primary research interview and discussion panels are typically composed of the most experienced industry members. These participants include, however, are not limited to:
- Chief executives and VPs of leading corporations specific to the industry
- Product and sales managers or country heads; channel partners and top level distributors; banking, investment, and valuation experts
- Key opinion leaders (KOLs)
Secondary Research
The publisher refers to a broad array of industry sources for their secondary research, which typically includes, however, is not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Patent and regulatory databases for understanding of technical & legal developments
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic new articles, webcasts, and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecasts
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | May 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 1.96 Billion |
| Forecasted Market Value ( USD | $ 3.5 Billion |
| Compound Annual Growth Rate | 6.6% |
| Regions Covered | North America |
| No. of Companies Mentioned | 8 |
