Dublin, July 29, 2025 (GLOBE NEWSWIRE) -- The "North America Autoimmune Disease Diagnostics Market Size and Share Analysis - Growth Trends and Forecast Report 2025-2033" report has been added to ResearchAndMarkets.com's offering.
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. 
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.
Key Players Analysis: Overview, Key Persons, Recent Developments, Revenue
- Bio-Rad Laboratories
- Abbott Laboratories
- Roche Diagnostics
- Quest Diagnostics Incorporated
- Thermo Fisher Scientific Inc.
- BioMerieux SA
- Myriad Genetics, Inc.
- Siemens Healthineers
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 200 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value (USD) in 2024 | $1.96 Billion |
| Forecasted Market Value (USD) by 2033 | $3.5 Billion |
| Compound Annual Growth Rate | 6.6% |
| Regions Covered | North America |
Key Topics Covered:
1. Introduction
2. Research & Methodology
2.1 Data Source
2.1.1 Primary Sources
2.1.2 Secondary Sources
2.2 Research Approach
2.2.1 Top-Down Approach
2.2.2 Bottom-Up Approach
2.3 Forecast Projection Methodology
3. Executive Summary
4. Market Dynamics
4.1 Growth Drivers
4.2 Challenges
5. North America Autoimmune Disease Diagnostics Market
5.1 Historical Market Trends
5.2 Market Forecast
6. Market Share
6.1 By Product
6.2 By Type
6.3 By Indication
6.4 By End Users
6.5 By Country
7. Product
7.1 Therapeutic & Monitoring Equipment
7.2 Diagnostics Equipment
7.3 Drugs
8. Type
8.1 Systemic
8.2 Localized
9. Indication
9.1 Rheumatic Disease
9.2 Diabetes
9.3 Multiple Sclerosis
9.4 Inflammatory Bowel Disease
9.5 Others
10. End Users
10.1 Hospitals
10.2 Diagnostics Centers
10.3 Others
11. Countries
11.1 United States
11.2 Canada
11.3 Mexico
11.4 Rest of North America
12. Porter's Five Forces Analysis
12.1 Bargaining Power of Buyers
12.2 Bargaining Power of Suppliers
12.3 Degree of Rivalry
12.4 Threat of New Entrants
12.5 Threat of Substitutes
13. SWOT Analysis
13.1 Strength
13.2 Weakness
13.3 Opportunity
13.4 Threat
14. Key Players Analysis
For more information about this report visit https://www.researchandmarkets.com/r/t34qyj
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