The "North America Autoimmune Disease Diagnostics Market Size and Share Analysis - Growth Trends and Forecast Report 2025-2033" 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.

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.

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:

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

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