North America Autoimmune Disease Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The North America Autoimmune Disease Diagnostics Market is segmented by Disease Type, Diagnosis Tests (Regular Laboratory Tests, Inflammatory Markers, Immunologic Assays, Antibody Tests, and other Tests), and Geography.

Market Snapshot

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Study Period: 2018 - 2026
Base Year: 2021
CAGR: 8.6 %

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Market Overview

The North America Autoimmune Disease Diagnostics Market is expected to register a CAGR of 8.6% during the forecast period. The rising awareness about autoimmune diseases through programs of research, education, support, and advocacy is a key factor boosting the usage rates of autoimmune disease diagnostics market in North America. The United States has the highest incidence of autoimmune diseases, where about 50 million patients suffer from autoimmune diseases. In 2017, according to the National Institutes of Health (NIH) estimates, approximately more than 23.5 million Americans live with an autoimmune disease, and its prevalence is on the rise. On the other hand, AARDA says that about 50 million Americans live with an autoimmune disease (*The NIH only includes 24 diseases for which they had epidemiology studies they considered appropriate available).

The American Autoimmune Related Diseases Association (AARDA) and other organizations aim to increase awareness about the socioeconomic impact of autoimmunity, through fostering and facilitating collaboration in the areas of education, public awareness, research, and patient services in an effective, ethical, and efficient manner. The other factors, such as improved laboratory automation, partnerships with physicians and clinical laboratories, technological advancements, and expansion in coverage allowed by the Patient Protection and Affordable Care Act are driving the market. However, the slow turn around time of the diagnosis and high frequency of false positive are hindering the market.

Scope of the Report

As per scope of the report, autoimmunity involves the loss of normal immune homeostasis, as the organism produces an abnormal response to its own tissue. Autoimmune diseases generally involve the presence of self-reactive T cells, autoantibodies, and inflammation. Diagnosis of potential autoimmune diseases is very difficult, because not one laboratory test alone can produce diagnosis results for the disease. The diagnosis can be useful in the management of patients suffering from autoimmune diseases and help in providing a prognosis or indicating the severity of organ involvement or damage. The North America autoimmune disease diagnostics market is segmented by by disease type, diagnosis, and geography.

Disease Type
Systemic Autoimmune Disease
Rheumatoid Arthritis
Systemic Lupus Erythematosus (SLE)
Multiple Sclerosis
Other Disease Types
Localized Autoimmune Disease
Inflammatory Bowel disease
Type 1 Diabetes
Other Localized Autoimmune Diseases
Diagnostic Test
Regular Laboratory Tests
Inflammatory Markers
Immunologic Assays
Antibody Tests
Other Tests
North America
United States

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Key Market Trends

Immunologic Assays Segment is Expected to Hold a Major Market Share in the North America Autoimmune Disease Diagnostics Market

The immunologic assays segment is expected to register a healthy CAGR, over the forecast period. Factors that are responsible for the growth of this market include cost-effectiveness, growth in the biotechnology and pharmaceutical sectors, and high sensitivity and specificity of immunoassays. Compared to conventional tests, immunoassays have been proven to provide highly accurate results even with very small samples. 

Immunologic reactions are highly specific, as they can take place only in the presence of proper immunologic agents. For instance, an antibody against a viral protein cannot bind with an antigen that is derived from bacteria. This high specificity indicates high accuracy in results, which enable high sensitivity in the detection of diseases. This high sensitivity not only helps in easy detection but also eliminates the need for secondary verifications, which ultimately saves a lot of costs. For instance, in December 2018, Quidel received a CE mark approval for its product Quidel’s Sofia 2 Lyme+ FIA, which is to be used with Sofia 2 Fluorescent Immunoassay Analyzer.

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Competitive Landscape

The North America Autoimmune Disease Diagnostics Market is competitive. The market comprises of major market players, who are focusing on R&D activities and significant growth strategies. Recently, few diagnostic companies entered into strategic partnerships with hospitals. This trend is expected to continue over the next few years, to meet the high volume of patient needs across different regions. 

In July 2017, AARDA, in partnership with the Relapsing Polychondritis Awareness and Support Foundation (RPASF), hosted the first Bowling Green Autoimmune Walk and Warriors 5K Fun Run, to raise awareness and funding for innovative research. 

In August 2017, Thermo Fisher Scientific acquired Patheon. 

In June 2017, Abbott introduced the Alinity HQ hematology analyzer, the newest addition to the Alinity family of harmonized systems. In June 2017, Bio-Rad signed an agreement with VISIA imaging, for fully-automated IFA Slide Processing and Reading System. 

The market has been noticing technological developments on a large scale, for the past couple of years. Some of the market players are Abbott Laboratories, Biomérieux, Bio-rad Laboratories, Euroimmun AG, F. Hoffmann-la Roche, Inova Diagnostics Inc., Myriad Genetics, Siemens Healthineers Inc., Thermo Fisher Scientific, and Trinity Biotech.

Table of Contents


    1. 1.1 Study Deliverables

    2. 1.2 Study Assumptions

    3. 1.3 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Growing Public Awareness of Autoimmune Disease

      2. 4.2.2 Improved Laboratory Automation

      3. 4.2.3 Partnerships with Physicians and Clinical Laboratories

      4. 4.2.4 Technological Advancements

    3. 4.3 Market Restraints

      1. 4.3.1 Slow Turnaround Time for Autoimmune Disease Diagnostic Test Results

      2. 4.3.2 High Frequency of False Positive Result

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry


    1. 5.1 Disease Type

      1. 5.1.1 Systemic Autoimmune Disease

        1. Rheumatoid Arthritis

        2. Psoriasis

        3. Systemic Lupus Erythematosus (SLE)

        4. Multiple Sclerosis

        5. Other Disease Types

      2. 5.1.2 Localized Autoimmune Disease

        1. Inflammatory Bowel disease

        2. Type 1 Diabetes

        3. Thyroid

        4. Other Localized Autoimmune Diseases

    2. 5.2 Diagnostic Test

      1. 5.2.1 Regular Laboratory Tests

      2. 5.2.2 Inflammatory Markers

      3. 5.2.3 Immunologic Assays

      4. 5.2.4 Antibody Tests

      5. 5.2.5 Other Tests

    3. 5.3 Geography

      1. 5.3.1 North America

        1. United States

        2. Canada

        3. Mexico


    1. 6.1 Company Profiles

      1. 6.1.1 Abbott Laboratories

      2. 6.1.2 Biomerix

      3. 6.1.3 Bio-rad Laboratories

      4. 6.1.4 Euroimmun AG

      5. 6.1.5 F. Hoffmann-la Roche

      6. 6.1.6 Inova Diagnostics Inc.

      7. 6.1.7 Myriad Genetics

      8. 6.1.8 Siemens Healthineers Inc.

      9. 6.1.9 Thermo Fisher Scientific

      10. 6.1.10 Trinity Biotech

    2. *List Not Exhaustive

**Competitive Landscape Covers - Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The North America Autoimmune Disease Diagnostics Market market is studied from 2018 - 2026.

The North America Autoimmune Disease Diagnostics Market is growing at a CAGR of 8.6% over the next 5 years.

Abbott Laboratories, Biomérieux, Bio-Rad Laboratories Inc., Trinity Biotech, Thermo Fisher Scientific are the major companies operating in North America Autoimmune Disease Diagnostics Market.

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