North America Autoimmune Disease Diagnostics Market Size, Share, and COVID-19 Impact Analysis, Disease Type (Systemic Autoimmune Disease, and Localised Autoimmune Disease), By Diagnostic Tests (Regular Laboratory Tests, Inflammatory Markers, Immunologic Assays, Antibody Tests, and Others), and North America Autoimmune Disease Diagnostics Market Insights, Industry Trend, Forecasts to 2035

North America Autoimmune Disease Diagnostics Market Insights Forecasts to 2035

• The North America Autoimmune Disease Diagnostics Market Size Was Estimated at USD 1.53 Billion in 2024
• The Market Size is Expected to Grow at a CAGR of Around 5.61% from 2025 to 2035
• The North America Autoimmune Disease Diagnostics Market Size is Expected to Reach USD 2.79 Billion by 2035

According to a research report published by Spherical Insights & Consulting, The North America Autoimmune Disease Diagnostics Market Size is anticipated to reach USD 2.79 Billion by 2035, Growing at a CAGR of 5.61% from 2025 to 2035. The autoimmune disease diagnostics market is driven by ageing populations, rising incidence of chronic conditions like rheumatoid arthritis and lupus, growing awareness about autoimmune disease diagnosis and advanced healthcare infrastructure.

Market Overview

The North America autoimmune disease diagnostics market refers to a specialised range of medical assays and imaging technologies designed to identify conditions where the immune system mistakenly attacks healthy somatic tissues. This sector is currently experiencing rapid evolution, characterised by ground-breaking innovations such as multiplex testing, which allows for the simultaneous detection of multiple antibodies and the integration of Artificial Intelligence to enhance the precision of pattern recognition in laboratory results.

Government support serves as a critical backbone for this growth; agencies like the National Institutes of Health (NIH) provide substantial research funding, while the FDA’s streamlined approval pathways for breakthrough devices incentivise private-sector investment. The primary driving factors behind the market’s expansion include a rising incidence of chronic conditions like rheumatoid arthritis and lupus, an ageing population, and an increased clinical emphasis on early intervention. Furthermore, the presence of a sophisticated healthcare infrastructure and high diagnostic awareness among patients ensures that North America remains the global frontrunner in the adoption of advanced immunological diagnostic tools.

Report Coverage

This research report categorises the market for the North America autoimmune disease diagnostics market based on various segments and regions, and forecasts revenue growth and analyses trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the North America autoimmune disease diagnostics market. Recent market developments and competitive strategies, such as expansion, product launch, development, partnership, merger, and acquisition, have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the North America autoimmune disease diagnostics market.

Driving Factors

The autoimmune disease diagnostics market in North America is driven by various factors, such as the surging prevalence of chronic conditions. This rising patient pool is further expanded by an ageing demographic, as the geriatric population is increasingly susceptible to immunological malfunctions. The role of technological integration, particularly the adoption of Artificial Intelligence and multiplex testing, which streamlines complex antibody detection. Furthermore, robust healthcare infrastructure and favourable reimbursement frameworks, such as recent hikes in Medicare Advantage rates, lower the financial barriers for patients seeking early screening. Finally, heightened public awareness campaigns and strategic public-private partnerships are fostering a proactive diagnostic culture, ensuring sustained market expansion through the end of the decade.

Restraining Factors

The North America autoimmune disease diagnostics market is mostly constrained by a chronic shortage of specialised laboratory personnel, which complicates the interpretation of complex immunological data. Strict regulatory requirements and long FDA approval timelines further delay the commercialisation of novel platforms. Finally, the high frequency of false-positive results and slow turnaround times for specialised tests can hinder clinical efficiency and timely patient intervention.

Market Segmentation

The North America autoimmune disease diagnostics market share is classified into disease type and diagnostic test.

• The systemic autoimmune disease segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period. 

The North America autoimmune disease diagnostics market is segmented by disease type into systemic autoimmune and localised autoimmune disease. Among these, the systemic autoimmune disease segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period. Because systemic conditions (such as Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE) affect multiple organs and tissues simultaneously, these diseases are more complex to diagnose, requiring frequent, high-volume testing and longitudinal monitoring. In North America, the surging prevalence of RA and Lupus affecting millions of Americans drives the continuous demand for these comprehensive diagnostic panels.

• The antibody tests segment dominated the share in 2024 and is anticipated to grow at a remarkable CAGR during the forecast period. 

Based on diagnostic test The North America autoimmune disease diagnostics market is segmented into regular laboratory tests, inflammatory markers, immunologic assays, antibody tests, and others. Among these, the antibody segment dominated the share in 2024 and is anticipated to grow at a remarkable CAGR during the forecast period. Because of its high sensitivity, a negative result can effectively rule out many complex diseases, saving costs on further testing. This makes it the highest-volume test in the market. Furthermore, the shift toward automated multiplexing has allowed laboratories to consolidate multiple antibodies checks into a single run, significantly increasing the revenue generated by this specific segment compared to general inflammatory markers or routine lab work.

Competitive Analysis:

The report offers the appropriate analysis of the key organisations/companies involved within the North America autoimmune disease diagnostics market, along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborate analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Abbott Laboratories
• Thermo Fisher Scientific
• Danaher Corporation
• Bio-Rad Laboratories
• Quest Diagnostics
• Exagen Inc
• Myriad Genetics
• SQI Diagnostics
• Werfen
• Savara Inc
• Immco Diagnostics
• Scipher Medicine
• Progentec Diagnostics
• Others

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Recent Developments:

• In March 2025, Savara launched aPAP ClearPath Dried Blood Spot (DBS) Test in the United States, allowing physicians to test patients for autoimmune pulmonary alveolar proteinosis using simple, minimally invasive finger-prick rather than traditional, complex blood draws.

• In January 2025, Exagen Inc launched new, highly sensitive biomarker assays for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) after securing conditional approval from the New York State Department of Health. By integrating these novel T-Cell and anti-RA33 biomarkers into its flagship AVISE CTD platform, the company improved the ability of rheumatologists to definitively diagnose ambiguous or seronegative cases

• In October 2024, Werfen completed the acquisition of Omixon to strengthen Werfen’s underlying genomic and immunological testing infrastructure, directly supporting its broader autoimmune capabilities in the North American sector.

Market Segment

This study forecasts revenue at the North America, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the North America autoimmune disease diagnostics market based on the below-mentioned segments:

North America Autoimmune Disease Diagnostics Market, By Disease Type

• Systemic Autoimmune Disease
• Localised Autoimmune Disease

North America Autoimmune Disease Diagnostics Market, By Diagnostic Test

• Regular laboratory tests
•  Inflammatory markers
• Immunologic assays
•  Antibody tests
• Others