The U.S. allergy and autoimmune disease diagnostics market size was estimated at USD 4.03 billion in 2024 and is projected to reach USD 8.40 billion by 2033, growing at a CAGR of 8.67% from 2025 to 2033. The market is primarily driven by the rising incidence of allergic and autoimmune disorders, increasing patient awareness, and improved access to specialized diagnostic testing. Allergy diagnostics are widely used to identify specific IgE-mediated reactions, while autoimmune disease diagnostics support early detection and differentiation of complex conditions such as rheumatoid arthritis, systemic lupus erythematosus, and multiple sclerosis.
In addition, the growing volume of diagnostic testing for allergy and autoimmune conditions has prompted significant improvements in sample handling, assay throughput, and data reporting. These enhancements support more efficient laboratory operations and expand access to specialized tests. Laboratories are increasingly adopting automation and integrated platforms to manage rising demand, streamline workflows, and maintain accuracy in high-complexity testing.
Digitized reporting systems and connectivity with electronic health records further improve coordination between diagnostic teams and clinicians. These tools reduce turnaround times and support timely clinical decision-making in managing chronic allergic and autoimmune conditions.
The U.S. market is experiencing continuous innovation, driven by research-focused developments and a shift toward more targeted diagnostic solutions. In April 2025, Beckman Coulter Life Sciences introduced its Next-Generation Basophil Activation Test (BAT) to support allergy research. Although designed for research use only, the test reflects a growing emphasis on functional assays that offer deeper insights into immune cell behavior and allergic triggers.
In a related development, WellTheory launched an enterprise solution in October 2023 to address autoimmune care through employer and payer networks. This platform focuses on structured, lifestyle-based management of autoimmune symptoms, underscoring a broader market trend toward integrating diagnostics with ongoing patient support. These efforts reflect how diagnostics are increasingly paired with care delivery models to improve long-term outcomes for individuals with chronic immune conditions.
The U.S. market is evolving toward more specialized, data-driven approaches that align diagnostics with personalized care. As testing technologies become more sophisticated and accessible, the market is expected to benefit from stronger clinical integration, improved patient engagement, and broader adoption across traditional healthcare settings and emerging care platforms.
This product will be delivered within 1-3 business days.
In addition, the growing volume of diagnostic testing for allergy and autoimmune conditions has prompted significant improvements in sample handling, assay throughput, and data reporting. These enhancements support more efficient laboratory operations and expand access to specialized tests. Laboratories are increasingly adopting automation and integrated platforms to manage rising demand, streamline workflows, and maintain accuracy in high-complexity testing.
Digitized reporting systems and connectivity with electronic health records further improve coordination between diagnostic teams and clinicians. These tools reduce turnaround times and support timely clinical decision-making in managing chronic allergic and autoimmune conditions.
The U.S. market is experiencing continuous innovation, driven by research-focused developments and a shift toward more targeted diagnostic solutions. In April 2025, Beckman Coulter Life Sciences introduced its Next-Generation Basophil Activation Test (BAT) to support allergy research. Although designed for research use only, the test reflects a growing emphasis on functional assays that offer deeper insights into immune cell behavior and allergic triggers.
In a related development, WellTheory launched an enterprise solution in October 2023 to address autoimmune care through employer and payer networks. This platform focuses on structured, lifestyle-based management of autoimmune symptoms, underscoring a broader market trend toward integrating diagnostics with ongoing patient support. These efforts reflect how diagnostics are increasingly paired with care delivery models to improve long-term outcomes for individuals with chronic immune conditions.
The U.S. market is evolving toward more specialized, data-driven approaches that align diagnostics with personalized care. As testing technologies become more sophisticated and accessible, the market is expected to benefit from stronger clinical integration, improved patient engagement, and broader adoption across traditional healthcare settings and emerging care platforms.
U.S. Allergy and Autoimmune Disease Diagnostics Market Report Segmentation
This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. The analyst has segmented the U.S. allergy and autoimmune disease diagnostics market report based on products & services, diagnostic type, test type, and end use:- Products & Services Outlook (Revenue in USD Million, 2021-2033)
- Allergy Diagnostics
- Instruments
- Consumables
- Services
- Autoimmune Disease Diagnostics
- Instruments
- Consumables
- Services
- Test Type Outlook (Revenue in USD Million, 2021-2033)
- Allergy Diagnostics
- In vivo Test
- Skin Prick Test
- Intradermal Test
- Patch Test
- In vitro Test
- Autoimmune Disease Diagnostics
- Antinuclear Antibody Tests
- Autoantibody Tests
- C-reactive Protein (CRP)
- Complete Blood Count (CBC)
- Urinalysis
- Others
- Diagnostics Type Outlook (Revenue in USD Million, 2021-2033)
- Allergy Diagnostics
- Food
- Dairy Products
- Poultry Product
- Tree Nuts
- Peanuts
- Shellfish
- Wheat
- Soys
- Other Food Allergens
- Inhaled
- Drug
- Other Allergens
- Autoimmune Disease Diagnostics
- Systemic Autoimmune Disease Diagnostics
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Systemic Lupus Erythematosus (SLE)
- Others
- Localized Autoimmune Disease Diagnostics
- Multiple Sclerosis
- Type 1 Diabetes
- Hashimoto's Thyroiditis
- Idiopathic Thrombocytopenic Purpura
- Others
- End Use Outlook (Revenue in USD Million, 2021-2033)
- Allergy Diagnostics
- Hospitals & Clinics
- Diagnostics Laboratories
- Research Institutions
- Others
- Autoimmune Disease
- Hospitals & Clinics
- Diagnostics Laboratories
- Research Institutions
- Others
Why should you buy this report?
- Comprehensive Market Analysis: Gain detailed insights into the industry across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segmental and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listings for you to stay ahead of the curve
- COVID-19's impact and how to sustain in these fast-evolving markets
This product will be delivered within 1-3 business days.
Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. Allergy and Autoimmune Disease Diagnostics Market Variables, Trends & Scope
Chapter 4. U.S. Allergy and Autoimmune Disease Diagnostics Market: Products and Services Estimates & Trend Analysis
Chapter 5. U.S. Allergy and Autoimmune Disease Diagnostics Market: Test Type Estimates & Trend Analysis
Chapter 6. U.S. Allergy and Autoimmune Disease Diagnostics Market: Diagnostics Type Estimates & Trend Analysis
Chapter 7. U.S. Allergy and Autoimmune Disease Diagnostics Market: End Use Estimates & Trend Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The major companies profiled in this U.S. Allergy and Autoimmune Disease Diagnostics market report include:- Thermo Fisher Scientific, Inc.
- HYCOR Biomedical
- EUROIMMUN Medizinische Labordiagnostika AG (PerkinElmer, Inc.)
- Omega Diagnostics Group PLC
- Lincoln Diagnostics, Inc.
- AESKU.GROUP GmbH
- Minaris Medical America, Inc.
- HOB Biotech Group Corp., Ltd.
- DASIT Group SPA
- R-Biopharm AG
- bioMérieux
- Siemens Healthcare GmbH
- Hoffmann-La Roche Ltd
- Abbott
- Beckman Coulter, Inc.
- Danaher Corporation
- Quest Diagnostics
- Nova Diagnostics Pte Ltd.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 150 |
| Published | August 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 4.03 Billion |
| Forecasted Market Value ( USD | $ 8.4 Billion |
| Compound Annual Growth Rate | 8.6% |
| Regions Covered | United States |
| No. of Companies Mentioned | 18 |
