U.S. Allergy And Autoimmune Disease Diagnostics Market Size, Share & Trends Analysis Report By Product & Services (Allergy Diagnostics, Autoimmune Disease), By Test Type, By Diagnostics Type, By End-use, And Segment Forecasts, 2025 - 2033
Description
Market Size & Trends
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.
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. For this study, Grand View Research has segmented the U.S. allergy and autoimmune disease diagnostics market report based on products & services, diagnostic type, test type, and end use:
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.
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. For this study, Grand View Research 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
Table of Contents
150 Pages
- Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Segment Definitions
- 1.2.1. Products and Services
- 1.2.2. Test Type
- 1.2.3. Diagnostic Type
- 1.2.4. End Use
- 1.2.5. Estimates and forecasts timeline
- 1.3. Research Methodology
- 1.4. Information Procurement
- 1.4.1. Purchased database
- 1.4.2. GVR’s internal database
- 1.4.3. Secondary sources
- 1.4.4. Primary research
- 1.4.5. Details of primary research
- 1.4.5.1. Data for primary interviews in U.S.
- 1.5. Information or Data Analysis
- 1.5.1. Data analysis models
- 1.6. Market Formulation & Validation
- 1.7. Model Details
- 1.7.1. Commodity flow analysis (Model 1)
- 1.7.2. Approach 1: Commodity flow approach
- 1.7.3. Volume price analysis (Model 2)
- 1.7.4. Approach 2: Volume price analysis
- 1.8. List of Secondary Sources
- 1.9. List of Primary Sources
- 1.10. Objectives
- Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Outlook
- 2.2.1. Products and Services and Test type Snapshot
- 2.2.2. Diagnostics Type Snapshot
- 2.2.3. End Use Snapshot
- 2.3. Competitive Insights
- Chapter 3. U.S. Allergy and Autoimmune Disease Diagnostics Market Variables, Trends & Scope
- 3.1. Market Lineage Outlook
- 3.1.1. Parent market outlook
- 3.1.2. Related/ancillary market outlook
- 3.2. Market Dynamics
- 3.2.1. Market driver analysis
- 3.2.1.1. Rising Prevalence of Immune-Related Disorders
- 3.2.1.2. Shift Toward Early and Personalized Diagnosis
- 3.2.1.3. Expansion of Decentralized and Home-Based Testing
- 3.2.2. Market restraint analysis
- 3.2.2.1. High Cost of Advanced Diagnostic Technologies
- 3.2.2.2. Underdiagnosis and Limited Awareness in Emerging Markets
- 3.2.2.3. Regulatory and Reimbursement Barriers
- 3.3. U.S. Allergy And Autoimmune Disease Diagnostics Market Analysis Tools
- 3.3.1. Industry Analysis - Porter’s
- 3.3.1.1. Supplier power
- 3.3.1.2. Buyer power
- 3.3.1.3. Substitution threat
- 3.3.1.4. Threat of new entrants
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political landscape
- 3.3.2.2. Technological landscape
- 3.3.2.3. Economic landscape
- Chapter 4. U.S. Allergy And Autoimmune Disease Diagnostics Market: Products and Services Estimates & Trend Analysis
- 4.1. Products and Services Market Share, 2024 & 2033
- 4.2. Segment Dashboard
- 4.3. U.S. Allergy And Autoimmune Disease Diagnostics Market, by Products and Services Outlook
- 4.4. Allergy Diagnostics
- 4.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.4.2. Instruments
- 4.4.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.4.3. Consumables
- 4.4.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.4.4. Services
- 4.4.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.5. Autoimmune Disease Diagnostics
- 4.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.5.2. Instruments
- 4.5.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.5.3. Consumables
- 4.5.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 4.5.4. Services
- 4.5.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- Chapter 5. U.S. Allergy And Autoimmune Disease Diagnostics Market: Test Type Estimates & Trend Analysis
- 5.1. Test Type Market Share, 2024 & 2033
- 5.2. Segment Dashboard
- 5.3. U.S. Allergy And Autoimmune Disease Diagnostics Market by Test Type Outlook
- 5.4. Allergy Diagnostics
- 5.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.4.2. In vivo Test
- 5.4.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.4.2.2. Skin Prick Test
- 5.4.2.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.4.2.3. Intradermal Test
- 5.4.2.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.4.2.4. Patch Test
- 5.4.2.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.4.2.5. In vitro Test
- 5.4.2.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.5. Autoimmune Disease Diagnostics
- 5.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.5.2. Antinuclear Antibody Tests
- 5.5.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.5.3. Autoantibody Tests
- 5.5.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.5.4. C-reactive Protein (CRP)
- 5.5.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.5.5. Complete Blood Count (CBC)
- 5.5.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.5.6. Urinalysis
- 5.5.6.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 5.5.7. Others
- 5.5.7.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- Chapter 6. U.S. Allergy And Autoimmune Disease Diagnostics Market: Diagnostics Type Estimates & Trend Analysis
- 6.1. Diagnostics Type Market Share, 2024 & 2033
- 6.2. Segment Dashboard
- 6.3. U.S. Allergy And Autoimmune Disease Diagnostics Market by Diagnostics Type Outlook
- 6.4. Allergy Diagnostics
- 6.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.2. Food
- 6.4.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.2.2. Dairy Products
- 6.4.2.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.2.3. Poultry Product
- 6.4.2.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.2.4. Tree Nuts
- 6.4.2.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.2.5. Peanuts
- 6.4.2.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.2.6. Shellfish
- 6.4.2.6.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.2.7. Wheat
- 6.4.2.7.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.2.8. Soys
- 6.4.2.8.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.2.9. Other Food Allergens
- 6.4.2.9.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.3. Inhale
- 6.4.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.4. Drug
- 6.4.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.5. Other allergens
- 6.4.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5. Autoimmune Disease
- 6.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.2. Systemic Autoimmune Disease Diagnostics
- 6.5.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.2.2. Rheumatoid Arthritis
- 6.5.2.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.2.3. Ankylosing Spondylitis
- 6.5.2.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.2.4. Systemic Lupus Erythematosus (SLE)
- 6.5.2.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.2.5. Others
- 6.5.2.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.3. Localized Autoimmune Disease Diagnostics
- 6.5.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.3.2. Multiple Sclerosis
- 6.5.3.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.3.3. Type 1 Diabetes
- 6.5.3.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.3.4. Hashimoto's Thyroiditis
- 6.5.3.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.3.5. Idiopathic Thrombocytopenic Purpura
- 6.5.3.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.3.6. Others
- 6.5.3.6.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- Chapter 7. U.S. Allergy And Autoimmune Disease Diagnostics Market: End Use Estimates & Trend Analysis
- 7.1. End Use Market Share, 2024 & 2033
- 7.2. Segment Dashboard
- 7.3. Allergy and Autoimmune Disease Diagnostics Market: End Use Movement Analysis
- 7.4. Allergy Diagnostics
- 7.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.4.2. Hospitals & Clinics
- 7.4.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.4.3. Diagnostics Laboratories
- 7.4.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.4.4. Research Institutions
- 7.4.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.4.5. Others
- 7.4.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5. Autoimmune Diagnostics
- 7.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.2. Hospitals & Clinics
- 7.5.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.3. Diagnostics Laboratories
- 7.5.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.4. Research Institutions
- 7.5.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- 7.5.5. Others
- 7.5.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
- Chapter 8. Competitive Landscape
- 8.1. Company Categorization
- 8.2. Strategy Mapping
- 8.2.1. New Products and Services Launch
- 8.2.2. Partnerships
- 8.2.3. Acquisition
- 8.2.4. Collaboration
- 8.2.5. Funding
- 8.3. Key Company Market Share Analysis, 2024
- 8.4. Company Heat Map Analysis
- 8.5. Company Profiles
- 8.5.1. Thermo Fisher Scientific, Inc.
- 8.5.1.1. Company Overview
- 8.5.1.2. Financial Performance
- 8.5.1.3. Products and Services Benchmarking
- 8.5.1.4. Strategic Initiatives
- 8.5.2. HYCOR Biomedical
- 8.5.2.1. Company Overview
- 8.5.2.2. Financial Performance
- 8.5.2.3. Products and Services Benchmarking
- 8.5.2.4. Strategic Initiatives
- 8.5.3. EUROIMMUN Medizinische Labordiagnostika AG (PerkinElmer)
- 8.5.3.1. Company Overview
- 8.5.3.2. Financial Performance
- 8.5.3.3. Products and Services Benchmarking
- 8.5.3.4. Strategic Initiatives
- 8.5.4. Omega Diagnostics GROUP PLC
- 8.5.4.1. Company Overview
- 8.5.4.2. Financial Performance
- 8.5.4.3. Products and Services Benchmarking
- 8.5.4.4. Strategic Initiatives
- 8.5.5. Lincoln Diagnostics, Inc.
- 8.5.5.1. Company Overview
- 8.5.5.2. Financial Performance
- 8.5.5.3. Products and Services Benchmarking
- 8.5.5.4. Strategic Initiatives
- 8.5.6. AESKU.GROUP GmbH
- 8.5.6.1. Company Overview
- 8.5.6.2. Financial Performance
- 8.5.6.3. Products and Services Benchmarking
- 8.5.6.4. Strategic Initiatives
- 8.5.7. Minaris Medical America, Inc.
- 8.5.7.1. Company Overview
- 8.5.7.2. Financial Performance
- 8.5.7.3. Products and Services Benchmarking
- 8.5.7.4. Strategic Initiatives
- 8.5.8. HOB Biotech Group Corp., Ltd.
- 8.5.8.1. Company Overview
- 8.5.8.2. Financial Performance
- 8.5.8.3. Products and Services Benchmarking
- 8.5.8.4. Strategic Initiatives
- 8.5.9. DASIT Group SPA
- 8.5.9.1. Company Overview
- 8.5.9.2. Financial Performance
- 8.5.9.3. Products and Services Benchmarking
- 8.5.9.4. Strategic Initiatives
- 8.5.10. R-Biopharm AG
- 8.5.10.1. Company Overview
- 8.5.10.2. Financial Performance
- 8.5.10.3. Products and Services Benchmarking
- 8.5.10.4. Strategic Initiatives
- 8.5.11. BIOMÉRIEUX
- 8.5.11.1. Company Overview
- 8.5.11.2. Financial Performance
- 8.5.11.3. Products and Services Benchmarking
- 8.5.11.4. Strategic Initiatives
- 8.5.12. Siemens Healthcare GmbH
- 8.5.12.1. Company Overview
- 8.5.12.2. Financial Performance
- 8.5.12.3. Products and Services Benchmarking
- 8.5.12.4. Strategic Initiatives
- 8.5.13. Hoffmann-La Roche Ltd
- 8.5.13.1. Company Overview
- 8.5.13.2. Financial Performance
- 8.5.13.3. Products and Services Benchmarking
- 8.5.13.4. Strategic Initiatives
- 8.5.14. Abbott
- 8.5.14.1. Company Overview
- 8.5.14.2. Financial Performance
- 8.5.14.3. Products and Services Benchmarking
- 8.5.14.4. Strategic Initiatives
- 8.5.15. Beckman Coulter, Inc.
- 8.5.15.1. Company Overview
- 8.5.15.2. Financial Performance
- 8.5.15.3. Products and Services Benchmarking
- 8.5.15.4. Strategic Initiatives
- 8.5.16. Danaher Corporation
- 8.5.16.1. Company Overview
- 8.5.16.2. Financial Performance
- 8.5.16.3. Products and Services Benchmarking
- 8.5.16.4. Strategic Initiatives
- 8.5.17. Quest Diagnostics
- 8.5.17.1. Company Overview
- 8.5.17.2. Financial Performance
- 8.5.17.3. Products and Services Benchmarking
- 8.5.17.4. Strategic Initiatives
- 8.5.18. Nova Diagnostics Pte Ltd.
- 8.5.18.1. Company Overview
- 8.5.18.2. Financial Performance
- 8.5.18.3. Products and Services Benchmarking
- 8.5.18.4. Strategic Initiatives
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