미국의 알레르기 및 자가면역질환 진단 시장 규모, 점유율, 동향 분석 보고서 : 제품 및 서비스별, 검사 유형별, 진단 약 유형별, 최종 용도별, 부문별 예측(2025-2033년)
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
상품코드:1813840
리서치사:Grand View Research
발행일:2025년 08월
페이지 정보:영문 150 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
시장 규모와 동향 :
미국의 알레르기 및 자가면역질환 진단 시장 규모는 2024년 40억 3,000만 달러로 평가되었습니다. 2033년에는 84억 달러에 달하고, 2025-2033년 연평균 8.67%의 연평균 복합 성장률(CAGR)을 보일 것으로 예측됩니다.
이 시장은 주로 알레르기 및 자가면역 질환의 유병률 증가, 환자의 인식 개선, 전문 진단 검사에 대한 접근성 향상에 의해 주도되고 있습니다. 알레르기 진단제는 IgE를 매개로 한 특이적 반응을 확인하기 위해 널리 사용되고 있으며, 자가면역질환 진단제는 류마티스 관절염, 전신성 홍반성 루푸스, 다발성 경화증과 같은 복잡한 질환의 조기 발견 및 감별을 돕고 있습니다.
또한, 알레르기 및 자가면역질환의 진단 검사량이 증가함에 따라 시료 취급, 분석 처리량, 데이터 보고의 대폭적인 개선이 요구되고 있습니다. 이러한 강화는 보다 효율적인 검사실 운영을 지원하고 특수 검사에 대한 접근성을 확대합니다. 검사실에서는 증가하는 수요를 관리하고, 워크플로우를 간소화하며, 복잡한 검사의 정확성을 유지하기 위해 자동화 및 통합 플랫폼을 도입하고 있습니다.
디지털화된 보고 시스템과 전자의무기록과의 연결은 진단팀과 임상의와의 협업을 더욱 향상시킵니다. 이 도구들은 처리 시간을 단축하고 만성 알레르기 질환 및 자가면역질환 관리에 있어 적시에 임상적 의사결정을 지원할 수 있도록 돕습니다.
미국 시장에서는 연구개발과 보다 타겟팅된 진단 솔루션으로의 전환을 통해 지속적인 혁신이 일어나고 있습니다. 2025년 4월, 벡크만 콜터 생명과학는 알레르기 연구를 지원하는 차세대 호염기구 활성화 검사(BAT)를 발표했습니다. 이 검사는 연구용으로 설계되었지만, 면역 세포의 행동과 알레르기 유발 요인에 대한 더 깊은 통찰력을 제공하는 기능적 분석에 중점을 두고 있음을 반영합니다.
이와 관련하여, 웰시올리는 2023년 10월 고용주 및 지불자 네트워크를 통해 자가면역 치료에 대응하는 기업용 솔루션을 발표했습니다. 이 플랫폼은 자가면역 증상의 생활습관 기반 체계적 관리에 중점을 두고 있으며, 진단과 지속적인 환자 지원의 통합을 지향하는 시장 동향을 명확히 보여줍니다. 이러한 노력은 만성 면역 질환 환자의 장기적인 결과를 개선하기 위해 진단약과 치료 제공 모델을 결합하는 사례가 점점 더 많아지고 있음을 반영하고 있습니다.
미국 시장은 진단약과 개인 맞춤형 치료를 연계하는 보다 전문적이고 데이터 중심의 접근 방식으로 진화하고 있습니다. 검사 기술이 더욱 정교해지고, 더 쉽게 이용할 수 있게 됨에 따라, 시장은 임상 통합 강화, 환자 참여도 향상, 기존 의료 환경 및 신흥 의료 플랫폼에서의 광범위한 채택을 통해 혜택을 누릴 것으로 예측됩니다.
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
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
