미국의 세포 및 유전자 치료 임상시험 시장 규모, 점유율, 동향 분석 리포트 : 단계별, 적응증별, 부문별 예측(2025-2033년)

U.S. Cell And Gene Therapy Clinical Trials Market Size, Share & Trends Analysis Report By Phase (Phase I, II, III, IV), By Indication (Oncology, Cardiology, CNS, Musculoskeletal, Infectious Diseases), And Segment Forecasts, 2025 - 2033

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한글목차

미국의 세포·유전자 치료 임상시험 시장 개요

미국의 세포·유전자 치료 임상시험 시장 규모는 2024년에 46억 4,000만 달러로 추정되며, 2033년에는 170억 3,000만 달러에 달할 것으로 예측되며, 2025-2033년 CAGR은 15.60%로 성장합니다. 이 시장을 촉진하는 요인으로는 연구개발비 증가, 암, 희귀유전질환, 신경퇴행성 질환의 질병 부담 증가, 암 치료를 위한 세포 및 유전자 치료에 대한 관심 증가, 양호한 규제 환경 등이 있습니다.

또한 파이프라인 후보물질의 급증으로 현재 2,000개 이상의 CGT 자산이 다양한 전임상 및 임상 단계에서 개발 중에 있습니다. 바이오 제약사, 스타트업, 정부기관에서 제공하는 막대한 연구개발 자금의 혜택을 받고 있습니다. 또한 FDA의 조기 승인 경로, RMAT 지정, INTERACT 회의 등의 규제 발전은 세포 및 유전자 치료제의 임상시험 시작 및 개발의 필요성을 촉진하고 있습니다.

또한 대형 제약사들의 투자와 M&A 증가는 특히 자가 CAR-T 치료제, AAV 기반 유전자 치료제, 동종 플랫폼에서 CGT 임상시험의 확장을 촉진하고 있습니다. 서비스 프로바이더와 CDMO는 GMP 벡터 생산, 바이러스 전달 시스템, 분산형 임상시험 물류 등 CGT에 특화된 역량을 강화하고 있습니다.

목차

제1장 조사 방법과 범위

제2장 개요

제3장 미국의 세포·유전자 치료 임상시험 시장 변수, 동향, 범위

• 시장 계통 전망
  • 모시장 전망
  • 관련/보조 시장 전망
• 시장 역학
  • 시장 성장 촉진요인 분석
  • 시장 성장 억제요인 분석
• 가격 모델 분석
• 기술
• 시장 분석 툴
  • Porter's Five Forces 분석
  • SWOT 분석에 의한 PESTEL
  • COVID-19의 영향 분석

제4장 미국의 세포·유전자 치료 임상시험 시장 : 단계별, 추정·동향 분석

• 미국의 세포·유전자 치료 임상시험 시장(단계별) : 부문 대시보드
• 미국의 세포·유전자 치료 임상시험 시장(단계별) : 변동 분석
• 단계별, 2021-2033년
• 단계 I
• 단계 II
• 단계 III
• 단계 IV

제5장 미국의 세포·유전자 치료 임상시험 시장 : 적응증별, 추정·동향 분석

• 미국의 세포·유전자 치료 임상시험 시장(적응증별) : 부문 대시보드
• 미국의 세포·유전자 치료 임상시험 시장(적응증별) : 변동 분석
• 적응증별, 2021-2033년
• 종양학
• 심장병학
• 중추신경계
• 근골격
• 감염증
• 피부과
• 내분비, 대사, 유전
• 면역학과 염증
• 안과
• 혈액학
• 소화기 내과
• 기타

제6장 경쟁 구도

• 시장 참여 기업의 분류
• 기업 시장 점유율/평가 분석, 2024년
• 기업 개요
  • IQVIA
  • ICON Plc
  • LabCorp
  • Charles River Laboratories
  • PAREXEL International Corp.
  • Syneos Health
  • Medpace
  • Thermo Fisher Scientific, Inc.
  • Novotech
  • Veristat, LLC

제7장 주요 권장사항

KSA

영문 목차

영문목차

U.S. Cell And Gene Therapy Clinical Trials Market Summary

The U.S. cell and gene therapy clinical trials market size was estimated at USD 4.64 billion in 2024 and is projected to reach USD 17.03 billion by 2033, growing at a CAGR of 15.60% from 2025 to 2033. The market is driven by an increase in R&D funding, increasing disease burden in oncology, rare genetic disorders, and neurodegenerative conditions, growing interest in cell and gene therapies for cancer treatment, and a favorable regulatory environment.

Besides, the surge in pipeline candidates with over 2,000 CGT assets is currently in development at various preclinical and clinical stages. It has benefited from substantial R&D funding provided by biopharma companies, startups, and government entities. In addition, regulatory advancements, including the FDA's accelerated approval pathways, RMAT designations, and INTERACT meetings, support the need for cell and gene therapy initiation and development of trials.

Moreover, increased investments and M&A activities from large pharmaceutical companies are propelling the expansion of CGT trials, particularly in autologous CAR-T therapies, AAV-based gene therapies, and allogeneic platforms. Service providers and CDMOs are enhancing their CGT-specific capabilities, such as GMP vector production, viral delivery systems, and decentralized trial logistics.

U.S. Cell And Gene Therapy Clinical Trials Market Report Segmentation

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. cell and gene therapy clinical trials market report based on phase and indication.

• Phase Outlook (Revenue, USD Million, 2021 - 2033)
• Phase I
• Phase II
• Phase III
• Phase IV
• Indication Outlook (Revenue, USD Million, 2021 - 2033)
• Oncology
• Cardiology
• CNS
• Musculoskeletal
• Infectious diseases
• Dermatology
• Endocrine, metabolic, genetic
• Immunology & inflammation
• Ophthalmology
• Hematology
• Gastroenterology
• Others

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Phase
  • 1.2.2. Indication
• 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
• 1.5. 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. Value chain based analysis (Model 2)
  • 1.7.3. Multivariate Analysis (Model 3)
• 1.8. List of Secondary Sources
• 1.9. List of Abbreviations
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. U.S. Cell and Gene Therapy Clinical Trials 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. Growing Interest in Cell and Gene Therapy
    • 3.2.1.2. Adoption of New Technology in Clinical Research
    • 3.2.1.3. Increasing Investments and R&D Funding
    • 3.2.1.4. Rising Prevalence of Rare and Genetic Disorders
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Recruitment Obstacles
• 3.3. Pricing Model Analysis
• 3.4. Technology Landscape
• 3.5. Market Analysis Tools
  • 3.5.1. Porter's Five Force Analysis
  • 3.5.2. PESTEL by SWOT Analysis
  • 3.5.3. COVID-19 Impact Analysis

Chapter 4. U.S. Cell and Gene Therapy Clinical Trials Market: Phase Estimates & Trend Analysis

• 4.1. U.S. Cell and Gene Therapy Clinical Trials Market, By Phase: Segment Dashboard
• 4.2. U.S. Cell and Gene Therapy Clinical Trials Market, By Phase: Movement Analysis
• 4.3. U.S. Cell and Gene Therapy Clinical Trials Market Estimates & Forecasts, By Phase, 2021 - 2033 (USD Million)
• 4.4. Phase I
  • 4.4.1. Phase I Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Phase II
  • 4.5.1. Phase II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Phase III
  • 4.6.1. Phase III Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.7. Phase IV
  • 4.7.1. Phase IV Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Cell and Gene Therapy Clinical Trials Market: Indication Estimates & Trend Analysis

• 5.1. U.S. Cell and Gene Therapy Clinical Trials Market, By Indication: Segment Dashboard
• 5.2. U.S. Cell and Gene Therapy Clinical Trials Market, By Indication: Movement Analysis
• 5.3. U.S. Cell and Gene Therapy Clinical Trials Market Estimates & Forecasts, By Indication, 2021 - 2033 (USD Million)
• 5.4. Oncology
  • 5.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Cardiology
  • 5.5.1. Cardiology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. CNS
  • 5.6.1. CNS Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.7. Musculoskeletal
  • 5.7.1. Musculoskeletal Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.8. Infectious diseases
  • 5.8.1. Infectious diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.9. Dermatology
  • 5.9.1. Dermatology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.10. Endocrine, metabolic, genetic
  • 5.10.1. Endocrine, metabolic, genetic Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.11. Immunology & inflammation
  • 5.11.1. Immunology & inflammation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.12. Ophthalmology
  • 5.12.1. Ophthalmology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.13. Hematology
  • 5.13.1. Hematology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.14. Gastroenterology
  • 5.14.1. Gastroenterology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.15. Others
  • 5.15.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Competitive Landscape

• 6.1. Market Participant Categorization
• 6.2. Company Market Share/Assessment Analysis, 2024
• 6.3. Company Profiles
  • 6.3.1. IQVIA
    • 6.3.1.1. Company Overview
    • 6.3.1.2. Financial Performance
    • 6.3.1.3. Service Benchmarking
    • 6.3.1.4. Strategic Initiatives
  • 6.3.2. ICON Plc
    • 6.3.2.1. Company Overview
    • 6.3.2.2. Financial Performance
    • 6.3.2.3. Service Benchmarking
    • 6.3.2.4. Strategic Initiatives
  • 6.3.3. LabCorp
    • 6.3.3.1. Company Overview
    • 6.3.3.2. Financial Performance
    • 6.3.3.3. Service Benchmarking
    • 6.3.3.4. Strategic Initiatives
  • 6.3.4. Charles River Laboratories
    • 6.3.4.1. Company Overview
    • 6.3.4.2. Financial Performance
    • 6.3.4.3. Service Benchmarking
    • 6.3.4.4. Strategic Initiatives
  • 6.3.5. PAREXEL International Corp.
    • 6.3.5.1. Company Overview
    • 6.3.5.2. Financial Performance
    • 6.3.5.3. Service Benchmarking
    • 6.3.5.4. Strategic Initiatives
  • 6.3.6. Syneos Health
    • 6.3.6.1. Company Overview
    • 6.3.6.2. Financial Performance
    • 6.3.6.3. Service Benchmarking
    • 6.3.6.4. Strategic Initiatives
  • 6.3.7. Medpace
    • 6.3.7.1. Company Overview
    • 6.3.7.2. Financial Performance
    • 6.3.7.3. Service Benchmarking
    • 6.3.7.4. Strategic Initiatives
  • 6.3.8. Thermo Fisher Scientific, Inc.
    • 6.3.8.1. Company Overview
    • 6.3.8.2. Financial Performance
    • 6.3.8.3. Service Benchmarking
    • 6.3.8.4. Strategic Initiatives
  • 6.3.9. Novotech
    • 6.3.9.1. Company Overview
    • 6.3.9.2. Financial Performance
    • 6.3.9.3. Service Benchmarking
    • 6.3.9.4. Strategic Initiatives
  • 6.3.10. Veristat, LLC
    • 6.3.10.1. Company Overview
    • 6.3.10.2. Financial Performance
    • 6.3.10.3. Service Benchmarking
    • 6.3.10.4. Strategic Initiatives

Chapter 7. Key Recommendations

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