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市场调查报告书
商品编码
1790372

美国细胞和基因治疗临床试验市场规模、份额和趋势分析报告：按阶段、适应症和细分市场预测，2025 年至 2033 年

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
出版日期: | 出版商: Grand View Research | 英文 150 Pages | 商品交期: 2-10个工作天内

价格

美国细胞与基因治疗临床试验市场概述

美国细胞和基因疗法临床试验市场规模预计在 2024 年为 46.4 亿美元，预计到 2033 年将达到 170.3 亿美元，2025 年至 2033 年的复合年增长率为 15.60%。该市场受到研发支出增加、癌症、罕见遗传疾病和神经退化性疾病疾病负担增加、人们对癌症治疗的细胞和基因治疗兴趣日益浓厚以及有利的法规环境的推动。

此外，候选药物研发管线的快速成长意味着目前有超过2,000个CGT专案处于不同的临床前和临床开发阶段，受益于来自生物製药公司、新兴企业和政府机构的大量研发资金。此外，FDA的加速核准途径、RMAT资格认定以及INTERACT会议等监管方面的进步，正在推动启动和开发细胞和基因疗法临床试验的需求。

此外，各大製药公司不断增加的投资和併购正在推动CGT试验的扩展，尤其是在自体CAR-T疗法、基于AAV的基因疗法和同种异体平台方面。服务供应商和CDMO正在加强其CGT特定能力，包括GMP载体生产、病毒递送系统和分散临床实验物流。

目录

第一章调查方法与范围

第二章执行摘要

第三章美国细胞和基因治疗临床试验市场变数、趋势和范围

  • 市场体系展望
    • 母市场展望
    • 相关/辅助市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
  • 定价模式分析
  • 科技
  • 市场分析工具
    • 波特五力分析
    • PESTEL 与 SWOT 分析
    • COVID-19影响分析

第四章：美国细胞与基因治疗临床试验市场：阶段、估计与趋势

  • 美国细胞与基因疗法临床试验市场（按阶段）：细分仪表板
  • 美国细胞与基因治疗临床试验市场（分阶段）：波动分析
  • 阶段，2021-2033
  • 第一阶段
  • 第二阶段
  • 第三阶段
  • 第四阶段

第五章：美国细胞和基因治疗临床试验市场：按适应症分類的估计和趋势

  • 美国细胞与基因疗法临床试验市场（按适应症）：细分仪表板
  • 美国细胞与基因疗法临床试验市场（按适应症）：波动分析
  • 依适应症，2021-2033年
  • 肿瘤学
  • 心臟病学
  • 中枢神经系统
  • 肌肉骨骼
  • 感染疾病
  • 皮肤科
  • 内分泌学、代谢和遗传学
  • 免疫学和炎症
  • 眼科
  • 血液学
  • 胃肠病学
  • 其他的

第六章 竞争态势

  • 市场参与企业分类
  • 2024 年公司市场占有率/估值分析
  • 公司简介
    • IQVIA
    • ICON Plc
    • LabCorp
    • Charles River Laboratories
    • PAREXEL International Corp.
    • Syneos Health
    • Medpace
    • Thermo Fisher Scientific, Inc.
    • Novotech
    • Veristat, LLC

第七章 主要建议

Product Code: GVR-4-68040-687-2

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

List of Tables

  • Table 1 List of Tables
  • Table 2 List of Secondary Sources
  • Table 3 List of Abbreviations
  • Table 4 U.S. Cell And Gene Therapy Clinical Trials Market Estimates and Forecasts, By Phase, 2021 - 2033 (USD Million)
  • Table 5 U.S. Cell And Gene Therapy Clinical Trials Market Estimates and Forecasts, By Indication, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information procurement
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 Market formulation & validation
  • Fig. 6 Commodity flow analysis
  • Fig. 7 Value-chain-based sizing & forecasting
  • Fig. 8 QFD model sizing & forecasting
  • Fig. 9 Bottom-up approach
  • Fig. 10 Market snapshot
  • Fig. 11 Segment snapshot 1
  • Fig. 12 Segment snapshot 2
  • Fig. 13 Competitive landscape snapshot
  • Fig. 14 Parent market outlook, 2024 (USD Billion)
  • Fig. 15 Ancillary market outlook, 2024 (USD Billion)
  • Fig. 16 U.S. Cell and Gene Therapy Clinical Trials Market Dynamics
  • Fig. 17 Porter's five forces analysis
  • Fig. 18 PESTEL analysis
  • Fig. 19 U.S. Cell and Gene Therapy Clinical Trials Market: Phase outlook and key takeaways
  • Fig. 20 U.S. Cell and Gene Therapy Clinical Trials Market: Phase movement analysis
  • Fig. 21 Phase I Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 22 Phase II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 23 Phase III Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 24 Phase IV Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 25 U.S. Cell and Gene Therapy Clinical Trials Market: Indication outlook and key takeaways
  • Fig. 26 U.S. Cell and Gene Therapy Clinical Trials Market: Indication movement analysis
  • Fig. 27 Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 Cardiology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 29 CNS Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 30 Musculoskeletal Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 Infectious Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 32 Dermatology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 33 Endocrine, metabolic, genetic Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 Immunology & Inflammation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Ophthalmology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 Hematology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 37 Gastroenterology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 38 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 39 Key company categorization
  • Fig. 40 Service heat map analysis
  • Fig. 41 Strategic framework