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市場調查報告書
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1790372

美國細胞和基因治療臨床試驗市場規模、佔有率和趨勢分析報告：按階段、適應症和細分市場預測，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個工作天內

價格

美國細胞與基因治療臨床試驗市場概述

美國細胞和基因療法臨床試驗市場規模預計在 2024 年為 46.4 億美元，預計到 2033 年將達到 170.3 億美元，2025 年至 2033 年的複合年成長率為 15.60%。該市場受到研發支出增加、癌症、罕見遺傳疾病和神經退化性疾病疾病負擔增加、人們對癌症治療的細胞和基因治療興趣日益濃厚以及有利的法規環境的推動。

此外，候選藥物研發管線的快速成長意味著目前有超過2,000個CGT專案處於不同的臨床前和臨床開發階段，受益於來自生物製藥公司、新興企業和政府機構的大量研發資金。此外，FDA的加速核准途徑、RMAT資格認定以及INTERACT會議等監管方面的進步，正在推動啟動和開發細胞和基因療法臨床試驗的需求。

此外，各大製藥公司不斷增加的投資和併購正在推動CGT試驗的擴展，尤其是在自體CAR-T療法、基於AAV的基因療法和同種異體平台方面。服務供應商和CDMO正在加強其CGT特定能力，包括GMP載體生產、病毒遞送系統和分散臨床實驗物流。

目錄

第1章調查方法與範圍

第2章執行摘要

第3章美國細胞和基因治療臨床試驗市場變數、趨勢和範圍

  • 市場體系展望
    • 母市場展望
    • 相關/輔助市場展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
  • 定價模式分析
  • 科技
  • 市場分析工具
    • 波特五力分析
    • PESTEL 與 SWOT 分析
    • COVID-19影響分析

第4章：美國細胞與基因治療臨床試驗市場：階段、估計與趨勢

  • 美國細胞與基因療法臨床試驗市場（按階段）：細分儀表板
  • 美國細胞與基因治療臨床試驗市場（分階段）：波動分析
  • 階段，2021-2033
  • 第一階段
  • 第二階段
  • 第三階段
  • 第四階段

第5章：美國細胞和基因治療臨床試驗市場：按適應症分類的估計和趨勢

  • 美國細胞與基因療法臨床試驗市場（按適應症）：細分儀表板
  • 美國細胞與基因療法臨床試驗市場（按適應症）：波動分析
  • 依適應症，2021-2033年
  • 腫瘤學
  • 心臟病學
  • 中樞神經系統
  • 肌肉骨骼
  • 感染疾病
  • 皮膚科
  • 內分泌學、代謝和遺傳學
  • 免疫學和炎症
  • 眼科
  • 血液學
  • 胃腸病學
  • 其他

第6章 競爭態勢

  • 市場參與企業分類
  • 2024 年公司市場佔有率/估值分析
  • 公司簡介
    • IQVIA
    • ICON Plc
    • LabCorp
    • Charles River Laboratories
    • PAREXEL International Corp.
    • Syneos Health
    • Medpace
    • Thermo Fisher Scientific, Inc.
    • Novotech
    • Veristat, LLC

第7章 主要建議

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