米国の細胞・遺伝子治療臨床試験市場規模、シェア、動向分析レポート：フェーズ別、適応症別、セグメント別予測、2025年～2033年

米国の細胞・遺伝子治療臨床試験市場概要

米国の細胞・遺伝子治療臨床試験市場規模は、2024年に46億4,000万米ドルと推定され、2033年には170億3,000万米ドルに達すると予測され、2025～2033年のCAGRは15.60%で成長します。この市場を牽引しているのは、研究開発費の増加、がん、希少遺伝性疾患、神経変性疾患における疾病負担の増加、がん治療のための細胞・遺伝子治療への関心の高まり、良好な規制環境などがあります。

また、パイプライン候補の急増により、現在2,000を超えるCGT資産が様々な前臨床と臨床段階で開発中です。バイオ製薬会社、新興企業、政府機関から提供される多額の研究開発資金の恩恵を受けています。加えて、FDAの早期承認パスウェイ、RMAT指定、INTERACT会議などの規制の進歩が、細胞・遺伝子治療の臨床試験開始・開発の必要性を後押ししています。

さらに、大手製薬会社による投資やM&Aの増加が、特に自己CAR-T療法、AAVベース遺伝子療法、同種プラットフォームにおけるCGT試験の拡大を後押ししています。サービスプロバイダやCDMOは、GMPベクタ生産、ウイルス送達システム、分散型治験ロジスティクスなど、CGTに特化した能力を強化しています。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 米国の細胞・遺伝子治療臨床試験市場の変数、動向、範囲

• 市場系統の展望
  • 親市場の展望
  • 関連/補助市場展望
• 市場力学
  • 市場促進要因分析
  • 市場抑制要因分析
• 価格モデル分析
• 技術
• 市場分析ツール
  • ポーターのファイブフォース分析
  • SWOT分析によるPESTEL
  • COVID-19の影響分析

第4章 米国の細胞・遺伝子治療臨床試験市場：フェーズ別、推定・動向分析

• 米国の細胞・遺伝子治療臨床試験市場（フェーズ別）：セグメントダッシュボード
• 米国の細胞・遺伝子治療臨床試験市場（フェーズ別）：変動分析
• フェーズ別、2021～2033年
• フェーズI
• フェーズII
• フェーズIII
• フェーズIV

第5章 米国の細胞・遺伝子治療臨床試験市場：適応症別、推定・動向分析

• 米国の細胞・遺伝子治療臨床試験市場（適応症別）：セグメントダッシュボード
• 米国の細胞・遺伝子治療臨床試験市場（適応症別）：変動分析
• 適応症別、2021～2033年
• 腫瘍学
• 心臓病学
• 中枢神経系
• 筋骨格
• 感染症
• 皮膚科
• 内分泌、代謝、遺伝
• 免疫学と炎症
• 眼科
• 血液学
• 消化器内科
• その他

第6章 競合情勢

• 市場参入企業の分類
• 企業市場シェア/評価分析、2024年
• 企業プロファイル
  • IQVIA
  • ICON Plc
  • LabCorp
  • Charles River Laboratories
  • PAREXEL International Corp.
  • Syneos Health
  • Medpace
  • Thermo Fisher Scientific, Inc.
  • Novotech
  • Veristat, LLC

第7章 主要推奨事項

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

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