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封面
市场调查报告书
商品编码
1842042

美国细胞和基因治疗CDMO市场：市场规模、份额和趋势分析（按阶段、产品和适应症划分），细分市场预测（2025-2033年）

U.S. Cell And Gene Therapy CDMO Market Size, Share & Trends Analysis Report By Phase, By Product, By Indication, 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

市场规模与趋势：

美国细胞和基因治疗 CDMO 市场预计在 2024 年达到 16.2 亿美元，预计到 2033 年将达到 103.4 亿美元，2025 年至 2033 年的复合年增长率为 23.26%。

推动这一市场发展的因素包括：对先进治疗方法的投资不断增加、基因疗法和CAR-T疗法的核准不断增长，以及对专业化生产能力的需求日益增长。製药和生物技术公司越来越多地与合约研发生产机构（CDMO）合作，以克服病毒载体生产、细胞扩增、符合GMP规范的设施等方面的瓶颈。

推动这一市场发展的因素主要是生物技术和製药产业对细胞和基因疗法（CGT）研发投入的增加。细胞和基因疗法在治疗包括癌症、遗传性疾病和某些感染疾病在内的多种疾病方面具有巨大潜力。因此，鑑于这些治疗方法的巨大潜力，公共和私营部门都对创新细胞和基因治疗方法的研发表现出浓厚的兴趣。目前，大多数大型製药公司都在投资CGT，以期在市场中占据稳固地位。此外，创业投资也显着增加，尤其是在生命科学领域。

此外，不断成长的临床研发管线以及由于生产需要专业技术和基础设施而对生产外包的持续依赖，也是推动市场成长的因素。根据clinicaltrials.org网站发布的数据，目前有超过2000项正在进行的细胞和基因治疗临床试验，这些试验处于不同的研发阶段，每次从早期到晚期的过渡都会增加对病毒载体、质体和临床级细胞处理的需求。 FDA核准Casgevy用于治疗镰状细胞贫血症，Elevidys用于治疗Duchenne氏肌肉失养症（预计2023-2024年上市），以及EMA核准Roctavian用于治疗A型血友病（预计2023-2024年上市），都凸显了先进疗法进入商业化阶段的强劲势头。

「大多数引领这些创新的小型生技公司缺乏大规模的GMP生产设施，迫使它们与合约研发生产力机构（CDMO）合作才能惠及病患。为了因应这项需求激增，龙沙（Lonza）、凯达伦（Catalent）、药明康德和赛默飞世尔科技等领先企业正大力投资扩大其病毒载体和细胞疗法的生产能力，这表明核准对持续的外包需求充满信心。

目录

第一章 分析方法和范围

第二章执行摘要

第三章美国细胞与基因治疗CDMO市场：驱动因素、趋势与范围

  • 市场关联性展望
  • 美国细胞与基因治疗CDMO市场动态
  • 技术格局
  • 定价模式分析
  • 美国细胞与基因治疗CDMO市场：分析工具

第四章：美国细胞与基因治疗CDMO市场：依阶段分類的估算与趋势分析

  • 细分仪表板
  • 美国细胞与基因治疗CDMO市场：按阶段分類的趋势分析
  • 美国细胞基因治疗CDMO市场规模及发展趋势分析（依阶段划分，2021-2033年）
  • 临床前
  • 临床

第五章：美国细胞与基因治疗CDMO市场：依产品分類的估算与趋势分析

  • 细分仪表板
  • 美国细胞和基因治疗CDMO市场：波动分析（按产品分类）
  • 美国细胞及基因治疗CDMO市场规模及产品趋势分析（2021-2033年）
  • 基因治疗
    • 体外
    • 体内
  • 基因改造细胞疗法
    • CAR-T细胞疗法
    • CAR-NK细胞疗法
    • TCR-T细胞疗法
    • 其他的
  • 细胞疗法

第六章：美国细胞与基因治疗CDMO市场：依适应症分類的估算与趋势分析

  • 细分仪表板
  • 美国细胞与基因治疗CDMO市场：按适应症分類的波动分析
  • 美国细胞与基因治疗CDMO市场规模及趋势分析（依适应症划分）（2021-2033年）
  • 瘤
  • 感染疾病
  • 神经系统疾病
  • 罕见疾病
  • 其他的

第七章 竞争情势

  • 公司分类
  • 美国细胞和基因治疗CDMO市场份额分析（2024年）
  • 公司简介
    • Lonza
    • Catalent, Inc.
    • Cytiva
    • Samsung Biologics
    • Thermo Fisher Scientific Inc.
    • Novartis AG
    • WuXi AppTec
    • AGC Biologics
    • OmniaBio
    • Rentschler Biopharma SE
    • Charles River Laboratories
Product Code: GVR-4-68040-736-6

Market Size & Trends:

The U.S. cell and gene therapy CDMO market size was estimated at USD 1.62 billion in 2024 and is projected to reach USD 10.34 billion by 2033, growing at a CAGR of 23.26% from 2025 to 2033. The market is driven by rising investments in advanced therapeutic modalities, increasing approvals of gene and CAR-T therapies, and the growing need for specialized manufacturing capacity. Pharmaceutical and biotech companies are increasingly partnering with CDMOs to overcome bottlenecks in viral vector production, cell expansion, and GMP-compliant facilities, as internal capabilities often cannot keep pace with the rapid innovation in this sector.

The market is primarily driven by the biotechnology and pharmaceutical industries' increased R&D funding and investments in cell and gene therapeutics (CGT). Cell and gene therapies hold significant potential in treating a wide range of diseases, including cancer, genetic disorders, and certain infectious diseases. Hence, owing to the great potential of these therapeutics, there has been a considerable increase in interest from both private and public sectors in the development and discovery of innovative cell and gene therapies. Most big pharmaceutical companies are now investing in CGT to create a strong position in the market. There has been a considerable increase in venture capital investments, especially in the life sciences sector.

Furthermore, an increased clinical pipeline and persistent reliance on outsourcing due to the specialized expertise and infrastructure required for production drive market growth. According to the data published by clinicaltrials.org, there are currently over 2,000 ongoing clinical trials in cell and gene therapies progressing through development stages, and each transition from early to late phase amplifies the demand for viral vectors, plasmids, and clinical-grade cell processing. FDA approvals of novel treatments such as Casgevy for sickle cell disease and Elevidys for Duchenne muscular dystrophy in 2023-24, alongside EMA's approval of Roctavian for hemophilia A, highlight the growing momentum of advanced therapies entering the commercial stage.

Most small and mid-sized biotech firms pioneering these innovations lack large-scale GMP facilities, making partnerships with CDMOs essential to reach patients. To meet this surge, leading players like Lonza, Catalent, WuXi Advanced Therapies, and Thermo Fisher have invested heavily in expanding viral vector and cell therapy capacity, indicating strong confidence in sustained outsourcing demand. Together, these drivers position the market for sustained high growth as approvals accelerate, pipelines deepen, and manufacturing needs outpace in-house capabilities.

U.S. Cell And Gene Therapy CDMO Market Report Segmentation

This report forecasts revenue growth at country levels 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 CDMO market report based on phase, product, and indication.

  • Phase Outlook (Revenue, USD Million, 2021 - 2033)
  • Pre-clinical
  • Clinical
  • Product Outlook (Revenue, USD Million, 2021 - 2033)
  • Gene Therapy
    • Ex-vivo
    • In-vivo
  • Gene-Modified Cell Therapy
    • CAR T-cell therapies
    • CAR-NK cell therapy
    • TCR-T cell therapy
  • Cell Therapy
  • Indication Outlook (Revenue, USD Million, 2021 - 2033)
  • Oncology
  • Infectious Diseases
  • Neurological disorders
  • Rare Diseases
  • Others

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation and Scope
  • 1.2. Market Definitions
  • 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 Primary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Snapshot
  • 2.3. Competitive Landscape Snapshot

Chapter 3. U.S. Cell And Gene Therapy CDMO Market: Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent Market Outlook
    • 3.1.2. Ancillary Market Outlook
  • 3.2. U.S. Cell And Gene Therapy CDMO Market Dynamics
    • 3.2.1. Market Driver Impact Analysis
    • 3.2.2. Market Restraint Analysis
  • 3.3. Technological Landscape
  • 3.4. Pricing Model Analysis
  • 3.5. U.S. Cell And Gene Therapy CDMO Market: Analysis Tools
    • 3.5.1. Porter's Five Forces Analysis
    • 3.5.2. PESTEL Analysis

Chapter 4. U.S. Cell And Gene Therapy CDMO Market: Service Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. Cell And Gene Therapy CDMO Market Phase Movement Analysis
  • 4.3. U.S. Cell And Gene Therapy CDMO Market Size & Trend Analysis, by Phase, 2021 to 2033 (USD Million)
  • 4.4. Pre-clinical
    • 4.4.1. Pre-clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5. Clinical
    • 4.5.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Cell And Gene Therapy CDMO Market: Product Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. U.S. Cell And Gene Therapy CDMO Market Product Movement Analysis
  • 5.3. U.S. Cell And Gene Therapy CDMO Market Size & Trend Analysis, by Product, 2021 to 2033 (USD Million)
  • 5.4. Gene Therapy
    • 5.4.1. Gene Therapy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.2. Ex-vivo
      • 5.4.2.1. Ex-vivo Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.3. In-vivo
      • 5.4.3.1. In-vivo Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Gene-Modified Cell Therapy
    • 5.5.1. Gene-Modified Cell Therapy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.5.2. CAR T-cell therapies
      • 5.5.2.1. CAR T-cell therapies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.5.3. CAR-NK cell therapy
      • 5.5.3.1. CAR-NK cell therapy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.5.4. TCR-T cell therapy
      • 5.5.4.1. TCR-T cell therapy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.5.5. Other
      • 5.5.5.1. Other Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.6. Cell Therapy
    • 5.6.1. Cell Therapy Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Cell And Gene Therapy CDMO Market: Indication Estimates & Trend Analysis

  • 6.1. Segment Dashboard
  • 6.2. U.S. Cell And Gene Therapy CDMO Market Indication Movement Analysis
  • 6.3. U.S. Cell And Gene Therapy CDMO Market Size & Trend Analysis, by Indication, 2021 to 2033 (USD Million)
  • 6.4. Oncology
    • 6.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5. Infectious Diseases
    • 6.5.1. Infectious Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6. Neurological disorders
    • 6.6.1. Neurological disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.7. Rare Diseases
    • 6.7.1. Rare Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.8. Others
    • 6.8.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Competitive Landscape

  • 7.1. Company Categorization
  • 7.2. U.S. Cell And Gene Therapy CDMO Market Share Analysis, 2024
  • 7.3. Company Profiles
    • 7.3.1. Lonza
      • 7.3.1.1. Company overview
      • 7.3.1.2. Financial performance
      • 7.3.1.3. Product benchmarking
      • 7.3.1.4. Strategic initiatives
    • 7.3.2. Catalent, Inc.
      • 7.3.2.1. Company overview
      • 7.3.2.2. Financial performance
      • 7.3.2.3. Product benchmarking
      • 7.3.2.4. Strategic initiatives
    • 7.3.3. Cytiva
      • 7.3.3.1. Company overview
      • 7.3.3.2. Financial performance
      • 7.3.3.3. Product benchmarking
      • 7.3.3.4. Strategic initiatives
    • 7.3.4. Samsung Biologics
      • 7.3.4.1. Company overview
      • 7.3.4.2. Financial performance
      • 7.3.4.3. Product benchmarking
      • 7.3.4.4. Strategic initiatives
    • 7.3.5. Thermo Fisher Scientific Inc.
      • 7.3.5.1. Company overview
      • 7.3.5.2. Financial performance
      • 7.3.5.3. Product benchmarking
      • 7.3.5.4. Strategic initiatives
    • 7.3.6. Novartis AG
      • 7.3.6.1. Company overview
      • 7.3.6.2. Financial performance
      • 7.3.6.3. Product benchmarking
      • 7.3.6.4. Strategic initiatives
    • 7.3.7. WuXi AppTec
      • 7.3.7.1. Company overview
      • 7.3.7.2. Financial performance
      • 7.3.7.3. Product benchmarking
      • 7.3.7.4. Strategic initiatives
    • 7.3.8. AGC Biologics
      • 7.3.8.1. Company overview
      • 7.3.8.2. Financial performance
      • 7.3.8.3. Product benchmarking
      • 7.3.8.4. Strategic initiatives
    • 7.3.9. OmniaBio
      • 7.3.9.1. Company overview
      • 7.3.9.2. Financial performance
      • 7.3.9.3. Product benchmarking
      • 7.3.9.4. Strategic initiatives
    • 7.3.10. Rentschler Biopharma SE
      • 7.3.10.1. Company overview
      • 7.3.10.2. Financial performance
      • 7.3.10.3. Product benchmarking
      • 7.3.10.4. Strategic initiatives
    • 7.3.11. Charles River Laboratories
      • 7.3.11.1. Company overview
      • 7.3.11.2. Financial performance
      • 7.3.11.3. Product benchmarking
      • 7.3.11.4. Strategic initiatives

List of Tables

  • Table 1 List of abbreviation
  • Table 2 U.S. Cell And Gene Therapy CDMO Market estimates and forecasts, by phase, 2021 - 2033 (USD Million)
  • Table 3 U.S. Cell And Gene Therapy CDMO Market estimates and forecasts, by product, 2021 - 2033 (USD Million)
  • Table 4 U.S. Cell And Gene Therapy CDMO Market estimates and forecasts, by indication, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 U.S. Cell And Gene Therapy CDMO Market segmentation
  • Fig. 2 Market research process
  • Fig. 3 Information procurement
  • Fig. 4 Primary research pattern
  • Fig. 5 Market research approaches
  • Fig. 6 Market formulation & validation
  • Fig. 7 Commodity flow analysis
  • Fig. 8 Value-Chain-Based Sizing & Forecasting
  • Fig. 9 QFD model sizing & forecasting
  • Fig. 10 Bottom-up approach
  • Fig. 11 Market snapshot
  • Fig. 12 Segment snapshot
  • Fig. 13 Segment snapshot
  • Fig. 14 Segment snapshot
  • Fig. 15 Competitive landscape snapshot
  • Fig. 16 Parent market outlook, 2024 (USD Million)
  • Fig. 17 Ancillary market outlook, 2024 (USD Million)
  • Fig. 18 U.S. Cell And Gene Therapy CDMO Market dynamics
  • Fig. 19 Total R&D drug pipeline size, 2021 - 2024
  • Fig. 20 Total drug pipeline by development phase, 2024
  • Fig. 21 Porter's five forces analysis
  • Fig. 22 PESTEL analysis
  • Fig. 23 U.S. Cell And Gene Therapy CDMO Market Phase outlook: Segment dashboard
  • Fig. 24 U.S. Cell And Gene Therapy CDMO Market, by Phase segment: Market share, 2025 & 2033
  • Fig. 25 Pre-clinical market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 26 Clinical market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 U.S. Cell And Gene Therapy CDMO Market Product outlook: Segment dashboard
  • Fig. 28 U.S. Cell And Gene Therapy CDMO Market, by Product segment: Market share, 2025 & 2033
  • Fig. 29 Gene Therapy market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 30 Ex-vivo market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 In-vivo market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 32 Gene-Modified Cell Therapy market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 33 CAR T-cell therapies market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 CAR-NK cell therapy market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 TCR-T cell therapy market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 Cell Therapy market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 37 U.S. Cell And Gene Therapy CDMO Market Indication outlook: Segment dashboard
  • Fig. 38 U.S. Cell And Gene Therapy CDMO Market, by Indication segment: Market share, 2025 & 2033
  • Fig. 39 Oncology market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 Infectious Diseases market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 41 Neurological disorders market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 42 Rare Diseases market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 43 Others market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 44 Market participant categorization
  • Fig. 45 Heat map analysis