查看購物車
  • Simplified Chinese
  • English
  • Japanese
封面
市場調查報告書
商品編碼
1842042

美國細胞和基因治療CDMO市場：市場規模、佔有率和趨勢分析（按階段、產品和適應症分類），細分市場預測（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個工作天內

價格

市場規模與趨勢：

美國細胞和基因治療 CDMO 市場預計在 2024 年達到 16.2 億美元，預計到 2033 年將達到 103.4 億美元，2025 年至 2033 年的複合年成長率為 23.26%。

推動這一市場發展的因素包括：對先進治療方法的投資不斷增加、基因療法和CAR-T療法的核准不斷成長，以及對專業化生產能力的需求日益成長。製藥和生物技術公司擴大與合約研發生產機構（CDMO）合作，以克服病毒載體生產、細胞擴增、符合GMP規範的設施等方面的瓶頸。

推動這一市場發展的因素主要是生物技術和製藥產業對細胞和基因療法（CGT）研發投入的增加。細胞和基因療法在治療包括癌症、遺傳性疾病和某些感染疾病在內的多種疾病方面具有巨大潛力。因此，鑑於這些治療方法的巨大潛力，公共和私營部門都對創新細胞和基因治療方法的研發表現出濃厚的興趣。目前，大多數大型製藥公司都在投資CGT，以期在市場中佔據穩固地位。此外，創業投資也顯著增加，尤其是在生命科學領域。

此外，不斷成長的臨床研發管線以及由於生產需要專業技術和基礎設施而對生產外包的持續依賴，也是推動市場成長的因素。根據clinicaltrials.org網站發布的數據，目前有超過2000項正在進行的細胞和基因治療臨床試驗，這些試驗處於不同的研發階段，每次從早期到晚期的過渡都會增加對病毒載體、質體和臨床級細胞處理的需求。 FDA核准Casgevy用於治療鐮狀細胞貧血症，Elevidys用於治療Duchenne氏肌肉失養症（預計2023-2024年上市），以及EMA核准Roctavian用於治療A型血友病（預計2023-2024年上市），都凸顯了先進療法進入商業化階段的強勁勢頭。

「大多數引領這些創新的小型生技公司缺乏大規模的GMP生產設施，迫使它們與合約研發生產力機構（CDMO）合作才能惠及病患。為了因應這項需求激增，龍沙（Lonza）、凱達倫（Catalent）、藥明康德和賽默飛世爾科技等領先企業正大力投資擴大其病毒載體和細胞療法的生產能力，這表明核准對持續的外包需求充滿信心。

目錄

第1章 分析方法和範圍

第2章執行摘要

第3章美國細胞與基因治療CDMO市場：促進因素、趨勢與範圍

  • 市場關聯性展望
  • 美國細胞與基因治療CDMO市場動態
  • 技術格局
  • 定價模式分析
  • 美國細胞與基因治療CDMO市場：分析工具

第4章：美國細胞與基因治療CDMO市場：依階段分類的估算與趨勢分析

  • 細分儀表板
  • 美國細胞與基因治療CDMO市場：按階段分類的趨勢分析
  • 美國細胞基因治療CDMO市場規模及發展趨勢分析（依階段分類，2021-2033年）
  • 臨床前
  • 臨床

第5章：美國細胞與基因治療CDMO市場：依產品分類的估算與趨勢分析

  • 細分儀表板
  • 美國細胞和基因治療CDMO市場：波動分析（按產品分類）
  • 美國細胞及基因治療CDMO市場規模及產品趨勢分析（2021-2033年）
  • 基因治療
    • 體外
    • 體內
  • 基因改造細胞療法
    • CAR-T細胞療法
    • CAR-NK細胞療法
    • TCR-T細胞療法
    • 其他
  • 細胞療法

第6章：美國細胞與基因治療CDMO市場：依適應症分類的估算與趨勢分析

  • 細分儀表板
  • 美國細胞與基因治療CDMO市場：按適應症分類的波動分析
  • 美國細胞與基因治療CDMO市場規模及趨勢分析（依適應症分類）（2021-2033年）
  • 瘤
  • 感染疾病
  • 神經系統疾病
  • 罕見疾病
  • 其他

第7章 競爭情勢

  • 公司分類
  • 美國細胞和基因治療CDMO市場佔有率分析（2024年）
  • 公司簡介
    • 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