미국의 세포 및 유전자 치료 CDMO 시장 규모, 점유율, 동향 분석 : 상별, 제품별, 적응증별, 부문별 예측(2025-2033년)

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