미국의 AAV 수탁 개발 및 제조 기관 시장 : 규모, 점유율, 동향 분석, 워크플로우별, 배양 유형별, 용도별, 최종 용도별, 부문 예측(2025-2030년)

Market Size & Trends:

The U.S. AAV contract development and manufacturing organization market size was valued at USD 375.4 million in 2024 and is expected to grow at a CAGR of 16.5% from 2025 to 2030. This growth is fueled by the rapidly increasing approval and adoption of gene therapies utilizing AAV vectors, driven primarily by the urgent need to treat rare genetic and complex diseases such as spinal muscular atrophy and inherited retinal disorders. According to the FDA, over 40 gene therapy products have been approved globally as of 2024, with many more in clinical development, reflecting robust growth in this field. This surge in gene therapies significantly fuels demand for specialized Adeno-associated virus (AAV) manufacturing services, which require advanced expertise to ensure product safety and efficacy.

The rising demand for AAV-based gene therapies in the U.S. is driving a significant increase in clinical trial activity. This surge highlights the urgent need for scalable, compliant manufacturing infrastructure to support early- to late-stage development. As a result, pharmaceutical and biotech companies are increasingly turning to specialized CDMOs for efficient vector production and quality control. In addition, growing government and private sector investments in gene therapy research are expediting trial initiation, further strengthening the demand for robust contract manufacturing support.

The complexity of manufacturing AAV vectors, which involves precise viral vector design, purification, and regulatory compliance, presents a significant challenge for many companies. As a result, biotech firms increasingly outsource production to CDMOs with the advanced technical capabilities needed for GMP-grade manufacturing. This outsourcing trend is vital for accelerating timelines and managing costs, which are critical in bringing gene therapies to market swiftly and safely.

The U.S. Adeno-Associated Virus (AAV) Contract Development and Manufacturing Organization (CDMO) market has experienced notable mergers and acquisitions (M&A) and strategic collaborations, underscoring its dynamic growth and innovation. In November 2023, Forge Biologics, a prominent AAV-focused CDMO, was acquired by Ajinomoto Co., Inc., for USD 620 million. In October 2023, Andelyn Biosciences partnered with Purespring Therapeutics to accelerate the clinical development of gene therapies targeting chronic kidney diseases.

U.S. AAV Contract Development And Manufacturing Organization Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. AAV contract development and manufacturing organization market report based on workflow, culture type, application, and end use.

• Workflow Outlook (Revenue, USD Million, 2018 - 2030)
• Upstream Processing
  • Vector Amplification & Expansion
  • Vector Recovery & Harvesting
• Downstream Processing
  • Purification
  • Fill Finish
• Culture Type Outlook (Revenue, USD Million, 2018 - 2030)
• Adherent Culture
• Suspension Culture
• Application Outlook (Revenue, USD Million, 2018 - 2030)
• Cell & Gene Therapy Development
• Vaccine Development
• Biopharmaceutical and Pharmaceutical Discovery
• Biomedical Research
• End Use Outlook (Revenue, USD Million, 2018 - 2030)
• Pharmaceutical and Biopharmaceutical Companies
• Academic & Research Institutes
  • Drug Discovery
  • Preclinical
  • Clinical

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definition
• 1.3. Information Procurement
  • 1.3.1. Purchased Database
  • 1.3.2. GVR's Internal Database
  • 1.3.3. Secondary Sources and Third-Party Perspectives
  • 1.3.4. Primary Research
• 1.4. Information Analysis
  • 1.4.1. Data Analysis Models
• 1.5. Market Formulation and Data Visualization
• 1.6. Data Validation and Publishing

Chapter 2. Executive Summary

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

Chapter 3. U.S. AAV Contract Development and Manufacturing Organization Market Variables, Trends and Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
  • 3.2.3. Industry Challenge
• 3.3. Industry Analysis Tools
  • 3.3.1. PORTER's Analysis
    • 3.3.1.1. Bargaining power of the suppliers
    • 3.3.1.2. Bargaining power of the buyers
    • 3.3.1.3. Threats of substitution
    • 3.3.1.4. Threats from new entrants
    • 3.3.1.5. Competitive rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political landscape
    • 3.3.2.2. Economic and social landscape
    • 3.3.2.3. Technological landscape

Chapter 4. U.S. AAV Contract Development and Manufacturing Organization Market: Workflow Estimates and Trend Analysis

• 4.1. U.S. AAV Contract Development and Manufacturing Organization Market, By Workflow: Key Takeaways
• 4.2. Workflow Movement Analysis and Market Share, 2024 and 2030
• 4.3. Market Estimates and Forecasts, By Workflow, 2018 - 2030 (USD Million)
  • 4.3.1. Upstream Processing
    • 4.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 4.3.1.2. Vector Amplification & Expansion
      • 4.3.1.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 4.3.1.3. Vector Recovery & Harvesting
      • 4.3.1.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.3.2. Downstream Processing
    • 4.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 4.3.2.2. Purification
      • 4.3.2.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 4.3.2.3. Fill Finish
      • 4.3.2.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. U.S. AAV Contract Development and Manufacturing Organization Market: Culture Type Estimates and Trend Analysis

• 5.1. U.S. AAV Contract Development and Manufacturing Organization Market, By Culture Type: Key Takeaways
• 5.2. Culture Type Movement Analysis and Market Share, 2024 and 2030
• 5.3. Market Estimates and Forecasts, By Culture Type, 2018 - 2030 (USD Million)
  • 5.3.1. Adherent Culture
    • 5.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.3.2. Suspension Culture
    • 5.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. U.S. AAV Contract Development and Manufacturing Organization Market: Application Estimates and Trend Analysis

• 6.1. U.S. AAV Contract Development and Manufacturing Organization Market, By Application: Key Takeaways
• 6.2. Application Movement Analysis and Market Share, 2024 and 2030
• 6.3. Market Estimates and Forecasts, By Application, 2018 - 2030 (USD Million)
  • 6.3.1. Cell & Gene Therapy Development
    • 6.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.3.2. Vaccine Development
    • 6.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.3.3. Biopharmaceutical and Pharmaceutical Discovery
    • 6.3.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.3.4. Biomedical Research
    • 6.3.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. U.S. AAV Contract Development and Manufacturing Organization Market: End Use Estimates and Trend Analysis

• 7.1. U.S. AAV Contract Development and Manufacturing Organization Market, By End Use: Key Takeaways
• 7.2. End Use Movement Analysis and Market Share, 2024 and 2030
• 7.3. Market Estimates and Forecasts, By End Use, 2018 - 2030 (USD Million)
  • 7.3.1. Pharmaceutical and Biopharmaceutical Companies
    • 7.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.3.2. Academic & Research Institutes
    • 7.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 7.3.2.2. Drug Discovery
      • 7.3.2.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 7.3.2.3. Preclinical
      • 7.3.2.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    • 7.3.2.4. Clinical
      • 7.3.2.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
• 8.2. Company Market Positioning
• 8.3. Company Heat Map Analysis
• 8.4. Company Profiles/Listing
  • 8.4.1. Thermo Fisher Scientific Inc.
    • 8.4.1.1. Company Overview
    • 8.4.1.2. Financial Performance
    • 8.4.1.3. Workflow Portfolio
    • 8.4.1.4. Recent Developments/ Strategic Initiatives
  • 8.4.2. Forge Biologics
    • 8.4.2.1. Company Overview
    • 8.4.2.2. Financial Performance
    • 8.4.2.3. Workflow Portfolio
    • 8.4.2.4. Recent Developments/ Strategic Initiatives
  • 8.4.3. Andelyn Biosciences
    • 8.4.3.1. Company Overview
    • 8.4.3.2. Financial Performance
    • 8.4.3.3. Workflow Portfolio
    • 8.4.3.4. Recent Developments/ Strategic Initiatives
  • 8.4.4. National Resilience, Inc.
    • 8.4.4.1. Company Overview
    • 8.4.4.2. Financial Performance
    • 8.4.4.3. Workflow Portfolio
    • 8.4.4.4. Recent Developments/ Strategic Initiatives
  • 8.4.5. Akron Biotech
    • 8.4.5.1. Company Overview
    • 8.4.5.2. Financial Performance
    • 8.4.5.3. Workflow Portfolio
    • 8.4.5.4. Recent Developments/ Strategic Initiatives
  • 8.4.6. ViroCell Biologics, Ltd.
    • 8.4.6.1. Company Overview
    • 8.4.6.2. Financial Performance
    • 8.4.6.3. Workflow Portfolio
    • 8.4.6.4. Recent Developments/ Strategic Initiatives
  • 8.4.7. ElevateBio.
    • 8.4.7.1. Company Overview
    • 8.4.7.2. Financial Performance
    • 8.4.7.3. Workflow Portfolio
    • 8.4.7.4. Recent Developments/ Strategic Initiatives
  • 8.4.8. VintaBio LLC.
    • 8.4.8.1. Company Overview
    • 8.4.8.2. Financial Performance
    • 8.4.8.3. Workflow Portfolio
    • 8.4.8.4. Recent Developments/ Strategic Initiatives
  • 8.4.9. Clover Biopharmaceuticals
    • 8.4.9.1. Company Overview
    • 8.4.9.2. Financial Performance
    • 8.4.9.3. Workflow Portfolio
    • 8.4.9.4. Recent Developments/ Strategic Initiatives
  • 8.4.10. iVexSol
    • 8.4.10.1. Company Overview
    • 8.4.10.2. Financial Performance
    • 8.4.10.3. Workflow Portfolio
    • 8.4.10.4. Recent Developments/ Strategic Initiatives