美国AAV 合约开发与製造组织市场规模、份额、趋势分析报告：按工作流程、文化类型、应用、最终用途、细分市场预测，2025 年至 2030 年

市场规模与趋势：

美国腺相关病毒（AAV）合约研发与製造组织市场规模预计将在2024年达到3.754亿美元，2025年至2030年的复合年增长率为16.5%。这一增长主要源于基于AAV载体的基因疗法核准和应用的快速增长，而这主要源于治疗脊髓性肌肉萎缩症和遗传性视网膜病变等罕见遗传性疾病和复杂疾病的迫切需求。根据美国食品药物管理局（FDA）统计，截至2024年，全球已有40多种基因疗法产品核准，还有更多产品处于临床开发阶段，反映了该领域的强劲成长动能。基因疗法的激增极大地推动了对专业腺结合病毒（AAV）製造服务的需求，而这类服务需要先进的专业知识来确保产品的安全性和有效性。

美国对基于AAV的基因疗法的需求不断增长，推动了临床试验活动的大幅成长。这一激增凸显了对可扩展、合规的生产基础设施的迫切需求，以支持从早期到后期的开发。因此，製药和生物技术公司正在转向专业的CDMO，以实现高效的载体生产和品管。此外，政府和私营部门对基因疗法研究的持续投资正在加速临床试验的启动，进一步推动了对强有力的受託製造支援的需求。

AAV载体製造过程复杂，涉及精确的病毒载体设计、精製和法规遵循，对许多公司构成了重大挑战。因此，越来越多的生物技术公司将生产委託给拥有GMP级生产所需先进技术力的CDMO。这种外包趋势对于缩短生产週期和控製成本至关重要，而这对于快速且安全地将基因疗法推向市场至关重要。

美国腺结合病毒(AAV)受託製造厂商(CDMO) 市场出现了引人注目的併购和策略联盟，凸显了其蓬勃发展和创新的势头。 2023 年 11 月，专注于 AAV 的知名 CDMO 公司 Forge Biologics 被味之素公司以 6.2 亿美元收购。 2023 年 10 月，安德林生物科学公司 (Andelin Biosciences) 与 PureSpring Therapeutics 合作，加速针对慢性肾臟病的基因疗法的临床开发。

目录

第一章调查方法与范围

第二章执行摘要

第 3 章美国AAV 合约开发与製造组织市场变数、趋势与范围

• 市场展望
• 市场动态
  • 市场驱动因素分析
  • 市场限制因素分析
  • 产业挑战
• 产业分析工具
  • 波特分析
  • PESTEL分析

第四章美国AAV 合约开发与製造组织市场：工作流程评估与趋势分析

• 美国AAV 合约开发与製造组织市场（按工作流程）：关键要点
• 2024 年及 2030 年工作流程趋势分析及市场占有率
• 按工作流程，2018-2030
  • 上游处理
  • 下游加工

第五章美国AAV 合约开发与製造组织市场：文化类型估计与趋势分析

• 美国AAV 合约开发与製造组织市场（按培养类型）：关键要点
• 2024年及2030年文化类型变化分析及市场占有率
• 依文化类型，2018-2030 年
  • 贴壁培养
  • 悬浮培养

第六章美国AAV 合约开发与製造组织市场：应用评估与趋势分析

• 美国AAV 合约开发与製造组织市场（按应用）：关键要点
• 2024 年及 2030 年应用趋势分析及市场占有率
• 按应用，2018-2030 年
  • 细胞和基因治疗的发展
  • 疫苗研发
  • 生物製药和药物发现
  • 生物医学研究

第七章美国AAV 合约开发与製造组织市场：最终用途估计与趋势分析

• 美国AAV 合约开发与製造组织市场（按最终用途）：关键要点
• 2024 年和 2030 年最终用途变化分析和市场占有率
• 按应用，2018-2030 年
  • 製药和生物製药公司
  • 学术研究所

第八章 竞争态势

• 公司分类
• 公司市场定位
• 公司热图分析
• 公司简介/上市公司
  • Thermo Fisher Scientific Inc.
  • Forge Biologics
  • Andelyn Biosciences
  • National Resilience, Inc.
  • Akron Biotech
  • ViroCell Biologics, Ltd.
  • ElevateBio.
  • VintaBio LLC.
  • Clover Biopharmaceuticals
  • iVexSol

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

List of Tables

• Table 1 List of abbreviations
• Table 2 U.S. AAV contract development and manufacturing organization market: key market driver analysis
• Table 3 U.S. AAV contract development and manufacturing organization market: Key market restraint analysis
• Table 4 U.S. AAV contract development and manufacturing organization market estimates and forecast, by workflow (USD Million)
• Table 5 U.S. AAV contract development and manufacturing organization market estimates and forecast, by culture type (USD Million)
• Table 6 U.S. AAV contract development and manufacturing organization market estimates and forecast, by application (USD Million)
• Table 7 U.S. AAV contract development and manufacturing organization market estimates and forecast, by end use (USD Million)
• Table 8 Recent developments and impact analysis by key market participants
• Table 9 Company heat map analysis, 2024
• Table 10 Companies implementing key strategies

List of Figures

• Fig. 1 U.S AAV contract development and manufacturing organization market segmentation
• Fig. 2 Market research process
• Fig. 3 Information procurement
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Value chain-based sizing and forecasting
• Fig. 7 Parent market analysis
• Fig. 8 Market formulation and validation
• Fig. 9 U.S AAV contract development and manufacturing organization market snapshot
• Fig. 10 U.S AAV contract development and manufacturing organization market segment snapshot
• Fig. 11 U.S AAV contract development and manufacturing organization market competitive landscape snapshot
• Fig. 12 Market research process
• Fig. 13 Market driver relevance analysis (Current and future impact)
• Fig. 14 Market restraint relevance analysis (Current and future impact)
• Fig. 15 U.S AAV contract development and manufacturing organization market: Workflow outlook key takeaways (USD Million)
• Fig. 16 U.S AAV contract development and manufacturing organization market: Workflow movement analysis 2024 & 2030 (USD Million)
• Fig. 17 Upstream processing market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 18 Downstream processing market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 19 U.S AAV Contract Development and Manufacturing Organization market: Culture Type outlook key takeaways (USD Million)
• Fig. 20 U.S AAV Contract Development and Manufacturing Organization market: Culture Type movement analysis 2024 & 2030 (USD Million)
• Fig. 21 Adherent culture market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 22 Suspension culture market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 23 U.S AAV contract development and manufacturing organization market: Application outlook key takeaways (USD Million)
• Fig. 24 U.S AAV contract development and manufacturing organization market: Application movement analysis 2024 & 2030 (USD Million)
• Fig. 25 Cell & Gene Therapy Development market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 26 Vaccine Developments market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 27 Biopharmaceutical and Pharmaceutical Discovery market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 28 Biomedical Research market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 29 U.S AAV contract development and manufacturing organization market: End Use outlook key takeaways (USD Million)
• Fig. 30 U.S AAV contract development and manufacturing organization market: End Use movement analysis 2024 & 2030 (USD Million)
• Fig. 31 Pharmaceutical and biopharmaceutical companies market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 32 Academic & research institutes market estimates & forecasts, 2018 - 2030 (USD million)
• Fig. 33 Strategy framework
• Fig. 34 Company categorization