美國AAV 合約開發與製造組織市場規模、佔有率、趨勢分析報告：按工作流程、文化類型、應用、最終用途、細分市場預測，2025 年至 2030 年

市場規模與趨勢：

美國腺相關病毒（AAV）合約研發與製造組織市場規模預計將在2024年達到3.754億美元，2025年至2030年的複合年成長率為16.5%。這一成長主要源於基於AAV載體的基因療法核准和應用的快速成長，而這主要源於治療脊髓性肌肉萎縮症和遺傳性視網膜病變等罕見遺傳性疾病和複雜疾病的迫切需求。根據美國食品藥物管理局（FDA）統計，截至2024年，全球已有40多種基因療法產品核准，還有更多產品處於臨床開發階段，反映了該領域的強勁成長動能。基因療法的激增極大地推動了對專業腺結合病毒（AAV）製造服務的需求，而這類服務需要先進的專業知識來確保產品的安全性和有效性。

美國對基於AAV的基因療法的需求不斷成長，推動了臨床試驗活動的大幅成長。這一激增凸顯了對可擴展、合規的生產基礎設施的迫切需求，以支持從早期到後期的開發。因此，製藥和生物技術公司正在轉向專業的CDMO，以實現高效的載體生產和品管。此外，政府和私營部門對基因療法研究的持續投資正在加速臨床試驗的啟動，進一步推動了對強力的受託製造支援的需求。

AAV載體製造過程複雜，涉及精確的病毒載體設計、精製和法規遵循，對許多公司構成了重大挑戰。因此，越來越多的生物技術公司將生產委託給擁有GMP級生產所需先進技術力的CDMO。這種外包趨勢對於縮短生產週期和控制成本至關重要，而這對於快速且安全地將基因療法推向市場至關重要。

美國腺結合病毒(AAV)受託製造廠商(CDMO) 市場出現了引人注目的併購和策略聯盟，凸顯了其蓬勃發展和創新的勢頭。 2023 年 11 月，專注於 AAV 的知名 CDMO 公司 Forge Biologics 被味之素公司以 6.2 億美元收購。 2023 年 10 月，安德林生物科學公司 (Andelin Biosciences) 與 PureSpring Therapeutics 合作，加速針對慢性腎臟病的基因療法的臨床開發。

目錄

第1章調查方法與範圍

第2章執行摘要

第 3 章美國AAV 合約開發與製造組織市場變數、趨勢與範圍

• 市場展望
• 市場動態
  • 市場促進因素分析
  • 市場限制因素分析
  • 產業挑戰
• 產業分析工具
  • 波特分析
  • PESTEL分析

第4章美國AAV 合約開發與製造組織市場：工作流程評估與趨勢分析

• 美國AAV 合約開發與製造組織市場（按工作流程）：關鍵要點
• 2024 年及 2030 年工作流程趨勢分析及市場佔有率
• 按工作流程，2018-2030
  • 上游處理
  • 下游加工

第5章美國AAV 合約開發與製造組織市場：文化類型估計與趨勢分析

• 美國AAV 合約開發與製造組織市場（按培養類型）：關鍵要點
• 2024年及2030年文化類型變化分析及市場佔有率
• 依文化類型，2018-2030 年
  • 貼壁培養
  • 懸浮培養

第6章美國AAV 合約開發與製造組織市場：應用評估與趨勢分析

• 美國AAV 合約開發與製造組織市場（按應用）：關鍵要點
• 2024 年及 2030 年應用趨勢分析及市場佔有率
• 按應用，2018-2030 年
  • 細胞和基因治療的發展
  • 疫苗研發
  • 生物製藥和藥物發現
  • 生物醫學研究

第7章美國AAV 合約開發與製造組織市場：最終用途估計與趨勢分析

• 美國AAV 合約開發與製造組織市場（按最終用途）：關鍵要點
• 2024 年和 2030 年最終用途變化分析和市場佔有率
• 按應用，2018-2030 年
  • 製藥和生物製藥公司
  • 學術研究所

第8章 競爭態勢

• 公司分類
• 公司市場定位
• 公司熱圖分析
• 公司簡介/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