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米国のAAV受託開発・製造機関市場規模、シェア、動向分析レポート：ワークフロー別、培養タイプ別、用途別、最終用途別、セグメント予測、2025年～2030年

U.S. AAV Contract Development And Manufacturing Organization Market Size, Share & Trends Analysis Report By Workflow, By Culture Type, By Application, By End Use, And Segment Forecasts, 2025 - 2030

出版日
ページ情報
英文 60 Pages
納期
2～10営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=148.47円
米国のAAV受託開発・製造機関市場規模、シェア、動向分析レポート：ワークフロー別、培養タイプ別、用途別、最終用途別、セグメント予測、2025年～2030年
出版日: 2025年06月24日
発行: Grand View Research
ページ情報: 英文 60 Pages
納期: 2～10営業日
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  • 概要
  • 図表
  • 目次
概要

市場規模と動向：

米国のAAV受託開発・製造機関の市場規模は2024年に3億7,540万米ドルとなり、2025年から2030年にかけてCAGR 16.5％で成長すると予測されています。

この成長は、主に脊髄性筋萎縮症や遺伝性網膜障害などの希少な遺伝性疾患や複雑な疾患を治療する緊急の必要性によって、AAVベクターを利用した遺伝子治療の承認と採用が急速に増加していることが背景にあります。FDAによると、2024年現在、世界で40以上の遺伝子治療製品が承認されており、さらに多くの製品が臨床開発中で、この分野の力強い成長を反映しています。このような遺伝子治療の急増は、製品の安全性と有効性を確保するために高度な専門知識を必要とする、専門的なアデノ随伴ウイルス（AAV）製造サービスへの需要を大きく促進しています。

米国におけるAAVベースの遺伝子治療に対する需要の高まりは、臨床試験活動の大幅な増加を促しています。この急増は、初期段階から後期段階の開発をサポートするための、スケーラブルで準拠性の高い製造インフラの緊急ニーズを浮き彫りにしています。その結果、製薬会社やバイオテクノロジー企業は、効率的なベクター生産と品質管理のために、専門のCDMOを利用するようになってきています。加えて、遺伝子治療研究に対する政府および民間セクターの投資拡大が試験開始を迅速化し、強固な製造受託サポートへの需要をさらに強めています。

精密なウイルスベクター設計、精製、規制遵守を伴うAAVベクター製造の複雑さは、多くの企業にとって大きな課題となっています。その結果、GMPグレードの製造に必要な高度な技術力を持つCDMOに製造を委託するバイオ企業が増えています。このようなアウトソーシングの流れは、遺伝子治療を迅速かつ安全に市場に投入する上で重要な、タイムラインの短縮とコスト管理に不可欠です。

米国のアデノ随伴ウイルス（AAV）開発・製造受託機関（CDMO）市場では、注目すべきM&Aや戦略的提携が行われ、そのダイナミックな成長とイノベーションが強調されています。2023年11月、AAVに特化したCDMOとして著名なForge Biologicsが味の素株式会社に6億2,000万米ドルで買収されました。2023年10月、アンデリン・バイオサイエンシズはピュアスプリング・セラピューティクスと提携し、慢性腎臓病をターゲットとする遺伝子治療の臨床開発を加速します。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 米国のAAV受託開発・製造機関の市場変数、動向、範囲

  • 市場系統の見通し
  • 市場力学
    • 市場促進要因分析
    • 市場抑制要因分析
    • 業界の課題
  • 業界分析ツール
    • PORTERの分析
    • PESTEL分析

第4章 米国のAAV受託開発・製造組織市場：ワークフローの推定・動向分析

  • 米国のAAV受託開発・製造組織市場、ワークフロー別：主なポイント
  • ワークフローの変動分析と市場シェア、2024年と2030年
  • ワークフロー別、2018年～2030年
    • 上流処理
    • 下流処理

第5章 米国のAAV受託開発・製造機関市場：培養タイプの推定・動向分析

  • 米国のAAV受託開発・製造組織市場（培養タイプ別）：主なポイント
  • 文化タイプの変動分析と市場シェア、2024年と2030年
  • 文化タイプ別、2018年～2030年
    • 接着培養
    • 懸濁培養

第6章 米国のAAV受託開発・製造機関市場：用途の推定・動向分析

  • 米国のAAV受託開発・製造組織市場（用途別）：主なポイント
  • 用途変動分析と市場シェア、2024年および2030年
  • 用途別、2018年～2030年
    • 細胞・遺伝子治療開発
    • ワクチン開発
    • バイオ医薬品および医薬品の発見
    • 生物医学調査

第7章 米国のAAV受託開発・製造機関市場：最終用途の推定・動向分析

  • 米国のAAV受託開発・製造機関市場（最終用途別）：主なポイント
  • 最終用途変動分析と市場シェア、2024年および2030年
  • 用途別、2018年～2030年
    • 製薬会社およびバイオ医薬品会社
    • 学術研究機関

第8章 競合情勢

  • 企業分類
  • 企業の市場ポジショニング
  • 企業ヒートマップ分析
  • 企業プロファイル/上場企業
    • Thermo Fisher Scientific Inc.
    • Forge Biologics
    • Andelyn Biosciences
    • National Resilience, Inc.
    • Akron Biotech
    • ViroCell Biologics, Ltd.
    • ElevateBio.
    • VintaBio LLC.
    • Clover Biopharmaceuticals
    • iVexSol
図表

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
目次
Product Code: GVR-4-68040-636-2

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