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

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

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

상품코드 : 1771753

리서치사 : Grand View Research

발행일 : 2025년 06월

페이지 정보 : 영문 60 Pages

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한글목차

샘플 요청 목록에 추가

시장 규모와 동향 :

미국의 AAV 수탁 개발 및 제조 기관 시장 규모는 2024년에 3억 7,540만 달러로 평가되었고, 2025년부터 2030년까지 연평균 복합 성장률(CAGR) 16.5%로 성장할 것으로 예측됩니다. 이 성장은 주로 척수성 근위축증이나 유전성 망막 장애 등의 희귀한 유전성 질환이나 복잡한 질환을 치료하는 긴급의 필요성에 의해 AAV 벡터를 이용한 유전자 치료의 승인과 채택이 급속히 증가하고 있는 것이 배경에 있습니다. FDA에 따르면 2024년 현재 전 세계적으로 40개 이상의 유전자 치료 제품이 승인되고 있으며, 더 많은 제품이 임상 개발 중이며, 이 분야의 강력한 성장을 반영하고 있습니다.

미국의 AAV 기반 유전자 치료에 대한 수요가 증가함에 따라 임상시험 활동의 현저한 증가를 촉진하고 있습니다. 그리고 생명 공학 기업은 효율적인 벡터 생산과 품질 관리를 위해 전문적인 CDMO를 활용하기 위해 노력하고 있습니다.

정밀한 바이러스 벡터 설계, 정제 및 규제 준수를 수반하는 AAV 벡터 제조의 복잡성은 많은 기업들에게 큰 도전이 되고 있습니다. 그 결과 GMP 등급 제조에 필요한 첨단 기술력을 갖춘 CDMO에 제조를 위탁하는 바이오 기업이 늘고 있습니다. 이러한 아웃소싱의 흐름은 유전자 치료를 신속하고 안전하게 시장에 투입하는데 중요한 타임라인의 단축과 비용 관리에 필수적입니다.

미국의 AAV 수탁 개발 및 제조 기관 시장에서는 주목할 만한 M&A와 전략적 제휴가 이루어져, 그 역동적인 성장과 혁신이 강조되고 있습니다. 2023년 11월, AAV에 특화된 CDMO로서 유명한 Forge Biologics가 Ajinomoto 주식회사에 6억 2,000만 달러에 인수되었습니다. 2023년 10월, Andelyn Biosciences는 Purespring Therapeutics와 제휴하여 만성 신장병을 대상으로 하는 유전자 치료의 임상 개발을 가속화합니다.

기업 분류
기업의 시장 포지셔닝
기업 히트맵 분석
기업 프로파일/상장 기업
- Thermo Fisher Scientific Inc.
- Forge Biologics
- Andelyn Biosciences
- National Resilience, Inc.
- Akron Biotech
- ViroCell Biologics, Ltd.
- ElevateBio.
- VintaBio LLC.
- Clover Biopharmaceuticals
- iVexSol

SHW

영문 목차

영문목차

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

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

한글목차

시장 규모와 동향 :

목차

제1장 조사 방법과 범위

제2장 주요 요약

제3장 미국의 AAV 수탁 개발 및 제조 기관 시장 변수, 동향, 범위

제4장 미국의 AAV 수탁 개발 및 제조 기관 시장 : 워크플로우의 추정 및 예측 분석

제5장 미국의 AAV 수탁 개발 및 제조 기관 시장 : 배양 유형의 추정 및 예측 분석

제6장 미국의 AAV 수탁 개발 및 제조 기관 시장 : 용도의 추정 및 예측 분석

제7장 미국의 AAV 수탁 개발 및 제조 기관 시장 : 최종 용도의 추정 및 예측 분석

제8장 경쟁 구도