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, the analyst 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
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- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
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- Competition strategy and market share analysis
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Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. AAV Contract Development and Manufacturing Organization Market Variables, Trends and Scope
Chapter 4. U.S. AAV Contract Development and Manufacturing Organization Market: Workflow Estimates and Trend Analysis
Chapter 5. U.S. AAV Contract Development and Manufacturing Organization Market: Culture Type Estimates and Trend Analysis
Chapter 6. U.S. AAV Contract Development and Manufacturing Organization Market: Application Estimates and Trend Analysis
Chapter 7. U.S. AAV Contract Development and Manufacturing Organization Market: End Use Estimates and Trend Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
- Thermo Fisher Scientific Inc.
- Forge Biologics
- Andelyn Biosciences
- National Resilience, Inc.
- Akron Biotech
- ViroCell Biologics, Ltd.
- ElevateBio.
- VintaBio LLC.
- Clover Biopharmaceuticals
- iVexSol
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 60 |
| Published | June 2025 |
| Forecast Period | 2024 - 2030 |
| Estimated Market Value ( USD | $ 375.4 Million |
| Forecasted Market Value ( USD | $ 959.2 Million |
| Compound Annual Growth Rate | 16.5% |
| Regions Covered | United States |
| No. of Companies Mentioned | 10 |
