Adeno Associated Virus Vector Manufacturing Market Size to Reach USD 4,829.1 Million in 2032
The Adeno Associated Virus Vector Manufacturing market, valued at USD 1,148.4 million in 2024, is expected to register robust revenue CAGR of 19.6%.
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March 14, 2025 - Increase in prevalence of chronic disorders is a key driver of revenue growth in the global Adeno Associated Virus (AAV) Vector Manufacturing market According to the American Lung Association, Cystic fibrosis affects around 40,000 persons in the United States and an estimated 100,000 people worldwide. Approximately one in every thirty people in the United States is a carrier. Over 2,000 mutations in the CFTR gene can cause cystic fibrosis, each of which disrupts chloride ion transport, resulting in thick mucus accumulation, organ malfunction, and electrolyte imbalances. Every year, approximately 1,000 new cases of cystic fibrosis are diagnosed. More than 75% of people with CF are diagnosed by the age of two.
More than half of the CF population is 18 years or older.
On April 2024, Ascend Advanced Therapies (Ascend), an end-to-end gene therapy development partner, has purchased Beacon Therapeutics' Chemistry, Manufacturing, and Controls (CMC) team and Alachua, Florida headquarters. The acquisition adds an operational good manufacturing practice (GMP) facility, process and analytical development capabilities, and new specialists to the Ascend team. It also involves a long-term collaboration with Beacon to continue manufacturing its products for clinical and commercial usage, ensuring product availability and allowing Beacon to focus on clinical research.
However, there are certain hurdles to overcome. Limited manufacturing capacity is a significant impediment to the development of the Adeno Associated Virus (AAV) Vector Manufacturing market. Because of its excellent safety profile and effective transduction to multiple target tissues, adeno-associated virus (AAV) has emerged as a critical platform for gene delivery in the treatment of a wide range of conditions. However, large-scale synthesis and long-term storage of viral vectors are inefficient, resulting in lower yields, moderate purity, and a shorter shelf life compared to recombinant protein therapies. Scaling up requires considerations such as consistency, quality control, and regulatory compliance. One of the most difficult challenges is ensuring that the production process remains consistent and scalable from small laboratory batches to large-scale clinical outputs.
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Segments market overview and growth Insights
Based on the application, the global Adeno Associated Virus (AAV) vector manufacturing market is segmented into gene therapy, vaccine, and cell therapy. Gene therapy segment is expected to register the largest market revenue share during the forecast period Adeno-associated virus (AAV) vectors have emerged as the preferred option in clinical trials and FDA-approved applications. This is due to its broad tissue tropism, low risk profile, and flexible manufacturing techniques. Importantly, AAV is not toxic, seldom integrates into host DNA, and can sustain long-term transgenic expression. Furthermore, vectors based on specific AAV serotypes have an inherent potential to efficiently enter cells and express transgenes, hence increasing transduction efficacy.
On January 2024, Charles River Laboratories International, Inc. has announced the availability of their off-the-shelf Rep/Cap plasmid product, which is intended to expedite AAV-based gene therapy operations. Ready-to-use plasmid products are manufactured and released in accordance with batch production records, and include CMC advice and a Certificate of Analysis (COA) to support IND and CTA filings.
Regional market overview and growth insights
North America held the largest market share in the adeno associated virus vector manufacturing market in 2024, driven by increase in prevalence of chronic disorders and rising demand for gene therapy. According to the Centres for Disease Control and Prevention (CDC), around 47,984 new cancer cases are diagnosed each year in the United States in parts of the body where human papillomavirus (HPV) is often found. HPV causes approximately 37,800 of these cancers. Cervical cancer is the most common HPV-related cancer in women, whereas oropharyngeal cancer is the most common in men.
On February 2024, Form Bio, a cutting-edge provider of computational life sciences solutions, and Ginkgo Bioworks, which is developing the leading platform for cell programming and biosecurity, have announced a new collaboration to provide a complete and holistic solution offering for AAV gene therapy design and development. The combined offering combines the power of Ginkgo's licensable assets, cell lines, and foundry capabilities with Form's award-winning in silico solutions for characterization.
Competitive Landscape and Key Competitors
The Adeno Associated Virus Vector Manufacturing market is characterized by a fragmented structure, with many competitors holding a significant share of the market. List of major players included in the Adeno Associated Virus Vector Manufacturing market report are:
- Thermo Fisher Scientific Inc
- Cytiva
- Hoffman La Roche
- Charles River Laboratories
- Oxford Biomedica PLC
- WuXi AppTec
- Sarepta Therapeutics, Inc.
- AGC Biologics
- Genezen
- Lonza Group
- Catalent Biologics
- Creative Biogene
- Pfizer CentreOne
- Merck KGaA
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Major strategic developments by leading competitors
Polyplus: On September 2023, Polyplus, a division of Satorius, a leading upstream solutions supplier for advanced biologic, cell, and gene therapy production from research to commercial grade, has announced the launch of pPLUS AAV-Helper, which improves AAV production efficiency and lowers cost per dose. The novel pHelper plasmid incorporates new helper components into a distinct sequence, which also improves viral vector quality. pPLUS AAV-Helper plasmid was created using e-Zyvec technology and optimized for transfection using FectoVIR-AAV transfection reagent. The latest inclusion broadens the product line beyond transfection reagents by incorporating another important raw material for the AAV manufacturing process. All goods are accessible at industry-standard quality levels, allowing for smooth scalability.
AGC Biologics: On May 2023, AGC Biologics launches BravoAAV and ProntoLVV viral vector systems. AGC Biologics' new platforms provide fast, efficient, and reproducible clinical and commercial GMP production and release, drawing on three decades of LVV and AAV development, manufacturing, and analytical experience. The CDMO's proprietary process and capsid-specific platform methods can shorten development time, resulting in GMP product in nine months.
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Navistrat Analytics has segmented global Adeno Associated Virus Vector Manufacturing market based on Product, Technology, Application, End-Use, and region:
- Scale of Operations Outlook (Revenue, USD Million; 2022-2032)
- Clinical
- Preclinical
- Commercial
- Method Outlook (Revenue, USD Million; 2022-2032)
- Ex Vivo
- In Vivo
- Purification Outlook (Revenue, USD Million; 2022-2032)
- Chromatography
- Density Gradient Centrifugation
- Ion Exchange Chromatography
- Affinity Chromatography
- Ultrafiltration
- Chromatography
- Therapeutic Area Outlook (Revenue, USD Million; 2022-2032)
- Genetic Disorders
- Neurological Disorders
- Infectious Diseases
- Ophthalmic Disorders
- Hematological Diseases
- Others
- Application Outlook (Revenue, USD Million; 2022-2032)
- Gene Therapy
- Vaccine
- Cell Therapy
- Regional Outlook (Revenue, USD Million; 2022-2032)
- North America
- S.
- Canada
- Mexico
- Europe
- Germany
- France
- K.
- Italy
- Spain
- Benelux
- Nordic Countries
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- South Korea
- Oceania
- ASEAN Countries
- Rest of APAC
- Latin America
- Brazil
- Rest of LATAM
- Middle East & Africa
- GCC Countries
- South Africa
- Israel
- Turkey
- Rest of MEA
- North America
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