Cell and Gene Therapy Biomanufacturing CDMO Market to Reach $2.56 Billion by 2033

28 May 2024

The global market for cell and gene therapy biomanufacturing CDMOs, specifically those concentrating on Adeno-Associated Virus (AAV), is experiencing a phase of growth. Gene therapies utilizing AAV have attracted considerable focus and research investment, which has fueled a surge in demand for CDMOs that specialize in this area. This heightened interest largely stems from the capability of AAV-based treatments to address a range of genetic conditions and diseases.  

In 2022, the global market for cell and gene therapy biomanufacturing CDMOs concentrating on AAV was estimated at $231.3 million and is projected to reach $2,566.6 million by 2033. This market is expected to grow at a compound annual growth rate (CAGR) of 24.61% from 2023 to 2033.  

The anticipated expansion in the AAV-focused cell and gene therapy biomanufacturing CDMO sector is likely to be propelled by an increase in clinical trials involving viral-vector based gene therapies, along with substantial investments by CDMOs in enhancing both viral-vector manufacturing capabilities and research into gene therapies.  

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Cell and Gene Therapy Biomanufacturing CDMO Market Overview 

Partnerships and collaborations between therapy developers and CDMOs are instrumental in expediting the release of innovative AAV-based therapies. Through such collaborations, developers can concentrate on research and clinical efforts while delegating the manufacturing tasks to CDMOs. This collaborative model not only speeds up production but also shortens the time-to-market for these groundbreaking therapies. Moreover, significant investments in research and development are propelling advancements in this field, opening up new avenues for therapeutic innovation. 

However, the global market for cell and gene therapy biomanufacturing CDMOs focused on AAV faces several challenges. A primary issue is the need to scale up production while adhering to stringent quality control standards. With rising demand for AAV-based therapies, CDMOs must enhance their manufacturing processes to support increased production volumes without sacrificing quality. 

Furthermore, the market is experiencing heightened competition as more CDMOs enter the industry to cater to the growing demand. This increased competition could lead to price wars and potentially lower profit margins, potentially affecting the financial sustainability of CDMOs.  

Market Segmentation: 

Segmentation 1: by Phase of Development 
• Clinical Phases I 
• Clinical Phases II 
• Clinical Phases III 
• Commercial Phase 

Segmentation 2: by Workflow 
• Upstream Processing 
• Downstream Processing 
• Formulation, Fill & Finish 

Segmentation 3: by Indication 
• Oncology 
• Ophthalmology 
• Infectious Diseases 
• Metabolic Disorder 
• Neurological Disorder 
• Other 

Segmentation 4: by Culture Type 
• Adherent Culture 
• Suspension Culture 

Segmentation 5: by Region 
• North America 
• Europe 
• Asia-Pacific 
• Latin America 
• Middle East and Africa 

Demand Drivers, Restraints and Opportunities in the Cell and Gene Therapy Biomanufacturing CDMO Market  

Market Demand Drivers: 

•    Rise in Preclinical and Clinical Activities around Viral-Vector Based Gene Therapies Propel the Demand for CDMOs in the Market 
•    Increasing Number of Emerging Players in the Cell and Gene Therapy (CGT) Sector Upsurge the Demand for CDMOs Services 
•    High Investment of CDMOs in Advancing Viral-vector Manufacturing and Research in Gene Therapies 

Market Restraints: 

•    Limitations in Development of Analytical Methods for Large-scale Adeno-associated virus (AAV) Biomanufacturing 
•    High Cost of Viral-vector Manufacturing Creates a Challenge for Emerging CDMOs player in the Market 

Market Opportunities: 

•    Development in the Advancements of AAV Biomanufacturing Facilities by Strategic Collaborations of CDMO Services 

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Key Market Players and Competition Synopsis  

The global market for cell and gene therapy biomanufacturing CDMOs focused on AAV is poised for significant growth in the coming years. AAV-based gene therapies have demonstrated considerable potential in treating a range of diseases, resulting in high demand for CDMOs specializing in these therapies. Partnerships between therapy developers and CDMOs are expected to accelerate the availability of these groundbreaking treatments, ultimately transforming patient care and revolutionizing the treatment of genetic disorders and other serious conditions. 

As the market evolves, CDMOs must continue to invest in advanced technologies, robust quality systems, and regulatory compliance to meet the growing demand for AAV-based cell and gene therapies. This high demand is driving the growth of AAV-focused cell and gene therapy CDMO manufacturers, creating ample opportunities for expansion into various geographies and strengthening their market presence. 

Key Companies Profiled: 

•    AGC Biologics. 
•    Charles River Laboratories International, Inc. 
•    Catalent, Inc. 
•    Creative Biogene 
•    Danaher. (Cytiva) 
•    FUJIFILM Diosynth Biotechnologies 
•    Genscript Biotech Corporation (GenScript ProBio) 
•    Lonza. 
•    Merck KGaA 
•    Porton Advanced Solution Ltd. 
•    PackGene Biotech 
•    Oxford Biomedica plc 
•    Thermo Fisher Scientific Inc. (Patheon Pharma Services) 
•    WuXi AppTec 

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Analyst View 

According to Akash Mhaskar, Principal Analyst, BIS Research, “The global cell and gene therapy biomanufacturing CDMO market- focused on AAV is in progressing phase and it is expected to rapidly increase in the forecast period. The market is fueled by the rising demand for AAV-based gene therapies for the treatment of various genetic disorders and diseases. These therapies hold great promise in addressing unmet medical needs, driving research, development, and manufacturing efforts.  

In addition, there have been substantial investments in research and development to advance AAV-based gene therapies. Increased funding and collaborations have accelerated the development of cutting-edge therapies, contributing to the market's growth.”