Cell and Gene Therapy Biomanufacturing CDMO Market Set to Reach $2.57 Billion by 2033 – BIS Research

Market Overview 

Market Size and Growth Rate 

The global cell and gene therapy biomanufacturing CDMO market, focused on AAV, was valued at $231.3 million in 2022 and is projected to grow at a CAGR of 24.61%, reaching $2,566.6 million by 2033. This growth is attributed to the demand for scalable manufacturing solutions and the increasing adoption of gene therapies to treat rare diseases. 

Trends and Innovations 

Innovations in gene-editing tools, automation in biomanufacturing, and integration of AI-driven quality control systems are reshaping the industry. These advancements are making production processes more efficient, reducing costs, and enhancing product consistency for cell and gene therapies. 

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Key Highlights 

Report USP 

• In-depth competitive analysis and detailed regional insights. 
• Thorough evaluation of demand drivers, challenges, and growth opportunities. 
• Comprehensive regional segmentation and profiles of key industry players. 

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Demand Drivers, Challenges, and Opportunities 

Demand Drivers 

The rising prevalence of genetic disorders and chronic diseases is significantly boosting demand for advanced cell and gene therapies, particularly for conditions previously deemed untreatable. Additionally, the industry shift toward personalized treatments is spurring investments in CDMO capabilities to ensure flexible, scalable biomanufacturing processes that can meet the unique needs of individualized therapies. Furthermore, increased awareness and acceptance of gene therapies among healthcare providers and patients are creating a favorable market environment, encouraging further growth. 

Challenges 

High costs and complex regulatory frameworks continue to present considerable challenges for market expansion. The stringent guidelines for safety, quality, and production standards not only add operational complexity but also lead to increased costs, impacting the affordability of these therapies. Additionally, the limited availability of skilled professionals in biomanufacturing poses a workforce challenge, while frequent regulatory changes can delay product development timelines, affecting market scalability and accessibility for patients in need. 

Opportunities 

The market holds vast opportunities, especially as technological advancements like CRISPR and other gene-editing tools drive rapid therapeutic development. Increased government support, including grants and tax incentives, is accelerating innovation in the biotech sector and fostering collaboration between academia and industry, facilitating new discoveries. There is also a growing trend of strategic partnerships between CDMOs and pharmaceutical companies, enabling quicker market entry for novel therapies and expanding the reach of cell and gene therapies across emerging markets, thus broadening the scope of biomanufacturing growth. 

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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 

Competitive Landscape 

Key Players 

•    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 

Strategic Initiatives 

Leading players are heavily investing in R&D and forming partnerships to enhance their biomanufacturing capabilities. Technological advancements in automation and digital monitoring tools are providing companies with a competitive edge in meeting the growing demand for personalized medicine. 

Case Studies and Success Stories 

A notable example is Lonza’s successful integration of advanced gene-editing tools, which enables efficient and scalable production of cell therapies for various chronic conditions. Through its state-of-the-art biomanufacturing facilities, Lonza has streamlined production processes, reducing costs and time-to-market for therapies. Additionally, the company collaborates closely with biotech firms to develop customized solutions, further accelerating the adoption of gene and cell therapies and addressing the growing demand for personalized treatments. 

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About BIS Research 

BIS Research is a global B2B market intelligence and advisory firm focusing on deep technology and related emerging trends, which can disrupt the market dynamics in the near future. We publish over 200 market intelligence studies annually, focusing on several deep technology verticals.   

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