The global cell & gene therapy (CGT) biomanufacturing market size reached US$ 14.03 billion in 2024 and is anticipate to increase to US$ 15.63 billion in 2025. By 2034, the market is forecasted to achieve a value of around US$ 41.41 billion, growing at a CAGR of 11.43%.
In April 2025, Immune Bio Inc., a clinical-stage biotechnology company, teamed up with the Cell and Gene Therapy Catapult (CGT) to target immunology and inflammation through the innate immune system. Catapult) to develop commercially viable, large-scale production for its cell therapy platforms. Cell and gene therapy industry advancement is the focus of CGT Catapult, an independent technology and innovation organization. It was founded by Innovate UK, with whom it collaborates.
In July 2025, BioTech Social Inc. (BS') and Charles River Laboratories International, Inc. announced that they are investigating a possible client-centric partnership to make the BioTech Funding Portal, an investment crowdfunding platform for life science companies, accessible to participants in the Charles River Incubator (CIP) and Accelerator (CAP) Program.
The industry is shifting from manual to highly specialized automated systems tailored for small-batch and personalized manufacturing needs. These include real-time, inline/online analytics and machine learning based data management to ensure consistent quality and streamlined process control.
This stage involves discovery, preclinical research, and process development for cell and gene therapies. Activities include identifying therapeutic targets, developing viral and non-viral vectors, and optimizing cell culture and gene-editing processes.
Organizations/Companies involved: Novartis – CAR-T therapy development (Kymriah), Gilead Sciences / Kite Pharma – Cell therapy R&D, Bluebird Bio – Gene therapy vector development, University of California, San Francisco (UCSF) – Academic research in CGT, and Harvard Stem Cell Institute – Stem cell and gene therapy research, among others.
This step includes phases I–III clinical trials, regulatory submissions, and approvals from authorities to ensure safety and efficacy.
Organizations/Companies Involved: FDA (U.S.) – Regulatory approvals, EMA (Europe) – Conditional marketing authorizations, Health Canada – Regulatory oversight, Novartis, Gilead Sciences, Bluebird Bio – Conducting multi-center clinical trials, CROs like ICON plc and Parexel – Contract research for clinical trial management
Focuses on cell expansion, viral/non-viral vector production, purification, and fill-finish operations. May involve CDMO partnerships or in-house facilities.
Organizations/Companies Involved: Lonza – CGT contract manufacturing, WuXi AppTec – End-to-end CGT manufacturing, Fate Therapeutics – In-house cell therapy manufacturing, and Samsung Biologics – Process scale-up and manufacturing
Encompasses therapy administration, follow-up, post-marketing safety monitoring, and reimbursement support. Patient engagement and education are crucial due to the personalized therapy complexity.
Organizations/Companies Involved: Novartis Patient Assistance Program – Kymriah therapy support, Gilead Sciences Patient Support – Kite Pharma CAR-T therapies, BioMarin – Genetic disorder therapy support programs, and Local hospitals and oncology centers – Administer and monitor therapy
In December 2024, Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River, announced the introduction of the Charles River Incubator Program (CIP), which focuses on assisting early-stage biotechnology companies in the discovery, development, and phase-appropriate manufacturing of advanced therapies.
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