The cell and gene therapy manufacturing market is set to experience significant growth, expanding from an estimated USD 5.08 billion in 2024 to USD 22.88 billion by 2034, with a compound annual growth rate (CAGR) of 16.25% from 2025 to 2034. This growth is fueled by the rapidly advancing biotechnology sector, increasing cell and gene therapy research, and growing investments in the field.
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Cell and gene therapy manufacturing involves the large-scale production of therapies designed to treat diseases by using cells and genes. Cell therapy entails transplanting cells into patients to replace or repair damaged tissues, while gene therapy involves modifying genes within a patient’s cells to treat or prevent diseases. Both therapies require highly specialized manufacturing processes.
The steps involved in cell therapy manufacturing include sourcing and isolating cells, activating and genetically modifying them, and expanding and culturing them. Gene therapy manufacturing includes viral vector expression, cell growth, harvesting viral vectors, and filtration and purification.
As cell and gene therapies show great promise, particularly in cancer treatment, they are attracting substantial interest. The complexity of the sector has led to the rise of Contract Development and Manufacturing Organizations (CDMOs) to help streamline the production of these therapies.
For instance, in August 2022, Cytiva (a subsidiary of Danaher Corporation) partnered with Forecyte Bio, a CDMO for cell and gene therapy, to accelerate the development and manufacturing of therapies in China and the U.S. Forecyte Bio is utilizing Cytiva’s Flex Factory platform to support its CDMO operations.
Josh Ludwig, Global Director of Operations at ScaleReady, shared his perspective on the future direction of cell and gene therapy. He highlighted a significant shift that is expected to take place, moving away from autologous therapies and toward allogeneic approaches. This shift is anticipated to bring more durable responses and could potentially transform the market by eliminating the need for viral vectors like lentivirus and retrovirus. Instead, the focus will be on nonviral gene-editing techniques, which promise to create off-the-shelf versions of CAR-T therapies, ultimately reducing production costs and increasing accessibility for patients.
In October 2024, a promising collaboration was announced between Cellular Origins and Fresenius Kabi. This partnership aims to incorporate Fresenius Kabi’s advanced cell therapy processing technologies into Cellular Origins’ innovative robotic manufacturing platform, Constellation, which could significantly enhance the scale and efficiency of cell and gene therapy production.
Earlier, in August 2024, PHC Corporation’s Biomedical Division introduced a groundbreaking new system called LiCellGrow, designed to facilitate cell expansion. This system aims to streamline the development of cell and gene therapy products, contributing to more efficient and scalable manufacturing processes.
Additionally, in May 2024, Merck made a strategic move to acquire Mirus Bio for $600 million. This acquisition bolsters Merck’s capabilities in viral vector manufacturing, particularly through Mirus Bio’s advanced transfection reagents. The deal enhances Merck’s integrated offering for the cell and gene therapy market, providing new opportunities for accelerating the development and production of innovative therapies.
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