The growth of cell and gene therapy (CGT) manufacturing has been saved
Perspectives
The growth of cell and gene therapy (CGT) manufacturing
Strategic location considerations
Manufacturing in cell and gene therapies (CGTs) brings unique, strategic considerations regarding locations. Discover why access to talent and proximity to major treatment networks will be key in scaling manufacturing capacity.
Explore content
- The rapid expansion of clinical cell and gene therapies
- Strategic location considerations for CGT manufacturing
- Interested in expanding your CGT manufacturing footprint?
- Get in touch
- Endnotes
The rapid expansion of clinical cell and gene therapies
Since the first approval in 2017, the US Food and Drug Administration (FDA) has approved 32 CGT products and is expected to approve 10–20 therapies annually by 2025.1 This reflects an enthusiasm for their potential to cure or significantly improve the management of diseases that have historically had no treatment options.
- Cell therapies involve the transfer of intact and live cells into the body to replace damaged or diseased cells—and have made a significant impact on the treatment of blood cancers and hematological conditions (lymphomas, leukemias, and multiple myeloma). They are also showing success in clinical trials for the treatment of solid tumors.
- Gene therapies involve the use of genetic material for the treatment or prevention of disease by altering the genes inside the body—and hold promise for treating diseases such as cancer, heart disease, and acquired immunodeficiency syndrome (AIDS), as well as inherited disorders such as cystic fibrosis and sickle cell disease.
Strategic location considerations for CGT manufacturing
Due to location dependencies in CGTs, the proximity of the manufacturing location to the patient treatment center and the ability to safely and efficiently transport the therapy itself are critical parts of the CGT manufacturing approach.
Interested in expanding your CGT manufacturing footprint?
Proximity to major treatment centers, utility costs and rate structures, logistics costs and service solutions, and skilled labor availability are just some of the factors to consider when making a site selection decision. A comprehensive location strategy can help to assess the trade-offs associated with such cost and non-cost factors. Contact the Deloitte Location Strategy Life Sciences working group to learn more.
Endnotes
1 US Food and Drug Administration, “Approved cellular and gene therapy products,” last updated December 8, 2023.
2 Angus Stewart, “Cell and gene: Generating the next generation,” The Medicine Maker, January 9, 2023.
3 Linda D. Ho, Hadassah L. Robbins, and Aaron D. Levine, “Assessing workforce needs for the emerging CAR-T cell therapy industry,” Nature Biotechnology 40 (2022): pp. 275–78.
4 Peter Walters, “Scalability in cell and gene therapy facilities: How today’s developers are preparing for tomorrow’s commercial success,” BioProcess International, April 19, 2022.
5 Sanjay Srivastava et al., “Scaling cell and gene therapy manufacturing operations,” Cell & Gene, October 13, 2020.
6 Patricia Van Arnum, “Cell and gene therapies: Expansions by CDMOs and CMOs and key trends,” DCAT Value Chain Insights, November 3, 2022.
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