The Promise of Cell Therapy Manufacturing
Cell therapy is the transplantation of human cells to replace or repair damaged tissue and/or cells, spanning from blood transfusion to CAR-T cell therapy and from treating cancer and hematologic conditions to autoimmune disease, infectious disease, metabolic disorders, and many more applications. The origin of the cells can be from the patient themselves (autologous) or from a donor (allogenic).
Cell therapies represent an exciting and complex new treatment paradigm, with the potential to treat an enormous range of indications, and in some cases offer the possibility of a cure with only a single treatment.
As of today, there are 6 FDA-approved and marketed cell therapies in the US.
- Carticel - Vericel Corp
- Gintuit - Organogenesis Inc
- Kymriah - Novartis Pharmaceuticals Corp
- Maci - Vericel Corp
- Provenge - Dendreon Pharmaceuticals LLC
- Yescarta - Kite Pharma Inc (Gilead)
Cell therapy manufacturing is still nascent and many manufacturers are utilizing time, space, and labor-intensive techniques that are practical for current volumes but are currently developed to scale for commercial volume and larger patient groups in the future. However, decentralization, proximity to hospitals, and boutique manufacturing for clinical phase I, I/II trials, and for ultra-rare indications will maintain a healthy and flexible niche market for small CDMOs.
Indeed, the current cell therapy contract manufacturing space is fragmented between small contractors including medical centers and big players such as, Wuxi AppTec, Lonza, GE Healthcare. Such big players are heavily invested in capacity building to support the prospective cell therapy pipeline.
Of that current cell therapy pipeline, most candidates are preclinical or in Phase II.
Let’s assume a 5% success rate of all current candidates across the development stages, that leaves us with more than 70 candidates destined for market approval. This creates an incentive for current manufacturing contractors to improve and enhance their abilities to automate many of their processes to handle the upcoming flow of marketed candidates in the years to come.
Although heavy investment has poured in from major players, this shouldn’t hinder smaller contractors from investing in their capabilities, as many early-stage biotech startups will keep relying on smaller contractors to push their most promising candidates forward and to integrate in the point of care system in the growing autologous cell therapy market. We are at an interesting place in time and it’ll be very exciting to see how the market field plays out in the next decade.