The next wave of cell and gene therapies is coming
By World Courier
From pipeline to patients: preparing for the next wave of cell and gene therapies
The pipeline for cell, gene, and RNA therapies points to enormous potential. There are currently 4,487 therapies in development globally, spanning preclinical research through to pre-registration.1 Yet still only a small proportion of therapies break through.
That contrast highlights both the opportunity ahead and the complexity involved in turning scientific innovation into treatments that can reach patients.
As more therapies progress through development, readiness will be critical. Decisions made early can have consequences much further along the journey, particularly when a therapy moves from the controlled environment of a clinical trial towards commercial scale.
Looking beyond the next immediate milestone is therefore essential. Regulatory requirements, clinical trial design, supply chain strategy, specialist logistics, distribution, pharmacovigilance, and eventual patient access can all influence the path towards commercialization. Considering these areas together can help development teams anticipate potential challenges and understand how decisions made at one stage may affect requirements further along the journey.
Collaboration starts early
No organization can internally provide every specialist capability required to bring an advanced therapy to patients. The right external expertise can help development teams anticipate what comes next and build those considerations into their plans earlier.
This is particularly important for cell and gene therapies (CGTs), which can present complex manufacturing and clinical requirements.² Products may also have specific handling, storage, transportation, and distribution requirements.³
Early collaboration gives partners the opportunity to understand the therapy, its development pathway, and the challenges that could emerge as it progresses. It can also help developers consider whether processes designed for today's clinical requirements will remain appropriate when volumes increase, new markets are introduced, or a therapy approaches commercialization.
Connecting expertise across the journey
Collaboration also becomes more valuable when expertise is connected across different stages of development.
Cencora brings together capabilities spanning areas including consulting, specialty logistics, distribution, and pharmacovigilance. Connecting those perspectives can help developers look further ahead, identify dependencies between different parts of the commercialization journey, and prepare for the requirements that may follow. The size of today's pipeline suggests many organizations could find themselves addressing these questions in the years ahead. The latest ASGCT landscape report recorded eight new gene, cell, and RNA therapy approvals in the second quarter of 2026 alone.1
For the thousands of therapies still progressing through development, scientific potential is only the beginning.
Early readiness, specialist expertise, and collaboration across the development journey can help create a stronger path from pipeline to patients.
References
- American Society of Gene & Cell Therapy (ASGCT) and Citeline, Gene, Cell, & RNA Therapy Landscape Report, Q2 2026.
- U.S. Food and Drug Administration (FDA), Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products: Guidance for Industry, August 2026. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-developing-potential-cellular-and-gene-therapy-products
- European Medicines Agency (EMA), Guidance on good manufacturing practice and good distribution practice: Questions and answers. Available at https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers
