Q&A: What It Will Take to Scale CGT Supply Chains

With 20 of the 30 largest biopharma companies by market capitalization now actively investing in the development or commercialization of cell and gene therapies (CGTs), and $11.1 billion in sector funding recorded across 216 financings in 2025 alone, the commercial momentum behind these therapies is undeniable.¹ The pipeline reflects it: more than 4,000 therapies are currently in development, ranging from preclinical through pre-registration.² Biopharma is nearing an inflection point, one at which the supply chain infrastructure required to deliver these therapies must scale as fast as the science behind them.

Where those therapies are administered is changing just as fast. According to the Alliance for Regenerative Medicine, CAR-T cell therapies moved from nearly exclusively inpatient delivery in 2017 to 45% outpatient in 2025, a shift that pushes distribution further into community care settings, broadens the network of sites that require specialized logistics support, and raises the stakes for last-mile cold chain execution.¹

To unpack the implications for 3PLs in this growing sector, Pharmaceutical Commerce spoke with Krystal Haynes, senior director of international 3PL business development at Cencora, on what it will take to get these therapies from manufacturer to patient reliably and at scale.

PC: The Cell and gene therapy market is growing fast. What are the primary challenges in scaling these sensitive and personalized therapies?

Haynes: Gene, cell and RNA therapies don’t fit within the traditional, often patient-specific pharmaceutical model, and come with complex storage and transportation requirements that demand precise handling and strict temperature control throughout the journey.

One critical consideration is maintaining a precise chain of identity and chain of custody from vein to vein. Patient-specific packaging and labeling, supported by redundant verification processes reduces risk, prevent mix-ups, and ensures the right therapy remains connected to the right patient throughout the journey.

Storage and handling are equally important. Many of these therapies require ultra-low or cryogenic storage, validated controls, continuous monitoring, and rapid deviation response to protect product integrity at every step. As organizations move from clinical development to commercial launch, this places even more importance on specialized infrastructure, quality systems and site readiness.

Distribution must also be tightly orchestrated. Time-critical logistics with real-time visibility are needed to help make sure the right product reaches the right patient at the right time and under the right conditions, aligned with treatment schedules. This ‘4D distribution’ mindset is imperative to scaling personalized therapies safely and reliably.

Scaling successfully starts with understanding each therapy’s bespoke needs and recognizing how decisions across channel strategy, distribution, and site readiness connect. This requires thinking about logistics, site readiness, and access much earlier in development, rather than trying to solve for them closer to launch. What makes the difference is being able to translate these considerations into practical, coordinated processes that hold up across all stakeholders.

Where are you seeing the most critical supply chain bottlenecks in this space today? Which constraints are proving hardest for organizations to solve?

Many of the most pressing bottlenecks stem from the operational realities of moving these therapies globally. Customs clearance, documentation accuracy, and maintaining strict temperature conditions across borders all present challenges, especially when timelines are tight and shipments are highly sensitive. Even small disruptions, like a delay at customs or a gap in documentation, can slow things down and have a significant downstream impact, ultimately affecting when a patient is able to receive treatment.

Another constraint is that these supply chains are still evolving. Complex requirements cannot always be fully assessed through planning alone, so organizations need to validate the physical flow of therapies through hands-on testing. Areas like packaging, labeling, and site readiness tend to surface issues that are difficult to anticipate upfront, which is why they continue to be some of the hardest challenges to resolve quickly.

Reliability is everything for patient-specific therapies. How are leading organizations building more resilient, end-to-end delivery models?

Leading organizations are putting a focus on end-to-end coordination and visibility across the full supply chain. That includes real-time monitoring of shipments, more proactive customs pre-clearance, and having contingency plans in place, such as alternate routing or backup storage, so there is a clear path forward if disruptions occur.

They are also spending more time on cross-functional alignment. Successful programs establish clear roles and accountability across teams and invest in detailed end-to-end value stream mapping. Reliability in this space doesn’t come from a single function; it comes from coordinated execution and whether teams are prepared to manage exceptions along the way.

What will separate companies that successfully scale cell and gene therapy supply chains from those that struggle?

Organizations that scale successfully tend to recognize early that these therapies require flexible solutions and customizable support models. Rather than trying to force standard approaches to fit, they build strategies that reflect the unique demands of cell and gene therapies and can evolve as those needs change.

They also place a strong focus on readiness and collaboration. With a growing pipeline and relatively few therapies (only 3% of CGTs) approved today, there is a clear need to prepare for what’s ahead. Companies that engage stakeholders early and understand site requirements in advance are better positioned to scale effectively and consistently. They think realistically about scalability and how these therapies will be delivered across sites, looking beyond just how they are manufactured.

How does the industry need to rethink supply chain design to support reliable growth for personalized therapies?

Supply chain design is becoming more interconnected and patient-centric, and it needs to be approached that way. Decisions around distribution, site onboarding, and packaging are closely linked, so supply chain models need to reflect that level of coordination. If those decisions aren’t aligned early, it can create delays in how therapies move through the supply chain and most importantly, in patient access.

There is also a need to move beyond high-level planning and start validating how therapies will move in practice. This includes testing the physical flow of therapies, accounting for exception management and master data, and ensuring that elements like labeling and packaging are aligned early to avoid delays.

At the end of the day, supporting reliable growth comes down to supply chains that are flexible, coordinated, and designed around the realities of how these therapies are delivered in practice.

References

1. Alliance for Regenerative Medicine. State of the Industry Briefing. January 12, 2026. https://alliancerm.org/wp-content/uploads/2026/01/SOTI-2026-Industry-Update.pdf
2. American Society of Gene & Cell Therapy. Gene, Cell, & RNA Therapy Landscape Report: Q1 2026 Quarterly Data Report. Citeline, a Norstella Company. April 2026. https://www.asgct.org/uploads/files/general/Landscape-Report-2026-Q1.pdf