2025 Cell and Gene Therapy Report Looks at Industry Challenges

InspiroGene by McKesson released their 2025 Cell and Gene Therapy (CGT) Report, detailing how experts are using CGT technology and the barriers faced by the industry.

The report identifies reimbursement, infrastructure, and geographic patient access as some of the biggest obstacles in the way of further streamlining CGT across the country. The CGT report also states that 90% of payers believe CGTs are safe and effective, and that physician experience has grown over the last year, with the average number of patients treated rising from 17 to 25.1

In an interview with Targeted Oncology, Joe DePinto, head of Cell, Gene, and Advanced Therapies at McKesson, broke down the details of the 2025 CGT study and how that relates to the work of oncologists.

Targeted Oncology: You stated, “The CGT field is reaching an inflection point. Progress is undeniable, but so are the barriers standing in the way of broader access.”¹ Could you expand on the inflection point that the CGT field is reaching, and the barriers being faced currently?

Joe DePinto: The cell and gene therapy marketplace is an exciting market. The science is undeniable. The progress scientifically has been great. You see continuous evolution of the science and products through the phases of development.

While it's still a nascent space, we're at a point where you're starting to see a confluence of factors, including a lot of these products getting to pivotal phases and making the transition from clinical to commercial. That's the point we are at in the market. It's really critical that we understand how to transition from strong clinical science to patients having commercial access to these products. 

There are different challenges and different barriers that exist when you move from clinical to commercial, especially in a place of high science like cell and gene therapy. What we do at InspiroGene is, since we are well-situated in the value chain, we help the key stakeholders, being the biopharma manufacturers, the providers who give the drug, as well as the payers, navigate the complexities of the value chain. Because these products are individualized, they're personalized in many ways. If you've seen one cell or gene therapy, you've only seen one cell or gene therapy, and we try to make it available in a scaled process for the masses.That's what our job is as an enabler of the ecosystem.

Why do you think that reimbursement continues to impede broader access if the payer confidence in the safety and efficacy is high?

This year, in the 2025 cell and gene therapy report, we expanded our audience. Last year focused on the providers, the oncologists, the physicians that give these products. This year we wanted to tackle one of the perceived barriers in the marketplace, which was reimbursement and payer activity. We interviewed government payers, national payers, and regional payers to see their thoughts on cell and gene therapy and how they were handling the commercialization of these products in the marketplace.

What we found is that these payers believe that the scientific breakthrough is significant and that they generally think that these products are safe and effective. What we also found is that many of the payers felt like there was a disconnect between how the healthcare system is set up to reimburse products and how these products are given twofold.

One, there is a cost density issue where many cell and gene therapies are given one time, and the benefit is seen over many years. Our US health care system is not set up like that. Typically, these payers look at years at a time, and products are typically given within that calendar year, and you see the benefit after that year.

The other component is, because it's more of a nascent space, these products are not on the market for 10, 15 years. They're looking for durability of response. We're starting to see the early cell and gene therapy manufacturers and biopharma companies reporting 5-year follow-up data. The more that data gets reported, the more the durability of the product's efficacy and safety is seen. Those are 2 key components that factor into the payer's challenges and decision making.

What is a “CGT desert,”¹ and what actions are in place to combat that?

In the 2024 cell and gene therapy report, we started out by looking at publicly available data sets like the transplant websites and pharma websites. We wanted to look at geographic metropolitan areas that were serving cell and gene therapies. This year we updated that report. Our goal was to see how these deserts have dissipated.

Most cell and gene therapies are being given in major metropolitan areas. Our hope was to see more of a migration to community-based access. What we saw was actually a bit disappointing in the slow pace and expansion to smaller, more rural areas. We saw basically a flattening of where these therapies are going. We didn't see a great increase; we didn't see a decrease. We saw some incremental value of more sites giving these products.

That's a challenge because these products being available locally to where the patients are have a greater deal of uptake. It's always good to have the patient and their caregivers be able to get care close to home. When we did the analysis this year, we were hoping for a greater increase in sites of care and a reduction in those treatment deserts. What we found were small, incremental increases. As we look to the future, our hope is that more of this migration will continue to communities, so we're reducing these treatment deserts so patients can get care locally for these groundbreaking therapeutic interventions.

The report identified reimbursement, infrastructure, and geographic patient access as the biggest barriers. Which do you believe is the largest issue and which would be the first to solve?

I believe that we must attack all of them and not one at a time. As an ecosystem, it's going to take collaboration amongst multiple players. Multiple players being the biopharma manufacturers, the healthcare providers who give these products, as well as the healthcare providers who are referring these products, as well as the sites of care and the governing bodies that allow for authorized treatment centers to be able to bring along these cell and gene therapies. You just can't give these therapies at any center. I think we must attack all of them as an ecosystem.

Geographically, sometimes one may be more important than another based on where that specific patient and product is in the United States. It's hard to say one thing over the other. But I think we're at a point where the value of these products are so great that as a cell and gene therapy ecosystem, all of us have to collaborate to make sure that we're addressing those 3 key issues, because I think they're important as we think about increasing commercial patient access to these groundbreaking interventions.

How does CGT affect oncologists today, and how can they use this technology?

Oncologists are the primary experts in cell and gene therapy. That's why we continue to go back year after year in our research and poll them. The research shows this year that from last year, we've seen an increase in familiarity with cell and gene therapies. We've seen an increase in how many actual patients, the number of raw patients that are treated by the average oncologist every year. We went from 17 last year to 25 this year. We're also seeing an increase in the percentage of oncologists who self-identify as a treater vs a referrer. We're starting to see more earlier lines of therapy for cell and gene therapy in hematologic malignancies and rare diseases. Those were the 2 key areas where it started.

They are the experts, they are the functional experts from a clinical trial standpoint as well as commercially that are using the product, that we continue to go back and get their perceptions, their thoughts, their ideas on how we continue to optimize the value chain and the delivery of these complex scientific breakthroughs to patients.

What led to the increase in usage of CGT therapies among oncologists?

I think there's a couple of different ways to look at the self-reported increases we found in the research. We try to keep the research as consistent as we can year after year and then ask additional clarifying questions. On average, the physicians tell us that they're treating more, but you also have to see the evolution of the product. So many of these products are moving up in the lines of therapy. They're going from later lines of therapy to earlier lines of therapy. There are generally more available patients to go after in the earlier lines vs the later lines. The data continues to evolve.

While durability of response was one of the areas that was a bit of a challenge or a barrier, we're starting to see more and more of the early cell and gene therapy products report out 5-year follow-up data, and that's quite strong. The science is exciting. The outcomes from that science are exciting. A lot of times, making that therapeutic option available to the patient is something that as this nascent marketplace continues to evolve, we're seeing more patients get access because the physicians are offering that as a choice.

What are the next steps in research?

The future is always difficult to predict in science, especially with science this complex. What we'd like to see in the future is more patients have commercial access to these products close to home. That would be the ideal state. The exciting part in this space is that [the science evolves] not only in oncology but into larger therapeutic areas like autoimmune disease. We even see some early data in diabetes and cardiovascular disease for cell and gene therapies. These are larger patient populations with high unmet medical needs. I think the future is that the science continues to evolve, and I hope as an ecosystem, we can all work together to assure that commercial patient access is streamlined and facilitated so that not only the clinical benefits from a clinical trial are achieved, but the commercial access is achieved as well.

REFERENCE:

1. 2025 Cell and Gene Therapy Report: Advancing the Future of Medicine. McKesson. Accessed October 15, 2025. https://tinyurl.com/57tjpcpv