In lower- and middle-income countries, accessibility, cost, and talent are obstacles to broadly implementing cellular therapeutics into cancer care.
In lower- and middle-income countries, accessibility, cost, and talent are obstacles to broadly implementing cellular therapeutics into cancer care.
Surrounding the 2025 Immune Cell Effector Therapy (ICE-T) Congress, CancerNetwork® spoke with Syed Osman Ali Ahmed, MBBS, BSc (Hons), MRCP, FRCPath, CCT, about his presentation titled “Global Experience with Cellular Therapeutics”.
Ahmed’s presentation detailed the current state of cellular therapies across the globe, covering topics such as accessibility, training, talent, and guidelines. Ahmed is an attending physician at King Faisal Specialist Hospital and Research Centre in Saudi Arabia.
Read highlights from the interview below.
What I was hoping to give was a [presentation] that addressed some issues related to access, or a 30,000-foot view of the global perspective of CAR T-cell and cellular therapy access. Access is a challenge, and it’s a buzzword that’s mentioned quite a bit. It’s a cause for some concern even in the US and in Europe; even in the US, there are certain states where patients don’t have as equitable access to these advanced therapies as people who live on the East or West Coasts.
In Asia, we think that everybody in the US or Europe has access, but they don’t. But when you look at a global perspective, it’s a challenge to the cellular therapy community on a much greater scale than one would imagine. You realize that most of the world’s population lives in the [Global] South or in the East, like in Asia or in India, and they don’t have access at all. Even in terms of the diseases, approximately 50% of lymphoma or deaths will happen in China and Asia. They don’t have access. What [the presentation] gave was the perspective that a lot of the challenges that people, physicians, and providers in healthcare [experience] in the East are very applicable to [countries in] Europe and richer countries.
The elephant in the room is cost. These are very expensive therapies. In the US and Europe, you’re still talking about $300,000 up to $500,000. Those are for the FDA- and European Medicines Agency [EMA]–approved CAR T products. That is beyond the reach of most of the world’s population, so cost is number 1. If we were to circumvent that problem of cost, then the bottlenecks are similar to the bottlenecks that exist in the West, which are production capabilities, bottlenecks in manufacturing facilities, waiting times, and the reagents—like vector and components—of CAR T cells. Those are the obstacles, but the biggest obstacle by far, at the moment, is cost. Then, it’s having equitable access even to more affordable products that are being produced in China, India, and some parts of Asia.
There are a number of strategies to address this now. The actual cost of manufacturing, if you break it down, is not as high as the price that’s currently marketed. There are various reasons why the costs and the pricing in the US and Europe are what they are, and it serves the market and the buying power of the payers. That can’t be translated to a lot of Asia and a lot of Africa—there are hardly any centers in Africa that are able to provide these sorts of cellular therapies at the moment—and India. For example, some of the things that could circumvent [the bottlenecks] are models, such as the decentralized manufacturing of these cellular therapies. We’ve been able to demonstrate in our institution, for example, if you do decentralized point-of-care manufacturing in a closed system, the actual costs are about 20% to 30% of the cost of a commercial product. Then, the challenge is, how do you provide that at scale, and how do you address the regulatory challenges of that so we know we can bring the cost down?
Another solution has been brought forth by what’s happened in India, for example. Colleagues in India at the Tata Memorial Hospital…and many others have been able to make CAR T-cell therapies affordable at a much lower cost—like $25,000 to $50,000. That has other reasons as well. You could talk about how the labor costs are lower, the costs of materials, the costs of renting space, et cetera. The production costs are lower. You can, in those economies, scale it down to a price that is more affordable. It’s still expensive for a lot of people, but it is, in real terms, a fraction of the cost that it is in the West and the Global North. Point-of-care manufacturing, scalable manufacturing, and bringing the cost down [can help]. The other thing is subsidizing. Governments can subsidize some of these technologies and platforms. That’s another model that can be replicated in other places. There are ways, and we think with time, costs can come down. The market pressures in the US and Europe may make that slightly challenging, but it’s doable.
Genetic disorders are particularly a challenge in the Middle East. In the Middle East, you have countries of different income groups. You have high-income countries, you have middle-income countries, and you have low/middle-income countries. [Some] things that are more common in the Middle East and the Near East are the genetic disorders. For example, you have a belt of certain diseases or genetic disorders that you come across, such as sickle cell disease or thalassemia, that are more prevalent in these areas. To add to that, you have larger family sizes. You have practices like marital consanguinity, for example. You have a higher incidence of these genetic disorders. When you have a higher prevalence, and you have potential innovative therapies that can address these problems but are more expensive, you have a challenge of how to square the circle. That is something that the scientific, medical, and research communities have to work together on.
How do we get these amazing, groundbreaking findings that humanity has been able to reach? How do we get that knowledge, these breakthroughs, and these inventions to everybody else? The stakeholders that are going to make this happen are government payers, philanthropy, and research funds to develop platforms in conjunction with industry that make these therapies cheaper to manufacture at scale. There are [several] outfits that are doing that in Africa, for example, to try to address HIV through cell and gene therapies and to take this platform to South America, for example.
These [platforms] can be cheaper than the commercial products per unit, but they still have a significant cost because of the equipment, the reagents, and the consumables that need to go with these. There are other ways that can significantly reduce costs, especially if CAR T with simpler flasks can be made scalable. It requires a concerted will to address this from an affordability point of view. Then, to bring these stakeholders together, there has to be a degree of funding at the outset to develop the platforms. Once that activation energy is achieved—once you’re able to overcome that—you’re able to produce these therapies at a lower cost in a way that’s more affordable for healthcare systems in these low- and middle-income countries.
It has to be cheaper for most of humanity to be able to benefit from [treatment]. There are ways that we can innovate to do that, such as automation, training, and making these scalable platforms available.
Talent is at a premium at every level. [There are] trained nurses and trained physicians in those fields that can deliver these therapies. That could be for the CAR T-cell therapy and a lot of gene therapies. It could be hematologists or oncologists and specialist nurses who deliver the therapy. It’s the staff who do the collection of cells, or the apheresis—the lab staff. That needs to be addressed within countries, at the levels of the authorities that produce the number of training lines available. There has been an expansion in training more oncologists, training more hematologists, or training more scientists in apheresis. That’s an issue. Then, if you go further up the entire supply chain—especially if you’re talking about manufacturing locally—there is a huge demand and a huge shortage of trained technical scientists who can manufacture an ATMP [advanced therapy medicinal product], whether it’s a CAR T-cell therapy or a gene therapy. Often, it’s not just the people producing it; it’s the quality assurance people, the people who are doing the analytics, the people who are doing the actual manufacturing in the cleanrooms, and the people who know how the regulatory framework works. Talent is one of the major bottlenecks, even in advanced countries. Even in a European country that has a large manufacturing facility for commercial CAR T, 50% of their staff had to come from overseas. You’re just not able to train enough of the people. As this field grows, that’ll be an even greater challenge. Even if you’re able to afford it, and if you’re able to have the healthcare system reimburse it, you need the people who are able to produce it and deliver it. That’s going to be a challenge that has to be addressed at every level.
It’s amazing what’s happening in this field, and it’s happening in a way that has never happened before. As they say, necessity is the mother of invention. In a lot of countries, you just have to wait or accept the fact that this certain therapy, X, will not be available and accessible. Because of the cost of these therapies, it’s an impossibility for certain countries to be able to afford an FDA or EMA-approved cell therapy. They have invented ways around it. You’re talking about countries in Asia; countries like Thailand, Pakistan, and Nepal. India has a relatively more advanced ecosystem, as does Singapore, but in these countries—even in Bangladesh and the Gulf countries in North Africa, Jordan, and Lebanon—all these countries have now developed or are developing cleanroom facilities and closed systems for manufacturing CAR T cells. They’re training themselves.
We’re helping to train healthcare professionals from some of these countries, at least on the clinical side, and giving them an idea of how manufacturing happens. People have now had to force themselves to go up a few rungs to develop capabilities that, in the past, they would not have, simply because of the way that these things are produced. You have to produce a product per patient. You can’t produce them, at the moment, at scale; you just have to get in there and build capabilities. In a paradoxical way, the very high costs of these commercial products have forced low- and middle-income countries to innovate and develop capabilities that they would not have thought of 10 years ago. Even we wouldn’t have thought that it would be easy to do, and it wasn’t easy to do, but there’s been this drive to say we have to produce this amazing therapy so it’s accessible to our patients.
Ahmed SO. Global experience with cellular therapeutics. Presented at the 2025 Immune Cell Effector Therapy Congress; September 27-28, 2025; Kansas City, KS.