For decades, advanced medical breakthroughs have followed a familiar pattern: scientific discovery, clinical promise, followed at length by broad patient access–if it comes at all. Cancer treatments are no exception.
CAR-T therapy represents one of the most powerful advances in modern cancer treatment. For patients with aggressive blood cancers, like leukemia, who have exhausted every other option, it offers the potential for durable, sometimes years-long remissions. For diseases with rapid relapse and short survival rates, a single CAR-T infusion has, for some patients, reset expectations from “terminal care” to “long-term recovery.”
Yet for years, its extraordinary potential has been constrained by costs exceeding USD$300,000 per patient, and a complex, globally centralized manufacturing model.
At King Faisal Specialist Hospital and Research Centre (KFSHRC), we decided to challenge this norm. Saudi Arabia’s leukemia incidence of ~5.9 cases per 100,000 is roughly three times the global benchmark. This reality demanded a different approach: Why can’t this therapy be produced locally—safely, affordably and at world-class standards?
The answer is that it can—and must.
Understanding the Promise and the Barriers
CAR-T therapy is a form of personalized medicine that reprograms a patient’s own immune cells to recognize and attack cancer. After reinfusion into the patient’s body, the modified cells act like a living drug.
While the science is elegant, the manufacturing process is highly complex, lengthy and logistically inefficient. A typical journey starts by extracting the patient’s cells at a treatment site, shipping them for engineering and manufacturing, and then transporting them back to the original facility to reinfuse into the patient—all within a limited timeline and precise transportation conditions.
On top of these highly complicated logistics, fewer than 40 GMP facilities currently manufacture CAR-T therapies at scale globally. Most are concentrated in North America and Europe, contributing to high costs, lengthy turnaround times and inequitable access.
Getting cell therapy to eligible patients, particularly those outside North America and Europe, often means treatment delays. But cancer does not wait, even for a month.
The pandemic showed us how fragile global medical supply chains can be. In advanced therapies, supply chain dependence is not just an economic risk; it is a human one.
Building Gene Therapy Self-Reliance
At KFSHRC, we are charting a different path. We invested in local CAR-T manufacturing on our campus—integrating cell collection, processing, quality control and patient treatment, all within a single institutional framework.
By adopting an automated, closed-system process, we have cut costs by 80 percent, to around USD$67,000, and halved production time to two weeks, while maintaining the highest international quality standards expected of advanced therapies. Eligible cancer patients can now receive treatments when they are clinically ready—not when global production and supply chains dictate—and at roughly one-tenth the prevailing global costs.
These savings strengthen the sustainability of Saudi Arabia’s national health ecosystem, enabling reinvestment in early diagnosis, prevention and further research. Since 2020, KFSHRC has treated more than 200 patients with CAR-T therapies manufactured abroad. Our new 5,000-square-meter facility is designed to produce 2,400 doses a year, which will meet a significant share of national demand.
This is not theoretical efficiency. It is real, operational and already benefiting patients.
What This Means for Patients
The ultimate test of localized CAR-T production is whether it improves patient outcomes. Our early clinical results are clear: The first patient treated with in-house CAR-T cells achieved remission after a single dose of 20 million cells.
Our 27-year-old patient was enrolled in a Phase I clinical trial for relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). She had tried multiple prior lines of therapy, including a commercial CAR-T, all of which ended in relapse. With no remaining options, she received KFSHRC’s Lentigen CD19 CAR-T therapy. Months after the infusion, she remains cancer-free, with no severe adverse events or toxicity.
Beyond clinical metrics, the impact is deeply human. For families of cancer patients, fewer delays and treatment delivered closer to home mean more time with loved ones—for cancer patients, that is invaluable.
The Case for Soft Infrastructure
Successful localization is not only about infrastructure; it is about people.
CAR-T therapy requires tightly integrated teams spanning research, manufacturing, regulatory affairs and clinical care. Bringing all this expertise under one roof has enabled faster learning, tighter feedback loops and ongoing improvement, but continuous talent development and international collaboration remain essential. Through targeted fellowships and international training rotations, KFSHRC is cultivating a Saudi workforce skilled in translational research, CAR-T manufacturing and clinical delivery—ensuring that advanced cell therapies can be developed, produced and scaled locally.
Our teams are not just replicating global protocols; they are advancing them. The clinical trials conducted within our own population contribute data that can refine CAR-T therapies for broad applicability and improved safety globally. In this way, localized research and production can strengthen global science.
A Blueprint for the Future
The implications of this model extend beyond Saudi Arabia. Dramatically lower manufacturing costs allow CAR-T therapy to move from a last-resort intervention to a sustainable component of routine cancer care for eligible patients globally.
But CAR-T therapy for oncology is only the beginning. As cell and gene therapies expand into solid tumors, autoimmune diseases and rare genetic conditions, demand will grow exponentially. No global system can meet that demand through centralized production alone.
Hospital-anchored manufacturing hubs—supported by smart regulation, automation and local talent development—offer a scalable alternative. The benefits of enhanced resilience, patient care and improved access speak for themselves. For health care leaders, this is no longer an experimental idea; it is a proven blueprint.
Policymakers can accelerate progress by evolving regulatory frameworks that support safe, localized production without compromising standards. For industry leaders and investors, opportunity lies not only in discovery but in enabling distributed manufacturing platforms that deliver measurable health and economic returns.
Moving from Exception to Expectation
At KFSHRC, we did not localize CAR-T production to make a statement—we did it to solve a problem. The result has been a system that is more affordable, more responsive and more equitable.
The question facing global health care leaders today is not whether localized CAR-T production is possible—we have shown that it is—but whether outdated models will continue to limit access to therapies that already exist and work.
In oncology, time is everything. When the tools to save lives are within reach, delay is a decision. Localizing CAR-T production moves us closer to a future where breakthrough therapies do not need to be scarce, and where innovation serves patients first, everywhere.
H.E. Dr. Majid Al Fayyadh is a member of the Newsweek CEO Circle, an invite-only executive community of subscribers.