King Faisal Specialist Hospital and Research Centre (KFSHRC) in Saudi Arabia has achieved a groundbreaking national milestone by producing clinical-grade CAR-T cells in-house for cancer treatment.
This innovation promises to enhance the timeliness of treatment and minimize delays for patients, aligning with KFSHRC’s dedication to advancing healthcare through pioneering therapies and excellence in clinical research. This accomplishment also bolsters national efforts to localize biotechnological industries, positioning Saudi Arabia and KFSHRC as leaders in the medical field.
Current CAR-T cell treatment processes often face significant delays of 21 to 28 days due to reliance on overseas manufacturing, which involves navigating complex logistical challenges such as freezing and shipping to and from manufacturing centers, potentially leading to extended patient waiting times. By shifting to internal production, KFSHRC has streamlined the treatment timeline to just 12 to 14 days, enhancing accessibility and reducing delays in patient care.
Global milestones in CAR-T cell therapy
CAR-T cell therapy represents a revolutionary approach in the fight against cancer. By genetically modifying a patient’s own T cells to target and destroy cancer cells, this therapy offers new hope for patients with certain types of aggressive cancers. Its significance lies in its potential to achieve long-term remission through its personalized nature, tailoring treatment to the individual patient’s immune system.
This innovative therapy is rapidly gaining traction worldwide, with numerous clinical trials demonstrating its efficacy and safety. In 2023, the CAR-T cell therapy market was valued at $8.44 billion globally, projected to reach approximately $88.52 billion by 2032.
By 2024, the global clinical landscape had seen the approval of over 30 gene therapies, including those involving genetically modified cells. This significant growth reflects the expanding role of CAR-T therapies in cancer treatment. Currently, over 4,000 cell, gene, and RNA therapies are in development, with more than 1,000 ongoing clinical trials focused on CAR-T cells. Over the next decade, it is estimated that more than two million patients could benefit from CAR-T cell therapies globally.
Significant progress has also been made in treating conditions like sickle cell anemia and hemophilia, which are particularly relevant for Saudi Arabia and the region. Leading gene-editing technologies, such as CRISPR-Cas9, base editing, prime editing, and RNA-based therapies, are swiftly moving from research to clinical practice, signaling a new era of personalized medicine.
Adoption challenges in Mena
CAR-T treatments, despite their renowned effectiveness, come with a hefty price tag, often reaching USD400,000 per treatment due to intricate manufacturing processes. Complex logistics, cost considerations, and the need for specialized medical infrastructure often hinder the widespread implementation of CAR-T cell therapy. In light of these challenges, the cell and gene therapy market in the MENA region is expected to grow to $211.46 million by 2030.
In Saudi Arabia, efforts are underway to overcome these challenges and align with global growth trends. Saudi Vision 2030’s Health Sector Transformation Program emphasizes medical research and advanced treatments to enhance patient outcomes and position Saudi Arabia as a healthcare leader. This includes the National Biotechnology Strategy, launched in 2024, which focuses on investing in government initiatives and strategic projects to drive the accessibility and implementation of CAR-T cell therapy.
Reducing cost of treatment
The advancement in internal production of CAR-T cells at KFSHRC has reduced treatment costs from 1.3 million Saudi riyals to approximately 250,000 Saudi riyals per product. Once the in-house manufacturing processes are fully optimized, the cost per product could be further reduced to 150,000 Saudi riyals per patient dose. By enhancing the efficacy and availability of CAR-T cell therapy through cutting-edge research and innovative approaches, KFSHRC ensures that patients, both regionally and globally, have access to state-of-the-art treatment options.
In keeping with its ambition to be a regional hub for cell and gene therapies and aligning with Saudi Vision 2030’s goal of enhancing patient access to innovative treatments, KFSHRC aims to increase the number of clinical trials in CAR-T cell therapy and gene therapy and help build the national cell and gene therapy ecosystem. KFSHRC’s CAR-T program achieved a significant breakthrough, with the first patient receiving treatment in 2020. Since then, KFSHRC has treated more than 120 patients with CAR-T cell therapy (as of Q1 2024). While demonstrating its commitment to utilizing the technology in pioneering breakthroughs in oncology, KFSHRC was the first in the region to treat patients with gene therapy for hemophilia A and B and has initiated clinical trials for gene therapy in sickle cell disease.
KFSHRC’s Department of Hematology has one of the longest-standing hematopoietic cell transplantation (HCT) and cellular therapy programmes, running since 1984. More than 7,000 transplants, including adult and pediatric patients, have been successfully performed under this programme.
Since 2020, KFSHRC has facilitated prospective clinical trial activities through the Clinical Research Department (CRD), providing access for patients to be enrolled and treated in international prospective clinical trials.
Hub for CAR-T Cell Therapy
KFSHRC’s recent achievement in CAR-T cell therapy demonstrates Saudi Arabia’s commitment to adopting the latest therapies and technologies. By advancing treatments and fostering a supportive medical research ecosystem, KFSHRC contributes to Saudi Arabia’s emergence as a leader in innovative healthcare solutions and a leading destination for medical tourism.
As Saudi Arabia seizes the opportunities presented by CAR-T cell therapy and other transformative treatments, it is poised to lead in medical innovation, offering patients from around the globe access to groundbreaking therapies and superior healthcare outcomes.