KFSHRC accounted for 48% of all clinical trials registered in Saudi Arabia in the first half of 2025, with 104 active trials and 80 new studies, and reported first-patient treatment using locally manufactured CAR-T cells in a Phase I study for relapsed acute lymphoblastic leukemia.
The core development is concentration and capability. KFSHRC is operating as the Kingdom’s de facto trial hub while moving upstream into advanced therapy development, anchored by in-country cell manufacturing. Trial activity spans oncology, cardiovascular, musculoskeletal, dermatology and autoimmune, gastrointestinal and liver, and endocrine/metabolic indications, signaling breadth across therapeutic service lines rather than a single-asset push. The CAR-T milestone is notable less for efficacy at this stage than for supply-chain independence and technical readiness in a modality that typically relies on imported products and long, fragile logistics.
Strategically, this looks like a deliberate consolidation play aligned with Saudi Arabia’s push to localize high-complexity healthcare under Vision 2030. Centralizing volume at a flagship academic medical center can compress study start-up timelines, standardize governance, and create a repeatable operating model attractive to global sponsors. The move into cell and gene therapy manufacturing reduces lead times, customs friction, and vein-to-vein variability, positioning the site for studies where release testing, chain-of-identity, and turnaround drive feasibility. The trade-off is concentration risk: when one institution carries nearly half the country’s registered trials, throughput, staffing, and lab capacity become single points of failure. It also raises competitive tension for other Saudi sites seeking to scale their research portfolios.
For sponsors and CROs, KFSHRC offers a credible anchor site in the Middle East with cross-indication capability and growing ATMP infrastructure. This can simplify regional feasibility, particularly for programs that require apheresis, GMP manufacturing, and specialized cell handling. The volume signal suggests predictable recruitment channels, but it also indicates potential scheduling bottlenecks, shared equipment constraints, and investigator bandwidth issues if study mix skews toward complex protocols. Vendors in cold-chain logistics, QC analytics, and digital trial infrastructure will see a receptive market for solutions that de-risk cell therapy workflows and harmonize data capture across modalities. For other Saudi research hospitals, the path forward likely involves networked participation—acting as feeder or expansion sites within multicenter designs to distribute recruitment and meet geographic diversity objectives. Regulators and the national research apparatus will need to ensure that review capacity and site accreditation keep pace, particularly for oversight of ATMPs and alignment with ICH expectations, to maintain the global acceptability of data.
The next set of signals to watch includes whether KFSHRC expands from single-center leadership to a hub-and-spoke model that onboards additional Saudi sites into complex studies, and whether time-to-first-patient and cycle times improve as volumes scale. On the CAR-T front, comparability, batch-release reliability, and vein-to-vein metrics will determine whether local manufacturing can underpin multi-protocol portfolios rather than isolated pilots. Resource risk is material: advanced therapy programs are staff-intensive and sensitive to facility downtime, making workforce development and redundancy planning essential. For global sponsors, the question is whether Saudi-based trials can be operationalized at a Phase 3 scale with data packages that align cleanly with FDA and EMA expectations. If the system can demonstrate sustained throughput without quality slippage, Saudi Arabia could become a reliable node for complex trials, shifting its regional strategy from opportunistic enrollment to an integrated program design.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
