Advanced Therapies Week 2025: Developing Advanced Therapies in Saudi Arabia

This ATW 2025 session presented an in-depth discussion of Saudi Arabia’s Vision 2030, focusing on positioning the Kingdom as a global leader in cell and gene therapy and biotechnology. The panel, representing Saudi Arabia’s medical and industrial sectors, outlined strategic efforts to build a robust biotech ecosystem through government programs, international partnerships, infrastructure development, and talent cultivation. Saudi Arabia’s demographic and genetic landscape, characterized by a younger population and a high prevalence of inherited diseases linked to consanguinity, creates strong demand for advanced therapies in genetic disorders, cancer, and rare diseases. The Kingdom is advancing clinical trials, regulatory pathways, and manufacturing capabilities, with a stated aim to localize the full cell and gene therapy value chain by 2030.

Key institutions such as King Abdullah International Medical Research Center (KAIMRC) and King Faisal Specialist Hospital & Research Centre (KFSH&RC) are leading clinical and research initiatives, including biobanks, clinical trial networks, and accredited facilities. The Saudi Food and Drug Authority (SFDA) is recognized for rapid and mature regulatory processes that support faster approvals of novel therapies. The government has introduced financial incentives, tax benefits, and infrastructure support to attract local and international biopharma companies. Manufacturing ambitions are reinforced by strategic geography, political stability, and sustained investment in industrial cities and talent.

The panel also addressed challenges, including the need for broader international recognition of Saudi capabilities, aligning clinical trial sites with patient populations, and cultivating highly specialized talent. Even so, case examples such as early adoption of CAR T-cell therapies, vaccine development for endemic diseases, and high-profile complex procedures illustrate growing momentum. Panelists were optimistic that by 2030 Saudi Arabia will have a thriving biotech industry contributing to non-oil GDP and to global healthcare innovation.

• Saudi Arabia aims to become a global biotech hub by 2030, with a focus on cell and gene therapy.
• A unique genetic profile, including higher rates of inherited disorders, drives strong demand for advanced therapies.
• Clinical infrastructure and streamlined approvals support fast trial activation and patient access.
• Government incentives and funding programs encourage R&D and localized manufacturing.
• Partnerships with international pharma and biotech companies are accelerating innovation and access.
• The biotech market is projected to grow at a 14% CAGR, reaching an estimated $12 billion by 2030.
• Vision 2030 includes biotech clusters and scale-up plans aimed at regional and global export.

• Strategic vision and government commitment: Vision 2030 places biotechnology at the center of economic diversification. New bodies such as the Research, Development and Innovation Authority and the Saudi NIH, combined with regulatory advances, show sustained top-level commitment that helps overcome funding, regulatory, and infrastructure barriers in emerging markets.
• Genetic disease burden as a demand driver: Higher rates of consanguinity and larger family sizes increase the prevalence of inherited conditions, including sickle cell anemia, Fanconi anemia, and rare metabolic disorders. This creates an urgent need for gene and cell therapies that are often underrepresented in Western pipelines. The ability to recruit sizable cohorts makes Saudi Arabia attractive for rare and orphan disease trials.
• Regulatory maturity and trial acceleration: The SFDA’s rapid timelines for new drug approvals and clinical trial clearances, along with a high regulatory maturity ranking, position the Kingdom as a competitive environment for advanced therapeutics. Faster site activation shortens time to access for patients and sponsors.
• Manufacturing and talent development: Strategic location, stability, and incentives make the Kingdom a strong candidate for regional biomanufacturing. Programs such as the National Industrial Development and Logistics Program, along with initiatives like the Rafid Program, help offset the capital intensity of cell and gene therapy manufacturing. Developing a specialized workforce remains a priority, with academic and incubator efforts underway.
• End-to-end value chain integration: Localizing R&D, clinical operations, manufacturing, and commercialization supports sustainability and export readiness. This approach reduces reliance on imports and enables access to broader Middle East, North Africa, and Organization of Islamic Cooperation markets.
• Partnerships as a force multiplier: Deep, trust-based collaborations with global companies are essential. Technology transfer, joint development, and early commercial launches, including CAR T-cell therapies, show how partnerships can accelerate clinical and commercial milestones.
• Economic impact: Forecast growth of the biotech sector at roughly 14% CAGR to about $12 billion by 2030, with more than 11,000 innovation-oriented jobs, aligns with broader diversification objectives and public health gains.

Speakers

• George Goldberger – Founder and CEO, Cell One Partners (Chair)

• Ahmed Alaskar – Chief Executive Director, King Abdullah International Medical Research Center (KAIMRC)

• Syed Ahmed – Consultant Director, CAR-T Cell Program, King Faisal Specialist Hospital & Research Centre (KFSH&RC), Riyadh

• Khaled Alanazi – Pharma & Biotech Manager, Ministry of Industry & Mineral Resources

This ATW 2025 panel underscored a clear pathway for Saudi Arabia to become a leader in cell and gene therapy and biotechnology. Demographic need, political will, regulatory readiness, infrastructure investment, and international collaboration are converging to build a durable ecosystem. While talent development and international visibility are ongoing challenges, early clinical and manufacturing successes signal strong progress. By 2030, the Kingdom aims to operate a self-sustaining, globally connected biotech sector that advances regional health outcomes and contributes meaningfully to economic diversification.