Multinationals: Launchpad for Innovation
Saudi Arabia is creating a launch environment where multinational biotech and pharmaceutical companies can bring therapies to market faster, trial at scale, and localize with strategic clarity.
With a regulatory framework aligned to global standards, expanding clinical trial capacity, and government-backed localization support, the Kingdom offers multinationals not just access – but momentum. At BIO 2025, the Pavilion presents a biotech system built for real-world results.
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Clinical Trial Expansion with Strategic Reach
Saudi Arabia is scaling its trial capacity through targeted national coordination. The King Abdullah International Medical Research Center (KAIMRC) and the Saudi National Institute of Health (SNIH) are expanding investigator networks, hospital sites, and trial infrastructure across therapeutic areas – including cancer, rare disease, cardiovascular, and vaccines.
There have been more than 600 clinical trials are across the Kingdom, with sponsors benefitting from diverse patient populations, modern clinical infrastructure, and national platforms that support enrollment, data sharing, and remote participation.
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Localization with Strategic Partnership
The Kingdom is not just enabling trials – it’s investing in long-term production and regional resilience. For multinationals, that means more than incentives. It means co-development, guaranteed offtake, and scale-ready facilities.
Lifera, backed by the Public Investment Fund, is Saudi Arabia’s national platform for biologics and vaccine production. With capacity for over 250 million units, including GLP-1s, injectables, and biosimilars, Lifera is already hosting technology transfer partnerships with firms.
In Phase 1, Sanofi is localizing two vaccines for export – a first for the company globally. In Phase 2, five more will follow.
Lean Business Services, another PIF-backed platform, supports data infrastructure and digital integration for localized healthcare and biotech solutions, leveraging over 52 million structured health records.
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Speed to Market, Real-World Ready
Multinationals are entering a market where approvals move quickly and trial environments are built for scale. Regulatory and ethics approvals are now processed with streamlined licensing support and integrated oversight.
This agility is backed by national digital health platforms offering access to structured, population-scale data. Nphies, Saudi Arabia’s national health data network, has already logged over 450 million transactions, providing a foundational layer for post-market surveillance, pharmacovigilance, and trial enrichment.
Seha Virtual Hospital, recognized by Guinness World Records as the largest virtual hospital in the world, connects 224 hospitals nationwide and supports over 100 million online prescriptions – enabling decentralized trials, remote follow-up, and real-time evidence generation.
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Regulatory Alignment for Global Confidence
The Saudi Food and Drug Authority (SFDA) is at the center of Saudi Arabia’s agile regulatory system. With ML4 designation from the World Health Organization – the highest level of regulatory maturity globally – SFDA offers fast-track approval pathways, centralized ethics coordination, and internationally recognized processes.
Multinationals are already using Saudi Arabia as a first-in-region launch base. Vertex Pharmaceuticals' CASGEVY™ became the first gene-edited therapy approved under SFDA’s Breakthrough Medicines Program, setting a precedent for future high-complexity products.
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