Saudi Arabia is building the regulatory framework, partnerships infrastructure and IP landscape needed to support a biotech ecosystem, despite regional political instability. Whether it can produce sustainable biotech companies and a resilient manufacturing base for global production remains an open question, but the future looks bright.
Saudi Arabia is making strides to becoming a major biotech and manufacturing player in the regional and global life sciences landscape, but can it fulfill its hopes?
BioSpace heard experts praise recent regulatory reforms, growing international partnerships and a national focus on technology transfer that has bolstered the trajectory of the Saudi science ecosystem. Even geopolitical issues in the Middle East have not overly negatively affected progress.
The next stage of growth will depend on clinical trial and hospital engagement, intellectual property (IP) generation and training experienced biotech leaders.
“Saudi Arabia has the financial resources to build a pharmaceutical manufacturing industry,” said Ravi Kiron, managing director at Biopharma Strategy Advisors. Its next challenge is demonstrating that it can build an internationally competitive biotechnology innovation ecosystem.
Progressive regulatory revisions
One of the most significant developments over the past year has been the Saudi Food and Drug Authority’s (SFDA’s) effort to connect accelerated regulatory pathways across the entire drug development lifecycle, said George Syrmalis, CEO at Bioscience Equity Partners.
At the Drug Information Association Singapore Annual Meeting in September, SFDA CEO Hisham Aljadhey spoke on the integration of the Breakthrough Medicine Program, the New Accelerator Program for Drugs in Rare Diseases (NADR) and the Research and Investigational Drugs (RAID) pathway. Notably, the SFDA CEO highlighted a 20-working-day process for rare-disease drug classification under NADR.
Syrmalis explained this allows clearer and more responsive processes to help companies plan their development programs.
More recently, on October 7, the SFDA and the Saudi National Institute of Health announced five initiatives to advance clinical trials. These measures address practical issues that determine whether a company can run a development program efficiently, Symralis said, such as contracting, identifying suitable sites, establishing research capabilities and navigating regulatory review.
Additionally, Singapore’s Health Sciences Authority signed an MOU with the SFDA on September 14. It covers regulatory cooperation, information and expertise exchange, and exploration of pathways for conventional and novel products, including biotechnology.
“For companies developing medicines internationally, that cooperation has the potential to make development and registration more efficient,” Syrmalis said.
Combined, these announcements can be seen as evidence of increasing regulatory sophistication, Syrmalis concluded.
Robust partnerships
The transition from ambitious investment announcements to tangible execution, is noteworthy, Kiron said. He highlighted Saudi CDMO Lifera’s MOUs with Pfizer, Sanofi, MSD and others, alongside expanding clinical research activity.
“Saudi Arabia is beginning to demonstrate that its sovereign capital can attract international pharmaceutical expertise and build capabilities, although the ultimate test will be how successfully these partnerships translate into commercially sustainable operations,” he said.
An encouraging sign for the life science ecosystem is having institutions such as the King Abdullah International Medical Research Center (KAIMRC) deepen ties with international groups, especially in infectious disease research, said Stefan Wagener, CEO at Biorisk Management International. The Ministry of Health’s BioLabs accelerator, launched under the Kingdom’s National Biotechnology Strategy in its Vision 2030 initiative, has also helped Saudi founders develop research strategies and commercial plans.
“For me, these are practical examples of investment linked to scientific expertise and entrepreneurship,” Wagener said. What remains to be seen is how planned collaborations become active research programs, training opportunities and possibly centers of excellence, for example, in biorisk management, he added.
Having the Riyadh Global Medical Biotechnology Summit in September, despite the escalated regional tension, brought together many cross-border collaborators, said Abdulrahman Alshaya, KAIMRC’s chairman of collaboration and partnerships. Forty-six agreements were signed.
“That shows the global interest is real,” he said.
Manufacturing capabilities
The role of manufacturing is also important, to give local scientists responsibility for improving the production process and for developing IP, Wagener said. “To me, that is how localization builds lasting innovation capability,” he added.
Manufacturing is an important foundation for the broader innovation ambition, Syrmalis said, with the development of technical skills, quality systems, supply chains and experience in operating within a regulated industry. Biomanufacturing is one of the four pillars in the National Biotechnology Strategy of Vision 2030.
“Manufacturing is an entry point, not the destination,” said Alshaya, noting the Saudi leadership’s focus is on technology transfer. He referenced how South Korea moved from electronics into global biologics through decades of sustained R&D investment; Singapore paired manufacturing with discovery through biomedical sciences research and development hub Biopolis and its Agency for Science, Technology and Research.
Geopolitical turbulence impact
Despite recent geopolitical instability, Alshaya said he continues to see sustained engagement with international partners. “To me, that shows global partners believe the current [geopolitical] circumstances are temporary and that things will return to track, even stronger,” he said.
In addition, he noted that South Korea, Israel and Taiwan built world-leading industries under persistent security pressure.
Saudi Arabia’s ambitions can withstand the turbulence, Symralis said, provided the country continues to execute consistently and companies plan realistically for the operating environment. Still, investment decisions may take longer, visits may be postponed and partnerships may require additional safeguards.
“I remain positive about the opportunity, while recognizing that the pace of progress will depend on both execution and the security environment,’” he said.
Practical continuity and resilience are of ultimate concern in biorisk management, Wagener said. For example, a biotech needs to know whether temperature-sensitive materials can reach its laboratories during transport disruptions. Saudi Arabia’s efforts to reroute trade during recent disruptions offer a concrete example of meaningful resilience, he added. That preparedness should be reflected in research institutions and companies as well.
Success considerations and obstacles
“In five years, I would like to see Saudi-founded biotech companies reaching major M&A or IPO stage, multinational firms running real R&D and tech transfer programs here, regulators and investors moving at the same speed and a trained Saudi biotech workforce leading facilities and research,” Alshaya said.
In that timeframe, Symralis said biotech success would mean companies progressing through meaningful clinical milestones, hospitals participating effectively in international trials and Saudi research producing IP that attracts serious commercial interest.
The biggest challenge is building and sustaining the expertise required, such as having an experienced, local team remain through product development, regulatory review and commercial scale-up, Wagener said.
Building experienced management teams, generating and protecting commercially valuable IP and establishing the entrepreneurial culture needed to convert promising science into successful businesses are further concerns, Kiron noted.
Regardless, all experts expressed optimism for Saudi Arabia’s biotech future.
“My genuine belief is that this sector is growing - slowly but steadily - and will continue to expand even more,” Alshaya said. “My message to partners is to be part of the journey and take it one step at a time.”
