With Saudi Arabia striving to position itself as a regional leader in biopharmaceutical R&D by 2030 and to cement itself as a global hub before 2040, there has been a coordinated attempt to align research centres across the country under a unified national framework. This National Biotech Strategy, unveiled by Crown Prince Mohammed bin Salman in January 2024, focuses on strategic opportunities to drive innovation, research, and development, notably in local biomanufacturing, vaccine development, and cell and gene therapies.
“First and foremost, it is remarkable to see a country not only launch a clear and comprehensive biotech strategy but to also publicly share it, ensuring that all stakeholders, both public and private, properly understand its direction,” observes Mohamed Fawzy, country president at the American originator drug developer, Pfizer. “Aside from being admirably ambitious and well-structured, the sheer level of clarity and transparency around the Kingdom’s vision helps facilitate partnerships as it provides a solid foundation for identifying common ground between the government and industry players.”
“I am very passionate and optimistic about the potential of this strategy the overarching goals of which are to build a knowledge-based economy driven by scientific innovation,” concurs Deloitte’s partner & chief medical officer for the Middle East, Vineta Bhalla. “Having a dedicated strategy like this represents a fundamental first step and signals that the country is taking biotechnology very seriously, though, it is imperative that it be implemented and nurtured in the right way if its ambitious aspirations are to reach full fruition.”
To support the strategy, a welter of programs and initiatives have been launched, carefully designed to entice in investors, generate financing, and develop the talent needed for biotech advancement. “The kingdom has already committed more than USD 11 billion to biotechnology research and development, positioning the sector to contribute USD 34.66 billion to the national GDP by 2040, while keystone facilities such as Riyadh BioCentral are being established with a view to hopefully, over time, spawning specific clusters,” notes Majid Al Fayyadh, CEO of King Faisal Specialist Hospital and Research Centre (KFSHRC).
The plan is for the Ministry of Investment (MISA) to provide investment incentives, while anchor companies catalyse the growth of smaller start-ups. Riyadh BioCentral, sponsored by the Royal Commission of Riyadh City (RCRC), is emblematic of this process at work. “Investors shall find unprecedented opportunities in areas such as biologics development, genomics, AI-driven healthtech, and cell and gene editing with Riyadh providing a strong foundation and platform for growth,” promises Adel AlMarshad, general supervisor of health and biotechnology at the Royal Commission for Riyadh City (RCRC). “My function is to oversee and guide the strategic development of these sectors within Riyadh’s broader transformation, working closely with government bodies, private sector partners, and international institutions to shape policies, expand research capabilities, attract investments, and ensure that major projects optimally align with the national long-term vision.”
Innovation Safeguards
Concerted effort has also gone into establishing robust IP frameworks with a view to reassuring any potential investors. “Protecting and enabling intellectual creation is an essential prerequisite to encouraging entrepreneurship and promoting the growth of a knowledge-based economy,” affirms Abdulaziz Alswailem, CEO of Saudi Authority for Intellectual Property (SAIP).
Whereas historically the Kingdom had prioritised secondary manufacturing, which limited local ownership of intellectual property with multinational companies primarily controlling final-stage processes, the more recent determination to scale the biotech value chain by enhancing capabilities in R&D, commercialization, and local biomanufacturing has rendered topics like patent protection much more pressing.
“Now that we are strategically aiming to retain more intellectual property within our borders and to capture greater value locally, this logically requires an altogether higher level of safeguards,” acknowledges Alswailem, noting that the decision to consolidate all aspects of IP – including patents, trademarks, copyrights, trade secrets, and geographical indications – under a single roof within SAIP was a move to create a streamlined and comprehensive system that would be reassuring for innovators.
“SAIP’s mandate extends well beyond simply registering IP rights. Recognizing that registration alone is insufficient, we are also responsible for enabling and enforcing those rights, as well as for providing guidance and support to rights holders in taking action against infringements,” he continues. In fact, last year the agency helped over 5,000 clients through dedicated IP Clinics, offering free support to individuals, SMEs, and companies unsure of how to protect their intellectual property. “We also established an IP Academy in collaboration with WIPO, which provides local and international training, as we are aware that a major challenge within biotech relates to the optimal timing of patenting,” insists AlSwailem.
Such endeavours seem to be paying off. While Saudi Arabia may not yet boast the same volume of IP registrations as some rival markets, the tempo of registration is accelerating. In 2024, SAIP registered over 4,300 patents, while the number of trademark registrations look set to almost double within five years.
Translational Research
At the same time a brand-new national research strategy, recently approved by the Supreme Committee — chaired by the Minister of Health and comprising representatives from major regulatory and economic bodies — provides a roadmap for raising the Kingdom’s capabilities as a global research powerhouse.
“This framework is grounded upon four central principles that guide and infuse our efforts: namely strengthening research institutions to enhance translational research, ensuring a structured and sustainable funding ecosystem for research centres and investigators, prioritizing the transformation of research into tangible impact, and fostering long-term benefits for the healthcare sector and the broader economy,” explains Majed AlJeraisy, executive director of research & education at the Saudi National Institute for Health (Saudi NIH).
He and his team are especially keen to ensure that research priorities are not just theoretical but are actionable, contributing directly to national objectives and societal needs, with the Saudi NIH operating more as a national funding and research-enabling entity, rather than conducting research directly. “Unlike traditional models where funds are allocated directly to investigators, we implement a three-party agreement framework, engaging institutions to enhance accountability, streamline administration, and foster long-term institutional commitment to research excellence,” he reveals.
Again, there is plenty of evidence to suggest that these initiatives are already having an impact, with the Kingdom recently registering a series of headline-grabbing wins in terms of fresh breakthroughs in medical science. “We are extremely proud to have been at the forefront of new developments in cardio treatment, by performing the world’s first-ever robotic heart transplant, and in biomedical research, our scientists developed Saudi Arabia’s first genetically engineered mice using CRISPR-Cas9,” says KFSHRC’s Majid Al Fayyadh.
“Meanwhile we are also contributing significantly to the advancement of global genetic research, through the Saudi Human Genome Project, a national initiative aimed at identifying genetic mutations specific to the Saudi population which is heralding new breakthroughs in the diagnosis and targeted treatments for hereditary diseases and helping to shift towards precision medicine,” he adds.
“Saudi Arabia currently stands at a pivotal juncture in its research and development journey,” confides Fars Alanazi, CEO of the Saudi NIH. “As a member of the G20, we have made significant strides, ranking highly in terms of international collaborations in research publications, and often leading the region in publications co-authored with international scientists. Moreover, our H-Index, a measure of research impact, places us in a competitive position regionally, though we recognise that we still have a long way to go to match our ambitions.”
As is common with most fledgling biotech scenes, the Kingdom currently struggles to bridge the gap between innovation and commercialization. “The real question is how many products can successfully make it. Some may progress quickly, while others may struggle and ultimately not make it through. Ultimately, we have to acknowledge that this is a natural part of the innovation process, and we are still learning how to navigate it,” concedes Dr. Ahmed Alaskar, executive director of the King Abdullah International Medical Research Centre (KAIMRC).
He points to significant efforts underway to bring about a stronger commercialization pipeline. “Entities such as the Research Development & Innovation Authority (RDIA), the NIH, and Riyadh BioCentral, have been formed to support this process, and universities in Saudi Arabia are increasingly encouraged to focus on developing products,” he asserts. Government initiatives like Monshiat are also stepping in to help start-ups, entrepreneurs, and scientists bring innovative products to market. “These efforts link up scientists with industry leaders, investors, and other key players while simultaneous schemes such as the National Industry and Logistic Support Program are endeavouring to cultivate an open economy that welcomes the injection of foreign capital,” elaborates Alaskar.
In many respects it is a case of ‘all hands to the deck’ where all major public entities are being mobilised to play their part. “Researchers and entrepreneurs cannot do it alone. Global biotech leaders did not emerge in isolation. They flourished through networks of research institutions, private-sector investment, and government support. That is why KFSHRC has joined forces with the King Abdulaziz City for Science and Technology in establishing a National Biotechnology Centre and developing bio incubators and spin-off companies to help contribute to the formation of a flourishing ecosystem,” affirms Al Fayyadh.
Clinical Trials Catchup
Another domain where Saudi Arabia is looking to improve is the participation in clinical trials. “Biotech localization is only one part of the equation. Many people tend to focus on the brick-and-mortar aspect of biotech this is especially true of the strategies being led by the Ministry of Industry. But there is another critical component that must go hand in hand with localization: knowledge-based innovation and the establishment of the Kingdom as a go-to clinical trials destination,” argues Pfizer’s Mohamed Fawzy. “If new biotech assets are going to be localised, then it is essential to create an environment where these innovations can also be tested through clinical research.”
Sameh ElFangary, country president for the GCC and Pakistan at AstraZeneca, agrees. “While high-sophistication manufacturing remains critical to meeting self-sufficiency goals, innovator drug developers believe our true value lies in areas like knowledge and technology transfer for clinical trials that will position Saudi Arabia on the global drug discovery map.”
It is, however, illustrative that though KAIMRC has now achieved the significant milestone of being able manufacture cellular therapies in-country and successfully mastered the production of induced pluripotent stem cells, they are still waiting for the requisite approvals to be able to deploy them in clinical trials. “Our CAR-T cell development is a notable achievement because it is entirely our own work. The product is already produced here, but we are awaiting further regulatory approval before we can begin patient trials,” reveals Alaskar.
That is not to suggest that the country’s prominence as a clinical trials destination has not grown substantially over the past decade, even surpassing MENA markets such as Egypt and Algeria. “The Saudi Clinical Trial Enterprise (SCTE) continues to make significant progress by enhancing communication among stakeholders including hospitals, the pharmaceutical industry, and regulatory authorities. These efforts have already resulted in a notable increase in the volume of in-country as more hospitals are join the initiative,” recounts Alaskar, claiming that KAIMRC has successfully launched multi-centre clinical trials led by local institutions
“By far and away the most mature aspect of the local clinical research ecosystem is the quality of our principal investigators. Many of them are highly trained and certified, often having received their education abroad at prestigious medical universities, making them valuable assets when they return,” reflects Walid Abbas Zaher, CEO and co-founder of CAREXSO FZ LLC, an entity specializing in site management organisation.
At the same time, “Saudi Arabia’s size and commercial power, its robust and technologically enabled healthcare infrastructure, and its strong harmonization with international norms make it an increasingly appealing location for Big Pharma with heavyweight players such as Novartis, AstraZeneca, MSD, and Pfizer all having recognised its potential,” says Mohamed Mostafa , the CEO of the regional contract research organisation, PDC.
“These days, we tend to spearhead clinical trials in the region, conducting nearly 25 percent of all trials in the Kingdom, primarily in Phase 3,” confirms AstraZeneca’s Sameh ElFangary. Moreover, his company is keen to accelerate the maturation of the country’s clinical research capabilities by proactively partnering with the Saudi FDA to help refine clinical trial regulations and organizing summits to train investigators.
Likewise, Amgen’s general manager, Lyes Salah, says that his company “has also been running phase 2 and 3 trials locally and will be aiming to further expand these efforts by certifying research centres and preparing healthcare providers to conduct high-quality studies.”
Others, however, still spot an opportunity loss. “Taking Saudi Arabia’s clinical research sector to the next level will require additional coordination and joined-up thinking, considering factors such as timelines, logistical challenges, and operational efficiencies. This includes having standard operating procedures (SOPs) in place that everyone adheres to and having the capabilities ready to address potential delays that could arise from any participating country within a multicentre trial,” muses Ashraf Daoud, general manager at AbbVie. “While the Kingdom is undeniably already a member of world-class clinical trials, the real focus now needs to shift towards enhancing capabilities for Phase 1 and Phase 2 studies.”
“Saudi Arabia predominantly engages in more advanced trials, typically phase 2B and phase 3 studies, comparing unfavourably to neighbours like the UAE, where there is instead a notable concentration of phase 1 and phase 2 trials,” agrees Zaher.
While the national objective of becoming a clinical trials powerhouse may still appear overly aspirational to some, many market insiders point to the tangible and meaningful progress underway. “One of the most important enablers has been the shift in societal and institutional mindset. Where once there was considerable hesitancy toward investigational treatments, there is now a broader understanding of their value,” contends Abed Sabra, General Manager at Roche.
“This change is particularly evident among healthcare professionals. Today, the majority of treating physicians are Saudi nationals, many of whom have trained in leading international institutions and bring with them a strong appreciation for the role of clinical research.”
“At the same time, government stakeholders increasingly view clinical trials as an essential lever for improving healthcare outcomes,” adds Sabra.
Time to Focus
Some argue that there may be a lack of focus. “It is important to avoid having too many scattered initiatives. Without a clear, prioritised focus, efforts can become too fragmented. Identifying key areas of research that align with the country’s unique needs and priorities is crucial,” Deloitte’s Vineta Bhalla argues.
“This might mean centring on diseases that have a high burden in Saudi Arabia, or leveraging the country’s unique position as a global religious tourism hub, which might bring infectious diseases into focus. Once these areas are identified, building robust infrastructure—grant mechanisms, ethical and regulatory oversight, data standards, and strong clusters of expertise —must surely follow,” she surmises.
“Saudi Arabia offers distinct research opportunities, particularly in non-communicable diseases such as diabetes, cardiovascular disorders, and hyperlipidaemia, which are highly prevalent across the population. However, by far the most compelling opportunity for pharmaceutical investment lies in rare genetic diseases, where Saudi Arabia holds a unique position,” opines the Saudi NIH’s AlJeraisy.
“Due to the high rate of consanguinity, the country has an elevated incidence of genetic disorders, creating an exceptional landscape for gene therapies, next-generation biologics, and advanced therapeutics. Experts suggest that a concerted focus on thalassemia alone could attract significant investment from the originator drug developers and biotechs specializing in orphan drugs and personalised medicine, as innovative treatments such as gene therapy and biologics represent the only viable solutions.
“The opportunities to pioneer cutting-edge gene and cellular therapies are immense, and we frankly should not be relying on research centres in Boston, Paris, or Tokyo to develop treatments for conditions endemic to our region,” agrees Al Fayyadh.
“It is possible to shape the Kingdom’s clinical research landscape and biotech ecosystem into something unique and special. The world is watching, and while it might presently have a sceptical eye, this is also a golden opportunity for Saudi,” concludes Vineta Bhalla.
