The rise of Spain: A key player in global clinical trials

Spain clinical trials

Spain has climbed the research and development (R&D) ladder in recent years, and has made it to the top as one of the world leaders in the life science industry. A report by El País states that Spain stands as a benchmark in European drug clinical trials.

As the country with the highest participation in clinical trials of new medicines, Spain’s leadership is largely thanks to the structure of its national healthcare system, Javier Padilla, Secretary of State for Health expressed at a healthcare event organized by Farmaindustria, Spain’s National Trade Association.

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    Spain leads clinical trials in Europe

    Out of the 2,500 clinical studies that were carried out last year, 45% were held in national research centers. As this puts Spain on the map for biomedical research, Raúl Martín-Ruiz, partner at venture capital (VC) Ysios Capital Partners, believes that this is a move in the right direction.

    “In my view, it is important because of several reasons. It gives patients new therapeutic opportunities, especially to those that have not responded to approved drugs. It allows physicians to work with the newest drugs and technologies. This attracts funding from the pharmaceutical companies to the hospitals and it provides important savings to the national health system,” said Martín-Ruiz.

    Spain takes part in one out of every three tests that are launched in Europe, and comes second in the world – after the U.S. – in partaking in clinical trials. Back in 2021, the country accounted for a 4.1% share of clinical trials globally. To add to that, more than 145,000 patients in the country were said to have been involved in clinical studies last year.

    Moreover, the nation was ranked fifth in the number of scientific publications in the field of cell therapies last year, according to a report by the Spanish biotech association Asebio. It is ahead of countries like South Korea, the U.K., and Italy, where rigorous biotech research takes place. Plus, more than 100 studies conducted in the region test advanced therapies.

    “There is strong institutional commitment to research, development, and manufacturing activities around advanced therapies. In March 2024, a public-private partnership was announced in this field involving CDTI, Rovi, and Insud Pharma, with an initial commitment of more than €74 million ($79.67 million). The goal is to foster innovation and to access these types of products to patients for which advanced therapies could be the best therapeutic approach,” said Martín-Ruiz.

    Partnering for progress: Spain’s collaborative research initiatives 

    This initiative has been born out of two VCs, and was approved by the Council of Ministers. It is a part of the Vanguard Health Strategic Project for Economic Recovery and Transformation (PERTE) that is promoted by Spain’s government. PERTE aims to enable the public and private sectors to partner on projects in order to boost economic growth and employment within the Spanish economy. 

    As a part of the Rovi-Insud Pharma drug development alliance, almost half the share capital will be held by the government. 

    But Spain’s caliber to lead clinical trials has not come out of the blue. It is very much rooted in a strong sense of collaboration, according to Martín-Ruiz. One such example of R&D partnerships is Biocat, an organization meant to drive life science in Catalonia, a region in Spain that is named the BioRegion. 

    The BioRegion makes up more than 1,300 companies and 91 research institutions, and it represents 8.7% of the country’s gross domestic product (GDP) as well as 8% of employment in Catalonia. Investors in the region looking to spend on startups have doubled in the past three years, making it a more attractive place to conduct biotech research.

    Most drug trials are held in Spain’s capital Madrid as well as the bustling city of Barcelona in Catalonia. In fact, American vaccine maker Moderna chose Madrid as the ideal place outside of the U.S. to test its mRNA vaccines. The multinational pharmaceutical shelled out €500 million ($538.08 million) as a part of these collaborative efforts. This is following Spain’s notable involvement in trialing vaccines and drugs during the COVID-19 pandemic as it led Europe’s coronavirus studies.

    “On the one hand, I would say that it (Spain’s clinical success) is a combination of collaborative work between the Spanish health authorities, hospitals and pharmaceutical companies. On the other hand, the education of patients and their families by the healthcare stakeholders around the value of clinical research has been also key to reach the leading situation that we have in Spain when it comes to conducting clinical trials,” said Martín-Ruiz.

    Precision medicine grows in Spain

    Spain is also invested in precision medicine research. As of last year, cancer was the therapeutic area with the most number of personalized medicine projects, making up nearly 30% of all precision medicine studies and programs, according to Statista. An AseBio report revealed that precision medicine products made up more than half of all new medicines in 2020, compared to 12% previously. Spain continues to forge ahead through this field, and has gained a particular interest in cell therapies, according to Padilla.

    While the Spanish biotech industry has come a long way since VCs like Ysios began investing in 2007, the life science industry could be pushed further to convert clinical research into healthcare innovations. 

    “The sector has attracted experienced human capital, specialized investors and there are already nice success stories of companies that have completed the cycle from inception to acquisition, initial public offering (IPO) and commercialization. However, there is room for improvement in aspects such as the translation of the excellent science that the country generates into company creation and product development,” said Martín-Ruiz.

    Reaching every corner of Spain with decentralized clinical trials

    Moreover, encouraging decentralized clinical trials could bolster access to people across Spain. At present, clinical trials seem to be concentrated in big cities like Madrid and Barcelona, but calls for studies to be dispersed across various parts of the country are growing. Digital tools to allow patients from any region in Spain to participate in therapeutic research could help, according to Raquel Yotti, commissioner of PERTE in the El Pais report. Martín-Ruiz echoes these thoughts, and believes that Spain’s attempts to improve patient access are increasing. 

    “According to Farmindustria, 50% of the clinical trials conducted in Spain are carried out in the autonomous regions of Madrid and Catalonia. It is my understanding that there is a plan to increase the participation of the hospitals from other autonomous regions in the clinical trials conducted in Spain. The quality of the centers in those regions certainly justifies this strategy, and it will provide the opportunity to pharmaceutical companies to access more patients, and to patients in those regions to access novel therapies,” said Martín-Ruiz.

    Network clinical trials are being organized, where multiple healthcare centers, such as hospitals, clinics, and research centers join hands to bring investigational therapies to patients all over the country. These trials take place across different sites in multiple locations simultaneously. 

    As the region builds a stronghold for healthcare research, its success goes to show how collaboration is key to research and innovation

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