AseBio presents the ‘Map of advanced-therapy capacities of the biotech industry’ in Spain

AseBio is presenting the ‘Map of advanced-therapy capacities’ for the first time. Advanced therapies are a new generation of innovative drugs based on genes (gene therapy), cells (cell therapy) or tissues (tissue therapy). They have a huge therapeutic potential because they allow degenerative and genetic diseases, including some types of cancer, to be treated which could otherwise not be treated with other approaches, making them a cornerstone in cutting-edge health systems.

In the past 12 years, the European Medicines Agency (EMA) has given the green light to eight advanced-therapy drugs in therapeutic areas like ophthalmology, immunology, haematology, oncology and hepatology. 

The development of advanced therapies in Spain

Spain has become one of the benchmark countries in advanced therapies because of both the level of science and the number of clinical trials. In fact, Spain has the highest clinical trial activity in all types of advanced therapies, with more than 100 per year, as reported by AseBio in its position paper on advanced therapies. 

Spain is ranked fifth in number of scientific publications in the field of cell therapy compared to GDP, ahead of countries like South Korea, the United Kingdom and Italy. In the past five years, Spain has increased the number of scientific publications in all three types of advanced therapies described.  

Out of AseBio's more than 300 members, 46 are working in the field of advanced therapies. Of them, 12 are in academia and 34 are biotech companies working in Spain. 

Cell therapy is the leading-advanced therapy in which AseBio members work. Of these 46 members, 87% work in cell therapy, 63% in gene therapy and 47% in tissue therapy. More than 30% of these organisations work in all three areas. 

SMEs and micro-enterprises, top industrial producers in Spain

The ‘Map of advanced-therapy capacities’ reveals that the Spanish biotech industry is present throughout the entire advanced-therapy development and manufacturing value chain. Academic AseBio members focus on the research and development processes, while the member companies are not only present in the initial research and development phases but also cover other activities like manufacturing, technology transfer, engineering and storage and distribution. 

Almost 70% of the more than 30 AseBio member companies that work in advanced therapies are SMEs, and nine have industrial production plants in all three types of therapies scattered throughout Spain. By autonomous community, the Basque Country ranks first, with five of these nine companies. It is followed by the Community of Madrid (two companies), Navarra and Andalusia (one each). 

“There is a huge need for investment”

“The number of companies working in advanced therapies in Spain is significant. These companies are facing the same challenges as the rest of the biotech sector: growth, internationalisation and digitalisation. What lies behind these challenges is boosting their productivity and competitiveness in a global sector”, says Gurutz Linazasoro, CEO of Vive Biotech and leader of AseBio's Advanced Therapies working group.  

The diseases that are treated with advanced therapies are global, which mean that Spanish companies “have to reach every corner of the world and compete with others that are larger and have many more resources behind them. There is a huge need for investment”, he says.

“Furthermore, many biotech companies working in advanced therapies are start-ups which have come from academia, so early, intense and loyal public-private partnerships are needed. AseBio can play a prominent role in technology transfer because it is familiar with both academia and the business and industrial sectors. This is what biotech is all about: turning scientific knowledge into GDP”, stresses Linazasoro.

Regarding the Map, he believes that “it shows all the capacities that exist in our country, which are often unknown but should be known. One example is CAR-T therapies, which are indicated for oncohaematological diseases and come from academic institutions. In this context, Vive Biotech could produce lentiviral vectors to cover the country's CAR-T needs. We are currently producing for more than 40 projects around the world”, he says.

“Our country has the capacities, but we need to think about instruments and incentives to promote them. We are at a turning point in which we have to look to the future and lay the groundwork for a new health system, with a steady focus on investments that help small, innovative companies and allow them to grow and become solid”, adds Ion Arocena, AseBio CEO.

Advanced therapies in PERTE for cutting-edge health

Advanced therapies are characterised by being complex to produce and develop, so they require long periods from when they are discovered until they finally reach patients as approved drugs (up to 20 years in some cases).

These therapies occupy a prime place in the PERTE for cutting-edge health as one of the engines transforming the health sector with actions in which science, innovation and digitalisation go hand-in-hand to face the new healthcare challenges. 

“Spain is poised to be a global power in generating knowledge on advanced therapies. We are facing the challenge of building cutting-edge healthcare in which advanced therapies should play a key role in protecting and improving people's health’, notes the AseBio CEO, Ion Arocena. “We have to harness all the potential of the biotech sector, including its industry, from R&D in therapies to production, manufacturing and distribution”, Arocena concludes.