Sweden is a leader in ATMP

Sweden needs to focus on cell, gene and tissue therapies through a national system for the development, commercialization and implementation of ATMPs. This is so that Sweden can meet the ambition to be a leader in ATMP by 2030, but also so that Sweden's R&D investments in the field will fully create value in the form of industrial competitiveness, growth and benefits for healthcare and patients.

Advanced medicines for gene, cell and tissue therapies are on the verge of a global breakthrough, offering great opportunities for industrial growth as well as for patients and healthcare. The development is very fast and there is now a rapid increase in the number of development projects and companies operating in ATMP.

A number of universities and university hospitals conduct outstanding research projects and Swedish life science is of high international quality. The commercialization of successful research projects is driven by start-ups or small and medium-sized research and development companies. A critical stage is when the project is approaching the first clinical trials where they will be tested in patients for the first time. Companies then need access to support services, infrastructure, capital and, not least, a well-functioning collaboration with healthcare and the medical profession on clinical trials. As more and more projects approach the clinical phase, companies’ need for this support is increasing.

There is a need for a support system with cost-effective services for the development of the manufacturing processes required for the industrialization of development projects, but also for the manufacturing of ATMPs for clinical trials. There are limited academic and healthcare infrastructures and private initiatives for GMP manufacturing, but we need to accelerate assets, increase capacity and link the same existing initiatives in a national process chain to meet the needs of industry, academic research and healthcare. Investments in this area are necessary for Sweden to benefit from the investments in research and innovation that take place in the country, but also for us to be able to attract investments and establishments from abroad.

To be successful, the initiative needs:

  • Create a sustainable and comprehensive ecosystem in collaboration between public and private actors for the development, manufacturing and deployment of ATMPs;
  • Linking the whole country’s assets in a coherent process chain;
  • Build on existing actors, already implemented initiatives and planned initiatives in industry, academia and healthcare, with the aim of strengthening, accelerating, complementing and coordinating the private and public actors that contribute to development in Sweden;
  • Act quickly and capture the actors who step forward with initiatives and resources to enable a national effort.