European Regenerative Medicine Firms & Their Strategic Approaches Michael Morrison University of York
OVERVIEW • Creating the European RM ‘Universe’ of firms • Characterizing the European RM Universe • Strategic Analysis
DEFINING REGENERATIVE MEDICINE Regenerative medicine is a heterogeneous domain, incorporating multiple technological avenues of investigation. United by a shared goal of stimulating, directing or augmenting the body’s capacity for self-repair and regeneration. Our approach concentrates on technologies using novel biomaterials – living cells, genes and bioscaffolds.
DEFINING REGENERATIVE MEDICINE Excludes small molecules and biologicals (e.g. antibodies) that aim to stimulate in vivo regenerative action. Large pharmaceutical companies with an interest in aspects of regenerative medicine such as Pfizer, Sanofi-Aventis, Smith and Nephew etc not included on the list Basic cell culture tools/media suppliers not included unless have specialist focus.
DEFINING REGENERATIVE MEDICINE ‘European’ companies must be based entirely in a European state, or have their headquarters there. Subsidiaries of non-European firms are not included. Company must have some publicly available details (usually in the form of a website).
SUMMARY OF FIRM CHARACTERISTICS Cell therapy is the largest single sector Significant no. of bioscaffold and service firms Most firms are small (< 99 employees) Wide range of company ages – many remaining from 1990s and pre 2002 ‘crash’ UK and Germany are the main geographic hubs of commercial RM activity
GENE THERAPY LANDSCAPE Engagement with Advanced Therapy Medicinal Products regulation: Ark’s Cerepro rejected in 2009 but has named-patient approval in France and Finland Amsterdam Molecular Therapeutics’ Glybera submitted for MAA in 2010 MolMed (Italy) have cell-based ex-vivo gene therapy in phase III trials
CONCLUSIONS Companies pursuing newer regenerative medicine models appear to co-exist with older tissue engineering and gene therapy firms. Strong industry preference for less risky technologies – autologous cell therapy with somatic cells or adult stem cells. Little commercial investment in iPS and embryonic stem cell technologies.
CONCLUSIONS Commercial development concentrated in Western Europe, and concentrated in hubs. Importance of biotechnology infrastructure and financial support. Regulatory environment is also an important shaping factor – as with hESCs Can be illustrated by Germany – UK RM firm breakdown