Facing an innovation crisis marked by escalating research and development (R&D) costs, declining R&D productivity and recurrent patent expirations. Big Pharma companies have undergone a profound business model transformation from the traditional blockbuster model to the specialty pharma model, centered on targeted therapies for complex and rare diseases. This study aims to examine how this transformation reshaped R&D organization, analyzing the opening of corporate R&D to external participants and the emergence of multi-stakeholder R&D ecosystems.
The paper adopts a document-based analysis of R&D practices of ten leading Big Pharma firms. Peer-reviewed empirical studies, industry reports and company disclosures are analyzed, compared and strategically interpreted to trace the evolution of open R&D in the context of business model change, with particular attention to the increased adoption of digital technologies in drug development.
The specialty pharma model required Big Pharma companies to access biotechnological and digital competencies complementary to their internal capabilities, making open R&D a central strategic response. Over time, these companies established a broad range of long-term collaborative R&D arrangements with diverse external partners. Across companies, a novel R&D organization structure in the form of multi-stakeholder R&D ecosystems is emerging around Big Pharma firms, coordinated through soft management mechanisms. Findings also indicate that digital technologies, particularly artificial intelligence, are expanding the pool of potential collaborators and enabling new forms of interaction and coordination across the R&D value chain.
The study reframes open R&D in Big Pharma not as an isolated strategic choice but as a business model-driven shift from acquisition-led integration and ad hoc partnering to the orchestration of R&D ecosystems, linking business model theory with open innovation and ecosystem literature in a pharma-specific frame.
