Effect of External Innovation on Advanced Pharmaceutical R&D: The Case of Monoclonal Antibody Drug Development

With the progress of biotechnology, the strategic foci of research and development (R&D) in drug discovery have diversified from small molecules to biologics and new modalities, such as cell and gene therapies. To create innovative drugs, pharmaceutical companies are actively adopting external innovation approaches to acquire complicated and diversified technologies. Although pharmaceutical companies have built their own R&D models and accelerated collaborations with external organizations, the impact of this on R&D productivity has not been fully clarified. In this study, we analyzed the typology of external collaborations for R&D in the case of monoclonal antibodies and explored its relation to the effectiveness of new drug discovery. Specifically, the monoclonal antibody drugs approved in the United States to date (n=66) were examined and described in terms of technological differences, the pattern of collaborations, and the sequence of key milestones. Our observation of the new drug creation processes of topranked pharmaceutical companies (n=12) revealed that they tend to internalize external expertise to improve their intrinsic R&D capabilities. These findings suggested that the contribution of phased external innovation models to monoclonal antibody drug development. Further, the findings highlighted the significance of internal mechanisms to internalize external innovation experiences, which leads to sustainable innovation.