Quality-by-Design as an enabler of pharmaceutical innovation : mapping the ecosystem

Abstract

This thesis explores the organizational and geographical variety of implementation of pharmaceutical Quality-by-Design (QbD), a quality management approach that emphasizes product and process understanding and control based on sound science. To date, the literature on QbD has been predominantly focused on technical and scientific pharmaceutical research, leaving a gap in its exploration from a management and innovation perspective. Through a bibliometric analysis of 1625 scientific publications, this study reveals a rapidly expanding but institutionally fragmented field. The United States and India emerge as key players, exhibiting high publication output and strong collaborative networks. Also, a strong presence of pharmaceutical companyies and regulatory and public agencies at the core of QbD research. However, universities dominate knowledge production (62.1% of publications), while full tripartite collaborations between academia, industry, and government (Triple Helix) are scarce (1.3%). Thus, the limited integration of industry and government actors highlights a weak systemic articulation that may hinder QbD’s full innovation potential. The findings suggest that for QbD to operate as a true enabler of innovation, institutional collaboration must be strengthened. This study contributes to the literature by mapping the global QbD research landscape and identifying key institutional and geographical patterns in scientific production within the field. It concludes with recommendations for policymakers, industry leaders, and researchers to foster more integrated and innovationdriven QbD practices.