Life Cycle of Drug Regulation

Abstract

Pharmaceutical regulations across the world play an important role in ensuring the safety and efficacy of the approved drugs. They not only regulate the pricing of drugs but the quality as well. The regulations are required both for new innovations and already existing products, in order to improve health status. An important agenda of pharmaceutical companies is the establishment of therapeutic area strategies, drug modality, and geographic strategies for research and development. It is worthwhile to understand the changes in therapeutic area, modality and internationalization of the top-selling pharmaceutical drugs over the past. Hence, the purposes of this study are to investigate changes in therapeutic area, modality and internationalization of the top-selling drugs and to identify their life cycle patterns. We compared the top-selling drugs between 2011 and 2017, and found that the percentages of nichebuster cancer drugs and home region-oriented drugs have increased whereas the proportions of traditional blockbuster cardiovascular drugs and global drugs have decreased. We compared product life cycle patterns via a Kruskal–Wallis test, and identified the features of product life cycle patterns per therapeutic area and modality. We performed a case study on drugs in the same class with the same pharmacological mechanism but found no differences across cases. Our results provide insights into therapeutic area strategies that consider life cycle patterns and geographic strategies that consider the competitive advantages of home region-oriented drugs. Finally, we presented new and simple models of life cycle patterns. This approach may help such enterprises establish and maintain sustainable growth.