Abstract
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.
Highlights
Pharmaceutical companies must first receive regulatory body approval before they can launch and market new drug products, change their specifications or formulation, or add an indication
Pharmaceutical companies strive for sustainable growth by maintaining a cycle consisting of launching new drugs, gaining market share, making sales, reinvesting profits into research and development (R&D), and launching the new drugs [44,45]
Decision-making in the R&D phase in terms of therapeutic area, modality, and geographic strategy is critical for achieving sustainable growth
Summary
Pharmaceutical companies must first receive regulatory body approval before they can launch and market new drug products, change their specifications or formulation, or add an indication. To these ends, clinical trials meeting stringent requirements must be conducted. Pharmaceutical companies first identify countries wherein the drug will be launched Thence, they design global clinical trials to meet the regulatory requirements of all target countries and endeavor to meet those needs as closely as possible. In view of the aforementioned facts, we believe that it is worthwhile to understand the changes in therapeutic area, drug modality, and internationalization of the top-selling pharmaceutical drugs over the past decade to reopen a debate about commercial success in the pharmaceutical industry. As the sustainable growth of pharmaceutical companies depends heavily on decision-making in the R&D phase, relative to drug characteristics and geographic strategies, our study will have important implications in the decision-making process
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