The advent of Biosimilars: study of their impact on the strategies adopted by market players in the Pharma industry

This thesis focuses on the study of the pharmaceutical industry and the introduction of biosimilar medicinal products which are following specific new pathways to access the health market. To best understand the long term impact biosimilars will have on the industry, the study is divided in two main parts. 1) In the first part of our study we will analyze, according to the PESTEL framework, the macro environment pharmaceutical companies operate in and the main factors that influence their strategic choices. Political treaties governing trade and markets, global macroeconomic trends, expanding market for chronic and degenerative diseases in the aging population, technology innovations, the patent cliff phenomena and public health regulations are all contributing to the rise and growth of the biosimilars market. 2) The second part will focus on the complexities of the consolidating biosimilars market and how players are dealing with the arising competitive pressure. Existing R&D based companies, once main players in the biopharmaceutical market, are in fact experiencing high pressure from new entrants which reproduce their blockbuster products at a lower cost thus enjoying high returns on investments (ROI). In the words of the Bloomberg intelligence senior healthcare analyst A. Goonewardene : ¿If creating a generic drug is like designing a tricycle, then a biosimilar is like building a spaceship, in terms of complexity and size¿. Purpose of this study is therefore to analyze biosimilars in the changing pharma industry and the impact of their development on the competitive strategies of the main market players.