Lokalisering av kliniska prövningar : Faktorer som driver etableringar i Indien och Kina

by Eriksson, Ylva

Abstract As the world’s population is getting older and older and an increasing number of people can afford buying drugs, the pharmaceutical market is steadily increasing. However, the industry faces a number of challenges including intensifying competition, price pressure and decreasing R & D (research and development) productivity. The number of new drugs entering the market each year is decreasing at the same time as the R & D cost for each new drug has increased dramatically. The clinical phase (when the drug is tested in humans) makes up the largest cost increase. There has been an increase in the number of clinical trials in India and China. Is this increase part of the pharmaceutical companies’ strategies for increasing R & D productivity? The aim of this study is to investigate which factors are of importance for decisions of geographic location of clinical trials, and which business models that has been utilised when conducting clinical trials in India and China. The effect on R & D productivity of conducting clinical trials in India and China is also investigated. Respondents from AstraZeneca, GlaxoSmithKline and Pfizer have been interviewed and a literature study has been performed in order to gain access to the answers of the research questions. The findings suggest that access to patients in the country is the most important factor when deciding on geographic location for clinical trials, as the most common reason for delays is difficulties in recruiting patients. Other factors of importance are the cost level in the country and the importance of the market in the country to the company. All companies in this study have chosen to establish clinical trials in India and China through their own investments rather than fully using outsourcing or partnership with a local company. Further, the study suggests that conducting clinical trials in India or China potentially can contribute to increasing R & D productivity, as the ease in recruiting patients in the countries enables a shorter development time. Moreover, conducting clinical trials in the countries opens the doors to two large, rapidly growing markets, which can contribute to increasing the total sales figure for each drug, at the same time as the cost for conducting clinical trials in the countries are low compared to many other countries. I