Impact of generic competition on market share and prices of cardiovascular medicines on the Bulgarian pharmaceutical market

Background: During the last three decades tremendous progress has been made in the discovery and development of a lot of new molecules in many pharmaceutical areas. These families of real innovative treatment comprise "originator" molecules (first molecule released, which can be under patent or with expired patent), as well a "generic" version of those originator molecules, whose patent has expired. Usually the patent expires 15-20 years after the creation of the originator molecule. Main objective: This research focuses on the effects of the arrival of generic and or therapeutic competitors on the market, in terms of impact on the market share and prices. Methodology: Between 2005 and 2007 we follow three classes of medicinal products in the cardiovascular area: ACE inhibitors, sartans and statins. They have been studied on the Bulgarian market because there is no regulation in the country stimulating the generic market. The official database of the Bulgarian Health Insurance Fund was used to test our two hypotheses concerning the impact of the generics on market share and prices. To test our hypotheses, a t-test analysis, Kolmogorov Smirnov, one and two way ANOVA analyses were performed. Results: Our results confirm that the generic competition, in general, changes the market. These changes decrease the price of the medicines. The generic competition is not regulated in the country and this fact could negatively influence our study because it does not correspond to world trends. Furthermore, our results confirm that the creation of a sustainable generic pharmaceutical market requires active regulatory and marketing measures at all levels including incentives for manufactures, physicians and dispensers. © 2010 Springer-Verlag.