Whither Generics? Why Major Restructuring Lies Ahead

Generics manufacturers have undergone some of the fastest growth in the pharmaceutical sector in recent years, but can their impressive growth rate be maintained post-2006–2007, when a number of blockbusters are due to lose exclusivity? Some of their major long-term challenges include the dearth of new blockbusters as branded pharma's pipeline dwindles; aggressive defence tactics — such as the development of combination products and over-the-counter switching; authorised generics deals; the lack of an established approval path for biogenerics; and increasing competition from manufacturers in developing countries. For many, maintaining market share will require a transformation of their business practices. The successful organisations will be those that recognise the need for change early and start to plan their campaign of response accordingly. This paper outlines the issues they face and discusses some of the potential ramifications.