What it means to produce generic drugs in Italy today? Assogenerici has visited the main production sites of generic drugs in Italy and point out for key topics talking about challenges and criticalities of producing generics in our country: raw materials, quality, Data Integrity, extra EU.

Generic drugs, a growing market

The  companies of the generics confirm a growth trend in the main economic indicators: revenues and production costs increased significantly both between 2010 and 2015 (+ 56% and + 63% respectively). A partial difference is instead found in the dynamics of margins and investments. In the last two years, in fact, there has been a trend of contraction in margins (increased over the period by only 17%) and a doubling of investments (+ 105%). The two tendencies are not, of course, disconnected. The investments necessary to maintain a high level of competitiveness together with those made mandatory by the adaptation to some standards have had the effect of contracting margins of the companies themselves.

… the costs of raw materials increase

The costs have increased more than revenues in a context in which companies have no strategies to reduce the costs that can be passed. Infact, in the last five-year period the cost of raw materials is increased by 92%, weighing 47% of all production costs, and the investments that some companies define as “tied up”, necessary to maintain a high level of competitiveness and to meet the stringent regulations, are significantly increased.

The scenario, therefore, is that of a dynamic micro-sector from the point of view of economic growth, but subject to both structural and cyclical challenges, which become evident by looking at some numbers on production processes.