What will 2008 be like for the pharmaceutical sector? Unlike the astrological forecasts of specialized newspapers, here it is possible to present some projections and, burning the time of the other analysts, IMS has published its report quite clear in the conclusions. The coming year will not be exceptional, and what is defined as a decline in the curve will be determined by two main factors: the first, exclusively economic, will be the progressive shift towards the generic; the second, more sanitary, will be the evolution of the regulatory aspects, potentially capable of making the market more volatile.
Starting with the facts, in 2008 the sector will grow again, but only by 5-6% (equal to 509-516 billion euros) compared to 2007, a year which in December should capitalize on an increase of 6-7% compared to 2006. Not a catastrophe, but probably the first sign of a trend reversal, also because the expected growth will be driven by other protagonists. For the first time, sales of medicines used in primary care will fall and, also for the first time, the seven main world markets will see their contribution to global turnover fall to 50%. This is one of the strong changes underway, which is accompanied by the growth of markets hitherto considered marginal. In the US, to start growth in 2008 will hit 5% at best, in Japan, at best, 2% and the five major European markets will do no better than the US. On the other hand, some areas, China, Brazil, Mexico, South Korea, India, Turkey and Russia, will have double-digit growth, of the order of 12%, totaling 85-90 billion euros. And this obviously bears the effect of the fall in patent coverage, which in 2008 will concern a group of products "worth" 13.8 billion euros which includes, among others, Risperdal (risperidone), Fosamax (alendronate), Topomax (topiramate), Lamictal (lamotrigine). At the same time, the generics sector is expected to grow by 14-15% (for 48.3 billion euro) and so, for example, IMS predicts that in 2008 two-thirds of the prescriptions issued in the United States will concern equivalent drugs. A scenario in which the arrival of biosimilars also weighs, for which the European registrations of the so-called generic versions of the epoetin have paved the way.
Then there is the regulatory aspect, which mainly concerns safety issues. Given the many precedents, and the criticisms received from the FDA, IMS predicts that the approvals of new molecules will see a reduction in the number of indications, and an increase in the number of black box warnings. The first result will probably be an extension of the approval times. And if risk communication initiatives to the public increase, it is logical to expect, at least in the United States, a greater attention in post-marketing surveillance. A greater attention that could materialize in the multiplication of studies (or meta-analyses) for the most widely used drugs.
The conclusions of the report are clear in their uncertainty, in the sense that they indicate the need to overcome the current model of the pharmaceutical industry, although it is not easy to say what this means in detail. For now, it can be guessed that there will be a division of functions: keeping the commercial apparatus and research and development under the same roof may no longer be sustainable, especially below a certain size. And the continuation of outsourcing of the ISF network, for example, bears witness in this sense.
Swabian Prati
Source “pharmama
