The drug industry in Europe may like to claim that its health is at risk, but it is still showing plenty of vital signs. In the first ten months of 2008, 81 applications for marketing authorisation were submitted to the EU through its centralised approval procedure. More than 60 of these were officially classed as innovative – because they were new substances, developed through biotechnology process, or of special value for patients, particularly for rare diseases. The others were generic copies. By the end of October, marketing authorisations had been granted for 43 products – although only four generics.
Compared to the level of applications over the 13 years since the EU's centralised registration system came into operation, the 2008 approval rate is above average. Since 1995, a total of 749 applications have been made, and 477 authorisations have been granted. In all that time, only 20 negative opinions have been issued, but 135 applications have been dropped during the course of evaluation – and some applications remain in the evaluation process.
Of the authorisations issued between May and November, Merck Sharp & Dohme of the US had six and Glaxo of the UK had three. Janssen – the Belgian subsidiary of US Johnson & Johnson – and CV Therapeutics and Ratiopharm, both of Germany, had two. Boehringer Ingelheim, Lilly, Bayer, Sanofi, Wyeth, Novartis, UCB, Organon, Bristol-Myers Squibb, Teva, Novo mesto, EpiCept, Mylan, Omrix, CT Arzneimittel and Jerini had one.
Major players
There are no single or simple ways of measuring performance or success – and a six-month snapshot of European authorisations is only anecdotal evidence. In a global market as complex as pharmaceuticals, nearly every player can find a way of selectively analysing and presenting data to show itself in the best light and its rivals in the worst light. But there is nevertheless consensus about who the biggest hitters are.
By 2007 revenues, Pfizer of the US is generally regarded as the world's heavyweight, with income of around €30 billion. But three European firms are hard on its heels – GlaxoSmithKline, France's Sanofi-Aventis, and the UK-Swedish AstraZeneca. Novartis and Roche, both of Switzerland, also make it into the top ten. But there are only a few other non-US firms that appear in the top 20. Amid the other US giants – Eli Lilly, Wyeth, Bristol-Myers Squibb, Abbott, and Schering-Plough – only Bayer Schering and Boehringer Ingelheim, both of Germany, can confidently claim a place in the world pantheon. Japan's Takeda, Daiichi-Sankyo and Esai also make it, and Belgium's UCB scrambles to stay in touch.
The lifeblood of new products is pumping at different rates through the arteries of the world's pharma firms, however, and Glaxo is widely tipped to overtake Pfizer in this year's sales rankings, on the strength of its more buoyant product range.
Roche and Novartis are also expected to show above-sector growth rates in the next few years, and could work themselves into a position to challenge for the top spot. But in pharmaceuticals, as in life itself, assumptions about untroubled health are frequently exposed as delusions.
