Sunday, January 20, 2013

The class of 2012. - 37 NDA's analysed

Only 13 drugs out of 37 (35%) were licensed to Big Pharma. This is consistent with data from the last 8 years when the share of Big Pharma has hovered between 25% and 40%.

Based on historical data, only about 4 or 5 of these 13 drugs will become blockbusters. The rest will peak on average at about $500 million. This is insufficient to support the sales of the top 13 pharma, which in 2011 where just short of $400 billion. Despite their chief executives’ best intentions, we can expect significant turbulence ahead.

The companies that need new drugs the most did not get them. Since 2005, Abbott, AstraZeneca and Lilly have collectively received 3 NME approvals (excluding imaging agents), a troublesome performance for companies that have historically made major contributions to innovation. By comparison, the top 3 companies, J&J, GSK, and Novartis received 31 approvals during the same period.

The top 13 pharma spend about $72 billion a year on R&D. This is too much for too little output. It lends credence to the CEOs who have argued that the return on pharma R&D is now globally negative, and it is a problem that must be fixed.

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