R&D spending per NME declines
estimated $1.25 billion for each new molecular entity (NME)
approved by the FDA in 2004. The figure represents the second
consecutive year in which this figure has declined from the high of
$1.82 billion in 2002, and reflects the sharp upturn in NME
approvals in 2003 and 2004.
The analysis revealed that the pharma industry spent an estimated $1.25 billion (€1.03 billion) for each NME submission (i.e., to the FDA) - a figure that is indicative of the current state the R&D pipeline is in.
This measure has been stable for the last three years, remaining within a narrow range ($1.29 billion to $1.23 billion). Still, the 2004 R&D spending per NME submission metric is almost four times what it was in 1995 ($317 million/NME submission).
One major factor, thought to be contributing to this trend, was the negative impact mergers and acquisitions were having on R&D output. The high profile deals between French pharmaceutical group Sanofi-Synthelabo and Aventis, forming Sanofi-Aventis and Sweden's Astra and Britain's Zeneca in 1999's $36 billion merger has clearly dented pharma R&D budgets.
Worldwide pharma R&D spending per global new active substance (NAS) launch reached a record $2.3 billion in 2004, up 43 per cent from 2003. Global NAS launches fell another 26 per cent, to an all-time low, according to an analysis by Scrip Magazine.
Despite the continuing downturn in global NAS launches, worldwide R&D spending rose to $53 billion last year, according to CMR International estimates..
The analysis, which appears in the newly released Paraxel's Pharmaceutical R&D Statistical Sourcebook 2005/2006, reveals findings that are similar to industry findings across the globe.
Of the 31 new molecular (chemical and biological) entities launched on the world market in 2003, 14 were launched by US-based firms, ten by European firms, three by Japanese firms, and four by companies based in other countries.
According to one projection released by The European Federation of Pharmaceutical Industries and Associations (EFPIA), "fewer than 10 per cent of first [new medicine] launches are projected to occur in Europe by 2010."
The sourcebook also quoted the world pharmaceutical market's value at an estimated €550 billion (€456 billion) in 2004. Over the past decade, the North American market (US and Canada) has grown the fastest and remained the world's largest, with a 48 per cent share (up from a 31.3 per cent share in 1990 and a 43 per cent share in 2000).
This remains well ahead of Europe, which has a 30 per cent share, down from 37.8 per cent in 1990.
Pharmaceutical R&D investment is currently the highest in the world, a measure of the risk involved. Research-based pharmaceutical companies use 17 per cent of their total sales on research and investment compared to the computer software and services industry, which uses 10.5 per cent.
Parexel's Pharmaceutical R&D Statistical Sourcebook 2005/2006 is available at Barnett International - a division of Parexel International.
