Beyond Borders: Global biotechnology report 2010

FDA product approvals, 1996–2009
Number of approvals
New molecular entity Biologic license application
60
50
40
30
20
10
0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Source: Ernst & Young, FDA
Chart shows product approvals by the FDA’s Center for Drug Evaluation and Research.
Europe
Pipeline strength: continued growth
The total number of drugs in clinical
development in Europe climbed to 1,199
in 2009, a 16% annual increase that is
relatively on par with the growth seen over
the last several years. Phase II programs led
the growth with an increase of 120 products
(22%) over 2008. There were also increases
in late- and early-stage development, with a
12% increase in Phase III and 7% increase in
Phase I products.
UK-based companies continue to lead the
European pipeline, accounting for 20% of
products in clinical development, on par
with their share in 2008. The majority of
clinical programs in development (71%) for
British companies are in Phase II or later.
Germany and Denmark were in second and
third place in 2009, with their companies
accounting for 12% and 11% of the European
clinical pipeline. France and Switzerland
round out the top five countries, with each
representing about 10% of developmental
programs. The relative positions of the top
five are unchanged from 2008.
Swiss companies’ contribution to the overall
European pipeline had declined in the past
couple of years because of the acquisitions
of prominent Swiss biotech players,
including Speedel (acquired by Novartis
in 2008) and Serono (acquired by Merck
KGaA in 2007). In 2009 — in the absence
of any such large Swiss acquisitions — the
aggregate pipelines of Swiss companies
88 Beyond borders Global biotechnology report 2010
increased by a healthy 20%. Israeli
companies also had a big year in stoking
their clinical pipelines, as they increased
their clinical development portfolio by 26%
and overtook Italy to reach the number
seven spot.
As in previous years, cancer therapeutics
led the European drug pipeline with 22%
of Phase III candidates in development.
The oncology segment has declined
somewhat from levels seen in 2007, when
oncology made up 28% of the late-stage
pipeline. The “metabolic and endocrine”
and “autoimmune” indications rounded
out the top three late-stage development
therapeutic categories, representing 13%
and 12%, respectively.