The Global Use of Medicines - IMS Health

POLICY-DRIVEN CHANGES AND THEIR IMPACTS THROUGH 2015
Biosimilars are emerging rapidly but adoption to date is limited
$138Bn
2006-
2010
CAGR
11.7%
Global Biologics Spending
2010 2015
Biosimilars
$2-2.5Bn
Biosimilars $190 –
11%
$311Mn 200Bn
5%
33%
25%
42%
2011-
2015
CAGR
6-9%
Source: IMS Institute for Healthcare Informatics; MIDAS Dec 2010
70%
epoeitin alfa
somatropin
filgrastim
14%
New Biosimilars
Global Biosimilars
Originator Biologics
• Global biologic spending was $138Bn in
2010, compared to $311Mn for biosimilars.
• Much of the global biologics spending is
concentrated in the U.S. Biosimilar spending
is concentrated in Germany and other
European markets which adopted approval
guidelines earlier, and now account for over
80% of global biosimilars spending.
• Europe’s approval guidelines for monoclonal
antibodies, expected later this year, will add
new molecules to the competitive space
through 2015.
• The U.S. approval pathway, included in the
Affordable Care Act, grants 12 years of
market exclusivity to originator biologics.
New biosimilars are expected to enter the
U.S. market by 2014, including epoeitin alfa
and filgrastim, which currently have
approved biosimilars only outside the U.S.
Chart notes
Spending in US$ with variable exchange rates.
Biosimilar products are biologic products approved in a
country which has an abbreviated approval process for
biologic products that reference an originator biologic in
the regulatory submission.
Products marketed in countries without a biosimilar
approval pathway and for which the originator has not
granted a license are not considered biosimilars.
.
The Global Use of Medicines: Outlook Through 2015
Report by the IMS Institute for Healthcare Informatics
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