Biomedical Engineering Reference
In-Depth Information
FIGURE 2.1
FP market sales forecasts from 2010-16E for FPs in Phase III clinical trials, in
regulatory submission and on the market.
2.2.1 Enbrel Founded the FP Market Following Its
Launch in 1998
development. Given the relatively small number of marketed
drugs as of 2010, and because only a few FPs generate the
vast majority of our 2016 sales forecast for the FP market,
we believe this market can be characterized as an early-stage
biotech market.
In 1998, Amgen/Pfizer/Takeda's Enbrel (etanercept)
became the first FP with substantial commercial potential
to be approved in the United States. It was approved by the
FDA for the treatment of moderate to severe rheumatoid
arthritis (RA) and was also the first biologic drug to be
launched to treat this indication. One year later, Eisai's
Ontak
1
1
became the first targeted toxin FP to be approved
to treat human indications. FPs continued to be launched
through the 2000s and as of the end of 2010, we count seven
sales-generating FPs on at least one of the major western
pharmaceutical markets.
2
We scanned through resources including Pubmed, Clin-
icalTrials.gov, FP developer websites and company-related
publications, and industry reports, and we have identified a
total of 43 FPs in Phase II development or above that meet
our definition of an FP. Products known to have been
discontinued have been excluded, as are FPs in the Phase
I portion of a Phase I/II trial, as these are considered to be in
Phase I development. Of these 43 FPs, seven are on the
market, 13 are in later-stage clinical development (Phase
II/III, Phase III and in registration), and a further 23 FPs are
in Phase II. Of these, we forecast six FPs will account for
93.5% of FP market share by 2016: three of these are already
marketed, whereas
2.2.2 We Forecast the FP Market Will Grow
to $10.1 Billion by 2016
We estimate the FP market generated sales of $7.9 billion in
2010 (based on seven marketed drugs) in the major pharma-
ceutical markets,
3
and we forecast that this market will rise to
$10.1 billion on a risk-adjusted basis
4
by 2016 (Figure 2.1),
based on forecasts of currently marketed FP drugs, those
that have been submitted to regulatory authorities, and those
in Phase III clinical trials (these forecasts are detailed in
Section 2.3). This 4.1% 2010-16E compound annual growth
rate (CAGR) estimate is relatively low compared with other
biotech drug classes such as monoclonal antibodies (mAbs;
independent market analysts forecast a 2009-15 sales CAGR
of 9.5%
5
), although it is stronger than small molecule growth
forecasts (independent market analysts forecast a 2009-15
3
This includes the United States, Europe, and Japan. Unless otherwise
specified in this chapter, references to the market refer primarily to major
western pharmaceutical markets (the United States and Europe).
4
Drugs included in the forecast which have not yet been approved by the
regulatory agencies are risk adjusted, with the level of risk adjustment
correlated to stage, clinical trial data and indication (see also [1] for clinical
trial progression and impact of indication on likely success).
5
Both mAb market forecasts and small molecule forecasts are based on
Datamonitor's “Fast growth MAb market to offer great rewards to a select
few over 2009-15” from “Monoclonal Antibodies: 2010”, November, 1
2010.
three
are
in
late-stage
clinical
1
Ontak was developed by Seragen, which was acquired by Ligand Phar-
maceuticals, which then sold Ontak in 2006 to Japanese pharmaceutical
company Eisai.
2
In addition to these seven drugs, Bristol-Myers Squibb's Nulojix (bela-
tacept) was approved in the United States in June 2011.
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