Introduction:
Depression plays a prominent role in bipolar disorder as the
most frequent, and usually the presenting, symptom of the disorder. Since we
last reported on the market for bipolar depression, only a single drug,
quetiapine/quetiapine XR (AstraZeneca’s Seroquel/Seroquel XR), has received
approval to treat bipolar depression, for a total of two. At the same time, our
report has expanded the epidemiological definition of bipolar disorder to
include more mildly afflicted cases of the disorder—subthreshold bipolar
disorder—and expanded the bipolar disorder population and, consequently, the
bipolar depression population.
Questions Answered in This Report:
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Expert consensus is that bipolar depression should be treated
differently than unipolar depression.
How are cases of bipolar depression
managed? To what extent are bipolar depressives mistaken for, and mistreated
as, unipolar depressives? Which agents are perceived as safe and effective in
bipolar depression?
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High-priced atypical antipsychotics have been approved for
bipolar mania and as adjuncts to mood-stabilizing drugs in the treatment of
bipolar disorder. These indications have proven to be lucrative line extensions
for these schizophrenia drugs.
To what extent has sales in bipolar
depression contributed to these drugs’ sales? How valuable is a label for
bipolar depression? In which markets is a regulatory label for bipolar
depression possible? To what extent will psychiatrists use an unlabeled agent
in bipolar depression? Which of the atypical antipsychotics is favored in each
market and why?
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Numerous branded agents will face generic competition in the
next two years.
Will the bipolar depression pipeline sustain the
multibillion-dollar market in the face of generics competition? Which companies
are poised to seize the opportunity left by the critical need for more drugs
approved to treat bipolar depression?
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Few drugs are seeking approval for bipolar depression, some
with a novel mechanism of action.
How will physicians accept these novel
mechanisms of action? Will emerging drugs with similar mechanisms of action to
current agents be able to differentiate themselves?Scope:
Markets covered: United States, France, Germany, Italy,
Spain, United Kingdom, Japan.
Primary research: 35 country-specific interviews with
thought-leading psychiatrists.
Epidemiology: Lifetime prevalence of bipolar disorder;
12-month prevalence of major depressive episodes among lifetime cases of
bipolar disorder, segmented by bipolar I, bipolar II, and subthreshold bipolar
disorder.
Emerging therapies: Phase II: 3 drugs; Phase III: 2
drugs; Coverage of 10 other emerging therapies with potential to impact the
bipolar depression market.
Market forecast features: We provide an in-depth
examination of the current and future bipolar depression market performance
over a ten-year forecast period (2007-2017), taking into account several
anticipated new product launches and future subpopulation approvals. Using a
proprietary generic erosion model, we also forecast the effect of generics
launches for current and emerging therapies on the U.S. and European markets through
2017.