Introduction:
Last Updated 23 August 2010Bipolar disorder (BPD) is a chronic and debilitating
psychiatric illness. Found across all major pharmaceutical markets, the
disorder is increasingly thought of as a spectrum disorder, with relatively
mild patients at one end of the spectrum, with subthreshold hypomanic and
subthreshold depressive symptoms, and manic and major depressive symptoms at
the other end of the spectrum, with many patients lying in between. The
disorder has a high drug-treatment rate and high rate of polypharmacy to care
for or prevent mood episodes. The greatest commercial opportunity continues to
be for an efficacious therapy that can target depressive symptoms, but other
unmet needs, such as rapid cycling and cognitive deficits, also present
significant market opportunities.
Questions Answered in This Report:
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The BPD market will face steep declines in sales as
market-leading atypical antipsychotics face generic competition.
Will a
newer branded atypical antipsychotic emerge as a market leader? How will
marketers of newer branded atypical antipsychotics differentiate brands from
low-cost generics? What opportunities remain for marketers of branded drugs?
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Beta versions of the DSM-V and ICD-11 codes being released in
2010 will likely include an updated diagnosis for subthreshold bipolar patients
that will produce an increase in the size of
the drug-treated patient pool.
Will there be changes in the medical practice
of BPD to treat these patients? How will this affect the size of the diagnosed
and drug-treated pools, and what will be the impact on drug sales?
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We forecast the launch of two new atypical antipsychotics within our forecast period for BPD:
Dainippon Sumitomo Pharma/Sepracor’s lurasidone and Gedeon Richter, Forest
Laboratories, and Mitsubishi Pharma’s cariprazine.
How will these new agents
be differentiated from current antipsychotics? Will the new agents be used in
combination with current therapies or in place of them? Which patient segment
will earn the most market share for novel agents at launch? In 2019?
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Janssen’s Risperdal Consta depot received approval for
bipolar disorder in 2009, making it the first depot formulation specifically
approved for the indication of bipolar disorder.
What is the anticipated
uptake of newer depot formulations of atypical antipsychotics over the forecast
period? How do depot formulations fit into the treatment algorithm of bipolar
disorder? Will these more-expensive agents make a significant market impact in
this increasingly generic market?Scope:
Markets covered: United States, France, Germany,
Italy, Spain, United Kingdom, Japan.
Primary research: 32 country-specific interviews with
thought-leading psychiatrists.
Epidemiology: Total lifetime prevalence of BPD by
country; total prevalence of BPD divided between BPD I, BPD II, and subthreshold
BPD by country. Percentage diagnosed and drug-treated by forecast year, by
country. Total lifetime prevalent cases of BPD with comorbid generalized
anxiety disorder.
Emerging therapies: Phase I/II and Phase II: 5 drugs;
Phase III: 4 drugs; preregistration and registration: 1 drug. Coverage of 5
select preclinical and Phase I products.
Market forecast features: Using market research, primary
research with key opinion leaders, and our proprietary forecasting model, we
provide an in-depth examination of current and future BPD
diagnosis/drug-treatment trends and market performance over a ten-year forecast
period (2009-2019).
Alternative market scenarios: Schering-Plough’s
asenapine (Saphris/Sycrest) gains regulatory approval for bipolar depression.
Repligen’s mitochondrial modulator RG-2417 is approved as a treatment for
bipolar depression in the United States.