Bipolar disorder (BPD) is a debilitating psychiatric illness affecting more than 20 million people across the seven major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan). BPD is increasingly viewed as a spectrum disorder, within which patients experience varying disease severities, from subthreshold hypomanic and depressive symptoms to severe manic and major depressive episodes; we expect increasing awareness and recognition of subtle hypomanic or subthreshold symptoms to moderately increase the diagnosis rate in BPD in the 2014-2024 study period. The disorder often requires lifetime treatment, and polypharmacy is common. Many currently available therapies effectively target the manic symptoms of the disorder; however, significant commercial opportunity remains for a therapy that can effectively control depressive symptoms or one that can better prevent future mood episodes as a maintenance therapy.

Questions Answered in This Report:

  • Sales in the BPD market will decline sharply in the first half of our forecast period as market-leading atypical antipsychotics face generic competition (e.g., Otsuka/Bristol-Myers Squibb’s Abilify [aripiprazole]). How can drug developers differentiate emerging atypical antipsychotics within this crowded and increasingly genericized class? What BPD subindications offer the most attractive opportunities for emerging agents and current brands to achieve sizable uptake in the BPD market?

  • Beginning in 2019, the BPD market will begin a slow but steady upswing in sales, though in 2024, the major-market sales will still be less than total 2014 sales. The uptake of which therapies is contributing to the increase in sales? Will particular drug classes recover more than others, and if so, what factors are contributing to this dynamic? What reimbursement hurdles prevent the BPD market from fully rebounding from the generic erosion in the first part of the study period?

  • Recent Phase III failures have left the late-stage BPD pipeline sparse with few promising new therapies to fulfill the unmet needs for pharmacological BPD therapies. According to interviewed physicians, what are the biggest unmet needs for BPD treatment? What attributes would meaningfully differentiate emerging agents from the current mainstays of treatment? Which emerging therapies have the most potential to treat bipolar depression or prevent future mood episodes?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 8 country-specific interviews with thought-leaders.

Epidemiology: Number of total, diagnosed, and drug-treated prevalent cases of lifetime BPD. Number of total prevalent cases of lifetime BPD by subtype (BPD I, BPD II, and subthreshold BPD). Number of total prevalent cases of lifetime BPD with a major depressive episode or generalized anxiety disorder within the last 12 months. Number of lifetime BPD I prevalent cases who experienced a manic episode within the last 12 months.

Emerging therapies: Phase II: 8 drugs; Phase III: 2 drugs; registered and recently launched: 3 drugs. Coverage of 8 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 (2014-2024).

Author(s): Angela M. Sparrow, Ph.D.
Kristin Dorfman, M.P.H., M.S.

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