Introduction:Last Updated 16 October 2013
Unipolar depression, which consists of major depressive disorder (MDD), minor depression, and dysthymia, is a highly prevalent psychiatric disorder. Throughout our 2012-2022 study period, the unipolar depression market will consist almost entirely of generic products that will dominate first- and even second-line treatment. Only a small number of branded products—including Forest Laboratories’ vilazodone (Viibryd), Lundbeck/Takeda’s vortioxetine (Brintellix), Forest Laboratories/Pierre Fabre’s levomilnacipran (Fetzima), Eli Lilly’s edivoxetine, Otsuka/Lundbeck’s brexpiprazole, and Dainippon Sumitomo Pharma/Sunovion/Takeda Pharmaceutical’s (Latuda)—will be competing for market share during the forecast period in this highly genericized space. Although the age of blockbuster antidepressants may be drawing to an end for now, low patient response rates and even lower remission rates following treatment with first-line therapies continue to create opportunity for adjunctive agents as well as monotherapies targeting specific patient subpopulations, particularly those with treatment-resistant depression (TRD) or residual symptoms of depression.
Questions Answered in This Report:
The unipolar depression market will contract significantly over our forecast period, with a loss of 30% in sales from 2012 to 2022. The greatest factor contributing to this decline will be the continued generic erosion of escitalopram (Lundbeck’s Cipralex/Seroplex, other manufacturers, generics; Forest Laboratories’ Lexapro, generics; Lundbeck/Mochida Pharmaceuticals/Mitsubishi Tanabe Pharma’s Lexapro) and the upcoming loss of market exclusivity for two prominent agents in this market, duloxetine (Eli Lilly/Shionogi’s Cymbalta/Xeristar) and aripiprazole (Bristol-Myers Squibb/Otsuka Pharmaceutical’s Abilify). To what extent will emerging therapies be able to recoup sales lost due to the influx of generics? In which of the covered major pharmaceutical market(s) will antidepressant sales continue to experience growth during the forecast period, and what factor(s) will contribute to such growth?
The late-stage pipeline consists largely of agents targeting the monoaminergic system, and, therefore, they have mechanisms of action similar to those of existing antidepressants. These include Eli Lilly’s edivoxetine, Lundbeck/Takeda’s vortioxetine, and Forest Laboratories’ levomilnacipran. What are interviewed physicians’ opinions of emerging antidepressants, and how do the similarities or dissimilarities in their mechanisms of action compared with those of current agents influence experts’ opinions?
Lundbeck and Takeda’s vortioxetine is preregistered in the United States for the treatment of major depression. The NDA submitted to the FDA included data from six positive short-term studies and one positive long-term study. Lundbeck and Takeda have also filed an MAA in Europe and have plans to file in Japan in 2013. How do we expect the companies to position this multimodal serotonergic antidepressant when it launches? How do we expect the drug to perform in this market in light of such positioning?
Therapies targeting the N-methyl-D-aspartic acid (NMDA) receptor hold great promise as fast-acting antidepressant therapies; currently, patients wait weeks to experience relief from depression symptoms with available agents. Two emerging agents, Naurex’s GLYX-13 and AstraZeneca’s AZD-6765, have demonstrated efficacy in Phase II trials in patients who had previously demonstrated an inadequate response to antidepressant therapy). What role do psychiatrists interviewed perceive that emerging NMDA modulators will play in TRD? Where would these agents fit into the depression treatment algorithm should they launch for the indication?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 25 country-specific interviews with psychiatrists and PCPs.
Epidemiology: 12-month prevalence of the unipolar depression population (consisting of patients with MDD, minor depression, or dysthymia); TRD (stages 1and 2); MDD comorbidity with chronic pain.
Emerging therapies: Phase II: 20 drugs; Phase III: 5 drugs; preregistration: 2 drugs. Coverage of 10 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 unipolar depression diagnosis/drug-treatment trends and market performance over a ten-year forecast period (2012-2022).