The Impact of Genericization in the Unipolar Depression Market Will be Tempered by the Continued Uptake of Novel Antidepressants and Antipsychotics

BURLINGTON, Mass., Aug. 13, 2014 /PRNewswire/ -- Decision Resources Group finds that in the unipolar depression* market, the expanding use of two recently approved therapies—Lundbeck/Takeda Pharmaceutical's Brintellix (vortioxetine), Actavis (formerly Forest Laboratories)/Pierre Fabre's Fetzima (levomilnacipran ER)—together with the forecasted launch of Otsuka Pharmaceutical/Lundbeck's brexpiprazole in the major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom and Japan) will offset a steep near-term decline in sales resulting from the loss of market exclusivity for the two key drugs prescribed for unipolar depression—duloxetine (Eli Lilly/Shionogi's Cymbalta/Xeristar, generics) and the atypical antipsychotic Abilify (Bristol-Myers Squibb/Otsuka Pharmaceutical's aripiprazole). By 2023, total major-market sales for unipolar depression will reach under $10 billion.

Other key findings from the Pharmacor report entitled Unipolar Depression:

• Later-line treatments: Newer antidepressant therapies will be prescribed as third- and fourth-line treatment for patients whose depressive symptoms are inadequately addressed by generic selective serotonin reuptake inhibitors (SSRIs) and/or serotonin and norepinephrine reuptake inhibitors (SNRIs), or for patients who cannot tolerate available therapies.
• Use of atypical antipsychotics: In the absence of more-efficacious alternatives, use of atypical antipsychotics as adjunctive treatment in patients with a poor response to antidepressants will continue to grow; in particular, the launch of generic aripiprazole during the study period will drive greater use of this drug in this capacity.
• Brintellix use in treatment non-responders: Brintellix, supported by extensive clinical trial data in depression, will experience modest uptake during the forecast period as a later line alternative in treatment non-responders. Studies have shown that Brintellix may confer improvements in cognition—a significant advantage over other antidepressants—and offers a low risk of weight-gain and sexual dysfunction. Even as a later-line option, Brintellix's relatively high price will drive its major-market peak-year sales to more than $2.4 billion in 2022.
• Remaining opportunity for novel agents: Despite extensive generic availability of early-line antidepressants and increasingly restrictive reimbursement environments across the markets under study, opportunity remains for novel antidepressants because a sizable proportion of the drug-treated population responds suboptimally to available monoaminergic-targeted drugs.

Comments from Decision Resources Group Analyst Alana K. Simorellis, Ph.D.:

• "The launch of generic versions of two key therapies—duloxetine and Abilify—will not only result in a dramatic near-term drop in sales due to extensive and rapid uptake of generics but also create market access pressures for newer agents launching in these drug classes: Fetzima and brexpiprazole, respectively."
• "Treatment-resistant depression—that is, major depressive disorder that does not respond to at least two adequate courses of antidepressant therapy—has and will continue to be the area of greatest unmet need in the treatment of depression over the next ten years. An agent proven to be more effective than current agents in treatment-resistant patients would be welcomed by physicians and would likely be used as part of combination therapy."

*Unipolar depression encompasses major depressive disorder, minor depression and dysthymia.

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SOURCE Decision Resources Group