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Datamonitor Healthcare CNS Disease Analysis: Bipolar Disorder

September 30, 2026

The bipolar disorder (BD) market is highly genericized, consisting of antipsychotics, anticonvulsants, and mood stabilizers such as lithium. The atypical antipsychotic market is the most dominant of the drug classes indicated for BD, and the oral atypical antipsychotic market is highly competitive, with many generic alternatives available. Bipolar patients are typically on more than one drug for the treatment of their symptoms because of the complexity of the disease, including the cycling between manic and depressive phases. Mood stabilizers, such as lithium and valproate, tend to be the first line of therapy in the US, followed by antipsychotics such as risperidone, aripiprazole, and olanzapine, and some patients also require low-dose antidepressants. For maintenance treatment, if a patient is tolerating a certain drug, such as risperidone, then they will continue on it, but if the patient has issues with tolerability, they are normally switched to an alternative with a more benign metabolic profile or a better safety profile. 

Recent developments in the BD space include the FDA approval of Teva's Uzedy (LAI risperidone), BioXcel's bankruptcy filing and the proposed acquisition of its assets by Teva (including Igalmi), the sNDA submission for at-home dosing of Igalmi and an EMA marketing authorization refusal for Fanapt.

Indications Covered: Bipolar Disorder