Lucrative opportunities remain for new entrants in the currently declining bipolar disorder market, as there is a considerable dearth of products that fully address the needs of sufferers, according to research and consulting firm GlobalData.

The company's report states that the current bipolar pipeline is sparse, with only two drugs, Abilify Maintena and ITI-007, expected to receive regulatory approval by 2024.

GlobalData forecasts that Abilify Maintena will achieve sales of $643 million in 2024 across the eight major markets of the US, France, Germany, Italy, Spain, UK, Japan and Canada.

However, bipolar disorder has a range of unmet needs, including the need for novel, effective treatment options for bipolar depression, drugs with improved safety profiles, improved physician education about the diagnostic process, and for drugs developed specifically for bipolar disorder, as opposed to manufacturers targeting approval simultaneously with other indications.

Mr Thomas Parker, GlobalData's Senior Analyst covering Neurology and Ophthalmology, says targeting the treatment of major depressive episodes will represent a significant ongoing opportunity, owing to the paucity of currently available treatments.

He explains: "A novel product that demonstrates efficacy in terms of reducing depressive symptoms versus placebo would likely be viewed favorably by physicians, providing its safety profile is comparable to the newer atypical antipsychotics.

"An important opportunity also exists for the development of a novel mood stabilizer with an improved safety profile that is indicated for the long-term maintenance treatment of bipolar disorder. Current mood stabilizers are associated with a variety of adverse events that can significantly impact treatment outcomes."

GlobalData believes that future mood stabilizers will need to demonstrate placebo-like tolerability while also possessing low teratogenicity, limited drug interactions, and an efficacy that is comparable to lithium.

Mr Parker concludes: "It is generally believed that the paucity of novel agents in development is influenced by the absence of preclinical animal models for bipolar disorder. In this way, a major imperative for developers could be to cultivate a novel preclinical animal model of bipolar disorder in order to identify novel products with high efficacy."