The bipolar disorder (BD) market across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) is poised to grow at a compound annual growth rate of 5.3% from $5.6bn in 2024 to $9.4bn in 2034, according to leading data and analytics company GlobalData’s recently published report, ‘Bipolar Disorder – Opportunity Assessment and Forecast’. This growth will be driven by an increase in diagnosed prevalent cases, as well as the introduction of six late-stage pipeline products: Azetukalner, Bysanti, Cyclurad, NRX-100, endoxifen, and Cobenfy.
The treatment paradigm for BD is multifaceted, aiming to stabilise mood, prevent relapse, and improve functional outcomes through a combination of pharmacological and psychosocial interventions. In some instances, particularly refractory cases, neurostimulation techniques such as electroconvulsive therapy are also used. Pharmacotherapy typically includes mood stabilisers (eg, lithium, valproate, lamotrigine), atypical antipsychotics (eg, quetiapine, olanzapine, lurasidone), and adjunctive antidepressants, though the latter must be used cautiously due to the risk of inducing mania or rapid cycling. The choice of treatment is dependent on a patient’s disease state, whether they are presenting with manic or depressive symptoms. The treatment for bipolar I and bipolar II is similar given the significant symptom overlap between the two indications. Treatment for bipolar I disorder prioritises the management of acute manic episodes, often with antipsychotics, mood stabilisers, or both, followed by long-term maintenance therapy. Lithium remains a gold standard due to its efficacy in reducing suicide risk. In treating bipolar II disorder, although hypomania is less severe than mania and depressive episodes predominate, treatment also focuses on using mood stabilisers or atypical antipsychotics to manage symptoms. Mood stabilisers and anticonvulsants are familiar treatments for physicians and are widely available in cheap generic forms.
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There are significant clinical unmet needs in the bipolar disorder treatment landscape. Poor public and physician awareness of the disease means that patients are often misdiagnosed, or there is a significant delay in diagnosis and thus treatment. This limits the growth potential of the market. Also, poor patient compliance and a lack of consensus regarding the treatment algorithm mean that current treatments may be misused, and patient outcomes vary. Physicians are reluctant to adopt newer therapies due to a strong preference for older, more familiar treatments. Furthermore, despite the plethora of mood stabilisers and atypical antipsychotics available for bipolar disorder, there is a significant unmet need for treatments targeting bipolar depression. This has been recognised by pharmaceutical companies: Of the six late-stage pipeline agents, four of them – Cyclurad, NRX-10, Bysanti, and azetukalner – are being trialled in patients exhibiting symptoms of bipolar depression. This signals a shift in the treatment paradigm towards therapies targeting bipolar depression. GlobalData forecasts that the late-stage pipeline products could drive combined sales of approximately $2.8bn by 2034 in the 7MM. GlobalData also anticipates that the most promising pipeline product will be Bristol Myers Squibb’s Cobenfy, which is currently being trialled in manic episodes associated with bipolar I disorder. It has the potential to see strong uptake due to its established efficacy in treating schizophrenia and its novel mechanism of action, leveraging cholinergic modulation beyond the traditional dopamine antagonism shared by most currently available atypical antipsychotics.
Although the BD market is dominated by cheap generics that will act as a major barrier to growth, late-stage pipeline products have potential to generate significant growth in the BD market. This, coupled with the increase in diagnosed prevalent cases, will act as the main drivers of growth across the 7MM.
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By GlobalData
