DelveInsight’s “Bipolar Disorder Market Insights, Epidemiology, and Market Forecast – 2036” report delivers an in-depth understanding of Bipolar Disorder, historical and forecasted epidemiology, as well as the Bipolar Disorder Market Trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
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Key Takeaways from the Bipolar Disorder Market Report
- As per DelveInsight’s estimates, diagnosed prevalent cases of bipolar depression in the United States was around 70% of the total cases in the 7MM in 2023.
- In the United States, severe cases constituted the maximum number of cases based on severity with approximately 75% cases in 2023.
- Analyzing data from the National Comorbidity Survey Replication (NCS-R) indicates that approximately 2.8% of the US adults experience bipolar disorder annually, while an estimated 4.4% are affected at some point in their lives.
- Analysis based on Sheehan Disability Scale found that 82.9% of adults with bipolar depression experienced serious impairment—the highest among mood disorders—while 17.1% had moderate impairment, emphasizing its signifcant effect on daily functioning.
- Among the 7MM, the highest number of treated cases of bipolar depression was observed in the United States, which accounted for more than 60% of the total treated cases in 2023.
- Germany accounted for the highest diagnosed prevalent cases of bipolar depression in 2023 among the EU4 and the UK.
- The leading Bipolar Disorder Companies such as Allergan (AbbVie)/Gedeon Richter, Sunovion Pharmaceuticals (Sumitomo Dainippon Pharma), Intra-Cellular Therapies, NeuroRx, Sunovion (Sumitomo Dainippon Pharma), Lundbeck/Otsuka Pharmaceutical, Celon Pharma, COMPASS Pathways and others.
- Promising Bipolar Disorder Therapies such as Azetukalner, Elunetirom (ABX-002), ABBV-932, ALTO-100, NRX-101, LB-102, Icalcaprant (ABBV-1354), and others.
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Bipolar Disorder Overview
Bipolar Disorder is a chronic mental health condition characterized by extreme mood swings that include emotional highs (mania or hypomania) and lows (depression). These mood changes can affect energy levels, behavior, thinking, and the ability to carry out daily activities.
Bipolar Disorder Epidemiology Segmentation in the 7MM
- Total Bipolar Disorder Diagnosed Prevalent Cases
- Bipolar Disorder Type-specific Diagnosed Prevalent Cases
- Bipolar Disorder Severity-specific Diagnosed Prevalent Cases
- Total Bipolar Disorder Treated Cases
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Bipolar Disorders Marketed Therapies
- VRAYLAR (Cariprazine): Allergan (AbbVie)/Gedeon Richter
VRAYLAR is an oral capsule containing cariprazine as an active ingredient. It is approved in the US for schizophrenia, Bipolar Depression, and bipolar disorder. VRAYLAR was discovered and co-developed by Gedeon Richter Plc and is licensed by Allergan in the US. In May 2019, the US FDA approved a supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults. The FDA approval for the expanded indication of VRAYLAR was based on three pivotal trials, including RGH-MD-53, RGH-MD-54, and RGH-MD-56, in which cariprazine demonstrated greater improvement than placebo for the change from baseline to weeks on the Montgomery – Asberg Depression Rating Scale (MADRS) total score.
- LYBALVI (olanzapine, samidorphan L-malate): Alkermes
LYBALVI is composed of olanzapine, an established antipsychotic agent, co-formulated with samidorphan, a new chemical entity, in a single bilayer tablet. In Jun 2021, the US. FDA approved Lybalvi (olanzapine and samidorphan) for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. The FDA approval of Lybalvi was supported by the results of the ENLIGHTEN program’s pivotal ENLIGHTEN-1 efficacy study and ENLIGHTEN-2 weight study.
- FANAPT: Vanda Pharmaceuticals
FANAPT is an oral atypical antipsychotic approved for treating schizophrenia and acute manic or mixed episodes in bipolar I disorder in adults. It belongs to the piperidinyl-benzisoxazole class and is available in tablet strengths from 1 mg to 12 mg. It also has a boxed warning as an increased mortality risk in elderly patients with dementia-related psychosis. In April 2024, Vanda Pharmaceuticals reported that FANAPT (iloperidone) had received US FDA approval for the acute treatment of bipolar I disorder.
Emerging Bipolar Depression Drugs
- Azetukalner: Xenon Pharmaceuticals
Azetukalner is an investigational oral Kv7 potassium channel modulator being studied for bipolar depression, designed to normalize neuronal hyperexcitability and improve depressive symptoms without triggering mania or typical antipsychotic adverse effects. In January 2026, JP Morgan Healthcare Conference reported that Phase III X-CEED study evaluating azetukalner in patients with bipolar depression I or II is underway.
- Elunetirom (ABX-002): Autobahn Therapeutics
ABX-002 is an oral, brain-enhanced thyroid hormone beta receptor (TRβ) agonist designed to target brain regions associated with depression. It exhibits strong efficacy while reducing peripheral side effects compared to synthetic thyroid hormones. This innovative approach offers a promising treatment option for mood disorders, potentially improving patient outcomes with fewer systemic complications. In January 2025, Autobahn Therapeutics reported the initiation of a Phase II clinical trial evaluating ABX-002 as an adjunctive treatment for bipolar depression, marking a significant step in advancing novel therapeutic options for mood disorders. Currently, it is being investigated in Phase II for the treatment of bipolar depression.
- ABBV-932: AbbVie
ABBV-932 is a selective D3 dopamine receptor modulator being developed as a monotherapy for bipolar disorder and generalized anxiety disorder. In collaboration with Gedeon Richter, this investigational therapy aims to regulate dopamine pathways involved in mood and anxiety regulation. By targeting D3 receptors, ABBV-932 seeks to provide a novel, more precise treatment approach, potentially improving symptom control and reducing side effects compared to existing therapies. In October 2024, AbbVie and Gedeon Richter reported new collaboration for the discovery and development of novel targets for neuropsychiatric conditions along with the discovery of investigational drug candidate ABBV-932 for the treatment of bipolar depression and generalized anxiety disorder. Currently, it is being investigated in Phase II for the treatment of bipolar disorder and early readout expected in 2026.
Discover more about therapies set to grab major Bipolar Disorder Market Share @ Bipolar Disorder Market Drivers and Barriers
Bipolar Disorders Market Outlook
Key Bipolar Depression Companies, such as Xenon Pharmaceuticals, Autobahn Therapeutics, AbbVie, Alto Neuroscience, NRx Pharmaceuticals, LB Pharmaceuticals, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of bipolar depression.
Bipolar Disorders Disease Treatment Landscape
Major drug classes that are recommended for the treatment of bipolar depression are antipsychotics, mood stabilizers, anti-seizure medications, and atypical neuroleptics. Other than pharmacological therapy, stimulants, electroconvulsive therapy, and transcranial magnetic stimulation are a few options available for patients suffering from bipolar depression. Monotherapy with quetiapine or LATUDA (lurasidone) and combination pharmacotherapy with lithium and lamotrigine, and either quetiapine or lurasidone plus a mood stabilizer (lithium or valproate), are majorly used in acute bipolar depressive episodes. The combination of olanzapine and fluoxetine is approved for treating Bipolar-I depression. Also, for the refractory patient or first line for treating bipolar depression with psychotic features, electroconvulsive therapy is considered. Cariprazine is a new second‐generation antipsychotic (SGA) that received FDA approval for bipolar mania with and without mixed features in 2015. In June 2019, cariprazine received FDA approval for acute bipolar depression in doses of 1.5 or 3 mg daily.
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Scope of the Bipolar Disorder Market Report
- Coverage- 7MM
- Study Period- 2022-2036
- Bipolar Disorder Companies- Allergan (AbbVie)/Gedeon Richter, Sunovion Pharmaceuticals (Sumitomo Dainippon Pharma), Intra-Cellular Therapies, NeuroRx, Sunovion (Sumitomo Dainippon Pharma), Lundbeck/Otsuka Pharmaceutical, Celon Pharma, COMPASS Pathways and others.
- Bipolar Disorder Therapies- Azetukalner, Elunetirom (ABX-002), ABBV-932, ALTO-100, NRX-101, LB-102, Icalcaprant (ABBV-1354), and others.
- Bipolar Disorder Therapeutic Assessment: Bipolar Disorder current marketed and Bipolar Disorder Emerging Therapies
- Bipolar Disorder Market Dynamics: Bipolar Disorder Market Drivers and Bipolar Disorder Market Barriers
- Bipolar Disorder Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
- Bipolar Disorder Unmet Needs, KOL’s views, Analyst’s views, Bipolar Disorder Market Access and Reimbursement
To know more about Bipolar Disorder Companies working in the treatment market, visit @ Bipolar Disorder Market Ongoing Clinical Trials Assessment
Table of Contents
- Key Insights
- Bipolar Disorder Market Report Introduction
- Bipolar Disorder Market Overview at a Glance
- Methodology of Bipolar Disorder Epidemiology and Market
- Executive Summary
- Key Events
- Disease Background and Overview
- Bipolar Disorder Patient Journey
- Bipolar Disorder Epidemiology and Patient Population
- Bipolar Disorder Marketed Drugs
- Bipolar Disorder Emerging Drugs
- Bipolar Disorder: Market Analysis
- Key Opinion Leaders’ Views
- Bipolar Disorder SWOT Analysis
- Bipolar Disorder Unmet Needs
- Bipolar Disorder Market Access and Reimbursement
- Appendix
- DelveInsight Capabilities
- Disclaimer
- About DelveInsight
About Us
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