Bipolar Depression Market 2034: EMA, PDMA, FDA Approvals, Medication, Clinical Trials, NDA Approval, Therapies, ROA, MOA and Companies by DelveInsight

(Albany, USA) DelveInsight's "Bipolar Depression Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the Bipolar Depression, historical and forecasted epidemiology as well as the Bipolar Depression market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

The Bipolar Depression market growth is driven by factors like increase in the prevalence of Bipolar Depression, investments in research and development, entry of emerging therapies during the study period 2020-2034.

The Bipolar Depression market report also offers comprehensive insights into the Bipolar Depression market size, share, Bipolar Depression epidemiology, emerging therapies, market drivers and barriers, ongoing clinical trials, key collaboration in the space, market uptake by key therapies and companies actively pushing Bipolar Depression market size growth forward.

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Some of the key highlights from the Bipolar Depression Market Insights Report:
• Several key pharmaceutical companies, including 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, are developing novel products to improve the Bipolar Depression treatment outlook.
• In January 2025, Johnson & Johnson and Intra-Cellular Therapies announced a definitive agreement in which Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies, a biopharmaceutical company focused on developing and commercializing treatments for CNS disorders, for $132.00 per share in cash, amounting to an equity value of approximately $14.6 billion.
• In December 2024, NRx Pharmaceuticals submitted the first section of its New Drug Application (NDA) for NRX-100 (ketamine) to the FDA. NRX-100, which received Fast Track Designation in 2017, is being developed in combination with NRX-101 (D-cycloserine/lurasidone) for the treatment of suicidal bipolar depression.
• According to DelveInsight's estimates, the total prevalent cases of Bipolar Depression in the 7MM were approximately 3.6 million in 2023, with severe cases comprising the majority (~75%) of the total cases.
• DelveInsight's consultants estimate that Bipolar II Disorder accounted for the highest proportion of cases, making up nearly 60% of type-specific diagnosed prevalent cases of bipolar depression in the 7MM in 2023.
• Several medications have received approval from the U.S. Food and Drug Administration (FDA) for the treatment of acute bipolar depression. The olanzapine‐fluoxetine combination (OFC) was the first to receive approval in 2003, followed by quetiapine in 2006. In 2013, LATUDA (lurasidone) was approved as both a monotherapy and an adjunct to lithium or valproate for bipolar I depression. Cariprazine received approval in 2019, while CAPLYTA (lumateperone) was approved in 2021
• The United States holds the largest market share for bipolar depression, accounting for approximately 85% compared to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Among the currently marketed therapies, CAPLYTA (lumateperone) is projected to achieve the highest market size in the 7MM by 2034.
• As per DelveInsight analysis, the Bipolar Depression market is anticipated to witness growth at a considerable CAGR.

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Bipolar Depression Overview
Bipolar depression is a phase of bipolar disorder, a mood disorder characterized by alternating episodes of depression and mania or hypomania. It occurs in Bipolar I and Bipolar II disorders, with individuals experiencing prolonged periods of low mood, fatigue, and loss of interest in activities, often accompanied by feelings of hopelessness and suicidal thoughts. Unlike unipolar depression, bipolar depression is interspersed with manic or hypomanic episodes, making diagnosis challenging.

The exact cause is not fully understood, but it is believed to result from a combination of genetic, neurochemical, and environmental factors. Neurotransmitter imbalances, circadian rhythm disruptions, and high stress levels are linked to bipolar depression. Symptoms include persistent sadness, sleep disturbances, appetite changes, cognitive difficulties, and social withdrawal.

Diagnosis is based on clinical evaluation and patient history, distinguishing bipolar depression from major depressive disorder. Mood stabilizers (lithium, valproate), atypical antipsychotics (quetiapine, lurasidone), and antidepressants (used cautiously with mood stabilizers) are key treatment options. Psychotherapy (CBT, psychoeducation), lifestyle modifications, and social support also play a crucial role.

If left untreated, bipolar depression can severely impact daily life, relationships, and work, increasing the risk of suicide. Early diagnosis and personalized treatment improve long-term outcomes.

Do you know the treatment paradigms for different countries? Download our Bipolar Depression Market Sample Report - https://www.delveinsight.com/report-store/bipolar-disorder-manic-depression-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Bipolar Depression Epidemiology Insights
• According to DelveInsight's estimates, the United States accounted for approximately 70% of the total diagnosed prevalent cases of bipolar depression in the 7MM in 2023.
• Within the U.S., severe cases made up the majority, representing around 75% of the total cases based on severity.

Bipolar Depression Epidemiology Segmentation
DelveInsight's Bipolar Depression market report is prepared on the basis of an epidemiology model. It offers comprehensive insights to the Bipolar Depression historical patient pools and forecasted Bipolar Depression patients. The report provides in-depth data of various subtypes and for the same epidemiology is segmented further. The Bipolar Depression Market report proffers epidemiological analysis for the study period 2020-34 in the 7MM segmented into:
• Bipolar Depression Prevalence
• Age-Specific Bipolar Depression Prevalence
• Gender-Specific Bipolar Depression Prevalence
• Diagnosed and Treatable Cases of Bipolar Depression

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Bipolar Depression Market Outlook
• Leading companies in the Bipolar Disorder market, including NeuroRx and COMPASS Pathways, are actively evaluating their key drug candidates at various stages of clinical development, aiming to explore their potential in treating bipolar depression.
• Among the 7MM, the United States held the largest market share for Bipolar Disorder in 2023, valued at approximately USD 2,300 million, followed by Germany and Italy.
• By 2034, NRX-100 and NRX-101 are expected to secure a significant market share for Bipolar Disorder across the 7 major markets.
• Within the EU4 and the UK, Germany accounted for the highest market share (~30%) in 2023.
• By 2034, CAPLYTA (lumateperone) is anticipated to dominate the Bipolar Disorder market among currently available therapies in the 7MM.

Bipolar Disorder Marketed Drugs
• VRAYLAR (Cariprazine): Allergan (AbbVie)/Gedeon Richter
• LYBALVI (olanzapine, samidorphan L-malate): Alkermes

Bipolar Depression Emerging Drugs
• COMP 360 (Psilocybin): COMPASS Pathways
• NRX-100 and NRX-101: NeuroRx

Bipolar Depression Key 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

For more information, visit Bipolar Depression Market Analysis, Patient Pool, and Emerging Therapies - https://www.delveinsight.com/sample-request/bipolar-disorder-manic-depression-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Scope of the Bipolar Depression Market Report:
• 11 Years Forecast
• 7MM Coverage
• Descriptive overview of Bipolar Depression, causes, signs and symptoms, diagnosis, treatment
• Comprehensive insight into Bipolar Depression epidemiology in the 7MM
• Bipolar Depression marketed and emerging therapies
• Bipolar Depression companies
• Bipolar Depression market drivers and barriers

Table of Contents:
1 Bipolar Depression Market Key Comprehensive Insights
2 Bipolar Depression Market Report Introduction
3 Competitive Intelligence Analysis for Bipolar Depression
4 Bipolar Depression Market Analysis Overview at a Glance
5 Executive Summary of Bipolar Depression
6 Bipolar Depression Epidemiology and Market Methodology
7 Bipolar Depression Epidemiology and Patient Population
8 Bipolar Depression Patient Journey
9 Bipolar Depression Treatment Algorithm, Bipolar Depression Current Treatment, and Medical Practices
10 Key Endpoints in Bipolar Depression Clinical Trials
11 Bipolar Depression Marketed Therapies
12 Bipolar Depression Emerging Therapies
13 Bipolar Depression: 7 Major Market Analysis
14 Attribute analysis
15 Access and Reimbursement Overview of Bipolar Depression
16 Bipolar Depression Market Key Opinion Leaders Reviews
18 Bipolar Depression Market Drivers
19 Bipolar Depression Market Barriers
20 SWOT Analysis
21 Disclaimer
22 DelveInsight Capabilities
23 About DelveInsight

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