DelveInsight’s “Bipolar Depression Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding, historical and forecasted epidemiology, as well as the Bipolar Depression market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

 

The Bipolar Depression Market is an evolving segment of the global healthcare landscape, driven by the increasing Bipolar Depression prevalence of the disorder and the continuous development of innovative treatment options. The Bipolar Depression market encompasses various therapeutic categories, including antipsychotics, adjunctive therapies, and emerging treatment modalities.

 

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Key Takeaways from the Bipolar Depression Market Report

• In November 2024:- Neumora Therapeutics, Inc.- This is a randomized, double-blind, placebo-controlled pilot study aiming to evaluate the effects of NMRA-335140 on symptoms of major depression in adults with Bipolar (BP) II disorder. The study design consists of a Screening Period (up to 28 days), a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo), and a 6-week Safety Follow-up Period.
• 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.
• 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 Depression Companies such as Allergan (AbbVie)/Gedeon Richter, Alkermes, Glaxo SmithKline (GSK), ELI Lilly and Company, Janssen Pharmaceuticals, Astellas Pharma Inc., Bristol Myers Squibb, Gedeon Richter Plc., H. Lundbeck A/S, Pfizer Inc., Novartis AG, Otsuka Holdings Co. Ltd, Validus Pharmaceuticals LLC, NeuroRx, Sunovion (Sumitomo Dainippon Pharma), COMPASS Pathways, SAGE Therapeutics, Forest Laboratories, Target Health Inc., Vanguard, Inc., AstraZeneca, Celon Pharma SA, Intra-Cellular Therapies, Inc., Arvid Carlsson Research AB, Solvay Pharmaceuticals, Shire, Intra-Cellular Therapies, Inc., and others
• Promising Bipolar Depression Therapies such as VRAYLAR (Cariprazine), LYBALVI (olanzapine, samidorphan L-malate), NRX-100, NRX-101, SEP-4199, COMP 360 (Psilocybin Therapy), Sage-217, cariprazine, Ketamine Hydrochloride, Lurasidone HCl, Quetiapine Fumarate (SEROQUEL), Esketamine, Lumateperone, Brexpiprazole, OSU6162, Bifeprunox, carbamazepine ER, ITI-007 (Lumateperone), Olanzapine Fluoxetine Combination (OFC), lamotrigine, FK949E, SM-13496, and others

 

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Bipolar Depression Epidemiology Segmentation in the 7MM

• Total Bipolar Depression Prevalence
• Prevalent Cases of Bipolar Depression by severity
• Bipolar Depression Gender-specific Prevalence
• Diagnosed Cases of Episodic and Chronic Bipolar Depression

 

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Bipolar Depression Marketed Drugs

• 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 disorder, and bipolar depression. 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.

 

Bipolar Depression Emerging Drugs

• NRX-100 and NRX-101: NeuroRx

NeuroRx has developed a sequential therapy consisting of intravenous NRX-100 (ketamine HCL) for rapid stabilization of symptoms of depression and suicidal ideation followed by oral NRX-101 (fixed-dose combination of D-cycloserine and lurasidone) for maintenance of stabilization of symptoms of depression and suicidal ideation. In September 2017, the US FDA granted fast track designation to NRX-100 (ketamine HCl) followed by NRX-101 (D-cycloserine + lurasidone) for bipolar depression with suicidal ideation.

Currently, the company is planning to file an NDA by first half of 2024 and expects to get PDUFA date by 2024 for NRX-100 (IV Ketamine). Recently, in April 2024, the company has posted promising results for NRX-101 that showed 33% advantage in sustained remission in suicidality (not statistically significant at this sample size) and 75% advantage in relief from Akathisia relative to lurasidone.

 

• COMP 360 (Psilocybin): COMPASS Pathways

Psilocybin therapy is an approach being investigated for the treatment of mental health challenges. It combines the pharmacological effects of psilocybin, a psychoactive substance, with psychological support. Psilocybin is an active ingredient in some species of mushrooms, often referred to as ‘magic mushrooms.’ COMPASS Pathways have developed a synthesized formulation of psilocybin, COMP360, and is investigating the effectiveness of psilocybin therapy, initially in treatment-resistant depression/bipolar depression. It is currently being investigated under Phase II clinical trial. However, it is not currently in the developmental pipeline of the Compass Pathway for bipolar depression and the company suggests that research on bipolar depression could reveal potential findings for them to investigate more deeply and incorporate into their development process.

 

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Scope of the Bipolar Depression Market Report

• Coverage- 7MM
• Bipolar Depression Companies- Allergan (AbbVie)/Gedeon Richter, Alkermes, Glaxo SmithKline (GSK), ELI Lilly and Company, Janssen Pharmaceuticals, Astellas Pharma Inc., Bristol Myers Squibb, Gedeon Richter Plc., H. Lundbeck A/S, Pfizer Inc., Novartis AG, Otsuka Holdings Co. Ltd, Validus Pharmaceuticals LLC, NeuroRx, Sunovion (Sumitomo Dainippon Pharma), COMPASS Pathways, SAGE Therapeutics, Forest Laboratories, Target Health Inc., Vanguard, Inc., AstraZeneca, Celon Pharma SA, Intra-Cellular Therapies, Inc., Arvid Carlsson Research AB, Solvay Pharmaceuticals, Shire, Intra-Cellular Therapies, Inc., and others
• Bipolar Depression Therapies- VRAYLAR (Cariprazine), LYBALVI (olanzapine, samidorphan L-malate), NRX-100, NRX-101, SEP-4199, COMP 360 (Psilocybin Therapy), Sage-217, cariprazine, Ketamine Hydrochloride, Lurasidone HCl, Quetiapine Fumarate (SEROQUEL), Esketamine, Lumateperone, Brexpiprazole, OSU6162, Bifeprunox, carbamazepine ER, ITI-007 (Lumateperone), Olanzapine Fluoxetine Combination (OFC), lamotrigine, FK949E, SM-13496, and others
• Bipolar Depression Market Dynamics: Bipolar Depression Market Drivers and Barriers
• Bipolar Depression Market Access and Reimbursement, Unmet Needs and Future Perspectives

 

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Table of Content

1. Key Insights

2. Report Introduction

3. Bipolar Depression Market Overview at a Glance

4. Executive Summary of Bipolar Depression

5. Key Events

6. Epidemiology and Market Methodology

7. Disease Background and Overview

8. Epidemiology and Patient Population

9. Patient Journey

10. Marketed Therapies

11. Emerging Therapies

12. Bipolar Depression: 7 Major Market Analysis

13. Market Access and Reimbursement

14. KOL Views

15. SWOT Analysis

16. Unmet Needs

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

 

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