Bipolar Disorder Manic Depression Market
The Bipolar Disorder (Manic Depression) market report provides current treatment practices, emerging drugs, Bipolar Disorder (Manic Depression) market share of the individual therapies, current and forecasted Bipolar Disorder (Manic Depression) market size from 2017 to 2030 segmented by seven major markets. The Report also covers current Bipolar Disorder (Manic Depression) treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geography Covered
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
- Japan
Bipolar Disorder (Manic Depression) Overview
Bipolar disorder (BD), previously known as manic depressive illness or manic depression, is a mental disorder characterized by wide mood swings from high (manic) to low (depressed). In manic episodes, a person can be delighted, irritable, and there is a marked increase in activity level, whereas, in depressive episodes, someone might feel sad, indifferent, or hopeless, in combination with a deficient activity level. Hypomanic episodes are also seen in patients, and it is a less severe form of mania. It is divided mainly into four subtypes BD-I, BD-II, cyclothymic disorder, and BD not otherwise specified (BD-NOS); the classification is based on the characteristics of mood swings.
Bipolar Disorder (Manic Depression) Epidemiology
The Bipolar Disorder (Manic Depression) epidemiology division provides insights about the historical and current Bipolar Disorder (Manic Depression) patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
Key Findings
- In the year 2020, the total diagnosed prevalent case of Bipolar Disorder (Manic Depression) was 3,552,076 cases in the 7MM which are expected to grow during the study period, i.e., 2017–2030.
- The disease epidemiology covered in the report provides historical as well as forecasted Bipolar Disorder (Manic Depression) epidemiology [segmented as Total Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression), Type-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression), Severity-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression), and Total Treated Cases of Bipolar Disorder (Manic Depression)] in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.
Bipolar Disorder Emerging Drugs
Lumateperone/ITI-007 (Intra-Cellular Therapies)
Lumateperone (ITI-007) is an investigational, first-in-class small molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate, three neurotransmitter pathways implicated in severe mental illness. It is a potent serotonin 5-HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM) acting as a presynaptic partial agonist and postsynaptic antagonist at dopamine D2 receptors, a dopamine D1 receptor-dependent indirect modulator of glutamate (both NDMA and AMPA), and a serotonin reuptake inhibitor. Currently, lumateperone is in Phase III clinical development as a novel treatment for Bipolar Disorder (Manic Depression). Lumateperone Bipolar Disorder (Manic Depression) clinical program consists of three monotherapy studies and one adjunctive study. The company submitted the sNDA to the US FDA in February 2021, and if approved, this drug would be the first therapy indicated for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults
NRX-100/NRX-101 (NeuroRx)
NeuroRx is developing 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 from symptoms of depression and suicidal ideation. NRX-101 is a proprietary, oral fixed-dose combination of two FDA-approved drugs: D-cycloserine, an NMDA receptor modulator; and Lurasidone (Latuda), a 5-HT2a receptor antagonist. NRX-101’s proprietary dual-mechanism of action targets the NMDA and 5-HT2a receptors – two key receptors in the brain. Currently, the molecule is under investigation in Phase III clinical trial for rapid stabilization of acute suicidal ideation and behavior in patients with Bipolar Disorder (Manic Depression). Additionally, the company is also initiating a Phase IIb/III clinical trial of NRX-100/NRX-101 to treat Bipolar Disorder (Manic Depression) in patients with ASIB. In September 2017, the US FDA granted fast track designation to NRX-100 (ketamine HCl) followed by NRX-101 (D-cycloserine + lurasidone) for Bipolar Disorder (Manic Depression) with suicidal ideation.
SEP-4199 (Sunovion/Sumitomo Dainippon Pharma)
SEP-4199 is a nonracemic ratio of amisulpride enantiomers with the potential to be the first benzamide treatment available in the US for mood disorders. Sunovion discovered that the pharmacology of amisulpride is enantiomer-specific and that increasing the ratio of R-amisulpride to S-amisulpride increases the potency for serotonin 5-HT7 receptors relative to dopamine D2 receptors. SEP-4199 was designed to increase levels of serotonin 5-HT7 activity intended to enhance antidepressant efficacy and produce reduced levels of D2 receptor occupancy appropriate for the treatment of Bipolar Disorder (Manic Depression). The pharmacological effect of SEP-4199 is distinct from racemic amisulpride, which is approved in several countries outside the US for the treatment of schizophrenia and other psychiatric condition.
Brexpiprazole (Lundbeck/Otsuka Pharmaceutical)
Brexpiprazole is a molecule discovered by Otsuka and co-developed by Otsuka and Lundbeck. Brexpiprazole is an atypical antipsychotic agent with a partial dopamine receptor D2 agonist effect. It is a partial agonist at dopamine D2 receptors designed to have a similar binding affinity to dopamine and serotonin receptors. The efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits high affinity (subnanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors.
Bipolar Disorder Market Outlook
At present, some companies have initiated clinical trials that investigate new treatment options. Key players such as Intra-Cellular Therapies (Caplyta, also known as Lumateperone), NeuroRx (NRX-100/NRX-101), Sunovion (Sumitomo Dainippon Pharma) (SEP-4199), Lundbeck/Otsuka Pharmaceutical (Rexulti/Rxulti, also known as Brexpiprazole), COMPASS Pathways (COMP 360, also known as Psilocybin therapy), Celon Pharma (Falkieri), and several others are investigating their candidates for the management of Bipolar Disorder (Manic Depression) in the 7MM.
Key Findings
The Bipolar Disorder (Manic Depression) market size in the 7MM is expected to change during the study period 2017–2030. The therapeutic market of Bipolar Disorder (Manic Depression) in the seven major markets is expected to increase during the study period (2017–2030) with a CAGR of 11.9%. According to the estimates, the highest market size of Bipolar Disorder (Manic Depression) is found in the United States followed by Germany.
The United States Market Outlook
The total market size of Bipolar Disorder (Manic Depression) therapies in the United States is expected to increase with a CAGR of 11.6% in the study period (2017–2030).
EU-5 Countries: Market Outlook
The total market size of Bipolar Disorder (Manic Depression) therapies in EU-5 countries is expected to increase with a CAGR of 13.4% in the study period (2017–2030).
Japan Market Outlook
The total market size of Bipolar Disorder (Manic Depression) therapies in Japan is expected to increase with a CAGR of 11.5% in the study period (2017–2030).
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Table of contents
1. Key Insights
2. Report Introduction
3. Bipolar Disorder (Manic Depression) Market Overview at a Glance
3.1. Market Share (%) Distribution of Bipolar Disorder (Manic Depression) in 2017
3.2. Market Share (%) Distribution of Bipolar Disorder (Manic Depression) in 2030
4. Executive Summary of Bipolar Disorder (Manic Depression)
5. Epidemiology and Market Methodology
6. Disease Background and Overview
6.1. Introduction
6.2. Difference between Bipolar and Unipolar Depression
6.3. Classification of BD According to DSM-5
6.4. Signs and symptoms
6.5. Causes
6.6. Risk Factors
6.7. Pathophysiology
6.8. Genetic Findings in BD
6.9. Biomarkers
7. Diagnosis of Bipolar Disorder
7.1. Diagnostic criteria for major forms of BD
7.1.1. Diagnosis to rule out thyroid disorders
7.2. Differential Diagnosis
7.3. Diagnostic Guidelines
7.3.1. Evidence-based guidelines for treating bipolar disorder: Revised third edition recommendations from the British Association for Psychopharmacology Guidelines
7.3.2. The National Institute for Health and Care Excellence (NICE) guidelines for the diagnosis of the bipolar disorder
8. Current Treatment Practices of Bipolar Disorder
8.1. Treatment of Bipolar Disorder
8.1.1. Treatment Algorithm
8.2. Treatment Guidelines
8.2.1. The World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the Biological Treatment of Bipolar Disorders: Update 2010 on the treatment of acute Bipolar Disorder (Manic Depression)
8.2.2. The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2012 on the long-term treatment of the bipolar disorder
8.2.3. The American Psychiatric Association Practice Guideline for the Treatment of Bipolar Disorder
8.2.4. The National Institute for Health and Care Excellence (NICE) guidelines for the treatment of the bipolar disorder
8.2.5. Evidence-based guidelines for treating bipolar disorder: Revised third edition recommendations from the British Association for Psychopharmacology
8.2.6. Guideline for the treatment of bipolar disorder by the Japanese Society of Mood Disorders, 2012
8.2.7. International Society for Bipolar Disorders Clinical (ISBD) Recommendations for Antidepressant Use in Bipolar Disorders
8.2.8. The International College of Neuro-psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017)
8.3. Comparison of Bipolar disorder guidelines
9. Epidemiology and Patient Population
9.1. Key Findings
9.2. Epidemiology of Bipolar Disorder (Manic Depression)
9.3. Epidemiology Scenario: 7MM
9.3.1. Total Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
9.3.2. Type-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
9.3.3. Severity-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
9.3.4. Total Treated Cases of Bipolar Disorder (Manic Depression)
10. The United States
10.1. Total Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
10.2. Type-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
10.3. Severity-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
10.4. Total Treated Cases of Bipolar Disorder (Manic Depression)
11. EU-5
11.1. Germany
11.1.1. Total Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.1.2. Type-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.1.3. Severity-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.1.4. Total Treated Cases of Bipolar Disorder (Manic Depression)
11.2. France
11.2.1. Total Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.2.2. Type-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.2.3. Severity-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.2.4. Total Treated Cases of Bipolar Disorder (Manic Depression)
11.3. Italy
11.3.1. Total Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.3.2. Type-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.3.3. Severity-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.3.4. Total Treated Cases of Bipolar Disorder (Manic Depression)
11.4. Spain
11.4.1. Total Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.4.2. Type-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.4.3. Severity-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.4.4. Total Treated Cases of Bipolar Disorder (Manic Depression)
11.5. The United Kingdom
11.5.1. Total Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.5.2. Type-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.5.3. Severity-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
11.5.4. Total Treated Cases of Bipolar Disorder (Manic Depression)
12. Japan
12.1. Total Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
12.2. Type-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
12.3. Severity-specific Diagnosed Prevalent Cases of Bipolar Disorder (Manic Depression)
12.4. Total Treated Cases of Bipolar Disorder (Manic Depression)
13. Patient Journey
14. Key Endpoints in Bipolar Disorder (Manic Depression) Clinical Trials
15. Marketed Therapies
15.1. Vraylar (Cariprazine): Allergan (AbbVie)/Gedeon Richter
15.1.1. Drug Description
15.1.2. Regulatory Milestones
15.1.3. Other Developmental Activities
15.1.4. Pivotal Clinical Trial
15.1.5. Ongoing Current Pipeline Activity
15.2. Latuda (Lurasidone Hydrochloride): Sunovion Pharmaceuticals (Sumitomo Dainippon Pharma)
15.2.1. Drug Description
15.2.2. Regulatory Milestones
15.2.3. Other Developmental Activities
15.2.4. Pivotal Clinical Trial
16. Emerging Therapies
16.1. Caplyta (ITI-007; Lumateperone): Intra-Cellular Therapies
16.1.1. Product Description
16.1.2. Other Developmental Activities
16.1.3. Clinical Development
16.1.4. Safety and Efficacy
16.2. NRX-100/NRX-101: NeuroRx
16.2.1. Product Description
16.2.2. Other Developmental Activities
16.2.3. Clinical Development
16.2.4. Safety and Efficacy
16.3. SEP-4199: Sunovion (Sumitomo Dainippon Pharma)
16.3.1. Product Description
16.3.2. Other Developmental Activities
16.3.3. Clinical Development
16.3.4. Safety and Efficacy
16.4. Rexulti/Rxulti (Brexpiprazole): Lundbeck/Otsuka Pharmaceutical
16.4.1. Product Description
16.4.2. Other Developmental Activities
16.4.3. Clinical Development
16.4.4. Safety and Efficacy
16.5. Falkieri (Esketamine): Celon Pharma
16.5.1. Product Description
16.5.2. Other Developmental Activities
16.5.3. Clinical Development
16.5.4. Safety and Efficacy
16.6. COMP 360 (Psilocybin): COMPASS Pathways
16.6.1. Product Description
16.6.2. Other Developmental Activities
16.6.3. Clinical Development
17. Bipolar Disorder (Manic Depression): 7 Major Market Analysis
17.1. Key Findings
17.2. Market Outlook
17.3. 7MM Market Size
17.3.1. Total Market Size of Bipolar Disorder (Manic Depression) in the 7MM
17.3.2. Market Size of Bipolar Disorder (Manic Depression) by Therapies in the 7MM
18. The United States Market Size
18.1. Total Market Size of Bipolar Disorder (Manic Depression) in the United States
18.2. Market Size of Bipolar Disorder (Manic Depression) by Therapies in the United States
19. EU-5 Market Size
19.1. Germany
19.1.1. Total Market size of Bipolar Disorder (Manic Depression) in Germany
19.1.2. Market Size of Bipolar Disorder (Manic Depression) by Therapies in Germany
19.2. France
19.2.1. Total Market size of Bipolar Disorder (Manic Depression) in France
19.2.2. Market Size of Bipolar Disorder (Manic Depression) by Therapies in France
19.3. Italy
19.3.1. Total Market size of Bipolar Disorder (Manic Depression) in Italy
19.3.2. Market Size of Bipolar Disorder (Manic Depression) by Therapies in Italy
19.4. Spain
19.4.1. Total Market size of Bipolar Disorder (Manic Depression) in Spain
19.4.2. Market Size of Bipolar Disorder (Manic Depression) by Therapies in Spain
19.5. The United Kingdom
19.5.1. Total Market size of Bipolar Disorder (Manic Depression) in the United Kingdom
19.5.2. Market Size of Bipolar Disorder (Manic Depression) by Therapies in the United Kingdom
20. Japan
20.1. Total Market size of Bipolar Disorder (Manic Depression) in Japan
20.2. Market Size of Bipolar Disorder (Manic Depression) by Therapies in Japan
21. Market Access and Reimbursement
21.1. Key HTA decisions for Bipolar Disorder (Manic Depression)
21.2. Patient Access Programs
22. Market Drivers
23. Market Barriers
24. SWOT Analysis
25. Unmet Needs
26. Appendix
26.1. Bibliography
26.2. Report Methodology
27. DelveInsight Capabilities
28. Disclaimer
29. About DelveInsight
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