Bipolar Disorder - 5EU Drug Forecast and Market Analysis to 2024

Bipolar Disorder - 5EU Drug Forecast and Market Analysis to 2024


Bipolar disorder is a mental disorder characterized by periods of mania and depression. The frequency, severity, and pattern of these episodes can vary considerably over time and between individuals, making bipolar disorder one of the most challenging psychiatric disorders to manage. The bipolar disorder market is widely genericized, with additional key brands expected to face patent or data exclusivity expiries during the forecast period. The bipolar disorder market size is anticipated to contract significantly between 2014 and 2024, driven largely by the generic erosion of Otsuka’s Abilify, the highest selling bipolar disorder product in 2014. The uptake of novel atypical antipsychotic products will be a principal driver of growth over the forecast period, as these products offer clinical advantages that will drive strong uptake. However, sales of these agents will be limited by the continued utilization of established generic products. There are currently only two products in Phase III development, which indicates that bipolar disorder will remain a field of high unmet need during the forecast period.

GlobalData estimates that drug sales for bipolar disorder in the 5EU reached $773.8m in 2014. The generic erosion of Otsuka’s Abilify is expected to cause an initial contraction in market size between 2014 and 2016. However, the market is expected to grow starting from 2017, driven by the uptake of pipeline agents in combination with increasing diagnosis and treatment rates throughout the 5EU. The market growth is forecast to slow towards the end of the forecast period as the market uptake of both generics and pipeline products becomes established.


  • Overview of Bipolar Disorder including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on the key drugs in 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in 5EU (France, Germany, Italy, Spain, and the UK) from 2014-2024.
  • Analysis of the impact of key events as well the drivers and restraints affecting 5EU Bipolar Disorder market.
Reasons to buy
  • Understand and capitalize by identifying products that are most likely to ensure a robust return
  • Stay ahead of the competition by understanding the changing competitive landscape for Bipolar Disorder.
  • Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  • Make more informed business decisions from insightful and in-depth analysis of drug performance
  • Obtain sales forecast for drugs from 2014-2024 in 5EU (France, Germany, Italy, Spain, and the UK).

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification
3.3 Symptoms
3.4 Prognosis
4 Disease Management
4.1 Diagnosis Overview
4.1.1 Clinical Evaluation
4.1.2 Screening Tools
4.2 Treatment Overview
4.2.1 Treatment Initiation and Maintenance Therapy
4.2.2 Manic or Mixed Episodes
4.2.3 Acute Agitation
4.2.4 Hypomanic Episodes
4.2.5 Major Depressive Episodes
4.2.6 Rapid Cycling
4.2.7 Cyclothymia
4.2.8 Other Treatment Factors
4.3 Treatment Guidelines and Leading Prescribed Drugs
4.4 5EU
5 Competitive Assessment
5.1 Overview
5.2 Product Profiles - Major Brands
5.2.1 Lithium
5.2.2 Anticonvulsants
5.2.3 Typical Antipsychotics
5.2.4 Atypical Antipsychotics
5.2.5 Antidepressants
5.3 Other Therapeutic Classes
6 Unmet Need and Opportunity
6.1 Overview
6.2 Effective Treatment Options for Bipolar Depression
6.2.1 Unmet Need
6.2.2 Gap Analysis
6.2.3 Opportunity
6.3 Antipsychotics with a Low Risk of EPS and Metabolic Changes
6.3.1 Unmet Need
6.3.2 Gap Analysis
6.3.3 Opportunity
6.4 Mood Stabilizers with Improved Safety Profiles
6.4.1 Unmet Need
6.4.2 Gap Analysis
6.4.3 Opportunity
6.5 Education for Physicians in Order to Improve Diagnosis Rates
6.5.1 Unmet Need
6.5.2 Gap Analysis
6.5.3 Opportunity
6.6 Novel Drugs Developed Specifically for Bipolar Disorder
6.6.1 Unmet Need
6.6.2 Gap Analysis
6.6.3 Opportunity
7 Pipeline Assessment
7.1 Overview
7.1.1 Clinical Trials by Class of Therapy
7.2 Promising Drugs in Clinical Development
7.2.1 Abilify Maintena
7.2.2 ITI-007
7.3 Off-label Pipeline and Recently Approved Therapies
7.4 Promising Drugs in Early-Stage Development
7.5 Other Drugs in Development
8 Market Outlook
8.1 5EU
8.1.1 Forecast
8.1.2 Key Events
8.1.3 Drivers and Barriers
9 Appendix
9.1 Bibliography
9.2 Abbreviations
9.3 Methodology
9.4 Forecasting Methodology
9.4.1 Diagnosed Bipolar Disorder Patients
9.4.2 Percent Drug-Treated Patients
9.4.3 Launch and Patent Expiry Dates
9.4.4 General Pricing Assumptions
9.4.5 Individual Drug Assumptions
9.4.6 Generic Erosion
9.5 Primary Research - KOLs Interviewed for this Report
9.6 Primary Research - Prescriber Survey
9.7 About the Authors
9.7.1 Analyst
9.7.2 Therapy Area Director
9.7.3 Epidemiologist
9.7.4 Global Director of Therapy Research and Analysis
9.8 About GlobalData
9.9 Disclaimer
1.1 List of Tables
Table 1: Classification and Criteria of Bipolar Disorder According to DSM-V and ICD-10-CM
Table 2: DSM-V Bipolar Disorder Specifiers
Table 3: Symptoms of Manic, Hypomanic, and Major Depressive Episodes in Bipolar Disorder
Table 4: Screening Tools Used for Bipolar Disorder
Table 5: Treatment Guidelines for Bipolar Disorder
Table 6: Most Prescribed Drugs for Bipolar Disorder by Episode Type in the Global Markets, 2014
Table 7: Country Profile - 5EU
Table 8: Leading Treatments for Bipolar Disorder, 2015
Table 9: Product Profile - Lithium
Table 10: Lithium SWOT Analysis, 2015
Table 11: Global Sales Forecasts ($m) for Lithium, 2014-2024
Table 12: Product Profile - Carbamazepine
Table 13: Efficacy Results for Equetro in Bipolar Mania Trials
Table 14: Adverse Events at ≥5% Incidence in Bipolar Mania Trials of Equetro
Table 15: Carbamazepine SWOT Analysis, 2015
Table 16: Global Sales Forecasts ($m) for Carbamazepine, 2014-2024
Table 17: Product Profile - Lamotrigine
Table 18: Adverse Events at ≥5% Incidence in Bipolar Maintenance Trials of Lamictal
Table 19: Lamotrigine SWOT Analysis, 2015
Table 20: Global Sales Forecasts ($m) for Lamotrigine, 2014-2024
Table 21: Product Profile - Valproate
Table 22: Efficacy Results for Depakote in Bipolar Mania Trials
Table 23: Adverse Events at ≥5% Incidence in Bipolar Mania Trials of Depakote
Table 24: Valproate SWOT Analysis, 2015
Table 25: Global Sales Forecasts ($m) for Valproate, 2014-2024
Table 26: Typical Antipsychotics by Chemical Class
Table 27: Typical antipsychotics SWOT Analysis, 2015
Table 28: Global Sales Forecasts ($m) for the Typical Antipsychotics, 2014-2024
Table 29: Product Profile - Adasuve
Table 30: Efficacy Results for Adasuve in Agitation Trial of Bipolar I Disorder Patients
Table 31: Decrease in FEV1 in Pulmonary Safety Trials of Adasuve
Table 32: Adasuve SWOT Analysis, 2015
Table 33: Global Sales Forecasts ($m) for Adasuve, 2014-2024
Table 34: Product Profile - Abilify
Table 35: Efficacy Results for Abilify in Bipolar Mania Trials
Table 36: Efficacy Results for Abilify in Agitation Trials
Table 37: Adverse Events at ≥2% Incidence in Bipolar I Disorder and Schizophrenia Trials of Abilify
Table 38: Abilify SWOT Analysis, 2015
Table 39: Global Sales Forecasts ($m) for Abilify, 2014-2024
Table 40: Product Profile - Geodon
Table 41: Adverse Events at ≥2% Incidence in Bipolar Mania Trials of Geodon
Table 42: Geodon SWOT Analysis, 2015
Table 43: Global Sales Forecasts ($m) for Geodon, 2014-2024
Table 44: Product Profile - Latuda
Table 45: Efficacy Results for Latuda in Bipolar Depression Trials
Table 46: Adverse Events at ≥2% Incidence in Bipolar Depression Trials of Latuda
Table 47: Latuda SWOT Analysis, 2015
Table 48: Global Sales Forecasts ($m) for Latuda, 2014-2024
Table 49: Product Profile - Risperdal
Table 50: Efficacy Results for Risperdal in Trial of Manic and Mixed Bipolar Episodes
Table 51: Adverse Events at ≥2% Incidence in Bipolar Mania Trials of Risperdal
Table 52: Adverse Events at ≥2% Incidence in Bipolar Maintenance Trials of Risperdal Consta
Table 53: Risperdal SWOT Analysis, 2015
Table 54: Global Sales Forecasts ($m) for Risperdal, 2014-2024
Table 55: Global Sales Forecasts ($m) for Risperdal Consta, 2014-2024
Table 56: Product Profile - Saphris
Table 57: Efficacy Results for Saphris in Bipolar Mania Studies
Table 58: Adverse Events at ≥2% Incidence in Bipolar I Disorder Trials of Saphris
Table 59: Saphris SWOT Analysis, 2015
Table 60: Global Sales Forecasts ($m) for Saphris, 2014-2024
Table 61: Product Profile - Seroquel
Table 62: Efficacy Results for Seroquel in Bipolar Mania Studies
Table 63: Efficacy Results for Seroquel in Bipolar Depression Trials
Table 64: Efficacy Results for Seroquel XR in Bipolar Disorder Trials
Table 65: Adverse Events at ≥2% Incidence in Bipolar Disorder Trials of Seroquel
Table 66: Adverse Events at ≥2% Incidence in Bipolar Disorder Trials of Seroquel XR
Table 67: Seroquel SWOT Analysis, 2015
Table 68: Global Sales Forecasts ($m) for Seroquel, 2014-2024
Table 69: Global Sales Forecasts ($m) for Seroquel XR, 2014-2024
Table 70: Product Profile - Symbyax
Table 71: Efficacy Results for Symbyax in Bipolar Depression Trials
Table 72: Adverse Events at ≥2% Incidence in Bipolar Depression and Treatment-Resistant Depression Trials of Symbyax
Table 73: Symbyax SWOT Analysis, 2015
Table 74: Global Sales Forecasts ($m) for Symbyax, 2014-2024
Table 75: Product Profile - Vraylar
Table 76: Vraylar SWOT Analysis, 2015
Table 77: Global Sales Forecast ($) for Vraylar, 2014-2024
Table 78: Product Profile - Zyprexa
Table 79: Adverse Events at ≥2% Incidence in Bipolar Mania Trials of Zyprexa
Table 80: Adverse Events at ≥2% Incidence in Trials of Zyprexa IntraMuscular in Agitation Associated with Schizophrenia or Bipolar I Mania
Table 81: Zyprexa SWOT Analysis, 2015
Table 82: Global Sales Forecasts ($m) for Zyprexa, 2014-2024
Table 83: Product Information for the Most Commonly Prescribed “Other Antipsychotics”
Table 84: International Society for Bipolar Disorders Clinical Recommendations for Antidepressant Use in Bipolar Disorder
Table 85: Antidepressants SWOT Analysis, 2015
Table 86: Global Sales Forecasts ($m) for the Antidepressants, 2014-2024
Table 87: Summary of Minor Therapeutic Classes, 2015
Table 88: Unmet Need and Opportunity in Bipolar Disorder
Table 89: Product Profile - Abilify Maintena
Table 90: Adverse Events at ≥2% Incidence in a Schizophrenia Trial of Abilify Maintena
Table 91: Abilify Maintena SWOT Analysis, 2015
Table 92: Global Sales Forecast ($) for Abilify Maintena, 2014-2024
Table 93: Product Profile - ITI-007
Table 94: Efficacy Results for ITI-007 in a Phase II Schizophrenia Trial
Table 95: Key Safety Data From a Phase II in a Schizophrenia Trial of ITI-007
Table 96: ITI-007 SWOT Analysis, 2015
Table 97: Potential Off-label Bipolar Disorder Late-Stage Pipeline Drugs
Table 98: Drugs in Development, 2015
Table 99: Sales Forecasts ($m) for Bipolar Disorder in the 5EU, 2014-2024
Table 100: Key Events Impacting Sales for Bipolar Disorder in the 5EU, 2014-2024
Table 101: Bipolar Disorder Market in the 5EU - Drivers and Barriers, 2014-2024
Table 102: Key Launch Dates
Table 103: Key Patent Expiries
Table 104: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country
1.2 List of Figures
Figure 1: The Etiology and Pathophysiology of Bipolar Disorders
Figure 2: The Effects of Lithium on Neurotransmission
Figure 3: The Effects of Lithium on Second Messenger Pathways
Figure 4: Bipolar Disorder Therapeutics - Class of Therapy, 2016
Figure 5: Bipolar Disorder - Phase II-III Pipeline, 2015
Figure 6: Clinical and Commercial Positioning of Abilify Maintena
Figure 7: Clinical and Commercial Positioning of ITI-007
Figure 8: Sales for Bipolar Disorder in the 5EU by Drug Class, 2014-2024

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