Bipolar Disorder - US Drug Forecast and Market Analysis to 2024

  • ID: 3756911
  • Report
  • Region: United States
  • 312 pages
  • GlobalData
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Bipolar Disorder - US Drug Forecast and Market Analysis to 2024

Summary

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.

The author estimates that drug sales for bipolar disorder in the US reached $4.5 billion during 2014, making the US the largest market within the 8MM. A steep decline in sales is forecast to occur between 2015 and 2017, attributed largely to the generic erosion of Otsuka’s Abilify. This will be followed by a more gradual contraction in market size between 2017 and 2020 due to the generic erosion of other key brands such as Dainippon Sumitomo’s Latuda and AstraZeneca’s Seroquel XR.

Scope

- 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 the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2014-2024.
- Analysis of the impact of key events as well the drivers and restraints affecting the US 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 US.
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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 US

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 United States

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

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 - US

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 Forecast ($m) for Bipolar Disorder in the US, 2014-2024

Table 100: Key Events Impacting Sales for Bipolar Disorder in the US, 2014-2024

Table 101: Bipolar Disorder Market in the US - 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 US by Drug Class, 2014-2024
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