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PharmaPoint: Bipolar Disorder - Global Drug Forecast and Market Analysis to 2024

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PharmaPoint: Bipolar Disorder - Global Drug Forecast and Market Analysis to 2024

Summary

Bipolar disorder is a mental disorder characterized by periods of mania and depression. The frequency,...
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PharmaPoint: Bipolar Disorder - Global 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.

Highlights

Key Questions Answered

- The bipolar disorder market is heavily genericized and many key players have chosen to deprioritize the indication. In light of this, what are the current clinical and environmental unmet needs? Will there be opportunities in this market for drug developers throughout the forecast period?
- The current late-stage bipolar disorder pipeline is sparse, with only two products in Phase III development. What impact will these drugs have on the market? How will they affect the treatment algorithm for bipolar disorder? Will these drugs fulfil any of the unmet needs for bipolar disorder?
- The management of bipolar disorder patients is challenging and a large number of variables can impact treatment outcomes. How does the diagnosis and treatment of bipolar disorder differ amongst the 8MM? Which treatment options are most commonly prescribed in each market, and how will prescribing patterns change over the forecast period?

Key Findings

- The main driver of growth in the bipolar disorder market will be the uptake of novel atypical antipsychotic products, such as Otsuka/Lundbeck's Abilify Maintena and Allergan/Gedeon Richter/Mitsubishi Tanabe's Vraylar. These agents are forecast to be the highest selling bipolar disorder products by 2024, accounting for 34.9% of the bipolar disorder market in the 8MM.
- There are very few products approved for the treatment of major depressive episodes, despite the fact that patients most commonly experience this episode type. This unmet need is not expected to be addressed during the forecast period due to the sparsity of the late-stage pipeline.
- The biggest barrier for growth in the bipolar disorder market will be fierce competition from generic products. This limits market opportunities for new and existing players, as uptake of novel pipeline products would be hindered by their premium price point.
- Considerable opportunity remains for products with superior safety profiles compared to the currently available drugs. KOLs noted that EPS and metabolic changes were significant concerns related to the antipsychotic drugs.

Scope

- Overview of bipolar disorder, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized bipolar disorder market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
- Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the bipolar disorder therapeutics market.
- Pipeline analysis: focus on two late-stage pipeline bipolar disorder drugs, discussing emerging trends as well as an overview of earlier phase drugs and a top-line analysis of off-label treatments.
- Analysis of the current and future market competition in the global bipolar disorder therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global bipolar disorder therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global bipolar disorder therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global bipolar disorder therapeutics market from 2014-2024.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Additional Information

Additional Information

Publisher name GlobalData.
Format PDF
Page count 440
Publication date 1 Mar 2016
Table of contents 1 Table of Contents
1 Table of Contents 12
1.1 List of Tables 17
1.2 List of Figures 24
2 Introduction 26
2.1 Catalyst 26
2.2 Related Reports 27
2.3 Upcoming Related Reports 27
3 Disease Overview 28
3.1 Etiology and Pathophysiology 28
3.1.1 Etiology 28
3.1.2 Pathophysiology 30
3.2 Classification 34
3.3 Symptoms 40
3.4 Prognosis 41
4 Epidemiology 43
4.1 Disease Background 43
4.2 Risk Factors and Comorbidities 43
4.3 Global Trends 45
4.4 Forecast Methodology 47
4.4.1 Sources Used 53
4.4.2 Sources Not Used 56
4.4.3 Forecast Assumptions and Methods 56
4.5 Epidemiological Forecast of Bipolar Disorder (2014-2024) 60
4.5.1 12-Month Total Prevalent Cases of Bipolar Spectrum Disorder 60
4.5.2 12-Month Total Prevalent Cases of Bipolar I 61
4.5.3 12-Month Total Prevalent Cases of Bipolar II 63
4.5.4 12-Month Total Prevalent Cases of Cyclothymic Disorder 65
4.5.5 Lifetime Total Prevalent Cases of Bipolar Spectrum Disorder 67
4.5.6 Age-Specific 12-Month Total Prevalent Cases of Bipolar I 68
4.5.7 Age-Specific 12-Month Total Prevalent Cases of Bipolar II 70
4.5.8 Age-Specific 12-Month Total Prevalent Cases of Cyclothymic Disorder 72
4.5.9 Sex-Specific 12-Month Total Prevalent Cases of Bipolar I 74
4.5.10 Sex-Specific 12-Month Total Prevalent Cases of Bipolar II 76
4.5.11 Sex-Specific 12-Month Total Prevalent Cases of Cyclothymic Disorder 78
4.5.12 Age-Standardized 12-Month Total Prevalence of Bipolar Spectrum Disorder 80
4.6 Discussion 82
4.6.1 Epidemiological Forecast Insight 82
4.6.2 Limitations of the Analysis 83
4.6.3 Strengths of the Analysis 84
5 Disease Management 85
5.1 Diagnosis Overview 85
5.1.1 Clinical Evaluation 85
5.1.2 Screening Tools 86
5.2 Treatment Overview 88
5.2.1 Treatment Initiation and Maintenance Therapy 88
5.2.2 Manic or Mixed Episodes 91
5.2.3 Acute Agitation 93
5.2.4 Hypomanic Episodes 94
5.2.5 Major Depressive Episodes 96
5.2.6 Rapid Cycling 99
5.2.7 Cyclothymia 101
5.2.8 Other Treatment Factors 102
5.3 Treatment Guidelines and Leading Prescribed Drugs 105
5.4 US 106
5.5 5EU 110
5.6 Japan 115
5.7 Canada 120
6 Competitive Assessment 125
6.1 Overview 125
6.2 Product Profiles - Major Brands 127
6.2.1 Lithium 127
6.2.2 Anticonvulsants 136
6.2.3 Typical Antipsychotics 157
6.2.4 Atypical Antipsychotics 170
6.2.5 Antidepressants 261
6.3 Other Therapeutic Classes 268
7 Unmet Need and Opportunity 270
7.1 Overview 270
7.2 Effective Treatment Options for Bipolar Depression 271
7.2.1 Unmet Need 271
7.2.2 Gap Analysis 274
7.2.3 Opportunity 275
7.3 Antipsychotics with a Low Risk of EPS and Metabolic Changes 276
7.3.1 Unmet Need 276
7.3.2 Gap Analysis 277
7.3.3 Opportunity 278
7.4 Mood Stabilizers with Improved Safety Profiles 279
7.4.1 Unmet Need 279
7.4.2 Gap Analysis 282
7.4.3 Opportunity 282
7.5 Education for Physicians in Order to Improve Diagnosis Rates 284
7.5.1 Unmet Need 284
7.5.2 Gap Analysis 286
7.5.3 Opportunity 286
7.6 Novel Drugs Developed Specifically for Bipolar Disorder 286
7.6.1 Unmet Need 286
7.6.2 Gap Analysis 288
7.6.3 Opportunity 289
8 Pipeline Assessment 290
8.1 Overview 290
8.1.1 Clinical Trials by Class of Therapy 290
8.2 Promising Drugs in Clinical Development 292
8.2.1 Abilify Maintena 293
8.2.2 ITI-007 303
8.3 Off-label Pipeline and Recently Approved Therapies 310
8.4 Promising Drugs in Early-Stage Development 311
8.5 Other Drugs in Development 312
9 Current and Future Players 314
9.1 Overview 314
9.2 Trends in Corporate Strategy 317
9.3 Company Profiles 318
9.3.1 Otsuka 318
9.3.2 AstraZeneca 322
9.3.3 Eli Lilly 324
9.3.4 Allergan 327
9.3.5 Dainippon Sumitomo 329
9.3.6 Janssen 332
9.3.7 Lundbeck 335
9.3.8 Meiji Seika 338
10 Market Outlook 341
10.1 Global Markets 341
10.1.1 Forecast 341
10.1.2 Drivers and Barriers - Global Issues 348
10.2 United States 349
10.2.1 Forecast 349
10.2.2 Key Events 354
10.2.3 Drivers and Barriers 355
10.3 5EU 356
10.3.1 Forecast 356
10.3.2 Key Events 362
10.3.3 Drivers and Barriers 363
10.4 Japan 364
10.4.1 Forecast 364
10.4.2 Key Events 369
10.4.3 Drivers and Barriers 370
10.5 Canada 371
10.5.1 Forecast 371
10.5.2 Key Events 376
10.5.3 Drivers and Barriers 377
11 Appendix 378
11.1 Bibliography 378
11.2 Abbreviations 413
11.3 Methodology 418
11.4 Forecasting Methodology 418
11.4.1 Diagnosed Bipolar Disorder Patients 418
11.4.2 Percent Drug-Treated Patients 419
11.4.3 Launch and Patent Expiry Dates 419
11.4.4 General Pricing Assumptions 420
11.4.5 Individual Drug Assumptions 421
11.4.6 Generic Erosion 432
11.5 Primary Research - KOLs Interviewed for this Report 433
11.6 Primary Research - Prescriber Survey 436
11.7 About the Authors 437
11.7.1 Analyst 437
11.7.2 Therapy Area Director 437
11.7.3 Epidemiologist 438
11.7.4 Global Director of Therapy Research and Analysis 438
11.8 About GlobalData 439
11.9 Disclaimer 439

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