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

Published: Mar 1, 2016 | Pages: 440 | Publisher: GlobalData | Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

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.
 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
List of Tables
Table 1: Classification and Criteria of Bipolar Disorder According to DSM-V and ICD-10-CM 37 Table 2: DSM-V Bipolar Disorder Specifiers 39 Table 3: Symptoms of Manic, Hypomanic, and Major Depressive Episodes in Bipolar Disorder 41 Table 4: Risk Factors and Comorbidities for Bipolar Disorder 44 Table 5: 8MM, Sources Used to Forecast the 12-Month Total Prevalent Cases of Bipolar Disorder I 48 Table 6: 8MM, Sources Used to Forecast the Lifetime Total Prevalent Cases of Bipolar Disorder I 49 Table 7: 8MM, Sources Used to Forecast the 12-Month Total Prevalent Cases of Bipolar Disorder II 50 Table 8: 8MM, Sources Used to Forecast the Lifetime Total Prevalent Cases of Bipolar Disorder II 51 Table 9: 8MM, Sources Used to Forecast 12-Month Total Prevalent Cases of Cyclothymic Disorder 52 Table 10: 8MM, Sources Used to Forecast Lifetime Total Prevalent Cases of Cyclothymic Disorder 52 Table 11: 8MM, 12-Month Total Prevalent Cases of Bipolar Spectrum Disorder Summary, Both Sexes, Ages ?13 Years, N (Row %), 2014 61 Table 12: 8MM, 12-Month Total Prevalent Cases of Bipolar I, Both Sexes, Ages ?13 Years, 2014-2024 62 Table 13: 8MM, 12-Month Total Prevalent Cases of Bipolar II, Both Sexes, Ages ?13 Years, 2014-2024 64 Table 14: 8MM, 12-Month Total Prevalent Cases of Cyclothymic Disorder, Both Sexes, Ages ?13 Years, 2014-2024 66 Table 15: 8MM, Lifetime Total Prevalent Cases of Bipolar Spectrum Disorder Summary, Both Sexes, Ages ?13 Years, N (Row %), 2014 68 Table 16: 8MM, Age-Specific 12-Month Total Prevalent Cases of Bipolar I, Both Sexes, Ages ?13 Years, N (Row %), 2014 69 Table 17: 8MM, Age-Specific 12-Month Total Prevalent Cases of Bipolar II, Both Sexes, Ages ?13 Years, N (Row %), 2014 71 Table 18: 8MM, Age-Specific 12-Month Total Prevalent Cases of Cyclothymic Disorder, Both Sexes, Ages ?13 Years, N (Row %), 2014 73 Table 19: 8MM, Sex-Specific 12-Month Total Prevalent Cases of Bipolar I, Ages ?13 Years, N (Row %), 2014 75 Table 20: 8MM, Sex-Specific 12-Month Total Prevalent Cases of Bipolar II, Ages ?13 Years, N (Row %), 2014 77 Table 21: 8MM, Sex-Specific 12-Month Total Prevalent Cases of Cyclothymic Disorder, Ages ?13 Years, N (Row %), 2014 79 Table 22: Screening Tools Used for Bipolar Disorder 87 Table 23: Treatment Guidelines for Bipolar Disorder 105 Table 24: Most Prescribed Drugs for Bipolar Disorder by Episode Type in the Global Markets, 2014 106 Table 25: Country Profile - US 109 Table 26: Country Profile - 5EU 114 Table 27: Country Profile - Japan 119 Table 28: Country Profile - Canada 123 Table 29: Leading Treatments for Bipolar Disorder, 2015 126 Table 30: Product Profile - Lithium 132 Table 31: Lithium SWOT Analysis, 2015 135 Table 32: Global Sales Forecasts ($m) for Lithium, 2014-2024 136 Table 33: Product Profile - Carbamazepine 139 Table 34: Efficacy Results for Equetro in Bipolar Mania Trials 140 Table 35: Adverse Events at ?5% Incidence in Bipolar Mania Trials of Equetro 141 Table 36: Carbamazepine SWOT Analysis, 2015 142 Table 37: Global Sales Forecasts ($m) for Carbamazepine, 2014-2024 143 Table 38: Product Profile - Lamotrigine 145 Table 39: Adverse Events at ?5% Incidence in Bipolar Maintenance Trials of Lamictal 147 Table 40: Lamotrigine SWOT Analysis, 2015 149 Table 41: Global Sales Forecasts ($m) for Lamotrigine, 2014-2024 150 Table 42: Product Profile - Valproate 153 Table 43: Efficacy Results for Depakote in Bipolar Mania Trials 154 Table 44: Adverse Events at ?5% Incidence in Bipolar Mania Trials of Depakote 155 Table 45: Valproate SWOT Analysis, 2015 156 Table 46: Global Sales Forecasts ($m) for Valproate, 2014-2024 157 Table 47: Typical Antipsychotics by Chemical Class 159 Table 48: Typical antipsychotics SWOT Analysis, 2015 162 Table 49: Global Sales Forecasts ($m) for the Typical Antipsychotics, 2014-2024 163 Table 50: Product Profile - Adasuve 166 Table 51: Efficacy Results for Adasuve in Agitation Trial of Bipolar I Disorder Patients 167 Table 52: Decrease in FEV1 in Pulmonary Safety Trials of Adasuve 168 Table 53: Adasuve SWOT Analysis, 2015 169 Table 54: Global Sales Forecasts ($m) for Adasuve, 2014-2024 170 Table 55: Product Profile - Abilify 174 Table 56: Efficacy Results for Abilify in Bipolar Mania Trials 175 Table 57: Efficacy Results for Abilify in Agitation Trials 177 Table 58: Adverse Events at ?2% Incidence in Bipolar I Disorder and Schizophrenia Trials of Abilify 178 Table 59: Abilify SWOT Analysis, 2015 180 Table 60: Global Sales Forecasts ($m) for Abilify, 2014-2024 181 Table 61: Product Profile - Geodon 183 Table 62: Adverse Events at ?2% Incidence in Bipolar Mania Trials of Geodon 186 Table 63: Geodon SWOT Analysis, 2015 187 Table 64: Global Sales Forecasts ($m) for Geodon, 2014-2024 188 Table 65: Product Profile - Latuda 191 Table 66: Efficacy Results for Latuda in Bipolar Depression Trials 192 Table 67: Adverse Events at ?2% Incidence in Bipolar Depression Trials of Latuda 194 Table 68: Latuda SWOT Analysis, 2015 195 Table 69: Global Sales Forecasts ($m) for Latuda, 2014-2024 196 Table 70: Product Profile - Risperdal 199 Table 71: Efficacy Results for Risperdal in Trial of Manic and Mixed Bipolar Episodes 200 Table 72: Adverse Events at ?2% Incidence in Bipolar Mania Trials of Risperdal 204 Table 73: Adverse Events at ?2% Incidence in Bipolar Maintenance Trials of Risperdal Consta 206 Table 74: Risperdal SWOT Analysis, 2015 207 Table 75: Global Sales Forecasts ($m) for Risperdal, 2014-2024 208 Table 76: Global Sales Forecasts ($m) for Risperdal Consta, 2014-2024 209 Table 77: Product Profile - Saphris 212 Table 78: Efficacy Results for Saphris in Bipolar Mania Studies 214 Table 79: Adverse Events at ?2% Incidence in Bipolar I Disorder Trials of Saphris 217 Table 80: Saphris SWOT Analysis, 2015 218 Table 81: Global Sales Forecasts ($m) for Saphris, 2014-2024 219 Table 82: Product Profile - Seroquel 222 Table 83: Efficacy Results for Seroquel in Bipolar Mania Studies 224 Table 84: Efficacy Results for Seroquel in Bipolar Depression Trials 225 Table 85: Efficacy Results for Seroquel XR in Bipolar Disorder Trials 226 Table 86: Adverse Events at ?2% Incidence in Bipolar Disorder Trials of Seroquel 228 Table 87: Adverse Events at ?2% Incidence in Bipolar Disorder Trials of Seroquel XR 230 Table 88: Seroquel SWOT Analysis, 2015 232 Table 89: Global Sales Forecasts ($m) for Seroquel, 2014-2024 233 Table 90: Global Sales Forecasts ($m) for Seroquel XR, 2014-2024 234 Table 91: Product Profile - Symbyax 236 Table 92: Efficacy Results for Symbyax in Bipolar Depression Trials 237 Table 93: Adverse Events at ?2% Incidence in Bipolar Depression and Treatment-Resistant Depression Trials of Symbyax 239 Table 94: Symbyax SWOT Analysis, 2015 241 Table 95: Global Sales Forecasts ($m) for Symbyax, 2014-2024 242 Table 96: Product Profile - Vraylar 244 Table 97: Vraylar SWOT Analysis, 2015 247 Table 98: Global Sales Forecast ($) for Vraylar, 2014-2024 248 Table 99: Product Profile - Zyprexa 251 Table 100: Adverse Events at ?2% Incidence in Bipolar Mania Trials of Zyprexa 255 Table 101: Adverse Events at ?2% Incidence in Trials of Zyprexa IntraMuscular in Agitation Associated with Schizophrenia or Bipolar I Mania 257 Table 102: Zyprexa SWOT Analysis, 2015 258 Table 103: Global Sales Forecasts ($m) for Zyprexa, 2014-2024 259 Table 104: Product Information for the Most Commonly Prescribed "Other Antipsychotics" 260 Table 105: International Society for Bipolar Disorders Clinical Recommendations for Antidepressant Use in Bipolar Disorder 263 Table 106: Antidepressants SWOT Analysis, 2015 267 Table 107: Global Sales Forecasts ($m) for the Antidepressants, 2014-2024 268 Table 108: Summary of Minor Therapeutic Classes, 2015 269 Table 109: Unmet Need and Opportunity in Bipolar Disorder 271 Table 110: Product Profile - Abilify Maintena 296 Table 111: Adverse Events at ?2% Incidence in a Schizophrenia Trial of Abilify Maintena 299 Table 112: Abilify Maintena SWOT Analysis, 2015 302 Table 113: Global Sales Forecast ($) for Abilify Maintena, 2014-2024 303 Table 114: Product Profile - ITI-007 305 Table 115: Efficacy Results for ITI-007 in a Phase II Schizophrenia Trial 306 Table 116: Key Safety Data From a Phase II in a Schizophrenia Trial of ITI-007 307 Table 117: ITI-007 SWOT Analysis, 2015 310 Table 118: Potential Off-label Bipolar Disorder Late-Stage Pipeline Drugs 311 Table 119: Drugs in Development, 2015 313 Table 120: Key Companies in the Bipolar Disorder Market in the 8MM, 2015 315 Table 121: Otsuka's Bipolar Disorder Portfolio Assessment, 2015 321 Table 122: AstraZeneca's Bipolar Disorder Portfolio Assessment, 2015 323 Table 123: Eli Lilly's Bipolar Disorder Portfolio Assessment, 2015 326 Table 124: Allergan's Bipolar Disorder Portfolio Assessment, 2015 328 Table 125: Dainippon Sumitomo's Bipolar Disorder Portfolio Assessment, 2015 331 Table 126: Janssen Bipolar Disorder Portfolio Assessment, 2015 334 Table 127: Lundbeck Bipolar Disorder Portfolio Assessment, 2015 337 Table 128: Meiji Seika Bipolar Disorder Portfolio Assessment, 2015 339 Table 129: Global Sales Forecast ($m) for Bipolar Disorder, 2014-2024 344 Table 130: Bipolar Disorder Market - Drivers and Barriers, 2014-2024 348 Table 131: Sales Forecast ($m) for Bipolar Disorder in the US, 2014-2024 351 Table 132: Key Events Impacting Sales for Bipolar Disorder in the US, 2014-2024 354 Table 133: Bipolar Disorder Market in the US - Drivers and Barriers, 2014-2024 355 Table 134: Sales Forecasts ($m) for Bipolar Disorder in the 5EU, 2014-2024 359 Table 135: Key Events Impacting Sales for Bipolar Disorder in the 5EU, 2014-2024 362 Table 136: Bipolar Disorder Market in the 5EU - Drivers and Barriers, 2014-2024 363 Table 137: Sales Forecasts ($m) for Bipolar Disorder in Japan, 2014-2024 367 Table 138: Key Events Impacting Sales for Bipolar Disorder in Japan, 2014-2024 369 Table 139: Bipolar Disorder Market in Japan - Drivers and Barriers, 2014-2024 370 Table 140: Sales Forecasts ($m) for Bipolar Disorder in Canada, 2014-2024 374 Table 141: Key Events Impacting Sales for Bipolar Disorder in Canada, 2014-2024 376 Table 142: Bipolar Disorder Market in Canada - Drivers and Barriers, 2014-2024 377 Table 143: Key Launch Dates 419 Table 144: Key Patent Expiries 420 Table 145: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 436


List of Figures
Figure 1: The Etiology and Pathophysiology of Bipolar Disorders 34 Figure 2: 8MM, 12-Month Total Prevalent Cases of Bipolar I, Both Sexes, Ages ?13 Years, 2014-2024 63 Figure 3: 8MM, Bipolar II 12-Month Total Prevalent Cases, Both Sexes, Ages ?13 Years, 2014-2024 65 Figure 4: 8MM, 12-Month Total Prevalent Cases of Cyclothymic Disorder, Both Sexes, Ages ?13 Years, 2014-2024 66 Figure 5: 8MM, Age-Specific 12-Month Total Prevalent Cases of Bipolar I, Both Sexes, 2014 70 Figure 6: 8MM, Age-Specific 12-Month Total Prevalent Cases of Bipolar II, Both Sexes, 2014 72 Figure 7: 8MM, Age-Specific 12-Month Total Prevalent Cases of Cyclothymic Disorder, Both Sexes, 2014 74 Figure 8: 8MM, Sex-Specific 12-Month Total Prevalent Cases of Bipolar I, Ages ?13 Years, 2014 76 Figure 9: 8MM, Sex-Specific 12-Month Total Prevalent Cases of Bipolar II, Ages ?13 Years, 2014 78 Figure 10: 8MM, Sex-Specific 12-Month Total Prevalent Cases of Cyclothymic Disorder, Ages ?13 Years, 2014 80 Figure 11: 8MM, Age-Standardized 12-Month Total Prevalence of Bipolar Spectrum Disorder, Men, Ages ?13 Years, 2014 81 Figure 12: 8MM, Age-Standardized 12-Month Total Prevalence of Bipolar Spectrum Disorder, Women, Ages ?13 Years, 2014 82 Figure 13: The Effects of Lithium on Neurotransmission 129 Figure 14: The Effects of Lithium on Second Messenger Pathways 130 Figure 15: Bipolar Disorder Therapeutics - Class of Therapy, 2016 291 Figure 16: Bipolar Disorder - Phase II-III Pipeline, 2015 293 Figure 17: Clinical and Commercial Positioning of Abilify Maintena 301 Figure 18: Clinical and Commercial Positioning of ITI-007 309 Figure 19: Global Sales of Products for Bipolar Disorder by Company, 2014-2024 316 Figure 20: Company Portfolio Gap Analysis in Bipolar Disorder, 2014-2024 317 Figure 21: Otsuka SWOT Analysis in Bipolar Disorder, 2014-2024 321 Figure 22: AstraZeneca SWOT Analysis in Bipolar Disorder, 2014-2024 324 Figure 23: Eli Lilly SWOT Analysis in Bipolar Disorder, 2014-2024 326 Figure 24: Allergan SWOT Analysis in Bipolar Disorder, 2014-2024 329 Figure 25: Dainippon Sumitomo SWOT Analysis in Bipolar Disorder, 2014-2024 332 Figure 26: Janssen SWOT Analysis in Bipolar Disorder, 2014-2024 335 Figure 27: Lundbeck SWOT Analysis in Bipolar Disorder, 2014-2024 338 Figure 28: Meiji Seika SWOT Analysis in Bipolar Disorder, 2014-2024 340 Figure 29: Global Sales for Bipolar Disorder by Region, 2014-2024 346 Figure 30: Global Sales for Bipolar Disorder by Drug Class, 2014-2024 347 Figure 31: Sales for Bipolar Disorder in the US by Drug Class, 2014-2024 353 Figure 32: Sales for Bipolar Disorder in the 5EU by Drug Class, 2014-2024 361 Figure 33: Sales for Bipolar Disorder in Japan by Drug Class, 2014-2024 368 Figure 34: Sales for Bipolar Disorder in Canada by Drug Class, 2014-2024 375

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