866-997-4948(US-Canada Toll Free)

PharmaPoint: Epilepsy - Global Drug Forecast and Market Analysis to 2026

Published By :

GlobalData

Published Date : Oct 2017

Category :

Pharmaceutical

No. of Pages : 299 Pages

PharmaPoint: Epilepsy - Global Drug Forecast and Market Analysis to 2026

Summary

Epilepsy is a brain disorder characterized by spontaneously occurring and recurrent seizures. Seizures result from abnormal electrical discharges in the brain and vary in their manifestations, from the brief staring spells that are characteristic of absence seizures, to full-body convulsions known as tonic-clonic seizure. Epilepsy can be considered a spectrum disorder due to its different causes, different seizure types, and different disease severities.

There are several anti-epileptic drugs (AEDs) on the market, with an older generation fully genericized across the 7MM (US, France, Germany, Italy, Spain, UK and, Japan) and a second generation, which are patent protected. There are five drugs in the late stage pipeline, which address some of the unmet needs in the market and, as such are expected to drive growth while patent expiries for major brand are expected to act as a barrier to growth for the epilepsy market over the forecast period.

GlobalData estimates that drug sales for epilepsy in 2016 were approximately $6.1 billion across the seven major markets covered in this report. Over the 10-year forecast period, the market is expected to grow to $7.5 billion at a CAGR of 2.1%. This growth will be driven by the launch of five late-stage pipeline products. The two highest selling drugs are expected to be GW Pharmaceuticals Epidiolex (cannabidiol) and Zogenixs flenfluramine, which both target rare, orphan epilepsy syndrome, are forecast to be the top selling pipeline drugs in the forecast period.

Scope

- Overview of epilepsy, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized epilepsy therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (focal, generalized, and unclassified seizures) forecast from 2016 to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the epilepsy therapeutics market
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for epilepsy therapy. The most promising candidates in Phase III development are profiled.
- Analysis of the current and future market competition in the global epilepsy 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.
- Develop business strategies by understanding the trends shaping and driving the global epilepsy therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global epilepsy therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 9
2 Executive Summary 10
2.1 Epilepsy Market Anticipated To Grow to $7.5B by 2026 11
2.2 Companies Targeting Niche Epilepsy Types 12
2.3 Refractory Patients Are Still Underserved in the Epilepsy Market 14
2.4 Market Opportunities for New Entrants 15
2.5 Late-Stage Pipeline Drugs Will Be a Key Driver of Growth 16
2.6 What Do Physicians Think? 17
3 Introduction 21
3.1 Catalyst 21
3.2 Related Reports 21
3.3 Upcoming Related Reports 22
4 Disease Overview 23
4.1 Classification of Seizures 25
4.2 Etiology and Pathophysiology 28
4.2.1 Etiology 28
4.2.2 Pathophysiology 30
4.2.3 Prognosis 34
4.2.4 Quality of Life 35
5 Epidemiology 37
5.1 Disease Background 37
5.2 Risk Factors and Comorbidities 38
5.3 Global and Historical Trends 39
5.3.1 US 41
5.3.2 5EU 42
5.3.3 Japan 43
5.4 Forecast Methodology 43
5.4.1 Sources 44
5.4.2 Forecast Assumptions and Methods 47
5.5 Epidemiological Forecast for Epilepsy (2016-2026) 60
5.5.1 Lifetime Diagnosed Prevalent Cases of Epilepsy 60
5.5.2 Active Diagnosed Prevalent Cases of Epilepsy 61
5.5.3 Age-Specific Active Diagnosed Prevalent Cases of Epilepsy 62
5.5.4 Sex-Specific Active Diagnosed Prevalent Cases of Epilepsy 63
5.5.5 Active Diagnosed Prevalent Cases by Seizure Type 64
5.5.6 Drug Resistant Active Diagnosed Prevalent Cases 65
5.6 Discussion 66
5.6.1 Epidemiological Forecast Insight 66
5.6.2 Limitations of the Analysis 68
5.6.3 Strengths of the Analysis 69
6 Disease Management 70
6.1 Diagnosis Overview 70
6.2 Treatment Overview 74
6.2.1 Treatment Guidelines and Leading Prescribed Drugs 74
6.2.2 Clinical Practice 75
6.3 US. 84
6.4 5EU. 88
6.5 Japan. 91
7 Competitive Assessment 95
7.1 Overview 95
7.2 Product Profiles - Major Brands 96
7.2.1 Aptiom/Zebinix (Eslicarbazepine Acetate) 96
7.2.2 Banzel/Inovelon (Rufinamide) 102
7.2.3 Briviact (Brivaracetam) 106
7.2.4 Carnexiv (Carbamazepine IV) 110
7.2.5 Fycompa (Perampanel) 113
7.2.6 Keppra (Levetiracetam) 119
7.2.7 Lamictal (Lamotrigine) 125
7.2.8 Lyrica (Pregabalin) 133
7.2.9 Onfi (Clobazam) 138
7.2.10 Oxtellar XR (Oxcarbazepine ER) 141
7.2.11 Qudexy XR (Topiramate ER) 145
7.2.12 Sabril (Vigabatrin) 148
7.2.13 Spritam (Levetiracetam) 153
7.2.14 Trokendi XR (Topiramate ER) 155
7.2.15 Vimpat (Lacosamide) 159
7.3 Older-Generation AEDs 163
8 Unmet Needs and Opportunity Assessment 165
8.1 Overview 165
8.2 Improved Treatment Options for Treatment-Resistant Patients 166
8.2.1 Unmet Need 166
8.2.2 Gap Analysis 167
8.2.3 Opportunity 168
8.3 Curative or Disease-Modifying Therapies 169
8.3.1 Unmet Need 169
8.3.2 Gap Analysis 170
8.3.3 Opportunity 170
8.4 Treatments for Acute Repetitive Seizures 171
8.4.1 Unmet Need 171
8.4.2 Gap Analysis 171
8.4.3 Opportunity 172
8.5 Drugs with Improved Safety Profile 173
8.5.1 Unmet Need 173
8.5.2 Gap Analysis 174
8.5.3 Opportunity 175
8.6 Better Drug Formulations or Duration of Action 175
8.6.1 Unmet Need 175
8.6.2 Gap Analysis 176
8.6.3 Opportunity 177
9 Pipeline Assessment 179
9.1 Overview 179
9.2 Clinical Trial Mapping 180
9.2.1 Clinical Trials by Development Stage 180
9.3 Promising Drugs in Clinical Development 181
9.3.1 Cenobamate (YKP3089) 184
9.3.2 Epidiolex (Cannabidiol) 188
9.3.3 Fenfluramine (ZX-008) 196
9.3.4 Diazepam (NRL-1) 203
9.3.5 Midazolam (USL261) 207
9.4 Other Drugs in Development 213
10 Current and Future Players 214
10.1 Overview 214
10.2 Trends in Corporate Strategy 217
10.3 UCB. 219
10.3.1 Overview 219
10.3.2 Portfolio Assessment 221
10.4 Eisai. 221
10.4.1 Overview 221
10.4.2 Portfolio Assessment 222
10.5 Pfizer .223
10.5.1 Overview 223
10.5.2 Portfolio Assessment 223
10.6 Lundbeck 224
10.6.1 Overview 224
10.6.2 Portfolio Assessment 225
10.7 GW Pharmaceuticals 225
10.7.1 Overview 225
10.7.2 Portfolio Assessment 226
10.8 SK Biopharmaceuticals 226
10.8.1 Overview 226
10.8.2 Portfolio Assessment 227
10.9 Zogenix 227
10.9.1 Overview 227
10.9.2 Portfolio Assessment 228
10.10 Other Companies 228
10.10.1 Overview 228
10.10.2 Portfolio Assessment 229
11 Market Outlook 230
11.1 Global Markets 230
11.1.1 Forecast 230
11.1.2 Drivers and Barriers - Global Issues 232
11.2 US 232
11.2.1 Forecast 232
11.2.2 Key Events 235
11.2.3 Drivers and Barriers 236
11.3 5EU. 236
11.3.1 Forecast 236
11.3.2 Key Events 238
11.3.3 Drivers and Barriers 239
11.4 Japan.. 239
11.4.1 Forecast 239
11.4.2 Key Events 242
11.4.3 Drivers and Barriers 243
12 Appendix 244
12.1 Bibliography 244
12.2 Abbreviations 268
12.3 Methodology 272
12.4 Forecasting Methodology 272
12.4.1 Diagnosed Epilepsy Patients 273
12.4.2 Percent Drug-Treated Patients 273
12.4.3 Launch Dates and Patent and Market Exclusivity Expiry Dates 273
12.4.4 General Pricing Assumptions 274
12.4.5 Individual Drug Assumptions 275
12.4.6 Generic Erosion 293
12.4.7 Pricing of Pipeline Agents 293
12.5 Physicians and Specialists Included in this Study 293
12.6 Primary Research - Prescriber Survey 295
12.7 About the Authors 296
12.7.1 Co-Authors 296
12.7.2 Therapy Area Director 296
12.7.3 Epidemiologist 297
12.7.4 Managing Epidemiologist 297
12.7.5 Global Director of Therapy Analysis and Epidemiology 297
12.7.6 Global Head and EVP of Healthcare Operations and Strategy 298
12.8 About GlobalData 299
12.9 Contact Us 299
12.10 Disclaimer 299

1.1 List of Tables
Table 1: Epilepsy: Key Metrics in the 7MM 10
Table 2: Epilepsy Syndromes by Age at Onset (2010 Revised ILAE Classification) 24
Table 3: Description of the Symptoms and Characteristics Included in the Classification of Seizure Types by the ILAE 27
Table 4: Etiology of Epilepsy According to Age 28
Table 5: Etiology of Seizures 29
Table 6: Some of the Genes Involved in Epilepsy 30
Table 7: Risk Factors and Comorbidities for Epilepsy 39
Table 8: 7MM, Lifetime Diagnosed Prevalent Cases of Epilepsy, Men and Women, All Ages, Select Years 2016-2026. 61
Table 9: 7MM, Active Diagnosed Prevalent Cases of Epilepsy, Men and Women, All Ages, Select Years 2016-2026 62
Table 10: Summary of Diagnostic Tools for Epilepsy 71
Table 11: Treatment Guidelines for Epilepsy 75
Table 12: AED Options by Seizure Type 80
Table 13: Types of Epilepsy Surgery 83
Table 14: Country Profile - US 87
Table 15 Country Profile - 5EU 90
Table 16 Country Profile - Japan 93
Table 17: Leading Treatments for Epilepsy, 2017 96
Table 18: Product Profile - Aptiom/Zebinix 99
Table 19: Summary of Aptiom/Zebinix Efficacy 100
Table 20: Aptiom/Zepinix SWOT Analysis, 2017 101
Table 21: Product Profile - Banzel 104
Table 22: Summary of Banzel Efficacy 105
Table 23: Banzel SWOT Analysis, 2017 106
Table 24: Product Profile - Briviact 108
Table 25: Summary of Briviact Efficacy 109
Table 26: Briviact SWOT Analysis, 2017 110
Table 27: Product Profile - Carnexiv 112
Table 28: Carnexiv SWOT Analysis, 2017 113
Table 29: Product Profile - Fycompa 116
Table 30: Summary of Fycompa Efficacy 117
Table 31: Fycompa SWOT Analysis, 2017 118
Table 32: Product Profile - Keppra 121
Table 33: Summary of Keppra Efficacy 122
Table 34: Summary of Keppra XR Efficacy 123
Table 35: Keppra SWOT Analysis, 2017 124
Table 36: Product Profile - Lamictal 127
Table 37: Summary of Lamictal Efficacy 128
Table 38: Summary of Lamictal XR Efficacy 130
Table 39: Lamictal SWOT Analysis, 2017 132
Table 40: Product Profile - Lyrica 135
Table 41: Summary of Lyrica Efficacy 136
Table 42: Lyrica SWOT Analysis, 2017 137
Table 43: Product Profile - Onfi 139
Table 44: Summary of Onfi Efficacy 140
Table 45: Onfi SWOT Analysis, 2017 141
Table 46: Product Profile - Oxtellar XR 143
Table 47: Summary of Oxtellar XR Efficacy 143
Table 48: Oxtellar XR SWOT Analysis, 2017 144
Table 49: Product Profile - Qudexy XR 146
Table 50: Summary of Qudexy XR Efficacy 147
Table 51: Qudexy XR SWOT Analysis, 2017 148
Table 52: Product Profile - Sabril 150
Table 53: Summary of Sabril Efficacy 151
Table 54: Sabril SWOT Analysis, 2017 152
Table 55: Product Profile - Spritam 154
Table 56: Spritam SWOT Analysis, 2017 155
Table 57: Product Profile - Trokendi XR 157
Table 58: Trokendi XR SWOT Analysis, 2017 158
Table 59: Product Profile - Vimpat 161
Table 60: Summary of Vimpat Efficacy 162
Table 61: Vimpat SWOT Analysis, 2017 163
Table 62: Summary of Older Generation AEDs, 2017 164
Table 63: Promising Drugs in Clinical Development for Epilepsy, 2017 182
Table 64: Comparison of Drugs in Development for Epilepsy, 2017 183
Table 65: Product Profile - cenobamate 185
Table 66: Cenobamate Phase II Results 186
Table 67: cenobamate SWOT Analysis, 2017 187
Table 68: Product Profile - Epidiolex 192
Table 69: Epidiolex Phase III Results 193
Table 70: Epidiolex SWOT analysis, 2017 195
Table 71: Product Profile - Fenfluramine 199
Table 72: Fenfluramine SWOT analysis, 2017. 202
Table 73: Product Profile - NRL-1 205
Table 74 NRL-1 SWOT Analysis, 2017. 206
Table 75: Product Profile - USL261 209
Table 76 USL261 SWOT Analysis, 2017. 211
Table 77: Drugs in Development, 2017 213
Table 78: Key Companies in the Epilepsy Market in the 7MM, 2017. 215
Table 79: UCBs Disease Portfolio Assessment, 2017 221
Table 80: Eisais Disease Portfolio Assessment, 2017 222
Table 81: Pfizers Disease Portfolio Assessment, 2017 223
Table 82: Lundbecks Disease Portfolio Assessment, 2017 225
Table 83: GW Pharmaceuticals Disease Portfolio Assessment, 2017 226
Table 84: SK Biopharmaceuticals Disease Portfolio Assessment, 2017 227
Table 85: Zogenixs Disease Portfolio Assessment, 2017 228
Table 86: other Players Disease Portfolio Assessment, 2016 229
Table 87: Epilepsy Market - Global Drivers and Barriers, 2016-2026 232
Table 88: Key Events Impacting Sales for Epilepsy in the US, 2016-2026 235
Table 89: Epilepsy Market - US Drivers and Barriers, 2016-2026 236
Table 90: Key Events Impacting Sales for Epilepsy in the 5EU, 2016-2026 238
Table 91: Epilepsy Market - 5EU Drivers and Barriers, 2016-2026 239
Table 92: Key Events Impacting Sales for Epilepsy in Japan, 2016-2026 242
Table 93: Epilepsy Market - Global Drivers and Barriers, Japan, 2016-2026 243
Table 94: Key Launch Dates 273
Table 95: Key Patent/Exclusivity Expiries 274
Table 96: Physicians Surveyed, by Country 295

1.2 List of Figures
Figure 1: Global Sales Forecast by Country for Epilepsy in 2016 and 2026 12
Figure 2: Company Portfolio Gap Analysis in Epilepsy During the Forecast Period 14
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of Epilepsy During the Forecast Period 16
Figure 4: Operational Classification of Seizure Types by the ILAE, 2017 25
Figure 5: Summary of the Pathophysiology of Seizures by Net Increased Neuronal Excitation 32
Figure 6: Mechanisms of Action of AEDs at the Synapse 34
Figure 7: 7MM Age-Standardized Lifetime Diagnosed Prevalence, Men, Women, All Ages, 2016 (%) 40
Figure 8: 7MM Age-standardized Active Diagnosed Prevalence, Men, Women, All Ages, 2016 (%) 41
Figure 9: The Sources Used to Calculate the Lifetime Diagnosed Prevalence of Epilepsy 44
Figure 10: The Sources Used and Not Used in the Forecast for the Active Diagnosed Prevalence 45
Figure 11: The Sources Used and Not Used in the Forecast for the Seizure Type Distribution of Active Diagnosed Prevalent Cases 46
Figure 12: The Sources Used in the Forecast for the Drug Resistant Active Diagnosed Prevalent Cases 47
Figure 13: 7MM, Age-Specific Active Diagnosed Prevalent Cases of Epilepsy, Men and Women, All Ages, 2016 63
Figure 14: 7MM Sex-Specific Active Diagnosed Prevalent Cases of Epilepsy, All Ages, 2016. 64
Figure 15: 7MM, Active Diagnosed Prevalent Cases of Epilepsy by Seizure Type, Men and Women, All Ages, 2016 65
Figure 16: 7MM, Active Diagnosed Prevalent Cases by Response to AED Treatment, Men and Women, All Ages, 2016. 66
Figure 17: A summary of the factors that physicians must consider when diagnosing a patient with a specific epilepsy syndrome 70
Figure 18: AED Selection Based on Comorbidity 77
Figure 19: Major Unmet Needs, Epilepsy Market 166
Figure 20: Epilepsy Therapeutics, 2017 180
Figure 21: Epilepsy Therapeutics - Ongoing Clinical Trials in the 7MM, 2017 181
Figure 22: Epilepsy - Promising Late-Stage Phase IIb-III Pipeline Drugs, 2017 182
Figure 23: Competitive Assessment of Promising Late-Stage Pipeline Agents in Epilepsy, 2016-2026 183
Figure 24: Clinical and Commercial Positioning of Cenobamate 187
Figure 25: Clinical and Commercial Positioning of Epidiolex 195
Figure 26: Clinical and Commercial Positioning of Fenfluramine 202
Figure 27: Clinical and Commercial Positioning of NRL-1 206
Figure 28: Clinical and Commercial Positioning of USL261 211
Figure 29: Global Sales of Branded Products for Epilepsy, by Company, in 2016 and 2026 216
Figure 30: Analysis of the Company Portfolio Gap in Epilepsy During the Forecast Period 217
Figure 31: Global (7MM) Sales Forecast for Epilepsy, by Country, 2016 and 2026 231
Figure 32: Sales Forecast Split by Current/Pipeline Therapies for Epilepsy in the US, 2026 233
Figure 33: Adult and Pediatric Sales for Epilepsy, US, 2016 and 2026 234
Figure 34: 5EU Sales Forecast, by Country, 2016 and 2026 237
Figure 35: Sales Forecast Split by Current/Pipeline Therapies for Epilepsy, Japan, 2026 240
Figure 36: Adult and Pediatric Sales for Epilepsy, Japan, 2016 and 2026 241

Make an enquiry before buying this Report

Please fill the enquiry form below.

  • Full Name *
  • Your Email *
  • Job Title
  • Company
  • Phone No. * (Pls. Affix Country Code)
  • Message
  • Security Code *