PharmaPoint: Epilepsy - Global Drug Forecast and Market Analysis

Summary

Epilepsy is a brain disorder characterized by spontaneously occurring and recurrent seizures. The market is heavily driven by the sales of antiepileptic drugs (AEDs) targeted at seizure reduction. The AED market is currently dominated by UCB’s Keppra and GlaxoSmithKline’s Lamictal. Although both drugs have experienced significant generic erosion, they form the mainstay of epilepsy treatment in the nine markets and will continue to have significant market share during the forecast period. Other key drugs include older generation AEDs such as Pfizer’s Dilantin, Abbott’s Depakote, and Novartis’ Tegretol and Trileptal which still have significant usage due to their longevity in the market. However, the AED dominance landscape will continue to shift towards newer generation drugs particularly following the recent market entry of GlaxoSmithKline’s Trobalt/Potiga and Eisai’s Fycompa which both offer first-in-class mechanisms of action.

Highlights

Key Questions Answered

- Even with more than 20 AEDs on the market, there are still ~20% refractory patients. Additional unmet needs still exists in terms of safety and efficacy. Will the drugs under development fulfil the unmet needs of the epilepsy market?
- Several brands of AEDs are due for patent expiry. How will the patent expiries impact the epilepsy therapeutics market?
- The developmental pipeline consists of several novel drugs. Which of these drugs will attain high sales revenues during 2012-2022?
- What governmental changes are likely to change the epilepsy treatment landscape in the markets researched? Which is the biggest growth market globally?

Key Findings

- New market entrants particularly Fycompa, Trobalt/Potiga and brivaracetam will increase competitiveness and cannibalize sales of existing AEDs.
- Drivers for market growth will include the introduction of the newer epilepsy drugs into the Asian market, particularly in Japan.
- Government cost-cutting measures will negatively impact epilepsy drug market in the EU

Scope

- Overview of epilepsy, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.

- Annualized epilepsy therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012 and forecast for ten years to 2022.

- 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 split across different phases, emerging trends and mechanisms of action under development, including ion channel modulators, GABA modulators, glutamate receptor antagonists, inflammation inhibitors, synaptic and gap junction blockers, sigma receptor agonists and acetylcholine modulators.

- 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

- 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 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 epilepsy therapeutics market from 2012-2022.
- 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
1 Table of Contents 8
1.1 List of Tables 15
1.2 List of Figures 20
2 Introduction 21
2.1 Catalyst 21
2.2 Upcoming Related Reports 22
3 Disease Overview 23
3.1 Classification of Seizures 25
3.2 Etiology and Pathophysiology 26
3.2.1 Etiology 26
3.2.2 Pathophysiology 29
3.2.3 Prognosis 34
3.2.4 Quality of Life 35
4 Epidemiology 36
4.1 Risk Factors and Comorbidities 36
4.1.1 Risk factors in newborns often include brain malformations and lack of oxygen 36
4.1.2 Genetic factors and head trauma are risk factors in adults and children 36
4.1.3 Common seizure triggers include lack of sleep, stress, and photosensitivity 37
4.1.4 Epilepsy comorbidities in adults and children include pain disorders 37
4.1.5 Anxiety and depression are major epilepsy comorbidities 37
4.1.6 Epilepsy with a known cause can be prevented by the avoidance of head injuries 38
4.2 Global Trends 38
4.2.1 United States 39
4.2.2 5EU Markets (France, Germany, Italy, Spain, and the UK) 40
4.2.3 Asia 41
4.3 Forecast Methodology 43
4.3.1 Sources Used 44
4.3.2 Forecast Assumptions and Methods 49
4.3.3 Sources Not Used 51
4.4 Epidemiologic Forecast 52
4.4.1 Total Active Prevalent Cases of Epilepsy 52
4.4.2 Total Lifetime Prevalent Cases of Epilepsy 54
4.4.3 Age-Specific Total Active Prevalent Cases of Epilepsy 56
4.4.4 Gender-Specific Total Active Prevalent Cases of Epilepsy 57
4.4.5 Seizure-Specific Total Active Prevalent Cases of Epilepsy 58
4.5 Discussion 59
4.5.1 Conclusion on Epidemiological Trends 59
4.5.2 Limitations of the Analysis 60
4.5.3 Strengths of the Analysis 60
5 Disease Management 61
5.1 Diagnosis 61
5.2 Treatment Guidelines 62
5.3 Clinical Practice 63
5.4 US 69
5.4.1 Diagnosis 69
5.4.2 Clinical Practice 71
5.5 UK 74
5.5.1 Diagnosis 74
5.5.2 Clinical Practice 75
5.6 France 76
5.6.1 Diagnosis 76
5.6.2 Clinical Practice 77
5.7 Germany 78
5.7.1 Diagnosis 78
5.7.2 Clinical Practice 79
5.8 Spain 81
5.8.1 Diagnosis 81
5.8.2 Clinical Practice 82
5.9 Italy 83
5.9.1 Diagnosis 83
5.9.2 Clinical Practice 84
5.10 Japan 85
5.10.1 Diagnosis 85
5.10.2 Clinical Practice 86
5.11 India 87
5.11.1 Diagnosis 87
5.11.2 Clinical Practice 87
5.12 China 89
5.12.1 Diagnosis 89
5.12.2 Clinical Practice 91
6 Competitive Assessment 93
6.1 Overview 93
6.2 Strategic Competitor Assessment 94
6.3 Product Profiles - Major Brands 97
6.3.1 Keppra (levetiracetam) 97
6.3.2 Lamictal (lamotrigine) 102
6.3.3 Lyrica (pregabalin) 107
6.3.4 Vimpat (lacosamide) 111
6.3.5 Zonegran (zonisamide) 115
6.3.6 Banzel/Inovelon (rufinamide) 120
6.3.7 Trobalt/Potiga (retigabine/ezogabine) 124
6.3.8 Zebinix (eslicarbazepine acetate) 127
6.3.9 Fycompa (perampanel) 131
6.3.10 Older-Generation AEDs 134
7 Opportunity and Unmet Need 136
7.1 Overview 136
7.2 Unmet Needs 137
7.2.1 Refractory Epilepsy 137
7.2.2 Safety/Side Effect Profiles 137
7.2.3 Curative/Disease-Modifying Agents 138
7.2.4 Predictive Tools and Need for More Directed Treatments 139
7.2.5 Improved Preclinical Models and Clinical Trial Paradigms 139
7.2.6 Treatment Gap 140
7.3 Unmet Needs Gap Analysis 141
7.4 Opportunities 142
7.4.1 Disease-Modifying Agents 142
7.4.2 Improved Preclinical Models and Clinical Trial Paradigms 142
7.4.3 Treatment Gap 142
8 Pipeline Assessment 143
8.1 Overview 143
8.2 Clinical Trial Mapping 143
8.2.1 Clinical Trials by Country 143
8.3 Clinical Trials by Phase and Trial Status 145
8.4 Strategic Pipeline Assessment 146
8.5 Pipeline by Phases of Development 147
8.5.1 Phase III Pipeline 147
8.5.2 Phase III Pipeline - Reformulations/New Delivery Systems 148
8.5.3 Phase IIb Pipeline 148
8.5.4 Phase II Pipeline 149
8.5.5 Phase I Pipeline 149
8.5.6 Preclinical Pipeline 150
8.5.7 Discovery Pipeline 151
8.6 Pipeline by Mechanism of Action 151
8.7 Promising Drugs in Clinical Development 153
8.7.1 Brivaracetam 154
8.7.2 Ganaxolone 157
8.7.3 VX-765 161
9 Current and Future Players 165
9.1 Overview 165
9.2 Trends in Corporate Strategy 168
9.3 Company Profiles 169
9.3.1 UCB 169
9.3.2 Eisai 171
9.3.3 Pfizer 172
9.3.4 GlaxoSmithKline 174
9.3.5 Novartis 175
9.3.6 Abbott 177
9.3.7 Dainippon Sumitomo Pharma 179
10 Market Outlook 181
10.1 Global Markets 181
10.1.1 Forecast 181
10.1.2 Drivers and Barriers - Global Issues 184
10.2 United States 186
10.2.1 Forecast 186
10.2.2 Key Events 189
10.2.3 Drivers and Barriers 189
10.3 France 191
10.3.1 Forecast 191
10.3.2 Key Events 194
10.3.3 Drivers and Barriers 194
10.4 Germany 195
10.4.1 Forecast 195
10.4.2 Key Events 199
10.4.3 Drivers and Barriers 199
10.5 Italy 201
10.5.1 Forecast 201
10.5.2 Key Events 204
10.5.3 Drivers and Barriers 204
10.6 Spain 206
10.6.1 Forecast 206
10.6.2 Key Events 209
10.6.3 Drivers and Barriers 209
10.7 United Kingdom 210
10.7.1 Forecast 210
10.7.2 Key Events 214
10.7.3 Drivers and Barriers 214
10.8 Japan 216
10.8.1 Forecast 216
10.8.2 Key Events 219
10.8.3 Drivers and Barriers 219
10.9 India 221
10.9.1 Forecast 221
10.9.2 Key Events 224
10.9.3 Drivers and Barriers 224
10.10 China 226
10.10.1 Forecast 226
10.10.2 Key Events 229
10.10.3 Drivers and Barriers 229
11 Appendix 231
11.1 Bibliography 231
11.2 Abbreviations 244
11.3 Methodology 247
11.4 Forecasting Methodology 247
11.4.1 Prevalent Epilepsy Patients 247
11.4.2 Percent Drug-Treated Patients 248
11.4.3 Drugs Included in Each Therapeutic Class Based on MOA 248
11.4.4 Launch Dates and Patent and Market Exclusivity Expiry Dates 249
11.4.5 General Pricing Assumptions 251
11.4.6 Individual Drug Assumptions 252
11.4.7 Generic Erosion 266
11.4.8 Pricing of Pipeline Agents 266
11.5 Physicians and Specialists Included in this Study 267
11.6 Primary Research - Prescriber Survey 268
11.7 About the Authors 269
11.7.1 Authors 269
11.7.2 Epidemiologist 270
11.7.3 Global Head of Healthcare 270
11.8 About GlobalData 271
11.9 Contact Us 271
11.10 Disclaimer 271

List of Tables

Table 1: Epilepsy Syndromes by Age at Onset (2009 ILAE Classification) 24
Table 2: Classification of Seizures 25
Table 3: Etiology of Epilepsy According to Age 26
Table 4: Etiology of Partial Seizures 27
Table 5: Etiology of Generalized Seizures 28
Table 6: Some of the Genes Involved in Epilepsy 33
Table 7: Nine Markets, Sources for Prevalent Cases of Epilepsy Data 44
Table 8: Nine Markets, Total Active Prevalent Cases of Epilepsy, All Ages, Male and Female, Selected Years, 2012-2022 53
Table 9: Nine Markets, Total Lifetime Prevalent Cases of Epilepsy, All Ages, Male and Female, Selected Years, 2012-2022 55
Table 10: Summary of Diagnostic Tools for Epilepsy 61
Table 11: Treatment Guidelines for Epilepsy 62
Table 12: AED Options by Seizure Type 66
Table 13: Top Three AEDs Prescribed for Epilepsy by Market 67
Table 14: Types of Epilepsy Surgery 68
Table 15: Types of Epilepsy Surgery 70
Table 16: US, Most-Prescribed First-Line and Second-Line AEDs 71
Table 17: UK, Epilepsy Patient Referrals to Neurologist 74
Table 18: UK, Most-Prescribed First-Line and Second-Line AEDs 75
Table 19: France, Epilepsy Patient Referrals to Neurologist 76
Table 20: France, Most-Prescribed First-Line and Second-Line AEDs 77
Table 21: Germany, Epilepsy Patient Referrals to Neurologist 79
Table 22: Germany, Most-Prescribed First-Line and Second-Line AEDs 80
Table 23: Spain, Epilepsy Patient Referrals to Neurologist 81
Table 24: Spain, Most-Prescribed First-Line and Second-Line AEDs 82
Table 25: Italy, Epilepsy Patient Referrals to Neurologist 83
Table 26: Italy, Most-Prescribed 1st-line and 2nd-line AEDs 84
Table 27: Japan, Epilepsy Patient Referrals to Neurologist 85
Table 28: Japan, Epilepsy Patient Referrals to Neurologist 86
Table 29: Japan, Epilepsy Patient Referrals to Neurologist 87
Table 30: India, Most-Prescribed 1st-line and 2nd-line AEDs 88
Table 31: India, Most-Prescribed 1st-line and 2nd-line AEDs 90
Table 32: China, Most-Prescribed First-Line and Second-Line AEDs 91
Table 33: Leading Treatments for Epilepsy, 2012 97
Table 34: Product Profile - Keppra 98
Table 35: Keppra SWOT Analysis, 2012 100
Table 36: Global Sales Forecasts ($m) for Keppra (levetiracetam), 2012-2022 101
Table 37: Product Profile - Lamictal 102
Table 38: Lamictal SWOT Analysis, 2012 105
Table 39: Global Sales Forecasts ($m) for Lamictal (lamotrigine), 2012-2022 106
Table 40: Product Profile - Lyrica 107
Table 41: Lyrica SWOT Analysis, 2012 109
Table 42: Global Sales Forecasts ($m) for Lyrica (pregabalin), 2012-2022 110
Table 43: Product Profile - Vimpat 111
Table 44: Vimpat SWOT Analysis, 2012 113
Table 45: Global Sales Forecasts ($m) for Vimpat (lacosamide), 2012-2022 114
Table 46: Product Profile - Zonegran 115
Table 47: Zonegran SWOT Analysis, 2012 117
Table 48: Global Sales Forecasts ($m) for Zonegran (zonisamide), 2012-2022 119
Table 49: Product Profile - Banzel/Inovelon 120
Table 50: Banzel/Inovelon SWOT Analysis, 2012 122
Table 51: Global Sales Forecasts ($m) for Banzel/Inovelon (rufinamide), 2012-2022 123
Table 52: Product Profile - Trobalt/Potiga 124
Table 53: Trobalt/Potiga SWOT Analysis, 2012 126
Table 54: Global Sales Forecasts ($m) for Trobalt/Potiga (retigabine/ezogabine), 2012-2022 127
Table 55: Product Profile - Zebinix 128
Table 56: Zebinix SWOT Analysis, 2012 130
Table 57: Global Sales Forecasts ($m) for Zebinix (eslicarbazepine acetate), 2012-2022 131
Table 58: Product Profile - Fycompa 132
Table 59: Fycompa SWOT Analysis, 2012 133
Table 60: Global Sales Forecasts ($m) for Fycompa (perampanel), 2012-2022 134
Table 61: Summary of Minor Drug Classes, 2012 135
Table 62: Overall Unmet Needs - Current Level of Attainment 136
Table 63: Clinical Unmet Needs - Gap Analysis, 2012 141
Table 64: Epilepsy - Clinical Trials by Phase and Status, 2012 145
Table 65: Epilepsy - Phase III Pipeline, 2012 147
Table 66: Epilepsy - Phase III Pipeline (Reformulations), 2012 148
Table 67: Epilepsy - Phase IIb Pipeline, 2012 148
Table 68: Epilepsy - Phase II Pipeline, 2012 149
Table 69: Epilepsy - Phase I Pipeline, 2012 149
Table 70: Epilepsy - Preclinical Pipeline, 2012 150
Table 71: Epilepsy - Discovery Pipeline, 2012 151
Table 72: Comparison of MOA of Drugs in Development for Epilepsy, 2012 152
Table 73: Epilepsy - Promising Drugs in Clinical Development 153
Table 74: Product Profile - Brivaracetam 154
Table 75: Brivaracetam SWOT Analysis, 2012 156
Table 76: Global Sales Forecasts ($m) for Brivaracetam, 2012-2022 157
Table 77: Product Profile - Ganaxolone 158
Table 78: Ganaxolone SWOT Analysis, 2012 160
Table 79: Global Sales Forecasts ($m) for Ganaxolone, 2012-2022 161
Table 80: Product Profile - VX-765 162
Table 81: VX-765 SWOT Analysis, 2012 163
Table 82: Global Sales Forecasts ($m) for VX-765, 2012-2022 164
Table 83: Key Companies in the Epilepsy Market, 2012 166
Table 84: UCB’s Epilepsy Portfolio Assessment, 2012 170
Table 85: UCB SWOT Analysis, 2012 170
Table 86: Eisai’s Epilepsy Portfolio Assessment, 2012 171
Table 87: Eisai SWOT Analysis, 2012 172
Table 88: Pfizer’s Epilepsy Portfolio Assessment, 2012 173
Table 89: Pfizer SWOT Analysis, 2012 173
Table 90: GlaxoSmithKline’s Epilepsy Portfolio Assessment, 2012 174
Table 91: GlaxoSmithKline SWOT Analysis, 2012 175
Table 92: Novartis’ Epilepsy Portfolio Assessment, 2012 176
Table 93: Novartis SWOT Analysis, 2012 176
Table 94: Abbott’s Epilepsy Portfolio Assessment, 2012 178
Table 95: Abbott SWOT Analysis, 2012 178
Table 96: Dainippon Sumitomo’s Epilepsy Portfolio Assessment, 2012 179
Table 97: Dainippon Sumitomo SWOT Analysis, 2012 180
Table 98: Global Sales Forecasts ($m) for Epilepsy, 2012-2022 182
Table 99: Global Epilepsy Market - Drivers and Barriers, 2012-2022 184
Table 100: Sales Forecasts ($m) for Epilepsy in the United States, 2012-2022 187
Table 101: Key Events Impacting Sales for Epilepsy in the United States, 2012-2022 189
Table 102: Epilepsy Market in the US - Drivers and Barriers, 2012-2022 189
Table 103: Sales Forecasts ($m) for Epilepsy in France, 2012-2022 192
Table 104: Key Events Impacting Sales for Epilepsy in France, 2012-2022 194
Table 105: Epilepsy Market in France - Drivers and Barriers, 2012-2022 194
Table 106: Sales Forecasts ($m) for Epilepsy in Germany, 2012-2022 197
Table 107: Key Events Impacting Sales for Epilepsy in Germany, 2012-2022 199
Table 108: Epilepsy Market in Germany - Drivers and Barriers, 2012-2022 199
Table 109: Sales Forecasts ($m) for Epilepsy in Italy, 2012-2022 202
Table 110: Key Events Impacting Sales for Epilepsy in Italy, 2012-2022 204
Table 111: Epilepsy Market in Italy - Drivers and Barriers, 2012-2022 204
Table 112: Sales Forecasts ($m) for Epilepsy in Spain, 2012-2022 207
Table 113: Key Events Impacting Sales for Epilepsy in Spain, 2012-2022 209
Table 114: Epilepsy Market in Spain - Drivers and Barriers, 2012-2022 209
Table 115: Sales Forecasts ($m) for Epilepsy in the United Kingdom, 2012-2022 212
Table 116: Key Events Impacting Sales for Epilepsy in the United Kingdom, 2012-2022 214
Table 117: Epilepsy Market in the UK - Drivers and Barriers, 2012-2022 214
Table 118: Sales Forecasts ($m) for Epilepsy in Japan, 2012-2022 217
Table 119: Key Events Impacting Sales for Epilepsy in Japan, 2012-2022 219
Table 120: Epilepsy Market in Japan - Drivers and Barriers, 2012-2022 219
Table 121: Sales Forecasts ($m) for Epilepsy in India, 2012-2022 222
Table 122: Key Events Impacting Sales for Epilepsy in India, 2012 224
Table 123: Epilepsy Market in India - Drivers and Barriers, 2012-2022 224
Table 124: Sales Forecasts ($m) for Epilepsy in China, 2012-2022 227
Table 125: Key Events Impacting Sales for Epilepsy in China, 2012 229
Table 126: Epilepsy Market in China - Drivers and Barriers, 2012-2022 229
Table 127: Key Launch Dates 249
Table 128: Key Patent Expiries and Market Exclusivity Expiries* 250
Table 129: Physicians Surveyed, By Country 268

1.2 List of Figures
Figure 1: Summary of the Pathophysiology of Seizures by Net Increased Neuronal Excitation 30
Figure 2: Mechanisms of Action of AEDs at the Synapse 32
Figure 3: Nine Markets, Total Active Prevalent Cases of Epilepsy, All Ages, Male and Female, Selected Years, 2012-2022 53
Figure 4: Nine Markets, Total Lifetime Prevalent Cases of Epilepsy, All Ages, Male and Female, Selected Years, 2012-2022 55
Figure 5: Nine Markets, Age-Specific Total Active Prevalent Cases of Epilepsy, All Ages, Male and Female, 2012 56
Figure 6: Nine Markets, Gender-Specific Total Active Prevalent Cases of Epilepsy, All Ages, 2012 57
Figure 7: Nine Markets, Seizure-Specific Proportions of Epilepsy, All Ages, Male and Female, 2012 58
Figure 8: AED Selection Based on Comorbidity 65
Figure 9: Epilepsy Therapeutics -Clinical Trials by Country, 2012 144
Figure 10: Epilepsy - Pipeline by MOA, 2012 152
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in Epilepsy, 2012-2022 153
Figure 12: Company Portfolio Gap Analysis in Epilepsy, 2012-2022 167
Figure 13: Global Sales for Epilepsy by Region, 2012-2022 183
Figure 14: Sales for Epilepsy in the United States by Drug Class, 2012-2022 188
Figure 15: Sales for Epilepsy in France by Drug Class, 2012-2022 193
Figure 16: Sales for Epilepsy in Germany by Drug Class, 2012-2022 198
Figure 17: Sales for Epilepsy in Italy by Drug Class, 2012-2022 203
Figure 18: Sales for Epilepsy in Spain by Drug Class, 2012-2022 208
Figure 19: Sales for Epilepsy in the United Kingdom by Drug Class, 2012-2022 213
Figure 20: Sales for Epilepsy in Japan by Drug Class, 2012-2022 218
Figure 21: Sales for Epilepsy in India by Drug Class, 2012-2022 223
Figure 22: Sales for Epilepsy in China by Drug Class, 2012-2022 228

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