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 9
1.1 List of Tables17
1.2 List of Figures 22

2 Introduction 24
2.1 Catalyst 24
2.2 Upcoming Related Reports 25

3 Disease Overview 26
3.1 Classification of Seizures 28
3.2 Etiology and Pathophysiology 29
3.2.1 Etiology 29
3.2.2 Pathophysiology 32
3.2.3 Prognosis 38
3.2.4 Quality of Life 39

4 Epidemiology 40
4.1 Risk Factors and Comorbidities 40
4.1.1 Risk factors in newborns often include brain malformations and lack of oxygen 40
4.1.2 Genetic factors and head trauma are risk factors in adults and children 41
4.1.3 Common seizure triggers include lack of sleep, stress, and photosensitivity 41
4.1.4 Epilepsy comorbidities in adults and children include pain disorders 41
4.1.5 Anxiety and depression are major epilepsy comorbidities 42
4.1.6 Epilepsy with a known cause can be prevented by the avoidance of head injuries 42
4.2 Global Trends 43
4.2.1 United States 44
4.2.2 5EU Markets (France, Germany, Italy, Spain, and UK) 45
4.2.3 Asia 46
4.3 Forecast Methodology 48
4.3.1 Sources Used 49
4.3.2 Forecast Assumptions and Methods 55
4.3.3 Sources Not Used 58
4.4 Epidemiologic Forecast 59
4.4.1 Total Active Prevalent Cases of Epilepsy 59
4.4.2 Total Lifetime Prevalent Cases of Epilepsy 61
4.4.3 Age-Specific Total Active Prevalent Cases of Epilepsy 63
4.4.4 Gender-Specific Total Active Prevalent Cases of Epilepsy 64
4.4.5 Seizure-Specific Total Active Prevalent Cases of Epilepsy 65
4.5 Discussion 66
4.5.1 Conclusion on Epidemiological Trends 66
4.5.2 Limitations of the Analysis 67
4.5.3 Strengths of the Analysis 67

5 Disease Management 68
5.1 Diagnosis 68
5.2 Treatment Guidelines 69
5.3 Clinical Practice 70
5.4 US 77
5.4.1 Diagnosis 77
5.4.2 Clinical Practice 78
5.5 UK 81
5.5.1 Diagnosis 81
5.5.2 Clinical Practice 82
5.6 France 83
5.6.1 Diagnosis 83
5.6.2 Clinical Practice 84
5.7 Germany 86
5.7.1 Diagnosis 86
5.7.2 Clinical Practice 87
5.8 Spain 89
5.8.1 Diagnosis 89
5.8.2 Clinical Practice 90
5.9 Italy 91
5.9.1 Diagnosis 91
5.9.2 Clinical Practice 92
5.10 Japan 94
5.10.1 Diagnosis 94
5.10.2 Clinical Practice 95
5.11 India 96
5.11.1 Diagnosis 96
5.11.2 Clinical Practice 97
5.12 China 99
5.12.1 Diagnosis 99
5.12.2 Clinical Practice 100

6 Competitive Assessment 102
6.1 Overview 102
6.2 Strategic Competitor Assessment 104
6.3 Product Profiles - Major Brands 107
6.3.1 Keppra (levetiracetam) 107
6.3.2 Lamictal (lamotrigine) 113
6.3.3 Lyrica (pregabalin) 119
6.3.4 Vimpat (lacosamide) 123
6.3.5 Zonegran (zonisamide) 128
6.3.6 Banzel/Inovelon (rufinamide) 133
6.3.7 Trobalt/Potiga (retigabine/ezogabine) 137
6.3.8 Zebinix/Aptiom (eslicarbazepine acetate) 142
6.3.9 Fycompa (perampanel) 146
6.3.10 Older-Generation AEDs 149

7 Opportunity and Unmet Need 151
7.1 Overview 151
7.2 Unmet Needs 152
7.2.1 Refractory Epilepsy 152
7.2.2 Safety/Side Effect Profiles 152
7.2.3 Curative/Disease-Modifying Agents 153
7.2.4 Predictive Tools and Need for More Directed Treatments 154
7.2.5 Improved Preclinical Models and Clinical Trial Paradigms 155
7.2.6 Treatment Gap 156
7.3 Unmet Needs Gap Analysis 157
7.4 Opportunities 157
7.4.1 Disease-Modifying Agents 157
7.4.2 Improved Preclinical Models and Clinical Trial Paradigms 157
7.4.3 Treatment Gap 158

8 Pipeline Assessment 159
8.1 Overview 159
8.2 Clinical Trial Mapping 159
8.2.1 Clinical Trials by Country 159
8.3 Clinical Trials by Phase and Trial Status 161
8.4 Strategic Pipeline Assessment 162
8.5 Pipeline by Phases of Development 163
8.5.1 Phase III Pipeline 163
8.5.2 Phase III Pipeline - Reformulations/New Delivery Systems 163
8.5.3 Phase IIb Pipeline 164
8.5.4 Phase II Pipeline 164
8.5.5 Phase I Pipeline 165
8.5.6 Preclinical Pipeline 166
8.5.7 Discovery Pipeline 167
8.6 Pipeline by Mechanism of Action 167
8.7 Promising Drugs in Clinical Development 170
8.7.1 Brivaracetam 171
8.7.2 Ganaxolone 175
8.7.3 VX-765 180

9 Current and Future Players 184
9.1 Overview 184
9.2 Trends in Corporate Strategy 187
9.3 Company Profiles 189
9.3.1 UCB 189
9.3.2 Eisai 191
9.3.3 Pfizer 193
9.3.4 GlaxoSmithKline 195
9.3.5 Novartis 197
9.3.6 Abbott 199
9.3.7 Dainippon Sumitomo Pharma 201

10 Market Outlook 203
10.1 Global Markets 203
10.1.1 Forecast 203
10.1.2 Drivers and Barriers - Global Issues 207
10.2 United States 209
10.2.1 Forecast 209
10.2.2 Key Events 213
10.2.3 Drivers and Barriers 213
10.3 France 215
10.3.1 Forecast 215
10.3.2 Key Events 219
10.3.3 Drivers and Barriers 219
10.4 Germany 221
10.4.1 Forecast 221
10.4.2 Key Events 225
10.4.3 Drivers and Barriers 225
10.5 Italy 227
10.5.1 Forecast 227
10.5.2 Key Events 231
10.5.3 Drivers and Barriers 231
10.6 Spain 233
10.6.1 Forecast 233
10.6.2 Key Events 237
10.6.3 Drivers and Barriers 237
10.7 United Kingdom 239
10.7.1 Forecast 239
10.7.2 Key Events 243
10.7.3 Drivers and Barriers 243
10.8 Japan 246
10.8.1 Forecast 246
10.8.2 Key Events 249
10.8.3 Drivers and Barriers 249
10.9 India 252
10.9.1 Forecast 252
10.9.2 Key Events 255
10.9.3 Drivers and Barriers 255
10.10 China 258
10.10.1 Forecast 258
10.10.2 Key Events 261
10.10.3 Drivers and Barriers 261

11 Appendix 263
11.1 Bibliography 263
11.2 Abbreviations 278
11.3 Methodology 282
11.4 Forecasting Methodology 282
11.4.1 Prevalent Epilepsy Patients 282
11.4.2 Percent Drug-Treated Patients 283
11.4.3 Drugs Included in Each Therapeutic Class Based on MOA 283
11.4.4 Launch Dates and Patent and Market Exclusivity Expiry Dates 284
11.4.5 General Pricing Assumptions 286
11.4.6 Individual Drug Assumptions 287
11.4.7 Generic Erosion 300
11.4.8 Pricing of Pipeline Agents 300
11.5 Physicians and Specialists Included in this Study 301
11.6 Primary Research - Prescriber Survey 302
11.7 About the Authors 303
11.7.1 Authors 303
11.7.2 Epidemiologist 304
11.7.3 Global Head of Healthcare 304
11.8 About GlobalData 305
11.9 Disclaimer 305

List of Tables

Table 1: Epilepsy Syndromes by Age at Onset (2009 ILAE Classification) 27
Table 2: Classification of Seizures 28
Table 3: Etiology of Epilepsy According to Age 29
Table 4: Etiology of Partial Seizures 30
Table 5: Etiology of Generalized Seizures 31
Table 6: Some of the Genes Involved in Epilepsy 37
Table 7: Nine Markets, Sources for Prevalent Cases of Epilepsy Data 50
Table 8: Nine Markets, Total Active Prevalent Cases of Epilepsy, All Ages, Male and Female, Selected Years, 2012-2022 60
Table 9: Nine Markets, Total Lifetime Prevalent Cases of Epilepsy, All Ages, Male and Female, Selected Years, 2012-2022 62
Table 10: Summary of Diagnostic Tools for Epilepsy 68
Table 11: Treatment Guidelines for Epilepsy 69
Table 12: AED Options by Seizure Type 74
Table 13: Top Three AEDs Prescribed for Epilepsy by Market 75
Table 14: Types of Epilepsy Surgery 76
Table 15: US, Epilepsy Patient Referrals to Neurologist 77
Table 16: US, Most-Prescribed First-Line and Second-Line AEDs 78
Table 17: UK, Epilepsy Patient Referrals to Neurologist 81
Table 18: UK, Most-Prescribed First-Line and Second-Line AEDs 82
Table 19: France, Epilepsy Patient Referrals to Neurologist 84
Table 20: France, Most-Prescribed First-Line and Second-Line AEDs 85
Table 21: Germany, Epilepsy Patient Referrals to Neurologist 87
Table 22: Germany, Most-Prescribed First-Line and Second-Line AEDs 88
Table 23: Spain, Epilepsy Patient Referrals to Neurologist 89
Table 24: Spain, Most-Prescribed First-Line and Second-Line AEDs 90
Table 25: Italy, Epilepsy Patient Referrals to Neurologist 92
Table 26: Italy, Most-Prescribed 1st-line and 2nd-line AEDs 93
Table 27: Japan, Epilepsy Patient Referrals to Neurologist 94
Table 28: Japan, Most-Prescribed 1st-line and 2nd-line AEDs 95
Table 29: India, Epilepsy Patient Referrals to Neurologist 97
Table 30: India, Most-Prescribed 1st-line and 2nd-line AEDs 98
Table 31: China, Epilepsy Patient Referrals to Neurologist 99
Table 32: China, Most-Prescribed First-Line and Second-Line AEDs 100
Table 33: Leading Treatments for Epilepsy, 2012 106
Table 34: Product Profile - Keppra 108
Table 35: Keppra SWOT Analysis, 2012 110
Table 36: Global Sales Forecasts ($m) for Keppra (levetiracetam), 2012-2022 112
Table 37: Product Profile - Lamictal 113
Table 38: Lamictal SWOT Analysis, 2012 117
Table 39: Global Sales Forecasts ($m) for Lamictal (lamotrigine), 2012-2022 118
Table 40: Product Profile - Lyrica 119
Table 41: Lyrica SWOT Analysis, 2012 121
Table 42: Global Sales Forecasts ($m) for Lyrica (pregabalin), 2012-2022 122
Table 43: Product Profile - Vimpat 124
Table 44: Vimpat SWOT Analysis, 2012 126
Table 45: Global Sales Forecasts ($m) for Vimpat (lacosamide), 2012-2022 127
Table 46: Product Profile - Zonegran 128
Table 47: Zonegran SWOT Analysis, 2012 131
Table 48: Global Sales Forecasts ($m) for Zonegran (zonisamide), 2012-2022 132
Table 49: Product Profile - Banzel/Inovelon 133
Table 50: Banzel/Inovelon SWOT Analysis, 2012 135
Table 51: Global Sales Forecasts ($m) for Banzel/Inovelon (rufinamide), 2012-2022 136
Table 52: Product Profile - Trobalt/Potiga 138
Table 53: Trobalt/Potiga SWOT Analysis, 2012 140
Table 54: Global Sales Forecasts ($m) for Trobalt/Potiga (retigabine/ezogabine), 2012-2022 141
Table 55: Product Profile - Zebinix/Aptiom 142
Table 56: Zebinix/Aptiom SWOT Analysis, 2012 144
Table 57: Global Sales Forecasts ($m) for Zebinix/Aptiom (eslicarbazepine acetate), 2012-2022 145
Table 58: Product Profile - Fycompa 146
Table 59: Fycompa SWOT Analysis, 2012 148
Table 60: Global Sales Forecasts ($m) for Fycompa (perampanel), 2012-2022 149
Table 61: Summary of Minor Drug Classes, 2012 150
Table 62: Overall Unmet Needs - Current Level of Attainment 151
Table 63: Clinical Unmet Needs - Gap Analysis, 2012 157
Table 64: Epilepsy - Clinical Trials by Phase and Status, 2012 161
Table 65: Epilepsy - Phase III Pipeline, 2012 163
Table 66: Epilepsy - Phase III Pipeline (Reformulations), 2012 163
Table 67: Epilepsy - Phase IIb Pipeline, 2012 164
Table 68: Epilepsy - Phase II Pipeline, 2012 164
Table 69: Epilepsy - Phase I Pipeline, 2012 165
Table 70: Epilepsy - Preclinical Pipeline, 2012 166
Table 71: Epilepsy - Discovery Pipeline, 2012 167
Table 72: Comparison of MOA of Drugs in Development for Epilepsy, 2012 169
Table 73: Epilepsy - Promising Drugs in Clinical Development 170
Table 74: Product Profile - Brivaracetam 171
Table 75: Brivaracetam SWOT Analysis, 2012 173
Table 76: Global Sales Forecasts ($m) for Brivaracetam, 2012-2022 174
Table 77: Product Profile - Ganaxolone 175
Table 78: Ganaxolone SWOT Analysis, 2012 178
Table 79: Global Sales Forecasts ($m) for Ganaxolone, 2012-2022 179
Table 80: Product Profile - VX-765 180
Table 81: VX-765 SWOT Analysis, 2012 182
Table 82: Global Sales Forecasts ($m) for VX-765, 2012-2022 183
Table 83: Key Companies in the Epilepsy Market, 2012 185
Table 84: UCB's Epilepsy Portfolio Assessment, 2012 190
Table 85: UCB SWOT Analysis, 2012 190
Table 86: Eisai's Epilepsy Portfolio Assessment, 2012 192
Table 87: Eisai SWOT Analysis, 2012 192
Table 88: Pfizer's Epilepsy Portfolio Assessment, 2012 194
Table 89: Pfizer SWOT Analysis, 2012 194
Table 90: GlaxoSmithKline's Epilepsy Portfolio Assessment, 2012 196
Table 91: GlaxoSmithKline SWOT Analysis, 2012 196
Table 92: Novartis' Epilepsy Portfolio Assessment, 2012 198
Table 93: Novartis SWOT Analysis, 2012 198
Table 94: Abbott's Epilepsy Portfolio Assessment, 2012 200
Table 95: Abbott SWOT Analysis, 2012 200
Table 96: Dainippon Sumitomo's Epilepsy Portfolio Assessment, 2012 202
Table 97: Dainippon Sumitomo SWOT Analysis, 2012 202
Table 98: Global Sales Forecasts ($m) for Epilepsy, 2012-2022 205
Table 99: Global Epilepsy Market - Drivers and Barriers, 2012-2022 207
Table 100: Sales Forecasts ($m) for Epilepsy in the United States, 2012-2022 211
Table 101: Key Events Impacting Sales for Epilepsy in the United States, 2012-2022 213
Table 102: Epilepsy Market in the US - Drivers and Barriers, 2012-2022 213
Table 103: Sales Forecasts ($m) for Epilepsy in France, 2012-2022 217
Table 104: Key Events Impacting Sales for Epilepsy in France, 2012-2022 219
Table 105: Epilepsy Market in France - Drivers and Barriers, 2012-2022 219
Table 106: Sales Forecasts ($m) for Epilepsy in Germany, 2012-2022 223
Table 107: Key Events Impacting Sales for Epilepsy in Germany, 2012-2022 225
Table 108: Epilepsy Market in Germany - Drivers and Barriers, 2012-2022 225
Table 109: Sales Forecasts ($m) for Epilepsy in Italy, 2012-2022 229
Table 110: Key Events Impacting Sales for Epilepsy in Italy, 2012-2022 231
Table 111: Epilepsy Market in Italy - Drivers and Barriers, 2012-2022 231
Table 112: Sales Forecasts ($m) for Epilepsy in Spain, 2012-2022 235
Table 113: Key Events Impacting Sales for Epilepsy in Spain, 2012-2022 237
Table 114: Epilepsy Market in Spain - Drivers and Barriers, 2012-2022 237
Table 115: Sales Forecasts ($m) for Epilepsy in the United Kingdom, 2012-2022 241
Table 116: Key Events Impacting Sales for Epilepsy in the United Kingdom, 2012-2022 243
Table 117: Epilepsy Market in the UK - Drivers and Barriers, 2012-2022 243
Table 118: Sales Forecasts ($m) for Epilepsy in Japan, 2012-2022 247
Table 119: Key Events Impacting Sales for Epilepsy in Japan, 2012-2022 249
Table 120: Epilepsy Market in Japan - Drivers and Barriers, 2012-2022 249
Table 121: Sales Forecasts ($m) for Epilepsy in India, 2012-2022 253
Table 122: Key Events Impacting Sales for Epilepsy in India, 2012 255
Table 123: Epilepsy Market in India - Drivers and Barriers, 2012-2022 255
Table 124: Sales Forecasts ($m) for Epilepsy in China, 2012-2022 259
Table 125: Key Events Impacting Sales for Epilepsy in China, 2012 261
Table 126: Epilepsy Market in China - Drivers and Barriers, 2012-2022 261
Table 127: Key Launch Dates 284
Table 128: Key Patent Expiries and Market Exclusivity Expiries* 285
Table 129: Physicians Surveyed, by Country 302

List of Figures

Figure 1: Summary of the Pathophysiology of Seizures by Net Increased Neuronal Excitation 34
Figure 2: Mechanisms of Action of AEDs at the Synapse 36
Figure 3: Nine Markets, Total Active Prevalent Cases of Epilepsy, All Ages, Male and Female, Selected Years, 2012-2022 60
Figure 4: Nine Markets, Total Lifetime Prevalent Cases of Epilepsy, All Ages, Male and Female, Selected Years, 2012-2022 62
Figure 5: Nine Markets, Age-Specific Total Active Prevalent Cases of Epilepsy, All Ages, Male and Female, 2012 63
Figure 6: Nine Markets, Gender-Specific Total Active Prevalent Cases of Epilepsy, All Ages, 2012 64
Figure 7: Nine Markets, Seizure-Specific Proportions of Epilepsy, All Ages, Male and Female, 2012 65
Figure 8: AED Selection Based on Comorbidity 72
Figure 9: Epilepsy Therapeutics - Clinical Trials by Country, 2012 160
Figure 10: Epilepsy - Pipeline by MOA, 2012 168
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in Epilepsy, 2012-2022 170
Figure 12: Company Portfolio Gap Analysis in Epilepsy, 2012-2022 186
Figure 13: Global Sales for Epilepsy by Region, 2012-2022 206
Figure 14: Sales for Epilepsy in the United States by Drug Class, 2012-2022 212
Figure 15: Sales for Epilepsy in France by Drug Class, 2012-2022 218
Figure 16: Sales for Epilepsy in Germany by Drug Class, 2012-2022 224
Figure 17: Sales for Epilepsy in Italy by Drug Class, 2012-2022 230
Figure 18: Sales for Epilepsy in Spain by Drug Class, 2012-2022 236
Figure 19: Sales for Epilepsy in the United Kingdom by Drug Class, 2012-2022 242
Figure 20: Sales for Epilepsy in Japan by Drug Class, 2012-2022 248
Figure 21: Sales for Epilepsy in India by Drug Class, 2012-2022 254
Figure 22: Sales for Epilepsy in China by Drug Class, 2012-2022 260