PharmaPoint: Epilepsy - US Drug Forecast and Market Analysis to 2022

GlobalData has released its new Country report, “PharmaPoint: Epilepsy - US Drug Forecast and Market Analysis to 2022”. 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.

The main drivers for growth in this market include the launch of new AEDs with novel MOAs; healthcare reform, which will increase treatment rates; and a growing elderly population with twice the risk of developing epilepsy.

Scope

• Overview of Epilepsy including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
• Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.
• Sales forecast for the top drugs in the US from 2012-2022.
• Analysis of the impact of key events as well the drivers and restraints affecting the US Epilesy market.

Reasons to buy

• Understand and capitalize by identifying products that are most likely to ensure a robust return
• Stay ahead of the competition by understanding the changing competitive landscape for Epilepsy
• Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
• Make more informed business decisions from insightful and in-depth analysis of drug performance
• Obtain sales forecast for drugs from 2012-2022 in the US

Table of Contents

1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 9

2 Introduction
2.1 Catalyst 10
2.2 Related Reports 11

3 Disease Overview
3.1 Classification of Seizures 15
3.2 Etiology and Pathophysiology 16
3.2.1 Etiology 16
3.2.2 Pathophysiology 19
3.2.3 Prognosis 24
3.2.4 Quality of Life 25

4 Disease Management
4.1 Diagnosis 26
4.2 Treatment Guidelines 27
4.3 Clinical Practice 28
4.4 US 34
4.4.1 Diagnosis 34
4.4.2 Clinical Practice 36

5 Competitive Assessment
5.1 Overview 39
5.2 Strategic Competitor Assessment 41
5.3 Product Profiles – Major Brands 43
5.3.1 Keppra (levetiracetam) 43
5.3.2 Lamictal (lamotrigine) 47
5.3.3 Lyrica (pregabalin) 51
5.3.4 Vimpat (lacosamide) 54
5.3.5 Zonegran (zonisamide) 57
5.3.6 Banzel/Inovelon (rufinamide) 60
5.3.7 Trobalt/Potiga (retigabine/ezogabine) 63
5.3.8 Zebinix (eslicarbazepine acetate) 66
5.3.9 Fycompa (perampanel) 69
5.3.10 Older-Generation AEDs 72

6 Opportunity and Unmet Need
6.1 Overview 73
6.2 Unmet Needs 74
6.2.1 Refractory Epilepsy 74
6.2.2 Safety/Side Effect Profiles 74
6.2.3 Curative/Disease-Modifying Agents 75
6.2.4 Predictive Tools and Need for More Directed Treatments 76
6.2.5 Improved Preclinical Models and Clinical Trial Paradigms 76
6.2.6 Treatment Gap 77
6.3 Unmet Needs Gap Analysis 78
6.4 Opportunities 79
6.4.1 Disease-Modifying Agents 79
6.4.2 Improved Preclinical Models and Clinical Trial Paradigms 79
6.4.3 Treatment Gap 79

7 Pipeline Assessment
7.1 Overview 80
7.2 Strategic Pipeline Assessment 80
7.3 Pipeline by Phases of Development 81
7.3.1 Phase III Pipeline 81
7.3.2 Phase III Pipeline – Reformulations/New Delivery Systems 82
7.3.3 Phase IIb Pipeline 82
7.3.4 Phase II Pipeline 83
7.3.5 Phase I Pipeline 83
7.3.6 Preclinical Pipeline 84
7.3.7 Discovery Pipeline 85
7.4 Pipeline by Mechanism of Action 85
7.5 Promising Drugs in Clinical Development 87
7.5.1 Brivaracetam 88
7.5.2 Ganaxolone 91
7.5.3 VX-765 94

8 Market Outlook
8.1 United States 97
8.1.1 Forecast 97
8.1.2 Key Events 100
8.1.3 Drivers and Barriers 100

9 Appendix
9.1 Bibliography 103
9.2 Abbreviations 109
9.3 Methodology 111
9.4 Forecasting Methodology 111
9.4.1 Prevalent Epilepsy Patients 111
9.4.2 Percent Drug-Treated Patients 112
9.4.3 Drugs Included in Each Therapeutic Class Based on MOA 112
9.4.4 Launch Dates and Patent and Market Exclusivity Expiry Dates 113
9.4.5 General Pricing Assumptions 115
9.4.6 Individual Drug Assumptions 116
9.4.7 Generic Erosion 131
9.4.8 Pricing of Pipeline Agents 131
9.5 Physicians and Specialists Included in this Study 132
9.6 Primary Research - Prescriber Survey 133
9.7 About the Authors 134
9.7.1 Authors 134
9.7.2 Global Head of Healthcare 135
9.8 About GlobalData 136
9.9 Contact Us 136
9.10 Disclaimer 136

List of Tables

Table 1: Epilepsy Syndromes by Age at Onset (2009 ILAE Classification) 14
Table 2: Classification of Seizures 15
Table 3: Etiology of Epilepsy According to Age 16
Table 4: Etiology of Partial Seizures 17
Table 5: Etiology of Generalized Seizures 18
Table 6: Some of the Genes Involved in Epilepsy 23
Table 7: Summary of Diagnostic Tools for Epilepsy 26
Table 8: Treatment Guidelines for Epilepsy 27
Table 9: AED Options by Seizure Type 31
Table 10: Top Three AEDs Prescribed for Epilepsy by Market 32
Table 11: Types of Epilepsy Surgery 33
Table 12: Types of Epilepsy Surgery 35
Table 13: US, Most-Prescribed First-Line and Second-Line AEDs 36
Table 14: Leading Treatments for Epilepsy, 2012 43
Table 15: Product Profile – Keppra 44
Table 16: Keppra SWOT Analysis, 2012 46
Table 17: Product Profile – Lamictal 47
Table 18: Lamictal SWOT Analysis, 2012 50
Table 19: Product Profile – Lyrica 51
Table 20: Lyrica SWOT Analysis, 2012 53
Table 21: Product Profile – Vimpat 54
Table 22: Vimpat SWOT Analysis, 2012 56
Table 23: Product Profile – Zonegran 57
Table 24: Zonegran SWOT Analysis, 2012 59
Table 25: Product Profile – Banzel/Inovelon 60
Table 26: Banzel/Inovelon SWOT Analysis, 2012 62
Table 27: Product Profile – Trobalt/Potiga 63
Table 28: Trobalt/Potiga SWOT Analysis, 2012 65
Table 29: Product Profile – Zebinix 66
Table 30: Zebinix SWOT Analysis, 2012 68
Table 31: Product Profile – Fycompa 69
Table 32: Fycompa SWOT Analysis, 2012 71
Table 33: Summary of Minor Drug Classes, 2012 72
Table 34: Overall Unmet Needs – Current Level of Attainment 73
Table 35: Clinical Unmet Needs – Gap Analysis, 2012 78
Table 36: Epilepsy – Phase III Pipeline, 2012 81
Table 37: Epilepsy – Phase III Pipeline (Reformulations), 2012 82
Table 38: Epilepsy – Phase IIb Pipeline, 2012 82
Table 39: Epilepsy – Phase II Pipeline, 2012 83
Table 40: Epilepsy – Phase I Pipeline, 2012 83
Table 41: Epilepsy – Preclinical Pipeline, 2012 84
Table 42: Epilepsy - Discovery Pipeline, 2012 85
Table 43: Comparison of MOA of Drugs in Development for Epilepsy, 2012 86
Table 44: Epilepsy – Promising Drugs in Clinical Development 87
Table 45: Product Profile – Brivaracetam 88
Table 46: Brivaracetam SWOT Analysis, 2012 90
Table 47: Product Profile – Ganaxolone 91
Table 48: Ganaxolone SWOT Analysis, 2012 93
Table 49: Product Profile – VX-765 94
Table 50: VX-765 SWOT Analysis, 2012 96
Table 51: Sales Forecasts ($m) for Epilepsy in the United States, 2012–2022 98
Table 52: Key Events Impacting Sales for Epilepsy in the United States, 2012–2022 100
Table 53: Epilepsy Market in the US – Drivers and Barriers, 2012–2022 100
Table 54: Key Launch Dates 113
Table 55: Key Patent Expiries and Market Exclusivity Expiries* 114
Table 56: Physicians Surveyed, By Country 133

List of Figures

Figure 1: Summary of the Pathophysiology of Seizures by Net Increased Neuronal Excitation 20
Figure 2: Mechanisms of Action of AEDs at the Synapse 22
Figure 3: AED Selection Based on Comorbidity 30
Figure 4: Epilepsy – Pipeline by MOA, 2012 86
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Epilepsy, 2012–2022 87
Figure 6: Sales for Epilepsy in the United States by Drug Class, 2012–2022 99