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

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

Summary

GlobalData has released its new Country report, “PharmaPoint: Epilepsy - Japan 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 driver for growth in this market will be the launch of new AEDs (Vimpat and Banzel), the continued uptake of recent AEDs (Lamictal, Keppra, and Topina [topiramate]), and the lower-than-average rate of generic substitution in Japan compared with other countries. Government regulations on drug approval and pricing, however, limit or delay drug entry and profitability Japan.

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 Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Japan from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting Japan 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 Japan

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 9
2 Introduction 10
2.1 Catalyst 10
2.2 Related Reports 11
3 Disease Overview 13
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 26
4.1 Diagnosis 26
4.2 Treatment Guidelines 27
4.3 Clinical Practice 28
4.4 Japan 34
4.4.1 Diagnosis 34
4.4.2 Clinical Practice 35
5 Competitive Assessment 36
5.1 Overview 36
5.2 Strategic Competitor Assessment 38
5.3 Product Profiles – Major Brands 41
5.3.1 Keppra (levetiracetam) 41
5.3.2 Lamictal (lamotrigine) 45
5.3.3 Lyrica (pregabalin) 49
5.3.4 Vimpat (lacosamide) 52
5.3.5 Zonegran (zonisamide) 55
5.3.6 Banzel/Inovelon (rufinamide) 58
5.3.7 Trobalt/Potiga (retigabine/ezogabine) 61
5.3.8 Zebinix (eslicarbazepine acetate) 64
5.3.9 Fycompa (perampanel) 67
5.3.10 Older-Generation AEDs 70
6 Opportunity and Unmet Need 71
6.1 Overview 71
6.2 Unmet Needs 72
6.2.1 Refractory Epilepsy 72
6.2.2 Safety/Side Effect Profiles 73
6.2.3 Curative/Disease-Modifying Agents 74
6.2.4 Predictive Tools and Need for More Directed Treatments 75
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 80
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 86
7.5 Promising Drugs in Clinical Development 88
7.5.1 Brivaracetam 89
7.5.2 Ganaxolone 92
7.5.3 VX-765 95
8 Market Outlook 98
8.1 Japan 98
8.1.1 Forecast 98
8.1.2 Key Events 101
8.1.3 Drivers and Barriers 102
9 Appendix 104
9.1 Bibliography 104
9.2 Abbreviations 109
9.3 Methodology 112
9.4 Forecasting Methodology 112
9.4.1 Prevalent Epilepsy Patients 112
9.4.2 Percent Drug-Treated Patients 113
9.4.3 Drugs Included in Each Therapeutic Class Based on MOA 113
9.4.4 Launch Dates and Patent and Market Exclusivity Expiry Dates 114
9.4.5 General Pricing Assumptions 116
9.4.6 Individual Drug Assumptions 117
9.4.7 Generic Erosion 131
9.4.8 Pricing of Pipeline Agents 132
9.5 Physicians and Specialists Included in this Study 132
9.6 Primary Research - Prescriber Survey 133
9.7 About the Authors 133
9.7.1 Authors 133
9.7.2 Global Head of Healthcare 134
9.8 About GlobalData 135
9.9 Contact Us 135
9.10 Disclaimer 135

1.1 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: Japan, Epilepsy Patient Referrals to Neurologist 34
Table 13: Japan, Epilepsy Patient Referrals to Neurologist 35
Table 14: Leading Treatments for Epilepsy, 2012 40
Table 15: Product Profile – Keppra 42
Table 16: Keppra SWOT Analysis, 2012 44
Table 17: Product Profile – Lamictal 45
Table 18: Lamictal SWOT Analysis, 2012 48
Table 19: Product Profile – Lyrica 49
Table 20: Lyrica SWOT Analysis, 2012 51
Table 21: Product Profile – Vimpat 52
Table 22: Vimpat SWOT Analysis, 2012 54
Table 23: Product Profile – Zonegran 55
Table 24: Zonegran SWOT Analysis, 2012 57
Table 25: Product Profile – Banzel/Inovelon 58
Table 26: Banzel/Inovelon SWOT Analysis, 2012 60
Table 27: Product Profile – Trobalt/Potiga 61
Table 28: Trobalt/Potiga SWOT Analysis, 2012 63
Table 29: Product Profile – Zebinix 64
Table 30: Zebinix SWOT Analysis, 2012 66
Table 31: Product Profile – Fycompa 67
Table 32: Fycompa SWOT Analysis, 2012 69
Table 33: Summary of Minor Drug Classes, 2012 70
Table 34: Overall Unmet Needs – Current Level of Attainment 71
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 87
Table 44: Epilepsy – Promising Drugs in Clinical Development 88
Table 45: Product Profile – Brivaracetam 89
Table 46: Brivaracetam SWOT Analysis, 2012 91
Table 47: Product Profile – Ganaxolone 92
Table 48: Ganaxolone SWOT Analysis, 2012 94
Table 49: Product Profile – VX-765 95
Table 50: VX-765 SWOT Analysis, 2012 97
Table 51: Sales Forecasts ($m) for Epilepsy in Japan, 2012–2022 99
Table 52: Key Events Impacting Sales for Epilepsy in Japan, 2012–2022 101
Table 53: Epilepsy Market in Japan – Drivers and Barriers, 2012–2022 102
Table 54: Key Launch Dates 114
Table 55: Key Patent Expiries and Market Exclusivity Expiries* 115
Table 56: Physicians Surveyed, By Country 133

1.2 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 88
Figure 6: Sales for Epilepsy in Japan by Drug Class, 2012–2022 100