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

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

Summary

GlobalData has released its new Country report, “PharmaPoint: Epilepsy - China 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.

Due to China’s vast general population, which drives the growth of the prevalent population of epilepsy patients, the AED market is fairly large, despite the relatively low cost of treatment. The main driver for growth in this market will be the continued uptake of recent AEDs, a growing middle class with better healthcare access, and increased epilepsy treatment in the whole population due to government efforts to increase healthcare access. However, loose government regulation of patent protection, as well as a reliance on traditional Eastern medicine, severely impact brand drug penetration and profitability in China.

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

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 China 34
4.4.1 Diagnosis 34
4.4.2 Clinical Practice 35
5 Competitive Assessment 37
5.1 Overview 37
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 Zonegran (zonisamide) 52
5.3.5 Older-Generation AEDs 55
6 Opportunity and Unmet Need 56
6.1 Overview 56
6.2 Unmet Needs 57
6.2.1 Refractory Epilepsy 57
6.2.2 Safety/Side Effect Profiles 57
6.2.3 Curative/Disease-Modifying Agents 58
6.2.4 Predictive Tools and Need for More Directed Treatments 59
6.2.5 Improved Preclinical Models and Clinical Trial Paradigms 59
6.2.6 Treatment Gap 60
6.3 Unmet Needs Gap Analysis 61
6.4 Opportunities 62
6.4.1 Disease-Modifying Agents 62
6.4.2 Improved Preclinical Models and Clinical Trial Paradigms 62
6.4.3 Treatment Gap 62
7 Pipeline Assessment 63
7.1 Overview 63
7.2 Strategic Pipeline Assessment 63
7.3 Pipeline by Phases of Development 64
7.3.1 Phase III Pipeline 64
7.3.2 Phase III Pipeline – Reformulations/New Delivery Systems 65
7.3.3 Phase IIb Pipeline 65
7.3.4 Phase II Pipeline 66
7.3.5 Phase I Pipeline 66
7.3.6 Preclinical Pipeline 67
7.3.7 Discovery Pipeline 68
7.4 Pipeline by Mechanism of Action 68
7.5 Promising Drugs in Clinical Development 70
7.5.1 Brivaracetam 71
7.5.2 Ganaxolone 73
7.5.3 VX-765 76
8 Market Outlook 79
8.1 China 79
8.1.1 Forecast 79
8.1.2 Key Events 82
8.1.3 Drivers and Barriers 82
9 Appendix 84
9.1 Bibliography 84
9.2 Abbreviations 90
9.3 Methodology 92
9.4 Forecasting Methodology 92
9.4.1 Prevalent Epilepsy Patients 92
9.4.2 Percent Drug-Treated Patients 93
9.4.3 Drugs Included in Each Therapeutic Class Based on MOA 93
9.4.4 General Pricing Assumptions 94
9.4.5 Individual Drug Assumptions 95
9.4.6 Generic Erosion 110
9.4.7 Pricing of Pipeline Agents 110
9.5 Physicians and Specialists Included in this Study 110
9.6 Primary Research - Prescriber Survey 111
9.7 About the Authors 112
9.7.1 Authors 112
9.7.2 Global Head of Healthcare 113
9.8 About GlobalData 114
9.9 Contact Us 114
9.10 Disclaimer 114

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: India, Most-Prescribed 1st-line and 2nd-line AEDs 34
Table 13: China, Most-Prescribed First-Line and Second-Line AEDs 35
Table 14: Leading Treatments for Epilepsy, 2012 41
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 – Zonegran 52
Table 22: Zonegran SWOT Analysis, 2012 54
Table 23: Summary of Minor Drug Classes, 2012 55
Table 24: Overall Unmet Needs – Current Level of Attainment 56
Table 25: Clinical Unmet Needs – Gap Analysis, 2012 61
Table 26: Epilepsy – Phase III Pipeline, 2012 64
Table 27: Epilepsy – Phase III Pipeline (Reformulations), 2012 65
Table 28: Epilepsy – Phase IIb Pipeline, 2012 65
Table 29: Epilepsy – Phase II Pipeline, 2012 66
Table 30: Epilepsy – Phase I Pipeline, 2012 66
Table 31: Epilepsy – Preclinical Pipeline, 2012 67
Table 32: Epilepsy - Discovery Pipeline, 2012 68
Table 33: Comparison of MOA of Drugs in Development for Epilepsy, 2012 69
Table 34: Epilepsy – Promising Drugs in Clinical Development 70
Table 35: Product Profile – Brivaracetam 71
Table 36: Brivaracetam SWOT Analysis, 2012 73
Table 37: Product Profile – Ganaxolone 74
Table 38: Ganaxolone SWOT Analysis, 2012 76
Table 39: Product Profile – VX-765 77
Table 40: VX-765 SWOT Analysis, 2012 78
Table 41: Sales Forecasts ($m) for Epilepsy in China, 2012–2022 80
Table 42: Key Events Impacting Sales for Epilepsy in China, 2012 82
Table 43: Epilepsy Market in China – Drivers and Barriers, 2012–2022 82
Table 44: Physicians Surveyed, By Country 111

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 69
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Epilepsy, 2012–2022 70
Figure 6: Sales for Epilepsy in China by Drug Class, 2012–2022 81