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

Published: February 2013
No. of Pages: 129
   

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

Summary

GlobalData has released its new Country report, “PharmaPoint: Epilepsy - Spain 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 are the launch of new AEDs, the continued uptake of recent AEDs, and the lower-than-average rate of generic substitution in Spain compared with other countries, although this may change during the forecast period due to government cost-cutting strategies.

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

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

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 Spain 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 Vimpat (lacosamide) 51
5.3.5 Zonegran (zonisamide) 55
5.3.6 Banzel/Inovelon (rufinamide) 58
5.3.7 Trobalt/Potiga (retigabine/ezogabine) 60
5.3.8 Zebinix (eslicarbazepine acetate) 63
5.3.9 Fycompa (perampanel) 66
5.3.10 Older-Generation AEDs 69
6 Opportunity and Unmet Need 70
6.1 Overview 70
6.2 Unmet Needs 71
6.2.1 Refractory Epilepsy 71
6.2.2 Safety/Side Effect Profiles 71
6.2.3 Curative/Disease-Modifying Agents 72
6.2.4 Predictive Tools and Need for More Directed Treatments 73
6.2.5 Improved Preclinical Models and Clinical Trial Paradigms 73
6.2.6 Treatment Gap 74
6.3 Unmet Needs Gap Analysis 75
6.4 Opportunities 76
6.4.1 Disease-Modifying Agents 76
6.4.2 Improved Preclinical Models and Clinical Trial Paradigms 76
6.4.3 Treatment Gap 76
7 Pipeline Assessment 77
7.1 Overview 77
7.2 Strategic Pipeline Assessment 77
7.3 Pipeline by Phases of Development 78
7.3.1 Phase III Pipeline 78
7.3.2 Phase III Pipeline – Reformulations/New Delivery Systems 79
7.3.3 Phase IIb Pipeline 79
7.3.4 Phase II Pipeline 80
7.3.5 Phase I Pipeline 80
7.3.6 Preclinical Pipeline 81
7.3.7 Discovery Pipeline 82
7.4 Pipeline by Mechanism of Action 82
7.5 Promising Drugs in Clinical Development 84
7.5.1 Brivaracetam 85
7.5.2 Ganaxolone 88
7.5.3 VX-765 91
8 Market Outlook 94
8.1 Spain 94
8.1.1 Forecast 94
8.1.2 Key Events 97
8.1.3 Drivers and Barriers 97
9 Appendix 99
9.1 Bibliography 99
9.2 Abbreviations 104
9.3 Methodology 106
9.4 Forecasting Methodology 106
9.4.1 Prevalent Epilepsy Patients 106
9.4.2 Percent Drug-Treated Patients 107
9.4.3 Drugs Included in Each Therapeutic Class Based on MOA 107
9.4.4 Launch Dates and Patent and Market Exclusivity Expiry Dates 108
9.4.5 General Pricing Assumptions 110
9.4.6 Individual Drug Assumptions 111
9.4.7 Generic Erosion 125
9.4.8 Pricing of Pipeline Agents 125
9.5 Physicians and Specialists Included in this Study 126
9.6 Primary Research - Prescriber Survey 127
9.7 About the Authors 127
9.7.1 Authors 127
9.7.2 Global Head of Healthcare 128
9.8 About GlobalData 129
9.9 Contact Us 129
9.10 Disclaimer 129

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: Spain, Epilepsy Patient Referrals to Neurologist 34
Table 13: Spain, 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 – 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 62
Table 29: Product Profile – Zebinix 63
Table 30: Zebinix SWOT Analysis, 2012 65
Table 31: Product Profile – Fycompa 66
Table 32: Fycompa SWOT Analysis, 2012 68
Table 33: Summary of Minor Drug Classes, 2012 69
Table 34: Overall Unmet Needs – Current Level of Attainment 70
Table 35: Clinical Unmet Needs – Gap Analysis, 2012 75
Table 36: Epilepsy – Phase III Pipeline, 2012 78
Table 37: Epilepsy – Phase III Pipeline (Reformulations), 2012 79
Table 38: Epilepsy – Phase IIb Pipeline, 2012 79
Table 39: Epilepsy – Phase II Pipeline, 2012 80
Table 40: Epilepsy – Phase I Pipeline, 2012 80
Table 41: Epilepsy – Preclinical Pipeline, 2012 81
Table 42: Epilepsy - Discovery Pipeline, 2012 82
Table 43: Comparison of MOA of Drugs in Development for Epilepsy, 2012 83
Table 44: Epilepsy – Promising Drugs in Clinical Development 84
Table 45: Product Profile – Brivaracetam 85
Table 46: Brivaracetam SWOT Analysis, 2012 87
Table 47: Product Profile – Ganaxolone 88
Table 48: Ganaxolone SWOT Analysis, 2012 90
Table 49: Product Profile – VX-765 91
Table 50: VX-765 SWOT Analysis, 2012 93
Table 51: Sales Forecasts ($m) for Epilepsy in Spain, 2012–2022 95
Table 52: Key Events Impacting Sales for Epilepsy in Spain, 2012–2022 97
Table 53: Epilepsy Market in Spain – Drivers and Barriers, 2012–2022 97
Table 54: Key Launch Dates 108
Table 55: Key Patent Expiries and Market Exclusivity Expiries* 109
Table 56: Physicians Surveyed, By Country 127

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 83
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Epilepsy, 2012–2022 84
Figure 6: Sales for Epilepsy in Spain by Drug Class, 2012–2022 96

Published By: GlobalData
Product Code: GlobalData27094


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