Epilepsy Therapeutics in Major Developed Markets to 2019 - New AEDs with Novel Mechanisms of Action Signal a Shift in Treatment Patterns

Epilepsy Therapeutics in Major Developed Markets to 2019 - New AEDs with Novel Mechanisms of Action Signal a Shift in Treatment Patterns

Summary

GBI Research has released its pharma research, "Epilepsy Therapeutics in Major Developed Markets to 2019 - New AEDs with Novel Mechanisms of Action Signal a Shift in Treatment Patterns", which provides in-depth analysis of epilepsy market within the eight major developed markets of the US, UK, France, Germany, Italy, Spain, Japan and Canada. The report provides an estimation of the market size for 2012, along with market forecasts to 2019. It also covers disease epidemiology, treatment algorithms, treatment patterns, in-depth analysis of the pipeline, and deal analysis.

The value of the epilepsy market in the major developed markets amounted to an estimated $3.4 billion in 2012 and is expected to register a Compound Annual Growth Rate (CAGR) of 3.9% to reach $4.5 billion by 2019. This modest growth is attributed to the recent approval of drugs with novel mechanisms of action that are expected to offer more therapeutic options to prescribers. The US takes major share of 55% of the global epilepsy market. In the US, three new anti-epileptic drugs have been approved since 2012: Trobalt, Aptiom, and Fycompa and another, brivaracetam, is expected also to be launched during the forecast period. Of these, Trobalt and Fycompa have novel mechanisms of action and improved safety and tolerability that elicited significant interest from prescribers. Continued uptake of second- and third-generation anti-epileptic drugs is also expected to contribute towards revenues in these eight regions. However, the epilepsy market could face the restricting influence of generic competition as a result of recent patent expiries in all major markets of two key branded drugs, Keppra and Lamictal.

Scope

- A brief introduction to epilepsy, including disease pathogenesis, risk factors, diagnosis and treatment options
- In-depth analysis of major marketed products covering product performance, product life-cycle and a heat map depicting comparative analysis of safety and efficacy parameters
- A comprehensive review of the epilepsy pipeline which includes individual analysis of promising late-stage pipeline drugs that are most likely to enter the market during the forecast period. The pipeline is analyzed on the basis of Phase distribution, molecule type and molecular target
- Additional clinical trial analysis by Phase, trial size, trial duration and program failure rate for each molecule type and mechanism of action
- Multi-scenario forecasts of the epilepsy market over the 2012–2019 period in the eight major developed markets
- In-depth analysis of licensing and co-development agreements and an overview of key agreements that could impact growth trends
- Key drivers and restraints that have had and are expected to have a significant impact upon the market

Reasons to buy

- Align your product portfolio to markets with high growth potential
- Develop market entry and expansion strategies by identifying the potential regions and therapeutic segments poised for strong growth
- Devise effective, tailored strategies for each country through the understanding of key drivers and barriers in the anti-epileptic drugs market
- Develop key strategic initiatives based upon an understanding of key focus areas and leading companies
- Accelerate and strengthen your market position by identifying key companies for mergers, acquisitions and strategic partnerships

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 9
2.1 Disease Overview 9
2.2 Epidemiology 9
2.3 Symptoms 11
2.4 Etiology 11
2.5 Pathophysiology 12
2.6 Co-morbidities/Complications 12
2.7 Diagnosis 12
2.8 Prognosis 13
2.9 Treatment Efficacy 13
2.10 Treatment Options 14
2.10.1 Ion Channel Modulators 14
2.10.2 GABA-ergic Facilitation 15
2.10.3 Excitatory Amino Acid Inhibitors 15
2.10.4 Synaptic Modulators 15
2.11 Non-pharmacological Management 15
2.11.1 Lobectomy and Lesionectomy 15
2.11.2 Ketogenic Diet and Modified Atkins Diet 15
2.11.3 Vagus Nerve Stimulation 16
3 Epilepsy Therapeutic Landscape 17
3.1 Overview 17
3.2 Lyrica (pregabalin) 17
3.3 Lamictal (lamotrigine) 18
3.4 Keppra (levetiracetam) 19
3.5 Zonegran (zonisamide) 21
3.6 Vimpat (lacosamide) 22
3.7 Aptiom/Zebinix (eslicarbazepine acetate) 24
3.8 Fycompa (perampanel) 24
3.9 Trobalt/Potiga (ezogabine/retigabine) 25
3.10 Banzel/Inovelon (rufinamide) 26
3.11 Comparative Efficacy and Safety of Marketed Products 26
4 Pipeline for Epilepsy Therapeutics 29
4.1 Overall Pipeline 29
4.2 Pipeline by Mechanism of Action 31
4.3 Clinical Trials 32
4.3.1 Failure Rate 32
4.3.2 Patient Enrolment and Clinical Trial Size 34
4.3.3 Clinical Trial Duration 36
4.4 Promising Pipeline Candidates 38
4.4.1 Brivaracetam – UCB 38
4.4.2 Ganaxolone – Marinus Pharmaceuticals 38
5 Epilepsy Therapeutics Market Forecast to 2019 39
5.1 Geographical Markets 39
5.1.1 Major Developed Markets 39
5.1.2 The US 40
5.1.3 Top Five EU Countries 43
5.1.4 Japan 46
5.1.5 Canada 48
5.2 Drivers and Barriers 50
5.2.1 Drivers 50
5.2.2 Barriers 50
6 Deals and Strategic Consolidations 52
6.1 Deals Analysis 52
6.2 Research and Development Co-development Agreements 54
6.3 Research and Development Licensing Agreements 55
7 Appendix 57
7.1 Abbreviations 57
7.2 References 58
7.3 References for Heat Maps 62
7.4 Pipeline Products by Phase 63
7.4.1 Discovery 63
7.4.2 Preclinical 63
7.4.3 IND-filed and Phase 0 64
7.4.4 Phase I 65
7.4.5 Phase II 65
7.4.6 Phase III 66
7.4.7 Pre-registration 66
7.5 Market Forecasting Data Tables to 2019 67
7.5.1 Major Developed Markets 67
7.5.2 US 67
7.5.3 UK 67
7.5.4 France 68
7.5.5 Germany 68
7.5.6 Italy 68
7.5.7 Spain 69
7.5.8 Japan 69
7.5.9 Canada 69
7.6 Research Methodology 70
7.6.1 Coverage 70
7.6.2 Secondary Research 70
7.6.3 Primary Research 70
7.6.4 Therapeutic Landscape 71
7.6.5 Geographical Landscape 74
7.6.6 Pipeline Analysis 74
7.7 Expert Panel Validation 74
7.8 Contact Us 74
7.9 Disclaimer 74

1.1 List of Tables
Table 1: Epilepsy Therapeutics, Global, Types of Seizures, 2013 9
Table 2: Epilepsy Therapeutics, Heat Maps for Efficacy and Safety of Marketed Products, References 62
Table 3: Epilepsy Therapeutics, Global, Pharmaceutical Pipeline (Discovery), 2013 63
Table 4: Epilepsy Therapeutics, Global, Pharmaceutical Pipeline (Preclinical), 2013 63
Table 5: Epilepsy Therapeutics, Global, Pharmaceutical Pipeline (IND/CTA-filed), 2013 64
Table 6: Epilepsy Therapeutics, Global, Pharmaceutical Pipeline (Phase I), 2013 65
Table 7: Epilepsy Therapeutics, Global, Pharmaceutical Pipeline (Phase II), 2013 65
Table 8: Epilepsy Therapeutics, Global, Pharmaceutical Pipeline (Phase III), 2013 66
Table 9: Epilepsy Therapeutics, Global, Pharmaceutical Pipeline (Pre-registration), 2013 66
Table 10: Epilepsy Therapeutics, Major Developed Markets, Market Forecast, 2012–2019 67
Table 11: Epilepsy Therapeutics, US, Market Forecast, 2012–2019 67
Table 12: Epilepsy Therapeutics, UK, Market Forecast, 2012–2019 67
Table 13: Epilepsy Therapeutics, France, Market Forecast, 2012–2019 68
Table 14: Epilepsy Therapeutics, Germany, Market Forecast, 2012–2019 68
Table 15: Epilepsy Therapeutics, Italy, Market Forecast, 2012–2019 68
Table 16: Epilepsy Therapeutics, Spain, Market Forecast, 2012–2019 69
Table 17: Epilepsy Therapeutics, Japan, Market Forecast, 2012–2019 69
Table 18: Epilepsy Therapeutics, Canada, Market Forecast, 2012–2019 69

1.2 List of Figures
Figure 1: Epilepsy Therapeutics, Epidemiology, Major Developed Markets, 2012 10
Figure 2: Epilepsy Therapeutics, Major Developed Markets, Approved Anti-epileptic Drugs, 2013 14
Figure 3: Epilepsy Therapeutics, Lyrica, Global, Revenue ($bn), 2013 18
Figure 4: Epilepsy Therapeutics, Lamictal, Global, Revenue ($m), 2009–2013 19
Figure 5: Epilepsy Therapeutics, Keppra, Global, Revenue ($bn), 2009–2013 20
Figure 6: Epilepsy Therapeutics, Zonegran, Global, Revenue ($m), 2009–2013 21
Figure 7: Epilepsy Therapeutics, Vimpat, Global, Revenue ($m), 2009–2013 23
Figure 8: Epilepsy Therapeutics, Global, Comparative Safety and Efficacy of Marketed Products (Heat Map), 2013 27
Figure 9: Epilepsy Therapeutics, Global, Overall Pipeline Analysis, 2013 30
Figure 10: Epilepsy Therapeutics, Global, Pipeline Analysis, by Mechanism of Action, 2013 31
Figure 11: Epilepsy Therapeutics, Global, Pipeline, Clinical Trial Failure Rate, 2013 33
Figure 12: Epilepsy Therapeutics, Global, Pipeline, Clinical Trial Size, 2013 35
Figure 13: Epilepsy Therapeutics, Global, Pipeline, Clinical Trial Duration, 2013 37
Figure 14: Epilepsy Therapeutics, Major Developed Markets, Treatment Usage Pattern and Market Size, 2012–2019 40
Figure 15: Epilepsy Therapeutics, US, Treatment Usage Pattern, ACoT and Market Size, 2012–2019 42
Figure 16: Epilepsy Therapeutics, Top Five EU Countries, Treatment Patterns (‘000), 2012–2019 43
Figure 17: Epilepsy Therapeutics, Top Five EU Countries, Annual Cost of Treatment ($), 2012–2019 44
Figure 18: Epilepsy Therapeutics, Top Five EU Countries, Market Size ($m), 2012–2019 45
Figure 19: Epilepsy Therapeutics, Japan, Treatment Usage Pattern, ACoT and Market Size, 2012–2019 47
Figure 20: Epilepsy Therapeutics, Canada, Market Size, 2012–2019 49
Figure 21: Epilepsy Therapeutics, Deals by Region, Value and Year, 2006–2013 52
Figure 22: Epilepsy Therapeutics, Deals by Molecule Type and Mechanism of Action, 2006–2013 53
Figure 23: Epilepsy Therapeutics, Co-development Deals, Territory, 2006–2013 54
Figure 24: Epilepsy Therapeutics, Licensing Deals, by Territory, 2006–2013 55
Figure 25: GBI Research Market Forecasting Model 73