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PharmaPoint: Epilepsy - Global Drug Forecast and Market Analysis to 2026

October 2017 | 299 pages | ID: PE2E559B734EN
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PharmaPoint: Epilepsy - Global Drug Forecast and Market Analysis to 2026

SUMMARY

Epilepsy is a brain disorder characterized by spontaneously occurring and recurrent seizures. Seizures result from abnormal electrical discharges in the brain and vary in their manifestations, from the brief staring spells that are characteristic of absence seizures, to full-body convulsions known as tonic-clonic seizure. Epilepsy can be considered a spectrum disorder due to its different causes, different seizure types, and different disease severities.

There are several anti-epileptic drugs (AEDs) on the market, with an older generation fully genericized across the 7MM (US, France, Germany, Italy, Spain, UK and, Japan) and a second generation, which are patent protected. There are five drugs in the late stage pipeline, which address some of the unmet needs in the market and, as such are expected to drive growth while patent expiries for major brand are expected to act as a barrier to growth for the epilepsy market over the forecast period.

GlobalData estimates that drug sales for epilepsy in 2016 were approximately $6.1 billion across the seven major markets covered in this report. Over the 10-year forecast period, the market is expected to grow to $7.5 billion at a CAGR of 2.1%. This growth will be driven by the launch of five late-stage pipeline products. The two highest selling drugs are expected to be GW Pharmaceuticals’ Epidiolex (cannabidiol) and Zogenix’s flenfluramine, which both target rare, orphan epilepsy syndrome, are forecast to be the top selling pipeline drugs in the forecast period.

SCOPE
  • Overview of epilepsy, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized epilepsy therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (focal, generalized, and unclassified seizures) forecast from 2016 to 2026.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the epilepsy therapeutics market
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for epilepsy therapy. The most promising candidates in Phase III development are profiled.
  • Analysis of the current and future market competition in the global epilepsy therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
REASONS TO BUY

The report will enable you to -
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global epilepsy therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global epilepsy therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 TABLE OF CONTENTS

1.1 List of Tables
1.2 List of Figures

2 EXECUTIVE SUMMARY

2.1 Epilepsy Market Anticipated To Grow to $7.5B by 2026
2.2 Companies Targeting Niche Epilepsy Types
2.3 Refractory Patients Are Still Underserved in the Epilepsy Market
2.4 Market Opportunities for New Entrants
2.5 Late-Stage Pipeline Drugs Will Be a Key Driver of Growth
2.6 What Do Physicians Think?

3 INTRODUCTION

3.1 Catalyst
3.2 Related Reports
3.3 Upcoming Related Reports

4 DISEASE OVERVIEW

4.1 Classification of Seizures
4.2 Etiology and Pathophysiology
  4.2.1 Etiology
  4.2.2 Pathophysiology
  4.2.3 Prognosis
  4.2.4 Quality of Life

5 EPIDEMIOLOGY

5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
  5.3.1 US
  5.3.2 5EU
  5.3.3 Japan
5.4 Forecast Methodology
  5.4.1 Sources
  5.4.2 Forecast Assumptions and Methods
5.5 Epidemiological Forecast for Epilepsy (2016-2026)
  5.5.1 Lifetime Diagnosed Prevalent Cases of Epilepsy
  5.5.2 Active Diagnosed Prevalent Cases of Epilepsy
  5.5.3 Age-Specific Active Diagnosed Prevalent Cases of Epilepsy
  5.5.4 Sex-Specific Active Diagnosed Prevalent Cases of Epilepsy
  5.5.5 Active Diagnosed Prevalent Cases by Seizure Type
  5.5.6 Drug Resistant Active Diagnosed Prevalent Cases
5.6 Discussion
  5.6.1 Epidemiological Forecast Insight
  5.6.2 Limitations of the Analysis
  5.6.3 Strengths of the Analysis

6 DISEASE MANAGEMENT

6.1 Diagnosis Overview
6.2 Treatment Overview
  6.2.1 Treatment Guidelines and Leading Prescribed Drugs
  6.2.2 Clinical Practice
6.3 US……….
6.4 5EU…….
6.5 Japan….

7 COMPETITIVE ASSESSMENT

7.1 Overview
7.2 Product Profiles - Major Brands
  7.2.1 Aptiom/Zebinix (Eslicarbazepine Acetate)
  7.2.2 Banzel/Inovelon (Rufinamide)
  7.2.3 Briviact (Brivaracetam)
  7.2.4 Carnexiv (Carbamazepine IV)
  7.2.5 Fycompa (Perampanel)
  7.2.6 Keppra (Levetiracetam)
  7.2.7 Lamictal (Lamotrigine)
  7.2.8 Lyrica (Pregabalin)
  7.2.9 Onfi (Clobazam)
  7.2.10 Oxtellar XR (Oxcarbazepine ER)
  7.2.11 Qudexy XR (Topiramate ER)
  7.2.12 Sabril (Vigabatrin)
  7.2.13 Spritam (Levetiracetam)
  7.2.14 Trokendi XR (Topiramate ER)
  7.2.15 Vimpat (Lacosamide)
7.3 Older-Generation AEDs

8 UNMET NEEDS AND OPPORTUNITY ASSESSMENT

8.1 Overview
8.2 Improved Treatment Options for Treatment-Resistant Patients
  8.2.1 Unmet Need
  8.2.2 Gap Analysis
  8.2.3 Opportunity
8.3 Curative or Disease-Modifying Therapies
  8.3.1 Unmet Need
  8.3.2 Gap Analysis
  8.3.3 Opportunity
8.4 Treatments for Acute Repetitive Seizures
  8.4.1 Unmet Need
  8.4.2 Gap Analysis
  8.4.3 Opportunity
8.5 Drugs with Improved Safety Profile
  8.5.1 Unmet Need
  8.5.2 Gap Analysis
  8.5.3 Opportunity
8.6 Better Drug Formulations or Duration of Action
  8.6.1 Unmet Need
  8.6.2 Gap Analysis
  8.6.3 Opportunity

9 PIPELINE ASSESSMENT

9.1 Overview
9.2 Clinical Trial Mapping
  9.2.1 Clinical Trials by Development Stage
9.3 Promising Drugs in Clinical Development
  9.3.1 Cenobamate (YKP3089)
  9.3.2 Epidiolex (Cannabidiol)
  9.3.3 Fenfluramine (ZX-008)
  9.3.4 Diazepam (NRL-1)
  9.3.5 Midazolam (USL261)
9.4 Other Drugs in Development

10 CURRENT AND FUTURE PLAYERS

10.1 Overview
10.2 Trends in Corporate Strategy
10.3 UCB…….
  10.3.1 Overview
  10.3.2 Portfolio Assessment
10.4 Eisai…….
  10.4.1 Overview
  10.4.2 Portfolio Assessment
10.5 Pfizer …………………………………………………………………………… …………………………………………………….223
  10.5.1 Overview
  10.5.2 Portfolio Assessment
10.6 Lundbeck
  10.6.1 Overview
  10.6.2 Portfolio Assessment
10.7 GW Pharmaceuticals
  10.7.1 Overview
  10.7.2 Portfolio Assessment
10.8 SK Biopharmaceuticals
  10.8.1 Overview
  10.8.2 Portfolio Assessment
10.9 Zogenix
  10.9.1 Overview
  10.9.2 Portfolio Assessment
10.10 Other Companies
  10.10.1 Overview
  10.10.2 Portfolio Assessment

11 MARKET OUTLOOK

11.1 Global Markets
  11.1.1 Forecast
  11.1.2 Drivers and Barriers - Global Issues
11.2 US …
  11.2.1 Forecast
  11.2.2 Key Events
  11.2.3 Drivers and Barriers
11.3 5EU…….
  11.3.1 Forecast
  11.3.2 Key Events
  11.3.3 Drivers and Barriers
11.4 Japan….
  11.4.1 Forecast
  11.4.2 Key Events
  11.4.3 Drivers and Barriers

12 APPENDIX

12.1 Bibliography
12.2 Abbreviations
12.3 Methodology
12.4 Forecasting Methodology
  12.4.1 Diagnosed Epilepsy Patients
  12.4.2 Percent Drug-Treated Patients
  12.4.3 Launch Dates and Patent and Market Exclusivity Expiry Dates
  12.4.4 General Pricing Assumptions
  12.4.5 Individual Drug Assumptions
  12.4.6 Generic Erosion
  12.4.7 Pricing of Pipeline Agents
12.5 Physicians and Specialists Included in this Study
12.6 Primary Research - Prescriber Survey
12.7 About the Authors
  12.7.1 Co-Authors
  12.7.2 Therapy Area Director
  12.7.3 Epidemiologist
  12.7.4 Managing Epidemiologist
  12.7.5 Global Director of Therapy Analysis and Epidemiology
  12.7.6 Global Head and EVP of Healthcare Operations and Strategy
12.8 About GlobalData
12.9 Contact Us
12.10 Disclaimer

LIST OF TABLES

Table 1: Epilepsy: Key Metrics in the 7MM
Table 2: Epilepsy Syndromes by Age at Onset (2010 Revised ILAE Classification)
Table 3: Description of the Symptoms and Characteristics Included in the Classification of Seizure Types by the ILAE
Table 4: Etiology of Epilepsy According to Age
Table 5: Etiology of Seizures
Table 6: Some of the Genes Involved in Epilepsy
Table 7: Risk Factors and Comorbidities for Epilepsy
Table 8: 7MM, Lifetime Diagnosed Prevalent Cases of Epilepsy, Men and Women, All Ages, Select Years 2016-2026.
Table 9: 7MM, Active Diagnosed Prevalent Cases of Epilepsy, Men and Women, All Ages, Select Years 2016-2026
Table 10: Summary of Diagnostic Tools for Epilepsy
Table 11: Treatment Guidelines for Epilepsy
Table 12: AED Options by Seizure Type
Table 13: Types of Epilepsy Surgery
Table 14: Country Profile - US
Table 15 Country Profile - 5EU
Table 16 Country Profile - Japan
Table 17: Leading Treatments for Epilepsy, 2017
Table 18: Product Profile - Aptiom/Zebinix
Table 19: Summary of Aptiom/Zebinix Efficacy
Table 20: Aptiom/Zepinix SWOT Analysis, 2017
Table 21: Product Profile - Banzel
Table 22: Summary of Banzel Efficacy
Table 23: Banzel SWOT Analysis, 2017
Table 24: Product Profile - Briviact
Table 25: Summary of Briviact Efficacy
Table 26: Briviact SWOT Analysis, 2017
Table 27: Product Profile - Carnexiv
Table 28: Carnexiv SWOT Analysis, 2017
Table 29: Product Profile - Fycompa
Table 30: Summary of Fycompa Efficacy
Table 31: Fycompa SWOT Analysis, 2017
Table 32: Product Profile - Keppra
Table 33: Summary of Keppra Efficacy
Table 34: Summary of Keppra XR Efficacy
Table 35: Keppra SWOT Analysis, 2017
Table 36: Product Profile - Lamictal
Table 37: Summary of Lamictal Efficacy
Table 38: Summary of Lamictal XR Efficacy
Table 39: Lamictal SWOT Analysis, 2017
Table 40: Product Profile - Lyrica
Table 41: Summary of Lyrica Efficacy
Table 42: Lyrica SWOT Analysis, 2017
Table 43: Product Profile - Onfi
Table 44: Summary of Onfi Efficacy
Table 45: Onfi SWOT Analysis, 2017
Table 46: Product Profile - Oxtellar XR
Table 47: Summary of Oxtellar XR Efficacy
Table 48: Oxtellar XR SWOT Analysis, 2017
Table 49: Product Profile - Qudexy XR
Table 50: Summary of Qudexy XR Efficacy
Table 51: Qudexy XR SWOT Analysis, 2017
Table 52: Product Profile - Sabril
Table 53: Summary of Sabril Efficacy
Table 54: Sabril SWOT Analysis, 2017
Table 55: Product Profile - Spritam
Table 56: Spritam SWOT Analysis, 2017
Table 57: Product Profile - Trokendi XR
Table 58: Trokendi XR SWOT Analysis, 2017
Table 59: Product Profile - Vimpat
Table 60: Summary of Vimpat Efficacy
Table 61: Vimpat SWOT Analysis, 2017
Table 62: Summary of Older Generation AEDs, 2017
Table 63: Promising Drugs in Clinical Development for Epilepsy, 2017
Table 64: Comparison of Drugs in Development for Epilepsy, 2017
Table 65: Product Profile - cenobamate
Table 66: Cenobamate Phase II Results
Table 67: cenobamate SWOT Analysis, 2017
Table 68: Product Profile - Epidiolex
Table 69: Epidiolex Phase III Results
Table 70: Epidiolex SWOT analysis, 2017
Table 71: Product Profile - Fenfluramine
Table 72: Fenfluramine SWOT analysis, 2017.
Table 73: Product Profile - NRL-1
Table 74 NRL-1 SWOT Analysis, 2017.
Table 75: Product Profile - USL261
Table 76 USL261 SWOT Analysis, 2017.
Table 77: Drugs in Development, 2017
Table 78: Key Companies in the Epilepsy Market in the 7MM, 2017.
Table 79: UCB’s Disease Portfolio Assessment, 2017
Table 80: Eisai’s Disease Portfolio Assessment, 2017
Table 81: Pfizer’s Disease Portfolio Assessment, 2017
Table 82: Lundbeck’s Disease Portfolio Assessment, 2017
Table 83: GW Pharmaceuticals’ Disease Portfolio Assessment, 2017
Table 84: SK Biopharmaceuticals’ Disease Portfolio Assessment, 2017
Table 85: Zogenix’s Disease Portfolio Assessment, 2017
Table 86: other Players’ Disease Portfolio Assessment, 2016
Table 87: Epilepsy Market - Global Drivers and Barriers, 2016-2026
Table 88: Key Events Impacting Sales for Epilepsy in the US, 2016-2026
Table 89: Epilepsy Market - US Drivers and Barriers, 2016-2026
Table 90: Key Events Impacting Sales for Epilepsy in the 5EU, 2016-2026
Table 91: Epilepsy Market - 5EU Drivers and Barriers, 2016-2026
Table 92: Key Events Impacting Sales for Epilepsy in Japan, 2016-2026
Table 93: Epilepsy Market - Global Drivers and Barriers, Japan, 2016-2026
Table 94: Key Launch Dates
Table 95: Key Patent/Exclusivity Expiries
Table 96: Physicians Surveyed, by Country

LIST OF FIGURES

Figure 1: Global Sales Forecast by Country for Epilepsy in 2016 and 2026
Figure 2: Company Portfolio Gap Analysis in Epilepsy During the Forecast Period
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of Epilepsy During the Forecast Period
Figure 4: Operational Classification of Seizure Types by the ILAE, 2017
Figure 5: Summary of the Pathophysiology of Seizures by Net Increased Neuronal Excitation
Figure 6: Mechanisms of Action of AEDs at the Synapse
Figure 7: 7MM Age-Standardized Lifetime Diagnosed Prevalence, Men, Women, All Ages, 2016 (%)
Figure 8: 7MM Age-standardized Active Diagnosed Prevalence, Men, Women, All Ages, 2016 (%)
Figure 9: The Sources Used to Calculate the Lifetime Diagnosed Prevalence of Epilepsy
Figure 10: The Sources Used and Not Used in the Forecast for the Active Diagnosed Prevalence
Figure 11: The Sources Used and Not Used in the Forecast for the Seizure Type Distribution of Active Diagnosed Prevalent Cases
Figure 12: The Sources Used in the Forecast for the Drug Resistant Active Diagnosed Prevalent Cases
Figure 13: 7MM, Age-Specific Active Diagnosed Prevalent Cases of Epilepsy, Men and Women, All Ages, 2016
Figure 14: 7MM Sex-Specific Active Diagnosed Prevalent Cases of Epilepsy, All Ages, 2016.
Figure 15: 7MM, Active Diagnosed Prevalent Cases of Epilepsy by Seizure Type, Men and Women, All Ages, 2016
Figure 16: 7MM, Active Diagnosed Prevalent Cases by Response to AED Treatment, Men and Women, All Ages, 2016.
Figure 17: A summary of the factors that physicians must consider when diagnosing a patient with a specific epilepsy syndrome
Figure 18: AED Selection Based on Comorbidity
Figure 19: Major Unmet Needs, Epilepsy Market
Figure 20: Epilepsy Therapeutics, 2017
Figure 21: Epilepsy Therapeutics - Ongoing Clinical Trials in the 7MM, 2017
Figure 22: Epilepsy - Promising Late-Stage Phase IIb-III Pipeline Drugs, 2017
Figure 23: Competitive Assessment of Promising Late-Stage Pipeline Agents in Epilepsy, 2016-2026
Figure 24: Clinical and Commercial Positioning of Cenobamate
Figure 25: Clinical and Commercial Positioning of Epidiolex
Figure 26: Clinical and Commercial Positioning of Fenfluramine
Figure 27: Clinical and Commercial Positioning of NRL-1
Figure 28: Clinical and Commercial Positioning of USL261
Figure 29: Global Sales of Branded Products for Epilepsy, by Company, in 2016 and 2026
Figure 30: Analysis of the Company Portfolio Gap in Epilepsy During the Forecast Period
Figure 31: Global (7MM) Sales Forecast for Epilepsy, by Country, 2016 and 2026
Figure 32: Sales Forecast Split by Current/Pipeline Therapies for Epilepsy in the US, 2026
Figure 33: Adult and Pediatric Sales for Epilepsy, US, 2016 and 2026
Figure 34: 5EU Sales Forecast, by Country, 2016 and 2026
Figure 35: Sales Forecast Split by Current/Pipeline Therapies for Epilepsy, Japan, 2026
Figure 36: Adult and Pediatric Sales for Epilepsy, Japan, 2016 and 2026

COMPANIES MENTIONED

GW Pharmaceuticals
Zogenix
UCB
Upsher-Smith Laboratories
Neurelis
Lundbeck
Sanofi
Pfizer
SK Biopharmaceuticals
Supernus Pharmaceuticals
Daiichi-Sankyo
Brabant Pharma
Eisai
Novartis
GlaxoSmithKline
Alfresa Pharma
Bial - Portela & CA, S.A
Ligand Pharmaceuticals
Aprecia Pharmaceuticals
Dainippon Sumitomo
Concordia
Sepracor (Sunovion Pharmaceuticals)
Mylan Pharmaceuticals
Glenmark Pharmaceuticals
Ovation Pharmaceuticals
Teva
Allergan
Twi Pharmaceuticals
Zydus
Cadila Healthcare
Catalyst Pharmaceuticals
Cadila Healthcare
Catalyst Pharmaceuticals
inVentiv Health
Janssen
Par Pharmaceuticals
Argentum Pharmaceuticals
Abbot
Valeant Pharmaceuticals
CURx Pharmaceuticals
Admas Pharmaceuticals
Greenwich Biosciences
Aegis Therapeutics
Roche
Shire
Ikano Therapeutics
Alexza Pharmaceuticals
Zynerba Pharmaceuticals
Monosol Rx
Marinus Pharmaceuticals
Johnson & Johnson
PTC Therapeutics
INSYS Therapeutics
Anavex Life Sciences
VistaGen Therapeutics
BioHealthonomics
Biscayne Pharmaceuticals
MMU PhytoTech
Bio-Pharm Solutions
Suda
Marathon Pharmaceuticals
Takeda
Idorsia
Otsuka
CuroNZ
Mucodel Pharma


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