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

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.

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 ...

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

Table of Contents

Table of Contents

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 ...

Table of Contents

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

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 ...

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 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

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