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PharmaPoint : 뇌전증 - 세계 치료제 시장 예측과 분석(-2026년)

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

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발행일 2017년 10월 상품 코드 599671
페이지 정보 영문 299 Pages
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PharmaPoint : 뇌전증 - 세계 치료제 시장 예측과 분석(-2026년) PharmaPoint: Epilepsy - Global Drug Forecast and Market Analysis to 2026
발행일 : 2017년 10월 페이지 정보 : 영문 299 Pages

한글목차

세계 주요 7개국의 뇌전증 치료제 시장 규모는 2016년 61억 달러에 이르렀습니다. 향후에는 2.1%의 연평균 시장 성장률(CAGR)을 나타낼 전망입니다.

세계의 뇌전증(Epilepsy) 치료제 시장을 분석했으며, 질환 개요, 역학적 배경, 환자수 동향 전망, 임상시험 진행 상황, 출시 치료제/임상시험 중인 주요 치료제, 현재 시장의 미충족 요구, 주요 기업 개요, 세계/주요 국가 시장 동향 전망 등의 정보를 정리하여 전해드립니다.

제1장 목차

제2장 개요

제3장 서론

제4장 질환 개요

  • 발작 분류
  • 병인과 병태생리
    • 병인
    • 병태생리
    • 예후
    • 삶의 질(QoL)

제5장 역학

  • 질환의 배경
  • 위험요인과 공존질환
  • 세계 각국에서의 추이
    • 미국
    • 유럽 5개국(5EU)
    • 일본
  • 예측 방법
    • 정보 출처
    • 예측 전제조건과 방법
  • 뇌전증의 역학적 예측(통산 11년간)
    • 뇌전증 진찰 환자수(누적)
    • 뇌전증 진찰 환자수(현재 발증)
    • 뇌전증 진찰 환자수 : 연령별
    • 뇌전증 진찰 환자수 : 남녀별
    • 뇌전증 진찰 환자수(현재 발증) : 발작 유형별
    • 뇌전증 진찰 환자수(현재 발증) : 약제 내성이 있는 경우
  • 논의
    • 역학 예측 인사이트
    • 분석의 한계
    • 분석의 강점

제6장 질환 관리

  • 진단 개요
  • 치료법 개요
    • 치료 가이드라인과 대표적인 처방약
    • 임상 진료
  • 미국
  • 유럽 주요 5개국(5EU)
  • 일본

제7장 경쟁 평가

  • 개요
  • 제품 개요 : 주요 브랜드 의약품
    • Aptiom/Zebinix(Eslicarbazepine Acetate)
    • Banzel/Inovelon(Rufinamide)
    • Briviact(Brivaracetam)
    • Carnexiv(Carbamazepine IV)
    • Fycompa(Perampanel)
    • Keppra(Levetiracetam)
    • Lamictal(Lamotrigine)
    • Lyrica(Pregabalin)
    • Onfi(Clobazam)
    • Oxtellar XR(Oxcarbazepine ER)
    • Qudexy XR(Topiramate ER)
    • Sabril(Vigabatrin)
    • Spritam(Levetiracetam)
    • Trokendi XR(Topiramate ER)
    • Vimpat(Lacosamide)
  • 구세대 항뇌전증약(AED)

제8장 미충족 요구 및 시장 기회 분석

  • 개요
  • 약제 내성이 있는 환자를 위한 치료 옵션 개선
    • 미충족 요구
    • 갭 분석
    • 시장 기회
  • 질환 근치 및 완화 요법
  • 급성/재발성 발작 치료
  • 안전성 프로파일을 개선한 의약품
  • 약제 처방 및 작용기전 개선

제9장 파이프라인 평가

  • 개요
  • 임상시험 매핑
    • 단계별 임상시험 동향
  • 임상시험 중인 유망한 의약품
    • Cenobamate(YKP3089)
    • Epidiolex(Cannabidiol)
    • Fenfluramine(ZX-008)
    • Diazepam(NRL-1)
    • Midazolam(USL261)
  • 기타 임상시험 중인 의약품

제10장 현재 및 향후의 시장 진출기업

  • 개요
  • 기업 전략 동향
  • UCB
    • 개요
    • 포트폴리오 평가
  • Eisai Inc.
  • Pfizer
  • Lundbeck
  • GW Pharmaceuticals
  • SK Biopharmaceuticals
  • Zogenix
  • 기타 기업

제11장 시장 전망

  • 세계 시장
    • 시장 예측
    • 시장 성장 촉진요인 및 억제요인 : 세계적인 과제
  • 미국
  • 유럽 주요 5개국(5EU)
  • 일본

제12장 부록

LSH 18.01.25

영문목차

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 seizures. Epilepsy can be considered a spectrum disorder due to its different causes, different seizure types, and different disease severities. Many different epilepsy syndromes have been characterized, with some of these syndromes appearing to be hereditary, while others have unknown causes.

It is estimated that sales of anti-epileptic drugs (AEDs) in the epilepsy market were approximately $6.1B throughout the 7MM in 2016. The highest selling drug in the epilepsy market was UCB's Vimpat (lacosamide). With that global sales in the epilepsy market are expected to grow at a moderate Compound Annual Growth Rate (CAGR) of 2.1%. The main driver of growth will be the launch of five late-stage pipeline drugs, in particularly GW Pharmaceutical's Epidiolex (cannabidiol) and Zogenix'sfenfluramine, which target rare, orphan epilepsy syndromes.

The major drivers of growth in the epilepsy market during the forecast period include -

  • The launch and uptake of GW Pharmaceutical's Epidiolex and Zogenix'sfenfluramine, which are expected to be approved in Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
  • The launch and uptake of Upsher-Smith Laboratories' USL-261 and Neurelis' NRL-1, which will be approved for the treatment of acute repetitive seizures. These reformulations are expected to drastically increase compliance.
  • The high annual cost of therapy for pipeline drugs means they will generate high sales and drive growth.

Future key players in the epilepsy market are acquiring companies or entering into partnerships for the co-development and co-marketing of products into different regions of the 7MM. This strategy provides an effective method for companies to join efforts and resources, to share the costs and risks of R&D, and to maximize the commercial potential of the marketed products. Lundbeck is the company that has embraced this strategy more than others. It entered into a partnership with Sanofi to market Sabril and Onfi in the US, while Sanofi takes marketing responsibilities in the EU.

The report "PharmaPoint: Epilepsy - Global Drug Forecast and Market Analysis to 2026", provides overview of epilepsy, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

In particular, this report provides the following -

  • 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.

Companies mentioned in this report:GW Pharmaceuticals, Zogenix, UCB, Upsher-Smith Laboratories, Neurelis, Lundbeck, Sanofi, Pfizer, SK Biopharmaceuticals, Supernus Pharmaceuticals, Daiichi-Sankyo

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.

Table of Contents

1 Table of Contents 2

  • 1.1 List of Tables 7
  • 1.2 List of Figures 9

2 Executive Summary 10

  • 2.1 Epilepsy Market Anticipated To Grow to $7.5B by 2026 11
  • 2.2 Companies Targeting Niche Epilepsy Types 12
  • 2.3 Refractory Patients Are Still Underserved in the Epilepsy Market 14
  • 2.4 Market Opportunities for New Entrants 15
  • 2.5 Late-Stage Pipeline Drugs Will Be a Key Driver of Growth 16
  • 2.6 What Do Physicians Think? 17

3 Introduction 21

  • 3.1 Catalyst 21
  • 3.2 Related Reports 21
  • 3.3 Upcoming Related Reports 22

4 Disease Overview 23

  • 4.1 Classification of Seizures 25
  • 4.2 Etiology and Pathophysiology 28
    • 4.2.1 Etiology 28
    • 4.2.2 Pathophysiology 30
    • 4.2.3 Prognosis 34
    • 4.2.4 Quality of Life 35

5 Epidemiology 37

  • 5.1 Disease Background 37
  • 5.2 Risk Factors and Comorbidities 38
  • 5.3 Global and Historical Trends 39
    • 5.3.1 US 41
    • 5.3.2 5EU 42
    • 5.3.3 Japan 43
  • 5.4 Forecast Methodology 43
    • 5.4.1 Sources 44
    • 5.4.2 Forecast Assumptions and Methods 47
  • 5.5 Epidemiological Forecast for Epilepsy (2016-2026) 60
    • 5.5.1 Lifetime Diagnosed Prevalent Cases of Epilepsy 60
    • 5.5.2 Active Diagnosed Prevalent Cases of Epilepsy 61
    • 5.5.3 Age-Specific Active Diagnosed Prevalent Cases of Epilepsy 62
    • 5.5.4 Sex-Specific Active Diagnosed Prevalent Cases of Epilepsy 63
    • 5.5.5 Active Diagnosed Prevalent Cases by Seizure Type 64
    • 5.5.6 Drug Resistant Active Diagnosed Prevalent Cases 65
  • 5.6 Discussion 66
    • 5.6.1 Epidemiological Forecast Insight 66
    • 5.6.2 Limitations of the Analysis 68
    • 5.6.3 Strengths of the Analysis 69

6 Disease Management 70

  • 6.1 Diagnosis Overview 70
  • 6.2 Treatment Overview 74
    • 6.2.1 Treatment Guidelines and Leading Prescribed Drugs 74
    • 6.2.2 Clinical Practice 75
  • 6.3 US………. 84
  • 6.4 5EU……. 88
  • 6.5 Japan…. 91

7 Competitive Assessment 95

  • 7.1 Overview 95
  • 7.2 Product Profiles - Major Brands 96
    • 7.2.1 Aptiom/Zebinix (Eslicarbazepine Acetate) 96
    • 7.2.2 Banzel/Inovelon (Rufinamide) 102
    • 7.2.3 Briviact (Brivaracetam) 106
    • 7.2.4 Carnexiv (Carbamazepine IV) 110
    • 7.2.5 Fycompa (Perampanel) 113
    • 7.2.6 Keppra (Levetiracetam) 119
    • 7.2.7 Lamictal (Lamotrigine) 125
    • 7.2.8 Lyrica (Pregabalin) 133
    • 7.2.9 Onfi (Clobazam) 138
    • 7.2.10 Oxtellar XR (Oxcarbazepine ER) 141
    • 7.2.11 Qudexy XR (Topiramate ER) 145
    • 7.2.12 Sabril (Vigabatrin) 148
    • 7.2.13 Spritam (Levetiracetam) 153
    • 7.2.14 Trokendi XR (Topiramate ER) 155
    • 7.2.15 Vimpat (Lacosamide) 159
  • 7.3 Older-Generation AEDs 163

8 Unmet Needs and Opportunity Assessment 165

  • 8.1 Overview 165
  • 8.2 Improved Treatment Options for Treatment-Resistant Patients 166
    • 8.2.1 Unmet Need 166
    • 8.2.2 Gap Analysis 167
    • 8.2.3 Opportunity 168
  • 8.3 Curative or Disease-Modifying Therapies 169
    • 8.3.1 Unmet Need 169
    • 8.3.2 Gap Analysis 170
    • 8.3.3 Opportunity 170
  • 8.4 Treatments for Acute Repetitive Seizures 171
    • 8.4.1 Unmet Need 171
    • 8.4.2 Gap Analysis 171
    • 8.4.3 Opportunity 172
  • 8.5 Drugs with Improved Safety Profile 173
    • 8.5.1 Unmet Need 173
    • 8.5.2 Gap Analysis 174
    • 8.5.3 Opportunity 175
  • 8.6 Better Drug Formulations or Duration of Action 175
    • 8.6.1 Unmet Need 175
    • 8.6.2 Gap Analysis 176
    • 8.6.3 Opportunity 177

9 Pipeline Assessment 179

  • 9.1 Overview 179
  • 9.2 Clinical Trial Mapping 180
    • 9.2.1 Clinical Trials by Development Stage 180
  • 9.3 Promising Drugs in Clinical Development 181
    • 9.3.1 Cenobamate (YKP3089) 184
    • 9.3.2 Epidiolex (Cannabidiol) 188
    • 9.3.3 Fenfluramine (ZX-008) 196
    • 9.3.4 Diazepam (NRL-1) 203
    • 9.3.5 Midazolam (USL261) 207
  • 9.4 Other Drugs in Development 213

10 Current and Future Players 214

  • 10.1 Overview 214
  • 10.2 Trends in Corporate Strategy 217
  • 10.3 UCB……. 219
    • 10.3.1 Overview 219
    • 10.3.2 Portfolio Assessment 221
  • 10.4 Eisai……. 221
    • 10.4.1 Overview 221
    • 10.4.2 Portfolio Assessment 222
  • 10.5 Pfizer
    • 10.5.1 Overview 223
    • 10.5.2 Portfolio Assessment 223
  • 10.6 Lundbeck 224
    • 10.6.1 Overview 224
    • 10.6.2 Portfolio Assessment 225
  • 10.7 GW Pharmaceuticals 225
    • 10.7.1 Overview 225
    • 10.7.2 Portfolio Assessment 226
  • 10.8 SK Biopharmaceuticals 226
    • 10.8.1 Overview 226
    • 10.8.2 Portfolio Assessment 227
  • 10.9 Zogenix 227
    • 10.9.1 Overview 227
    • 10.9.2 Portfolio Assessment 228
  • 10.10 Other Companies 228
    • 10.10.1 Overview 228
    • 10.10.2 Portfolio Assessment 229

11 Market Outlook 230

  • 11.1 Global Markets 230
    • 11.1.1 Forecast 230
    • 11.1.2 Drivers and Barriers - Global Issues 232
  • 11.2 US … 232
    • 11.2.1 Forecast 232
    • 11.2.2 Key Events 235
    • 11.2.3 Drivers and Barriers 236
  • 11.3 5EU……. 236
    • 11.3.1 Forecast 236
    • 11.3.2 Key Events 238
    • 11.3.3 Drivers and Barriers 239
  • 11.4 Japan…
    • 11.4.1 Forecast 239
    • 11.4.2 Key Events 242
    • 11.4.3 Drivers and Barriers 243

12 Appendix 244

  • 12.1 Bibliography 244
  • 12.2 Abbreviations 268
  • 12.3 Methodology 272
  • 12.4 Forecasting Methodology 272
    • 12.4.1 Diagnosed Epilepsy Patients 273
    • 12.4.2 Percent Drug-Treated Patients 273
    • 12.4.3 Launch Dates and Patent and Market Exclusivity Expiry Dates 273
    • 12.4.4 General Pricing Assumptions 274
    • 12.4.5 Individual Drug Assumptions 275
    • 12.4.6 Generic Erosion 293
    • 12.4.7 Pricing of Pipeline Agents 293
  • 12.5 Physicians and Specialists Included in this Study 293
  • 12.6 Primary Research - Prescriber Survey 295
  • 12.7 About the Authors 296
    • 12.7.1 Co-Authors 296
    • 12.7.2 Therapy Area Director 296
    • 12.7.3 Epidemiologist 297
    • 12.7.4 Managing Epidemiologist 297
    • 12.7.5 Global Director of Therapy Analysis and Epidemiology 297
    • 12.7.6 Global Head and EVP of Healthcare Operations and Strategy 298
  • 12.8 About GlobalData 299
  • 12.9 Contact Us 299
  • 12.10 Disclaimer 299

List of Tables

  • Table 1: Epilepsy: Key Metrics in the 7MM 10
  • Table 2: Epilepsy Syndromes by Age at Onset (2010 Revised ILAE Classification) 24
  • Table 3: Description of the Symptoms and Characteristics Included in the Classification of Seizure Types by the ILAE 27
  • Table 4: Etiology of Epilepsy According to Age 28
  • Table 5: Etiology of Seizures 29
  • Table 6: Some of the Genes Involved in Epilepsy 30
  • Table 7: Risk Factors and Comorbidities for Epilepsy 39
  • Table 8: 7MM, Lifetime Diagnosed Prevalent Cases of Epilepsy, Men and Women, All Ages, Select Years 2016-2026. 61
  • Table 9: 7MM, Active Diagnosed Prevalent Cases of Epilepsy, Men and Women, All Ages, Select Years 2016-2026 62
  • Table 10: Summary of Diagnostic Tools for Epilepsy 71
  • Table 11: Treatment Guidelines for Epilepsy 75
  • Table 12: AED Options by Seizure Type 80
  • Table 13: Types of Epilepsy Surgery 83
  • Table 14: Country Profile - US 87
  • Table 15 Country Profile - 5EU 90
  • Table 16 Country Profile - Japan 93
  • Table 17: Leading Treatments for Epilepsy, 2017 96
  • Table 18: Product Profile - Aptiom/Zebinix 99
  • Table 19: Summary of Aptiom/Zebinix Efficacy 100
  • Table 20: Aptiom/Zepinix SWOT Analysis, 2017 101
  • Table 21: Product Profile - Banzel 104
  • Table 22: Summary of Banzel Efficacy 105
  • Table 23: Banzel SWOT Analysis, 2017 106
  • Table 24: Product Profile - Briviact 108
  • Table 25: Summary of Briviact Efficacy 109
  • Table 26: Briviact SWOT Analysis, 2017 110
  • Table 27: Product Profile - Carnexiv 112
  • Table 28: Carnexiv SWOT Analysis, 2017 113
  • Table 29: Product Profile - Fycompa 116
  • Table 30: Summary of Fycompa Efficacy 117
  • Table 31: Fycompa SWOT Analysis, 2017 118
  • Table 32: Product Profile - Keppra 121
  • Table 33: Summary of Keppra Efficacy 122
  • Table 34: Summary of Keppra XR Efficacy 123
  • Table 35: Keppra SWOT Analysis, 2017 124
  • Table 36: Product Profile - Lamictal 127
  • Table 37: Summary of Lamictal Efficacy 128
  • Table 38: Summary of Lamictal XR Efficacy 130
  • Table 39: Lamictal SWOT Analysis, 2017 132
  • Table 40: Product Profile - Lyrica 135
  • Table 41: Summary of Lyrica Efficacy 136
  • Table 42: Lyrica SWOT Analysis, 2017 137
  • Table 43: Product Profile - Onfi 139
  • Table 44: Summary of Onfi Efficacy 140
  • Table 45: Onfi SWOT Analysis, 2017 141
  • Table 46: Product Profile - Oxtellar XR 143
  • Table 47: Summary of Oxtellar XR Efficacy 143
  • Table 48: Oxtellar XR SWOT Analysis, 2017 144
  • Table 49: Product Profile - Qudexy XR 146
  • Table 50: Summary of Qudexy XR Efficacy 147
  • Table 51: Qudexy XR SWOT Analysis, 2017 148
  • Table 52: Product Profile - Sabril 150
  • Table 53: Summary of Sabril Efficacy 151
  • Table 54: Sabril SWOT Analysis, 2017 152
  • Table 55: Product Profile - Spritam 154
  • Table 56: Spritam SWOT Analysis, 2017 155
  • Table 57: Product Profile - Trokendi XR 157
  • Table 58: Trokendi XR SWOT Analysis, 2017 158
  • Table 59: Product Profile - Vimpat 161
  • Table 60: Summary of Vimpat Efficacy 162
  • Table 61: Vimpat SWOT Analysis, 2017 163
  • Table 62: Summary of Older Generation AEDs, 2017 164
  • Table 63: Promising Drugs in Clinical Development for Epilepsy, 2017 182
  • Table 64: Comparison of Drugs in Development for Epilepsy, 2017 183
  • Table 65: Product Profile - cenobamate 185
  • Table 66: Cenobamate Phase II Results 186
  • Table 67: cenobamate SWOT Analysis, 2017 187
  • Table 68: Product Profile - Epidiolex 192
  • Table 69: Epidiolex Phase III Results 193
  • Table 70: Epidiolex SWOT analysis, 2017 195
  • Table 71: Product Profile - Fenfluramine 199
  • Table 72: Fenfluramine SWOT analysis, 2017. 202
  • Table 73: Product Profile - NRL-1 205
  • Table 74 NRL-1 SWOT Analysis, 2017. 206
  • Table 75: Product Profile - USL261 209
  • Table 76 USL261 SWOT Analysis, 2017. 211
  • Table 77: Drugs in Development, 2017 213
  • Table 78: Key Companies in the Epilepsy Market in the 7MM, 2017. 215
  • Table 79: UCB's Disease Portfolio Assessment, 2017 221
  • Table 80: Eisai's Disease Portfolio Assessment, 2017 222
  • Table 81: Pfizer's Disease Portfolio Assessment, 2017 223
  • Table 82: Lundbeck's Disease Portfolio Assessment, 2017 225
  • Table 83: GW Pharmaceuticals' Disease Portfolio Assessment, 2017 226
  • Table 84: SK Biopharmaceuticals' Disease Portfolio Assessment, 2017 227
  • Table 85: Zogenix's Disease Portfolio Assessment, 2017 228
  • Table 86: other Players' Disease Portfolio Assessment, 2016 229
  • Table 87: Epilepsy Market - Global Drivers and Barriers, 2016-2026 232
  • Table 88: Key Events Impacting Sales for Epilepsy in the US, 2016-2026 235
  • Table 89: Epilepsy Market - US Drivers and Barriers, 2016-2026 236
  • Table 90: Key Events Impacting Sales for Epilepsy in the 5EU, 2016-2026 238
  • Table 91: Epilepsy Market - 5EU Drivers and Barriers, 2016-2026 239
  • Table 92: Key Events Impacting Sales for Epilepsy in Japan, 2016-2026 242
  • Table 93: Epilepsy Market - Global Drivers and Barriers, Japan, 2016-2026 243
  • Table 94: Key Launch Dates 273
  • Table 95: Key Patent/Exclusivity Expiries 274
  • Table 96: Physicians Surveyed, by Country 295
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