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市場調查報告書

全球主要國家的癲癇治療藥市場:新的功能機制的新抗癲癇藥(AED)及治療模式的變化的徵兆

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

出版商 GBI Research 商品編碼 297630
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
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全球主要國家的癲癇治療藥市場:新的功能機制的新抗癲癇藥(AED)及治療模式的變化的徵兆 Epilepsy Therapeutics in Major Developed Markets to 2019 - New AEDs with Novel Mechanisms of Action Signal a Shift in Treatment Patterns
出版日期: 2014年03月14日 內容資訊: 英文
簡介

全球主要的先進國家(北美、歐洲、日本)的癲癇治療藥市場規模在2012年達到45億美元,一般推測到2019年前更將以年平均(CAGR)3.9%的速度成長,在2019年擴大到45億美金的規模。具有新功能機制的新一代治療藥在這十年間陸續開發,是市場成長的要素之一。但預計只有部分能真正上市推出。

本報告提供全球主要已開發國家(美國·法國·德國·義大利·西班牙·英國·日本·加拿大)的癲癇治療法的相關市場分析,提供疾病概要和主要的治療模式,已上市產品概要(安全性·功效等),目前開發中的治療藥管道資訊,地區整體及主要國家市場趨勢預測(今後8年的預測值),資本交易·產業聯盟的動向等調查,並將結果概述為以下內容。

第1章 目錄

第2章 簡介

  • 疾病概要
  • 流行病學
  • 症狀
  • 病因
  • 病理處理
  • 共生病症/併發症
  • 診斷
  • 預測
  • 治療效率
  • 治療選擇
    • 離子通道調控劑
    • GABA工作性的促進
    • 興奮性氨基酸抑制劑
    • 突觸調節劑
  • 非藥物療法
    • 肺葉切除(Lobectomy)及病灶切除手術(Lesionectomy)
    • 產酮飲食及改良式艾金斯低糖飲食療法
    • 迷走神經刺激

第3章 癲癇的治療環境

  • 概況
  • Lyrica (pregabalin)
  • Lamictal (lamotrigine)
  • Keppra (levetiracetam)
  • Zonegran (zonisamide)
  • Vimpat (lacosamide)
  • Aptiom/Zebinix (eslicarbazepine acetate)
  • Fycompa (perampanel)
  • Trobalt/Potiga (ezogabine/retigabine)
  • Banzel/Inovelon (rufinamide)
  • 上市產品的功效·安全性比較

第4章 癲癇治療藥的平台

  • 開發平台的整體情形
  • 各行動機制的平台
  • 臨床實驗
    • 失敗率
    • 參加的患者數和臨床實驗的規模
    • 臨床實驗的期間
  • 有前途的開發平台候補
    • Brivaracetam(UCB開發)
    • Ganaxolone(Marinus Pharmaceuticals開發)

第5章 癲癇的治療藥市場未來預測(今後6年份)

  • 各地區市場趨勢
    • 主要已開發國家
    • 美國
    • 歐洲主要5個國家
    • 日本
    • 加拿大
  • 推動及阻礙市場要素
    • 推動市場要素
    • 阻礙市場要素

第6章 資本交易與策略性的企業整合

  • 資本交易分析
  • 研究開發(R&D):共同開發契約
  • 研究開發(R&D):授權合約

第7章 附錄

圖表一覽

目錄
Product Code: GBIHC325MR

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

Abstract

Global Epilepsy Market Value to Reach $4.5 Billion by 2019 Thanks to Recent Drug Approvals, says GBI Research

The epilepsy therapeutics market value in the eight major countries - the US, Canada, France, Germany, Italy, Spain, the UK and Japan - will increase from $3.4 billion in 2012 to $4.5 billion by 2019, at a modest Compound Annual Growth Rate (CAGR) of 3.9%, says a new report from business intelligence provider GBI Research.

According to the report*, the US will grow at a higher CAGR of 4.8%, climbing from $1.9 billion in 2012 to $2.6 billion by 2019. Meanwhile, the five European countries and Canada will achieve a combined, smaller CAGR of 3.1% during the forecast period.

GBI Research attributes the anticipated market expansion to new Anti-Epileptic Drugs (AEDs) that have been approved during the last five years. However, further growth will be limited by the recent patent expiration of key AEDs, such as Keppra (levetiracetam) and Lamictal (lamotrigine).

Vijaya Vulapalli, Senior Analyst for GBI Research, says: "The epilepsy treatment arena has historically been dominated by Gamma Aminobutyric Acid modulators and ion channel blockers, although a sizeable proportion of patients don't respond to these existing treatment options.

"Second-generation AEDs, including levetiracetam, zonisamide and Vimpat (lacosamide), have signalled a shift in this trend in the last decade, with improved tolerability and safety through the use of new mechanisms of action. Recent approvals of Fycompa (perampanel) and Trobalt (retigabine) have continued this innovation by focusing on new molecular targets."

With most of the molecules being approved in the last few years, the current epilepsy pipeline is very weak. Phase III trials account for 18% of the overall pipeline, but the majority of these late-stage molecules are reformulations or line extensions of existing drugs.

"Furthermore, the recent epilepsy pipeline does not boast drugs with novel mechanisms of action, which are considered by most prescribers as an urgent need in epilepsy therapeutics today," Vulapalli concludes.

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

This report provides a comprehensive review of the epilepsy pipeline, including individual analysis of promising late-stage pipeline drugs that are most likely to enter the market during the forecast period. Additional clinical trial analysis by Phase, trial size, trial duration and program failure rate for each molecule type and mechanism of action is also included.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Disease Overview
  • 2.2. Epidemiology
  • 2.3. Symptoms
  • 2.4. Etiology
  • 2.5. Pathophysiology
  • 2.6. Co-morbidities/Complications
  • 2.7. Diagnosis
  • 2.8. Prognosis
  • 2.9. Treatment Efficacy
  • 2.10. Treatment Options
    • 2.10.1. Ion Channel Modulators
    • 2.10.2. GABA-ergic Facilitation
    • 2.10.3. Excitatory Amino Acid Inhibitors
    • 2.10.4. Synaptic Modulators
  • 2.11. Non-pharmacological Management
    • 2.11.1. Lobectomy and Lesionectomy
    • 2.11.2. Ketogenic Diet and Modified Atkins Diet
    • 2.11.3. Vagus Nerve Stimulation

3. Epilepsy Therapeutic Landscape

  • 3.1. Overview
  • 3.2. Lyrica (pregabalin)
  • 3.3. Lamictal (lamotrigine)
  • 3.4. Keppra (levetiracetam)
  • 3.5. Zonegran (zonisamide)
  • 3.6. Vimpat (lacosamide)
  • 3.7. Aptiom/Zebinix (eslicarbazepine acetate)
  • 3.8. Fycompa (perampanel)
  • 3.9. Trobalt/Potiga (ezogabine/retigabine)
  • 3.10. Banzel/Inovelon (rufinamide)
  • 3.11. Comparative Efficacy and Safety of Marketed Products

4. Pipeline for Epilepsy Therapeutics

  • 4.1. Overall Pipeline
  • 4.2. Pipeline by Mechanism of Action
  • 4.3. Clinical Trials
    • 4.3.1. Failure Rate
    • 4.3.2. Patient Enrolment and Clinical Trial Size
    • 4.3.3. Clinical Trial Duration
  • 4.4. Promising Pipeline Candidates
    • 4.4.1. Brivaracetam - UCB
    • 4.4.2. Ganaxolone - Marinus Pharmaceuticals

5. Epilepsy Therapeutics Market Forecast to 2019

  • 5.1. Geographical Markets
    • 5.1.1. Major Developed Markets
    • 5.1.2. The US
    • 5.1.3. Top Five EU Countries
    • 5.1.4. Japan
    • 5.1.5. Canada
  • 5.2. Drivers and Barriers
    • 5.2.1. Drivers
    • 5.2.2. Barriers

6. Deals and Strategic Consolidations

  • 6.1. Deals Analysis
  • 6.2. Research and Development Co-development Agreements
  • 6.3. Research and Development Licensing Agreements

7. Appendix

  • 7.1. Abbreviations
  • 7.2. References
  • 7.3. References for Heat Maps
  • 7.4. Pipeline Products by Phase
    • 7.4.1. Discovery
    • 7.4.2. Preclinical
    • 7.4.3. IND-filed and Phase 0
    • 7.4.4. Phase I
    • 7.4.5. Phase II
    • 7.4.6. Phase III
    • 7.4.7. Pre-registration
  • 7.5. Market Forecasting Data Tables to 2019
    • 7.5.1. Major Developed Markets
    • 7.5.2. US
    • 7.5.3. UK
    • 7.5.4. France
    • 7.5.5. Germany
    • 7.5.6. Italy
    • 7.5.7. Spain
    • 7.5.8. Japan
    • 7.5.9. Canada
  • 7.6. Research Methodology
    • 7.6.1. Coverage
    • 7.6.2. Secondary Research
    • 7.6.3. Primary Research
    • 7.6.4. Therapeutic Landscape
    • 7.6.5. Geographical Landscape
    • 7.6.6. Pipeline Analysis
  • 7.7. Expert Panel Validation
  • 7.8. Contact Us
  • 7.9. Disclaimer

List of Tables

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

List of Figures

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