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主要先進国における多形膠芽腫(GBM)治療薬の予測:個別化ワクチンのドイツでの早期承認後の成功に左右される市場成長

Glioblastoma Multiforme Therapeutics in Major Developed Markets to 2020 - Growth to Hinge on the Success of Personalized Vaccine Following Early Approval in Germany

発行 GBI Research 商品コード 305018
出版日 ページ情報 英文 112 Pages
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主要先進国における多形膠芽腫(GBM)治療薬の予測:個別化ワクチンのドイツでの早期承認後の成功に左右される市場成長 Glioblastoma Multiforme Therapeutics in Major Developed Markets to 2020 - Growth to Hinge on the Success of Personalized Vaccine Following Early Approval in Germany
出版日: 2014年06月30日 ページ情報: 英文 112 Pages
概要

2012年から2019年にかけて、多形膠芽腫(GBM)市場の規模は3億500万ドルから5億8,300万ドルへと大幅に成長する見通しです。この成長の大部分は、樹状細胞ベースの治療ワクチンであるNorthwest BiotherapeuticsのDCVax-Lが市場に参入し、新たに診断を受けた患者への通常の治療に追加されることに起因するでしょう。臨床試験では通常の治療単独よりも優れたOSを示しており、第三相試験でもその有効性が示されれば、市場の高い可能性を期待できるでしょう。また、癌ワクチンRindopepimut(CDX-110)および標的治療のCotaraもGBM市場に参入する見通しです。しかし市場成長を促す力はDCVax-Lに及ばないでしょう。

当レポートでは、多形膠芽腫(GBM)治療薬の市場について調査し、多形膠芽腫の概要、治療方法、主な上市済み製品のプロファイル、パイプラインの状況、主な候補薬のプロファイル、世界および主要地域市場の成長予測、市場成長への影響因子の分析、関連事業者間の各種契約・提携などの動向をまとめています。

第1章 目次

第2章 イントロダクション

  • 多形膠芽腫について
  • 脳腫瘍の分類
  • 腫瘍の悪性度グレード
  • 多形膠芽腫の亜型
  • 病因
  • 病態生理
  • 症状
  • 診断
  • 予後
  • 疫学
  • 治療オプション
    • 外科手術
    • 放射線治療
    • 化学療法
    • 標的療法
    • 症状緩和の薬剤
    • その他の代替療法
  • 治療アルゴリズム

第3章 上市済み製品

  • Temodar(テモゾロミド)- Merck
  • Avastin(ベバシズマブ)- Roche
  • BiCNU(カルムスチン)・Gliadel Wafer(ポリフェプロザンカルムスチン)
    • BiCNU(カルムスチン) - Bristol-Myers Squibb
    • Gliadel Wafer(ポリフェプロザンカルムスチン) -エーザイ
  • 多形膠芽腫へのへの未承認/オフラベル利用
    • ロムスチン
    • カルボプラチン
    • シクロホスファミド
    • エトポシド
    • イリノテカン
  • 有効性・安全性の比較
  • アンメットニーズ

第4章 膠芽腫のパイプライン

  • パイプライン全体
  • 分子標的
  • 臨床試験
    • 規模
    • 期間
    • 開発パイプラインの失敗率
    • サマリー・リスク分析
  • 確実視されているパイプライン薬
    • DCVax-L - Northwest Biotherapeutics
    • Rindopepimut(CDX-110)- Celldex Therapeutics
    • Avastin(ベバシズマブ)- Roche
    • ICT-107 - ImmunoCellular Therapeutics
    • Cotara- Peregrine Pharmaceuticals
    • Eir-060- EirGen Pharma
    • 安全性・有効性のヒートマップ・競合事業者のマトリックス

第5章 市場予測

  • 地域別市場
    • 世界市場
    • 北米
    • 欧州主要5カ国
    • 日本
  • 成長推進因子・阻害因子

第6章 各種契約・戦略的提携

  • 主な共同開発契約
  • 主なライセンシング契約

第7章 付録

このページに掲載されている内容は最新版と異なる場合があります。詳細はお問い合わせください。

目次

Summary

GBI Research, a leading business intelligence provider, has released its latest research report, "Glioblastoma Multiforme Therapeutics in Major Developed Markets to 2020 - Growth to Hinge on the Success of Personalized Vaccine Following Early Approval in Germany".

Due to the poor prognosis under currently available treatments, therapies with high potency are in strong demand in the Glioblastoma Multiforme (GBM) market. In newly diagnosed patients, the current standard of care, comprising resection surgery, radiation therapy and chemotherapy with Merck's Temodar (temozolomide), has a maximum Overall Survival (OS) of 15 months and almost inevitable tumor recurrence. Current therapeutic options for recurrent GBM are Roche's Avastin (bevacizumab), carmustine and other chemotherapy drugs used off-label. However, they only offer limited OS benefit, leaving high unmet need in this patient segment.

During the 2013-2020 forecast period, the GBM market is expected to grow rapidly from $301m to $623m. The market entry of Northwest Biotherapeutics' DCVax-L, a dendritic cell-based therapeutic vaccine that acts as an add-on to the standard treatment in newly diagnosed patients, will account for much of this growth. Having demonstrated superior OS improvement compared with the standard treatment alone in clinical trials, it is expected to bear high market potential, given that its efficacy is translated into larger Phase III trials. The cancer vaccine Rindopepimut (CDX-110) and targeted therapy Cotara will also enter the GBM market, but will drive growth to a lesser extent. However, unmet needs are likely to remain in the relapsed setting over the forecast period due to the lack of superior OS benefits in the late-stage pipeline.

Scope

  • The report assesses the current GBM market and forecasts market trends to 2020, analyzing key drivers and barriers.The report includes -
  • A brief introduction to GBM, including the disease pathogenesis, risk factors and diagnosis
  • In-depth analysis of the drugs available for the treatment of GBM, including safety, efficacy, treatment patterns, and strengths and weaknesses, as well as a heat map comparing drugs in terms of safety and efficacy
  • A comprehensive review of the developmental pipeline for GBM, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period, with the pipeline analyzed by Phase distribution, molecule type and molecular target
  • Additional in-depth analysis of GBM clinical trials by Phase, molecule type, trial size, trial duration and program failure rate
  • Multi-scenario forecast data for the GBM market to 2020, taking into account the introduction of new drugs, the expiry of key patents and the changes in disease epidemiology across the key developed markets of the US, Canada, Japan, Germany, the UK, France, Italy and Spain
  • Discussion of the drivers of and barriers to market growth
  • Discussion of the licensing and co-development deals landscape in GBM

Reasons to buy

  • The report will assist business development and enable marketing executives who wish to strategize their product launches by allowing them to -
  • Understand the different levels of GBM therapies for newly diagnosed and recurrent GBM
  • Understand the vast scope of the pipeline and determine which molecule types and mechanisms of action are prominent
  • Observe the trends in clinical trial duration and size by clinical Phase and molecule type, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for GBM therapeutics
  • Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the GBM therapeutics market

Table of Contents

1. Table of Contents

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

2. Introduction

  • 2.1. Disease Introduction
  • 2.2. Classification of Brain Tumors
  • 2.3. Tumor Grading
  • 2.4. Subtypes of Glioblastoma Multiforme
  • 2.5. Etiology
  • 2.6. Pathophysiology
    • 2.6.1. Loss of Heterozygosity of Chromosome 10
    • 2.6.2. Epidermal Growth Factor Receptor Amplification
    • 2.6.3. Phosphatase and Tensin Homolog Mutation
    • 2.6.4. Loss of p53 Function
    • 2.6.5. p16INK4a Alteration and Loss of Normal Retinoblastoma 1 Function
    • 2.6.6. Isocitrate Dehydrogenase 1 or Isocitrate Dehydrogenase 2 Mutation
  • 2.7. Symptoms
  • 2.8. Diagnosis
  • 2.9. Prognosis
  • 2.10. Epidemiology
  • 2.11. Treatment options
    • 2.11.1. Surgery
    • 2.11.2. Radiotherapy
    • 2.11.3. Chemotherapy
    • 2.11.4. Targeted Therapy
    • 2.11.5. Drugs for symptoms relief
    • 2.11.6. Other alternative therapies
  • 2.12. Treatment algorithm

3. Marketed drugs

  • 3.1. Temodar (temozolomide). Merck
  • 3.2. Avastin (bevacizumab). Roche
  • 3.3. BiCNU (carmustine) and Gliadel Wafer (carmustine in polifeprosan)
    • 3.3.1. BiCNU (carmustine). Bristol-Myers Squibb
    • 3.3.2. Gliadel Wafer (carmustine in polifeprosan). Eisai
  • 3.4. Unlicensed/Off-label Use in Glioblastoma Multiforme
    • 3.4.1. Lomustine
    • 3.4.2. Carboplatin
    • 3.4.3. Cyclophosphamide
    • 3.4.4. Etoposide
    • 3.4.5. Irinotecan
  • 3.5. Comparative Efficacy and Safety
  • 3.6. Unmet needs

4. Glioblastoma Pipeline

  • 4.1. Overall Pipeline
  • 4.2. Molecular Targets
  • 4.3. Clinical Trials
    • 4.3.1. Clinical Trial Size
    • 4.3.2. Clinical Trial Duration
    • 4.3.3. Failure Rate of Developmental Pipeline
    • 4.3.4. Summary of Clinical Trial and Risk Analysis
  • 4.4. Promising Pipeline Candidates
    • 4.4.1. DCVax-L. Northwest Biotherapeutics
    • 4.4.2. Rindopepimut (CDX-110). Celldex Therapeutics
    • 4.4.3. Avastin (bevacizumab)- Roche
    • 4.4.4. ICT-107. ImmunoCellular Therapeutics
    • 4.4.5. Cotara- Peregrine Pharmaceuticals
    • 4.4.6. Eir-060- EirGen Pharma
    • 4.4.7. Heat Map of Safety and Efficacy and Product Competitiveness Framework for Glioblastoma Multiforme Pipeline

5. Market forecasts

  • 5.1. Geographical Markets
    • 5.1.1. Global Market
    • 5.1.2. North America
    • 5.1.3. Top Five Countries of Europe
    • 5.1.4. Japan
  • 5.2. Drivers and Barriers
    • 5.2.1. Drivers
    • 5.2.2. Barriers

6. Deals and Strategic Consolidations

  • 6.1. Major Co-Development Deals
    • 6.1.1. Del Mar Pharmaceuticals Enters into Agreement with Guangxi Wuzhou Pharmaceutical
    • 6.1.2. Immatics Biotechnologies Enters into Agreement with Cancer Research UK
  • 6.2. Major Licensing Deals
    • 6.2.1. ImmunoCellular Therapeutics Enters into Agreement with University of Pennsylvania
    • 6.2.2. Bexion Pharmaceuticals Enters into Agreement with Cincinnati Children's Hospital Medical Center
    • 6.2.3. Celldex Therapeutics Enters into Agreement with Duke University Brain Tumor Cancer Center

7. Appendix

  • 7.1. Sources
  • 7.2. Market Definition
  • 7.3. Abbreviations
  • 7.4. All Pipeline Products, by Phase
    • 7.4.1. Discovery
    • 7.4.2. Preclinical
    • 7.4.3. Phase I
    • 7.4.4. Phase II
    • 7.4.5. Phase III and Pre-registration
    • 7.4.6. Undisclosed stage of development
  • 7.5. Tabular Forecast Data
    • 7.5.1. Global
    • 7.5.2. US
    • 7.5.3. Canada
    • 7.5.4. UK
    • 7.5.5. France
    • 7.5.6. Germany
    • 7.5.7. Italy
    • 7.5.8. Spain
    • 7.5.9. Japan
  • 7.6. Research Methodology
  • 7.7. Coverage
    • 7.7.1. Secondary Research
  • 7.8. Therapeutic Landscape
    • 7.8.1. Forecasting
  • 7.9. Geographical Landscape
  • 7.10. Pipeline Analysis
  • 7.11. Competitive Landscape
    • 7.11.1. Expert Panel Validation
  • 7.12. Contact Us
  • 7.13. Disclaimer

List of Tables

  • Table 1: Glioblastoma Multiforme, Classification of Brain Tumors by the American Association of Neurological Surgeons
  • Table 2: Glioblastoma Multiforme, World Health Organization Classification of Glioma
  • Table 3: Glioblastoma Multiforme, Glioblastoma Multiforme, Karnofsky Performance Status Score (%)
  • Table 4: Glioblastoma Multiforme, Top Five Countries of Europe, Changes in Demographics, 1999-2013
  • Table 5: Discovery
  • Table 6: Preclinical and IND/CTA-filed
  • Table 7: Phase I
  • Table 8: Phase II
  • Table 9: Phase III and pre-registration
  • Table 10: Undisclosed stage of development
  • Table 11: Glioblastoma Multiforme, Global, Market Forecast, 2013-2020
  • Table 12: Glioblastoma Multiforme, US, Market Forecast, 2013-2020
  • Table 13: Glioblastoma Multiforme, Canada, Market Forecast, 2013-2020
  • Table 14: Glioblastoma Multiforme, UK, Market Forecast, 2013-2020
  • Table 15: Glioblastoma Multiforme, France, Market Forecast, 2013-2020
  • Table 16: Glioblastoma Multiforme, Germany, Market Forecast, 2013-2020
  • Table 17: Glioblastoma Multiforme, Italy, Market Forecast, 2013-2020
  • Table 18: Glioblastoma Multiforme, Spain, Market Forecast, 2013-2020
  • Table 19: Glioblastoma Multiforme, Japan, Market Forecast, 2013-2020

List of Figures

  • Figure 1: Glioblastoma Multiforme, Genetic Pathways to Primary and Secondary GBM and the Incidence of Mutations
  • Figure 2: Glioblastoma Multiforme, Treatment Algorithm for Glioblastoma Multiforme
  • Figure 3: Glioblastoma Multiforme, Treatment Options for Recurrent Glioblastoma Multiforme
  • Figure 4: Glioblastoma Multiforme, Global, Historical Sales of Temodar ($m), 2008-2013
  • Figure 5: Glioblastoma Multiforme, Global, Historical Sales of Avastin ($bn), 2004-2013
  • Figure 6: Glioblastoma Multiforme, Global, Historical Sales of Gliadel Wafer ($m), 2003-2006
  • Figure 7: Glioblastoma Multiforme , Global, Heat Map for Marketed Products, 2013
  • Figure 8: Glioblastoma Multiforme, Global, Overall Pipeline, 2013
  • Figure 9: Glioblastoma Multiforme, Global, Program Type by Phase and Molecular Targets, 2013
  • Figure 10: Glioblastoma Multiforme, Global, Mean Clinical Trial Size by Molecule Type (participants), 2006-2013
  • Figure 11: Glioblastoma Multiforme, Global, Mean Clinical Trial Duration by Molecule Type (Months), 2006-2013
  • Figure 12: Glioblastoma Multiforme, Global, Clinical Trial Failure Rate by Phase by Molecule Type, and Reasons for Failure, 2006-2013
  • Figure 13: Glioblastoma Multiforme, Global, Sales Forecast for DCVax-L ($m), 2014-2020
  • Figure 14: Glioblastoma Multiforme, Global, Sales Forecast for Rindopepimut ($m), 2017-2020
  • Figure 15: Glioblastoma Multiforme, Global, Sales Forecast for Cotara ($m), 2016-2020
  • Figure 16: Glioblastoma Multiforme, Global, Heat Map for Pipeline Products, 2013
  • Figure 17: Glioblastoma Multiforme, Global, Product Competitiveness Framework, 2013
  • Figure 18: Glioblastoma Multiforme, Global, Treatment Usage Patterns and Market Size, 2013-2020
  • Figure 19: Glioblastoma Multiforme, North America, Treatment Usage Patterns ('000), 2013-2020
  • Figure 20: Glioblastoma Multiforme, North America, Annual Cost of Treatment ($), 2013-2020
  • Figure 21: Glioblastoma Multiforme, North America, Market Size ($m), 2013-2020
  • Figure 22: Glioblastoma Multiforme, Top Five Countries of Europe, Treatment Usage Patterns ('000), 2013-2020
  • Figure 23: Glioblastoma Multiforme, Top Five Countries of Europe, Annual Cost of Treatment ($), 2013-2020
  • Figure 24: Glioblastoma Multiforme, Top Five Countries of Europe, Market Size ($m), 2013-2020
  • Figure 25: Glioblastoma Multiforme, Japan, Treatment Usage Patterns and Annual Cost of Treatment, 2013-2020
  • Figure 26: Glioblastoma Multiforme, Japan, Market Size ($m), 2013-2020
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