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市場調查報告書

主要已開發國家的多形性膠質母細胞瘤(GBM)治療藥的預測:受到個體化疫苗在德國早期核准後的成功所左右的市場成長

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

出版商 GBI Research 商品編碼 305018
出版日期 內容資訊 英文 112 Pages
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主要已開發國家的多形性膠質母細胞瘤(GBM)治療藥的預測:受到個體化疫苗在德國早期核准後的成功所左右的市場成長 Glioblastoma Multiforme Therapeutics in Major Developed Markets to 2020 - Growth to Hinge on the Success of Personalized Vaccine Following Early Approval in Germany
出版日期: 2014年06月30日 內容資訊: 英文 112 Pages
簡介

2012年2019年間,多形性膠質母細胞瘤(GBM)市場規模預測將從3億500萬美元大幅度成長到5億8,300萬美元。這個成長大部分是由於 樹狀細胞基治療疫苗Northwest Biotherapeutics的DCVax-L加入市場,加入接受新診斷的患者的一般療程中所帶來的。臨床實驗上顯示出比單獨治療更出色的OS,只要能在第三代實驗也展現出其效能,市場上應可望有高度潛力。此外預測癌症疫苗Rindopepimut(CDX-110)及標的治療Cotara也將打入了GBM市場。但一認為其推動市場成長力應不及DCVax-L。

本報告提供多形性膠質母細胞瘤(GBM)治療藥的市場相關調查,提供多形性膠質母細胞瘤概要,治療方法,主要已上市產品簡介,開發平台狀況,主要的候補藥簡介,全球及主要地區市場的成長預測,影響市場成長因素分析,並彙整相關經營者間的各種契約·聯盟等趨勢

第1章 目錄

第2章 簡介

  • 關於多形性膠質母細胞瘤
  • 腦瘤的分類
  • 腫瘤的惡性度等級
  • 多形性膠質母細胞瘤的亞形式
  • 病因
  • 病理生理學
  • 症狀
  • 診斷
  • 預測
  • 流行病學
  • 治療選擇
    • 外科手術
    • 放射治療
    • 化療
    • 標靶治療
    • 症狀緩和的藥物
    • 其他替代療法
  • 治療流程

第3章 已上市產品

  • Temodar(temozoromido)- Merck
  • Avastin(Bevacizumab)- Roche
  • BiCNU(Carmustine)·Gliadel Wafer(多fepurozankarumusuchin)
    • BiCNU(Carmustine) - Bristol-Myers Squibb
    • Gliadel Wafer(多fepurozankarumusuchin) -Eisai
  • 對多形性膠質母細胞瘤所利用的未核准/非標籤藥物
    • Lomustine
    • Carboplatin
    • Cyclophosphamide
    • Etoposide
    • Irinotecan
  • 有效性·安全性比較
  • 未滿足需求

第4章 動物膠芽腫的開發平台

  • 開發平台全體
  • 分子標的
  • 臨床試驗
    • 規模
    • 期間
    • 開發平台的失敗率
    • 摘要與風險分析
  • 確實被視為開發平台藥物
    • DCVax-L - Northwest Biotherapeutics
    • Rindopepimut(CDX-110)- Celldex Therapeutics
    • Avastin(Bevacizumab)- Roche
    • ICT-107 - ImmunoCellular Therapeutics
    • Cotara- Peregrine Pharmaceuticals
    • Eir-060- EirGen Pharma
    • 安全性·有效性的熱圖·競爭經營者的矩陣

第5章 市場預測

  • 各地區市場
    • 全球市場
    • 北美
    • 歐洲主要5個國家
    • 日本
  • 成長推進因素·阻礙要素

第6章 各種契約·策略性聯盟

  • 主要的共同開發契約
  • 主要的授權契約

第7章 附錄

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目錄

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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