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市場調查報告書

亞太地區的多形性膠質母細胞瘤(GBM)治療藥市場:針對新診斷/復發患者的未滿足需求的新治療方法

Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM

出版商 GBI Research 商品編碼 310994
出版日期 內容資訊 英文 105 Pages
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亞太地區的多形性膠質母細胞瘤(GBM)治療藥市場:針對新診斷/復發患者的未滿足需求的新治療方法 Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM
出版日期: 2014年08月20日 內容資訊: 英文 105 Pages
簡介

亞太地區的多形性膠質母細胞瘤(GBM)治療藥市場在2013年達到4940萬美金的規模。一般更預測到2020年前將以年平均成長率(CAGR)11.5%的速度擴大,到該年市場規模將達到1億580萬美金。市場規模為日本最大,在2013年的當下佔區內整體的48%,但預測今後成長率將以印度為最高,到2020年前預估平均成長率將為14.4%。目前尚無針對新診斷出的患者及復發患者的有效治療藥,外科手術、放射線治療後給予Temozolomide是標準的治療方法。現在有無數的新藥正處於實驗階段,等這些產品上市,一般認為市場將大幅成長。

本報告提供亞太地區各國的多形性膠質母細胞瘤(GBM)治療方法相關市場分析,提供您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),現在正在開發的治療藥的開發平台資訊,地區整體及主要國的市場趨勢預測(今後8年的預測值),資本交易·產業聯盟的動向等資訊。

第1章 目錄

第2章 簡介

  • 疾病概要
  • 腦瘤的分類
  • 腫瘤惡性度等級分類
  • 多形性膠質母細胞瘤(GBM)的亞型
  • 病因
  • 病理生理學
    • 染色體缺失雜合性
    • 表皮生長因子受體的擴大
    • 磷酸酶同源基因突變
    • p53基因喪失功能
    • p16INK4a的改變和正常RB遺傳基因-1功能喪失
    • 異檸檬酸脫氫酶1或異檸檬酸脫氫酶2基因突變
  • 症狀
  • 診斷
  • 預後
  • 流行病學
  • 治療選擇
    • 外科手術
    • 放射治療
    • 化療
    • 標靶治療
    • 緩和症狀用藥物
    • 其他替代療法
  • 治療流程

第3章 已上市產品

  • 主要的已上市產品
  • Temodar(temozoromido):Merck
  • Avastin(Bevacizumab):Roche
  • BiCNU(Carmustine)及Gliadel Wafer(porifepurosan·Carmustine)
    • BiCNU(Carmustine):Bristol-Myers Squibb
    • Gliadel Wafer(porifepurosan·Carmustine):Eisai
  • 多形性膠質母細胞瘤的未認證核可藥/非適應症處方的利用
    • Lomustine
    • Carboplatin
    • teniposhido
  • 功效·安全性比較分析
  • 未滿足需求

第4章 開發中產品

  • 開發中產品的概要
  • 分子標的
  • 臨床實驗
    • 臨床實驗的規模
    • 臨床實驗期間
    • 開發中產品的損耗率
    • 臨床實驗相關指標比較分析
    • 臨床實驗的摘要與風險評估
  • 有前途的開發平台候補
    • Rindopepimut (CDX-110):Celldex Therapeutics
    • Avastin(Bevacizumab):Roche
    • Cotara:Peregrine Pharmaceuticals
    • BIOMAb(nimotsuzumabu):BioCon
  • 功效·安全性的熱圖分析,及開發中產品的競爭狀態分析架構

第5章 市場未來預測

  • 亞太地區市場
  • 澳洲
    • 治療方法的利用模式
    • 年度治療費用
    • 市場規模
  • 中國
  • 印度
  • 日本
  • 推動及阻礙市場要素

第6章 資本交易與策略性市場重組

  • 主要的共同開發契約(全2件)
  • 主要的授權合約(全6件)

第7章 附錄

圖表一覽

目錄
Product Code: GBIHC340MR

GBI Research, the leading business intelligence provider, has released its latest research, "Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM", which provides in-depth analysis of the Glioblastoma Multiforme (GBM) therapeutics market within the Asia-Pacific (APAC) region, covering Australia, China, India and Japan. The report provides estimates of market size for 2013, along with market forecasts until 2020. It also covers disease epidemiology, treatment algorithms, treatment patterns, and in-depth analysis of the marketed and pipeline products.

The value of the GBM market in the APAC region amounted to an estimated $49.4m in 2013, and is expected to register a Compound Annual Growth Rate (CAGR) of 11.5%, to reach $105.8m by 2020. The GBM market in India was the smallest of the APAC markets in 2013, but is expected to experience the highest growth rate in the forecast period, at a CAGR of 14.4%, due to having the highest number of promising candidates in the pipeline. Japan currently has the largest share of GBM market in the APAC region, at 48%, and is expected to experience healthy growth during the forecast period at a CAGR of 13.8%.

The existing treatment landscape is bleak for both newly diagnosed and recurrent GBM, with temozolomide alone serving as the standard of care after surgery and radiation. For first-line treatment Rindopepimut, a novel vaccine, is in late-stage development in India and Australia, but it is limited to EGFRvIII patients. There are two strong candidates in the current pipeline for second-line treatment: Avastin and Cotara. Avastin is the first and only targeted therapy for newly diagnosed GBM, is already approved as second-line treatment in Australia and Japan, and is in Phase III development in China and India. Cotara is a single-infusion drug with a novel delivery route, which is in Phase II development in India. The expected launch of these three drugs is the key driver for growth in APAC GBM market. As all are expensive, even a modest uptake will increase the annual cost of therapy, and subsequently the market size.

Scope

  • A brief introduction to GBM, including disease pathogenesis, risk factors, diagnosis, treatment options and algorithm
  • In-depth analysis of major marketed products, covering product performance, life-cycle, and a heat map depicting comparative analysis of safety and efficacy parameters
  • A comprehensive review of the GBM pipeline - including individual analysis of promising late-stage pipeline drugs that are likely to enter the market during the forecast period - analyzed on the basis of phase distribution, molecule types and molecular targets
  • Additional clinical trial analysis by phase, trial size, trial duration and program failure rate analyses, for each molecule type and mechanism of action
  • Multi-scenario forecasts of the GBM market from 2013 to 2020 in the four APAC countries
  • An overview of key licensing and co-development agreements that could have an impact on growth trends
  • Analysis of the key drivers and restraints that have had and are expected to have a significant impact on the market

Reasons to buy

  • Align your product portfolio to the markets with high growth potential
  • Develop market entry and expansion strategies by identifying the potential regions and therapeutic segments poised for strong growth
  • Devise a more effectively tailored strategy through the understanding of key drivers and barriers in the GBM market
  • Develop key strategic initiatives based on 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

Glioblastoma Multiforme Therapeutics Market in Asia-Pacific Region to Post High Growth to Reach $105.8m by 2020

The Glioblastoma Multiforme (GBM) therapeutics market in the four Asia-Pacific (APAC) markets of Australia, China, India and Japan was worth $49.4m in 2013, and is expected to grow at a Compound Annual Growth Rate (CAGR) of 11.5% to $105.8m by 2020. Japan was the largest of these markets in 2013, valued at $23.8m, equivalent to a share of 48%, closely followed by China at $19.7m or 40%. This significant expected growth is due to the probable approval and market entries of Rindopepimut (CDX-110), Cotara (TNT-1) and Avastin (bevacizumab) in some of the APAC regions during the forecast period.

India and Australia have more promising candidates for possible approval in the forecast period than China and Japan. The growth forecast for Japan, however, is still high, even though it has just one candidate in late-stage development that could be approved during the forecast period, due to recent approval of Avastin. Japan is expected to post a high CAGR of 13.8%, second only to India among the APAC countries. The GBM market in India is currently the smallest, estimated at $4.6m in 2013, but is expected to post the highest growth, at a CAGR of 14.4% until 2020. There are four promising GBM drugs in the pipeline in India that could have a significant impact on market growth - Rindopepimut and BIOMAb (nimotuzumab) for newly diagnosed GBM; Avastin and Cotara for treatment in the recurrent setting.

The pipeline presents two promising novel therapies - Rindopepimut and Cotara - that could have a significant bearing on the GBM market in the APAC region. Phase II studies of Rindopepimut demonstrated a relatively high median Overall Survival (OS), and a significant survival benefit when compared to historic controls treated with the standard of care. However, the vaccine is limited to the 30% of GBM patients who are Epidermal Growth Factor Receptor (EGFR) variant (v) III-positive. Phase II studies of Cotara showed similar OS to Avastin, with slightly better Progression Free Survival (PFS) improvement in recurrent GBM. As a single-infusion therapy, Cotara is likely to become a good alternative second-line treatment.

Pipeline Boasts High Diversity of Molecular Targets Despite Setbacks

Several targeted therapies have failed in late-stage development or have shown too little efficacy to be viable therapeutic alternatives. Growth Factor Receptors (GFR) are one of the most prevalent molecular targets in the GBM pipeline. Although EGFR gene amplification is the most common mutation seen in GBM patients, several drugs with EGFR as molecular targets have failed to demonstrate significant efficacy. Drugs that target EGFR but that failed to demonstrate significant benefit in improving median OS or PFS include Tarceva (erlotinib), Erbitux (cetuximab), and Iressa (gefitinib). Vascular Endothelial Growth Factor Receptor (VEGFR)-targeting drugs such as Recentin (cediranib) have also experienced some setbacks. Currently, Avastin (bevacizumab) is the only anti-VEGFR agent marketed for GBM. Despite these setbacks, the GBM pipeline consists of a sizeable share of drugs targeting GFRs - 35% - with some of them reaching late-stage development. EGFR inhibitors in the late-stage pipeline include ABT-414, gefitinib, AMG-595, and nimotuzumab. Similarly, 17% of the disclosed pipeline consists of kinases. While the majority of Phosphoinositide 3-Kinase (PI3K) inhibitors are unable to cross the Blood-Brain Barrier (BBB), 22% of the kinases in the GBM pipeline are PI3K inhibitors. PX-866, a PI3K inhibitor developed by Oncothyreon, was discontinued in Phase II development due to low efficacy. BKM-120 (buparlisib hydrochloride) is another PI3K inhibitor currently in Phase II trials for recurrent GBM. The current pipeline consists of a highly diverse set of molecular targets, which may potentially serve as effective treatments in the future.

Promising Future for Glioblastoma Multiforme Therapeutic Landscape

GBM is the most malignant of gliomas, which are an aggressive type of tumor with very poor prognosis, in spite of the improvements seen with the current standard of care temozolomide. There are very limited therapeutic alternatives currently available for newly diagnosed or recurrent GBM. Existing options include three chemotherapeutic agents - temozolomide, Gliadel Wafer (carmustine in polifeprosan) and BiCNU (carmustine); and Avastin, a monoclonal Antibody (mAb), which is the only approved targeted therapy. Extensive heterogeneity and the presence of the BBB are the two key challenges in the development of efficacious therapeutic options. Many of the existing chemotherapy drugs are hydrophilic and their molecular size is too large to penetrate the BBB and hence not suitable in the treatment of GBM.

There are some strong candidates in the current pipeline that promise to be effective agents in overcoming the BBB. Examples include BIOMAb (nimotuzumab) by Biocon, a mAb and an EGFR antagonist that binds preferentially to the cells overexpressing EGFR and holds promise in its capacity to cross the BBB; and Cotara, a targeted mAb developed by Peregrine Pharmaceuticals that uses Convection-Enhanced Delivery (CED) to overcome the BBB and is in Phase II trials for newly diagnosed GBM; and BKM-120 (buparlisib hydrochloride) developed by Novartis, a PI3K inhibitor in Phase II trials for recurrent GBM with proven ability to penetrate the BBB. Although a cure is not expected in the near future, the late-stage pipeline presents some strong candidates that have the potential to expand the therapeutic alternatives available for GBM.

Table of Contents

1. Table of Contents

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

2. Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - 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. Radiation Therapy
    • 2.11.3. Chemotherapy
    • 2.11.4. Targeted Therapy
    • 2.11.5. Drugs for Symptom Relief
    • 2.11.6. Other Alternative Therapies
  • 2.12. Treatment Algorithm

3. Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Marketed Products

  • 3.1. Key Marketed Products
  • 3.2. Temodar (temozolomide) - Merck
  • 3.3. Avastin (bevacizumab) - Roche
  • 3.4. BiCNU (carmustine) and Gliadel Wafer (carmustine in polifeprosan)
    • 3.4.1. BiCNU (carmustine) - Bristol-Myers Squibb
    • 3.4.2. Gliadel Wafer (carmustine in polifeprosan) - Eisai
  • 3.5. Unlicensed/Off-Label Use in Glioblastoma Multiforme
    • 3.5.1. Lomustine
    • 3.5.2. Carboplatin
    • 3.5.3. Teniposide
  • 3.6. Comparative Efficacy and Safety
  • 3.7. Unmet Needs

4. Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - 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. Rindopepimut (CDX-110) - Celldex Therapeutics
    • 4.4.2. Avastin (bevacizumab) - Roche
    • 4.4.3. Cotara - Peregrine Pharmaceuticals
    • 4.4.4. BIOMAb (nimotuzumab) - BioCon
  • 4.5. Heat Map of Safety and Efficacy and Product Competitiveness Framework for Glioblastoma Multiforme Pipeline

5. Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Market Forecast to 2020

  • 5.1. Asia-Pacific Market
    • 5.1.1. Treatment Use Patterns
    • 5.1.2. Market Size
  • 5.2. Australia
    • 5.2.1. Treatment Use Patterns
    • 5.2.2. Annual Cost of Therapy
    • 5.2.3. Market Size
  • 5.3. China
    • 5.3.1. Treatment Use Patterns
    • 5.3.2. Annual Cost of Therapy
    • 5.3.3. Market Size
  • 5.4. India
    • 5.4.1. Treatment Use Patterns
    • 5.4.2. Annual Cost of Therapy
    • 5.4.3. Market Size
  • 5.5. Japan
    • 5.5.1. Treatment Use Patterns
    • 5.5.2. Annual Cost of Therapy
    • 5.5.3. Market Size
  • 5.6. Drivers and Barriers for the Glioblastoma Multiforme Therapeutics in the Asia-Pacific Market to 2020
    • 5.6.1. Drivers
    • 5.6.2. Barriers

6. Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - 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. Eisai Received Marketing Authorization Holder License with Nobelpharma for Gliadel in Japan
    • 6.2.2. Teva Pharma Enters into Agreement with Perrigo for Generic Temozolomide
    • 6.2.3. SOM Biotech Enters into Licensing Agreement with Argon Pharma for SOM0777
    • 6.2.4. ImmunoCellular Therapeutics Enters into Agreement with University of Pennsylvania
    • 6.2.5. Bexion Pharmaceuticals Enters into Agreement with Cincinnati Children's Hospital Medical Center
    • 6.2.6. Celldex Therapeutics Enters into Agreement with Duke University Brain Tumor Cancer Center

7. Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Appendix

  • 7.1. Market Definitions
  • 7.2. Abbreviations
  • 7.3. Bibliography
  • 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. Market Forecasts to 2020
    • 7.5.1. Asia-Pacific
    • 7.5.2. Australia
    • 7.5.3. China
    • 7.5.4. India
    • 7.5.5. Japan
  • 7.6. Research Methodology
    • 7.6.1. Coverage
    • 7.6.2. Secondary Research
    • 7.6.3. Therapeutic Landscape
    • 7.6.4. Forecasting
    • 7.6.5. Geographical Landscape
    • 7.6.6. Pipeline Analysis
  • 7.7. Competitive Landscape
  • 7.8. Expert Panel Validation
  • 7.9. Contact Us
  • 7.10. Disclaimer

List of Tables

  • Table 1: Glioblastoma Multiforme, Classification of Brain Tumors by the American Association of Neurological Surgeons, 2014
  • Table 2: Glioblastoma Multiforme, World Health Organization Classification of Glioma, 2005
  • Table 3: Glioblastoma Multiforme, Karnofsky Performance Status Score (%), 1984
  • Table 4: Discovery
  • Table 5: Preclinical and IND/CTA-filed
  • Table 6: Phase I
  • Table 7: Phase II
  • Table 8: Phase III and pre-registration
  • Table 9: Undisclosed stage of development
  • Table 10: Glioblastoma Multiforme Therapeutics, Asia-Pacific, Forecast Data, 2013-2020
  • Table 11: Glioblastoma Multiforme Therapeutics, Australia, Forecast Data, 2013-2020
  • Table 12: Glioblastoma Multiforme Therapeutics, China, Forecast Data, 2013-2020
  • Table 13: Glioblastoma Multiforme Therapeutics, India, Forecast Data, 2013-2020
  • Table 14: Glioblastoma Multiforme Therapeutics, Japan, Forecast Data, 2013-2020

List of Figures

  • Figure 1: Glioblastoma Multiforme, Genetic Pathways to Primary and Secondary GBM and the Incidence of Mutations, 2014
  • Figure 2: Glioblastoma Multiforme, Treatment Algorithm for Glioblastoma Multiforme, 2014
  • Figure 3: Glioblastoma Multiforme, Treatment Options for Recurrent Glioblastoma Multiforme, 2014
  • 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 ($m), 2003-2006
  • Figure 7: Glioblastoma Multiforme , Global, Heat Map for Marketed Products, 2013
  • Figure 8: Glioblastoma Multiforme, Global, Overall Pipeline, 2013
  • Figure 9: Glioblastoma Multiforme, Global, Program Type by Phase and Molecular Targets, 2013
  • Figure 10: Glioblastoma Multiforme, Global, Mean Clinical Trial Size by Molecule Type, 2006-2013
  • Figure 11: Glioblastoma Multiforme, Global, Mean Clinical Trial Duration by Molecule Type (Months), 2006-2013
  • Figure 12: Glioblastoma Multiforme, Global, Clinical Trial Failure Rate by Phase by Molecule Type and Reasons for Failure, 2006-2013
  • Figure 13: Glioblastoma Multiforme, Asia-Pacific, Heat Map for Pipeline Products, 2013
  • Figure 14: Glioblastoma Multiforme, Asia-Pacific, Product Competitiveness Framework, 2013
  • Figure 15: Glioblastoma Multiforme Therapeutics, Asia-Pacific, Treatment Use Patterns ('000), 2013-2020
  • Figure 16: Glioblastoma Multiforme Therapeutics, Asia-Pacific, Market Size ($m), 2013-2020
  • Figure 17: Glioblastoma Multiforme Therapeutics, Australia, Treatment Use Patterns ('000), 2013-2020
  • Figure 18: Glioblastoma Multiforme Therapeutics, Australia, Annual Cost of Therapy ($), 2013-2020
  • Figure 19: Glioblastoma Multiforme Therapeutics, Australia, Market Size ($m), 2013-2020
  • Figure 20: Glioblastoma Multiforme Therapeutics, China, Treatment Use Patterns ('000), 2013-2020
  • Figure 21: Glioblastoma Multiforme Therapeutics, China, Annual Cost of Therapy ($), 2013-2020
  • Figure 22: Glioblastoma Multiforme Therapeutics, China, Market Size ($m), 2013-2020
  • Figure 23: Glioblastoma Multiforme Therapeutics, India, Treatment Use Patterns ('000), 2013-2020
  • Figure 24: Glioblastoma Multiforme Therapeutics, India, Annual Cost of Therapy ($), 2013-2020
  • Figure 25: Glioblastoma Multiforme Therapeutics, India, Market Size ($m), 2013-2020
  • Figure 26: Glioblastoma Multiforme Therapeutics, Japan, Treatment Use Patterns ('000), 2013-2020
  • Figure 27: Glioblastoma Multiforme Therapeutics, Japan, Annual Cost of Therapy ($), 2013-2020
  • Figure 28: Glioblastoma Multiforme Therapeutics, Japan, Market Size ($m), 2013-2020
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