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アジア太平洋地域の多形性膠芽腫(GBM)治療薬市場:新規診断/再発患者のアンメットニーズを対象とした、新たな治療アプローチ

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

発行 GBI Research 商品コード 310994
出版日 ページ情報 英文 105 Pages
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アジア太平洋地域の多形性膠芽腫(GBM)治療薬市場:新規診断/再発患者のアンメットニーズを対象とした、新たな治療アプローチ 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: 2014年08月20日 ページ情報: 英文 105 Pages
概要

アジア太平洋地域の多形性膠芽腫(GBM)治療薬市場は、2013年には4940万米ドルの規模に達しました。さらに2020年までの年平均成長率(CAGR)は11.5%、同年の市場規模は1億580万米ドルと予測されています。市場規模は日本が最大で、2013年現在で域内全体の48%を占めていますが、今後の成長率はインドが最高で、2020年までの平均成長率は14.4%と推計されています。現時点では、新規に診断された患者や再発患者に対する有効な治療薬が無く、外科手術・放射線治療の後にテモゾロミドを投与するのが標準的治療法となっています。現在、いくつかの新薬が治験段階にあり、それらが上市されれば、市場は大きく成長するものと思われます。

当レポートでは、アジア太平洋地域諸国における多形性膠芽腫(GBM)治療法の関連市場について分析し、疾患の概要や主な治療パターン、上市済み製品の概要(安全性・効能など)、現在開発中の治療薬のパイプライン情報、地域全体および主要国における市場動向の見通し(今後8年間の予測値)、資本取引・事業提携の動きなどを調査しております。

第1章 目次

第2章 イントロダクション

  • 疾患の概要
  • 脳腫瘍の分類
  • 腫瘍悪性度グレード分類
  • 多形性膠芽腫(GBM)のサブタイプ
  • 病因
  • 病態生理
    • 染色体のヘテロ接合度の喪失
    • 表皮成長因子受容体の拡大
    • ホスファターゼ・テンシン・ホモログ(PTEN)の突然変異
    • p53遺伝子の機能喪失
    • p16INK4aの改変と正常RB遺伝子-1の機能喪失
    • イソクエン酸デヒドロゲナーゼ-1/-2の突然変異
  • 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
    • 症状緩和用薬剤
    • その他の代替的療法
  • 治療アルゴリズム

第3章 上市済み製品

  • 主な上市済み製品
  • Temodar(テモゾロミド):Merck
  • Avastin(ベバシズマブ):Roche
  • BiCNU(カルムスチン)およびGliadel Wafer(ポリフェプロサン・カルムスチン)
    • BiCNU(カルムスチン):Bristol-Myers Squibb
    • Gliadel Wafer(ポリフェプロサン・カルムスチン):エーザイ
  • 多形性膠芽腫向けの未承認薬/適応外処方の利用
    • ロムスチン
    • カルボプラチン
    • テニポシド
  • 効能・安全性の比較分析
  • アンメットニーズ

第4章 パイプライン製品

  • パイプライン製品の概要
  • 分子標的
  • 治験
    • 治験の規模
    • 治験期間
    • パイプライン製品の損耗率
    • 治験関連指標の比較分析
    • 治験のサマリーとリスク評価
  • 有望なパイプライン候補
    • Rindopepimut (CDX-110):Celldex Therapeutics
    • Avastin(ベバシズマブ):Roche
    • Cotara:Peregrine Pharmaceuticals
    • BIOMAb(ニモツズマブ):BioCon
  • 効能・安全性のヒートマップ分析、およびパイプライン製品の競合状態の分析枠組み

第5章 市場の将来予測

  • アジア太平洋地域市場
  • オーストラリア
    • 治療法の利用パターン
    • 年間治療費
    • 市場規模
  • 中国
  • インド
  • 日本
  • 市場促進・抑制要因

第6章 資本取引と戦略的市場再編

  • 主な共同開発契約(全2件)
  • 主なライセンス契約(全6件)

第7章 付録

図表一覧

目次
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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