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OpportunityAnalyzer:膀胱がんの世界市場 - 市場機会の分析と将来予測

OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2017

発行 GlobalData 商品コード 293248
出版日 ページ情報 英文 191 Pages
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OpportunityAnalyzer:膀胱がんの世界市場 - 市場機会の分析と将来予測 OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2017
出版日: 2015年12月19日 ページ情報: 英文 191 Pages
概要

膀胱がん市場はこの10〜20年間は大きく変化しませんでしたが、様々な新規治療法が新たに導入されたことにより、2016年からは急激な成長を遂げると見られています。さらに、多数のパイプライン製品が治験の初期段階に突入しており、それが今後の市場成長に大きく貢献する見通しです。現在はジェネリック医薬品による化学療法・免疫療法が主に使われていますが、これらは初期段階では有効なものの、毒性や全体的な生存率引き上げといった課題があります。大手製薬企業はこれまでは膀胱がんの分野には関心を払ってきませんでしたが、上記のような新規治療法の開発の可能性や、巨大なアンメットニーズの存在を踏まえて、急速に関心を高めつつあります。

当レポートでは、膀胱癌の治療法の研究・開発の最新動向調査と、関連市場の将来予測とを実施し、疾患の概要や現段階の治療法、アンメットニーズ・市場機会の評価、今後10年間の発症件数の予測値、臨床試験の進行状況、新規治療薬のパイプライン評価、今後の市場動向などを調査・予測しております。

第1章 目次

第2章 イントロダクション

第3章 疾患の概要

  • 病因と病態生理
    • 病因
    • 病態生理
    • 臨床病期
  • 予後
  • QoL (生活の質)
  • 症状
  • 診断

第4章 疫学

  • 疾患の背景事情
  • リスク要因と共存症
    • 喫煙が膀胱がんの最大のリスク要因である
    • 男性の膀胱がん患者の最大25%が、業務中に芳香族アミンに晒されたことが原因である
  • 世界的動向
    • 有病者数、死亡率、今後5年間の発症件数見通し
    • 相対的な生存率
    • 障害調整生命年 (DALY) と損失生存年数 (YLL)
  • 予測手法
    • 利用した情報源
    • 利用しなかった情報源
    • 予測の前提条件と手法
  • 膀胱がんの疫学的予測
    • 膀胱がんの発症件数 (全体)
    • 膀胱がんの発症件数 (年齢別)
    • 膀胱がんの発症件数 (男女別)
    • 年齢調整済みの膀胱がん発症件数
    • 膀胱がんの発症件数 (診断時のステージ別)
    • 膀胱がんの5年有病者数
  • 議論
    • 疫学的傾向に関する考察
    • 分析の限界
    • 分析の強み

第5章 現在の治療オプション

  • 概要
  • 製品プロファイル:主要ブランド
    • 膀胱内部のBCG (カルメット-ゲラン桿菌)
    • GemCis (ゲムシタビン/シスプラチン)
    • マイトマイシンC
    • Valstar (バルルビシン)
    • Javlor (ビンフルニン二酒石酸塩)

第6章 アンメットニーズの評価と機会分析

  • 概要
  • アンメットニーズの分析
    • NMIBC (筋層非浸潤性膀胱がん) の治療率の改善
    • NMIBC患者の疾患進行防止のための治療
    • NMIBCのより効果的な治療法
    • プラチナ抵抗性/不耐性転移患者向けの治療オプション
    • 予測用バイオマーカーの不足
    • 初診・切除成功率の改善
  • 市場機会の分析
    • NMIBC環境下でのBCG療法の代替手段
    • 重症患者へのBCG療法が失敗した際のサルベージ療法
    • 第一線の筋層浸潤・転移患者の治療基準の再定義
    • プラチナ抵抗性患者のための新たな治療法
    • 膀胱がん治療のための免疫系の強化
    • 予測用バイオマーカー・標的治療薬の選定
    • ネオアジュバント療法 (術前補助化学療法)
    • コンパニオン診断検査

第7章 研究開発 (R&D) 戦略

  • 概要
    • 小規模な製薬企業による薬剤開発
    • BCG療法の成功:更なる免疫療法戦略への兆候
    • NMIBCの膀胱内アプローチが今後、組織的アプローチに代替される可能性
  • 治験のデザイン
    • 登録動向の研究:非盲検・非比較の治験デザインが未だに通用している
    • NMIBC・転移セッティングで利用されている、様々な治験のエンドポイント

第8章 パイプライン分析

  • 概要
  • 治験中の有望な薬剤
    • MCNA
    • Apaziquone
    • Keytruda (ペンブロリズマブ)
    • アテゾリズマブ
    • Cyramza (ラムシルマブ)
    • Vicinium (Oportuzumab Monatox)
    • Durvalumab
    • CG-0070
    • Apatorsen
    • Opdivo (ニボルマブ)
  • 早期段階の革新的なアプローチ
    • 免疫療法
    • 標的療法

第9章 パイプライン評価の分析

  • 主なパイプライン薬剤の臨床面での基準
  • 主なパイプライン薬剤の商業面での基準
  • 競争力の評価
  • 今後5年間の売上高の予測
    • 米国
    • 欧州主要5ヶ国

第10章 付録

図表一覧

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目次
Product Code: GDHC015EPOA

The bladder cancer market has remained largely unchanged in the past 10-20 years. However, significant expansion is expected starting in 2016, with the introduction of several new therapies that are projected to fuel market growth. In addition, bladder cancer has a robust early-stage pipeline that will contribute to market growth beyond the forecast period of 2012-2017. Currently, the bladder cancer market is dominated by generic chemotherapy and immunotherapy. Though initially effective, toxicity and lack of clinical efficacy in improving overall survival have left the door open for more tolerable and effective drugs to be developed. In the past, bladder cancer has not been an area of focus for pharmaceutical companies, but that is rapidly changing as more companies focus on the bladder cancer market, recognizing the high level of unmet need and relatively clear regulatory path. During the forecast period, the market landscape will begin to change dramatically with the introduction of targeted immunotherapies. These drugs will provide much-needed alternatives to bladder cancer patients who have not benefitted from traditional treatments.

Highlights

Key Questions Answered

  • The bladder cancer market is poised to undergo rapid expansion during the forecast period and beyond. What are the main drivers of this expansion? What are the main barriers that could dampen this expansion?
  • The bladder cancer market is plagued by the presence of high unmet needs not addressed by current treatments. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the bladder cancer market?
  • The current bladder cancer market is highly generic. How will the introduction of targeted immunotherapies, including the much-anticipated PD-1/PD-L1 class of immune checkpoint inhibitors, change the market landscape?

Key Findings

  • The main driver of the rapid expansion of the bladder market will be the launch of several highly anticipated drugs into the market starting in 2016.
  • The second largest driver will be the forecast increase in number of incident cases in bladder cancer.
  • To gain approval, it is essential for companies to demonstrate efficacy in delaying recurrence, but not necessarily improvement in overall survival. Thus, the bar for approval in bladder cancer is low.
  • In the future, companies will have to differentiate their drugs from others in the same class in order to successfully compete for patient share.
  • The number of pipeline agents being developed by small to mid-sized companies represents an opportunity for large pharma to enter this highly lucrative market through licensing and marketing partnerships.

Scope

  • Overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized bladder cancer therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2012 and forecast for 5 years to 2017.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the bladder cancer therapeutics market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global bladder cancer therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
  • Develop business strategies by understanding the trends shaping and driving the global bladder cancer therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global bladder cancer therapeutics market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the global bladder cancer therapeutics market from 2012-2017.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1. Table of Contents

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

2. Introduction

  • 2.1. Catalyst
  • 2.2. Related Reports
  • 2.3. Upcoming Related Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
    • 3.1.3. Clinical Staging
  • 3.2. Prognosis
  • 3.3. Quality of Life
  • 3.4. Symptoms
  • 3.5. Diagnosis

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Co-morbidities
    • 4.2.1. Smoking is the most significant risk factor for bladder cancer
    • 4.2.2. Up to 25% of male bladder cancer cases are due to occupational exposure to aromatic amines
  • 4.3. Global and Historical Trends
    • 4.3.1. Incidence, Mortality, and Five-Year Prevalence
    • 4.3.2. Relative Survival
    • 4.3.3. Disability-Adjusted Life Years and Years of Life Lost
  • 4.4. Forecast methodology
    • 4.4.1. Sources used
    • 4.4.2. Forecast assumptions and methods
    • 4.4.3. Sources not used
  • 4.5. Incident/Prevalent Cases of Bladder Cancer
    • 4.5.1. Incident Cases of Bladder Cancer
    • 4.5.2. Age-Specific Incident Cases of Bladder Cancer
    • 4.5.3. Sex-Specific Incident Cases of Bladder Cancer
    • 4.5.4. Age-Standardized Incidence Rates of Bladder Cancer
    • 4.5.5. Incident Cases of Bladder Cancer by Stage at Diagnosis
    • 4.5.6. Five-Year Prevalent Cases of Bladder Cancer
  • 4.6. Discussion
    • 4.6.1. Epidemiological Forecast Insight
    • 4.6.2. Limitations of the Analysis
    • 4.6.3. Strengths of the Analysis

5. Current Treatment Options

  • 5.1. Overview
  • 5.2. Product Profiles- Major Brands
    • 5.2.1. Intravesical Bacillus Calmette-Guerin
    • 5.2.2. GemCis (Gemcitabine/Cisplatin)
    • 5.2.3. Mitomycin c
    • 5.2.4. Valstar (Valrubicin)
    • 5.2.5. Javlor (Vinfluinine Ditartrate)

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Higher Cure Rate for Patients with NMIBC
    • 6.2.2. Therapies that Prevent Disease Progression in Patients with NMIBC
    • 6.2.3. More Efficacious Therapies for Muscle-Invasive and Metastatic Bladder Cancer
    • 6.2.4. Treatment Options for Platinum-Refractory/Intolerant Metastatic Patients
    • 6.2.5. Lack of Predictive Biomarkers
    • 6.2.6. Improved Initial Diagnosis and Resection Success Rates
  • 6.3. Opportunity Analysis
    • 6.3.1. Replacement for BCG Therapy in the NMIBC Setting
    • 6.3.2. Salvage Therapy after BCG Failure in High-Grade Patients
    • 6.3.3. Redefining the Standard of Care for First-Line Muscle-Invasive and Metastatic Patients
    • 6.3.4. Novel Treatments for Platinum-Refractory Patients
    • 6.3.5. Leveraging the Immune System to Fight Bladder Cancer
    • 6.3.6. Identification of Predictive Biomarkers and Targeted Drugs
    • 6.3.7. Neoadjuvant Therapy
    • 6.3.8. Companion Diagnostic Tests

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Drug Development by Small Pharmaceutical Companies
    • 7.1.2. Success of BCG Therapy is a Signal for Further Immunotherapy Strategies
    • 7.1.3. Intravesical Approaches for NMIBC May Give Way to Systemic Approaches in the Future
  • 7.2. Clinical trial design
    • 7.2.1. Registrational Studies: Open-Label, Non-Comparative Trial Designs Still Prevalent
    • 7.2.2. A Variety of Trial Endpoints are Used in the NMIBC and Metastatic Settings

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising drugs in clinical development
    • 8.2.1. MCNA
    • 8.2.2. Apaziquone
    • 8.2.3. Keytruda (Pembrolizumab)
    • 8.2.4. Atezolizumab
    • 8.2.5. Cyramza (Ramucirumab)
    • 8.2.6. Vicinium (Oportuzumab Monatox)
    • 8.2.7. Durvalumab
    • 8.2.8. CG-0070
    • 8.2.9. Apatorsen
    • 8.2.10. Opdivo (Nivolumab)
  • 8.3. Innovative Early-stage Approaches
    • 8.3.1. Immunotherapies
    • 8.3.2. Targeted Therapies

9. Pipeline Valuation Analysis

  • 9.1. Clinical Benchmark of Key Pipeline Drugs
  • 9.2. Commercial Benchmark of Key Pipeline Drugs
  • 9.3. Competitive Assessment
  • 9.4. Top Line Five Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. Diagnosed Bladder Cancer patients
    • 10.4.2. Percent Drug-treated Patients
    • 10.4.3. Drugs Included in Each Therapeutic Class
    • 10.4.4. Reconciliation of Epidemiological Staging with Clinical Staging
    • 10.4.5. Launch and Patent Expiry Dates
    • 10.4.6. General Pricing Assumptions
    • 10.4.7. Individual Drug Assumptions
    • 10.4.8. Generic Erosion
  • 10.5. Physicians and Specialists Included in this Study
  • 10.6. About the Authors
    • 10.6.1. Author
    • 10.6.2. Therapy Area Director
    • 10.6.3. Epidemiologist
    • 10.6.4. Global Director of Therapy Analysis and Epidemiology
    • 10.6.5. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: AJCC TNM Staging System for Bladder Cancer - Definitions of Stages
  • Table 2: Bladder Cancer Prognosis by Stage
  • Table 3: Symptoms of Bladder Cancer
  • Table 4: Bladder Cancer Risk Factors
  • Table 5: 6MM, GLOBOCAN Incidence, Five-Year Prevalence, and Mortality for Bladder Cancer, Ages ≥15 Years, Men and Women, 2008
  • Table 6: 6MM, Relative Survival of Bladder Cancer (%), Men and Women
  • Table 7: 6MM, GLOBOCAN DALYs and YLLs Due to Bladder Cancer, Men and Women, N, 2008
  • Table 8: 6MM, Sources of Bladder Cancer Incidence Data
  • Table 9: 6MM, Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, Selected Years, 2012-2022
  • Table 10: 6MM, Age-Specific Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N (Row %), 2012
  • Table 11: 6MM, Sex-Specific Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N (Row %), 2012
  • Table 12: 6MM, Incident Cases of Bladder Cancer by Stage at Diagnosis, Ages ≥15 Years, Men and Women, N (Row %), 2012
  • Table 13: 6MM, Five-Year Prevalent Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, Selected Years, 2012-2022
  • Table 14: Leading Treatments for Bladder Cancer
  • Table 15: Product Profile - TICE-BCG
  • Table 16: Efficacy of BCG (TheraCys)
  • Table 17: Safety of BCG
  • Table 18: BCG SWOT Analysis
  • Table 19: Product Profile - GemCis
  • Table 20: Efficacy of GemCis
  • Table 21: Safety of GemCis
  • Table 22: GemCis SWOT Analysis
  • Table 23: Product Profile - Mitomycin C
  • Table 24: Efficacy of Mitomycin C
  • Table 25: Safety of Mitomycin C
  • Table 26: Mitomycin C SWOT Analysis
  • Table 27: Product Profile - Valstar
  • Table 28: Efficacy of Valstar
  • Table 29: Safety of Valstar
  • Table 30: Valstar SWOT Analysis
  • Table 31: Product Profile - Javlor
  • Table 32: Efficacy of Javlor
  • Table 33: Safety of Javlor
  • Table 34: Javlor SWOT Analysis
  • Table 35: Overall Unmet Needs - Current Level of Attainment
  • Table 36: Clinical Trial Design of Key Pipeline Drugs in the NMIBC Setting
  • Table 37: Clinical Trial Design of Key Pipeline Drugs in the MIBC and Metastatic Settings
  • Table 38: Bladder Cancer - Late-Stage Pipeline, 2015
  • Table 39: Product Profile - MCNA
  • Table 40: Efficacy of MCNA
  • Table 41: Safety of MCNA
  • Table 42: MCNA SWOT Analysis
  • Table 43: Product Profile - Apaziquone
  • Table 44: Efficacy of Apaziquone
  • Table 45: Safety of Apaziquone
  • Table 46: EOquin SWOT Analysis
  • Table 47: Product Profile -Keytruda
  • Table 48: Efficacy of Keytruda
  • Table 49: Safety of Keytruda
  • Table 50: Keytruda SWOT Analysis
  • Table 51: Product Profile - Atezolizumab
  • Table 52: Efficacy of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer
  • Table 53: Efficacy of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer Previously Treated with Chemotherapy
  • Table 54: Safety of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer
  • Table 55: Safety of Atezolizumab in Patients with Locally Advanced or Metastatic Bladder Cancer Previously Treated with Platinum-Based Chemotherapy
  • Table 56: Atezolizumab SWOT Analysis
  • Table 57: Product Profile - Cyramza
  • Table 58: Efficacy of Cyramza
  • Table 59: Safety of Cyramza in Combination with Docetaxel
  • Table 60: Cyramza SWOT Analysis
  • Table 61: Product Profile -Vicinium
  • Table 62: Efficacy of Vicinium
  • Table 63: Safety of Vicinium
  • Table 64: Vicinium SWOT Analysis
  • Table 65: Product Profile - Durvalumab
  • Table 66: Efficacy of Durvalumab
  • Table 67: Durvalumab SWOT Analysis
  • Table 68: Product Profile - CG-0070
  • Table 69: Efficacy of CG-0070
  • Table 70: Safety of CG-0070
  • Table 71: CG-0070 SWOT Analysis
  • Table 72: Product Profile - Apatorsen
  • Table 73: Efficacy of Apatorsen
  • Table 74: Safety of Apatorsen
  • Table 75: Apatorsen SWOT Analysis
  • Table 76: Product Profile - Opdivo
  • Table 77: Efficacy of Opdivo
  • Table 78: Opdivo SWOT Analysis
  • Table 79: Early-Stage Pipeline Products in Bladder Cancer
  • Table 80: Clinical Benchmarking of Key Pipeline Drugs - NMIBC setting
  • Table 81: Clinical Benchmarking of Key Pipeline Drugs - MIBC and Metastatic Settings
  • Table 82: Commercial Benchmarking of Key Pipeline Drugs - NMIBC setting
  • Table 83: Commercial Benchmarking of Key Pipeline Drugs - MIBC and Metastatic Settings
  • Table 84: Top Line Sales Forecasts ($) for Bladder Cancer, 2012-2017
  • Table 85: Key Events Impacting Sales for Bladder Cancer, 2012-2017
  • Table 86: Bladder Cancer Market - Drivers and Barriers, US and EU, 2012-2017
  • Table 87: Key Launch Dates

List of Figures

  • Figure 1: Bladder Cancer Staging Systems
  • Figure 2: Primary Tumor Development in Bladder Cancer
  • Figure 3: 6MM, Incidence Rates of Bladder Cancer, Ages ≥15 Years, Men, Rate per 100,000 Population, 1993-2002
  • Figure 4: 6MM, Incidence Rates of Bladder Cancer, Ages ≥15 Years, Women, Rate per 100,000 Population, 1993-2002
  • Figure 5: 6MM, Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, Selected Years, 2012-2022
  • Figure 6: 6MM, Age-Specific Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, 2012
  • Figure 7: 6MM, Sex-Specific Incident Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, 2012
  • Figure 8: 6MM, Age-Standardized Bladder Cancer Incidence Rate, Ages ≥15 Years, Men and Women, Cases per 100,000 Population, 2012
  • Figure 9: 6MM, Incident Cases of Bladder Cancer by Stage at Diagnosis, Ages ≥15 Years, Men and Women, N, 2012
  • Figure 10: 6MM, Five-Year Prevalent Cases of Bladder Cancer, Ages ≥15 Years, Men and Women, N, Selected Years, 2012-2022
  • Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in Bladder Cancer, 2012-2017
  • Figure 12: Sales for Bladder Cancer by Region, 2012 and 2017
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