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OpportunityAnalyzer:非ホジキンB細胞リンパ腫 - 市場機会の分析と将来予測

OpportunityAnalyzer: Non-Hodgkin's B-Cell Lymphoma - Opportunity Analysis and Forecast to 2018

発行 GlobalData 商品コード 311411
出版日 ページ情報 英文 178 Pages
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OpportunityAnalyzer:非ホジキンB細胞リンパ腫 - 市場機会の分析と将来予測 OpportunityAnalyzer: Non-Hodgkin's B-Cell Lymphoma - Opportunity Analysis and Forecast to 2018
出版日: 2014年08月25日 ページ情報: 英文 178 Pages
概要

当レポートでは、非ホジキンB細胞リンパ(NHL)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、その結果を概略以下の構成でお届けします。

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
    • 無痛性・侵攻性B細胞非ホジキンリンパ腫(NHL)の病態生理
  • 症状

第4章 疾患の管理

  • 診断
    • 診断上の分類
  • 治療法の概要

第5章 疫学

  • 疾患の背景事情
  • リスク要因と共存症
  • 世界的な傾向
    • 米国
    • 欧州主要5ヶ国(5EU)
  • 予測手法
    • 利用した情報源
    • 予測の仮定・手法
    • 年齢調整済みの発症率
  • B細胞NHLの疫学的予測(今後11年間分)
    • 濾胞性リンパ腫
    • 辺縁帯リンパ腫
    • びまん性大細胞型B細胞リンパ腫(DLBCL)
    • マントル細胞リンパ腫
  • 議論
    • 疫学的な予測に関する結論
    • 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
  • 製品パイプライン:主要ブランド、濾胞性リンパ腫の場合
    • Imbruvica(イブルツニブ)
    • Revlimid(レナリドマイド)
    • Rituxan/MabThera(リツキシマブ)
    • Treanda(ベンダムスチン)
    • Velcade(ボルテゾミブ)
    • Zevalin(イブリツモマブチウキセタン)
    • Zydelig(イデラリシブ、GS-1101、CAL-101)

第7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
    • 無痛性NHL患者の延命促進・再発遅延のための、安全で耐性の高い第一線薬剤
    • マントル細胞リンパ腫患者の生存率改善
    • 第一線治療の後の、BLBCL患者の治療率改善
    • 予見・予後診断のための分子バイオマーカー
  • 市場機会の分析
    • よりコスト効率的な治療法
    • 濾胞性リンパ腫患者のための強化・維持療法の改善
    • 第一線のDLBCL・マントル細胞リンパ腫治療のための新規薬剤

第8章 研究開発(R&D)戦略

  • 概要
    • 患者シェア最大化のための、複数のNHLサブタイプの標的設定および各種治療法
    • 再発性NHL患者の内部での新規標的の抑制
    • 化学免疫療法体制を代替するための、リツキサン/MabTheraと組み合わせる形の新規薬剤の開発
    • 標準的治療法が特許失効となる際の、次世代の治療法の開発を通じたフランチャイズ管理
    • 検査企業がスポンサーとなる治験:治験最終段階でのリスク回避のための、初期段階での小規模バイオテクノロジー企業との協力
    • 患者の利便性向上のための、新たなドラッグデリバリ(薬剤送達)経路の開発
  • 治験のデザイン
    • 無痛性B細胞NHL
    • 侵攻性B細胞NHL
    • 治験達成度の評価法
    • 適切な対照薬群(Comparator Arms)

第9章 パイプライン分析

  • 概要
  • 治験段階にある有望な医薬品
    • Arzerra(オファツムマブ)
    • Gazyva(オビヌツズマブ)
  • 初期段階にある革新的なアプローチ
    • Adcetris(ブレンツキシマブベドチン)
    • Alisertib (MLN8237)
    • Blinatumomab (AMG-101)
    • Copanlisib (BAY 80-6946)
    • Y-90 Epratuzumab
    • キメラ抗原受容体T細胞療法

第10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
  • 各企業・製品の競争力の評価
  • 今後5年間の売上高の予測
    • 米国
    • 欧州主要5ヶ国

第11章 付録

図表一覧

目次

The competitive landscape in the B-cell NHL markets in the US, France, Italy, Germany, Spain and the UK is poised to undergo a dramatic shift during the forecast period. Disease management of the four largest B-cell NHL indications, which includes Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL), currently revolves around multiple rounds of Rituxan-based chemotherapy. Although patients can achieve durable remissions to induction therapy, those patients who relapse after primary treatment have poor prognosis and high unmet needs. Several promising pipeline agents are set to have a dramatic impact on treatment of these relapsed/refractory patients over the forecast period: Pharmacyclics'/Janssen's Imbruvica, which was approved for relapsed/refractory MCL patients in November 2013, Gilead's Zydelig, which was approved for relapsed/refractory FL patients in July 2014, and Roche's Gazyva, which will launch in 2015.

Highlights

Key Questions Answered

  • How will the launch of Imbruvica and Zydelig impact the treatment landscape of relapsed/refractory MCL and FL patients?
  • How will the launch of Gazyva and the subcutaneous formulation of MabThera help Roche protect their hematology franchise from biosimilar rituximab competition in the 5EU?
  • The new agents will launch first in one B-cell indication before seeking label expansion into broader NHL patient populations. How will companies expand their hematology candidates beyond their initial approvals?
  • Pharmacyclics has set a high pricing bar with a high ACOT for Imbruvica. How will this pricing strategy affect pricing of other pipeline agents, and will this be a barrier to entry in cost-conscious EU markets?
  • The new agents address significant unmet needs in the relapsed/refractory NHL population. What remaining opportunity will remain after their launch?

Key Findings

  • Imbruvica will gain significant patient share in the relapsed/refractory MCL market before expanding into the r/r FL setting. However, Zydelig's time-to-market advantage as well as potentially superior clinical profile in FL patients will result in Zydelig maintaining the market lead in these patients.
  • There is significant opportunity for the new agents Imbruvica and Zydelig, which are delivered orally and would greatly increase patient convenience in addition to providing superior clinical benefit over chemoimmunotherapy regimens.
  • Physicians in the US and 5EU are eager to eventually transition their patients onto chemo-free combination regimens, and the new oral agents in combination with Rituxan or Gazyva have the potential to address this need in the first line.
  • The loss of patent protection in 2013 for the gold-standard CD20 antibody MabThera (Rituxan) will have a significant impact on market growth in the 5EU, as biosimilar competition is expected beginning in 2018. By launching the second-generation CD20 antibody Gazyva, as well as a subcutaneous formulation of MabThera that greatly increases patient convenience, Roche will effectively maintain significant NHL patient share over biosimilar competitors in 2018.
  • Many relapsed/refractory NHL patients seek treatment in clinical trials, due to the low clinical efficacy conferred by available chemoimmunotherapy regimens after failure of first-line treatment. As the pipeline agents gain approval and enter the market, GlobalData anticipates that trial registration will decrease, contributing to overall market growth in the US and 5EU as more patients opt to receive treatment outside of the clinical trial setting.

Scope

  • Overview of B-cell NHL, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines for DLBCL, FL, MZL and MCL.
  • Annualized B-cell NHL (including DLBCL. FL. MZL and MCL) therapeutics market revenue, annual cost of therapy and patient share in the first-line and relapsed/refractory setting (as well as consolidation/maintenance for FL patients) forecast from 2013 to 2018.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the B-cell NHL therapeutics market
  • Pipeline analysis: The B-cell NHL pipeline is relatively small, but dominated by high profile novel therapies with the potential to be significant game changers.
  • Analysis of the current and future market competition in the global B-cell NHL markets, including insightful review of the key industry drivers, barriers and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

  • Develop business strategies by understanding the trends shaping and driving the B-cell NHL therapeutics markets in the US and 5EU.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global NHL therapeutics market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Forecast drug sales in the global B-cell NHL therapeutics market from 2013-2018.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies.

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. Pathophysiology of Indolent and Aggressive B-Cell NHL
  • 3.2. Symptoms

4. Disease Management

  • 4.1. Diagnosis
    • 4.1.1. Diagnostic Classification
  • 4.2. Treatment Overview

5. Epidemiology

  • 5.1. Disease Background
  • 5.2. Risk Factors and Comorbidities
  • 5.3. Global Trends
    • 5.3.1. US
    • 5.3.2. US
    • 5.3.3. 5EU
  • 5.4. Forecast Methodology
    • 5.4.1. Sources Used
    • 5.4.2. Forecast Assumptions and Methods
    • 5.4.3. Age-Standardized Incidence Rates
  • 5.5. Epidemiological Forecast for B-Cell NHL (2013-2023)
    • 5.5.1. Follicular Lymphoma
    • 5.5.2. Marginal Zone Lymphoma
    • 5.5.3. DLBCL
    • 5.5.4. Mantle Cell Lymphoma
  • 5.6. Discussion
    • 5.6.1. Epidemiological Forecast Insight
    • 5.6.2. Limitations of the Analysis
    • 5.6.3. Strengths of the Analysis

6. Current Treatment Options

  • 6.1. Overview
  • 6.2. Product Profiles - Major Brands, Follicular Lymphoma
    • 6.2.1. Imbruvica (ibrutinib)
    • 6.2.2. Revlimid (lenalidomide)
    • 6.2.3. Rituxan/MabThera (rituximab)
    • 6.2.4. Treanda (bendamustine)
    • 6.2.5. Velcade (bortezomib)
    • 6.2.6. Zevalin (ibritumomab tiuxetan)
    • 6.2.7. Zydelig (idelalisib, GS-1101, CAL-101)

7. Unmet Needs Assessment and Opportunity Analysis

  • 7.1. Overview
  • 7.2. Unmet Needs Analysis
    • 7.2.1. Unmet Need: Safe and Tolerable Front-Line Agents for Indolent NHL Patients that Prolong OS and Delay Relapse
    • 7.2.2. Unmet Need: Prolonged Survival Rates for Mantle Cell Patients
    • 7.2.3. Unmet Need: Improved Cure Rate for DLBCL Patients after Front-Line Therapy
    • 7.2.4. Unmet Need: Predictive and Prognostic Molecular Biomarkers
  • 7.3. Opportunity Analysis
    • 7.3.1. Opportunity: More Cost-Effective Therapies
    • 7.3.2. Opportunity: Better Consolidation/Maintenance Therapies for Follicular Patients
    • 7.3.3. Novel Agents for Front-Line DLBCL and Mantle Cell Lymphoma Therapy

8. R&D Strategies

  • 8.1. Overview
    • 8.1.1. Targeting Multiple NHL Subtypes and Lines of Therapy to Capture Greatest Patient Share
    • 8.1.2. Inhibiting New Targets in Relapsed/Refractory NHL Patients
    • 8.1.3. Developing Novel Drugs in Combination with Rituxan/MabThera to Replace Chemoimmunotherapy Regimens
    • 8.1.4. Franchise Management through Developing Novel Second-Generation Therapies to Replace Established Standards of Care at the End of Their Patent Life
    • 8.1.5. Small Biotechs Collaborating on Investigator-Sponsored Early-Stage Trials to De-Risk Later-Stage Studies
    • 8.1.6. Introducing New Routes of Drug Delivery to Improve Patient Convenience
  • 8.2. Clinical Trial Design
    • 8.2.1. Indolent B-Cell NHL
    • 8.2.2. Aggressive B-Cell NHL
    • 8.2.3. Clinical Endpoints
    • 8.2.4. Comparator Arms

9. Pipeline Assessment

  • 9.1. Overview
  • 9.2. Promising Drugs in Clinical Development
    • 9.2.1. Arzerra (ofatumumab)
    • 9.2.2. Gazyva (obinutuzumab)
  • 9.3. Innovative Early-Stage Approaches
    • 9.3.1. Adcetris (brentuximab vedotin)
    • 9.3.2. Alisertib (MLN8237)
    • 9.3.3. Blinatumomab (AMG-101)
    • 9.3.4. Copanlisib (BAY 80-6946)
    • 9.3.5. Y-90 Epratuzumab
    • 9.3.6. Chimeric Antigen Receptor T-Cell Therapies

10. Pipeline Valuation Analysis

  • 10.1. Clinical Benchmark of Key Pipeline Drugs
  • 10.2. Commercial Benchmark of Key Pipeline Drugs
  • 10.3. Competitive Assessment
  • 10.4. Top Line Five Year Forecast
    • 10.4.1. US
    • 10.4.2. 5EU

11. Appendix

  • 11.1. Bibliography
  • 11.2. Abbreviations
  • 11.3. Methodology
  • 11.4. Forecasting Methodology
    • 11.4.1. Diagnosed NHL patients
    • 11.4.2. Percent Drug-Treated Patients
    • 11.4.3. Drugs Included in Each Therapeutic Class
    • 11.4.4. Launch and Patent Expiry Dates
    • 11.4.5. General Pricing Assumptions
    • 11.4.6. Individual Drug Assumptions
    • 11.4.7. Generic Erosion
    • 11.4.8. Pricing of Pipeline agents
  • 11.5. Physicians and Specialists Included in This Study
  • 11.6. Survey of Prescribing Physicians
  • 11.7. About the Authors
    • 11.7.1. Authors
    • 11.7.2. Epidemiologist
    • 11.7.3. Global Head of Healthcare
  • 11.8. About GlobalData
  • 11.9. Disclaimer

List of Tables

  • Table 1: Non-Hodgkin's Lymphomas
  • Table 2: Symptoms of Non-Hodgkin's Lymphoma
  • Table 3: The Ann Arbor Staging Criteria for NHL (Cotswolds Modification)
  • Table 4: Molecular Characteristics of Non-Hodgkin's Lymphoma (2008 WHO Classification)
  • Table 5: Treatment Guidelines for Non-Hodgkin's Lymphoma
  • Table 6: Risk Factors and Comorbidities for NHL
  • Table 7: US, Age- and Sex-Specific Incidence of B-Cell NHL during 2001-2010
  • Table 8: 6MM, Sources of B-Cell NHL Incidence Data
  • Table 9: 6MM, Incident Cases of Follicular Lymphoma, Ages ≥30 Years, Both Sexes, N, Selected Years 2013-2023
  • Table 10: 6MM, Age-Specific Incident Cases of Follicular Lymphoma, Both Sexes, N (Row %), 2013
  • Table 11: 6MM, Sex-Specific Incident Cases of Follicular Lymphoma, Ages ≥30 Years, N (Row %), 2013
  • Table 12: 6MM, Incident Cases of Marginal Zone Lymphoma, Ages ≥30 Years, Both Sexes, N, Selected Years 2013-2023
  • Table 13: 6MM, Age-Specific Incident Cases of Marginal Zone Lymphoma, Both Sexes, N (Row %), 2013
  • Table 14: 6MM, Sex-Specific Incident Cases of Marginal Zone Lymphoma, Ages ≥30 Years, N (Row %), 2013
  • Table 15: 6MM, Incident Cases of DLBCL, Ages ≥30 Years, Both Sexes, N, Selected Years 2013-2023
  • Table 16: 6MM, Age-Specific Incident Cases of DLBCL, Both Sexes, N (Row %), 2013
  • Table 17: 6MM, Sex-Specific Incident Cases of DLBCL, Ages ≥30 Years, N (Row %), 2013
  • Table 18: 6MM, Incident Cases of Mantle Cell Lymphoma, Ages ≥30 Years, Both Sexes, N, Selected Years 2013-2023
  • Table 19: 6MM, Age-Specific Incident Cases of Mantle Cell Lymphoma, Both Sexes, N (Row %), 2013
  • Table 20: 6MM, Sex-Specific Incident Cases of Mantle Cell Lymphoma, Ages ≥30 Years, N (Row %), 2013
  • Table 21: Leading Treatments for NHL
  • Table 22: Product Profile - Imbruvica (ibrutinib)
  • Table 23: Imbruvica SWOT Analysis, 2013
  • Table 24: Product Profile - Revlimid (lenalidomide)
  • Table 25: Revlimid SWOT Analysis, 2013
  • Table 26: Product Profile - Rituxan (rituximab)
  • Table 27: Rituxan SWOT Analysis, 2013
  • Table 28: Product Profile - Treanda (bendamustine)
  • Table 29: Treanda SWOT Analysis, 2013
  • Table 30: Product Profile - Velcade (bortezomib)
  • Table 31: Velcade SWOT Analysis, 2013
  • Table 32: Product Profile - Zevalin (ibritumomab tiuxetan)
  • Table 33: Zevalin SWOT Analysis, 2013
  • Table 34: Product Profile - Zydelig (idelalisib)
  • Table 35: Zydelig SWOT Analysis, 2013
  • Table 36: Overall Unmet Needs - Current Level of Attainment
  • Table 37: Design of Current Registrational Trials in indolent NHL
  • Table 38: Design of Current Registrational Trials in Aggressive NHL
  • Table 39: Non-Hodgkin's Lymphoma - Phase III Pipeline, 2013
  • Table 40: Product Profile - Arzerra (ofatumumab)
  • Table 41: Arzerra SWOT Analysis, 2013
  • Table 42: Product Profile - Gazyva (obinutuzumab)
  • Table 43: Gazyva SWOT Analysis, 2013
  • Table 44: Early-Stage Pipeline Products in Non-Hodgkin's Lymphoma
  • Table 45: Clinical Benchmark of Key Marketed and Pipeline Drugs - Indolent NHL, Relapsed/Refractory Therapies
  • Table 46: Clinical Benchmark of Key Marketed and Pipeline Drugs - Aggressive NHL, Relapsed/Refractory Therapies
  • Table 47: Commercial Benchmark of Key Marketed and Pipeline Drugs
  • Table 48: Top Line Sales Forecasts ($bn) for NHL, 2013-2018
  • Table 49: Key Events Impacting Sales for NHL in the US and 5EU, 2013
  • Table 50: NHL Market in the US and 5EU - Drivers and Barriers, 2013
  • Table 51: Key Branded Drug Launch Dates
  • Table 52: Key Patent/Exclusivity Expiries
  • Table 53: Physicians Surveyed by Country

List of Figures

  • Figure 1: 6MM, Incident Cases of Follicular Lymphoma, Ages ≥30 Years, Both Sexes, N, 2013-2023
  • Figure 2: 6MM, Age-Specific Incident Cases of Follicular Lymphoma, Both Sexes, N, 2013
  • Figure 3: 6MM, Sex-Specific Incident Cases of Follicular Lymphoma, Ages ≥30 Years, N, 2013
  • Figure 4: 6MM, Age-Standardized Incidence of Follicular Lymphoma (Cases per 100,000 Population), Ages ≥30 Years, 2013
  • Figure 5: 6MM, Incident Cases of Marginal Zone Lymphoma, Ages ≥30 Years, Both Sexes, N, 2013-2023
  • Figure 6: 6MM, Age-Specific Incident Cases of Marginal Zone Lymphoma, Both Sexes, N, 2013
  • Figure 7: 6MM, Sex-Specific Incident Cases of Marginal Zone Lymphoma, Ages ≥30 Years, N, 2013
  • Figure 8: 6MM, Age-Standardized Incidence of Marginal Zone Lymphoma (Cases per 100,000 Population), Ages ≥30 Years, 2013
  • Figure 9: 6MM, Incident Cases of DLBCL, Ages ≥30 Years, Both Sexes, N, 2013-2023
  • Figure 10: 6MM, Age-Specific Incident Cases of DLBCL, Both Sexes, N, 2013
  • Figure 11: 6MM, Sex-Specific Incident Cases of DLBCL, Ages ≥30 Years, N, 2013
  • Figure 12:6MM, Age-Standardized Incidence of DLBCL (Cases per 100,000 Population), Ages ≥30 Years, 2013
  • Figure 13:6MM, Incident Cases of Mantle Cell Lymphoma, Ages ≥30 Years, Both Sexes, N, 2013-2023
  • Figure 14: 6MM, Age-Specific Incident Cases of Mantle Cell Lymphoma, Both Sexes, N, 2013
  • Figure 15: 6MM, Sex-Specific Incident Cases of Mantle Cell Lymphoma, Ages ≥30 Years, N, 2013
  • Figure 16:6MM, Age-Standardized Incidence of Mantle Cell Lymphoma (Cases per 100,000 Population), Ages ≥30 Years, 2013
  • Figure 17: Imbruvica - Phase II and III Trials in Indolent and Aggressive NHL
  • Figure 18: Revlimid - Phase II and III Trials in Indolent and Aggressive NHL
  • Figure 19: Velcade - Phase II and III Trials in Indolent and Aggressive NHL
  • Figure 20: Zevalin - Phase II and III Trials in Indolent and Aggressive NHL
  • Figure 21: Zydelig - Phase II and III Trials
  • Figure 22: Arzerra - Phase II and III Trials in Indolent and Aggressive NHL
  • Figure 23: Gazyva - Phase II and III Trials in Indolent and Aggressive NHL
  • Figure 24:Competitive Assessment of Key Marketed and Pipeline Drugs - Indolent NHL, Relapsed/Refractory Therapies, 2013-2018
  • Figure 25:Competitive Assessment of Key Marketed and Pipeline Drugs - Aggressive NHL, Relapsed/Refractory Therapies, 2013-2018
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