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OpportunityAnalyzer:慢性リンパ性白血病 - 市場機会の分析と将来予測

OpportunityAnalyzer: Chronic Lymphocytic Leukemia - Opportunity Analysis and Forecasts to 2018

発行 GlobalData 商品コード 307121
出版日 ページ情報 英文 153 Pages
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OpportunityAnalyzer:慢性リンパ性白血病 - 市場機会の分析と将来予測 OpportunityAnalyzer: Chronic Lymphocytic Leukemia - Opportunity Analysis and Forecasts to 2018
出版日: 2014年06月30日 ページ情報: 英文 153 Pages
概要

慢性リンパ性白血病(CLL)は、成人の白血病の中で最も一般的なもので、骨髄・血液・リンパ球組織内部のBリンパ球(白血球の一種)の過剰増殖が原因で発症します。現在は化学療法が主な治療法ですが、再発性・難治性患者や高齢者患者を対象とした新たな治療薬が現在開発中で、これが近年中に上市されれば、治療環境は劇的に変化するものと思われます。2018年には、市場全体の70%以上が高価格の新薬で占められると予想されています。

当レポートでは、慢性リンパ性白血病(CLL)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5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
  • 病態生理
  • 病期分類(ステージング)と予後マーカー
    • Rai/Binet病期診断システム
    • 染色体異常とその他の予後マーカー
  • 症状
  • QoL(生活の質)

第4章 疾患の管理

  • 診断
  • 治療法の概要
    • 第一選択治療
    • 第二選択治療
  • 治療結果の評価のための反応基準

第5章 疫学

  • 疾患の背景事情
  • リスク要因と共存症
  • 世界的動向
    • 発症者数
    • 生存率(米国・欧州主要5ヶ国)
  • 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
  • 慢性リンパ性白血病の疫学的予測(今後11年間分)
    • 診断された発症件数:総数
    • 診断された発症件数:年齢別
    • 診断された発症件数:男女別
    • 診断された発症件数:年齢調整済み総数
    • 診断を受けた有病者数:5年有病者数
    • 診断を受けた有病者数:Rai病期診断システム基準
  • 議論
    • 疫学的傾向に関する考察
    • 分析の限界
    • 分析の強み

第6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
    • Rituxan/MabThera(リツキシマブ)
    • Arzerra(オファツムマブ)
    • Campath(アレムツズマブ)
    • Treanda/Levact(ベンダムスチン)
    • Gazyva/Gazyvaro(オビヌツズマブ)
    • Imbruvica(イブルツニブ)

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
    • 高齢者で既存薬が合わない患者でも耐えられる治療薬
    • 高リスク17p欠失患者向けの効果的な治療薬
    • 再発性・難治性患者向けの安全で効果的な治療オプション
    • 最適な治療戦略を決定するための予後マーカー
    • 平均的患者を前提に設計された治験
  • 市場機会の分析
    • 耐容性の改善された治療薬の開発
    • 複合療法の開発
    • 新規療法のコスト効率性の改善
    • 予後指標の開発
    • 早期治療で回復可能な患者の判定

第8章 研究開発(R&D)戦略

  • 概要
    • 化学療法抜きで治療できる未来に向けての動き
    • 高リスク17p欠失患者を対象とした治療法
    • B細胞受容体対象(CLLにおけるシグナル経路)とした治療法
    • 複合療法
    • 経口剤形
  • 治験のデザイン
    • CLL治療用新薬の開発支援のための、治療結果基準の再評価
    • CLL向け治験の達成度の評価
    • 適切な対照薬群(Comparator Arms)およびその組み合わせの選定
    • 現在の治験デザイン

第9章 パイプライン分析

  • 概要
  • 治験中の有望な薬剤
    • Idelalisib (GS-1101, CAL-101)
    • IPI-145
    • ABT-199
  • 初期段階の革新的なアプローチ
    • CTL019
    • Otlertuzumab (TRU-016)
    • Afuresertib
    • GS-9973
    • NOX-A12

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
  • 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
Product Code: GDHC017POA

Chronic lymphocytic leukemia (CLL), the most common form of adult leukemia, is caused by the uncontrolled proliferation of B lymphocytes (a type of white blood cell) in the bone marrow, blood and lymphoid tissues. This report focuses on the current treatment landscape, unmet needs, pipeline and commercial opportunity in the CLL market with coverage of both the first-line and relapsed/refractory settings. While the current standard of care consists of chemoimmunotherapy, CLL disease management is poised for dramatic changes, particularly in the treatment of relapsed/refractory and elderly patients, as four new drugs (Gazyva, Imbruvica, idelalisib and IPI-145) will launch during the forecast period. As they address large unmet needs, GlobalData expects these premium-priced new drugs will have rapid uptake driving the overall CLL market and contributing to over 70% of total market sales by 2018.

Highlights

Key Questions Answered

  • Which CLL patients have the greatest unmet needs and how well will these needs be addressed by the new agents?
  • How will CLL disease management change as new agents enter the market?
  • What are the R&D and clinical trial design strategies pursued by companies in the CLL space?
  • What are the most promising late-stage pipeline agents for CLL? How do their clinical and commercial attributes compare to one another and the current standards of care?
  • What opportunities will remain for future players following the launch of these pipeline agents?
  • What exciting, innovative approaches are being investigated in the early-stage CLL pipeline?

Key Findings

  • The CLL market, in the 6MM is forecasted to rapidly increase from $1.4bn in 2013 to $3.3bn in 2018, at a CAGR of 18.8%. This growth will be driven by the launch and adoption of four new premium-priced drugs during the forecast period, including Gazyva, Imbruvica, idelalisib and IPI-145.
  • GlobalData expects there will be rapid uptake of the new agents in the relapsed/refractory setting, particularly in those patients who do not have a good response to first-line treatment. In the first-line setting, GlobalData foresees a slower uptake of the new agents, particularly among fit patients who can enjoy lengthy and deep remissions from the current standard of care chemoimmunotherapy-based regimens.
  • Among the new agents, GlobalData expects Imbruvica and idelalisib will dominate patient share and will account for more than 60% of all total sales in 2018 and drive 100% of total market growth. However, in GlobalData's assessment, idelalisib's use in combination with Rituxan and its overall stronger clinical development program will help it emerge as the market leader in the relapsed/refractory setting by 2018.

Scope

  • Key countries covered: US, France, Germany, Italy, Spain, and UK
  • Overview of CLL, including epidemiology, etiology, pathophysiology, clinical staging, symptoms, quality of life, and disease management.
  • Topline CLL therapeutics market revenue from 2013-2018. Annual cost of therapy, and major marketed and pipeline drug sales in this forecast period are included.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the CLL market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline drugs. An interactive clinical and commercial analyzer tool is available.
  • Analysis of the current and future market competition in the 6MM CLL 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

  • 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.
  • Develop business strategies by understanding the trends shaping and driving the 6MM CLL market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 6MM CLL therapeutics market in the 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.
  • 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
  • 3.2. Pathophysiology
  • 3.3. Staging and Prognostic Markers
    • 3.3.1. Rai and Binet Staging System
    • 3.3.2. Chromosomal Abnormalities and Other Prognostic Markers
  • 3.4. Symptoms
  • 3.5. Quality of Life

4. Disease Management

  • 4.1. Diagnosis
  • 4.2. Treatment Overview
    • 4.2.1. First-Line Treatment
    • 4.2.2. Second-Line Treatment and Beyond
  • 4.3. Response Criteria for Evaluating the Treatment Outcome

5. Epidemiology

  • 5.1. Disease Background
  • 5.2. Risk Factors and Comorbidities
  • 5.3. Global Trends
    • 5.3.1. Incidence
    • 5.3.2. Survival from CLL - US and 5EU
  • 5.4. Forecast Methodology
    • 5.4.1. Sources Used
    • 5.4.2. Sources Not Used
    • 5.4.3. Forecast Assumptions and Methods, Diagnosed Incident Cases
    • 5.4.4. Forecast Assumptions and Methods, 5-Year Diagnosed Prevalent Cases
    • 5.4.5. Forecast Assumptions and Methods, Rai Stage at Diagnosis
  • 5.5. Epidemiological Forecast for CLL (2013-2023)
    • 5.5.1. Diagnosed Incident Cases of CLL
    • 5.5.2. Age-Specific Diagnosed Incident Cases of CLL
    • 5.5.3. Sex-Specific Diagnosed Incident Cases of CLL
    • 5.5.4. Age-Standardized Diagnosed Incidence of CLL
    • 5.5.5. 5-Year Diagnosed Prevalent Cases of CLL
    • 5.5.6. Diagnosed Incident Cases of CLL by Rai Stage at Diagnosis
  • 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
    • 6.2.1. Rituxan/MabThera (rituximab)
    • 6.2.2. Arzerra (ofatumumab)
    • 6.2.3. Campath (alemtuzumab)
    • 6.2.4. Treanda/Levact (bendamustine)
    • 6.2.5. Gazyva/Gazyvaro (obinutuzumab)
    • 6.2.6. Imbruvica (ibrutinib)

7. Unmet Needs Assessment and Oppportunity Analysis

  • 7.1. Overview
  • 7.2. Unmet Needs Analysis
    • 7.2.1. Unmet Need: Therapies that are tolerable for elderly, unfit patients
    • 7.2.2. Unmet Need: Efficacious Therapies for High-Risk 17p Deletion Patients
    • 7.2.3. Unmet Need: Safe and Efficacious Therapeutic Options for Relapsed/Refractory Patients
    • 7.2.4. Unmet Need: Prognostic Markers to Determine the Best Treatment Strategy
    • 7.2.5. Unmet Need: Clinical Trials Designed to Reflect the Average CLL Patient
  • 7.3. Opportunity Analysis
    • 7.3.1. Opportunity: Development of Better Tolerated Therapies
    • 7.3.2. Opportunity: Development of Combination Therapy
    • 7.3.3. Opportunity: Increasing the Cost-Effectiveness of New Therapies
    • 7.3.4. Opportunity: Development of a Prognostic Index
    • 7.3.5. Opportunity: Identification of Patients Who Could Benefit from Early Treatment

8. R&D Strategies

  • 8.1. Overview
    • 8.1.1. Moving Towards a Chemotherapy-Free Future
    • 8.1.2. Targeting the High-Risk 17p Deletion Population
    • 8.1.3. Targeting the B-Cell Receptor Signaling Pathway in CLL
    • 8.1.4. Combination Therapy
    • 8.1.5. Oral Formulations
  • 8.2. Clinical Trial Design
    • 8.2.1. Re-Assessing Treatment Outcome Criteria to Support the Development of New Agents to Treat CLL
    • 8.2.2. Evaluating CLL Clinical Trial Endpoints
    • 8.2.3. Selecting Suitable Comparator Arms and Combinations
    • 8.2.4. Current Clinical Trial Design

9. Pipeline Assessment

  • 9.1. Overview
  • 9.2. Promising Drugs in Clinical Development
    • 9.2.1. Idelalisib (GS-1101, CAL-101)
    • 9.2.2. IPI-145
    • 9.2.3. ABT-199
  • 9.3. Innovative Early-Stage Approaches
    • 9.3.1. CTL019
    • 9.3.2. Otlertuzumab (TRU-016)
    • 9.3.3. Afuresertib
    • 9.3.4. GS-9973
    • 9.3.5. NOX-A12

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 CLL Patients
    • 11.4.2. Percentage of 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. About the Authors
    • 11.6.1. Authors
    • 11.6.2. Epidemiologist
    • 11.6.3. Global Head of Healthcare
  • 11.7. About GlobalData
  • 11.8. Disclaimer

List of Tables

  • Table 1: Rai and Binet Staging of CLL
  • Table 2: iwCLL Symptoms of Progressive CLL
  • Table 3: Definitions of the Response to Treatment of CLL
  • Table 4: CLL Clinical Stages at Diagnosis
  • Table 5: Risk Factors and Comorbidities for CLL
  • Table 6: Trends in the Age-Adjusted Incidence of CLL in the US, All Ages, 2003-2010
  • Table 7: Trends in the Age-Adjusted Incidence of CLL (Cases per 100,000 Population) in France, All Ages, 1980-2012
  • Table 8: Trends in the 5-Year Relative Survival (%) of CLL in the US and 5EU, Both Sexes, 1993-2009
  • Table 9: Sources of Epidemiological Data Used to Forecast the CLL Diagnosed Incident and Prevalent Cases, and the Rai Stage at Diagnosis
  • Table 10: 6MM, Diagnosed Incident Cases of CLL, Both Sexes, Ages ≥40 Years, N, 2013-2023
  • Table 11: 6MM, Age-Specific Diagnosed Incident Cases of CLL, Both Sexes, N (Row %), 2013
  • Table 12: 6MM, Sex-Specific Diagnosed Incident Cases of CLL, Ages ≥40 Years, N (Row %), 2013
  • Table 13: 6MM, 5-Year Diagnosed Prevalent Cases of CLL, Both Sexes, Ages ≥40 Years, N, 2013-2023
  • Table 14: Leading Treatments for CLL
  • Table 15: Product Profile - Rituxan
  • Table 16: Rituxan SWOT Analysis
  • Table 17: Product Profile - Arzerra
  • Table 18: Arzerra SWOT Analysis
  • Table 19: Product Profile - Campath
  • Table 20: Campath SWOT Analysis
  • Table 21: Product Profile - Treanda
  • Table 22: Treanda SWOT Analysis
  • Table 23: Product Profile - Gazyva
  • Table 24: Gazyva SWOT Analysis
  • Table 25: Product Profile - Imbruvica
  • Table 26: Imbruvica SWOT Analysis
  • Table 27: Overall Unmet Needs - Current Level of Attainment
  • Table 28: BCR Signaling Pathway Inhibitors in Clinical Development in CLL
  • Table 29: Design of Current Phase III Trials in CLL
  • Table 30: CLL - Late-Stage Pipeline, 2014
  • Table 31: Product Profile - Idelalisib (GS-1101, CAL-101)
  • Table 32: Idelalisib SWOT Analysis
  • Table 33: Product Profile - IPI-145
  • Table 34: IPI-145 SWOT Analysis
  • Table 35: Product Profile - ABT-199
  • Table 36: ABT-199 SWOT Analysis
  • Table 37: Early-Stage Pipeline Products in CLL
  • Table 38: Clinical Benchmark of Key Pipeline Drugs - First-Line CLL
  • Table 39: Clinical Benchmark of Key Pipeline Drugs - Relapsed/Refractory CLL
  • Table 40: Commercial Benchmark of Key Pipeline Drugs
  • Table 41: Top-Line Sales Forecasts ($) for CLL, 2013-2018
  • Table 42: Key Events Impacting Sales for CLL, 2013-2018
  • Table 43: CLL Market in the US and 5EU - Drivers and Barriers, 2013-2018
  • Table 44: Key Launch Dates
  • Table 45: Key Patent Expiries

List of Figures

  • Figure 1: Treatment Algorithm for CLL
  • Figure 2: 6MM, Diagnosed Incident Cases of CLL, Both Sexes, Ages ≥40 Years, N, 2013-2023
  • Figure 3: 6MM, Age-Specific Diagnosed Incident Cases of CLL, Both Sexes, N, 2013
  • Figure 4: 6MM, Sex-Specific Diagnosed Incident Cases of CLL, Ages ≥40 Years, N, 2013
  • Figure 5: 6MM, Age-Standardized Diagnosed Incidence of CLL (Cases per 100,000 Population), Ages ≥40 Years, by Sex, 2013
  • Figure 6: 6MM, 5-Year Diagnosed Prevalent Cases of CLL, Both Sexes, Ages ≥40 Years, N, 2013-2023
  • Figure 7: 6MM, Diagnosed Incident Cases of CLL by Rai Stage at Diagnosis, Ages ≥40 Years, N, 2013
  • Figure 8: Gazyva- Phase II and III Trials
  • Figure 9: Imbruvica - Phase II and III Trials
  • Figure 10: The BCR Signaling Pathway in CLL
  • Figure 11: The Evolving CLL Treatment Landscape
  • Figure 12: Idelalisib - Phase II and III Trials
  • Figure 13: IPI-145 - Phase Ib and III Trials
  • Figure 14: ABT-199 - Phase II and III Trials
  • Figure 15: Competitive Assessment of Key Marketed and Pipeline Drugs - First-Line CLL
  • Figure 16: Competitive Assessment of Key Marketed and Pipeline Drugs - Relapsed/Refractory CLL
  • Figure 17: Global Sales for CLL by Region (US and 5EU), 2013-2018
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