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市場調查報告書

OpportunityAnalyzer:慢性淋巴細胞白血病 - 市場機會的分析和未來預測

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

出版商 GlobalData 商品編碼 307121
出版日期 內容資訊 英文 153 Pages
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OpportunityAnalyzer:慢性淋巴細胞白血病 - 市場機會的分析和未來預測 OpportunityAnalyzer: Chronic Lymphocytic Leukemia - Opportunity Analysis and Forecasts to 2018
出版日期: 2014年06月30日 內容資訊: 英文 153 Pages
簡介

慢性淋巴細胞白血病(CLL)、是成人白血病中最普遍的、骨髓、血液、淋巴球組織內部的B淋巴球(白血球的一種)的過剩繁殖是發病的主要原因。目前化療是主要的治療方法、再發性、難治性患者及高齡者為對象的新治療藥目前正在開發中、如果在近年上市的話、治療環境會有戲劇性變化。2018年、市場整體的70%以上預測將會是高價格新藥的市場。

本報告書為、慢性淋巴細胞白血病(CLL)的治療法之研究、開發的最新趨勢調查和相關市場的未來預測之實施、患者的概要及現階段的治療法、未滿足的需求、市場機會的評價、今後5年間的發病件數之預測值、臨床試驗的進行狀況、新的治療藥生產線評價、今後的市場趨勢等調查。

第1章 目錄

第2章 介紹

第3章 疾病的概要

  • 病因
  • 病態生理
  • 病期分類(分期)和後期標記
    • Rai/Binet病期診斷系統
    • 染色體異常和其後期標記
  • 症狀
  • QoL(生活的品質)

第4章 患者的管理

  • 診斷
  • 治療法的概要
    • 第一選擇治療
    • 第二選擇治療
  • 治療結果評價的反應基準

第5章 免疫學

  • 患者的背景事情
  • 風險因素和共存症
  • 全球的趨勢
    • 發病者數
    • 生存率(美國、歐洲主要5國)
  • 預測方法
    • 所使用的資料來源
    • 沒有使用的資料來源
    • 預測的前提條件和方法
  • 慢性淋巴細胞白血病的免疫學預測(今後11年間)
    • 被診斷髮病件數:總數
    • 被診斷髮病件數:年齡分類
    • 被診斷髮病件數:男分類
    • 被診斷髮病件數:已調整年齡總數
    • 接受診斷的患病者數:5年患病者數
    • 接受診斷的患病者數:Rai病期診斷系統基準
  • 議論
    • 免疫學傾向的相關考察
    • 分析的界線
    • 分析的強勢

第6章 目前的治療選項

  • 概要
  • 產品介紹:主要品牌
    • Rituxan/MabThera(Rituximab)
    • Arzerra(Ofatumumab)
    • Campath(Alemtuzumab)
    • Treanda/Levact(Bendamustine)
    • Gazyva/Gazyvaro(Obinutsuzumabu)
    • Imbruvica(Iburutsunibu)

第7章 未滿足需求的評價和機會分析

  • 概要
  • 未滿足需求的分析
    • 高齡者中不適合既存藥患者也可以忍受的治療藥
    • 高風險17p欠缺患者用有效的治療藥
    • 重發性、難治性患者用安全且有效的治療附加選項
    • 最合適的治療對策所決定的預備標記
    • 平均患者為前提所設計的臨床試驗
  • 市場機會的分析
    • 改善耐容性的治療藥開發
    • 複合療法的開發
    • 新療法成本效率性的改善
    • 事後指標的開發
    • 早期治療中可回復患者的判斷

第8章 研究開發(R&D)策略

  • 概要
    • 沒有化學療法可治療的未來趨勢
    • 高風險17p欠缺患者為對象的治療法
    • B細胞受體對像(CLL的信號傳達途徑)之治療法
    • 複合療法
    • 經口劑形
  • 臨床試驗的設計
    • CLL治療用新藥的開發支援之治療結果基準的重新評價
    • CLL用臨床試驗達成度的評價
    • 切實的對照藥群(Comparator Arms)及其組合的選定
    • 目前的臨床試驗設計

第9章 生產線分析

  • 概要
  • 臨床實驗中有希望的藥劑
    • Idelalisib (GS-1101, CAL-101)
    • IPI-145
    • ABT-199
  • 初期階段的創新對策
    • CTL019
    • Otlertuzumab (TRU-016)
    • Afuresertib
    • GS-9973
    • NOX-A12

第10章 生產線評價的分析

  • 主要生產線藥劑的臨床層面基準
  • 主要生產線藥劑的商業層面基準
  • 競爭力的評價
  • 今後5年間的銷售額預測
    • 美國
    • 歐洲主要5國

第11章 附錄

圖表一覽

目錄
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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