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市場調查報告書

何杰金氏淋巴瘤 (HL) :機會分析與預測 2024年

OpportunityAnalyzer: Hodgkin's Lymphoma (HL) - Opportunity Analysis and Forecasts to 2024

出版商 GlobalData 商品編碼 356222
出版日期 內容資訊 英文 255 Pages
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何杰金氏淋巴瘤 (HL) :機會分析與預測 2024年 OpportunityAnalyzer: Hodgkin's Lymphoma (HL) - Opportunity Analysis and Forecasts to 2024
出版日期: 2016年01月01日 內容資訊: 英文 255 Pages
簡介

何杰金氏淋巴瘤 (HL) ,或杰金氏病病,是包含淋巴節及淋巴系統的惡性腫瘤。HL是比較稀有類型的癌症,構成淋巴瘤整體12%及新癌症案例整體的0.6%,不過,整體預後非常良好。可是,一次治療失敗的患者的治療選項非常少,對患者而言留下了龐大的未滿足需求。主要7個市場 (美國、歐盟五國、日本) 的HL市場規模,2014年為3億1600萬美金。預計HL市場在預測期間內以16%的年複合成長率發展,至2024年達到約4倍的14億美元。

本報告提供何杰金氏淋巴瘤 (HL) 相關臨床研究最新趨勢相關分析,HL概要,HL治療收益、治療的平均成本 (ACOT) 、主要開發中產品的銷售額的預測,競爭企業的評估,市場特徵化,未滿足需求,R&D策略,臨床實驗設計,開發平台分析,及現在、未來市場競爭情形分析,為您概述為以下內容。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因及病理學
  • 症狀
  • 診斷
  • 臨床階段、預後因素

第4章 流行病學

  • 疾病的背景
  • 風險因素和合併症
  • 全球的趨勢
    • 發病率
    • 存活率:主要7個市場
  • 預測手法
    • 使用來源
    • 未使用來源
    • 預測的前提條件、手法:發生案例
    • 預測的前提條件、手法:5年的患病案例
    • 預測的前提條件、手法:發生案例,臨床階段
    • 預測的前提條件、手法:細胞型
  • PAH的流行病學的預測
    • 發生案例
    • 診斷案例:各年齡
    • 診斷案例:性別
    • 發生案例:各年齡
    • 發生案例:各臨床階段
    • 發生案例:各細胞型
    • 5年的患病案例
  • 討論
    • 流行病學預測的考察
    • 分析的限制
    • 分析的優勢

第5章 目前治療選項

  • 概要
    • 傳統的HL的治療
    • 結節性淋巴細胞為主型何杰金氏淋巴瘤 (NLPHL) 的治療
    • 兒童、妊娠中的HL患者的治療
    • 市售的HL治療藥
  • 產品簡介
    • Adcetris (brentuximab vedotin)

第6章 未滿足需求評估與機會分析

  • 未滿足需求分析
  • 機會分析

第7章 研究開發策略

  • 概要
  • 臨床實驗設計

第8章 開發平台評估

  • 概要
  • 臨床實驗的後期階段藥物
  • 達到階段II臨床實驗的其他藥劑
  • 創新的早期階段的方法

第9章 開發平台核定

  • 主要開發平台藥物臨床基準
  • 主要開發平台藥物的商業基準
  • 競爭評估
  • top line:10年預測
    • 美國
    • 歐盟五國
    • 日本

第10章 附錄

圖表清單

目錄
Product Code: GDHC052POA

Hodgkin's lymphoma (HL), or Hodgkin's disease, is a malignancy which involves the lymph nodes and the lymphatic system. HL is a relatively rare type of cancer, accounting for 12% of all lymphomas and 0.6% of all new cancer cases, but overall prognosis is very good. However, treatment options for those patients who have failed first-line treatment are very few, and a significant unmet medical need remains in those patients. GlobalData estimated the HL market in the 7MM was valued at $316m in 2014. The HL market will increase approximately four-fold over the forecast period, reaching $1.4 billion by 2024 at a CAGR of 16%. This growth will be driven by label extensions for Adcetris (brentuximab vedotin), which is poised to enter earlier lines of HL therapy, as well as the approval and uptake of premium-priced products, such as the immune checkpoint inhibitors, Opdivo (nivolumab) and Keytruda (pembrolizumab). By the end of the forecast period, GlobalData expects Adcetris to retain and extend its lead as the HL market front-runner, with Opdivo and Keytruda making up a significant amount of the market. GlobalData anticipates that pipeline agents will have to show an efficacy advantage over currently used and inexpensive standard of care therapies. The challenge for new entrants in the HL market is to meet the high unmet need of relapsed or refractory (R/R) HL patients, reduce the long-term toxic side effects of current treatments, and improve overall survival.

Highlights

Key Questions Answered

  • Over the last forty years, only one targeted therapy has been approved for the treatment of HL - Adcetris. The HL space is now filled with excitement because Adcetris label extensions and approval of the first anti-PD-1 therapies are expected to change the treatment landscape. What will be the impact of these newly approved drugs on HL sales?
  • With the success of molecular-targeted therapies, including immune checkpoint inhibitors, across the oncology therapy area, what R&D strategies are being leveraged by companies to remain competitive in the HL space?
  • The survival of R/R HL patients remains poor, especially for those who fail transplant therapies. Therefore, there are considerably high unmet needs within this indication. What are the main unmet needs remaining in this space? Will the drugs under development fulfil the unmet needs of the HL market?

Key Findings

  • One of the main drivers in the expansion of the HL market will be the label extensions of Adcetris in earlier lines of HL therapy, which will include the post-transplantation consolidation setting, as well as newly diagnosed advanced stage patients. The premium-priced anti-PD1-therapies, Opdivo and Keytruda, will also launch and be used in the treatment of the R/R HL population. These drugs are poised to partially meet the remaining unmet medical need of these hard-to-treat patients.
  • Another driver of market growth will be the few players in the HL space; therefore, there is ample room for new market entrants. A major driver will also be an increase in HL incidence due to a growing population. This will lead to an overall increase of the number of drug-treatable HL patients, and market size.
  • Companies are focusing on the development of therapies targeting the R/R HL population, hoping to expedite the route to market for their pipeline products, and improving the complete remission rate and duration of remission of these patients.
  • One of the largest unmet needs is that of the newly diagnosed advanced stage HL population. Other unmet needs include the high proportion of patients failing transplant therapies and the toxicity of second-line treatment options.

Scope

  • Overview of HL, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, disease management, and current treatment options.
  • Top-line HL therapeutics market revenue from 2014-2024. Average cost of therapy (ACOT) and major pipeline product 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 HL 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 products. An interactive clinical and commercial analyzer tool is available.
  • Analysis of the current and future market competition in the global HL 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.
  • Develop business strategies by understanding the trends shaping and driving the global HL market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HL 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 and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. Pathophysiology
  • 3.2. Symptoms
  • 3.3. Diagnosis
  • 3.4. Clinical Staging and Prognostic Factors

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
    • 4.3.1. Incidence
    • 4.3.2. Survival Rates for HL - 7MM
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods, HL Diagnosed Incident Cases
    • 4.4.4. Forecast Assumptions and Methods, HL Five-Year Diagnosed Prevalent Cases
    • 4.4.5. Forecast Assumptions and Methods, HL Diagnosed Incident Cases, Clinical Stages at Diagnosis
    • 4.4.6. Forecast Assumptions and Methods, HL Diagnosed Incident Cases, Cellular Types
  • 4.5. Epidemiological Forecast for HL (2014-2024)
    • 4.5.1. Diagnosed Incident Cases of HL
    • 4.5.2. Age-Specific Diagnosed Incident Cases of HL
    • 4.5.3. Sex-Specific Diagnosed Incident Cases of HL
    • 4.5.4. Age-Standardized Diagnosed Incidence of HL
    • 4.5.5. Diagnosed Incident Cases of HL by Clinical Stage at Diagnosis
    • 4.5.6. Diagnosed Incident Cases of HL by Cellular Types
    • 4.5.7. Five-Year Diagnosed Prevalent Cases of HL
  • 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
    • 5.1.1. Treatment of Classical HL
    • 5.1.2. Treatment of NLPHL
    • 5.1.3. Treatment of Children and Pregnant HL Patients
    • 5.1.4. Marketed Agents for the Treatment of HL
  • 5.2. Product Profiles
    • 5.2.1. Adcetris (brentuximab vedotin)

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Unmet Needs Analysis
    • 6.1.1. Overview
    • 6.1.2. Low Cure Rate in Newly Diagnosed Advanced Unfavorable-Stage Patients
    • 6.1.3. Only Half of Relapse/Refractory Patients Are Cured by ASCT
    • 6.1.4. Toxic Second-Line Chemotherapy
    • 6.1.5. Long-Term Toxicity Associated With Radiotherapy
    • 6.1.6. Current Treatment Is Less Effective in Older HL Patients
    • 6.1.7. Underuse of Prognostic Factors for Treatment Planning in the Front-Line and Relapse/Refractory Settings
    • 6.1.8. Prohibitively High Cost of Therapy
    • 6.1.9. Lack of Patients to Participate in Clinical Trials
  • 6.2. Opportunity Analysis
    • 6.2.1. Overview
    • 6.2.2. Less Toxic and More Efficacious Front-Line Therapies Will Increase Acceptance for Premium Price
    • 6.2.3. Therapies and Strategies That Improve Cure Rates in the Relapse/Refractory Setting
    • 6.2.4. New Therapies Adapted for the Treatment of Older HL Patients
    • 6.2.5. Pharmacological Therapies That Can Replace Radiation Therapy
    • 6.2.6. Reducing Treatment Cost to Enhance Overall Treatment Rate and Drug Uptake

7. R&D Strategies

  • 7.1. Overview
    • 7.1.1. Targeting of Relapsed and Refractory Patients
    • 7.1.2. Developing Combination Therapies with Established and Novel Drugs
    • 7.1.3. Seeking Fast Track or Breakthrough Therapy Designation
    • 7.1.4. Including HL as an Indication in Multiple Tumor Type, Early Phase Clinical Trials
    • 7.1.5. Involving Academic Groups in HL Drug Discovery and Clinical Trials
  • 7.2. Clinical Trial Design
    • 7.2.1. Overview
    • 7.2.2. Selection of Primary Efficacy Endpoints to Support Regulatory Approval
    • 7.2.3. Target Patient Population
    • 7.2.4. Number of Patients Enrolled in Clinical Trials

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Late-Stage Drugs in Clinical Development
    • 8.2.1. Opdivo (nivolumab)
    • 8.2.2. Keytruda (pembrolizumab)
    • 8.2.3. INCB40093(+INCB39110)
    • 8.2.4. AFM-13
  • 8.3. Other Drugs That Reached Phase II Clinical Development
    • 8.3.1. JNJ-40346527
    • 8.3.2. Jakafi (ruxolitinib phosphate)
    • 8.3.3. MK-2206
    • 8.3.4. Entinostat
    • 8.3.5. Resminostat
  • 8.4. Innovative Early-Stage Approaches
    • 8.4.1. Overview
    • 8.4.2. Cell-Based Therapies
    • 8.4.3. Molecular-Targeted Therapies
    • 8.4.4. Epigenetic Modulators

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 Ten-Year Forecast
    • 9.4.1. US
    • 9.4.2. 5EU
    • 9.4.3. Japan

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. General Forecast Assumptions
    • 10.4.2. Drugs Included in Each Line of Treatment
    • 10.4.3. Key Launch Dates
    • 10.4.4. General Pricing Assumptions
    • 10.4.5. Individual Drug Assumptions
    • 10.4.6. Pricing of Pipeline Agents
  • 10.5. Primary Research
    • 10.5.1. Physicians and Specialists Included in this Study
    • 10.5.2. Online Survey of High-Prescribing Physicians
  • 10.6. About the Authors
    • 10.6.1. Author
    • 10.6.2. Epidemiologist
    • 10.6.3. Reviewer
    • 10.6.4. Therapy Area Director
    • 10.6.5. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Characteristics of the Five Histologic Subtypes of HL
  • Table 2: Notable Somatic Alterations Identified in RS and L and H cells of HL
  • Table 3: Symptoms of HL
  • Table 4: The Lugano Staging Classification of HL
  • Table 5: Prognostic Risk Factors of HL
  • Table 6: Cotswold Modification of the Ann Arbor Staging Classification for HL
  • Table 7: Risk Factors and Comorbidities for HL
  • Table 8: Trends in the Age-Standardized Incidence of HL in the US, All Ages, 1998-2007
  • Table 9: Trends in the Age-Standardized Incidence of HL in the 5EU, All Ages, 1998-2007
  • Table 10: Trends in the Age-standardized Incidence of HL in Japan, All Ages, 1998-2007
  • Table 11: Trends in the Five-Year Relative Survival (%) of HL in the 7MM, Both Sexes, 1995-2007
  • Table 12: 7MM, Sources of Epidemiological Data Used for the Forecast of HL Diagnosed Incident Cases
  • Table 13: 7MM, Sources of Epidemiological Data Used for the Forecast of HL Diagnosed Five-Year Prevalent Cases
  • Table 14: 7MM, Sources of Epidemiological Data Used for the Segmentation of HL Diagnosed Incident Cases by Clinical Stage at Diagnosis
  • Table 15: 7MM, Sources of Epidemiological Data Used for the Segmentation of HL Diagnosed Incident Cases by Cellular Type
  • Table 16: 7MM, Diagnosed Incident Cases of HL, Both Sexes, All Ages, N, 2014-2024
  • Table 17: 7MM, Age-Specific Diagnosed Incident Cases of HL, Both Sexes, N (Row %), 2014
  • Table 18: 7MM, Sex-Specific Diagnosed Incident Cases of HL, All Ages, N (Row %), 2014
  • Table 19: 7MM, Five-Year Diagnosed Prevalent Cases of HL, Both Sexes, All Ages, N, 2014-2024
  • Table 20: Treatment Guidelines for HL
  • Table 21: Leading Pharmacological Treatments for HL
  • Table 22: Product Profile - Adcetris (brentuximab vedotin)
  • Table 23: Efficacy of Adcetris in R/R HL patients
  • Table 24: Efficacy of Adcetris in the Post-ASCT HL Setting
  • Table 25: Safety of Adcetris in R/R HL patients
  • Table 26: Safety of Adcetris in the Post-ASCT HL setting
  • Table 27: Adcetris SWOT Analysis, 2015
  • Table 28: Global Sales Forecast ($m) for Adcetris, 2014-2024
  • Table 29: Overall Unmet Needs - Current Level of Attainment
  • Table 30: Design of Current Phase II and III Trials in HL
  • Table 31: Key Pipeline of HL Therapies in Clinical Development, 2015
  • Table 32: Product Profile - Opdivo (nivolumab)
  • Table 33: Efficacy of Opdivo in Patients with R/R HL
  • Table 34: Safety of Opdivo
  • Table 35: Opdivo SWOT Analysis, 2015
  • Table 36: Global Sales Forecast ($m) for Opdivo, 2014-2024
  • Table 37: Product Profile - Keytruda (pembrolizumab)
  • Table 38: Efficacy of Keytruda in Patients with R/R HL
  • Table 39: Safety of Keytruda
  • Table 40: Keytruda SWOT Analysis, 2015
  • Table 41: Global Sales Forecast ($m) for Keytruda, 2014-2024
  • Table 42: Product Profile - INCB40093 (+INCB39110)
  • Table 43: Efficacy of INCB40093 (+INCB39110) in Patients with R/R HL
  • Table 44: Safety of INCB40093 (+INCB39110)
  • Table 45: INCB40093 (+INCB39110) SWOT Analysis, 2015
  • Table 46: Global Sales Forecast ($m) for INCB40093 (+INCB39110), 2014-2024
  • Table 47: Product Profile - AFM-13
  • Table 48: Efficacy of AFM-13 Patients with R/R HL
  • Table 49: AFM-13 SWOT Analysis, 2015
  • Table 50: Global Sales Forecast ($m) for AFM-13, 2014-2024
  • Table 51: Product Profile - JNJ-40346527
  • Table 52: Product Profile - Jakafi (ruxolitinib phosphate)
  • Table 53: Product Profile - MK-2206
  • Table 54: Safety of MK-2206
  • Table 55: Product Profile - Entinostat
  • Table 56: Efficacy of Entinostat in Patients with R/R HL
  • Table 57: Safety of Entinostat
  • Table 58: Product Profile - Resminostat
  • Table 59: Efficacy of Resminostat in Patients with R/R HL
  • Table 60: Safety of Entinostat
  • Table 61: Early-Stage Pipeline Products in HL
  • Table 62: Clinical Benchmarking of Marketed Drugs for Newly Diagnosed and R/R HL
  • Table 63: Clinical Benchmarking of Key Pipeline Drugs for R/R HL
  • Table 64: Commercial Benchmarking of Marketed Drugs for Newly Diagnosed and R/R HL
  • Table 65: Commercial Benchmarking of Key Pipeline Drugs for R/R HL
  • Table 66: Top-Line Global Sales Forecasts ($m) for HL, 2014-2024
  • Table 67: Global HL Market - Drivers and Barriers, 2014-2024
  • Table 68: Key Events Impacting Sales of the US HL Market, 2014-2024
  • Table 69: Key Events Impacting Sales of the 5EU HL Market, 2014-2024
  • Table 70: Key Events Impacting Sales of the Japanese HL Market, 2014-2024
  • Table 71: Key Launch Dates
  • Table 72: Average Body Weight, Height and Surface Area Across the 7MM
  • Table 73: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: 7MM, Diagnosed Incident Cases of HL, Both Sexes, All Ages, N, 2014-2024
  • Figure 2: 7MM, Age-Specific Diagnosed Incident Cases of HL, Both Sexes, N, 2014
  • Figure 3: 7MM, Sex-Specific Diagnosed Incident Cases of HL, All Ages, N, 2014
  • Figure 4: 7MM, Age-Standardized Diagnosed Incidence of HL (Cases per 100,000 Population), All Ages, by Sex, 2014
  • Figure 5: 7MM, Diagnosed Incident Cases of HL by Clinical Stage at Diagnosis, All Ages, Both Sexes, N, 2014
  • Figure 6: 7MM, Diagnosed Incident Cases of HL by Cellular Types, All Ages, Both Sexes, N, 2014
  • Figure 7: 7MM, Five-Year Diagnosed Prevalent Cases of HL, Both Sexes, All Ages, N, 2014-2024
  • Figure 8: Treatment Overview for Adult HL
  • Figure 9: Adcetris - Phase II and III trials
  • Figure 10: Opdivo - Phase I and II Trials
  • Figure 11: Keytruda - Phase I and II Trials
  • Figure 12: INCB40093 (+INCB39110) - Phase I and II Trials
  • Figure 13: AFM-13 - Phase I and II Trials
  • Figure 14: JNJ-40346527 - Phase I and II trials
  • Figure 15: Entinostat (SNDX-275) - Phase II Trial
  • Figure 16: Resminostat - Phase II Trial
  • Figure 17: Competitive Assessment of Marketed and Pipeline HL Agents, 2014-2024
  • Figure 18: Sales from HL Therapeutic Agents by Region, 2014 and 2024
  • Figure 19: US Sales for HL Therapeutic Agents, 2014 and 2024
  • Figure 20: 5EU Sales for HL Therapeutic Agents, 2014 and 2024
  • Figure 21: Japan Sales for HL Therapeutic Agents, 2014 and 2024
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