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市場調查報告書

OpportunityAnalyzer:肝癌 (HCC) - 機會分析與預測

OpportunityAnalyzer: Hepatocellular Carcinoma - Opportunity Analysis and Forecasts to 2024

出版商 GlobalData 商品編碼 355156
出版日期 內容資訊 英文 237 Pages
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OpportunityAnalyzer:肝癌 (HCC) - 機會分析與預測 OpportunityAnalyzer: Hepatocellular Carcinoma - Opportunity Analysis and Forecasts to 2024
出版日期: 2015年12月17日 內容資訊: 英文 237 Pages
簡介

主要7個國家(美國、法國、德國、義大利、西班牙、英國、日本) 的肝癌 (HCC) 的治療藥市場,預計從2014年的4億2千萬美元,2024年 擴大到5億5千萬美元規模,以2.72%的年複合成長率 (CAGR) 年複合成長率成長。

本報告提供肝癌 (HCC) 的治療藥市場相關調查分析,疾病概要,流行病學,目前治療選項,未滿足需求和機會,研究開發策略,開發平台評估等相關的系統性資訊。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因、病理生理學
  • HCC的調查
  • 甲種胎兒蛋白 (AFP) 、其他生物標記
  • 病理生理學
  • 臨床階段和治療指南
  • 預後與進展

第4章 流行病學

  • 疾病的背景
  • 危險因素和合併症
  • 全球趨勢
  • 預測手法
    • 利用之資訊來源
    • 未利用之資訊來源
    • 預測的前提條件與手法
  • 肝癌 (HCC) 的流行病學預測
    • 確診的患者數
    • 確診的患者數 (各年齡)
    • 確診的患者數 (性別)
    • 確診的患者數 (年齡標準化) 、等
  • 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
  • 產品簡介:領導品牌
  • 治療方法
  • 其他治療

第6章 未滿足需求評估與機會分析

  • 概要
  • 未滿足需求分析

第7章 研究開發 (R&D) 策略

第8章 開發平台評估

  • 概要
  • 臨床開發中的有前途藥物
  • 創新的初期階段的方法

第9章 開發平台評估分析

  • 概要
  • 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
  • 銷售額的10年預測
    • 美國
    • EU5個國家
    • 日本

第10章 附錄

圖表

目錄
Product Code: GDHC046POA

Liver cancer is the second leading cause of cancer related death in the world in men and the sixth leading cause of cancer death in women. Hepatocellular carcinoma (HCC) is the most dominant form of liver cancer, accounting for approximately 85% of liver cancer cases. The prognosis of HCC is dependent on the stage of the disease at diagnosis. However, even with treatments such as surgical resection, liver transplantation, and ablative therapies, which are only suitable for early-stage HCC patients, the majority of patients are likely to progress onto the advanced stages of the disease.

Highlights

Key Questions Answered

  • Nexavar, approved in 2007, is the only available targeted treatment option for patients with advanced HCC and has dominated the HCC market in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) since its launch.
  • The current late and early stage pipeline is very strong and diverse. Which drug will have the biggest impact on the market? What strategies are developers undertaking to overcome the high risk of clinical trial failure?
  • Nexavar will lose patent protection within the forecast period. How will this impact the HCC market and will new market entries be able to stabilize the HCC market?

Key Findings

  • The main driver of growth in the HCC market is the expected launch of second-line treatments for patients with advanced HCC. The market growth will be further supported by an increase in HCC incidence numbers due to a growing aging population as well as market-specific increase in risk factors.
  • The biggest barrier for HCC is the patent expiry of Nexavar and expected introduction of generic sorafenib in the 7MM. The effect of this will be strongest in the US where it will have the largest impact on the HCC market. Further patent expiries will also have a negative impact on the HCC market.
  • The largest unmet needs in HCC are more treatment options for patients with advanced HCC. First line as well as second line and beyond treatments are urgently needed to improve the treatability of these patients.

Scope

  • Overview of HCC, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized HCC market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
  • Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the HCC therapeutics market.
  • Pipeline analysis: focus on the late-stage pipeline HCC drugs discussing emerging trends as well as overview of earlier phase drugs.
  • Analysis of the current and future market competition in the global HCC 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 HCC therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HCC 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 HCC therapeutics market from 2014-2024.
  • 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 Reports

3. Disease Overview

  • 3.1. Etiology and Pathophysiology
    • 3.1.1. Etiology
    • 3.1.2. HBV Infection
    • 3.1.3. HCV Infection
  • 3.2. Surveillance of HCC
  • 3.3. Alpha-Fetoprotein and other Biomarkers
  • 3.4. Pathophysiology
  • 3.5. Clinical Staging and Treatment Guidelines
  • 3.6. Prognosis and Progression

4. Epidemiology

  • 4.1. Disease Background
  • 4.2. Risk Factors and Comorbidities
  • 4.3. Global Trends
    • 4.3.1. Incidence
    • 4.3.2. Relative Survival
    • 4.3.3. Stage at Diagnosis
  • 4.4. Forecast Methodology
    • 4.4.1. Sources Used
    • 4.4.2. Sources Not Used
    • 4.4.3. Forecast Assumptions and Methods
  • 4.5. Epidemiological Forecast of HCC (2014-2024)
    • 4.5.1. Diagnosed Incident Cases of HCC
    • 4.5.2. Age-Specific Diagnosed Incident Cases of HCC
    • 4.5.3. Sex-Specific Diagnosed Incident Cases of HCC
    • 4.5.4. Age-Standardized Diagnosed Incidence of HCC
    • 4.5.5. Diagnosed Incident Cases of HCC by BCLC Stages
    • 4.5.6. Diagnosed Incident Cases of HCC with HBV and HCV Comorbidities
    • 4.5.7. Five-Year Diagnosed Prevalent Cases of HCC
  • 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. Nexavar (sorafenib)
  • 5.3. Therapy Approaches
    • 5.3.1. Early-Stage HCC Treatment
    • 5.3.2. Intermediate and Advanced-Stage HCC Treatment
  • 5.4. Other Treatments
    • 5.4.1. Adjunctive Therapy and Treatment of Underlying Diseases
    • 5.4.2. Systemic Chemotherapy
    • 5.4.3. Radiation Therapy

6. Unmet Needs Assessment and Opportunity Analysis

  • 6.1. Overview
  • 6.2. Unmet Needs Analysis
    • 6.2.1. Improved Treatability of Late-Stage HCC (First and Second Line)
    • 6.2.2. Better Prognostic Biomarkers
    • 6.2.3. Safe and Efficacious Adjuvant and Neoadjuvant Therapies
    • 6.2.4. Better HCC Surveillance and Prophylactic Treatments

7. R&D Strategies

  • 7.1. Overview
  • 7.2. Treatments for Nexavar-Refractory Patients
  • 7.3. C-Met as a Molecular Target for HCC as well as a Potential Biomarker
  • 7.4. HCC as an Add-on Indication for Marketed Products
  • 7.5. Multi-kinase Inhibitors Remain Well Represented in the Early- and Late-Stage Pipeline
  • 7.6. Clinical Trial Design
    • 7.6.1. Clinical Trial Failures 2007-2015
    • 7.6.2. HCC Phase III Clinical Trial Design 2015
    • 7.6.3. Clinical Trial Design Cornerstones

8. Pipeline Assessment

  • 8.1. Overview
  • 8.2. Promising Drugs in Clinical Development
    • 8.2.1. Multi Kinase Inhibitors
    • 8.2.2. Lenvima (lenvatinib)
    • 8.2.3. Stivarga (regorafenib)
    • 8.2.4. Cometriq (cabozantinib)
    • 8.2.5. Tivantinib (ARQ 197)
    • 8.2.6. Pexa-Vec (pexastimogene devacirepvec)
    • 8.2.7. Cyramza (ramucirumab)
    • 8.2.8. Pegargiminase (ADI-PEG 20)
    • 8.2.9. Livatag (doxorubicin Transdrug)
    • 8.2.10. ThermoDox (Heat-Activated Liposomal Encapsulation of Doxorubicin)
    • 8.2.11. Peretinoin (polyprenoic acid)
  • 8.3. Innovative Early-Stage Approaches
    • 8.3.1. Overview
    • 8.3.2. Immunotherapies

9. Pipeline Valuation Analysis

  • 9.1. Overview
  • 9.2. Clinical Benchmark of Key Pipeline Drugs
    • 9.2.1. First-Line Therapy for Patients with Advanced HCC
    • 9.2.2. Second-Line Therapy for Patients with Advanced HCC
    • 9.2.3. Adjunctive Therapy Following Resection/Ablation or RFA
  • 9.3. Commercial Benchmark of Key Pipeline Drugs
    • 9.3.1. First-Line Therapy for Patients with Advanced HCC
    • 9.3.2. Second-Line Therapy for Patients with Advanced HCC
    • 9.3.3. Adjunctive Therapy Following Resection/Ablation or RFA
  • 9.4. Competitive Assessment
    • 9.4.1. First-Line and Second-Line Therapy for Patients with Advanced HCC
    • 9.4.2. Adjunctive Therapy Following Resection/Ablation or RFA
  • 9.5. Top-Line 10-Year Forecast
    • 9.5.1. US
    • 9.5.2. 5EU
    • 9.5.3. Japan

10. Appendix

  • 10.1. Bibliography
  • 10.2. Abbreviations
  • 10.3. Methodology
  • 10.4. Forecasting Methodology
    • 10.4.1. HCC Incidence Patients
    • 10.4.2. Progression
    • 10.4.3. Percent Drug-Treated Patients
    • 10.4.4. Drugs Included in Each Therapeutic Class and Patient Distributions Not Included in HCC Sales
    • 10.4.5. Launch and Patent Expiry Dates
    • 10.4.6. General Pricing Assumptions
    • 10.4.7. Individual Drug and Pipeline Assumptions
    • 10.4.8. Generic Erosion
  • 10.5. Physicians and Specialists Included in this Study
    • 10.5.1. Primary Research - Prescriber Survey
  • 10.6. About the Authors
    • 10.6.1. Author
    • 10.6.2. Reviewer
    • 10.6.3. Epidemiologists
    • 10.6.4. Global Head of Healthcare
  • 10.7. About GlobalData
  • 10.8. Disclaimer

List of Tables

  • Table 1: Diagnostic Tools Utilized for HCC Surveillance in the 7MM
  • Table 2: Risk Factors and Comorbidities for HCC
  • Table 3: 7MM, Most Recent One-Year and Five-Year Relative Liver Cancer Survival in Men and Women
  • Table 4: US and Germany, Relative Survival Temporal Trend
  • Table 5: 7MM, BCLC and Child-Pugh Stage at Diagnosis, Men and Women (%)
  • Table 6: 7MM, Sources Used for Diagnosed Incidence of HCC
  • Table 7: 7MM, Sources of Epidemiological Data Used for Diagnosed Incident Cases Segmented by BCLC Clinical Stages
  • Table 8: 7MM, Sources of Epidemiological Data Used to Forecast Five-Year Diagnosed Prevalent Cases of HCC
  • Table 9: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Incident Cases of HCC with HBV and HCV Comorbidities
  • Table 10: 7MM, Diagnosed Incident Cases of HCC, Both Sexes, Ages ≥30 Years, N, 2014-2024
  • Table 11: 7MM, Age-Specific Diagnosed Incident Cases of HCC, Both Sexes, N, 2014
  • Table 12: 7MM, Sex-Specific Diagnosed Incident Cases of HCC, Ages ≥30 Years, N (Row %), 2014
  • Table 13: 7MM, Diagnosed Incident Cases of HCC by BCLC Stage, Ages ≥30 Years, N (Row %), 2014
  • Table 14: 7MM, Diagnosed Incident Cases of HCC with HBV and HCV, Ages ≥30 Years, Both Sexes, N, 2014 (Row %)
  • Table 15: 7MM, Five-Year Diagnosed Prevalent Cases of HCC, Ages ≥30 Years, Both Sexes, N, 2014-2024
  • Table 16: Leading Treatments for Hepatocellular Carcinoma
  • Table 17: Product Profile - Nexavar
  • Table 18: Efficacy of Nexavar
  • Table 19: Nexavar SWOT Analysis
  • Table 20: Early-Stage Treatment (BCLC Stage A) Approaches in the 7MM
  • Table 21: Success Rate of Ablation and Resection (BCLC Stage A/B) in the 7MM*
  • Table 22: Ablation Methods Used to Treat HCC
  • Table 23: Transarterial Therapies HCC
  • Table 24: Transarterial Regional Therapies used in BCLC B Patients in the 7MM
  • Table 25: Overall Unmet Needs - Current Level of Attainment
  • Table 26: BCLC Stage at Time of Diagnosis in the 7MM
  • Table 27: Key HCC Clinical Trial Successes and Failures* (2007-2015)
  • Table 28: Design of Current Phase III Trials in HCC
  • Table 29: Suitable Primary and Secondary Endpoints for HCC
  • Table 30: HCC - Late-Stage Pipeline, 2015
  • Table 31: Product Profile - Lenvima
  • Table 32: Efficacy of Lenvima
  • Table 33: Lenvima SWOT Analysis
  • Table 34: Global Sales Forecast ($m) for Lenvima, 2014-2024
  • Table 35: Product Profile - Stivarga
  • Table 36: Efficacy of Stivarga
  • Table 37: Stivarga SWOT Analysis
  • Table 38: Global Sales Forecast ($m) for Stivarga, 2014-2024
  • Table 39: Product Profile - Cometriq
  • Table 40: Efficacy of Cometriq
  • Table 41: Cometriq SWOT Analysis
  • Table 42: Global Sales Forecast ($m) for Cometriq, 2014-2024
  • Table 43: Product Profile - Tivantinib
  • Table 44: Efficacy of Tivantinib
  • Table 45: Efficacy of Tivantinib in Patients with High MET Tumors
  • Table 46: Safety of Tivantinib
  • Table 47: Drug-Related Events Occurring in ≥10% of Patients in any Treatment Group
  • Table 48: Tivantinib SWOT Analysis
  • Table 49: Global Sales Forecast ($m) for tivantinib, 2014-2024
  • Table 50: Product Profile - Pexa-Vec
  • Table 51: Efficacy of Pexa-Vec - High Dose vs Low Dose
  • Table 52: Efficacy of Pexa-Vec
  • Table 53: Pexa-Vec SWOT Analysis
  • Table 54: Product Profile - Cyramza
  • Table 55: Efficacy of Cyramza
  • Table 56: Safety of Cyramza (Grade 3 or Greater)
  • Table 57: Cyramza SWOT Analysis
  • Table 58: Global Sales Forecast ($m) for Cyramza, 2014-2024
  • Table 59: Product Profile - Pegargiminase (ADI-PEG 20)
  • Table 60: Efficacy of ADI-PEG 20
  • Table 61: ADI-PEG 20 SWOT Analysis
  • Table 62: Global Sales Forecast ($m) for ADI-Peg 20, 2014-2024
  • Table 63: Product Profile - Livatag
  • Table 64: Efficacy of Livatag
  • Table 65: Livatag SWOT Analysis
  • Table 66: Global Sales Forecast ($m) for Livatag, 2014-2024
  • Table 67: Product Profile - ThermoDox
  • Table 68: Efficacy of ThermoDox (Subgroup Analysis)
  • Table 69: ThermoDox SWOT Analysis
  • Table 70: Global Sales Forecast ($m) for ThermoDox, 2014-2024
  • Table 71: Product Profile - Peretinoin
  • Table 72: Efficacy of Peretinoin
  • Table 73: Safety of Peretinoin
  • Table 74: Peretinoin SWOT Analysis
  • Table 75: Global Sales Forecast ($m) for Peretinoin, 2014-2024
  • Table 76: Key Early-Stage HCC Pipeline
  • Table 77: Clinical Benchmark of Key Pipeline Drugs - First-Line Advanced Treatments
  • Table 78: Clinical Benchmark of Key Pipeline Drugs - Second-Line, Advanced HCC
  • Table 79: Clinical Benchmark of Key Pipeline Drugs - Adjuvant Treatment to Ablation and Resection
  • Table 80: Clinical Benchmark of Key Pipeline Drugs - Adjuvant Treatment to RFA
  • Table 81: Commercial Benchmark of Key Pipeline Drugs - First-Line Advanced HCC Treatments
  • Table 82: Commercial Benchmark of Key Pipeline Drugs - Second-Line, Advanced HCC
  • Table 83: Commercial Benchmark of Key Pipeline Drugs - Adjuvant to Resection/Ablation
  • Table 84: Commercial Benchmark of Key Pipeline Drugs - Adjuvant to RFA
  • Table 85: Top-Line Sales Forecast ($m) for HCC, 2014-2024
  • Table 86: Key Events Impacting Sales for HCC, 2014-2024
  • Table 87: HCC Market - Drivers and Barriers, 2014-2024
  • Table 88: Key Launch Dates
  • Table 89: Key Patent Expiries
  • Table 90: BCLC C Patient Shares Eligible for Second-Line (to Nexavar) Treatment
  • Table 91: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: Breakdown of Liver Cancer into Different Categories
  • Figure 2: Barcelona Clinic Liver Cancer Staging System for Hepatocellular Carcinoma
  • Figure 3: Surveillance and Diagnostic Algorithm for Hepatocellular Carcinoma in Japan
  • Figure 4: 7MM, Diagnosed Incidence Rate of HCC (Cases per 100,000 Population), Ages ≥30 Years, Both Sexes, 2004-2013
  • Figure 5: 7MM, Diagnosed Incident Cases of HCC, Ages ≥30 Years, Both Sexes, N, 2014-2024
  • Figure 6: 7MM, Age-Specific Diagnosed Incident Cases of HCC, Both Sexes, N, 2014
  • Figure 7: 7MM, Diagnosed Incident Cases of HCC, Ages ≥30 Years, N, 2014
  • Figure 8: 7MM, Age-Standardized Diagnosed Incidence Cases of HCC, Ages ≥30 Years, N, 2014
  • Figure 9: 7MM, Diagnosed Incident Cases of HCC by BCLC Stage, Ages ≥30 Years, Both Sexes N, 2014
  • Figure 10: 7MM, Diagnosed Incident Cases of HCC with HCV, Ages ≥30 Years, N, 2014
  • Figure 11: 7MM, Five-Year Diagnosed Prevalent Cases of HCC, Ages ≥30 Years, Both Sexes, N, 2014-2024
  • Figure 12: HCC Treatment Regimen by BCLC Stage
  • Figure 13: Principle of Transarterial Chemoembolization (TACE)
  • Figure 14: Loco Regional HCC Treatment Regimen Proposal
  • Figure 15: Clinical Positioning Overview of Late-Stage HCC Pipeline
  • Figure 16: Lenvima - Clinical Trial Overview
  • Figure 17: Stivarga - Clinical Trial Overview
  • Figure 18: Cometriq - Clinical Trial Overview
  • Figure 19: Cometriq -Study Design
  • Figure 20: Tivantinib - Clinical Trial Overview
  • Figure 21: Pexa-Vec - Clinical Trial Overview
  • Figure 22: Cyramza - Clinical Trial Overview
  • Figure 23: ADI-PEG 20 - Clinical Trial Overview
  • Figure 24: Livatag - Clinical Trial Overview
  • Figure 25: ThermoDox - Clinical Trial Overview
  • Figure 26: Peretinoin - Clinical Trial Overview
  • Figure 27: Competitive Assessment of Late-Stage Pipeline Agents in HCC - Advanced HCC, 2014-2024
  • Figure 28: Competitive Assessment of Late-Stage Pipeline Agents in HCC-Adjuvant Setting, 2014-2024
  • Figure 29: Global Sales for HCC by Region, 2014 and 2024
  • Figure 30: Recurrence-Free Survival as Basis for Assumed Progression from BCLC Stage A to B
  • Figure 31: Survival Probabilities as Basis for Assumed Progression from BCLC Stage B to C
  • Figure 32: Survival Probabilities as Basis for Assumed Progression from BCLC Stage C to D
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