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市場調查報告書

Imprime PGG(大腸癌症):市場預測與分析

Imprime PGG (Colorectal Cancer) - Forecast and Market Analysis to 2023

出版商 GlobalData 商品編碼 321690
出版日期 內容資訊 英文 71 Pages
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Imprime PGG(大腸癌症):市場預測與分析 Imprime PGG (Colorectal Cancer) - Forecast and Market Analysis to 2023
出版日期: 2014年11月28日 內容資訊: 英文 71 Pages
簡介

Biothera所開發的Imprime PGG是在美國、歐洲位於臨床實驗第Ⅲ期的免疫療法,與EGFR抑制劑Erbitux並用,可用於化療無效之野生型KRAS之轉移性大腸癌的治療。非盲檢型的關鍵研究獲得有795名(推估)患者的參與,由於是以2:1的比例隨機分組,所以分為讓Imprime PGG與Erbitux併用,或是單獨使用Erbitux二組。在針對所有生存者之主調查結束後,最終數據預測將在2016年完成。Biothera正在探索盡可能基於中間數據申請早期認証的可能性。

本報告提供大腸癌症的治療藥之一──Imprime PGG的全球市場相關分析,提供大腸癌症概要和治療方法,競爭的企業·藥品概要,市場競爭概況,Imprime PGG的商品資訊(特色·功效·安全性等),調查著全球主要國家的市場販售額預測(今後10年份)等。

第1章 目錄

第2章 簡介

  • 分析的背景情況
  • 相關報告
  • 預定出版的相關調查報告

第3章 疾病概要

  • 病因與病理學
    • 病因
    • 病理學
  • 臨床階段
  • 症狀

第4章 疾病管理

  • 診斷及治療概要
    • 篩檢及診斷
    • 治療的指南及代表性的處方藥
    • 臨床診療

第5章 競爭評估

  • 概要

第6章 未滿足需求及機會

  • 概要
  • 具有大幅改善轉移性患者存活率可能性的治療方法
    • 未滿足需求
    • 差距分析
    • 機會
  • 針對KRAS·BRAF突然變異陽性的患者之標靶治療
  • 是針對高風險且可切除之轉移部位,有效果的新佐劑/佐劑治療方法
  • 針對化療抗性患者之後期治療

第7章 開發平台評估

  • 概要
  • 臨床實驗階段的有潛力的藥劑

第8章 Imprime PGG

  • 概要
  • 有效性
  • 安全性
  • 給藥及製劑
  • 在臨床方面·商業方面的潛在的定位
  • SWOT分析
  • 預測

第9章 附錄

圖表一覽

目錄
Product Code: GDHC477DFR

GlobalData has released its new PharmaPoint Drug Evaluation report, "Imprime PGG (Colorectal Cancer) - Forecast and Market Analysis to 2023". Colorectal cancer (CRC) is the second leading cause of mortality among cancer patients in the world and is the third most diagnosed cancer globally, and thus represents a huge burden on healthcare systems. This report focuses on the current treatment landscape, unmet needs, current pipeline, and commercial opportunities in the colorectal cancer market, with coverage of multiple settings of the disease including neoadjuvant/adjuvant, first-, second-, third-line KRAS wild-type and mutation-positive, and fourth-line metastatic. In terms of targeted treatments, the metastatic CRC treatment landscape is mature, including the branded treatments Avastin (bevacizumab), Erbitux (cetuximab), and Vectibix (panitumumab), treatments that have extended the survival of metastatic patients compared to chemotherapy-only regimens. However, high unmet needs remain for the extension of survival of metastatic patients, and particularly those with KRAS mutation-positive disease, for whom the epidermal growth factor receptor (EGFR) inhibitors Erbitux and Vectibix are not recommended.

Biothera's Imprime PGG is an immunotherapy in Phase III development in the US and Europe for the treatment of chemotherapy-refractory KRAS wild-type metastatic CRC in combination with the EGFR inhibitor Erbitux. Its open-label pivotal study has an estimated enrollment of 795 patients, and these patients will be randomized (2:1) to either Imprime PGG and Erbitux or Erbitux alone. The trial has a primary endpoint of OS, with final data for this outcome expected in April 2016; the company is investigating the potential to apply for accelerated approval based on interim data when available.

Scope

  • Overview of Colorectal Cancer, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Imprime PGG including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Imprime PGG for the top six countries from 2013 to 2023.
  • Sales information covered for the US, France, Germany, Italy, Spain and the UK.

Reasons to buy

  • Understand and capitalize by identifying products that are most likely to ensure a robust return
  • Stay ahead of the competition by understanding the changing competitive landscape for Colorectal Cancer
  • Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  • Make more informed business decisions from insightful and in-depth analysis of Imprime PGG performance
  • Obtain sales forecast for Imprime PGG from 2013-2023 in top six countries (the US, France, Germany, Italy, Spain and the UK)

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. Clinical Staging
  • 3.3. Symptoms

4. Disease Management

  • 4.1. Diagnosis and Treatment Overview
    • 4.1.1. Screening and Diagnosis
    • 4.1.2. Treatment Guidelines and Leading Prescribed Drugs
    • 4.1.3. Clinical Practice

5. Competitive Assessment

  • 5.1. Overview

6. Unmet Need and Opportunity

  • 6.1. Overview
  • 6.2. Therapies That Provide Substantial Overall Survival Benefit for Metastatic Patients
    • 6.2.1. Unmet Need
    • 6.2.2. Gap Analysis
    • 6.2.3. Opportunity
  • 6.3. Targeted Treatments for KRAS and BRAF Mutaton-Positive Patients
    • 6.3.1. Unmet Need
    • 6.3.2. Gap Analysis
    • 6.3.3. Opportunity
  • 6.4. Effective Neoadjuvant/Adjuvant Therapies for High Risk Resectable Disease
    • 6.4.1. Unmet Need
    • 6.4.2. Gap Analysis
    • 6.4.3. Opportunity
  • 6.5. Tolerable Later-Line Therapies For Chemotherapy-Resistant Patients
    • 6.5.1. Unmet Need
    • 6.5.2. Gap Analysis
    • 6.5.3. Opportunity

7. Pipeline Assessment

  • 7.1. Overview
  • 7.2. Promising Drugs in Clinical Development

8. Imprime PGG

  • 8.1. Overview
  • 8.2. Efficacy
  • 8.3. Safety
  • 8.4. Dosing and Formulation
  • 8.5. Potential Clinical and Commercial Positioning
  • 8.6. SWOT Analysis
  • 8.7. Forecast

9. Appendix

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Methodology
  • 9.4. Forecasting Methodology
    • 9.4.1. Diagnosed Colorectal Cancer Patients
    • 9.4.2. Percent Drug-Treated Patients
    • 9.4.3. General Pricing Assumptions
    • 9.4.4. Average Body Weight and Surface Area Across the 8MM
    • 9.4.5. Generic Erosion
    • 9.4.6. Pricing of Pipeline Agents
  • 9.5. Primary Research - KOLs Interviewed for this Report
  • 9.6. Primary Research - Prescriber Survey
  • 9.7. About the Authors
    • 9.7.1. Analyst
    • 9.7.2. Global Head of Healthcare
  • 9.8. About GlobalData
  • 9.9. Disclaimer

List of Tables

  • Table 1: TNM and Staging Classification System for CRC
  • Table 2: Symptoms of Colorectal Cancer
  • Table 3: Treatment Guidelines for CRC
  • Table 4: Most-Prescribed Neoadjuvant/Adjuvant Regimens for Early-Stage CRC in the Global Markets, 2013
  • Table 5: Most Prescribed Targeted Therapies for Metastatic CRC by Segment in the Global Markets, 2013
  • Table 6: Leading Treatments for CRC, 2014
  • Table 7: Unmet Need and Opportunity in CRC
  • Table 8: Product Profile - Imprime PGG
  • Table 9: Imprime PGG SWOT Analysis, 2014
  • Table 10: Global Sales Forecasts ($m) for Imprime PGG, 2013-2023
  • Table 11: Average Body Weight and Surface Area Across the 8MM
  • Table 12: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: CRC - Phase III Pipeline
  • Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in CRC, 2013-2023
  • Figure 3: Clinical and Commercial Positioning of Imprime PGG
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