株式会社グローバルインフォメーション
TEL: 044-952-0102
表紙
市場調査レポート

Nintedanib(大腸がん):市場の予測と分析

Nintedanib (Colorectal Cancer) - Forecast and Market Analysis to 2023

発行 GlobalData 商品コード 321692
出版日 ページ情報 英文 70 Pages
即納可能
価格
本日の銀行送金レート: 1USD=114.71円で換算しております。
Back to Top
Nintedanib(大腸がん):市場の予測と分析 Nintedanib (Colorectal Cancer) - Forecast and Market Analysis to 2023
出版日: 2014年11月28日 ページ情報: 英文 70 Pages
概要

Boehringer Ingelheimでは現在、米国・欧州・日本にて、難治性大腸がんの治療向けに、経口投与式の抗VEGF阻害剤であるNintedanib (BIBF-1120)の開発を進めています。治験には764名の患者が参加し、プラセボ比較試験・二重盲検法・ランダム法などの様々な手法で、現在は第III相の治験が進められています。治験の有効性を高めるために、治験に参加する資格のある患者は、転移性の疾患の患者で、他の治療法(5-FU、xaliplatin、irinotecan、Avastin、Zaltrap、(野生型KRASの場合は)非EGFR療法)では効果の無かった人々に限られています。治験は現在、無憎悪生存期間(PFS)については一次試験が、全生存者(OS)・奏効率(ORR)・疾患管理については二次試験が終了した段階です。2016年下半期には治験データが完成する予定です。

当レポートでは、大腸がんの治療薬の一つ、Nintedanib(BIBF-1120)の世界市場について分析し、大腸がんの概要や治療法、競合する企業・薬品の概要、市場競争の概況、Nintedanibの商品情報(特色・効能・安全性など)、世界の主要国における市場販売額の見通し(今後10年間分)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

  • 分析の背景事情
  • 関連レポート
  • 刊行予定の関連調査レポート

第3章 疾患の概要

  • 病因と病態生理学
    • 病因
    • 病態生理学
  • 臨床病期
  • 症状

第4章 疾患管理

  • 診断および治療概要
    • スクリーニングおよび診断
    • 治療のガイドラインおよび代表的な処方薬
    • 臨床診療

第5章 競合評価

  • 概要

第6章 アンメットニーズおよび機会

  • 概要
  • 転移性患者の生存率を大幅に改善する可能性のある治療法
    • アンメットニーズ
    • ギャップ分析
    • 機会
  • KRAS・BRAF突然変異に陽性の患者向けの標的療法
  • 高リスクの切除可能な転移巣むけの効果的なネオアジュバント/アジュバント治療法
  • 化学療法耐性患者のための許容可能な後期治療

第7章 パイプライン評価

  • 概要
  • 治験段階の有望な薬剤

第8章 Nintedanib (BIBF-1120)

  • 概要
  • 有効性
  • 安全性
  • 投与および製剤
  • 臨床面・商業面での潜在的なポジショニング
  • SWOT分析
  • 予測

第9章 付録

図表一覧

目次
Product Code: GDHC479DFR

GlobalData has released its new PharmaPoint Drug Evaluation report, "Nintedanib (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.

Boehringer Ingelheim is developing nintedanib (BIBF-1120), an orally available anti-VEGF inhibitor, for the treatment of refractory CRC in the US, Europe, and Japan. The drug is being investigated in a placebo-controlled, double-blind, randomized Phase III study in 764 metastatic CRC patients. To be eligible for the trial, patients must be refractory to multiple previous treatments for metastatic disease, including 5-FU, oxaliplatin, irinotecan, Avastin or Zaltrap, and anti-EGFR therapy if KRAS wild-type. Previous treatment with Stivarga is allowed. The trial has a primary endpoint of PFS, with secondary endpoints including OS, ORR, and disease control. The trial is due to report data for PFS in the second half of 2016.

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 Nintedanib including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Nintedanib for the top seven countries from 2013 to 2023.
  • Sales information covered for the US, France, Germany, Italy, Spain, the UK and Japan.

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 Nintedanib performance
  • Obtain sales forecast for Nintedanib from 2013-2023 in top seven countries (the US, France, Germany, Italy, Spain, the UK and Japan)

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. Nintedanib (BIBF-1120)

  • 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 - Nintedanib
  • Table 9: Nintedanib SWOT Analysis, 2014
  • Table 10: Global Sales Forecasts ($m) for Nintedanib, 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 Nintedanib
Back to Top