胆管癌：上市済み薬剤およびパイプライン薬剤の評価・臨床試験・競合情勢

2022年における胆管癌の診断有病者数は16の医薬品市場で71,000人超と推計されています。胆管癌のR&D活動は世界的に活発で、米国、EU、アジア、世界市場で、3製品が承認前、16製品が第III相の開発段階にあります。

本レポートでは、世界の胆管癌治療薬の動向を調査し、疾患・治療の概要、上市済み薬のプロファイル、パイプライン薬および臨床試験の動向、取引情勢、主要企業の動向などをまとめています。

目次

目次

第1章 序文

第2章 主要調査結果

第3章 疾患の情勢

• 疾患の概要
• 疫学の概要
• 治療の概要

第4章 上市済み薬の評価

• 主要な上市済み薬の評価
• 概要：作用機序別
• 概要：投与経路別
• 上市済み薬のプロファイル・売上予測

第5章 価格設定・償還の評価

• メーカー価格
• 価格設定・償還までの時間

第6章 パイプライン薬の評価

• 第III相パイプライン薬
• 概要：開発段階別
• 概要：分子タイプ別
• 概要：作用機序別
• 概要：投与経路別
• 薬剤固有のPTSRおよびLoA
• 治療領域および適応症固有のPTSRおよびLoA

第7章 臨床試験の評価

• 歴史的概要
• 概要：フェーズ別
• 概要：ステータス別
• 進行中および計画中の試験の概要：段階別
• 仮想コンポーネントによる試験
• 概要：地域別
• 単一国および多国籍の試験：地域別
• スポンサー上位20の内訳：フェーズ別
• スポンサー上位20の内訳：ステータス別
• 概要：エンドポイントステータス別
• 概要：人種・民族別
• 登録データ
• 試験サイトの上位20か国
• 世界のトップ20サイト
• フィージビリティ分析：地域的概要
• フィージビリティ分析：ベンチマークモデル

第8章 取引情勢

• M&A・戦略的提携：地域別
• 最近のM&A・戦略的提携

第9章 商業的評価

• 主要企業

第10章 将来のマーケットカタリスト

第11章 付録

This reports provides a data-driven overview of the current and future competitive landscape in BDC therapeutics.

Synopsis

• In 2022, there will be more than 71,000 diagnosed prevalent cases of bile duct cancer across 16 pharmaceutical markets.
• There are seven marketed innovator drugs for the treatment of bile duct cancer, mostly tyrosine kinase inhibitors.
• R&D activity in bile duct cancer is robust globally, with three products in pre-registration and 16 products in Phase III development in the US, EU, Asia, and global markets.
• Institutional sponsors dominated the clinical trial development in bile duct cancer, with UK emerging as the key country for conducting Phase III trials in bile duct cancer.
• During the past 12 months, six strategic alliances and one merger and acquisition transactions involving bile duct cancer assets were successfully completed.
• Approvals expected in near future for molecules from key companies such as AstraZeneca, Otsuka and Servier.

Scope

GlobalData's Bile Duct Cancer (Cholangiocarcinoma) Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape combines data from the Pharma Intelligence Center with in-house analyst expertise to provide a competitive assessment of the disease marketplace.

Components of the report include -

• Disease Landscape
• Disease Overview
• Epidemiology Overview
• Treatment Overview
• Marketed Products Assessment
• Breakdown by Mechanism of Action, Molecule Type, Route of Administration
• Product Profiles with Sales Forecast
• Pricing and Reimbursement Assessment
• Retail or Manufacturer Price of Products
• Time to Pricing and Time to Reimbursement
• Pipeline Assessment
• Breakdown by Development Stage, Mechanism of Action, Molecule Type, Route of Administration
• Product Profiles with Sales Forecast
• Late-to-mid-stage Pipeline Drugs
• Phase Transition Success Rate and Likelihood of Approval
• Clinical Trials Assessment
• Breakdown of Trials by Phase, Status, Virtual Components, Sponsors, Geography, and Endpoint Status
• Enrolment Analytics, Site Analytics, Feasibility Analysis
• Deals Landscape
• Mergers, Acquisitions, and Strategic Alliances by Region
• Overview of Recent Deals
• Commercial Assessment
• Key Market Players
• Future Market Catalysts

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 BDC market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global BDC market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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

Table of Contents

1 Preface

• 1.1 Contents
• 1.2 Report Scope
• 1.3 List of Tables and Figures
• 1.4 Abbreviations

2 Key Findings

3 Disease Landscape

• 3.1 Disease Overview
• 3.2 Epidemiology Overview
• 3.3 Treatment Overview

4 Marketed Drugs Assessment

• 4.1 Leading Marketed Drugs
• 4.2 Overview by Mechanism of Action
• 4.3 Overview by Route of Administration
• 4.4 Marketed Drugs Profiles and Sales Forecasts

5 Pricing and Reimbursement Assessment

• 5.1 Manufacturer Price
• 5.2 Time to Pricing and Reimbursement

6 Pipeline Drugs Assessment

• 6.1 Phase III Pipeline Drugs
• 6.2 Overview by Development Stage
• 6.3 Overview by Molecule Type
• 6.4 Overview by Mechanism of Action
• 6.5 Overview by Route of Administration
• 6.6 Drug Specific Phase Transition Success Rate (PTSR) and Likelihood of Approval (LoA)
• 6.7 Therapy Area and Indication-specific PTSR and LoA

7 Clinical Trials Assessment

• 7.1 Historical Overview
• 7.2 Overview by Phase
• 7.3 Overview by Status
• 7.4 Overview by Phase for Ongoing and Planned Trials
• 7.5 Trials with Virtual Components
• 7.6 Geographic Overview
• 7.7 Single-Country and Multinational Trials by Region
• 7.8 Top 20 Sponsors with Breakdown by Phase
• 7.9 Top 20 Sponsors with Breakdown by Status
• 7.10 Overview by Endpoint Status
• 7.11 Overview by Race and Ethnicity
• 7.12 Enrollment Data
• 7.13 Top 20 countries for Trial Sites
• 7.14 Top 20 Sites Globally
• 7.15 Feasibility Analysis - Geographic Overview
• 7.16 Feasibility Analysis - Benchmark Models

8 Deals Landscape

• 8.1 Mergers, Acquisitions, and Strategic Alliances by Region
• 8.2 Recent Mergers, Acquisitions, and Strategic Alliances

9 Commercial Assessment

• 9.1 Key Market Players

10 Future Market Catalysts

11 Appendix

• 11.1 Methodology
• 11.2 Methodology - Sales Forecast
• 11.3 Methodology - Pricing and Reimbursement
• 11.4 Methodology - PTSR and LoA Analysis
• 11.5 About the Authors
• 11.6 Contact Us
• 11.7 Disclaimer