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市場調査レポート

コンパニオン診断および個別化医療市場レポート

Companion Diagnostics and Personalized Medicine Market Report 2012

発行 SELECTBIO, Ltd. 商品コード 249177
出版日 ページ情報 英文 130 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=114.77円で換算しております。
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コンパニオン診断および個別化医療市場レポート Companion Diagnostics and Personalized Medicine Market Report 2012
出版日: 2012年08月27日 ページ情報: 英文 130 Pages
概要

当レポートでは、個別化医療およびコンパニオン診断(CDx)の市場について調査分析し、予後・予測バイオマーカーのリスト、臨床上の潜在的有用性、各種疾患クラスにおける薬剤による転帰、個別化医療市場の市場規模(実績・予測)、RxとDxの収益の内訳、標的RxおよびCDxの価格設定の動向、コンパニオン診断の開発に関連する企業間提携の動向などをまとめ、概略下記の構成でお届けいたします。

第1章 個別化医療とコンパニオン診断:市場区分と定量的分析

  • コンパニオン診断の定義
  • バイオマーカーのクラスと個別化医療における活用
  • 予後バイオマーカー:リスト・概要・臨床上の意義
  • 予測バイオマーカー:リスト・概要・臨床上の意義
  • より広範な個別化医療領域における課題とその導入
  • コンパニオン診断の法的承認までの道筋:サマリー
  • CLIAの承認下のLDT
  • 各種疾患クラスにおける薬剤による転帰
  • 腫瘍クラスが腫瘍が特徴的な体細胞突然変異と関連しているかどうかの認知
  • 肺癌・消化器癌における体細胞突然変異の続発症
  • XalkoriRのストーリー
  • ZelborafRのストーリー
  • コンパニオン診断・個別化医療:定量的市場メトリクス
    • コンパニオン診断の開発コストとは?
    • 癌の標的治療における高額料金設定の前例
    • 主な個別化医療検査の価格
    • 個別化医療市場の成長:市場規模・予測・成長率

第2章 個別化医療産業の環境:主な適応症・バイオマーカー・治療薬

  • 治療薬
  • バイオマーカー
  • 適応症
  • 検査の義務
  • この包括的リストは以下の個別化医療検査で構成されています
    • "必要"
    • "推奨"
    • "情報利用のみ"
    • "薬剤ラベルに薬理ゲノム的情報はない"

第3章 CDx市場の動向と進化:過去20年におけるRx/CDxの共同開発タイムライン

  • Rx企業およびCDx企業の格差
  • Rx開発・Dx開発で異なる経済的インセンティブ
  • 癌領域における標的Rxの増大とCDx開発への影響
  • フェーズIIIの現在のRx/CDx共同開発プログラムと関連バイオマーカーのリスト
  • CDxで対応可能な癌クラス
  • 分子バイオマーカークラスの特性:出版物のホットスポット分析
  • 癌バイオマーカー
  • 癌遺伝子
  • 癌抑制遺伝子
  • ノンコーディングRNA
  • Dx領域における提携と協力
    • 2012年
    • 2011年
    • 2010年
    • 2009年

付録

目次

Abstract

Up-to-Date Market Analyses of the CDx Field

This is the latest and most up-to-date Market Report from Select Biosciences addressing the companion diagnostics (CDx) and personalized medicine marketplace. Personalized medicine is a broad field with several stakeholders all of which must be aligned in order to capture the immense potential value in targeting therapeutics to the correct patient population the field of stratified medicine.

Companion Diagnostics has been rapidly expanding over the past 3 years and in this market report we describe the current state of the marketplace from the following perspectives:

  • All the Prognostic and Predictive Biomarkers with Potential Clinical Utility are described a few have already been developed into CDx and we expect growth in this space
  • Targeted Therapeutics, Associated Biomarkers, Therapeutic Indications, and Testing Mandates are Described
  • Companion Diagnostics Partnerships and Collaborations from 2009 to 2012 are Presented Provides an Up-to-Date State of the Industry Describing the Disease Areas being Addressed and Types of Biomarkers Being Deployed
  • Quantitative Market Metrics
    • Quantitative Market Forecast: Market Sizing and Growth Rate
    • Revenue Breakout: Rx versus Dx
    • Targeted Rx and CDx Pricing
  • Publication Hotspot Analyses of the Various Cancer Biomarker Classes for Identifying Niches of Market Opportunity in Various Disease Classes

This data-driven characterization of the Companion Diagnostics and Personalized Medicine field is a hands-on document that can be used for competitive benchmarking, business planning, and strategy development all the data that have been collected in this industry analysis are presented and they form the basis for the conclusions drawn throughout the market report presented in a format enabling "drag-and-drop" into business presentations/business plans this Market Report is written and delivered to customers in PowerPoint format.

Extensive Market Analyses Presented in this Report

Personalized Medicine and Companion Diagnostics: Market Segmentation and Quantitative Analysis

  • Prognostic Biomarkers in Cancer Listing, Description, and Clinical Significance
  • Predictive Biomarkers in Cancer Listing, Description, and Clinical Significance
  • Summary of Pathways to Regulatory Approval of Companion Diagnostics
  • LDTs under CLIA Certification
  • Outcomes with Drugs in Various Disease Classes
  • Percent of Tumor Classes where Tumors are Associated with Characterized Somatic Mutations
  • Companion Diagnostics and Personalized Medicine: Quantitative Market Metrics
    • How Much Does it Cost to Develop a Companion Diagnostic?
    • Precedent for Premium Pricing in Cancer Targeted Therapeutics
    • Pricing of Selected Personalized Medicine Tests
    • Growth of the Personalized Medicine Marketplace: Market Size/Forecast and Growth Rate

Personalized Medicine Industry Landscape: Selected Indications, Biomarkers and Therapeutics

Market Trends and Evolution of the CDx Marketplace

  • Disparities between Rx and CDx Companies
  • Varying Economic Incentives between Rx and Dx Development
  • Increasing Targeted Rx in the Oncology Space and Effect on CDx Development
  • Current Rx/CDx Co-development Programs in Phase III Trials with Listing of Associated Biomarkers
  • Cancer Classes Addressable by CDx
  • Characterization of Molecular Biomarker Classes: Hotspot Analysis of Publications
    • Cancer Biomarkers
    • Oncogenes
    • Tumor Suppressor Genes
    • Non-coding RNAs
  • Collaborations and Partnering in the CDx Space
    • 2012
    • 2011
    • 2010
    • 2009

Table of Contents

Description of Chapters of the Report

Chapter I. Personalized Medicine and Companion Diagnostics: Market Segmentation and Quantitative Analysis

  • Definition of Companion Diagnostics
  • Classes of Biomarkers and their Utility in Personalized Medicine
  • Prognostic Biomarkers in Cancer Listing, Description, and Clinical Significance
  • Predictive Biomarkers in Cancer Listing, Description, and Clinical Significance
  • Challenges for the Broader Personalized Medicine Field and its Adoption
  • Summary of Pathways to Regulatory Approval of Companion Diagnostics
  • LDTs under CLIA Certification
  • Outcomes with Drugs in Various Disease Classes
  • Percept if Tumor Classes where Tumors are Associated with Characterized Somatic Mutations
  • Somatic Mutation Sequelae in Lung Cancer and Gastrointestinal Cancers
  • Xalkori® Story
  • Zelboraf® Story
  • Companion Diagnostics and Personalized Medicine: Quantitative Market Metrics
    • How Much Does it Cost to Develop a Companion Diagnostic?
    • Precedent for Premium Pricing in Cancer Targeted Therapeutics
    • Pricing of Selected Personalized Medicine Tests
    • Growth of the Personalized Medicine Marketplace: Market Size/Forecast and Growth Rate

Chapter II. Personalized Medicine Industry Landscape: Selected Indications, Biomarkers and Therapeutics

  • Therapeutic
  • Biomarker
  • Indication
  • Testing Mandate
  • This comprehensive listing frames the various personalized medicine tests that are either "Required", "Recommended", "For Information Use Only", or "With No Pharmacogenomic Information on the Drug Label"

Chapter III. Market Trends and Evolution of the CDx Marketplace Timeline of Rx/CDx Co-development over the Last Two Decades

  • Disparities between Rx and CDx Companies
  • Varying Economic Incentives between Rx and Dx Development
  • Increasing Targeted Rx in the Oncology Space and Effect on CDx Development
  • Current Rx/CDx Co-development Programs in Phase III Trials with Listing of Associated Biomarkers
  • Cancer Classes Addressable by CDx
  • Characterization of Molecular Biomarker Classes: Hotspot Analysis of Publications
  • Cancer Biomarkers
  • Oncogenes
  • Tumor Suppressor Genes
  • Non-coding RNAs
  • Collaborations and Partnering in the CDx Space
    • 2012
    • 2011
    • 2010
    • 2009

Appendix I. Research Methodology

Appendix II. Listing and Description of Cancer Biomarkers

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