藥物・診斷產品共同開發的主要動向：企業合作的機會及法規課題之解決

藥物・診斷產品共同開發的主要動向：企業合作的機會及法規課題之解決 是由出版商Business Insights在2009年06月所出版的。 這份英文市場調查報告書包含114 pages 價格從美金3835起跳。

簡介

疾病患治療用品相關利用基因的分子診斷法開發對標的藥物開發的未來而言有重大意義。分子診斷依照患者特性的個人化治療應用在配套產品上的可能性更成為製藥公司及診斷產品製造企業建立新的合作關係的助力。

本報告書內容包括：利用基因研究的診斷技術應用在新藥開發上、製藥・生物科技及診斷設備產業的可能性、該產業面臨的商業・法規相關問題、理想的製藥・診斷合作關係相關調查資訊等。內容網要摘記如下：

實施概要

• 製藥・診斷共同開發介紹
• 法規課題
• 商業課題
• 新進商業模式
• Rx-Dx協同合作
• 未來動向

第1章 製藥・診斷共同開發介紹

• 摘要
• 介紹
• 課題
• 生物標記及個別化醫療
• 進入企業的整合
• 個別化醫療中Dx的角色
• 標的治療開發
• 新的產業合作關係

第2章 法規課題

• 摘要
• 介紹
• 美國法規環境
• 歐洲法規程序
• 個案研究：K-RAS

第3章 商業課題

• 摘要
• 介紹
• 補貼
• 健康經濟學的角色
• 治療用途
• 智慧財產權

第4章 新進商業模式

• 摘要
• 介紹
• 一次消費
• Rx-Dx產業合作關係
• 進行中的協同合作

第5章 Rx-Dx協同合作

• 摘要
• 介紹
• 事例

第6章 未來動向

• 摘要
• 介紹
• 製藥R&D的新格局
• 逐漸變化的體外診斷（IVD）產業力學
• 針對現有藥物的生物標記的發現見
• 新一代測試
• 結論

附錄

圖表

目錄

Abstract

The development of genomics-based molecular diagnostics that are linked to therapeutic products is critical to targeted drug developments of the future. The potential for molecular diagnostics to be used as companion products for personalized treatments that are based on patient characteristics will contribute to a growing trend for new partnerships between drug companies and diagnostic firms. ' Key Trends in Drug-Diagnostic Co-Development' is a new report published by Business Insights that explores the potential for applying genomic-based diagnostics to new drug developments, and the resultant implications for the pharma/biotech and diagnostic industries. This report examines the commercial and regulatory challenges facing drug-diagnostic combinations and evaluates emerging business models to identify the most effective forms of pharmacodiagnostic partnership. This report also reviews 28 collaborative agreements for the co-development of drug-diagnostics and determines which combinations can be expected to result in commercial products in the near future.

Table of Contents

Executive summary

• Introduction to drug-diagnostic co-development
• Regulatory challenges
• Commercial challenges
• Emerging business models
• Rx-Dx collaborations
• Future trends

Chapter 1 Introduction to drug-diagnostic co-development

• Summary
• Introduction
• Technology driving change
• Biomarkers & personalized medicine
• Convergence of players
• The role of Dx in personalized medicine
• Targeted therapeutic developments
• New industry partnerships
• Companion test development models

Chapter 2 Regulatory challenges

• Summary
• Introduction
• US regulatory landscape
• Voluntary genomic data submissions (VGDS)
• Rx-Dx co-development guidance
• IVDMIA guidance
• Dx usage determines risk
• Study design
• EU regulatory process
• IVD regulatory framework under discussion
• Pharmacogenomics in drug development
• Potential advantages of the EU system
• Case Study: K-RAS

Chapter 3 Key commercial challenges

• Summary
• Introduction
• Reimbursement
• Information requirements
• European situation
• Case Study: Oncotype DX
• Role of health economics
• Third-party studies
• Clinical use
• Different clinical settings
• Intellectual property

Chapter 4 Emerging business models

• Summary
• Introduction
• One-stop shop
• Case Study: Roche
  • Acquisitions
  • Alignment of business areas
  • Companion Dx programs
• Rx-Dx industry partnerships
• Drivers of co-development partnerships
• Types of agreements
• Case Study: Pfizer-Monogram Biosciences
• Collaborations underway

Chapter 5 Rx-Dx collaborations

Summary

• Introduction

Asuragen

• Background
• Collaboration
  • Merck & Co

BG Medicine

• Background
• Collaboration
  • Cordex Pharma

bioMerieux

• Background
• Collaboration
  • Ispen
  • Merck & Co
• ADNA project

Celera

• Background
• Collaboration
  • Abbott
  • Merck & Co
  • Ipsen

Curidium

• Background
• Collaboration
  • Takeda

Dako

• Background
• Collaboration
  • OSI Pharmaceuticals
  • Genentech
  • Bristol-Myers Squibb

DxS

• Background
• Collaboration
  • Amgen
  • Roche Molecular Diagnostics

GE Healthcare

• Background
• Collaboration
  • Eli Lilly

Genomic Health

• Background
• Collaboration
  • Pfizer
  • Bristol-Myers Squibb and Imclone Systems

HistoRx

• Background
• Collaboration
  • Lilly

LabCorp

• Background
• Collaboration
  • ARCA biopharma
  • Vanda Pharmaceuticals
  • Medco Health Solutions

Monogram Biosciences

• Background
• Collaboration
  • Pfizer HIV partnership
  • Oncology

OncoMethylome Sciences

• Background
• Collaboration
  • Merck KGaA
  • Schering-Plough
  • GlaxoSmithKline Biologicals
  • Abbott

Source MDx

• Background
• Collaboration
  • Pfizer

XDx

• Background
• Collaboration
  • Bristol-Myers Squibb

Chapter 6 Future trends

• Summary
• Introduction
• New paradigm for pharma R&D
• Rx-Dx combinations in pipeline
• Changing dynamics of the IVD industry
• Biomarker discovery for existing drugs
• Next generation tests
• Conclusions

Appendix 112

• Research methodology
• Glossary
• Index

List of Figures

• Figure 1.1: Biomarker discovery is comparable to drug discovery
• Figure 1.2: Convergence of drug and diagnostic industries
• Figure 1.3: Main therapy areas for Rx-Dx co-development (number of diagnostic tests)
• Figure 1.4: Ideal Rx-Dx co-development scenario
• Figure 1.5: Alternative co-development scenarios
• Figure 2.6: Regulatory pathways for diagnostics in the US
• Figure 2.7: Problems when patient accrual is gated via non-final IVD
• Figure 3.8: Pre and post-approval challenges of Rx-Dx co-development
• Figure 3.9: Difference between obtaining reimbursement in US and Europe
• Figure 4.10: Roche Group sales by type (% of revenues), 2008
• Figure 4.11: Diagnostic input for pharma projects
• Figure 4.12: Rx-Dx partnership opportunities
• Figure 6.13: Biomarker R&D expenditure ($bn), 2003 vs 2009
• Figure 6.14: Forecast sales in IVD market ($bn), 2007-2012

List of Tables

• Table 1.1: Drugs for which testing is recommended/required in the US
• Table 1.2: Co-developed Rx-Dx combinations on market
• Table 4.3: Biomarker strategy for Phase I/II oncology drugs
• Table 4.4: Summary of Rx-Dx Co-Development Projects
• Table 5.5: Rx-Dx co-development projects under review
• Table 6.6: Patient population in whom selected drugs do not work (% population)

相關商品

製藥企業相關市場調查報告書

生物標記相關合作契約
Biomarker Partnering Terms and Agreements
價格 : US $ 2695
出版日期 : 2012年02月

最佳實務：轉譯研究-朝向產業轉換前進
Best Practices: Translational Research - Positive Steps on the Path to Industry Transformation
價格 : US $ 4500
出版日期 : 2011年12月

製藥產業的合作，授權，投資，收購與合併交易趨勢:2011年12月
Partnerships, Licensing, Investments and M&A Deals and Trends in Pharmaceuticals - December 2011
價格 : US $ 1000
出版日期 : 2011年12月

Business Insights發行的製藥相關市場調查報告書

歐洲的醫藥品支付制度和各適應症的藥價設定

Reimbursement in Europe and Indication-Specific Pricing

價格 : US $ 3835

出版日期 : 2011年12月

感染疾病分子診斷的技術創新

Innovations in Molecular Diagnostics for Infectious Diseases

價格 : US $ 3835

出版日期 : 2011年11月

醫療藥物開發委託機構市場 - 2016年止展望

The CRO Market Outlook to 2016

價格 : US $ 3835

出版日期 : 2011年11月

Email Alert(Email 通知) - 最新市場調查報告書

GII 將每天定期更新最新市場調查報書資訊，選擇您有興趣的市場分類，我們將用Email的方式讓您收到最新訊息!