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薬剤研究開発のためのバイオマーカー、試験、および動向

Biomarkers, Tests and Trends for Drug R&D

発行 Takeda Pacific 商品コード 112025
出版日 ページ情報 英文 144 Pages
納期: 即日から翌営業日
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こちらの商品の販売は終了いたしました。
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薬剤研究開発のためのバイオマーカー、試験、および動向 Biomarkers, Tests and Trends for Drug R&D
出版日: 2010年02月01日 ページ情報: 英文 144 Pages

当商品の販売は、2016年07月01日を持ちまして終了しました。

概要

当報告書では、バイオマーカーに関連する研究開発動向、投資やM&A、提携、技術サービス動向について検証し、2014年までの投資動向もまとめながら、概略下記の構成でお届けいたします。

第1章 薬剤研究開発のためのバイオマーカー市場

  • 医薬品業界の研究開発費と新製品
  • 安全性、効果、アンメットニーズ
  • バイオマーカー創薬ツール
  • 個別化医療
  • ファーマコゲノミクスおよびオミクスバイオマーカー
  • 市場の生態系

第2章 薬剤研究開発のためのバイオマーカー

  • バイオマーカーの定義
  • バイオマーカー、分析、試験
  • バイオマーカーが作り出す業界
  • バイオマーカー開発

第3章 バイオマーカー研究開発における提携とM&A

第4章 バイオマーカー技術と薬剤研究開発

第5章 市場規模と見通し

第6章 バイオマーカー研究開発に取り組み主な企業

  • Abbott Molecular
  • Affymetrix, Inc.
  • Asuragen, Inc.
  • Beckman Coulter, Inc.
  • bioMerieux SA
  • Celera Corporation
  • Cepheid
  • Dako A/S
  • Epigenomics AG
  • Expression Analysis, Inc.
  • Gen-Probe, Inc.
  • Helicos Biosciences Corporation
  • Hologic, Inc.
  • Illumina, Inc.
  • Ingenuity Systems, Inc.
  • KineMed
  • LabCorp
  • Life Technologies, Inc.
  • Luminex Corporation
  • Nanosphere, Inc.
  • Nymox Pharmaceutical Corporation
  • Orion Genomics LLC
  • QIAGEN N.V.
  • Quest Diagnostics, Inc.
  • Rules-Based Medicine, Inc.
  • Sequenom, Inc.
  • 454 Life Sciences (Roche)
  • Banyan Biomarkers, Inc.
  • Combimatrix Molecular Diagnostics, Inc.
  • Protagen AG
  • Singulex

第7章 動向と将来の方向性

  • 薬剤研究開発のためのバイオマーカー
  • 将来の方向性

第8章 付録

目次
Product Code: TPR3179

Abstract

This report is about the world market for biomarkers and tests used for drug R&D. The study reviews and analyzes the market by examining biomarker related drug R&D spending, trends, major diseases, applications, M&As, alliances, tools & technologies, products and R&D services. This report provides a detailed outlook of the market for biomarkers and related genomic, proteomic, or other tests used in drug R&D programs. The research report also touches on metabolomic and imaging biomarkers. This study sizes the world market and growth rate of biomarkers and tests for drug R&D spending to 2014.

The major drug makers face many daunting challenges that are being mitigated by the companies using key business and technical strategies that utilize biomarkers. Despite the recent severe recession, this business area is set for strong continued double-digit growth as biomarkers and tests in drug/therapeutic R&D enable emerging opportunities, potentially worth billions of dollars.

This business report updates our current view about biomarkers for drug R&D. The study discusses ongoing government initiatives that foster worldwide development in biomarkers and personalized medicine opportunities. Their expectation is to streamline commercializing new, safer, drugs and co-developed companion predictive tests by integrating biomarkers and pharmacogenomic (PGx) tests into the critical path of drug R&D. The study discusses how clinical trials are undergoing important emerging changes that integrate biomarkers and assays into the drug development process to provide more useful information in order for drug makers to make better product development decisions.

This study uses more than 51 figures and tables to illustrate its insightful findings. The report offers detailed information including data tables about key technologies, M&As, alliances and so on. More than thirty selected companies are profiled with details such as contact information, business overview, financial details and product information. This report uses hyperlinks to help readers jump to Table of Content items or to text-linked Internet sites.

This must-have report would benefit people with job titles including CEO, VPs, Director of Business Development, Research Directors, Entrepreneurs, Venture Capitalists, Investment Planners, Research Scientists, Consultants or Industry Analysts.

About Takeda Pacific

Analysts at Takeda Pacific developed this report. The company provides business consulting that focuses on facilitating business development and market research projects. The business projects may involve European, Japanese and North American Life Science companies. Since it' s founding in late 1992, TP has reviewed or analyzed thousands of life Science and technology firms for its clients.

Since 1992, Takeda Pacific has produced numerous industry reports about emerging pharma, biotech, medical devices and technology companies and markets. Takeda Pacific also offers follow-up consulting or custom research consulting to assist in your business development or benchmarking, market assessment projects.

Report Statistics

  • Authors: Jay K. Myers, Paula Mitchell Myers
  • Publication Date: February 2010
  • Number of Pages: 144 pages; can be printed; fully searchable PDF format.

Table of Contents

1.Biomarker Market for Drug R&D

  • Drug Industry R&D Spending and New Products
  • Limited Drug Safety, Effectiveness and Unmet Medical
  • Needs
    • Common Drug Types Are Not Very Effective
    • Drug-Related Adverse Events (AEs) Create Health
      • Risks for Large Patient Populations
    • Key Unmet Medical Needs
  • Tools for Biomarker Discovery and Qualification
  • Enables Personalized Medicine
  • Pharmacogenomic and ‘Omic Biomarkers
  • Government, Biomarkers and PGx
  • Market Ecosystem

2.Biomarkers For Drug R&D

  • Definitions of What Biomarkers Are
    • Healthcare and Biomarkers
    • The Definition of Biomarkers Continues to Evolve
    • The FDA' s Definitions of Biomarkers and Tests for
      • Drug R&D
    • Updated Definitions And Biomarker Qualification
    • FDA' s International Harmonization Progress
  • Biomarkers, Assays and Tests
    • Nucleic Acids, Proteins, Profiles and Metabolites
    • Pharmacogenomic (PGx) Biomarkers and Personalized
      • Medicine
    • New Clinical Trial Designs and Patient
      • Stratification
    • Drug-Test Synergies for Rx/ Dx Companion Tests
  • Biomarkers Generate Industry Buzz
    • FDA' s Biomarker Activities
    • FDA vXDS Program and International Harmonization
    • Other Government Initiatives in Personalized
      • Medicine
    • SNPs, CNVs, Haplotyping, Molecular Patterns and
      • Gene Expression Profiles Measure Complex
      • Diseases
    • The Goal to Drive Down the Cost of SNP Tests
    • MicroRNAs are Biomarkers; shRNAs Can Screen for
      • Biomarkers
    • Multiplexed Protein Patterns Can Be Biomarkers
  • Developing Biomarkers, Assays and Dx

3.Alliances and M&As in Biomarker R&D

  • Alliances in Biomarkers and Drug R&D
  • Alliances in Biomarkers By Major Diseases
  • Alliance Deals to Mid-2007

4.Technologies for Biomarkers and Drug R&D

  • PGx Tests for Drug R&D
  • Biomarker Testing and Analysis Technologies
    • Genomic Biomarker Testing
      • Direct Detection with Blots and ELISAs
      • PCR-based Target Amplification Technology
      • Non-PCR Target Amplification and Signal
        • Amplification
      • Signal Amplification
    • Microarrays and Microfluidic Systems
      • Microarrays
      • Microfluidic Systems (Lab-on-a-chips)
    • First-, Second- and Third-Generation DNA Sequencing
      • for Biomarker R&D
    • Proteomic Biomarker Testing
    • Metabolomics Biomarker Testing
    • Imaging Biomarker Testing
    • Bioinformatic Software is Key to Biomarker Analysis

5.Market Size and Outlook for Drug Industry Biomarker R&D

  • Spending
  • Global Drug Makers' Biomarker R&D Spending Trends
  • Global Drug Makers' Biomarker R&D Spending Market
  • Shares
    • Global Drug Makers' Biomarker R&D Market Size by
      • Application Segments
    • Global Drug Makers' Biomarker R&D Market Size by
      • Application/ Clinical Phase
    • Global Drug Makers' Biomarker R&D by Tools and
      • Services
  • Drug Makers' Biomarker R&D Spending by World Region

6.Selected Companies Working in Biomarker R&D

  • Abbott Molecular
  • Affymetrix, Inc.
  • Asuragen, Inc.
  • Beckman Coulter, Inc.
  • bioMerieux SA
  • Celera Corporation
  • Cepheid
  • Dako A/S
  • Epigenomics AG
  • Expression Analysis, Inc.
  • Gen-Probe, Inc.
  • Helicos Biosciences Corporation
  • Hologic, Inc.
  • Illumina, Inc.
  • Ingenuity Systems, Inc.
  • KineMed
  • LabCorp
  • Life Technologies, Inc.
  • Luminex Corporation
  • Nanosphere, Inc.
  • Nymox Pharmaceutical Corporation
  • Orion Genomics LLC
  • QIAGEN N.V.
  • Quest Diagnostics, Inc.
  • Rules-Based Medicine, Inc.
  • Sequenom, Inc.
  • 454 Life Sciences (Roche)
  • Banyan Biomarkers, Inc.
  • Combimatrix Molecular Diagnostics, Inc.
  • Protagen AG
  • Singulex

7.Trends and Future Directions

  • Biomarkers for Drug R&D
    • Government Initiatives Foster Drug R&D + Biomarker/
      • Test Co-development
    • Biomarkers, a Key Opportunity on the Critical Path
      • to Personalized Medicine
    • The Critical Path Linked to FDA' s VXDS Program
    • Biomarkers Enable New Clinical Trial Designs
  • Future Direction of PGx Tests and Targeted Therapies
    • Personalized Medicine is Here and is Set for Growth
    • Cancer Biomarkers and Tests
    • Future Direction for CNS Disease Tests
    • Infectious Disease Testing

8.Appendices

  • WW Populations by Diseases
  • Examples of Uses of Biomarker Tests for Drug R&D
    • Clinical PGx Biomarker Tests in the Drug R&D Paths
    • Biomarker Tests for Drug R&D
    • Links to Organizations Mentioned in this Report
  • About Takeda Pacific
  • About the Authors

List of Tables

  • Table 1. Annual Drug R&D Spending Estimates
  • Table 2. Common Drug Types and Low Drug Response Rates (%)
  • Table 3. Large Disease Populations with Unmet Medical Need
  • Table 4. Areas of Drug R&D Interest for vXDSs Sent to FDA
  • Table 5. Examples of Biomarker Topics For FDA vXDS
    • Submissions
  • Table 6. Path to Commercialize Biomarker Tests
  • Table 7. Summary of Alliances in Biomarker Pharma-Biotech
    • R&D by Alliance Type
  • Table 8. Alliances in Biomarkers and Pharma-Biotech R&D by
    • Major Disease
  • Table 9. Analysis of the ‘Others’ (Drug Response) Biomarker
    • Alliances By Indication/ Application
  • Table 10. Key Alliances in Biomarkers and Pharma-Biotech
    • R&D by Major Disease and Indication/ Application, 1H/2007
  • Table 11. Key Alliances in Biomarkers and Pharma-Biotech
    • R&D by Major Disease and Indication/ Application, 2006
  • Table 12. Key Alliances in Biomarkers and Pharma-Biotech
    • R&D by Major Disease and Indication/ Application, 2005
  • Table 13. Target Amplification Technologies
  • Table 14. Target Signal Amplification Technologies
  • Table 15. Microarray and Lab-on-a-chip Technologies
  • Table 16. First-, Second- and Third-Generation DNA
    • Sequencing Platforms
  • Table 17. Proteomic Technologies for Biomarker Testing or R&D
  • Table 18. Metabolomic Technologies and Biomarkers
  • Table 19. Global Drug Makers' Biomarker R&D Spending by Major Diseases or Applications to 2014
  • Table 20. Global Drug Makers' Biomarker R&D Spending Market Shares by Disease, 2008 & 2014
  • Table 21. Global Drug Makers' Biomarker R&D by Application/Clinical Phase
  • Table 22. Global Drug Makers' Biomarker R&D Spending by Tools and Services, 2008-2014
  • Table 23. Global Drug Makers' Biomarker R&D Spending by Region
  • Table 24. Six Major FDA Critical Path Topics
  • Table 25. Future Direction of PGx Tests
  • Table 26. Future Direction for Risk Prediction Genetic Tests
  • Table 27. Highlights of Biomarkers, Targeted Therapies, and Tests (PGx)
  • Table 28. Cancer Companion Tests and Targeted Therapies
  • Table 29. Future Direction of Cancer Companion Tests
  • Table 30. CNS Tests Likely in Five Years
  • Table 31. Future Direction of Infectious Disease Tests
  • Table 32. Major Diseases by Mortality, Incidence and Prevalence
  • Table 33. Top Health Risk Factors Leading to Death in the Developed World
  • Table 34. Path For Prediction of Drug Response Safety Risk
  • Table 35. Path For Drug Efficacy Testing v. Disease State
  • Table 36. Summary of PGx Biomarker Test Focus in Drug R&D
  • Table 37. Weblinks to Companies Mentioned in this Report
  • Table 38. Weblinks to Selected Government Organizations
  • Table 39. Weblinks to Biomarker Consortium Industry Members
  • Table 40. Weblinks to Biomarker Consortium Non-Profit Members

List of Illustrations

  • Figure 1. The Biomarker Pharma/ Biotech R&D/ PGx Market Ecosystem
  • Figure 2. Microarrays and Microfluidic Chips Used in Drug R&D
  • Figure 3. Affymetrix Microarray System
  • Figure 4. A Microfluidics Instrument for Drug R&D
  • Figure 5. Diagram of a Protein Capture Microarray
  • Figure 6. Analytical Software
  • Figure 7. Global Drug Makers' R&D Spending by Major Diseases to 2014
  • Figure 8. Global Drug Makers' Biomarker R&D Spending Market Shares by Disease, 2008 & 2014
  • Figure 9. Global Drug Makers' Biomarker R&D by Application/ Clinical Phase
  • Figure 10. Global Drug Makers' Biomarker R&D Spending by Tools and Services, 2008-2014
  • Figure 11. Global Drug Makers' Biomarker R&D Spending by Region
  • Figure 12. Biomarkers and the FDA Critical Path
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