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個別化医療および癌治療におけるコンパニオン診断

Companion Diagnostics in Personalized Medicine and Cancer Therapy

発行 TriMark Publications 商品コード 203886
出版日 ページ情報 英文 249 Pages
納期: 即日から翌営業日
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個別化医療および癌治療におけるコンパニオン診断 Companion Diagnostics in Personalized Medicine and Cancer Therapy
出版日: 2015年09月01日 ページ情報: 英文 249 Pages
担当者のコメント
米国ニューヨークに本社を置くTriMark Publicationsは、医療分野の市場分析に定評のある調査会社です。世界市場の中でもアメリカ市場の分析を得意とし、本レポートでもアメリカの主要な企業の情報が網羅されております。TriMark Publicationsが発行するレポートは、比較的短いスパンで情報が更新される商品が多く、最新データが網羅されているとして継続的に購入されるお客様の多い人気のシリーズです。
概要

コンパニオン診断は特殊な臨床診断検査で、既知の薬物療法と特に関連しています。個別化医療においては分子診断が重要な役割を果たし、過去20年で大きく成長してきました。コンパニオン診断も現在は規模が小さいものの、体外診断市場において急速に成長を遂げているセグメントのひとつです。

当レポートでは、個別化医療および癌治療におけるコンパニオン診断の使用動向について調査し、業界の定性的、定量的レビューを行なうとともに、法規制動向、技術動向、参入企業のプロファイルなどをまとめています。

第1章 概要

第2章 コンパニオン診断:動向と概要

  • コンパニオン診断におけるステークホルダー
  • 個別化医療のためのコンパニオン診断に関するステークホルダーのビジネスモデルの構築
  • コンパニオン診断取引動向
  • コンパニオン診断市場規模
  • 業界のSWOT分析
  • コンパニオン診断発展のための課題
  • コンパニオン診断における様々なセグメントの影響
  • 産業化検査を発展させるためのプロテオミクスの使用

第3章 コンパニオン診断:定性的および定量的市場分析

  • 分子診断とコンパニオン診断の市場分析
  • 医療費におけるコンパニオン診断のコスト
  • 分子診断市場
  • 分子診断技術プラットフォームとそれが臨床に及ぼす影響
  • コンパニオン診断業界構造概要
  • テラノスティック事例
  • コンパニオン診断市場分析

第4章 コンパニオン診断として癌治療と共同開発されるバイオマーカー検査

  • セクター概要
  • 市場におけるコンパニオン診断
  • 上皮成長因子受容体コンパニオン
  • IVDMIA技術に基づくコンパニオン
  • チロシンキナーゼ阻害剤のためのコンパニオン
  • イリノテカンとUGT1A1
  • Gleevecコンパニオン
  • 代謝酵素に関わるコンパニオン診断 他

第5章 コンパニオンバイオマーカー検査分野におけるビジネス動向と法規制動向

  • 業界統合
  • 製品概要と価格
  • 医療機器に関する法規制
  • 戦略的ビジネスとマーケティング懸案事項
  • コンパニオンマーカーにおける商業的機会
  • 成長促進因子
  • バイオテクノロジー業界動向
  • 医薬品業界動向
  • 買収、ライセンス契約、パートナーシップ
  • 法的整備
  • 腫瘍マーカー検査のための販売、マーケティング戦略
  • 製品の商業化
  • 償還  他

第6章 コンパニオン診断と個別化医療

  • この分野の範囲
  • コンパニオン診断と個別化医療のイントロダクション
  • 薬物代謝、コンパニオン診断および個別化医療
  • 個別化医療とコンパニオン診断検査の事例
  • 製品パイプライン
  • 個別化医療一体化
  • 法規制動向とガイドライン
  • コンパニオン診断は癌治療において役割を増大させている
  • コンパニオン診断が展開される臨床事例
  • 癌治療の有効性に関する個別化分析のための診断検査
  • バリューチェーン
  • コンパニオン診断/個別化医療が薬剤治験に及ぼす影響
  • 市場の問題

第7章 コンパニオン診断市場に参入する企業

  • 業界概要

付録

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目次
Product Code: TMRCDPM15-0901

Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. This linkage could be important in the therapeutic application and clinical outcome of a drug, such as with personalized medicine for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine and has greatly expanded over the past twenty years, expanding by more than 20% annually compared to most other laboratory procedures. Research will continue to produce an increased understanding of disease processes, and diagnostics manufacturers will continue to expand and refine the technology and automation needed for clinical testing. Companion diagnostics, although smaller at present, is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics. This TriMark Publications report examines the use of companion diagnostics in personalized medicine and cancer therapy. The study provides a qualitative and quantitative review of the industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis profiles the leading companies that are developing and manufacturing companion diagnostics solutions. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included.

Table of Contents

1. Overview

  • 1.1. Statement of Report
  • 1.2. About This Report
  • 1.3. Scope of the Report
  • 1.4. Objectives
  • 1.5. Methodology
  • 1.6. Executive Summary

2. Companion Diagnostics: Trends and Overview

  • 2.1. Stakeholders in Companion Diagnostics
  • 2.2. Development of Stakeholders' Business Models for Companion Diagnostics for Personalized Medicine
    • 2.2.1. Pharmaceutical Company Business Models for Developing Companion Diagnostics Products
    • 2.2.2. Diagnostic Company Business Models for Developing Companion Diagnostics Products
    • 2.2.3. Life Science Company Business Models for Developing Companion Diagnostics Products
    • 2.2.4. Pharmacy Benefit Management Company Business Models for Developing Companion Diagnostics Products
  • 2.3. Trends in Companion Diagnostic Deals
  • 2.4. Market Size of Companion Diagnostics
  • 2.5. Companion Diagnostics: Industry SWOT Analysis
  • 2.6. Challenges for Companion Diagnostics Development
  • 2.7. Timeline for Impact of Various Segments in Companion Diagnostics
  • 2.8. Use of Proteomics to Develop Individualized Tests

3. Companion Diagnostics: Qualitative and Quantitative Market Analysis

  • 3.1. Market Analysis of Molecular Diagnostics and Companion Diagnostics
  • 3.2. Costs of Companion Diagnostics in Healthcare Expenditures
  • 3.3. Molecular Diagnostic Market
  • 3.4. Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine
  • 3.5. Snapshot of Companion Diagnostics Industry Structure
  • 3.6. The Case for Theranostics
  • 3.7. Companion Diagnostics Market Analysis

4. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics

  • 4.1. Sector Overview
    • 4.1.1. Impact of New Technology Platforms
    • 4.1.2. Impact on Drug Discovery
    • 4.1.3. Biomarkers as Endpoints in Drug Discovery
    • 4.1.4. Targeted Therapy
  • 4.2. Companion Diagnostics on the Market
  • 4.3. Epidermal Growth Factor Receptor Companions
    • 4.3.1. Bevacizamab (Avastin)
    • 4.3.2. EGFR for CRC and Camptosar (Irinotecan)
      • 4.3.2.1. Companion Diagnostic Test Developed for UGT1A1 for Irinotecan
      • 4.3.2.2. Companion Diagnostic Test Developed for Bristol-Myers' SPRYCEL
    • 4.3.3. EGFR Express and Erbitux (Cetuximab)
    • 4.3.4. HER2 and Herceptin (Trastuzumab)
      • 4.3.4.1. Bayer's Advia Centaur HER2/neu Assay
      • 4.3.4.2. Companies Marketing HER2/neu Assays
    • 4.3.5. Iressa and Tarceva Companion Test
    • 4.3.6. Tykerb (GlaxoSmithKline (GSK)) and Vectibix (Amgen) Companion Tests
    • 4.3.7. EGFRx Assay
    • 4.3.8. Monogram eTag
    • 4.3.9. Veripath OncoDiagnostics EGFR PharmDX
    • 4.3.10. NSCLC Patients with EGFR Mutation
    • 4.3.11. A Personalized Medicine Program for CML
  • 4.4. Companions Based on Myriad's IVDMIA Technology
    • 4.4.1. Myriad's TheraGuide 5-FU
    • 4.4.2. Myriad's BRACAnalysis: Hereditary Cancer Testing for Hereditary Breast and Ovarian Cancer
  • 4.5. Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib
    • 4.5.1. TheraScreen: EGFR29
    • 4.5.2. The K-RAS Mutation Detection Kit
  • 4.6. Irinotecan and UGT1A1
  • 4.7. Gleevec (Imatinib) Companions
    • 4.7.1. DakoCytomation's c-Kit (9.7) pharmDx
  • 4.8. Companion Diagnostics Involving Metabolizing Enzymes
    • 4.8.1. Companions for TMPT, CYP2C9 and UGT1A1 Enzymes
    • 4.8.2. Companions for Aromatase Inhibitors
    • 4.8.3. Companions for Actos and Avandia
  • 4.9. Drivers and Barriers to Companion Diagnostics
  • 4.10. Partnerships with Pharma Companies to Identify Therapeutic Targets
  • 4.11. Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer
  • 4.12. Companion Diagnostics Used by Clinical Service Laboratories
  • 4.13. New Technologies and Products under Development
    • 4.13.1. MDx Health
    • 4.13.2. Ventana to Collaborate with Pfizer and CST on Companion Diagnostic to Identify Lung Cancer Patients with ALK Gene Rearrangements
    • 4.13.3. Abbott and Merck Collaborate to Develop Companion Diagnostic Test for Investigational Cancer Therapy
  • 4.14. Pharmacogenomics Tests
    • 4.14.1. MGMT Methylation Assay
    • 4.14.2. Other Pharmacogenomic Opportunities
  • 4.15. Recurrence Prediction Tests
  • 4.16. Blood-Based Technologies
    • 4.16.1. Oncotech, Inc.
  • 4.17. Monogram Biosciences HIV Personalized Platform
  • 4.18. Wako LBA AFP Test for Liver Cancer
  • 4.19. Future Developments for Companion Diagnostics
  • 4.20. Drug Response Predictors

5. Business and Regulatory Trends in the Companion Biomarker Testing Sector

  • 5.1. Industry Consolidation
  • 5.2. Breath of Product Offering and Pricing
  • 5.3. Government Regulation of Medical Devices
    • 5.3.1. FDA Guidance on Drug Test Co-development
    • 5.3.2. Device Classes
    • 5.3.3. Investigational Use of IVDMIAs
    • 5.3.4. Post-Market Requirements
    • 5.3.5. Voluntary vs. Required Submissions
    • 5.3.6. Examples of Recent Voluntary Genomic Data Submissions
    • 5.3.7. FDA Labeling Implications and Rules
    • 5.3.8. Regulatory Activities in Companion Diagnostic Testing-Translation of Diagnostic Testing Results into Clinical Practice
  • 5.4. Strategic Business and Marketing Considerations
  • 5.5. Commercial Opportunities in Companion Markers
  • 5.6. Moderators of Growth
    • 5.6.1. Roadblocks to Integrating Companion Biomarkers into Clinical Practice
    • 5.6.2. Management of Targeted Therapeutics by Third-Party Payers
  • 5.7. Biotechnology Industry Trends
  • 5.8. Pharmaceutical Industry Trends
  • 5.9. Acquisition, License Agreement, Partnerships
  • 5.10. Legal Developments
  • 5.11. Sales and Marketing Strategies for Tumor Marker Tests
    • 5.11.1. International Markets
    • 5.11.2. Europe
    • 5.11.3. Central and South America
    • 5.11.4. Asia-Pacific
  • 5.12. Product Commercialization
  • 5.13. Reimbursement
  • 5.14. Self-Referral Rules
  • 5.15. Health Insurance Portability and Accountability Act
  • 5.16. Clinical Laboratory Improvement Amendments (CLIA)
  • 5.17. In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations
  • 5.18. FDA's Quality System Regulation (QSR)
  • 5.19. The FDA's OIVD on IVDMIAs
  • 5.20. FDA's Qualification of Cancer Biomarkers
    • 5.20.1. Regulatory Perspectives of Biomarker Validation
  • 5.21. Genetic Tests and Medical Records
    • 5.21.1. Laws Against Genetic Discrimination
  • 5.22. Global Drivers of Clinical Laboratory Testing
  • 5.23. Global Outlook
  • 5.24. Oncology Biomarker Qualification Initiative
  • 5.25. FDA Critical Path
  • 5.26. Biomarkers and FDA's Voluntary Genomic Data Submission
  • 5.27. From Personalized to Predictive Medicine
  • 5.28. Analysis of Cost-Effectiveness at the Individual Level
  • 5.29. The Patient and Advocate Perspective: An Evolution of Influence
  • 5.30. Real-World Experiences Translating the Vision of Personalized Medicine into Practice
    • 5.30.1. Evolving Business Models in Companion Diagnostics and Personalized Medicine
    • 5.30.2. Current Pharma/Diagnostics Business Model Examples
  • 5.31. Reimbursement and Value Creation
  • 5.32. What is the Role of Governmental Agencies in Driving the Adoption of Companion Diagnostics?
  • 5.33. What is the Role of the Insurance Industry in Driving the Adoption of Pharmacogenomics (PGx)?
  • 5.34. What is the Role of the Pharma Industry in Driving the Adoption of PGx?
  • 5.35. FDA Guidance Document on Co-development
  • 5.36. What is the Role of the Diagnostic Industry in Driving the Adoption of PGx?
  • 5.37. What is the Future Role of PBMs in Laboratory Services?

6. Companion Diagnostics and Personalized Medicine

  • 6.1. Scope of This Section
  • 6.2. Introduction to Companion Diagnostics and Personalized Medicine
  • 6.3. Drug Metabolism, Companion Diagnostics and Personalized Medicine
  • 6.4. Examples of Personalized Medicine and Companion Diagnostic Tests
  • 6.5. Personalized Medicine and Companion Diagnostic Testing Product Pipeline
  • 6.6. The Personalized Medicine Coalition (PMC)
  • 6.7. Regulatory Trends and Guidelines in the Personalized Medicine Space
    • 6.7.1. The Changing Regulatory Landscape for Personalized Medicine
  • 6.8. Companion Diagnostics Play an Increasing Role in Cancer Care
  • 6.9. Specific Examples of Clinical Situations where Companion Diagnostics are being Deployed
    • 6.9.1. Epidermal Growth Factor Receptor Assay
    • 6.9.2. Individualized Warfarin Therapy
    • 6.9.3. UGT1A1 Molecular Assay for Camptosar
    • 6.9.4. Response to Gleevec in Gastrointestinal Stromal Tumors (GISTs)
    • 6.9.5. LabCorp and QIAGEN and Personalized Medicine for the treatment of Colorectal Cancer
    • 6.9.6. LabCorp and ARCA Discovery, Inc. Personalized Medicine for Cardiovascular Disease
    • 6.9.7. Roche's Metastatic Melanoma Treatment, Zelboraf (Vemurafenib)
    • 6.9.8. Abbott's Late-Stage NSCLC Treatment, Xalkori (Crizotinib)
  • 6.10. Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness
  • 6.11. Value Chain
  • 6.12. Impact of Companion Diagnostics/Personalized Medicine on Drug Clinical Trials
  • 6.13. The Market Problem: Finding Value with Diagnostics for Personalized Medicine

7. Companies Entering the Companion Diagnostics Market

  • 7.1. Industry Overview
    • 7.1.1. 20/20 GeneSystems, Inc.
    • 7.1.2. Abbott Molecular, Inc.
    • 7.1.3. Affymetrix, Inc.
    • 7.1.4. Agendia BV
    • 7.1.5. Agilent Technologies
    • 7.1.6. Almac Group
    • 7.1.7. AMDL, Inc. (Radient Pharmaceuticals)
    • 7.1.8. Applied Biosystems
    • 7.1.9. Asuragen, Inc.
    • 7.1.10. Aureon Laboratories, Inc.
    • 7.1.11. Beckman Coulter, Inc. (Danaher Corporation)
    • 7.1.12. Becton, Dickinson and Company (BD) Diagnostics-TriPath
    • 7.1.13. Biocode Hycel (Immunodiagnostics Systems [IDS])
    • 7.1.14. BioCurex, Inc.
    • 7.1.15. Biodesix
    • 7.1.16. Biomarker Technologies, LLC
    • 7.1.17. Biomedical Diagnostics, LLC
    • 7.1.18. Biomerica, Inc.
    • 7.1.19. bioMérieux, Inc.
    • 7.1.20. Biomira, Inc. (Oncothyreon, Inc.)
    • 7.1.21. BioModa, Inc.
    • 7.1.22. Bruker Daltonics
    • 7.1.23. Byk Gulden
    • 7.1.24. Cangen Biotechnologies, Inc.
    • 7.1.25. Caprion Proteomics
    • 7.1.26. Celera Diagnostics
    • 7.1.27. Cepheid, Inc.
    • 7.1.28. Clarient, Inc. (GE Healthcare)
    • 7.1.29. Claros Diagnostics, Inc.
    • 7.1.30. Clinical Data, Inc.: PGxHealth and Cogenics
    • 7.1.31. Correlogic Systems, Inc.
    • 7.1.32. CytoCore, Inc. (Formerly known as Molecular Diagnostics, Inc.)
    • 7.1.33. Cytogen Corporation (now EUSA Pharma)
    • 7.1.34. Dako (Agilent Technologies)
    • 7.1.35. diaDexus
    • 7.1.36. DiagnoCure
    • 7.1.37. DRG International
    • 7.1.38. EDP Biotech Corporation
    • 7.1.39. Eisai Co., Ltd.
    • 7.1.40. Eli Lilly & Co.
    • 7.1.41. Epigenomics
    • 7.1.42. Exact Sciences Corporation
    • 7.1.43. Exagen Diagnostics, Inc.
    • 7.1.44. Exigon
    • 7.1.45. Gene Logic, Inc.
    • 7.1.46. Genesis Genomics, Inc. (now known as Mitomics)
    • 7.1.47. GenMark Diagnostics
    • 7.1.48. Genomic Health, Inc.
    • 7.1.49. Gen-Probe, Inc. (now known as Hologic Gen-Probe )
    • 7.1.50. Health Discovery Corporation
    • 7.1.51. Ikonisys, Inc.
    • 7.1.52. Illumina
    • 7.1.53. Immunomedics
    • 7.1.54. InterGenetics, Inc.
    • 7.1.55. Ipsogen (QIAGEN Marseille)
    • 7.1.56. Johnson & Johnson
    • 7.1.57. LabCorp
    • 7.1.58. Life Technologies Corporation (Thermo Fisher Scientific)
    • 7.1.59. Matritech, Inc.
    • 7.1.60. Miraculins
    • 7.1.61. Mitsubishi Kagaku latron
    • 7.1.62. Monogram Biosciences (Formerly ViroLogic, Inc. and now part of LabCorp)
    • 7.1.63. Myriad Genetics, Inc.
    • 7.1.64. NimbleGen Systems, Inc.
    • 7.1.65. Northwest Biotherapeutics, Inc.
    • 7.1.66. Novartis MDx
    • 7.1.67. Nycomed (Takeda)
    • 7.1.68. Oncotech, Inc. (Exiqon A/S)
    • 7.1.69. Oncothyreon, Inc. (Formerly known as Biomira)
    • 7.1.70. OPKO Health, Inc.
    • 7.1.71. Orion Genomics
    • 7.1.72. Oxford BioTherapeutics (Formerly Oxford Genome Sciences)
    • 7.1.73. Panacea Pharmaceuticals, Inc.
    • 7.1.74. Polymedco, Inc.
    • 7.1.75. Power3 Medical Products
    • 7.1.76. Prometheus Laboratories, Inc. (Nestlé Health Science S.A)
    • 7.1.77. Proteome Systems Ltd. (Tyrian Diagnostics Ltd.)
    • 7.1.78. Qiagen N.V.
    • 7.1.79. Roche Molecular Diagnostics
    • 7.1.80. Sanko Junyaku Co., Ltd. (Eisai Co., Ltd.)
    • 7.1.81. SensiGen, LLC (Sequenom Center for Molecular Medicine)
    • 7.1.82. Siemens Healthcare Diagnostics, Inc.
    • 7.1.83. SuperArray Bioscience Corporation (Qiagen)
    • 7.1.84. Third Wave Technologies, Inc. (now owned by Hologic Gen-Probe)
    • 7.1.85. Tosoh Biosciences
    • 7.1.86. Transgenomic, Inc.
    • 7.1.87. TrimGen
    • 7.1.88. Upstream Biosciences, Inc. (RealSource Residential, Inc.)
    • 7.1.89. Ventana Medical Systems, Inc.
    • 7.1.90. Veridex, LLC
    • 7.1.91. Vermillion, Inc. (Formerly Ciphergen)
    • 7.1.92. Vertex Pharmaceuticals, Inc.

Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions

  • Appendix 1.1: Introduction
  • Appendix 1.2: Background
  • Appendix 1.3: Submission Policy
    • Appendix 1.3.1: General Principles
    • Appendix 1.3.2: Specific Uses of Pharmacogenomic Data in Drug Development and Labeling
    • Appendix 1.3.3: Benefits of Voluntary Submissions to Sponsors and FDA
  • Appendix 1.4: Submission of Pharmacogenomic Data
    • Appendix 1.4.1: Submission of Pharmacogenomic Data During the IND Phase
    • Appendix 1.4.2: Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement
    • Appendix 1.4.3: Submission to a Previously Approved NDA or BLA
    • Appendix 1.4.4: Compliance with 21 CFR Part 58
    • Appendix 1.4.5: Submission of Voluntary Genomic Data from Application-Independent Research
  • Appendix 1.5: Format and Content of a VGDS
  • Appendix 1.6: Process for Submitting Pharmacogenomic Data
  • Appendix 1.7: Agency Review of VGDSs

Appendix 2: FDA Issues Draft Companion Diagnostic Guidance

Appendix 3: Histochemical Markers for Cancer

Appendix 4: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions

  • Appendix 4.1: Introduction
  • Appendix 4.2: Background
  • Appendix 4.3: Scope
  • Appendix 4.4: General Principles
  • Appendix 4.5: Structure of Biomarker Qualification Submissions

Appendix 5: Selected Personalized Medicine Drugs, Treatments and Diagnostics as of June 2014

Glossary

INDEX OF FIGURES

  • Figure 2.1: Strategic and Tactical Considerations for Co-Development of Companion Diagnostics
  • Figure 2.2: Global Market for Companion Diagnostics, 2012-2019
  • Figure 2.3: Number of Companion Diagnostic Agreements, 2000-2013
  • Figure 2.4: Surface Binding Produces Phase Shifts that Increases the Diffraction Signal Intensity
  • Figure 3.1: From Genetic Content to Personalized Medicine
  • Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision-Making
  • Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending
  • Figure 3.4: Breakout of the Molecular Diagnostics Marketplace
  • Figure 3.5: Molecular Diagnostics Market Segmentation
  • Figure 3.6: Molecular Diagnostics Market Segmentation by Technology
  • Figure 3.7: Segmentation of the Personalized Medicine Market
  • Figure 4.1: Carcinogenesis is a Multi-Step Process
  • Figure 4.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC
  • Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH
  • Figure 5.1: Companion Diagnostics Partnering, 2007-2013
  • Figure 5.2: Companion Diagnostics Partnering by Stage of Development, 2013
  • Figure 5.3: Companion Diagnostics Partnering by Therapeutic Area, 2013
  • Figure 6.1: U.S. Healthcare Expenditures by Category of Service, 2010
  • Figure 6.2: Representation of the Trial-and-Error or One-Dose-Fits-All Approach vs. Personalized Medicine
  • Figure 6.3: Approaches to Personalized Medicine
  • Figure 6.4: Organizational Transformation to Support Personalized Medicine, 1998-2013
  • Figure 6.5: The Phase I and II Processes of Drug Metabolism
  • Figure 6.6: Hepatic Distribution of Human CYP450
  • Figure 6.7: Relative Contribution of CYP450 Enzymes to Drug Metabolism
  • Figure 6.8: Genetic Components Determine Drug Metabolism
  • Figure 6.9: Personalized Medicine Clinical Trials by Year, 1993-2008
  • Figure 6.10: Healthcare Value Chain

INDEX OF TABLES

  • Table 2.1: FDA Approved Companion Diagnostic Devices: In Vitro and Imaging Tools
  • Table 2.2: Personalized Medicine Industry SWOT Analysis
  • Table 2.3: Hurdles to Personalized Medicine and Companion Diagnostics Development
  • Table 2.4: Timeline of Impact in Areas of Personalized Medicine
  • Table 2.5: Impact of Personalized Medicine on Various Therapeutic Areas
  • Table 3.1: Diagnostic Facts
  • Table 3.2: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine
  • Table 3.3: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine
  • Table 3.4: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine
  • Table 3.5: FDA Classification of Diagnostics by Risk
  • Table 4.1: Potential Benefits of Biomarkers as Companion Diagnostics
  • Table 4.2: Utility of Biomarker as Companion Diagnostics to Drug Development
  • Table 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results
  • Table 4.4: Drivers of Companion Diagnostics Discovery
  • Table 4.5: Barriers to Companion Diagnostics Discovery
  • Table 4.6: Device Submission Elements for the FDA
  • Table 5.1: List and Discounted Prices for Abbott Tumor Marker Tests
  • Table 5.2: Recent Major Companion Diagnostics Deals
  • Table 5.3: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics
  • Table 5.4: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests
  • Table 6.1: Timeline for Development of Companion Diagnostics
  • Table 6.2: Personalized Medicine at the Nexus Point
  • Table 6.3: Percentage of Non-Responders in Various Drug Classes
  • Table 6.4: High-Profile Drug Withdrawals from the Marketplace
  • Table 6.5: Metabolism of Drugs by Hepatic Enzymes
  • Table 6.6: Drug Metabolism Drives Drug Efficacy/Toxicity
  • Table 6.7: Population Frequency of the Various Cytochromes
  • Table 6.8: Selected List of Personalized Medicine Tests
  • Table 6.9: Personalized Medicine and Companion Diagnostics Product Pipeline
  • Table 6.10: Members of the Personalized Medicine Coalition
  • Table 6.11: Typical Response Rates in Therapeutic Areas
  • Table 6.12: Prevalence of People Taking Medications Metabolized by Liver Enzymes
  • Table 6.13: UGT1A1 Helps to Determine Risks Associated with Irinotecan
  • Table 6.14: Current Product Labels: Enzyme Metabolism
  • Table 7.1: Major Players in Companion Diagnostics Sector and Summary List of Companion Diagnostics Agreements
  • Table 7.2: Major GeneChip Instrument Products
  • Table 7.3: Major GeneChip Array and Reagent Products
  • Table 7.4: Gene Titan Products
  • Table 7.5: Gene Atlas Products
  • Table 7.6: Gene Atlas Products
  • Table 7.7: Opportunities for Biomarkers in Cancer Diagnosis and Treatment
  • Table 7.8: Tumor Diagnosis Immunoassay
  • Table 7.9: Tumor Diagnosis Radioimmunoassay
  • Table 7.10: Johnson & Johnson Financial Figures-Net Sales by Major Medical and Diagnostics Businesses, 2010-2013
  • Table 7.11: Roche Group Financial Figures-Net Sales by Business Sector, 2008-2013
  • Table 7.12: Roche Group Diagnostics Division-Net Sales by Geographic Region, 2012 and 2013
  • Table 7.13: Roche Group Financial Figures-Net Sales by Diagnostics Sub-Division, 2008-2013
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