Personalized Medicine

Table of Contents

1. Overview

• 1.1 Statement of Report
• 1.2 Scope of this Report
• 1.3 Methodology
• 1.4 Executive Summary

2. The Case for Pharmacogenomics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends

• 2.1 Scope of this Section
• 2.2 Introduction to Pharmacogenomics/Personalized Medicine
• 2.3 The Compelling Case for Personalized Medicine
• 2.4 The Process of Drug Metabolism and Implications for Pharmacogenomics/Personalized Medicine
• 2.5 Examples of Personalized Medicine
  • 2.5.1 Herceptin
  • 2.5.2 Ziagen
  • 2.5.3 Iressa
  • 2.5.4 Erbitux
• 2.6 Personalized Medicine Product Pipeline
• 2.7 The Personalized Medicine Coalition
• 2.8 Regulatory Trends and Guidelines in the Personalized Medicine Space
• 2.9 FDA Approved Agendia' s MammaPrint® Diagnostic-The First IVDMIA to be Approved
• 2.10 A Changing Regulatory Landscape for Personalized Medicine
• 2.11 Patenting Personalized Medicine
  • 2.11.1 U.S. Supreme Court Dismisses LabCorp Appeal
• 2.12 The Leading Edge of Personalized Medicine: Specific Examples of Clinical Situations Where Personalized Medicine is Appropriate and Being Used
  • 2.12.1 EGFR Assay
  • 2.12.2 Individualized Warfarin Therapy
  • 2.12.3 UGT1A1 Molecular Assay for Camptosar
  • 2.12.4 Response to Gleevec in Gastrointestinal Stromal Tumors
  • 2.12.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases
  • 2.12.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Push into Pharmacogenomics

3. Pharmacogenomics/Personalized Medicine: Qualitative and Quantitative Market Analysis

• 3.1 Scope of this Section
• 3.2 Market Analysis of Molecular Diagnostics as it Relates to Pharmacogenomics/Personalized Medicine
• 3.3 Snapshot of Diagnostics Industry Structure
• 3.4 The Case for Theranostics (Therapeutic/Companion Diagnostic)
• 3.5 Classification of Diagnostics by Risk
• 3.6 Personalized Medicine Market Analysis-Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters
• 3.7 Segmentation of the Personalized Medicine Marketplace
• 3.8 Timeline for Impact of Various Segments in Personalized Medicine
• 3.9 Challenges for Personalized Therapeutics Development
• 3.10 Molecular Diagnostics Technology Platforms and Their Impact on Personalized Medicine
• 3.11 Macro Trends in Personalized Medicine
• 3.12 Personalized Medicine: Industry SWOT Analysis

4. Company Profiles

• 4.1 Abbott Molecular, Inc./Vysis
• 4.2 Affymetrix, Inc.
• 4.3 Agendia
• 4.4 Celera Diagnostics
• 4.5 Cepheid
• 4.6 Clinical Data, Inc.
• 4.7 Dakocytomation
• 4.8 deCODE Genetics
• 4.9 DNA Direct, Inc.
• 4.10 DxS Ltd.
• 4.11 Exact Sciences Corp.
• 4.12 Exagen Diagnostics, Inc.
• 4.13 Gen-Probe
• 4.14 Genelex Corp.
• 4.15 Gene Logic, Inc.
• 4.16 Genentech, Inc.
• 4.17 Genomic Health, Inc.
• 4.18 Genzyme Genetics
• 4.19 Illumina
• 4.20 Luminex Corporation/Tm Biosciences
• 4.21 Monogram Biosciences
• 4.22 Myriad Genetics, Inc.
• 4.23 Nanogen
• 4.24 Osmetech plc
• 4.25 Perlegen Sciences, Inc.
• 4.26 PGxl Laboratories
• 4.27 Prometheus Laboratories, Inc.
• 4.28 Roche Diagnostics
• 4.29 Siemens Medical Solutions Diagnostics
• 4.30 Target Discovery, Inc.
• 4.31 Third Wave Technologies
• 4.32 Ventana Medical Systems
• 4.33 XDx, Inc.

Appendix 1: Qualitative Market Responses

LIST OF FIGURES

• Figure 2.1: Phase I and II Processes of Drug Metabolism
• Figure 2.2: Human Phase I Enzymes
• Figure 2.3: Human Phase II Enzymes
• Figure 2.4: Hepatic Distribution of Human CYP450
• Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism
• Figure 2.6: Genetic Components Determine Drug Metabolism
• Figure 3.1: From Genetic Content to Personalized Medicine
• Figure 3.2: The Lopsided Remuneration for Diagnostics
• Figure 3.3: Breakout of the Molecular Diagnostics Marketplace
• Figure 3.4: Molecular Diagnostics Market Segmentation
• Figure 3.5: Molecular Diagnostics Market Segmentation by Technology
• Figure 3.6: Market Survey Respondent Demographics
• Figure 3.7: Breakout of the Respondent Pool by Affiliation
• Figure 3.8: Segmentation of the Personalized Medicine Market
• Figure 3.9: Personalized Medicine Market Drivers
• Figure 3.10: Challenges in the Personalized Medicine Space

LIST OF TABLES

• Table 2.1: Personalized Medicine at the Nexus Point
• Table 2.2: Percentage of Non-Responders in Various Drug Classes
• Table 2.3: High Profile Drug Withdrawals from the Marketplace
• Table 2.4: Drug Metabolism Drives Drug Efficacy/Toxicity
• Table 2.5: Population Frequency of the Various Cytochromes
• Table 2.6: List of Personalized Medicine Tests
• Table 2.7: Personalized Medicine Product Pipeline
• Table 2.8: Marketed Personalized Therapies, 2006
• Table 2.9: Current Targets, Drugs and Disease Areas Classified by their Clinical Applications
• Table 3.1: Areas in Personalized Medicine-Timeline of Impact
• Table 3.2: Impact of Personalized Medicine on Various Therapeutic Areas
• Table 3.3: Hurdles in Personalized Medicine Development in Various Therapeutic Areas
• Table 3.4: Various Molecular Diagnostics Technologies: Timeline for Impact
• Table 3.5: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine
• Table 3.6: Various Molecular Diagnostics Technologies: Technical Challenges in the Deployment for Personalized Medicine
• Table 3.7: Market Opportunities in Personalized Medicine
• Table 3.8: Challenges for Market Adoption of the Various Personalized Medicine Tests
• Table 3.9: Personalized Medicine Industry SWOT