Personalized Medicine

SUMMARY

Personalized medicine and pharmacogenomics are inextricably linked. Pharmacogenomics is the use of genetic variations (such as SNPs, gene expression variability, or other molecular signatures) to understand and correlate with differential response to pharmaceutical agents (drugs). Pharmacogenomics can be deployed clinically to stratify patients into responders and non-responders and this practice is termed personalized medicine. The purpose of this TriMark Publications report is to describe the specific market segment of the diagnostics market called personalized medicine. To frame the context of current approaches, pharmacogenomics seeks to identify and validate the signature(s) of molecular analytes and these are converted to assays using the tools of molecular diagnostics. The deployment of these molecular diagnostics assays on defining and targeting patient populations is the domain of personalized medicine. This study includes all of the generally-accepted imaging activities that are currently used in personalized medicine, including pharmacogenomics, genomics and theranostics. It examines associated clinical market segments in which personalized medicine has taken a prominent role including cancer treatment, cardiology and neurology markets.

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