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Personalized Medicine

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.Overview4
  • 1.1Statement of Report4
  • 1.2Scope of this Report4
  • 1.3Methodology5
  • 1.4Executive Summary7
  
  
• 2.The Case for Pharmacogenomics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends9
  • 2.1Scope of this Section9
  • 2.2Introduction to Pharmacogenomics/Personalized Medicine9
  • 2.3The Compelling Case for Personalized Medicine11
  • 2.4The Process of Drug Metabolism and Implications for Pharmacogenomics/Personalized Medicine12
  • 2.5Examples of Personalized Medicine16
    • 2.5.1Herceptin16
    • 2.5.2Ziagen17
    • 2.5.3Iressa17
    • 2.5.4Erbitux17
  • 2.6Personalized Medicine Product Pipeline19
  • 2.7The Personalized Medicine Coalition20
  • 2.8Regulatory Trends and Guidelines in the Personalized Medicine Space23
  • 2.9FDA Approved Agendia's MammaPrint® Diagnostic-The First IVDMIA to be Approved24
  • 2.10A Changing Regulatory Landscape for Personalized Medicine24
  • 2.11Patenting Personalized Medicine26
    • 2.11.1U.S. Supreme Court Dismisses LabCorp Appeal27
  • 2.12The Leading Edge of Personalized Medicine: Specific Examples of Clinical Situations Where Personalized Medicine is Appropriate and Being Used28
    • 2.12.1EGFR Assay28
    • 2.12.2Individualized Warfarin Therapy29
    • 2.12.3UGT1A1 Molecular Assay for Camptosar29
    • 2.12.4Response to Gleevec in Gastrointestinal Stromal Tumors29
    • 2.12.5LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases30
    • 2.12.6Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Push into Pharmacogenomics30
    
    
• 3.Pharmacogenomics/Personalized Medicine: Qualitative and Quantitative Market Analysis37
  • 3.1Scope of this Section37
  • 3.2Market Analysis of Molecular Diagnostics as it Relates to Pharmacogenomics/Personalized Medicine37
  • 3.3Snapshot of Diagnostics Industry Structure41
  • 3.4The Case for Theranostics (Therapeutic/Companion Diagnostic)42
  • 3.5Classification of Diagnostics by Risk42
  • 3.6Personalized Medicine Market Analysis-Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters43
  • 3.7Segmentation of the Personalized Medicine Marketplace44
  • 3.8Timeline for Impact of Various Segments in Personalized Medicine45
  • 3.9Challenges for Personalized Therapeutics Development47
  • 3.10Molecular Diagnostics Technology Platforms and Their Impact on Personalized Medicine48
  • 3.11Macro Trends in Personalized Medicine50
  • 3.12Personalized Medicine: Industry SWOT Analysis53
  
  
• 4.Company Profiles55
  • 4.1Abbott Molecular, Inc./Vysis55
  • 4.2Affymetrix, Inc.56
  • 4.3Agendia57
  • 4.4Celera Diagnostics58
  • 4.5Cepheid58
  • 4.6Clinical Data, Inc.59
  • 4.7Dakocytomation61
  • 4.8deCODE Genetics62
  • 4.9DNA Direct, Inc.63
  • 4.10DxS Ltd.64
  • 4.11Exact Sciences Corp.64
  • 4.12Exagen Diagnostics, Inc.65
  • 4.13Gen-Probe66
  • 4.14Genelex Corp.67
  • 4.15Gene Logic, Inc.67
  • 4.16Genentech, Inc.69
  • 4.17Genomic Health, Inc.69
  • 4.18Genzyme Genetics70
  • 4.19Illumina72
  • 4.20Luminex Corporation/Tm Biosciences73
  • 4.21Monogram Biosciences73
  • 4.22Myriad Genetics, Inc.75
  • 4.23Nanogen76
  • 4.24Osmetech plc77
  • 4.25Perlegen Sciences, Inc.77
  • 4.26PGxl Laboratories78
  • 4.27Prometheus Laboratories, Inc.79
  • 4.28Roche Diagnostics80
  • 4.29Siemens Medical Solutions Diagnostics80
  • 4.30Target Discovery, Inc.81
  • 4.31Third Wave Technologies82
  • 4.32Ventana Medical Systems83
  • 4.33XDx, Inc.84
  
  

Appendix 1: Qualitative Market Responses85

LIST OF FIGURES

Figure 2.1: Phase I and II Processes of Drug Metabolism12

Figure 2.2: Human Phase I Enzymes13

Figure 2.3: Human Phase II Enzymes13

Figure 2.4: Hepatic Distribution of Human CYP45014

Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism14

Figure 2.6: Genetic Components Determine Drug Metabolism15

Figure 3.1: From Genetic Content to Personalized Medicine37

Figure 3.2: The Lopsided Remuneration for Diagnostics38

Figure 3.3: Breakout of the Molecular Diagnostics Marketplace39

Figure 3.4: Molecular Diagnostics Market Segmentation40

Figure 3.5: Molecular Diagnostics Market Segmentation by Technology40

Figure 3.6: Market Survey Respondent Demographics43

Figure 3.7: Breakout of the Respondent Pool by Affiliation44

Figure 3.8: Segmentation of the Personalized Medicine Market44

Figure 3.9: Personalized Medicine Market Drivers50

Figure 3.10: Challenges in the Personalized Medicine Space51

LIST OF TABLES

Table 2.1: Personalized Medicine at the Nexus Point10

Table 2.2: Percentage of Non-Responders in Various Drug Classes11

Table 2.3: High Profile Drug Withdrawals from the Marketplace11

Table 2.4: Drug Metabolism Drives Drug Efficacy/Toxicity16

Table 2.5: Population Frequency of the Various Cytochromes16

Table 2.6: List of Personalized Medicine Tests18

Table 2.7: Personalized Medicine Product Pipeline19

Table 2.8: Marketed Personalized Therapies, 200620

Table 2.9: Current Targets, Drugs and Disease Areas Classified by their Clinical Applications31

Table 3.1: Areas in Personalized Medicine-Timeline of Impact45

Table 3.2: Impact of Personalized Medicine on Various Therapeutic Areas47

Table 3.3: Hurdles in Personalized Medicine Development in Various Therapeutic Areas47

Table 3.4: Various Molecular Diagnostics Technologies: Timeline for Impact48

Table 3.5: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine49

Table 3.6: Various Molecular Diagnostics Technologies: Technical Challenges in the Deployment for Personalized Medicine49

Table 3.7: Market Opportunities in Personalized Medicine52

Table 3.8: Challenges for Market Adoption of the Various Personalized Medicine Tests53

Table 3.9: Personalized Medicine Industry SWOT54

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