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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 4

1.1 Statement of Report 4

1.2 Scope of this Report 4

1.3 Methodology 5

1.4 Executive Summary 7



2. The Case for Pharmacogenomics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends 9

2.1 Scope of this Section 9

2.2 Introduction to Pharmacogenomics/Personalized Medicine 9

2.3 The Compelling Case for Personalized Medicine 11

2.4 The Process of Drug Metabolism and Implications for Pharmacogenomics/Personalized Medicine 12

2.5 Examples of Personalized Medicine 16

2.5.1 Herceptin 16

2.5.2 Ziagen 17

2.5.3 Iressa 17

2.5.4 Erbitux 17

2.6 Personalized Medicine Product Pipeline 19

2.7 The Personalized Medicine Coalition 20

2.8 Regulatory Trends and Guidelines in the Personalized Medicine Space 23

2.9 FDA Approved Agendia’s MammaPrint® Diagnostic—The First IVDMIA to be Approved 24

2.10 A Changing Regulatory Landscape for Personalized Medicine 24

2.11 Patenting Personalized Medicine 26

2.11.1 U.S. Supreme Court Dismisses LabCorp Appeal 27

2.12 The Leading Edge of Personalized Medicine: Specific Examples of Clinical Situations Where Personalized Medicine is Appropriate and Being Used 28

2.12.1 EGFR Assay 28

2.12.2 Individualized Warfarin Therapy 29

2.12.3 UGT1A1 Molecular Assay for Camptosar 29

2.12.4 Response to Gleevec in Gastrointestinal Stromal Tumors 29

2.12.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 30

2.12.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Push into Pharmacogenomics 30



3. Pharmacogenomics/Personalized Medicine: Qualitative and Quantitative Market Analysis 37

3.1 Scope of this Section 37

3.2 Market Analysis of Molecular Diagnostics as it Relates to Pharmacogenomics/Personalized Medicine 37

3.3 Snapshot of Diagnostics Industry Structure 41

3.4 The Case for Theranostics (Therapeutic/Companion Diagnostic) 42

3.5 Classification of Diagnostics by Risk 42

3.6 Personalized Medicine Market Analysis—Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 43

3.7 Segmentation of the Personalized Medicine Marketplace 44

3.8 Timeline for Impact of Various Segments in Personalized Medicine 45

3.9 Challenges for Personalized Therapeutics Development 47

3.10 Molecular Diagnostics Technology Platforms and Their Impact on Personalized Medicine 48

3.11 Macro Trends in Personalized Medicine 50

3.12 Personalized Medicine: Industry SWOT Analysis 53



4. Company Profiles 55

4.1 Abbott Molecular, Inc./Vysis 55

4.2 Affymetrix, Inc. 56

4.3 Agendia 57

4.4 Celera Diagnostics 58

4.5 Cepheid 58

4.6 Clinical Data, Inc. 59

4.7 Dakocytomation 61

4.8 deCODE Genetics 62

4.9 DNA Direct, Inc. 63

4.10 DxS Ltd. 64

4.11 Exact Sciences Corp. 64

4.12 Exagen Diagnostics, Inc. 65

4.13 Gen-Probe 66

4.14 Genelex Corp. 67

4.15 Gene Logic, Inc. 67

4.16 Genentech, Inc. 69

4.17 Genomic Health, Inc. 69

4.18 Genzyme Genetics 70

4.19 Illumina 72

4.20 Luminex Corporation/Tm Biosciences 73

4.21 Monogram Biosciences 73

4.22 Myriad Genetics, Inc. 75

4.23 Nanogen 76

4.24 Osmetech plc 77

4.25 Perlegen Sciences, Inc. 77

4.26 PGxl Laboratories 78

4.27 Prometheus Laboratories, Inc. 79

4.28 Roche Diagnostics 80

4.29 Siemens Medical Solutions Diagnostics 80

4.30 Target Discovery, Inc. 81

4.31 Third Wave Technologies 82

4.32 Ventana Medical Systems 83

4.33 XDx, Inc. 84



Appendix 1: Qualitative Market Responses 85





LIST OF FIGURES



Figure 2.1: Phase I and II Processes of Drug Metabolism 12

Figure 2.2: Human Phase I Enzymes 13

Figure 2.3: Human Phase II Enzymes 13

Figure 2.4: Hepatic Distribution of Human CYP450 14

Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism 14

Figure 2.6: Genetic Components Determine Drug Metabolism 15

Figure 3.1: From Genetic Content to Personalized Medicine 37

Figure 3.2: The Lopsided Remuneration for Diagnostics 38

Figure 3.3: Breakout of the Molecular Diagnostics Marketplace 39

Figure 3.4: Molecular Diagnostics Market Segmentation 40

Figure 3.5: Molecular Diagnostics Market Segmentation by Technology 40

Figure 3.6: Market Survey Respondent Demographics 43

Figure 3.7: Breakout of the Respondent Pool by Affiliation 44

Figure 3.8: Segmentation of the Personalized Medicine Market 44

Figure 3.9: Personalized Medicine Market Drivers 50

Figure 3.10: Challenges in the Personalized Medicine Space 51





LIST OF TABLES



Table 2.1: Personalized Medicine at the Nexus Point 10

Table 2.2: Percentage of Non-Responders in Various Drug Classes 11

Table 2.3: High Profile Drug Withdrawals from the Marketplace 11

Table 2.4: Drug Metabolism Drives Drug Efficacy/Toxicity 16

Table 2.5: Population Frequency of the Various Cytochromes 16

Table 2.6: List of Personalized Medicine Tests 18

Table 2.7: Personalized Medicine Product Pipeline 19

Table 2.8: Marketed Personalized Therapies, 2006 20

Table 2.9: Current Targets, Drugs and Disease Areas Classified by their Clinical Applications 31

Table 3.1: Areas in Personalized Medicine—Timeline of Impact 45

Table 3.2: Impact of Personalized Medicine on Various Therapeutic Areas 47

Table 3.3: Hurdles in Personalized Medicine Development in Various Therapeutic Areas 47

Table 3.4: Various Molecular Diagnostics Technologies: Timeline for Impact 48

Table 3.5: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine 49

Table 3.6: Various Molecular Diagnostics Technologies: Technical Challenges in the Deployment for Personalized Medicine 49

Table 3.7: Market Opportunities in Personalized Medicine 52

Table 3.8: Challenges for Market Adoption of the Various Personalized Medicine Tests 53

Table 3.9: Personalized Medicine Industry SWOT 54