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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.

1. 1. Overview 4
2. 1.1 Statement of Report 4
3. 1.2 Scope of this Report 4
4. 1.3 Methodology 5
5. 1.4 Executive Summary 7
7. 2. The Case for Pharmacogenomics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends 9
8. 2.1 Scope of this Section 9
9. 2.2 Introduction to Pharmacogenomics/Personalized Medicine 9
10. 2.3 The Compelling Case for Personalized Medicine 11
11. 2.4 The Process of Drug Metabolism and Implications for Pharmacogenomics/Personalized Medicine 12
12. 2.5 Examples of Personalized Medicine 16
13. 2.5.1 Herceptin 16
14. 2.5.2 Ziagen 17
15. 2.5.3 Iressa 17
16. 2.5.4 Erbitux 17
17. 2.6 Personalized Medicine Product Pipeline 19
18. 2.7 The Personalized Medicine Coalition 20
19. 2.8 Regulatory Trends and Guidelines in the Personalized Medicine Space 23
20. 2.9 FDA Approved Agendia's MammaPrint® Diagnostic-The First IVDMIA to be Approved 24
21. 2.10 A Changing Regulatory Landscape for Personalized Medicine 24
22. 2.11 Patenting Personalized Medicine 26
23. 2.11.1 U.S. Supreme Court Dismisses LabCorp Appeal 27
24. 2.12 The Leading Edge of Personalized Medicine: Specific Examples of Clinical Situations Where Personalized Medicine is Appropriate and Being Used 28
25. 2.12.1 EGFR Assay 28
26. 2.12.2 Individualized Warfarin Therapy 29
27. 2.12.3 UGT1A1 Molecular Assay for Camptosar 29
28. 2.12.4 Response to Gleevec in Gastrointestinal Stromal Tumors 29
29. 2.12.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 30
30. 2.12.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Push into Pharmacogenomics 30
32. 3. Pharmacogenomics/Personalized Medicine: Qualitative and Quantitative Market Analysis 37
33. 3.1 Scope of this Section 37
34. 3.2 Market Analysis of Molecular Diagnostics as it Relates to Pharmacogenomics/Personalized Medicine 37
35. 3.3 Snapshot of Diagnostics Industry Structure 41
36. 3.4 The Case for Theranostics (Therapeutic/Companion Diagnostic) 42
37. 3.5 Classification of Diagnostics by Risk 42
38. 3.6 Personalized Medicine Market Analysis-Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 43
39. 3.7 Segmentation of the Personalized Medicine Marketplace 44
40. 3.8 Timeline for Impact of Various Segments in Personalized Medicine 45
41. 3.9 Challenges for Personalized Therapeutics Development 47
42. 3.10 Molecular Diagnostics Technology Platforms and Their Impact on Personalized Medicine 48
43. 3.11 Macro Trends in Personalized Medicine 50
44. 3.12 Personalized Medicine: Industry SWOT Analysis 53
46. 4. Company Profiles 55
47. 4.1 Abbott Molecular, Inc./Vysis 55
48. 4.2 Affymetrix, Inc. 56
49. 4.3 Agendia 57
50. 4.4 Celera Diagnostics 58
51. 4.5 Cepheid 58
52. 4.6 Clinical Data, Inc. 59
53. 4.7 Dakocytomation 61
54. 4.8 deCODE Genetics 62
55. 4.9 DNA Direct, Inc. 63
56. 4.10 DxS Ltd. 64
57. 4.11 Exact Sciences Corp. 64
58. 4.12 Exagen Diagnostics, Inc. 65
59. 4.13 Gen-Probe 66
60. 4.14 Genelex Corp. 67
61. 4.15 Gene Logic, Inc. 67
62. 4.16 Genentech, Inc. 69
63. 4.17 Genomic Health, Inc. 69
64. 4.18 Genzyme Genetics 70
65. 4.19 Illumina 72
66. 4.20 Luminex Corporation/Tm Biosciences 73
67. 4.21 Monogram Biosciences 73
68. 4.22 Myriad Genetics, Inc. 75
69. 4.23 Nanogen 76
70. 4.24 Osmetech plc 77
71. 4.25 Perlegen Sciences, Inc. 77
72. 4.26 PGxl Laboratories 78
73. 4.27 Prometheus Laboratories, Inc. 79
74. 4.28 Roche Diagnostics 80
75. 4.29 Siemens Medical Solutions Diagnostics 80
76. 4.30 Target Discovery, Inc. 81
77. 4.31 Third Wave Technologies 82
78. 4.32 Ventana Medical Systems 83
79. 4.33 XDx, Inc. 84
81. Appendix 1: Qualitative Market Responses 85
84. LIST OF FIGURES
86. Figure 2.1: Phase I and II Processes of Drug Metabolism 12
87. Figure 2.2: Human Phase I Enzymes 13
88. Figure 2.3: Human Phase II Enzymes 13
89. Figure 2.4: Hepatic Distribution of Human CYP450 14
90. Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism 14
91. Figure 2.6: Genetic Components Determine Drug Metabolism 15
92. Figure 3.1: From Genetic Content to Personalized Medicine 37
93. Figure 3.2: The Lopsided Remuneration for Diagnostics 38
94. Figure 3.3: Breakout of the Molecular Diagnostics Marketplace 39
95. Figure 3.4: Molecular Diagnostics Market Segmentation 40
96. Figure 3.5: Molecular Diagnostics Market Segmentation by Technology 40
97. Figure 3.6: Market Survey Respondent Demographics 43
98. Figure 3.7: Breakout of the Respondent Pool by Affiliation 44
99. Figure 3.8: Segmentation of the Personalized Medicine Market 44
100. Figure 3.9: Personalized Medicine Market Drivers 50
101. Figure 3.10: Challenges in the Personalized Medicine Space 51
104. LIST OF TABLES
106. Table 2.1: Personalized Medicine at the Nexus Point 10
107. Table 2.2: Percentage of Non-Responders in Various Drug Classes 11
108. Table 2.3: High Profile Drug Withdrawals from the Marketplace 11
109. Table 2.4: Drug Metabolism Drives Drug Efficacy/Toxicity 16
110. Table 2.5: Population Frequency of the Various Cytochromes 16
111. Table 2.6: List of Personalized Medicine Tests 18
112. Table 2.7: Personalized Medicine Product Pipeline 19
113. Table 2.8: Marketed Personalized Therapies, 2006 20
114. Table 2.9: Current Targets, Drugs and Disease Areas Classified by their Clinical Applications 31
115. Table 3.1: Areas in Personalized Medicine-Timeline of Impact 45
116. Table 3.2: Impact of Personalized Medicine on Various Therapeutic Areas 47
117. Table 3.3: Hurdles in Personalized Medicine Development in Various Therapeutic Areas 47
118. Table 3.4: Various Molecular Diagnostics Technologies: Timeline for Impact 48
119. Table 3.5: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine 49
120. Table 3.6: Various Molecular Diagnostics Technologies: Technical Challenges in the Deployment for Personalized Medicine 49
121. Table 3.7: Market Opportunities in Personalized Medicine 52
122. Table 3.8: Challenges for Market Adoption of the Various Personalized Medicine Tests 53
123. Table 3.9: Personalized Medicine Industry SWOT 54