Companion Diagnostics in Personalized Medicine and Cancer Therapy

Published: June 2014
No. of Pages: 292
   

Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. This linkage could be important in the therapeutic application and clinical outcome of a drug, such as with personalized medicine for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine and has greatly expanded over the past twenty years, expanding by more than 20% annually compared to most other laboratory procedures. Research will continue to produce an increased understanding of disease processes, and diagnostics manufacturers will continue to expand and refine the technology and automation needed for clinical testing. Companion diagnostics, although smaller at present, is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics. This TriMark Publications report examines the use of companion diagnostics in personalized medicine and cancer therapy. The study provides a qualitative and quantitative review of the industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis profiles the leading companies that are developing and manufacturing companion diagnostics solutions. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included.

Companion Diagnostics in Personalized Medicine and Cancer Therapy

Table of Contents

1. Overview 9
1.1 Statement of Report 9
1.2 About This Report 9
1.3 Scope of the Report 10
1.4 Objectives 11
1.5 Methodology 12
1.6 Executive Summary 13

2. Companion Diagnostics: Trends and Overview 19
2.1 Stakeholders in Companion Diagnostics 19
2.2 Development of Stakeholders’ Business Models for Companion Diagnostics for Personalized Medicine 21
2.2.1 Pharmaceutical Company Business Models for Developing Companion Diagnostics Products 21
2.2.2 Diagnostic Company Business Models for Developing Companion Diagnostics Products  22
2.2.3 Life Science Company Business Models for Developing Companion Diagnostics Products 22
2.2.4 Pharmacy Benefit Management Company Business Models for Developing Companion Diagnostics Products  23
2.3 Trends in Companion Diagnostic Deals 23
2.4 Market Size of Companion Diagnostics 24
2.5 Companion Diagnostics: Industry SWOT Analysis  31
2.6 Challenges for Companion Diagnostics Development  31
2.7 Timeline for Impact of Various Segments in Companion Diagnostics  33
2.8 Use of Proteomics to Develop Individualized Tests  35

3. Companion Diagnostics: Qualitative and Quantitative Market Analysis  38
3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics  38
3.2 Costs of Companion Diagnostics in Healthcare Expenditures  40
3.3 Molecular Diagnostic Market 41
3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine 43
3.5 Snapshot of Companion Diagnostics Industry Structure 45
3.6 The Case for Theranostics  46
3.7 Companion Diagnostics Market Analysis 47

4. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics 49
4.1 Sector Overview  49
4.1.1 Impact of New Technology Platforms 49
4.1.2 Impact on Drug Discovery  49
4.1.3 Biomarkers as Endpoints in Drug Discovery  50
4.1.4 Targeted Therapy  51
4.2 Companion Diagnostics on the Market 51
4.3 Epidermal Growth Factor Receptor Companions 53
4.3.1 Bevacizamab (Avastin)  54
4.3.2 EGFR for CRC and Camptosar (Irinotecan)  55
4.3.2.1 Companion Diagnostic Test Developed for UGT1A1 for Irinotecan 55
4.3.2.2 Companion Diagnostic Test Developed for Bristol-Myers’ SPRYCEL  55
4.3.3 EGFR Express and Erbitux (Cetuximab) 55
4.3.4 HER2 and Herceptin (Trastuzumab) 56
4.3.4.1 Bayer’s Advia Centaur HER2/neu Assay 58
4.3.4.2 Companies Marketing HER2/neu Assays 58
4.3.5 Iressa and Tarceva Companion Test  58
4.3.6 Tykerb (GlaxoSmithKline (GSK)) and Vectibix (Amgen) Companion Tests 58
4.3.7 EGFRx Assay 59
4.3.8 Monogram eTag  59
4.3.9 Veripath OncoDiagnostics EGFR PharmDX  60
4.3.10 NSCLC Patients with EGFR Mutation 60
4.3.11 A Personalized Medicine Program for CML  60
4.4 Companions Based on Myriad’s IVDMIA Technology 61
4.4.1 Myriad’s TheraGuide 5-FU 61
4.4.2 Myriad’s BRACAnalysis: Hereditary Cancer Testing for Hereditary Breast and Ovarian Cancer 61
4.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib 62
4.5.1 TheraScreen: EGFR29 62
4.5.2 The K-RAS Mutation Detection Kit  62
4.6 Irinotecan and UGT1A1  62
4.7 Gleevec (Imatinib) Companions  63
4.7.1 DakoCytomation’s c-Kit (9.7) pharmDx 63
4.8 Companion Diagnostics Involving Metabolizing Enzymes 64
4.8.1 Companions for TMPT, CYP2C9 and UGT1A1 Enzymes 64
4.8.2 Companions for Aromatase Inhibitors 64
4.8.3 Companions for Actos and Avandia  65
4.9 Drivers and Barriers to Companion Diagnostics 65
4.10 Partnerships with Pharma Companies to Identify Therapeutic Targets 66
4.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer 66
4.12 Companion Diagnostics Used by Clinical Service Laboratories  67
4.13 New Technologies and Products under Development  68
4.13.1 MDx Health 69
4.13.2 Ventana to Collaborate with Pfizer and CST on Companion Diagnostic to Identify Lung Cancer Patients with ALK Gene Rearrangements  70
4.13.3 Abbott and Merck Collaborate to Develop Companion Diagnostic Test for Investigational Cancer Therapy  70
4.14 Pharmacogenomics Tests  71
4.14.1 MGMT Methylation Assay 71
4.14.2 Other Pharmacogenomic Opportunities 72
4.15 Recurrence Prediction Tests 73
4.16 Blood-Based Technologies 73
4.16.1 Oncotech, Inc.  73
4.17 Monogram Biosciences HIV Personalized Platform 74
4.18 Wako LBA AFP Test for Liver Cancer 74
4.19 Future Developments for Companion Diagnostics 74
4.20 Drug Response Predictors  76

5. Business and Regulatory Trends in the Companion Biomarker Testing Sector 77
5.1 Industry Consolidation 77
5.2 Breath of Product Offering and Pricing 78
5.3 Government Regulation of Medical Devices  78
5.3.1 FDA Guidance on Drug Test Co-development 80
5.3.2 Device Classes  80
5.3.3 Investigational Use of IVDMIAs 81
5.3.4 Post-Market Requirements  81
5.3.5 Voluntary vs. Required Submissions 82
5.3.6 Examples of Recent Voluntary Genomic Data Submissions 82
5.3.7 FDA Labeling Implications and Rules 82
5.3.8 Regulatory Activities in Companion Diagnostic Testing—Translation of Diagnostic Testing Results into Clinical Practice  83
5.4 Strategic Business and Marketing Considerations 83
5.5 Commercial Opportunities in Companion Markers 83
5.6 Moderators of Growth 85
5.6.1 Roadblocks to Integrating Companion Biomarkers into Clinical Practice 86
5.6.2 Management of Targeted Therapeutics by Third-Party Payers  86
5.7 Biotechnology Industry Trends 87
5.8 Pharmaceutical Industry Trends 87
5.9 Acquisition, License Agreement, Partnerships 88
5.10 Legal Developments 94
5.11 Sales and Marketing Strategies for Tumor Marker Tests 95
5.11.1 International Markets 97
5.11.2 Europe  97
5.11.3 Central and South America 98
5.11.4 Asia-Pacific 98
5.12 Product Commercialization 99
5.13 Reimbursement  100
5.14 Self-Referral Rules 101
5.15 Health Insurance Portability and Accountability Act  102
5.16 Clinical Laboratory Improvement Amendments (CLIA) 102
5.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations  103
5.18 FDA’s Quality System Regulation (QSR) 104
5.19 The FDA’s OIVD on IVDMIAs 104
5.20 FDA’s Qualification of Cancer Biomarkers  105
5.20.1 Regulatory Perspectives of Biomarker Validation 105
5.21 Genetic Tests and Medical Records  106
5.21.1 Laws Against Genetic Discrimination 107
5.22 Global Drivers of Clinical Laboratory Testing 107
5.23 Global Outlook  108
5.24 Oncology Biomarker Qualification Initiative  109
5.25 FDA Critical Path 109
5.26 Biomarkers and FDA’s Voluntary Genomic Data Submission  110
5.27 From Personalized to Predictive Medicine  110
5.28 Analysis of Cost-Effectiveness at the Individual Level 110
5.29 The Patient and Advocate Perspective: An Evolution of Influence 110
5.30 Real-World Experiences Translating the Vision of Personalized Medicine into Practice 110
5.30.1 Evolving Business Models in Companion Diagnostics and Personalized Medicine 111
5.30.2 Current Pharma/Diagnostics Business Model Examples 112
5.31 Reimbursement and Value Creation 112
5.32 What is the Role of Governmental Agencies in Driving the Adoption of Companion Diagnostics? 112
5.33 What is the Role of the Insurance Industry in Driving the Adoption of Pharmacogenomics (PGx)? 112
5.34 What is the Role of the Pharma Industry in Driving the Adoption of PGx? 113
5.35 FDA Guidance Document on Co-development 113
5.36 What is the Role of the Diagnostic Industry in Driving the Adoption of PGx? 113
5.37 What is the Future Role of PBMs in Laboratory Services? 114

6. Companion Diagnostics and Personalized Medicine 115
6.1 Scope of This Section 115
6.2 Introduction to Companion Diagnostics and Personalized Medicine 115
6.3 Drug Metabolism, Companion Diagnostics and Personalized Medicine  122
6.4 Examples of Personalized Medicine and Companion Diagnostic Tests  125
6.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 130
6.6 The Personalized Medicine Coalition (PMC)  132
6.7 Regulatory Trends and Guidelines in the Personalized Medicine Space  137
6.7.1 The Changing Regulatory Landscape for Personalized Medicine 138
6.8 Companion Diagnostics Play an Increasing Role in Cancer Care 140
6.9 Specific Examples of Clinical Situations where Companion Diagnostics are being Deployed 140
6.9.1 Epidermal Growth Factor Receptor Assay  141
6.9.2 Individualized Warfarin Therapy  143
6.9.3 UGT1A1 Molecular Assay for Camptosar  144
6.9.4 Response to Gleevec in Gastrointestinal Stromal Tumors (GISTs) 144
6.9.5 LabCorp and QIAGEN and Personalized Medicine for the treatment of Colorectal Cancer  144
6.9.6 LabCorp and ARCA Discovery, Inc. Personalized Medicine for Cardiovascular Disease  145
6.9.7 Roche’s Metastatic Melanoma Treatment, Zelboraf (Vemurafenib) 145
6.9.8 Abbott’s Late-Stage NSCLC Treatment, Xalkori (Crizotinib)  146
6.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 146
6.11 Value Chain 147
6.12 Impact of Companion Diagnostics/Personalized Medicine on Drug Clinical Trials 148
6.13 The Market Problem: Finding Value with Diagnostics for Personalized Medicine 149

7. Companies Entering the Companion Diagnostics Market 150
7.1 Industry Overview 150
7.1.1 20/20 GeneSystems, Inc.  152
7.1.2 Abbott Molecular, Inc. 153
7.1.3 Affymetrix, Inc.  156
7.1.4 Agendia BV 164
7.1.5  Agilent Technologies 166
7.1.6 Almac Group  167
7.1.7 AMDL, Inc. (Radient Pharmaceuticals) 169
7.1.8 Applied Biosystems 171
7.1.9 Asuragen, Inc. 172
7.1.10 Aureon Laboratories, Inc. 173
7.1.11 Beckman Coulter, Inc. (Danaher Corporation) 175
7.1.12 Becton, Dickinson and Company (BD) Diagnostics—TriPath  178
7.1.13 Biocode Hycel (Immunodiagnostics Systems [IDS])  180
7.1.14 BioCurex, Inc. 180
7.1.15 Biodesix  181
7.1.16 Biomarker Technologies, LLC 181
7.1.17 Biomedical Diagnostics, LLC 182
7.1.18 Biomerica, Inc.  182
7.1.19 bioMérieux, Inc.  183
7.1.20 Biomira, Inc. (Oncothyreon, Inc.)  184
7.1.21 BioModa, Inc. 185
7.1.22 Bruker Daltonics  186
7.1.23 Byk Gulden 186
7.1.24 Cangen Biotechnologies, Inc. 186
7.1.25 Caprion Proteomics 188
7.1.26 Celera Diagnostics 190
7.1.27 Cepheid, Inc. 191
7.1.28 Clarient, Inc. (GE Healthcare) 193
7.1.29 Claros Diagnostics, Inc.  194
7.1.30 Clinical Data, Inc.: PGxHealth and Cogenics  194
7.1.31 Correlogic Systems, Inc.  197
7.1.32 CytoCore, Inc. (Formerly known as Molecular Diagnostics, Inc.) 197
7.1.33 Cytogen Corporation (now EUSA Pharma)  198
7.1.34 Dako (Agilent Technologies) 199
7.1.35 diaDexus 200
7.1.36 DiagnoCure 201
7.1.37 DRG International 203
7.1.38 EDP Biotech Corporation  204
7.1.39 Eisai Co., Ltd. 205
7.1.40 Eli Lilly & Co. 205
7.1.41 Epigenomics 206
7.1.42 Exact Sciences Corporation 207
7.1.43 Exagen Diagnostics, Inc.  208
7.1.44 Exigon  208
7.1.45 Gene Logic, Inc.  208
7.1.46 Genesis Genomics, Inc. (now known as Mitomics) 209
7.1.47 GenMark Diagnostics 210
7.1.48 Genomic Health, Inc. 211
7.1.49 Gen-Probe, Inc. (now known as Hologic Gen-Probe )  212
7.1.50 Health Discovery Corporation 216
7.1.51 Ikonisys, Inc. 217
7.1.52 Illumina  218
7.1.53 Immunomedics  220
7.1.54 InterGenetics, Inc. 222
7.1.55 Ipsogen (QIAGEN Marseille) 222
7.1.56 Johnson & Johnson 224
7.1.57 LabCorp  225
7.1.58 Life Technologies Corporation (Thermo Fisher Scientific) 227
7.1.59 Matritech, Inc. 229
7.1.60 Miraculins 230
7.1.61 Mitsubishi Kagaku latron  231
7.1.62 Monogram Biosciences (Formerly ViroLogic, Inc. and now part of LabCorp) 231
7.1.63 Myriad Genetics, Inc. 232
7.1.64 NimbleGen Systems, Inc.  235
7.1.65 Northwest Biotherapeutics, Inc. 236
7.1.66  Novartis MDx  237
7.1.67 Nycomed (Takeda) 238
7.1.68 Oncotech, Inc. (Exiqon A/S) 239
7.1.69 Oncothyreon, Inc. (Formerly known as Biomira) 239
7.1.70 OPKO Health, Inc. 241
7.1.71 Orion Genomics  243
7.1.72 Oxford BioTherapeutics (Formerly Oxford Genome Sciences)  244
7.1.73 Panacea Pharmaceuticals, Inc. 245
7.1.74 Polymedco, Inc.  245
7.1.75 Power3 Medical Products  246
7.1.76  Prometheus Laboratories, Inc. (Nestlé Health Science S.A) 247
7.1.77 Proteome Systems Ltd. (Tyrian Diagnostics Ltd.) 247
7.1.78 Qiagen N.V. 248
7.1.79 Roche Molecular Diagnostics 252
7.1.80 Sanko Junyaku Co., Ltd. (Eisai Co., Ltd.) 254
7.1.81 SensiGen, LLC (Sequenom Center for Molecular Medicine) 255
7.1.82 Siemens Healthcare Diagnostics, Inc. 255
7.1.83 SuperArray Bioscience Corporation (Qiagen) 257
7.1.84 Third Wave Technologies, Inc. (now owned by Hologic Gen-Probe) 257
7.1.85 Tosoh Biosciences 259
7.1.86 Transgenomic, Inc. 259
7.1.87 TrimGen 259
7.1.88 Upstream Biosciences, Inc. (RealSource Residential, Inc.) 260
7.1.89 Ventana Medical Systems, Inc. 260
7.1.90 Veridex, LLC 262
7.1.91 Vermillion, Inc. (Formerly Ciphergen) 263
7.1.92 Vertex Pharmaceuticals, Inc. 263

Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions  265
Appendix 1.1: Introduction 265
Appendix 1.2: Background 265
Appendix 1.3: Submission Policy  266
Appendix 1.3.1: General Principles  266
Appendix 1.3.2: Specific Uses of Pharmacogenomic Data in Drug Development and Labeling 268
Appendix 1.3.3: Benefits of Voluntary Submissions to Sponsors and FDA 269
Appendix 1.4: Submission of Pharmacogenomic Data  269
Appendix 1.4.1: Submission of Pharmacogenomic Data During the IND Phase  270
Appendix 1.4.2: Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement 271
Appendix 1.4.3: Submission to a Previously Approved NDA or BLA 272
Appendix 1.4.4: Compliance with 21 CFR Part 58 272
Appendix 1.4.5: Submission of Voluntary Genomic Data from Application-Independent Research  272
Appendix 1.5: Format and Content of a VGDS 273
Appendix 1.6: Process for Submitting Pharmacogenomic Data  274
Appendix 1.7: Agency Review of VGDSs 274
Appendix 2: FDA Issues Draft Companion Diagnostic Guidance 276
Appendix 3: Histochemical Markers for Cancer 278
Appendix 4: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions 279
Appendix 4.1: Introduction 279
Appendix 4.2: Background 279
Appendix 4.3: Scope 279
Appendix 4.4: General Principles  279
Appendix 4.5: Structure of Biomarker Qualification Submissions 280
Appendix 5: Selected Personalized Medicine Drugs, Treatments and Diagnostics as of June 2014  287
Glossary  292

List of Tables

Table 2.1: FDA Approved Companion Diagnostic Devices: In Vitro and Imaging Tools 26
Table 2.2: Personalized Medicine Industry SWOT Analysis 31
Table 2.3: Hurdles to Personalized Medicine and Companion Diagnostics Development  32
Table 2.4: Timeline of Impact in Areas of Personalized Medicine 33
Table 2.5: Impact of Personalized Medicine on Various Therapeutic Areas 34
Table 3.1: Diagnostic Facts 39
Table 3.2: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine 44
Table 3.3: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine 44
Table 3.4: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine 45
Table 3.5: FDA Classification of Diagnostics by Risk  47
Table 4.1: Potential Benefits of Biomarkers as Companion Diagnostics  50
Table 4.2: Utility of Biomarker as Companion Diagnostics to Drug Development 51
Table 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 56
Table 4.4: Drivers of Companion Diagnostics Discovery 65
Table 4.5: Barriers to Companion Diagnostics Discovery 66
Table 4.6: Device Submission Elements for the FDA  66
Table 5.1: List and Discounted Prices for Abbott Tumor Marker Tests  78
Table 5.2: Recent Major Companion Diagnostics Deals 89
Table 5.3: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics  111
Table 5.4: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests  111
Table 6.1: Timeline for Development of Companion Diagnostics 118
Table 6.2: Personalized Medicine at the Nexus Point  120
Table 6.3: Percentage of Non-Responders in Various Drug Classes 120
Table 6.4: High-Profile Drug Withdrawals from the Marketplace 121
Table 6.5: Metabolism of Drugs by Hepatic Enzymes  122
Table 6.6: Drug Metabolism Drives Drug Efficacy/Toxicity 125
Table 6.7: Population Frequency of the Various Cytochromes  125
Table 6.8: Selected List of Personalized Medicine Tests 128
Table 6.9: Personalized Medicine and Companion Diagnostics Product Pipeline  131
Table 6.10: Members of the Personalized Medicine Coalition  133
Table 6.11: Typical Response Rates in Therapeutic Areas 141
Table 6.12: Prevalence of People Taking Medications Metabolized by Liver Enzymes 142
Table 6.13: UGT1A1 Helps to Determine Risks Associated with Irinotecan 142
Table 6.14: Current Product Labels: Enzyme Metabolism 143
Table 7.1: Major Players in Companion Diagnostics Sector and Summary List of Companion Diagnostics Agreements 150
Table 7.2: Major GeneChip Instrument Products 159
Table 7.3: Major GeneChip Array and Reagent Products 160
Table 7.4: Gene Titan Products 160
Table 7.5: Gene Atlas Products 160
Table 7.6: Gene Atlas Products 161
Table 7.7: Opportunities for Biomarkers in Cancer Diagnosis and Treatment 193
Table 7.8: Tumor Diagnosis Immunoassay  204
Table 7.9: Tumor Diagnosis Radioimmunoassay 204
Table 7.10: Johnson & Johnson Financial Figures—Net Sales by Major Medical and Diagnostics Businesses,2010-2013 224
Table 7.11: Roche Group Financial Figures—Net Sales by Business Sector, 2008-2013  254
Table 7.12: Roche Group Diagnostics Division—Net Sales by Geographic Region, 2012 and 2013  254
Table 7.13: Roche Group Financial Figures—Net Sales by Diagnostics Sub-Division, 2008-2013  254

List of Figures

Figure 2.1: Strategic and Tactical Considerations for Co-Development of Companion Diagnostics  24
Figure 2.2: Global Market for Companion Diagnostics, 2012-2019 25
Figure 2.3: Number of Companion Diagnostic Agreements, 2000-2013  26
Figure 2.4: Surface Binding Produces Phase Shifts that Increases the Diffraction Signal Intensity 36
Figure 3.1: From Genetic Content to Personalized Medicine 39
Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision-Making 40
Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending 40
Figure 3.4: Breakout of the Molecular Diagnostics Marketplace 42
Figure 3.5: Molecular Diagnostics Market Segmentation 43
Figure 3.6: Molecular Diagnostics Market Segmentation by Technology 43
Figure 3.7: Segmentation of the Personalized Medicine Market 47
Figure 4.1: Carcinogenesis is a Multi-Step Process 54
Figure 4.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 57
Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH  57
Figure 5.1: Companion Diagnostics Partnering, 2007-2013 88
Figure 5.2: Companion Diagnostics Partnering by Stage of Development, 2013 89
Figure 5.3: Companion Diagnostics Partnering by Therapeutic Area, 2013 90
Figure 6.1: U.S. Healthcare Expenditures by Category of Service, 2010  116
Figure 6.2: Representation of the Trial-and-Error or One-Dose-Fits-All Approach vs. Personalized Medicine 116
Figure 6.3: Approaches to Personalized Medicine 118
Figure 6.4: Organizational Transformation to Support Personalized Medicine, 1998-2013  119
Figure 6.5: The Phase I and II Processes of Drug Metabolism  122
Figure 6.6: Hepatic Distribution of Human CYP450  123
Figure 6.7: Relative Contribution of CYP450 Enzymes to Drug Metabolism 123
Figure 6.8: Genetic Components Determine Drug Metabolism  124
Figure 6.9: Personalized Medicine Clinical Trials by Year, 1993-2008  129
Figure 6.10: Healthcare Value Chain 147

Published By: TriMark Publications, LLC
Product Code: TriMark Publications, LLC1022


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