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Pharmacogenomic Testing Markets
Publication Date: 01-APR-08
Pages: 167
Study: TMRPGEN
Format/Price: PDF document / $3,400.00

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Pharmacogenomics, the science of individualizing drug therapy based on the genetic makeup of individual patients, offers an unusual opportunity for future market growth. Applying pharmacogenomics would allow doctors to treat specific segments of the population based on their particular responses to a drug. The knowledge of the likely effectiveness of a drug in a patient makes the drug more reliable, and fewer drugs would have to be taken off the market due to adverse reactions in some, but not all, of the patients to whom they were administered. Additionally, reducing the occurrence of adverse effects to a drug effectually reduces the cost of patient care overall. This TriMark Publications study examines the market for diagnostic tests based on this science and the clinical measurement methods, the reagents and supplies being utilized in clinical medicine and the pharmaceutical industry. This report presents an overview of the latest information regarding emerging new products and industry trends and will not only quantify, but also, qualify the pharmacogenomic market segments as an area of research, product development and investment opportunity. Forecasts of the pharmacogenomic market and an analysis of products in the worldwide diagnostics market will provide a basis for understanding the significance of past developments and the immense possibilities of the future. The principal objectives of this study are to:

· Identify viable technology drivers through a comprehensive look at various platform technologies for pharmacogenomic testing segments of the diagnostic testing markets.

· Obtain a complete understanding of the important pharmacogenomic targets and their diagnostic test value, and to gain an understanding of these elements from their basic principles to their applications.

· Discover feasible market opportunities by identifying high-growth applications in different pharmacogenomic diagnostic testing areas, with a focus on the largest and expanding markets concerned with diseases.

· Focus on global industry development through an in-depth analysis of the major world markets for pharmacogenomic diagnostic testing.

· Present market figures regarding the current value of the pharmacogenomic testing market, projections and growth rates.

· Examine the use of pharmacogenomic testing in pharmaceutical drug development and show specific examples of its use in development and repositioning of therapeutic agents.

Table of Contents:

1. Overview 6
1.1 Statement of Report 6
1.2 Objectives of this Report 6
1.3 Scope of the Study 7
1.4 Methodology 8
1.5 Executive Summary 8
2. Introduction 10
2.1 Pharmacogenomic Testing 10
2.1.1 Clinical Applications 10
2.1.2 Demand for Pharmacogenomic Diagnostic Tools Worldwide 11
2.1.3 Key Factors that Contributed to the Growth of Pharmacogenomic Demand 11
2.1.4 Clinical Applications 12
2.1.5 Drug and Diagnostic Combinations 13
2.1.6 Economic Impact of Healthcare Costs 14
2.2 Individual Genetic Differences 15
2.2.1 Population Genomics 15
2.2.2 SNPs and Haplotypes 15
2.2.3 HapMap 17
2.2.3.1 The International HapMap Project 17
2.2.3.2 HapMap Participants and Funding Sources 17
2.2.4 Metabolism 18
2.3 Drug Treatment Outcomes 19
2.3.1 Contribution of Cytochrome P450s 19
2.3.2 Adverse Drug Reactions (ADRs) 21
2.3.3 Drug-Test Combinations 21
2.4 Role of Pharmacogenomics 22
2.4.1 How Will Gene Variation be Used in Predicting Drug Response? 23
2.4.2 How will Drug Development and Testing Benefit from Pharmacogenomics? 23
2.4.3 Advantages of Pharmacogenomics 23
2.4.4 The Diagnostics-Therapeutics Fusion 24
2.4.5 Potential Challenges 24
2.4.6 Importance of Testing for the PM Phenotype 26
2.4.7 Drug Repositioning 27
2.5 Top Pharmacogenomic Tests 28
2.5.1 CYP2D6 28
2.5.2 CYP2C19 and CYP2C9 30
2.5.3 CYP3A4 and CYP3A5 Genotyping 31
2.6 Barriers to Pharmacogenomic Testing 31
2.7 Drivers of Pharmacogenomic Testing 32
3. Pharmacogenomic Testing Market: Size, Growth and Share 34
3.1 Global Pharmacogenomic Testing Markets by Technology Segments 34
3.1.1 Market Structure 34
3.1.2 Market Drivers in the Pharmacogenomic Diagnostics Testing Sector 35
3.1.3 Market Restraints in Pharmacogenomic Diagnostic Testing Segment 35
3.1.4 Principal Market Segments for Genomics Testing 35
3.1.4.1 Diagnostic Testing 35
3.1.4.2 Pharmacogenomic Testing 37
3.1.4.3 SNP Identification 38
3.1.5 Key Players in the Pharmacogenomic Diagnostics Testing Segment 39
3.1.6 Pharmacogenomic Testing Sector Analysis 39
3.2 U.S. Pharmacogenomic Testing Market 40
3.2.1 Market Overview 40
3.2.2 Diagnostic Testing Categories 42
3.3 European Pharmacogenomic Diagnostic Testing Market 42
3.4 Japanese Diagnostic Testing Market 42
4. Pharmacogenomic Disease Markers 44
4.1 SNPs 44
4.1.1 SNP Identification Market 44
4.1.2 Overview of SNP Identification 45
4.1.3 Strategies for SNP Identification 45
4.1.4 Candidate Gene Selection 45
4.1.5 Whole-Genome LD Mapping 46
4.1.6 SNP Databases 46
4.1.7 Computational Tools for SNP Identification 46
4.1.8 SNPbrowser, Applied Biosystems 47
4.1.9 ChromosomeBrowser™, Orchid Cellmark 47
4.1.10 Sentrix® Array Matrix, Illumina 48
4.1.11 Celera Discovery System™, Celera Genomics, Appelera Corporation 49
4.1.12 Third Wave Technologies 49
4.2 Predictive Pharmacogenomics 49
4.2.1 Cancer Testing 49
4.2.2 Breast Cancer 51
4.2.3 Melanoma 53
4.2.4 Colon Cancer 53
4.2.5 Cystic Fibrosis 54
4.2.6 Genetic Test for Cardiac Ion Channel Mutations (Cardiac Channelopathies) 54
4.2.7 Thiopurine S-methyltransferase (TPMT) Genetic Test 54
4.2.8 CARING Study 54
4.2.9 Vilazodone 55
4.2.10 STRENGTH Trials (Statin Response Examined by Genetic HAP Markers) 55
4.2.11 Predictive Cancer Testing Market Size 56
4.2.12 HIV and AIDS 57
4.2.13 Cardiac Transplants 62
4.2.14 Prostate Cancer 62
4.2.15 Herceptin and Tykerb 62
4.2.16 Asthma 64
4.2.17 Lung Cancer 65
4.2.18 Hepatitis C Viral Load 65
4.2.19 Acute Myelocytic Leukemia (AML) 65
4.3 Examining the Role of Pharmacogenomics in Specific Disease Application 66
4.3.1 The Role of Pharmacogenomics in Bipolar and Other Psychiatric Disorders 66
4.3.2 Pharmacogenomics in Warfarin Treatment 67
4.3.3 Pharmacogenomics and Breast Cancer Treatment 67
4.4 Gene Chips to Detect Cytochrome Variations 68
4.4.1 AmpliChip CYP450-Roche Diagnostics 68
4.4.2 GeneChip System 3000Dx-Affymetrix 69
4.4.3 NanoChip® Molecular Biology Workstation-Nanogen, Inc. 69
5. Pharmacogenomic Testing: Development Issues 70
5.1 Adoption of Pharmacogenomic Testing 70
5.2 Factors Influencing the Integration of Pharmacogenomics into Clinical Trials 70
5.3 Moderators of Growth 70
5.3.1 Classification of Extensive vs. Poor Metabolizer 70
5.3.2 Genetic Testing 71
5.3.3 Cost-Benefit of Pharmacogenomic Testing 71
5.3.4 Workforce Issues 72
5.3.5 Reimbursement 72
5.3.6 New CPT Test Codes and Payment Amounts 76
5.4 Clinical Guidelines and Pharmacogenomic Testing 76
5.5 Good Laboratory Practice 77
5.6 Quality Assurance Issues 77
5.6.1 Criteria Required to Establish a Genomic Test for Clinical Use 77
5.6.2 Microarrays in Clinical Diagnostic Use 77
5.7 Pre-therapeutic Pharmacogenomic Testing 77
5.8 Regulatory Requirements 78
5.9 Screening 79
5.10 Cost of Phenotyping vs. Genotyping 80
5.11 Pharmacogenomic Tests: New Product Development 80
6. Business Trends in the Industry 82
6.1 Pharmacogenomic Initiatives within Pharmaceutical Companies 82
6.2 Pharmacogenomic Testing Growth Factors 86
6.3 Acquisition, License Agreements, Internal Development and Partnerships 86
6.4 Product Testing Depth in Pharmacogenomic Testing 89
6.5 Government Regulation 89
6.5.1 U.S. Regulations 90
6.5.2 U.K. Regulations 91
6.5.3 E.U. Regulations 92
6.5.4 Japanese Regulations 94
6.6 Increased Market Penetration in Pharmacogenomic Testing 94
6.7 Legal Issues 95
6.8 Barriers to Growth 98
6.9 Drivers of Growth 99
6.10 Product Launches and Developments 99
6.11 Investment Parameters for Diagnostic Companies 100
6.12 Key Elements of the Pharmaceutical Value Chain 101
6.13 An Evaluation of Successful Pharmacogenomic Business Models 101
6.14 Pharmacogenomic Applications of Ethical Considerations 101
6.15 Drug Repositioning Services 101
6.16 Patent Protection of Pharmacogenomic Technology 103
6.17 FDA Pipeline for Pharmacogenomic Tests 104
7. Important Technology Trends in Pharmacogenomics 105
7.1 Trends in Pharmacogenomic Testing 105
7.1.1 Toxicogenomics 105
7.2 Drug Metabolism 106
7.3 Personalized Medicine for Cardiovascular Disorders: Genomic and Proteomic 106
7.4 Biomarkers 106
7.4.1 Cancer 107
7.4.1.1 Leukemia: Gleevec and Dasatinib (BMS-354825) 107
7.4.1.2 Colorectal Cancer 108
7.4.1.3 Cardiovascular Drugs 108
7.4.1.3.1 Arrhythmia 109
7.4.1.3.2 Hypertension 109
7.4.1.3.3 Hyperlipidemia 109
7.4.1.3.4 Myocardial Infarction 109
7.5 Future Developments 112
7.5.1 GSK's Pharmacogenomic Program 113
7.5.2 Roche's Biomarker Strategy 113
7.5.3 Hypertension Markets 114
7.5.4 Expression Data to Integrate Pharmacology and Chemistry Data 114
7.5.5 Metabonomics 115
8. Company Profiles 116
8.1 Abbott Diagnostics 116
8.2 Affymetrix 117
8.3 Ambion (Asuragen) 120
8.4 Applera Corporation 120
8.5 AstraZeneca 124
8.6 Bayer Healthcare 125
8.7 Bristol-Myers Squibb 127
8.8 Celera Diagnostics (Appelera Corporation) 128
8.9 Clinical Data 128
8.10 CuraGen Corporation 129
8.11 Dako (formerly DakoCytomation) 131
8.12 deCODE Genetics 132
8.13 DNAPrint Genomics 133
8.14 DxS 133
8.15 EraGen Biosciences 134
8.16 EXACT Sciences 134
8.17 Expression Analysis 135
8.18 FivePrime Therapeutics 135
8.19 GE Healthcare 136
8.20 Genaissance Pharmaceuticals (now Clinical Data) 136
8.21 Gene Logic (Ore Pharmaceuticals) 137
8.22 Genentech 138
8.23 Genomic Health 139
8.24 Gentris 139
8.25 Genzyme 139
8.26 GlaxoSmithKline 140
8.27 Human Genome Sciences 142
8.28 Iconix Pharmaceuticals, Inc. 143
8.29 Illumina 144
8.30 Incyte, Inc. 145
8.31 Interleukin Genetics 147
8.32 Johnson & Johnson 147
8.33 Luminex Corp. 149
8.34 Merck & Co. 150
8.35 Merck KGaA (now Merck Serano) 152
8.36 Merck Serano 153
8.37 Millennium Pharmaceuticals 153
8.38 Myriad Genetics, Inc. 154
8.39 Nanogen 155
8.40 Nanosphere 157
8.41 Nitromed 158
8.42 Nuvelo, Inc. 158
8.43 Orchid Cellmark 159
8.44 Prediction Sciences 159
8.45 PharmaSeq 160
8.46 PPGx (now Clinical Data) 160
8.47 Prometheus Laboratories 160
8.48 Roche Diagnostics 161
8.49 Sequenom 162
8.50 Third Wave Technologies 163
8.51 Tm Bioscience Corp. (now Luminex) 164
8.52 Vertex Pharmaceuticals 164
8.53 Warnex 164
8.54 Wyeth 165
INDEX OF FIGURES
Figure 2.1: Relative Contribution of Human CYP450s in Drug Metabolism. 20
INDEX OF TABLES
Table 2.1: Clinical Applications of Diagnostic Pharmacogenomic Testing 12
Table 2.2: Groups Participating in the International HapMap Project 17
Table 2.3: Drugs Pulled from the Market that Might Have Benefited from Pharmacogenomic Analysis 19
Table 2.4: Currently-Marketed Drugs that Might Benefit from Pharmacogenomic Analysis 19
Table 2.5: Major Cytochrome P450 Isozymes 19
Table 2.6: Examples of Test-Drug Combinations 22
Table 2.7: Factors that Determine a Successful Pharmacogenomic Test 25
Table 2.8: Pharmacogenomics' Influence on Drug Sales 25
Table 2.9: Pharmacogenomics' Effect on Maximizing R&D Productivity 25
Table 2.10: Prevalence of Metabolically-Active Enzymes 26
Table 2.11: Role of Pharmacogenomics in Phases II-III Drug Trials 26
Table 2.12: Pharmacogenomic Drug Development Tests 27
Table 2.13: AACC Top Ten List of PGx Tests 28
Table 2.14: CYP2D6 29
Table 2.15: CYP2D6 Drugs 29
Table 2.16: Response to Tricyclic Antidepressants 30
Table 2.17: CYP2C19 30
Table 2.18: CYP2C9 30
Table 2.19: Barriers to Pharmacogenomic Testing 31
Table 2.20: Drivers of Pharmacogenomic Testing 32
Table 2.21: Users of Pharmacogenomics 32
Table 2.22: Markets for Pharmacogenomic Testing 32
Table 3.1: Worldwide Pharmacogenomic Market Size by Technology Segments, 2001-2011 34
Table 3.2: Total Pharmacogenomic Testing Market Size, 2001-2011 34
Table 3.3: Diagnostic Pharmacogenomic Testing Market Size, 2001-2011 36
Table 3.4: Benefits of Pharmacogenomic Diagnostics in Patient Care 37
Table 3.5: Genotyping Pharmacogenomic Testing Market Size, 2001-2011 37
Table 3.6: Benefits of Pharmacogenomics in Clinical Trials and Drug Development 37
Table 3.7: Five Key Action Points for Pharmaceutical Companies 37
Table 3.8: Global SNP Identification Tools Market Size, 2001-2011 38
Table 3.9: Pharmacogenomic Testing Market Structure 38
Table 3.10: P450 Isozymes and Pharmaceuticals 39
Table 3.11: List of Companies that Market Pharmacogenomic Tests 40
Table 3.12: Key Collaborations in the Pharmacogenomics Industry 41
Table 3.13: Prominent Drugs' Withdrawals from the Market 41
Table 3.14: Key Elements in the Drug Development Process 41
Table 3.15: Major Suppliers of PCR-based Assays and PCR-based Technologies 41
Table 4.1: Methods for Performing NAT 44
Table 4.2: SNP Consortium Members 46
Table 4.3: Developmental Atherosclerosis Drugs 56
Table 4.4: Myriad Genetics Predictive Medicine Sales, 2001-2005 56
Table 4.5: DNA-based Predictive Medicine Product Sales for Cancer, 2006-2010 57
Table 4.6: Summary of Assays for HIV Viral Load Testing 57
Table 4.7: U.S. Market Share of HIV Testing Kits 58
Table 4.8: Monogram Bioscience, Inc. Products for HIV Testing 61
Table 4.9: Asthma Therapeutic Drug Pipeline 64
Table 4.10: Psychiatric Case Studies-Organized Pharmacokinetically 66
Table 6.1: U.S. Prescription Drug Expenditures, 2000-2012 82
Table 6.2: U.S. Pharmaceutical Market Size and Growth Rate, 1996-2006 83
Table 6.3: Top Ten Pharmaceutical Companies by U.S. Prescription Sales, 2006 84
Table 6.4: Top Categories of U.S. Prescription Drug Spending Percentage Total Sales, 2006 84
Table 6.5: Therapeutic Classes by U.S. Prescription Sales, 2006 84
Table 6.6: Number of NME Approvals and Mean Approval Times, 1984-2007 85
Table 6.7: Global Market for Tools and Consumables Used in Drug Discovery and Development, 1999-2010 85
Table 6.8: Drug Sales Therapeutic Categories as a Percentage of the World Market, 2002 and 2006 86

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