Personalized Medicine, Targeted Therapeutics & Companion Diagnostic Market to 2019
Table of Contents
1.0 Executive Summary 11
1.1 Objectives of Report 11
1.2 Scope of Study 12
1.3 Data Sources and Methodology 13
1.4 Key Findings and Observations 13
1.4.1 CYP2C9 and VKORC1 mutations and Warfarin Response 14
1.4.2 KRAS Mutations 14
1.4.3 Herceptin® and Breast Cancer 14
1.4.4 BRACAnalysis® 14
1.4.5 Oncotype Dx Test 14
1.4.6 Public and Private Funding for Personalized Medical Research 15
1.4.7 New Business Model Required for Personalized Medicine 15
1.4.8 Cost-effectiveness and Business Value of Personalized Medicine 15
1.4.9 Personalized Medicine Market 15
1.4.10 Personalized Medicine Main Industry Players 15
1.4.11 Personalized Medical Care Market 16
1.4.12 Global Personalized Medicine Sub-market Growth 16
2.0 Introduction and Background 17
2.1 Genetics Explained in Five Minutes 17
2.1.1 Why is the Central Dogma of Molecular Biology Important in Personalized Medicine? 18
2.1.2 Genetic Mutations Explained 19
2.1.3 What is the Difference between Genotype and Phenotype? 20
2.1.4 Why do we Need to Look at Genetic Diversity with Respect to Personalized Medicine? 20
2.2 Introduction to Personalized Medicine 22
2.3 Pharmacogenetics 23
2.4 How Personalized Medicine Monitoring can Reduce Adverse Drug Reactions 30
2.5 Pharmacogenetic Study Challenges 31
2.6 Pharmacogenomics 31
2.7 Applications of Pharmacogenomics 32
2.7.1 Pharmacogenomics: Improving the Safety of Medications 32
2.7.1.1 Adverse Drug Reactions 32
2.7.1.2 Pharmacogenomics: Improving the Efficacy of Therapeutics 33
2.7.2 Vioxx Disaster Could have been Prevented with Personalized Medicine 37
2.8 Pharmacogenetic Analysis 37
2.8.1 Single Base Primer Extension 38
2.8.2 Primer Based Base Extension 38
2.8.3 Hybridization Based SNP Analysis 39
2.8.4 Ligation Based Approach 39
2.8.5 New-Generation Sequencing Technologies 40
2.8.6 Ultra-High Throughput Sequencing 41
2.10 Companion Diagnostics 42
2.11 Selected Personalized Medicine Drugs by Biomarker and Indication 49
2.12 Selected Personalized Medicine Test/Kit According to Therapeutic and Indication 59
2.13 Targeted Cancer Therapy 65
2.14 What Percentage of Cancer Patients Could be Treated by Targeted Therapy? 68
3.0 Personalized Medicine Therapeutics and Associated Companion Diagnostics 69
3.1 CYP2C9 and VKORC1 mutations and Warfarin Response 69
3.2 HLA-B*5701 and Abacavir Response 70
3.3 KRAS Mutations 71
3.3.1 Erbitux 72
3.3.2 Vectibix 72
3.4 Herceptin® and Breast Cancer 72
3.5 BRACAnalysis® 84
3.5.1 Comprehensive BRACAnalysis® 87
3.5.2 BRACAnalysis® Rearrangement Test (BART) 87
3.5.3 Single Site BRACAnalysis® 87
3.5.4 Multisite 3 BRACAnalysis® 87
3.6 Oncotype Dx Test 87
3.7 Therascreen® EGFR RGQ PCR Kit 87
3.8 Therascreen KRAS RGQ PCR System 88
3.9 Therascreen® IDH1/2 test 88
3.10 THxID™ -BRAF Kit 88
3.11 Cobas® EGFR Mutation Test (Roche) 88
3.12 Prolaris Prostate Cancer Test 89
4.0 Personalized Medicine and Integration into the Healthcare System 90
4.1 The Personalized Medicine Coalition 90
4.2 Personalized Medicine and the Healthcare System 92
4.3 Clinical Application of Personalized Medicine 92
4.4 Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology 93
5.0 Private and Public Funding and Personalized Medicine Reimbursement 95
5.1 International Research and Development Personalized Medicine Activity 95
5.1.1 Publically Funded Personalized Medicine Research 95
5.1.2 Privately Funded Personalized Medicine Research 96
5.2 Popular Biological Targets/Pathways in Pharmacogenetic/Pharmacogenomic Research 101
5.3 Equitable Payer Reimbursement 103
5.3.1 Molecular Diagnostic Payments in Personalized Medicine 103
5.3.1.1 RVU-CPT-ICD Coding System 103
5.3.2 Laboratory Service Payments in Personalized Medicine 103
5.3.3 Revisions to Current Payment System 103
5.4 Biorepositories and Biobanks 103
5.5 Intellectual Property and Personalized Medicine 104
6.0 European Personalized Medicine Market – Payments and Investment 105
6.1 Personalized Medicine and The European Market 105
6.2 European Investment in Personalized Medicine 106
6.3 Overview of Reimbursement Policies in Europe 106
6.4 Gaining Market Penetration in the EU 107
6.5 Personalized (Stratified) Medicine Regulation and Reimbursement in the UK 112
6.5.1 Precision Medicine Catapult 117
6.6 CE-marked Personalized Medicine/Diagnostic Tests in the UK 117
6.7 Personalized Medicine Regulation in Germany 118
6.8 Personalized Medicine Regulation in France 119
6.9 Personalized Medicine Regulation in Spain 120
6.10 The Personalized Medicine Regulation in Italy 120
6.11 Challenges of Future Personalized Medicine Development in Europe 120
7.0 Personalized Medicine –Business Model Analysis 122
7.1 New Business Model Required for Personalized Medicine 122
7.2 Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies 122
7.3 Business Model Strategies for Providers. Provider Systems and Academic Medical Centres 123
7.4 Business Model Strategies for Payers 123
7.5 Business Model Strategies for Governments 124
7.6 Introduction of Non-Health Companies to the Personalized Medicine Market 124
7.7 Change to the Big Pharma Business Model 125
7.8 Cost-effectiveness and Business Value of Personalized Medicine 125
7.9 Comparative Effectiveness Research in Personalized Medicine 126
7.10 Reimbursement, Coverage and Payment Policy 126
8.0 Personalized Medicine Main Industry Players 129
8.1 23andMe 129
8.2 Affymetrix 130
8.3 Astex Pharmaceuticals 132
8.4 Atossa Genetics 134
8.5 CuraGen 135
8.6 Celera Corporation (Quest Diagnostics) 135
8.7 Celldex Therapeutics 136
8.8 deCode Genetics (Amgen) 137
8.9 Illumina 137
8.10 Genelex 139
8.11 Myriad 139
8.12 Nodality 140
8.13 Qiagen 142
8.14 Admera Health (GeneWiz) 144
8.15 Claritas Genomics 144
9.0 Personalized Medicine Industry Products and Kits 146
9.1 23andme 146
9.2 Affymetrix 153
9.3 Astex Pharmaceuticals 154
9.4 Atossa Genetics 155
9.4.1 Mammary Aspirate Specimen Cytology Test (MASCT™) 155
9.4.2 ForeCYTE Breast Health Test (SM) 155
9.4.3 ArgusCYTE Breast Health Test(SM) 155
9.4.4 FullCYTE Breast Health Test 155
9.4.5 NextCYTE Breast Health Test 155
9.5 Celera (Quest Diagnostics) 156
9.5.1 ViroSeq® HIV-1 Genotyping System 156
9.5.2 ViroSeq® HIV-1 Integrase Assay 156
9.5.3 ViroSeq® HCV Assay 156
9.5.4 ViroSeq® HBV Assay 157
9.5.5 Cystic Fibrosis Genotyping Assay 157
9.5.6 LDL-S3GGE® Test 157
9.5.7 HDL-S10GGE® Test 157
9.5.8 KIF6-StatinCheckTM Genotype Test 158
9.5.9 9p21-EarlyMICheckTM Genotype Test 158
9.5.10 LPA-AspirinCheckTM Genotype Test 158 9.5.11 AlleleSEQR® HLA PCR/Sequencing Kits 158 9.5.12 m2000® RealTime PCR System 159
9.5.13 CEGA -16™ Instrument 160
9.6 deCode Genetics 160
9.6.1 deCodeT2 Genetic Test 161
9.6.2 deCODE Breast Cancer™ 161
9.6.3 deCODE Prostate Cancer™ 162
9.6.4 deCODE AF™ 162
9.6.5 deCODE Glaucoma™ 162
9.6.6 deCODE MI™ 162
9.6.7 deCODE Complete™ 163
9.6.8 deCODE Cancer™ 163
9.6.9 deCODE Cardio™ 164
9.6.10 deCODE Services 164
9.7 Illumina 165
9.7.1 Illumina HiSeq 2000/1000 166
9.7.2 Genome Analyzer IIx 167
9.7.3 Illumina MiSeq 168
9.7.4 Illumina HiScanHQ 169
9.7.5 Illumina HiScan and iScan Array 169
9.8 Genelex 170
9.8.1 You Script™ 170
9.9 Myriad Genetics 172
9.9.1 BRACAnalysis® 172
9.9.2 COLARIS®/COLARIS AP® 173
9.9.3 MELARIS® 174
9.9.4 PANEXIA® 174
9.9.5 OnDose® 174
9.9.6 PREZEON™ 174
9.9.7 THERAGUIDE® 5FU 174
9.9.8 Prolaris® 175
9.10 Nodility 175
9.11 Qiagen 175
9.11.1 Genotyping Products 176
9.11.2 QIAsymphony Platform 178
9.12 Admera Health (GENEWIZ) 180
9.12.1 PGxOne 180
9.12.2 OncoGxOne 182
9.12.3 OncoGxOne Plus 183
9.12.4 FloraCheck 183
9.12.5 EGFR & KRAS Clinical Sequencing 183
9.13 Claritas Genomics 183
9.13.1 ClariFocus Exome for Pediatric Neurology 184
9.13.2 ClariView Array 184
10.0 Personalized Medicine Market Analysis 185
10.1 General Overview 185
10.2 Personalized Medicine Market 185
10.3 Personalized Medical Care Market 186
10.4 Personalized Medicine: Diagnostic and Therapeutic Sub-Market 187
10.4.1 Personalized Medicine Targeted Therapeutics – Oncology 188 10.4.2 Targeted Cancer Therapeutics 189 10.4.3 Top Ten Companies in Oncology Drug Sales 189 10.4.4 Top Five Oncology Drugs 190 10.4.5 Global Oncology Market by Cancer Type 191
10.4.6 Personalized Medicine Oncology Therapeutics Market 192
10.4.7 Personalized Medicine Diagnostic Assays – Oncology 196
10.4.8 Personalized Medicine Cardiovascular Therapeutics Market 199
10.4.9 Personalized Medicine Infectious Disease Therapeutics Market 201
10.4.10 Infectious Disease Diagnostic Assay Market 204
10.5 Global Personalized Medical Technology Market 206
10.6 Global Personalized Medicine Sub-Market Growth 206
10.6.1 PharmacoGenomics/PharmacoGenetics Market Analysis 209
10. 7 Molecular Diagnostics Market 210
10.8 Consumer Genomics Market 210
10.9 Major Player Profit Margin Analysis 211
10.10 Market Participant Analysis 216
10.10.1 23andme 216
10.10.2 Affymetrix 219
10.10.3 Astex Pharmaceuticals 228
10.10.4 Atossa Genetics 230
10.10.5 Celera (Quest Diagnostics) 233
10.10.6 Celldex Therapeutics 238
10.10.7 deCode Genetics (Amgen) 240
10.10.8 Illumina 241
10.10.9 Genelex 244
10.10.10 Myriad 246
10.10.11 Nodality 249
10.10.12 Qiagen 250
10.10.13 bioMerieux 255
11.0 Strengths and Advantages of Personalized Medicine 264
11.1 Sequencing of the Human Genome in 2000 264
11.2 Improving Patient Care and Reducing Side Effects 264
11.3 Personalized Medicine will Reduce Healthcare Costs 264
11.4 FDA Advances in Personalized Medicine Regulation 264
11.5 Advancing Technologies 265
11.5.1 Next Generation Sequencing 265
11.6 Industry Investing in Pharmacogenomics 266
11.7 Consumer Genomics and POC Market 266
11.8 Oncology a Driving Force of Personalized Medicine 267
12.0 Restraints of the Personalized Medicine Market 268
12.1 Lack of Sufficient Regulation 268
12.2 Lack of Sufficient Genotypic Linkage Studies to Disease Phenotype 269
12.3 Reimbursement Issues 269
13.0 Personalized Medicine and Regulatory Policies 271
13.1 Regulation 271
13.2 Genetic Information Non-discrimination Act (GINA) 273
13.3 FDA Advancements on Genetic Testing Approval 274
13.4 FDA- New Models to Assess Gene Therapy Safety 276
13.5 FDA- Companion Diagnostics 276
13.6 FDA - Partnership in Applied Comparative Effectiveness Science (PACES) Initiative 276
13.7 National Institutes of Health Genetic Testing Registry 276
14.0 Final Summary and Future Perspectives 279
List of Tables
Table 2.1: Glossary: Common Terms Used in Genetics and Personalized Medicine 19
Table 2.2: Types of Genetic Markers used as Biomarkers in Personalized Medicine 20
Table 2.3: Genetic Disease Associated with the Ashkenazi Jew Population 20
Table 2.4: Disease Types Associated with Specific Populations 21
Table 2.5: Personalized Medicine 23
Table 2.6: Genetic Mutations that Predispose Individuals to Disease 24
Table 2.7: Potential Applications of Pharmacogenetics & Pharmacogenomics in Personalized Medicine 24
Table 2.8: Main Cytochrome P450 Enzymes Involved in Drug Metabolism 24
Table 2.9: Rapid & Slow Metabolizer Phenotypes 25
Table 2.10: Population Frequency of Cytochrome P450(CYP) 2C19 Metabolizer Types 26
Table 2.11 Population Frequency of Cytochrome P450 (CYP) Metabolizer Types 26
Table 2.12 Depression Medications Affected by Genetic Mutations 26
Table 2.13 Cardiovascular Medications Affected by Genetic Mutations 27
Table 2.14: Cancer Medications that may be Affected by Genetic Mutations 27
Table 2.15: Diabetes Medications Affected by Genetic Mutations 28
Table 2.16: Anti-Epileptic Drugs Affected by Genetic Mutations 28
Table 2.17: Anti-Retroviral Drugs Affected by Genetic Mutations 28
Table 2.18: Anti-Reflux/Ulcer Drugs Affected by Genetic Mutations 28
Table 2.19: List of Therapeutics According to Cytochrome P450 Subtype Metabolism 29
Table 2.20: Cytochrome (CYP) P450 Drug-Interactions Inhibitor List 30
Table 2.21: Cytochrome (CYP) P450 Drug-Interactions Inducer List 30
Table 2.22: Main Aims of Pharmacogenomics 31
Table 2.23: How Pharmacogenomics has Influenced the Top Ten Selling Drugs Globally 33 Table 2.24: Advantages, Disadvantages and Cost of Popular Genotyping Methods 33
Table 2.25: Top Ten Pharmacogenomics Tests 34
Table 2.26: FDA Accepted Pharmacogenomic Biomarkers 34
Table 2.27: Benefits of Single Base Primer Extension in Pharmacogenetics 38
Table 2.28: Future Applications of Ultra-High Throughput Sequencing 41
Table 2.29: Comparison of Genotyping Techniques 41
Table 2.30: Problems associated with Microarray Sequencing 41
Table 2.31: Top Ten Genetic Findings by 23andMe 42
Table 2.32: FDA Companion Diagnostics Device List: In Vitro and Imaging Tools 43
Table 2.33: Important Strategies for a Successful Companion Diagnostic Launch 49
Table 2.34: Selected Personalized Medicine Drugs by Biomarker and Indication 49
Table 2.35: Selected Personalized Medicine Test/Kit According to Therapeutic and Indication 59
Table 2.36: Targeted Cancer Therapeutics by Tumor Type, Biological Target & Detection Method Availab 66 Table 2.37: FDA Approved Targeted Therapies and Approved Indiactions for Solid Tumors 66 Table 3.1 Predicted Warfarin Concentrations depending on CYP2C9 and VKORC1 Genotype 70
Table 3.2 Top Five Most Frequent Cancers in Men and Women, Globally 73
Table 3.3 Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer per Country, Worldwide 75
Table 3.4 Types of Diagnostic Tests Available to Determine HER2 Status in Breast Cancer Patients 80
Table 3.5 Validated HER2 Tests for Cancer 82
Table 3.6: Advantages and limitations of IHC HER2 testing applied to breast cancer 82
Table 3.7: In-SituHybridization Determination HER2 Expression: PathVysion® and HER2 FISH pharmDx 83
Table 3.8: HER2 CISH Determination 83
Table 3.9: Validated FISH Kits for HER2 Testing in Breast Cancer 83
Table 3.10: Validated SISH Kits for HER2 Testing in Breast Cancer 83
Table 3.11: Validated CISH Kits for HER2 Testing in Breast Cancer 83 Table 3.12: Advantages and limitations of ISH techniques applied to HER2 testing in breast cancer 84 Table 3.13: Prevalence of Deleterious Mutations in BRCA1 and BRCA2 Genes 84 Table 3.14: Prevalence of Deleterious Mutations in BRCA1 and BRCA2 in Individuals of Ashkenazi Ancestry 85
Table 3.15: Risk Factors for Hereditary Breast and Ovarian Cancer (HBOC) 86
Table 3.17: BRACAnalysis® Panel of Assays 87
Table 3.18: The Prolaris Score for Prostate Cancer 89
Table 4.1: Objectives of the Personalized Medicine Coalition 90
Table 4.2: Current Personalized Medicine Coalition Members 90
Table 4.3: Genetic Variants used in care of melanoma, gastrointestinal stromal tumors, non-small-cell lung cancer, thymic cancer and breast and ovarian cancers. 92
Table 4.4: Minimum Definition of a clinically Actionable Variant 94
Table 4.5: Minimum Criteria for Whole Genome Analysis in Clinical Laboratory Improvement Amendments Laboratory of Genomic Pathology, Clinical Whole Genome Analysis 94
Table 5.1: Public Funding Bodies for Pharmacogenetic/Pharmacogenomic Research 96
Table 5.2: American Companies Involved in Pharmacogenomics/genetics Drug Development & Diagnostics 97
Table 5.3: European Companies Involved in Pharmacogenomics/genetics Drug Development & Diagnostics 97
Table 5.4: North American Companies Involved in Pharmacogenomics/genetics Services 98
Table 5.5: European/Other Companies Involved in Pharmacogenomics/genetics Services 98
Table 5.6: American Companies Involved in Pharmacogenomics/genetics Tools Kits & Software 99
Table 5.7: European Companies Involved in Pharmacogenomics/genetics Tools Kits & Software 99
Table 5.8: North American Companies with Minor interest in Pharmacogenomics/genetics 99
Table 5.9: European/Other Companies with Minor interest in Pharmacogenomics/genetics 100
Table 5.10: Large US Companies with Investment into Pharmacogenomics/genetics 100
Table 5.11: Large European Companies with Investment into Pharmacogenomics/genetics 101
Table 5.12: Large Japanese Companies with Investment into Pharmacogenomics/genetics 101
Table 5.13: Top Ten Biological Areas of Interest in Pharmacogenetics/genomics 102
Table 5.14: Top International Pharmacogenetic/Pharmacogenomic Research Institutions 102
Table 5.15: Top European Pharmacogenetic/Pharmacogenomic Research Institutions 102
Table 6.1: Variation of Reimbursement Policies for HER2 & KRAS Testing in Europe 106
Table 6.2: Pharmaceutical Companies Providing Subsidization of Personalized Medicine Tests in Europe 107
Table 6.3: Challenges Within Personalized Medicine Market in Europe 108 Table 6.4: Function of the European network for Health Technology Assessment Organisation 108
Table 6.5: European network for Health Technology Assessment (EUnetHTA) Partners 109
Table 6.6: European network for Health Technology Assessment (EUnetHTA) Associates 111
Table 6.7: Diagnostics Guidance Assessment by the National Institute for Health and Clinical Excellence 113
Table 6.8: Current Diagnostics Guidance in Development by the Diagnostics Access Program, UK 114
Table 6.9: Published Diagnostics Guidance by the Diagnostics Access Program, UK 115
Table 6.10: Medical Technologies Guidance Assessment by NICE 116
Table 6.11: Published Medical Technologies Guidance by NICE 116
Table 6.12: Published Medical Technologies Guidance in Development NICE 116
Table 6.13 Precision Medicine Catapult Tools to Aid Market Entry 117
Table 6.14 Key Challenges to Personalized Medicine 120
Table 6.15 Personalized Medicine - Translation into Medical Applications 121
Table 7.1: Major Market Trends in Personalized Medicine 122
Table 7.2: Collaboration Strategies Required between Industry, Payers & Governments 112
Table 7.3: Business Model Recommendations: Diagnostic, Pharmaceutical & Biotechnology Companies 123
Table 7.4: Business Model Recommendations: Providers. Provider Systems & Medical Centres 123
Table 7.5: Business Model Recommendations for Payers 124
Table 7.6: Business Model Recommendations for Governments 124
Table 7.7: Non-Healthcare Companies with Potential to enter the Personalized Medicine Market 125
Table 7.8: Hurdles of Personalised Medicine with Respect to Cost-Effectiveness 126
Table 8.1: Patent Listing of Affymetrix Array technology 130
Table 8.2: Patent Listing of Affymetrix Genotyping Technology 130
Table 8.3: Patent Listing of Affymetrix Array technology 130 Table 8.4: Patent Listing of Affymetrix Genotyping Technology 133 Table 8.5 Astex Pharmaceuticals Pipeline Portfolio 133
Table 8.6: Astex Pharmaceuticals Pipeline Portfolio Funded Completely by Partner Companies 134
Table 8.7: Potential Business Partnerships of Celldex Therapeutics 136
Table 8.8: Illumina Core Technologies 137
Table 8.9: Illumina Core Technology Applications 137
Table 8.10: Illumina Instrument Product Portfolio 137
Table 8.11: Illumina Assay Product Portfolio 137
Table 8.12: Genetic Test Panel Available from Genelex for Research Institutions and Clinical Trials 138
Table 8.13: Pre-Clinical, Clinical and Commercial Applications of SCNP by Nodality 142
Table 8.14: Qiagen Timeline of Events, 1994-2012 142
Table 8.15: Range of Product Groups from Qiagen 146
Table 9.1: 23andMe Disease Risk Genetic Test Panel 148
Table 9.2: 23andMe Carrier Status Genetic Test Panel 149
Table 9.3: 23andMe Drug Response Genetic Marker Test Panel 151
Table 9.4: 23andMe Genetic Traits Test Panel 151
Table 9.5: Product Overview of Affymetrix 153
Table 9.6: Microarray Products by Affymetrix 153
Table 9.7: Affymetrix Research Services Laboratory (ARSL) Premier Services 154
Table 9.8: Genetic Applications of Axiom® Technology by Affymetrix 154
Table 9.9: Range of Small Molecule Therapeutics Available from Astex Pharmaceuticals 154
Table 9.10: Panel CFTR mutations screened for in Celera Cystic Fibrosis Genotyping Assay 157
Table 9.11: Genetic Tests Available from BHL/Celera 158
Table 9.12: Panel of BHL Clinical Diagnostic Tests 159 Table 9.13: Features of the m2000® RealTime PCR System by Celera 159
Table 9.14: Genetic Diagnostic Tests Available from deCode Genetics 160 Table 9.15: Type 2 Diabetes risk range and distribution according to deCodeT2 Genetic Test 161
Table 9.16: Genetic Mutations Identified by the deCODE MI™ Test in a European Population 162
Table 9.17: Genetic Mutations Identified by the deCODE MI™ Test in an East Asian Population 163
Table 9.18: Disease States that are Included in the deCODE Complete™ Genetic Screen 164
Table 9.19: Panel of Diseases Screened for in the deCODE Cancer™ Test 164
Table 9.20: Panel of Cardiovascular Diseases in the deCODE Cardio™ Test 165
Table 9.21: deCODE Genetics Genotyping and Sequencing Service 164
Table 9.22: deCODE Genetics Data Management, Protection and Storage Service 165
Table 9.23: deCODE Genetics Sequence Inputation and Data Analysis Service 165
Table 9.24: Illumina HiSeq 2500/1500 Performance Parameters 166
Table 9.25: Illumina HiSeq 2000/1000 Performance Parameters 167
Table 9.26: Genome Analyzer IIx Performance Parameters 168
Table 9.27: Illumina MiSeq Product Specifications 169
Table 9.28: Illumina HiScanHQ Product Specifications 169
Table 9.29: Illumina HiScan and iScan Array Product Applications 169
Table 9.30: Illumina iScan Array Kits 170
Table 9.31: Panel of Genetic Screens Available from Genelex 171
Table 9.32: Drug Sensitivity Screens Available from Genelex 171
Table 9.33: Predictive Genetic Tests Available from Myriad 172
Table 9.34: Services offered with BRACAnalysis® Testing from Myriad 172
Table 9.35: Advantages of BRACAnalysis® Testing 173
Table 9.36: COLARIS® Test Range by Myriad 173
Table 9.37: COLARIS AP® Test Range by Myriad 174
Table 9.38: MELARIS® Test Range from Myriad 174
Table 9.39 Personalized Medicine Tests from Myriad 175
Table 9.40: OnDose® Testing Procedure from Myriad 176
Table 9.41: Qiagen Genotyping Products for Sample Collection, stabilization and Storage 176
Table 9.42: Qiagen Genotyping Products for Genomic DNA Isolation and Purification 176
Table 9.43: Qiagen Genotyping Products for PCR Based Genotyping Analysis 177
Table 9.44: Qiagen Products for Genotyping Analysis 177
Table 9.45: Qiagen Genotyping Products for PCR Detection 178
Table 9.46: Qiagen Assays for Genetic Analysis 178
Table 9.47: Qiagen Pyrosequencing-Based Genetic Analysis Products 179
Table 9.48: Specifications and Features of Qiagen’s QIAsymphony and QIAsymphony RGQ 179
Table 9.49. Admera Health Commercial Drug List that are Covered by the PGxOne Assay 181
Table 9.50 Admera Health PGxOne Gene & Variant List, Therapeutic Area & Endorsing Agency 182
Table 9.51: Claritas Genomics Genetic Test Portfolio, by Gene 183 Table 10.1: Global Market for Oncology Drugs by Geography/Country, Through 2020 188 Table 10.2: Top Ten Companies in Oncology Sales Forecast 2013 – 2020 189 Table 10.3: Top Five Oncology Drugs, Through 2020 191
Table 10.4: Submarkets within the Personalized Medicine Technology Market 206
Table 10.5: Operating Profit Margin Analysis: Selected Personalized Medicine Industry Players 212
Table 10.6: Personalized Medicine Industry Segments and Companies Analysed 213
Table 10.7: Drug Classes Investigated by 23andMe Using Genome Wide Association Studies 217
Table 10.8: Acquisition Profile of Affymetrix 219
Table 10.9: Genetic Applications of Axiom® Technology by Affymetrix 219
Table 10.10: Diversified Business Units of Affymetrix 220
Table 10.11: Affymetrix AgBio Microarray Portfolio 221
Table 10.12: Celera (Quest Diagnostics) Historic Operating (Loss) Laboratory Services & Products 238
Table 10.13: Diagnostic Test Product Categories Manufactured by BHL/Celera & Distributed by Abbott 238
Table 10.14: Celldex Therapeutics R&D Expenses ($ Thousands) 2010-2012 241
Table 10.15: Price Listing of Genelex Familial Genetic Tests 245
Table 10.16: Myriad - Core Business Decisions and Impact on Industry 249
Table 10.17: Future Test Portfolio of Myriad 249
Table 10.18: Nodality’s Single Cell Network Profiling (SCNP) for Drug Discovery & Validation 251
Table 10.19: BioMerieux Immunodiagnostic Product Portfolio 256
Table 10.20: BioMerieux Microbiology Product Portfolio 258
Table 10.21: BioMerieux Molecular Diagnostic Product Portfolio 261
Table 11.1: Strengths and Advantages of Genotyping Techniques 265
Table 11.2: Strengths, Drivers and Advantages of Personalized Medicine Market 267
Table 12.1: Restraints of Personalized Medicine Market 270
Table 13.1: Summary of Clinical Laboratory Improvement Amendments (CLIA) 272
Table 13.2: Clinical Laboratory Improvement Amendments (CLIA) Testing Categories 272
Table 13.3: Test Features required prior to FDA Approval and Clearance 272
Table 13.4: Impact of Genetic Information Non-discrimination Act (GINA) on Healthcare Companies & Health Plans 273
Table 13.5: Impact of Genetic Information Non-discrimination Act (GINA) on US Employers, employment agencies, labor organizations and training programs 273
Table 13.6: FDA Commitment to the Personalized Medicine Industry 274
Table 13.7: Objectives of the ‘Advancing Regulatory Science at FDA: A Strategic Plan’ 274
Table 13.8: FDA Policy & Guidance Recommendations 275
Table 13.8: Implementation Strategy of the FDA to Advance Regulatory Science - Develop better Models of Human Adverse response 275
Table 13.9: Implementation Strategy of the FDA to Advance Regulatory Science - Identify and evaluate biomarkers and endpoints that can be used in non-clinical & clinical evaluations 275
Table 13.10: Implementation Strategy of the FDA to Advance Regulatory Science - Use and develop computational methods and in silico modelling 275
Table 13.11: National Institutes of Health Genetic Testing Registry Test Information 277
List of Figures
Figure 2.1: DNA, Histones and Chromosomes 17
Figure 2.2: DNA is Composed of Four Nucleotide Bases 18
Figure 2.3: The Central Dogma of Molecular Biology – How DNA Encodes Protein 19
Figure 2.4: How Research, Technology, Regulation, Clinical Implementation and Legislation Integrates into Personalized Medicine 22
Figure 2.5 Identification of Good and Non-Responders in a Patient Population 25
Figure 2.6 Pharmacodynamic and Pharmacokinetic Examples of Drug Targets and Drug metabolism in Pharmacogenomics 32
Figure 2.7 Flow Diagram of Pharmacogenetic Analysis 37
Figure 2.8: Primer Based Base Extension in Pharmacogenetics 38
Figure 2.9: Genetic Mutation Detection by Hybridization 39
Figure 2.10: Ligation based SNP Detection 40
Figure 2.11 New-Generation Sequencing: Pyrosequencing 40
Figure 2.12 Percentage of Cancer Patients with Genetic Mutations that could be Treated by Targeted Therapy 68
Figure 3.1: Warfarin Metabolism and Response 69
Figure 3.2: Percentage Frequency of CYP2C9 and VKORC1 mutations in Caucasian, African-American and Asian Populations 70
Figure 3.3: Anti-EGFR Therapy and KRAS Mutations 71
Figure 3.4: KRAS and BRAF Genetic Tests Available from Asuragen 72
Figure 3.5: Global Incidence and Mortality of Cancer in Women 73
Figure 3.6: Cancer Deaths in Women, Globally according to Cancer Type 74
Figure 3.7: Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer Globally 75
Figure 3.8: HER2 Testing Algorithm for Breast Cancer 81
Figure 3.9: HER2 Cellular Signalling 81
Figure 3.10: Herceptin – Mechanism of Action 82
Figure 3.11: BRCA Mutation Increases the Risk of Breast and Ovarian Cancer 86
Figure 3.12: Proactive Cancer Management and Preventative Measures Reduces the Risks of Developing BRCA-associated Breast and Ovarian Cancer 86
Figure 4.1: Integration of Multiple components for a Personalized Medicine Healthcare System 91
Figure 4.2: Workflow Diagram illustrating Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology 93
Figure 4.3: Hypothetical Flow Diagram of a Patient through the Genomic Pathology Clinical Laboratory 94
Figure 5.1: Personalized Medicine Scheme Interaction with Industry, Regulatory Bodies and Funding Agencies 95
Figure 5.2: Number of Publically Funded Pharmacogenetic and Pharmacogenomic Research Teams Internationally 96
Figure 6.1: Adverse Drug Reactions are the Fourth Leading Cause of Death 105
Figure 6.2: Efficacy Rate of Major Disease Types with Standard Treatment 105
Figure 6.3: The In Vitro Diagnostic Market in Europe 108
Figure 6.4: Organization of the European network for Health Technology Assessment (EUnetHTA) 109
Figure 6.5: Key Differences in Reimbursement Policy Approaches for Oncology Diagnostics and Therapeutics in Europe and the US 114
Figure 6.6: Flow Diagram of the German Healthcare System and Key Agencies 118
Figure 6.7: German Reimbursement Arrangement, Process and Implications 119
Figure 7.1: Annual Healthcare Expenditure for Major Industrial Nations 127
Figure 7.2: Estimated Life Expectancy from Birth for Major Industrialized Countries 128
Figure 8.1: Celldex Therapeutics Product Pipeline 137
Figure 8.2: Single Cell Network Profiling (SCNP) Technology by Nodality 141
Figure 8.3: Developed Functional Assays that Nodality has explored using new SCNP Technology 141
Figure 9.1: Flow Diagram of Celera CEGA -16™ Instrument for Cystic Fibrosis Gene Analysis 160
Figure 9.2: Percentage of Individual Populations who have an Increased Risk of Developing Type 2 Diabetes as Determined Using the deCodeT2 Genetic Test 161
Figure 9.3: Illumina New Generation Sequencing Technology Workflow Station 165
Figure 10.1: Combined Personalized Medicine Market in the US, 2009-2015 186
Figure 10.2: Core Personalized Medicine Sub-Market Growth 2009-2015 186
Figure 10.3: Personalized Medical Care Sub-Market Growth 2009-2015 187
Figure 10.4: Diagnostic and Therapeutic Personalized Medicine Market Growth US, 2009-2015 187 Figure 10.5: Global Market for Oncology Drugs by Geography/Country, Through 2020 188 Figure 10.6: Global Oncology Drug Sales by Top Five Companies, Through 2020 190 Figure 10.7: Top Five Oncology Drugs, Through 2020 191 Figure 10.8: Global Oncology Market by Cancer Type, 2014 192
Figure 10.9: Global Personalized Medicine Oncology Therapeutics Forecast 2014-2019 193
Figure 10.10: HER-2 Positive Breast Cancer Therapeutic Market Forecast 2014-2019 193
Figure 10.11: Personalized Medicine Oncology Therapeutic Market Forecast 2014-2019 194
Figure 10.12: Personalized Medicine Branded Oncology Therapeutics Market Share 2014 195
Figure 10.13: Personalized Medicine Branded Oncology Therapeutics Market Share 2019 195
Figure 10.14: Global Cancer Diagnostics Market 2014-2020 197
Figure 10.15: Most Popular Proteomic and Genomic Technologies Performed by End-Users 198
Figure 10.16: Global Personalized Medical Oncology Molecular Diagnostic Market Forecast 2014-2019 198
Figure 10.17: Oncogenic Biomarker Share of Total Personalized Medicine Biomarker Space 199
Figure 10.18: Oncogenic Biomarker Market Distribution by Cancer Type 199
Figure 10.19: Personalized Medicine Branded Cardiovascular Therapeutic Market 2014-2019 200
Figure 10.20: Personalized Medicine Branded Cardiovascular Market by Therapeutic Forecast 2014-2019 200
Figure 10.21: Personalized Medicine Branded Infectious Disease Therapeutics Market 2014-2019 203
Figure 10.22: Gilead Sciences Sovaldi and Harvoni Sales Revenue 2014-2019 203
Figure 10.23: HIV and Hepatitis Diagnostic Assay Market Growth 2014 to 2019 205
Figure 10.24: Global Market Personalized Medicine Technology Growth 2009-2015 203
Figure 10.25: Global Personalized Sub-market Growth 2015 207
Figure 10.26: Personalized Medicine Sub-Market Share (Percentage) 2009 207
Figure 10.27: Personalized Medicine Sub-Market Share (Percentage) 2014 208
Figure 10.28: Global Genomic Testing Market Forecast 2014-2019 209
Figure 10.29: Pharmacogenetics Market Forecast 2014-2019 209
Figure 10.30: Global Molecular Diagnostics Predicted Market Share 2015 210
Figure 10.31: Global Molecular Diagnostics Market Projection 2015 210
Figure 10.32: Average Operating Profit Margin Analysis for Selected Players in the Personalized Medicine Industry 2012-2014 212
Figure 10.33: Oncology, Infectious Disease, Cardiovascular and Genomic Submarket Operating Profit Margins 213
Figure 10.34: Personalized Medicine Oncology Submarket Operating Profit Margin Analysis 214
Figure 10.35: Personalized Medicine Infectious Disease Submarket Operating Profit Margin Analysis 214
Figure 10.36: Personalized Medicine Cardiovascular Submarket Operating Profit Margin Analysis 215
Figure 10.37: Personalized Medicine Genomics Submarket Operating Profit Margin Analysis 215
Figure 10.38: Private Funding Gained by 23andMe 2007-2012 216
Figure 10.39: Affymetrix Revenue by Business Segment (Percentage), 2014 216
Figure 10.40: Affymetrix Revenue From Affymetrix Core and eBioscience (Percentage), 2014 223
Figure 10.41: Affymetrix Total Revenue 2007-2014 224
Figure 10.42: Affymetrix Revenue by Product Division – Consumables, Instruments 2010-2014 224
Figure 10.43: Affymetrix Core Product Sales – Gene Expression, Genetic Analysis & Clinical Applications and Life Science Reagents, 2011-2014 225
Figure 10.44: Affymetrix Revenue Derived from Outside the US, 2009-2014 225
Figure 10.45: Affymetrix Revenue Derived from the US, 2009-2014 226
Figure 10.46: Affymetrix Net Loss, 2009-2014 226
Figure 10.47: Affymetrix Research and Development Funding, 2009-2014 227
Figure 10.48: Affymetrix Revenue Generated within USA (Percentage) 2010-2014 227
Figure 10.49: Astex Pharmaceuticals Priority Pipeline Products SGI-110 and AT13387 by Indication, Clinical Phase and Timeline 228
Figure 10.50: Astex Pharmaceuticals Revenue Generated 2008-2012 230
Figure 10.51: Astex Pharmaceuticals Net Income 2009-2012 230
Figure 10.52: Atossa Genetics Total Revenue (US$) 2012-2014 232
Figure 10.53: Atossa Genetics Revenue (US$) Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing 233
Figure 10.54: Atossa Genetics Percentage Revenue Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing 233
Figure 10.55: Quest Diagnostics Revenue ($ Billions) 2008-2014 235
Figure 10.56: Quest Diagnostics Operating Revenue ($ Billions) 2008-2014 236
Figure 10.57: Quest Diagnostics Net Income ($ Billions) 2008-2014 236
Figure 10.58: Celera (Quest Diagnostics) Historic Revenue Generated 2008-2010 237
Figure 10.59: Celera (Quest Diagnostics) Historic Gross Margin Generated 2008-2010 237
Figure 10.60: Celera (Quest Diagnostics) Historic Revenue Generated– Laboratory Services and
Products 2008-2010 237
Figure 10.61: Celera (Quest Diagnostics) Historic Revenue (%) Generated by Distribution Agreement with Abbott 2008-2010 238
Figure 10.62: Celera (Quest Diagnostics) Historic Research and Development Spending 2008-2010 239
Figure 10.63: deCode Genetics Historic Net Loss Incurred 2004-2008 242
Figure 10.64: Illumina Revenue Generated ($ Billions) 2010-2014 244
Figure 10.65: Illumina Net Income Generated ($ Billions) 2010-2014 244
Figure 10.66: Myriad Revenue Generated 2007-2014 248
Figure 10.67: Operating Income Generated by Myriad 2007-2014 248
Figure 10.68: Myriad Revenue Generated by Molecular Diagnostic Testing and Pharmaceutical and Clinical (Companion Diagnostic) Services, 2012-2014 249
Figure 10.68: Future Molecular Diagnostic Pipeline of Myriad 250
Figure 10.69: Customer Profile of Qiagen – Percentage of Net Sales 2014 254
Figure 10.70: Qiagen Global Net Sales 2007-2014 255
Figure 10.71: Qiagen Operating Income 2007-2014 255
Figure 10.72: Qiagen Global Net Income 2007-2014 255
Figure 11.1: Percentage Oncology (Lung, Colorectal, Breast, Prostate) Patients Undergoing Next Generation Sequencing Testing in the US, 2018 266
Figure 11.2: Pipeline and On-market Oncology (Lung, Breast, Colorectal, Prostate) Therapeutics Directed Against Specific Mutations, 2013 267
Global Thyroid Gland Disorders Treatment Market Research Report 2024
Published: 10-Jan-2024 Price: US 2900 Onwards Pages: 80
Thyroid Gland Disorder Treatment is a kind of treatment method, which aims to The thyroid disorder patients, such as hypothyroidism patients and hyperthyroidism patients. When The thyroid gland does not produce sufficient hypothyroidism or too much hyperthyroidism, The body metabolism and functioning will be disrupted.
The global Thyroid Gland Disorders Treatment market was valued at US$ 2950 million in 2023 and is anticipated to reach US$ 3871.9 million by 2030, witnessing a CAGR o......
Global Brachytherapy Afterloaders, Brachytherapy Seeds Market Growth 2024-2030
Published: 04-Jan-2024 Price: US 3660 Onwards Pages: 98
According to our LPI (LP Information) latest study, the global Brachytherapy Afterloaders, Brachytherapy Seeds market size was valued at US$ 150.8 million in 2023. With growing demand in downstream market, the Brachytherapy Afterloaders, Brachytherapy Seeds is forecast to a readjusted size of US$ 168.1 million by 2030 with a CAGR of 1.6% during review period.
The research report highlights the growth potential of the global Brachytherapy Afterloaders, Brachytherapy Seeds market. Brachyth......
Global Peptide Therapeutics Market Growth (Status and Outlook) 2024-2030
Published: 04-Jan-2024 Price: US 3660 Onwards Pages: 109
According to our LPI (LP Information) latest study, the global Peptide Therapeutics market size was valued at US$ 33800 million in 2023. With growing demand in downstream market, the Peptide Therapeutics is forecast to a readjusted size of US$ 63130 million by 2030 with a CAGR of 9.3% during review period.
The research report highlights the growth potential of the global Peptide Therapeutics market. Peptide Therapeutics are expected to show stable growth in the future market. However, pr......
Global Microbiome Therapeutics Market Growth (Status and Outlook) 2024-2030
Published: 04-Jan-2024 Price: US 3660 Onwards Pages: 155
According to our LPI (LP Information) latest study, the global Microbiome Therapeutics market size was valued at US$ 89 million in 2023. With growing demand in downstream market, the Microbiome Therapeutics is forecast to a readjusted size of US$ 916.3 million by 2030 with a CAGR of 39.5% during review period.
The research report highlights the growth potential of the global Microbiome Therapeutics market. Microbiome Therapeutics are expected to show stable growth in the future market. H......
Global Anti-inflammatory Therapeutics Market Growth (Status and Outlook) 2024-2030
Published: 04-Jan-2024 Price: US 3660 Onwards Pages: 109
According to our LPI (LP Information) latest study, the global Anti-inflammatory Therapeutics market size was valued at US$ 108140 million in 2023. With growing demand in downstream market, the Anti-inflammatory Therapeutics is forecast to a readjusted size of US$ 166150 million by 2030 with a CAGR of 6.3% during review period.
The research report highlights the growth potential of the global Anti-inflammatory Therapeutics market. Anti-inflammatory Therapeutics are expected to show stabl......
Global Enzyme Replacement Therapy Market Growth 2024-2030
Published: 04-Jan-2024 Price: US 3660 Onwards Pages: 113
According to our LPI (LP Information) latest study, the global Enzyme Replacement Therapy market size was valued at US$ 11570 million in 2023. With growing demand in downstream market, the Enzyme Replacement Therapy is forecast to a readjusted size of US$ 29900 million by 2030 with a CAGR of 14.5% during review period.
The research report highlights the growth potential of the global Enzyme Replacement Therapy market. Enzyme Replacement Therapy are expected to show stable growth in the f......
Global Infantile Spasms Therapeutics Market Growth (Status and Outlook) 2024-2030
Published: 04-Jan-2024 Price: US 3660 Onwards Pages: 84
According to our LPI (LP Information) latest study, the global Infantile Spasms Therapeutics market size was valued at US$ 138.9 million in 2023. With growing demand in downstream market, the Infantile Spasms Therapeutics is forecast to a readjusted size of US$ 179.6 million by 2030 with a CAGR of 3.7% during review period.
The research report highlights the growth potential of the global Infantile Spasms Therapeutics market. Infantile Spasms Therapeutics are expected to show stable grow......
Global Hormone Replacement Therapy Market Growth 2024-2030
Published: 04-Jan-2024 Price: US 3660 Onwards Pages: 128
According to our LPI (LP Information) latest study, the global Hormone Replacement Therapy market size was valued at US$ 16090 million in 2023. With growing demand in downstream market, the Hormone Replacement Therapy is forecast to a readjusted size of US$ 17930 million by 2030 with a CAGR of 1.6% during review period.
The research report highlights the growth potential of the global Hormone Replacement Therapy market. Hormone Replacement Therapy are expected to show stable growth in th......
Global Plasma Therapy Market Growth (Status and Outlook) 2024-2030
Published: 04-Jan-2024 Price: US 3660 Onwards Pages: 107
According to our LPI (LP Information) latest study, the global Plasma Therapy market size was valued at US$ 265.3 million in 2023. With growing demand in downstream market, the Plasma Therapy is forecast to a readjusted size of US$ 529.4 million by 2030 with a CAGR of 10.4% during review period.
The research report highlights the growth potential of the global Plasma Therapy market. Plasma Therapy are expected to show stable growth in the future market. However, product differentiation, ......
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