Personalized Medicine and Companion Diagnostic Market - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment

NEW YORK, March 5, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Personalized Medicine and Companion Diagnostic Market - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment

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This is a comprehensive account of the market size, segmentation, key players, SWOT analysis, influential technologies, and business and economic environments. The report is supported by 263 tables & figures over 224 pages. The personalized medicine (global) market is presented as follows:

• By Company (e.g., 23andMe, AFFYMETRIX, ATOSSA GENETICS, NODALITY, deCode /Amgen, CELERA, MYRIAD)• By Geography (US, UK, EU)• By Segment (Targeted therapeutics, Companion Diagnostics, Esoteric tests, Esoteric lab services)• By Sub-market (Companion diagnostics & therapeutic, nutrition & wellness, medical technology, pharmacogenomics, consumer genomics)

A wealth of financial data & business strategy information is provided including:

• Up-to-date company financials, sales & revenue figures• Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies• Business Model Strategies for Providers. Provider Systems and Academic Medical Centres• Business Model Strategies for Payers & Governments• Private and Public Funding and Personalized Medicine Reimbursement • Revisions to Current Payment Systems and intellectual property• How to Gain Market Penetration in the EU• Cost-effectiveness and Business Value of Personalized Medicine• Consumer genomics and POC market• Therapeutics and Companion Diagnostics (e.g., BRAC Analysis, Oncotype Dx , KRAS Mutations)• Comprehensive account of company product portfolios & kits

SWOT, Economic & Regulatory Environment specifics include:

• Key strengths, weaknesses and threats influencing leading player position within the market• Technologies driving the market (e.g., New-Generation Sequencing Technologies, Ultra-High Throughput Sequencing)• Top fastest growing market segments and emerging opportunities• Top pharmaceutical companies within the IPM by market share and revenue• Comprehensive product portfolios, R&D activity and pipeline therapeutics • M&A activity and future strategies of top personalized medicine pharmacos• Personalized Medicine Regulation (UK, Germany, France, Spain, Italy)• CE-marked Personalized Medicine/Diagnostic Tests• FDA Advances in Personalized Medicine Regulation

This report highlights a number of significant Indian pharmacos and gives details of their operations, products, financials and business strategy.

• 23andMe• Affymetrix• Astex Pharmaceuticals• Atossa Genetics• CuraGen• Celera Corporation (Quest Diagnostics)• Celldex Therapeutics• deCode Genetics (Amgen)• Illumina• Genelex• Myriad • Nodality• Qiagen

What you will gain:

• An in-depth understanding of the global personalized medicine market and it's environment• Current market facts, figures and product lines of key players in the industry• Emerging trends in key markets such as the US, UK, Germany and France• Knowledge of how the personalized medicine market will integrate into the global healthcare market • Technical insights into new generation sequencing technologies and ultra-high throughput sequencing• Updates on bioinformatics, high throughput systems, genetic analysis kits, companion diagnostics and future technologies• FDA approved pharmacogenetic tests and recognized biomarkers• Information on key government and regulatory policies • Strategies on how to adapt and restructure current business models to this industry

This report tackles key concerns to the personalized medicine market such as:

• Lack of regulatory policy and legislation in the US and Europe• Reimbursement schemes and payers concerns• Transition of investigational diagnostic assays and therapeutics to clinical practice• Direct to consumer (DTC) test kits and implications for the public

Who should read this report?

• Pharmaceutical, biotechnology and diagnostic companies with an interest in personalized medicine• Industry professionals and business strategists will discover key information to propel their policies• Investors will gain inside information to dominant players in the industry and future forecasts• Scientists will get a business perspective and industry insight into how scientific breakthroughs influence the market environment

This report will tell you if the companies mentioned are:

• Strong, competitive players• Pooling their resources for specific growth and therapeutic areas• Investing strategically in R&D• Have a history of strategic M&A activity

This detailed report is supported with 263 figures and tables over 224 pages and profiles the main pharmacos in personalized medicine.

1.0 Executive Summary 11

1.2 Scope of Study 12

1.3 Data Sources and Methodology 13

1.4 Key Findings and Observations 13

2.0 Introduction 17

2.2 How Personalized Medicine Monitoring can Reduce Adverse Drug Reactions 25

2.3 Pharmacogenetic Study Challenges 26

2.4 Pharmacogenomics 26

2.5 Applications of Pharmacogenomics 27

2.5.1 Pharmacogenomics: Improving the Safety of Medications 27

2.5.1.1 Adverse Drug Reactions 27

2.5.1.2 Pharmacogenomics: Improving the Efficacy of Therapeutics 28

2.6 Pharmacogenetic Analysis 32

2.6.1 Single Base Primer Extension 32

2.6.2 Primer Based Base Extension 32

2.6.3 Hybridization Based SNP Analysis 33

2.6.4 Ligation Based Approach 34

2.6.5 New-Generation Sequencing Technologies 35

2.6.6 Ultra-High Throughput Sequencing 35

2.7 Companion Diagnostics 37

3.0 Personalized Medicine Therapeutics and Companion Diagnostics 44

3.2 HLA-B*5701 and Abacavir Response 45

3.3 KRAS Mutations 46

3.3.1 Erbitux 47

3.3.2 Vectibix 47

3.4 Herceptin® and Breast Cancer 47

3.5 BRACAnalysis® 59

3.5.1 Comprehensive BRACAnalysis® 62

3.5.2 BRACAnalysis® Rearrangement Test (BART) 62

3.5.3 Single Site BRACAnalysis® 62

3.5.4 Multisite 3 BRACAnalysis® 62

3.6 Oncotype Dx Test 62

3.7 Therascreen® EGFR RGQ PCR Kit 62

3.8 Therascreen KRAS RGQ PCR System 63

3.9 Therascreen® IDH1/2 test 63

3.10 THxID™ -BRAF Kit 63

3.12 Cobas® EGFR Mutation Test (Roche) 64

3.13 Prolaris Prostate Cancer Test 64

4.0 Personalized Medicine and Integration into the Healthcare System 65

4.2 Personalized Medicine and the Healthcare System 67

4.3 Clinical Application of Personalized Medicine 67

4.4 Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology 68

5.0 Private and Public Funding and Personalized Medicine Reimbursement 70

5.1.1 Publically Funded Personalized Medicine Research 70

5.1.2 Privately Funded Personalized Medicine Research 71

5.2 Popular Biological Targets/Pathways in Pharmacogenetic/Pharmacogenomic Research 76

5.3 Equitable Payer Reimbursement 78

5.3.1 Molecular Diagnostic Payments in Personalized Medicine 78

5.3.1.1 RVU-CPT-ICD Coding System 78

5.3.2 Laboratory Service Payments in Personalized Medicine 78

5.3.3 Revisions to Current Payment System 78

5.4 Biorepositories and Biobanks 78

5.5 Intellectual Property and Personalized Medicine 79

6.0 European Personalized Medicine Market – Payments and Investment 80

6.2 European Investment in Personalized Medicine 81

6.3 Overview of Reimbursement Policies in Europe 81

6.4 Gaining Market Penetration in the EU 82

6.5 Personalized Medicine Regulation and Reimbursement in the UK 87

6.6 CE-marked Personalized Medicine/Diagnostic Tests in the UK 92

6.7 Personalized Medicine Regulation in Germany 92

6.8 Personalized Medicine Regulation in France 94

6.9 Personalized Medicine Regulation in Spain 94

6.10 The Personalized Medicine Regulation in Italy 94

6.11 Challenges of Future Personalized Medicine Development 95

7.0 Personalized Medicine –Business Model Analysis 96

7.2 Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies 97

7.3 Business Model Strategies for Providers. Provider Systems and Academic Medical Centres 97

7.4 Business Model Strategies for Payers 98

7.5 Business Model Strategies for Governments 98

7.6 Introduction of Non-Health Companies to the Personalized Medicine Market 98

7.7 Change to the Big Pharma Business Model 99

7.8 Cost-effectiveness and Business Value of Personalized Medicine 99

7.9 Comparative Effectiveness Research in Personalized Medicine 100

8.0 Personalized Medicine Main Industry Players 102

8.2 Affymetrix 103

8.3 Astex Pharmaceuticals 105

8.4 Atossa Genetics 107

8.5 CuraGen 108

8.6 Celera Corporation (Quest Diagnostics) 108

8.7 Celldex Therapeutics 109

8.8 deCode Genetics (Amgen) 110

8.9 Illumina 111

8.10 Genelex 112

8.11 Myriad 113

8.12 Nodality 114

8.13 Qiagen 116

9.0 Personalized Medicine Industry Products and Kits 119

9.2 Affymetrix 126

9.3 Astex Pharmaceuticals 127

9.4 Atossa Genetics 128

9.4.1 Mammary Aspirate Specimen Cytology Test (MASCT™) 128

9.4.2 ForeCYTE Breast Health Test (SM) 128

9.4.3 ArgusCYTE Breast Health Test(SM) 128

9.4.4 FullCYTE Breast Health Test 128

9.4.5 NextCYTE Breast Health Test 129

9.5 Celera (Quest Diagnostics) 129

9.5.1 ViroSeq® HIV-1 Genotyping System 129

9.5.2 ViroSeq® HIV-1 Integrase Assay 130

9.5.3 ViroSeq® HCV Assay 130

9.5.4 ViroSeq® HBV Assay 130

9.5.5 Cystic Fibrosis Genotyping Assay 130

9.5.6 LDL-S3GGE® Test 131

9.5.7 HDL-S10GGE® Test 131

9.5.8 KIF6-StatinCheckTM Genotype Test 131

9.5.9 9p21-EarlyMICheckTM Genotype Test 131

9.5.10 LPA-AspirinCheckTM Genotype Test 131

9.5.11 AlleleSEQR® HLA PCR/Sequencing Kits 131

9.5.12 m2000® RealTime PCR System 132

9.5.13 CEGA -16™ Instrument 133

9.6 deCode Genetics 133

9.6.1 deCodeT2 Genetic Test 134

9.6.2 deCODE Breast Cancer™ 134

9.6.3 deCODE Prostate Cancer™ 135

9.6.4 deCODE AF™ 135

9.6.5 deCODE Glaucoma™ 135

9.6.6 deCODE MI™ 135

9.6.7 deCODE Complete™ 136

9.6.8 deCODE Cancer™ 137

9.6.9 deCODE Cardio™ 137

9.6.10 deCODE Services 137

9.7 Illumina 138

9.7.1 Illumina HiSeq 2000/1000 139

9.7.2 Genome Analyzer IIx 140

9.7.3 Illumina MiSeq 141

9.7.4 Illumina HiScanHQ 142

9.7.5 Illumina HiScan and iScan Array 142

9.8 Genelex 143

9.8.1 You Script™ 143

9.9 Myriad Genetics 145

9.9.1 BRACAnalysis® 145

9.9.2 COLARIS®/COLARIS AP® 146

9.9.3 MELARIS® 147

9.9.4 PANEXIA® 147

9.9.5 OnDose® 147

9.9.6 PREZEON™ 147

9.9.7 THERAGUIDE® 5FU 147

9.9.8 Prolaris® 148

9.10 Nodility 148

9.11 Qiagen 148

9.11.1 Genotyping Products 149

9.11.2 QIAsymphony Platform 152

10.0 Personalized Medicine Market Analysis 154

10.2 Personalized Medicine Market Forecast 154

10.3 Personalized Medical Care Market Forecast 156

10.4 Personalized Medicine -Nutrition and Wellness Sub-Market Forecast 156

10.5 Personalized Medicine -Diagnostic and Therapeutic Sub-Market Forecast 157

10.6 Global Personalized Medical Technology Market Forecast 157

10.7 Global Personalized Medicine Sub-market Growth Forecast 158

10.8 Molecular Diagnostics Market 160

10.9 Consumer Genomics Market 160

10.10 Market Participant Analysis 161

10.10.1 23andme 161

10.10.2 Affymetrix 163

10.10.3 Astex Pharmaceuticals 173

10.10.4 Atossa Genetics 176

10.10.5 Celera (Quest Diagnostics) 179

10.10.6 Celldex Therapeutics 185

10.10.7 deCode Genetics (Amgen) 187

10.10.8 Illumina 188

10.10.9 Genelex 191

10.10.10 Myriad 192

10.10.11 Nodality 196

10.10.12 Qiagen 198

10.10.13 bioMerieux 202

11.0 Strengths and Advantages of Personalized Medicine 210

11.2 Improving Patient Care and Reducing Side Effects 210

11.3 Personalized Medicine will Reduce Healthcare Costs 210

11.4 FDA Advances in Personalized Medicine Regulation 210

11.5 Advancing Technologies 211

11.5.1 Next Generation Sequencing 211

11.6 Industry Investing in Pharmacogenomics 212

11.7 Consumer Genomics and POC Market 212

11.8 Oncology a Driving Force of Personalized Medicine 213

12.0 Restraints of the Personalized Medicine Market 215

12.2 Lack of Sufficient Genotypic Linkage Studies to Disease Phenotype 215

12.3 Reimbursement Issues 216

13.0 Personalized Medicine and Regulatory Policies 21713.1 Regulation 21713.2 Genetic Information Non-discrimination Act (GINA) 21713.3 FDA Advancements on Genetic Testing Approval 21913.4 FDA- New Models to Assess Gene Therapy Safety 22213.5 FDA- Companion Diagnostics 22213.6 FDA - Partnership in Applied Comparative Effectiveness Science (PACES) Initiative 222

14.0 Final Summary and Future Perspectives 223

List of Tables

Table 2.2: Genetic Mutations that Predispose Individuals to Disease 19

Table 2.3: Potential Applications of Pharmacogenetics and Pharmacogenomics in Personalized Medicine 19

Table 2.4: Main Cytochrome P450 Enzymes Involved in Drug Metabolism 19

Table 2.5: QUICK FACTS: Rapid & Slow Metabolizer Phenotypes 20

Table 2.6: Population Frequency of Cytochrome P450(CYP) 2C19 Metabolizer Types 21

Table 2.7: Population Frequency of Cytochrome P450 (CYP) Metabolizer Types 21

Table 2.8: Depression Medications Affected by Genetic Mutations 21

Table 2.9: Cardiovascular Medications Affected by Genetic Mutations 22

Table 2.10: Cancer Medications that may be Affected by Genetic Mutations 22

Table 2.11: Diabetes Medications Affected by Genetic Mutations 23

Table 2.12: Anti-Epileptic Drugs Affected by Genetic Mutations 23

Table 2.13: Anti-Retroviral Drugs Affected by Genetic Mutations 23

Table 2.14: Anti-Reflux/Ulcer Drugs Affected by Genetic Mutations 23

Table 2.15: List of Therapeutics According to Cytochrome P450 Subtype Metabolism 24

Table 2.16: Cytochrome (CYP) P450 Drug-Interactions Inhibitor List 25

Table 2.17: Cytochrome (CYP) P450 Drug-Interactions Inducer List 25

Table 2.18: QUICK FACTs - Main Aims of Pharmacogenomics 26

Table 2.19: How Pharmacogenomics has Influenced the Top Ten Selling Drugs Globally 28

Table 2.20: Advantages, Disadvantages and Cost of Popular Genotyping Methods 28

Table 2.21: QUICK FACTS - Top Ten Pharmacogenomics Tests 29

Table 2.22: QUICK FACTS - FDA Accepted Pharmacogenomic Biomarkers 29

Table 2.23: QUICK FACTS - Benefits of Single Base Primer Extension in Pharmacogenetics 32

Table 2.24: Future Applications of Ultra-High Throughput Sequencing 36

Table 2.25: QUICK FACTS - Comparison of Genotyping Techniques 36

Table 2.26: Problems associated with Microarray Sequencing 36

Table 2.27: QUICK-FACTS - Top Ten Genetic Findings of 2010 by 23andMe 36

Table 2.28: FDA Companion Diagnostics Device List: In Vitro and Imaging Tools 37

Table 2.29: Important Strategies for a Successful Companion Diagnostic Launch 43

Table 3.1: Predicted Warfarin Concentrations depending on CYP2C9 and VKORC1 Genotype 45

Table 3.2: QUICKFACTS - Top Five Most Frequent Cancers in Men and Women, Globally 48

Table 3.3: QUICKFACTs - Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer per Country, Worldwide 50

Table 3.4: QUICK-FACTS - Types of Diagnostic Tests Available to Determine HER2 Status in Breast Cancer Patients 55

Table 3.5: Validated HER2 Tests for Cancer 57

Table 3.6: QUICK FACTS - Advantages and limitations of IHC HER2 testing applied to breast cancer 57

Table 3.7: In-Situ Hybridization Determination of HER2 Expression by PathVysion® and HER2 FISH pharmDxTM 58

Table 3.8: HER2 CISH Determination 58

Table 3.9: Validated FISH Kits for HER2 Testing in Breast Cancer 58

Table 3.10: Validated SISH Kits for HER2 Testing in Breast Cancer 58

Table 3.11: Validated CISH Kits for HER2 Testing in Breast Cancer 58

Table 3.12: Advantages and limitations of ISH techniques applied to HER2 testing in breast cancer 59

Table 3.13: QUICK FACTs- Prevalence of Deleterious Mutations in BRCA1 and BRCA2 Genes 59

Table 3.14: QUICK FACTs- prevalence of deleterious mutations in BRCA1 and BRCA2 in individuals of Ashkenazi Ancestry 60

Table 3.15: QUICK FACTs- Risk Factors for Hereditary Breast and Ovarian Cancer (HBOC) 61

Table 3.17: QUICKFACTs- BRACAnalysis® Panel of Assays 62

Table 3.18: The Prolaris Score for Prostate Cancer 64

Table 4.1: QUICKFACTs - Objectives of the Personalized Medicine Coalition 65

Table 4.2: Current Personalized Medicine Coalition Members 65

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. 67

Table 4.4: Minimum Definition of a clinically Actionable Variant 68

Table 4.5: Minimum Criteria for Whole Genome Analysis in Clinical Laboratory Improvement Amendments Laboratory of Genomic Pathology, Clinical Whole Genome Analysis 69

Table 5.1: Public Funding Bodies for Pharmacogenetic/Pharmacogenomic Research 71

Table 5.2: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Drug Development and Diagnostics 72

Table 5.3: European Companies Involved in Pharmacogenomics/Pharmacogenetics Drug Development and Diagnostics 72

Table 5.4: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Diagnostics 72

Table 5.5: European & Other Companies Involved in Pharmacogenomics/Pharmacogenetics

Diagnostics 73

Table 5.6: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Services 73

Table 5.7: European/Other Companies Involved in Pharmacogenomics/Pharmacogenetics Services 73

Table 5.8: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Tools Kits and Software 74

Table 5.9: European Companies Involved in Pharmacogenomics/Pharmacogenetics Tools Kits and Software 74

Table 5.10: North American Companies with Minor interest in Pharmacogenomics/Pharmacogenetics 74

Table 5.11: European/Other Companies with Minor interest in Pharmacogenomics/Pharmacogenetics 75

Table 5.12: Large US Companies with Investment into Pharmacogenomics/Pharmacogenetics 75

Table 5.13: Large European Companies with Investment into Pharmacogenomics/Pharmacogenetics 76

Table 5.14: Large Japanese Companies with Investment into Pharmacogenomics/Pharmacogenetics 76

Table 5.15: Top Ten Biological Areas of Interest in Pharmacogenetics/Pharmacogenomics 76

Table 5.16: Top International Pharmacogenetic/Pharmacogenomic Research Institutions 77

Table 5.17: Top European Pharmacogenetic/Pharmacogenomic Research Institutions 77

Table 6.1: QUICK FACTs- Variation of Reimbursement Policies for HER2 and KRAS Testing in Europe 81

Table 6.2: Pharmaceutical Companies Providing Subsidization of Diagnostic Personalized Medicine Tests in Europe 82

Table 6.3: QUICKFACTs - Challenges Within Personalized Medicine Market in Europe 83

Table 6.4: QUICKFACTS- Function of the European network for Health Technology Assessment (EUnetHTA) Organisation 83

Table 6.5: European network for Health Technology Assessment (EUnetHTA) Partners 84

Table 6.6: European network for Health Technology Assessment (EUnetHTA) Associates 86

Table 6.7: Diagnostics Guidance Assessment by the National Institute for Health and Clinical Excellence (NICE) 88

Table 6.8: Current Diagnostics Guidance in Development by the Diagnostics Access Program, UK 89

Table 6.9: Published Diagnostics Guidance by the Diagnostics Access Program, UK 90

Table 6.10: Medical Technologies Guidance Assessment by the National Institute for Health and Clinical Excellence (NICE) 90

Table 6.11: Published Medical Technologies Guidance by the National Institute for Health and Clinical Excellence (NICE) 91

Table 6.12: Published Medical Technologies Guidance in Development by the National Institute for Health and Clinical Excellence (NICE) 91

Table 6.13: QUICK FACTs - Key Challenges to Personalized Medicine 95

Table 6.14: QUICKFACTs - Personalized Medicine - Translation into Medical Applications 95

Table 7.1: QUICK FACTS - Major Market Trends in Personalized Medicine 96

Table 7.2: Collaboration Strategies Required between Industry, Payers and Governments for a Productive Personalized Medicine Market 96

Table 7.3: QUICK FACTs - Business Model Recommendations for Diagnostic, Pharmaceutical and Biotechnology Companies 97

Table 7.4: QUICK FACTs - Business Model Recommendations for Providers. Provider Systems and Academic Medical Centres 97

Table 7.5: QUICK FACTS Business Model Recommendations for Payers 98

Table 7.6: QUICK FACTs - Business Model Recommendations for Governments 98

Table 7.7: QUICK FACTs - Non-Healthcare Companies with Potential to enter the Personalized Medicine Market 99

Table 7.8: Hurdles of Personalised Medicine with Respect to Cost-Effectiveness 100

Table 8.1: Patent Listing of Affymetrix Array technology 104

Table 8.2: Patent Listing of Affymetrix Genotyping Technology 104

Table 8.3: Patent Listing of Affymetrix Array technology 105

Table 8.4: Patent Listing of Affymetrix Genotyping Technology 106

Table 8.5 Astex Pharmaceuticals Pipeline Portfolio 106

Table 8.6: Astex Pharmaceuticals Pipeline Portfolio Funded Completely by Partner Companies 107

Table 8.7: Potential Business Partnerships of Celldex Therapeutics 109

Table 8.8: Illumina Core Technologies 111

Table 8.9: Illumina Core Technology Applications 111

Table 8.10: Illumina Instrument Product Portfolio 112

Table 8.11: Illumina Assay Product Portfolio 112

Table 8.12: Genetic Test Panel Available from Genelex for Research Institutions and Clinical Trials 113

Table 8.13: Pre-Clinical, Clinical and Commercial Applications of SCNP by Nodality 116

Table 8.14: Qiagen Timeline of Events, 1994-2012 116

Table 8.15: QUICKFACTs - Range of Product Groups from Qiagen 118

Table 9.1: 23andMe Disease Risk Genetic Test Panel 119

Table 9.2: 23andMe Carrier Status Genetic Test Panel 122

Table 9.3: 23andMe Drug Response Genetic Marker Test Panel 124

Table 9.4: 23andMe Genetic Traits Test Panel 124

Table 9.5: QUICKFACTs - Product Overview of Affymetrix 126

Table 9.6: Microarray Products by Affymetrix 126

Table 9.7: Affymetrix Research Services Laboratory (ARSL) Premier Services 127

Table 9.8: Genetic Applications of Axiom® Technology by Affymetrix 127

Table 9.9: Range of Small Molecule Therapeutics Available from Astex Pharmaceuticals 127

Table 9.10: Panel of cystic fibrosis transmembrane conductance regulator (CFTR) mutations screened for in Celera Cystic Fibrosis Genotyping Assay 130

Table 9.11: Genetic Tests Available from BHL/Celera 132

Table 9.12: Panel of BHL Clinical Diagnostic Tests 132

Table 9.13: Features of the m2000® RealTime PCR System by Celera 132

Table 9.14: Genetic Diagnostic Tests Available from deCode Genetics 133

Table 9.15: Type 2 Diabetes risk range and distribution according to continental ancestry as Determined by deCodeT2 Genetic Test 134

Table 9.16: Genetic Mutations Identified by the deCODE MI™ Test in a European Population 135

Table 9.17: Genetic Mutations Identified by the deCODE MI™ Test in an East Asian Population 136

Table 9.18: Disease States that are Included in the deCODE Complete™ Genetic Screen 136

Table 9.19: Panel of Diseases Screened for in the deCODE Cancer™ Test 137

Table 9.20: Panel of Cardiovascular Diseases in the deCODE Cardio™ Test 137

Table 9.21: deCODE Genetics Genotyping and Sequencing Service 137

Table 9.22: deCODE Genetics Data Management, Protection and Storage Service 138

Table 9.23: deCODE Genetics Sequence Inputation and Data Analysis Service 138

Table 9.24: Illumina HiSeq 2500/1500 Performance Parameters 139

Table 9.25: Illumina HiSeq 2000/1000 Performance Parameters 139

Table 9.26: Genome Analyzer IIx Performance Parameters 140

Table 9.27: Illumina MiSeq Product Specifications 141

Table 9.28: Illumina HiScanHQ Product Specifications 142

Table 9.29: Illumina HiScan and iScan Array Product Applications 142

Table 9.30: Illumina iScan Array Kits 142

Table 9.31: Panel of Genetic Screens Available from Genelex 144

Table 9.32: Drug Sensitivity Screens Available from Genelex 144

Table 9.33: Predictive Genetic Tests Available from Myriad 145

Table 9.34: Services offered with BRACAnalysis® Testing from Myriad 145

Table 9.35: Advantages of BRACAnalysis® Testing 146

Table 9.36: COLARIS® Test Range by Myriad 146

Table 9.37: COLARIS AP® Test Range by Myriad 147

Table 9.38: MELARIS® Test Range from Myriad 147

Table 9.39 Personalized Medicine Tests from Myriad 147

Table 9.40: OnDose® Testing Procedure from Myriad 148

Table 9.41: Qiagen Genotyping Products for Sample Collection, stabilization and Storage 149

Table 9.42: Qiagen Genotyping Products for Genomic DNA Isolation and Purification 149

Table 9.43: Qiagen Genotyping Products for PCR Based Genotyping Analysis 150

Table 9.44: Qiagen Products for Genotyping Analysis 150

Table 9.45: Qiagen Genotyping Products for PCR Detection 151

Table 9.46: Qiagen Assays for Genetic Analysis 151

Table 9.47: Qiagen Pyrosequencing-Based Genetic Analysis Products 151

Table 9.48: Specifications and Features of Qiagen's QIAsymphony and QIAsymphony RGQ 152

Table 10.1: QUICK FACTs - Submarkets within the Personalized Medicine Technology Market 157

Table 10.2: Drug Classes Investigated by 23andMe using genome wide association studies 162

Table 10.3: Acquisition Profile of Affymetrix 164

Table 10.4: Genetic Applications of Axiom® Technology by Affymetrix 164

Table 10.5 Diversified Business Units of Affymetrix 165

Table 10.6: Affymetrix AgBio Microarray Portfolio 167

Table 10.7: Celera (Quest Diagnostics) Historic Operating (Loss) (US$) – Laboratory Services and

Products 2008-2010 183

Table 10.8: Diagnostic Test Product Categories Manufactured by BHL/Celera and Exclusively Distributed by Abbott 183

Table 10.9: Celldex Therapeutics R&D Expenses ($) 2010-2012 186

Table 10.10: Price Listing of Genelex Familial Genetic Tests 191

Table 10.11: Myriad - Core Business Decisions and Impact on Industry 2012 195

Table 10.12: Future Test Portfolio of Myriad 195

Table 10.13: Nodality's Single Cell Network Profiling (SCNP) Technology as a Systems Based Biology Approach to Drug Discovery and Validation 197

Table 10.14: BioMerieux Immunodiagnostic Product Portfolio 202

Table 10.15: BioMerieux Microbiology Product Portfolio 204

Table 10.16: BioMerieux Molecular Diagnostic Product Portfolio 206

Table 11.1: QUICK FACTS: Strengths and Advantages of Genotyping Techniques 211

Table 11.2: QUICK FACTS: Strengths, Drivers and Advantages of Personalized Medicine Market 213

Table 12.1: QUICKFACTs: Restraints of Personalized Medicine Market 216

Table 13.1: QUICK FACTS - Summary of Clinical Laboratory Improvement Amendments (CLIA) 217

Table 13.2: Clinical Laboratory Improvement Amendments (CLIA) Testing Categories 218

Table 13.3: QUICK FACTS - Test Features required prior to FDA Approval and Clearance 218

Table 13.4: Impact of Genetic Information Non-discrimination Act (GINA) on Healthcare Companies and Health Plans 219

Table 13.5: Impact of Genetic Information Non-discrimination Act (GINA) on US Employers, employment agencies, labor organizations and training programs 219

Table 13.6: QUICK FACTS - FDA Commitment to the Personalized Medicine Industry 220

Table 13.7: Objectives of the 'Advancing Regulatory Science at FDA: A Strategic Plan' 220

Table 13.8: QUICKFACTS - Implementation Strategy of the FDA to Advance Regulatory Science - Develop better Models of Human Adverse response 221

Table 13.9: QUICKFACTS - Implementation Strategy of the FDA to Advance Regulatory Science - Identify and evaluate biomarkers and endpoints that can be used in non-clinical and clinical evaluations 221

Table 13.10: QUICKFACTS - Implementation Strategy of the FDA to Advance Regulatory Science - Use and develop computational methods and in silico modelling 221

List of Figures

Figure 2.2: Identification of Good and Non-Responders in a Patient Population 20

Figure 2.3: Pharmacodynamic and Pharmacokinetic Examples of Drug Targets and Drug metabolism in Pharmacogenomics 27

Figure 2.4: QUICK FACTS - Flow Diagram of Pharmacogenetic Analysis 32

Figure 2.5: Primer Based Base Extension in Pharmacogenetics 33

Figure 2.6: Genetic Mutation Detection by Hybridization 34

Figure 2.7: Ligation based SNP Detection 34

Figure 2.8: New-Generation Sequencing: Pyrosequencing 35

Figure 3.1: QUICK FACTS - Warfarin Metabolism and Response 44

Figure 3.2: QUICK FACTS - Percentage Frequency of CYP2C9 and VKORC1 mutations in Caucasian, African-American and Asian Populations 45

Figure 3.3: QUICK FACTS: Anti-EGFR Therapy and KRAS Mutations 46

Figure 3.4: KRAS and BRAF Genetic Tests Available from Asuragen 47

Figure 3.5: Global Incidence and Mortality of Cancer in Women 48

Figure 3.6: Cancer Deaths in Women, Globally according to Cancer Type 49

Figure 3.7: Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer Globally 49

Figure 3.8: HER2 Testing Algorithm for Breast Cancer 56

Figure 3.9: HER2 Cellular Signalling 56

Figure 3.10: QUICKFACTs - Herceptin – Mechanism of Action 57

Figure 3.11: BRCA Mutation Increases the Risk of Breast and Ovarian Cancer 61

Figure 3.12: Proactive Cancer Management and Preventative Measures Reduces the Risks of Developing BRCA-associated Breast and Ovarian Cancer 61

Figure 4.1: Integration of Multiple components for a Personalized Medicine Healthcare System 66

Figure 4.2: Workflow Diagram illustrating Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology 68

Figure 4.3: Hypothetical Flow Diagram of a Patient through the Genomic Pathology Clinical Laboratory 69

Figure 5.1: Personalized Medicine Scheme Interaction with Industry, Regulatory Bodies and Funding Agencies 70

Figure 5.2: Number of Publically Funded Pharmacogenetic and Pharmacogenomic Research Teams Internationally 71

Figure 6.1: Adverse Drug Reactions are the Fourth Leading Cause of Death 80

Figure 6.2: Efficacy Rate of Major Disease Types with Standard Treatment 80

Figure 6.3: The In Vitro Diagnostic Market in Europe 83

Figure 6.4: QUICK FACTS: Organization of the European network for Health Technology Assessment (EUnetHTA) 84

Figure 6.5: Key Differences in Reimbursement Policy Approaches for Oncology Diagnostics and Therapeutics in Europe and the US 89

Figure 6.6: Flow Diagram of the German Healthcare System and Key Agencies 93

Figure 6.7: German Reimbursement Arrangement, Process and Implications 93

Figure 7.1: Annual Healthcare Expenditure for Major Industrial Nations 101

Figure 7.2: Estimated Life Expectancy from Birth for Major Industrialized Countries 101

Figure 8.1: Celldex Therapeutics Product Pipeline 110

Figure 8.2: Single Cell Network Profiling (SCNP) Technology by Nodality 115

Figure 8.3: Developed Functional Assays that Nodality has explored using new SCNP Technology 115

Figure 9.1: Flow Diagram of Celera CEGA -16™ Instrument for Cystic Fibrosis Gene Analysis 133

Figure 9.2: Percentage of Individual Populations who have an Increased Risk of Developing Type 2 Diabetes as Determined Using the deCodeT2 Genetic Test 134

Figure 9.3: Illumina New Generation Sequencing Technology Workflow Station 138

Figure 10.1: Combined Personalized Medicine Market in the US, 2009-2015 155

Figure 10.2: Core Personalized Medicine Sub-Market Growth Forecast 2009-2015 155

Figure 10.3: Personalized Medical Care Sub-Market Growth Forecast 2009-2015 156

Figure 10.4: Nutrition and Wellness Sub-market of Personalized Medicine Growth Forecast 2009-2015 156

Figure 10.5: Diagnostic and Therapeutic Personalized Medicine Market Growth Projection in the US, 2009-2015 157

Figure 10.6: Global Market Personalized Medicine Technology Growth Forecast 2009-2015 158

Figure 10.7: Global Personalized Sub-market Growth Forecast 2009-2014 158

Figure 10.8: Personalized Medicine Sub-Market Share (Percentage) 2009 159

Figure 10.9: Personalized Medicine Sub-Market Share (Percentage) 2014 159

Figure 10.10: Global Molecular Diagnostics Predicted Market Share 2015 160

Figure 10.11: Global Molecular Diagnostics Market Projection 2015 160

Figure 10.12: Private Funding Gained by 23andMe 2007-2012 161

Figure 10.13: Affymetrix Revenue by Business Segment (Percentage), 2013 168

Figure 10.14: Affymetrix Revenue by Business Segment (Percentage), 2012 168

Figure 10.15: Affymetrix Total Revenue 2007-2013 169

Figure 10.16: Affymetrix Revenue by Product Division – Consumables, Instruments 2010-2012 169

Figure 10.17: Affymetrix Core Product Sales – Gene Expression, Genetic Analysis & Clinical Application and Life Science Reagents, 2011-2012 170

Figure 10.18: Affymetrix Revenue Derived from Outside the US, 2009-2012 170

Figure 10.19: Affymetrix Revenue Derived from the US, 2009-2012 171

Figure 10.20: Affymetrix Net Loss, 2009-2012 171

Figure 10.21: Affymetrix Research and Development Funding, 2009-2012 172

Figure 10.22: Affymetrix Revenue Generated within USA (Percentage) 2010-2012 172

Figure 10.23: Astex Pharmaceuticals Priority Pipeline Products SGI-110 and AT13387 by Indication, Clinical Phase and Timeline 173

Figure 10.24: Astex Pharmaceuticals Revenue Generated 2008-2012 175

Figure 10.25: Astex Pharmaceuticals Net Income 2009-2012 175

Figure 10.26: Atossa Genetics Total Revenue (US$) 2011, 2012 177

Figure 10.27: Atossa Genetics Revenue (US$) Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing, 2012 178

Figure 10.28: Atossa Genetics Percentage Revenue Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing, 2012 178

Figure 10.29: Quest Diagnostics Revenue ($ Billions) 2008-2013 180

Figure 10.30: Quest Diagnostics Operating Revenue ($ Billions) 2008-2013 181

Figure 10.31: Quest Di

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