Global Personalized Medicine Market & Companion Diagnostic Analysis and Trends Research Report

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14 Jul, 2014, 13:00 GMT

DALLAS, July 14, 2014 /PRNewswire/ --

Personalized Medicine and Companion Diagnostic Market - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment is a 224 pages research report that provides 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. Complete report is available at http://www.reportsnreports.com/reports/291984-personalized-medicine-and-companion-diagnostic-market-a-strategic-analysis-of-industry-trends-technologies-participants-and-environment.html .

The global personalized medicine market is presented as follows in this 2014 research report:

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)

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

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

Order a copy of Personalized Medicine and Companion Diagnostic Market - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment 2014 research report athttp://www.reportsnreports.com/Purchase.aspx?name=291984  .

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? (Target Audience for This Research 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

Explore more reports on the healthcare market at http://www.reportsnreports.com/market-research/healthcare/ .

Companion Diagnostics in Personalized Medicine and Cancer Therapy is a June 2014 market research report of 292 pages. This 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. Complete report is available at http://www.reportsnreports.com/reports/75195-companion-diagnostics-in-personalized-medicine-and-cancer-therapy.html .

Personalized Medicine Partnering Terms and Agreements is a April 2014 market research report of 1289 pages. This report contains over 1000 links tonline copies of actual personalized medicine deals and contract documents as submitted tthe Securities Exchange Commission by companies and their partners. Contract documents provide the answers tnumerous questions about a prospective partner's flexibility on a wide range of important issues, many of which will have a significant impact on each party's ability tderive value from the deal.  Complete report is available at http://www.reportsnreports.com/reports/148935-personalized-medicine-partnering-terms-agreements.html .

Table of Contents for Personalized Medicine and Companion Diagnostic Market - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment research report cover:

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

2.0 Introduction   17
2.1 Pharmacogenetics  18
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

3.0 Personalized Medicine Therapeutics and Companion Diagnostics 44
3.1 CYP2C9 and VKORC1 mutations and Warfarin Response 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
4.1 The Personalized Medicine Coalition   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 International Research and Development Personalized Medicine Activity   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
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
6.1 Personalized Medicine and The European Market  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
7.1 New Business Model Required for Personalized Medicine 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
8.1 23andMe   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
9.1 23andme   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

10.0 Personalized Medicine Market Analysis   154
10.1 General Overview  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
11.1 Sequencing of the Human Genome in 2000   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
12.1 Lack of Sufficient Regulation 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  217
13.1 Regulation   217
13.2 Genetic Information Non-discrimination Act (GINA)  217
13.3 FDA Advancements on Genetic Testing Approval  219
13.4 FDA- New Models to Assess Gene Therapy Safety  222
13.5 FDA- Companion Diagnostics 222
13.6 FDA - Partnership in Applied Comparative Effectiveness Science (PACES) Initiative  222

14.0 Final Summary and Future Perspectives   223 

List of Tables 

Table 2.1: Quick Facts: Personalized Medicine 18
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 2.1: QUICK FACTS - Elements of Personalized Genomic Medicine 17
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 Diagnostics Net Income ($ Billions) 2008-2013 181
Figure 10.32: Celera (Quest Diagnostics) Historic Revenue Generated 2008-2010 182
Figure 10.33: Celera (Quest Diagnostics) Historic Gross Margin Generated 2008-2010 182
Figure 10.34: Celera (Quest Diagnostics) Historic Revenue Generated- Laboratory Services and Products 2008-2010 183
Figure 10.35: Celera (Quest Diagnostics) Historic Revenue (%) Generated by Distribution Agreement with Abbott 2008-2010 184
Figure 10.36: Celera (Quest Diagnostics) Historic Research and Development Spending 2008-2010 184
Figure 10.37: deCode Genetics Historic Net Loss Incurred 2004-2008 188
Figure 10.38: Illumina Revenue Generated ($ Billions) 2010-2013 190
Figure 10.39: Illumina Net Income Generated ($ Billions) 2010-2013 190
Figure 10.40: Myriad Revenue Generated 2007-2014 194
Figure 10.41: Operating Income Generated by Myriad 2007-2014 194
Figure 10.42: Myriad Revenue Generated by Molecular Diagnostic Testing and Companion Diagnostic Services, 2012/2013 195
Figure 10.43: Future Molecular Diagnostic Pipeline of Myriad 196
Figure 10.44: Customer Profile of Qiagen - Percentage of Net Sales 2012/2013 200
Figure 10.45: Qiagen Global Net Sales 2007-2013 201
Figure 10.46: Qiagen Operating Income 2007-2013 201
Figure 10.47: Qiagen Global Net Income 2007-2013 202
Figure 11.1: Percentage Oncology (Lung, Colorectal, Breast, Prostate) Patients Undergoing Next Generation Sequencing Testing in the US, 2018 212
Figure 11.2: Pipeline and On-market Oncology (Lung, Breast, Colorectal, Prostate) Therapeutics Directed Against Specific Mutations, 2013 214

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