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

February 2014 | 224 pages | ID: PC09D378233EN
Kelly Scientific Publications

Abstracts

Different licenses subscription can be purchased: Single User Licence 7400$; Mid Level Usage (one department of up to 10 people) 10100$; and Enterprise Wide Licence 15000$.

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.

Contents

1. EXECUTIVE SUMMARY

1.1 Objectives of Report
1.2 Scope of Study
1.3 Data Sources and Methodology
1.4 Key Findings and Observations

2. INTRODUCTION

2.1 Pharmacogenetics
2.2 How Personalized Medicine Monitoring can Reduce Adverse Drug Reactions
2.3 Pharmacogenetic Study Challenges
2.4 Pharmacogenomics
2.5 Applications of Pharmacogenomics
  2.5.1 Pharmacogenomics: Improving the Safety of Medications
    2.5.1.1 Adverse Drug Reactions
    2.5.1.2 Pharmacogenomics: Improving the Efficacy of Therapeutics
2.6 Pharmacogenetic Analysis
  2.6.1 Single Base Primer Extension
  2.6.2 Primer Based Base Extension
  2.6.3 Hybridization Based SNP Analysis
  2.6.4 Ligation Based Approach
  2.6.5 New-Generation Sequencing Technologies
  2.6.6 Ultra-High Throughput Sequencing
2.7 Companion Diagnostics

3. PERSONALIZED MEDICINE THERAPEUTICS AND COMPANION DIAGNOSTICS

3.1 CYP2C9 and VKORC1 mutations and Warfarin Response
3.2 HLA-B*5701 and Abacavir Response
3.3 KRAS Mutations
  3.3.1 Erbitux
  3.3.2 Vectibix
3.4 Herceptin and Breast Cancer
3.5 BRACAnalysis
  3.5.1 Comprehensive BRACAnalysis
  3.5.2 BRACAnalysis Rearrangement Test (BART)
  3.5.3 Single Site BRACAnalysis
  3.5.4 Multisite 3 BRACAnalysis
3.6 Oncotype Dx Test
3.7 Therascreen EGFR RGQ PCR Kit
3.8 Therascreen KRAS RGQ PCR System
3.9 Therascreen IDH1/2 test
3.10 THxID -BRAF Kit
3.12 Cobas EGFR Mutation Test (Roche)
3.13 Prolaris Prostate Cancer Test

4. PERSONALIZED MEDICINE AND INTEGRATION INTO THE HEALTHCARE SYSTEM

4.1 The Personalized Medicine Coalition
4.2 Personalized Medicine and the Healthcare System
4.3 Clinical Application of Personalized Medicine
4.4 Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology

5. PRIVATE AND PUBLIC FUNDING AND PERSONALIZED MEDICINE REIMBURSEMENT

5.1 International Research and Development Personalized Medicine Activity
  5.1.1 Publically Funded Personalized Medicine Research
  5.1.2 Privately Funded Personalized Medicine Research
5.2 Popular Biological Targets/Pathways in Pharmacogenetic/Pharmacogenomic Research
5.3 Equitable Payer Reimbursement
  5.3.1 Molecular Diagnostic Payments in Personalized Medicine
    5.3.1.1 RVU-CPT-ICD Coding System
  5.3.2 Laboratory Service Payments in Personalized Medicine
  5.3.3 Revisions to Current Payment System
5.4 Biorepositories and Biobanks
5.5 Intellectual Property and Personalized Medicine

6. EUROPEAN PERSONALIZED MEDICINE MARKET – PAYMENTS AND INVESTMENT

6.1 Personalized Medicine and The European Market
6.2 European Investment in Personalized Medicine
6.3 Overview of Reimbursement Policies in Europe
6.4 Gaining Market Penetration in the EU
6.5 Personalized Medicine Regulation and Reimbursement in the UK
6.6 CE-marked Personalized Medicine/Diagnostic Tests in the UK
6.7 Personalized Medicine Regulation in Germany
6.8 Personalized Medicine Regulation in France
6.9 Personalized Medicine Regulation in Spain
6.10 The Personalized Medicine Regulation in Italy
6.11 Challenges of Future Personalized Medicine Development

7. PERSONALIZED MEDICINE –BUSINESS MODEL ANALYSIS

7.1 New Business Model Required for Personalized Medicine
7.2 Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies
7.3 Business Model Strategies for Providers. Provider Systems and Academic Medical Centres
7.4 Business Model Strategies for Payers
7.5 Business Model Strategies for Governments
7.6 Introduction of Non-Health Companies to the Personalized Medicine Market
7.7 Change to the Big Pharma Business Model
7.8 Cost-effectiveness and Business Value of Personalized Medicine
7.9 Comparative Effectiveness Research in Personalized Medicine

8. PERSONALIZED MEDICINE MAIN INDUSTRY PLAYERS

8.1 23andMe
8.2 Affymetrix
8.3 Astex Pharmaceuticals
8.4 Atossa Genetics
8.5 CuraGen
8.6 Celera Corporation (Quest Diagnostics)
8.7 Celldex Therapeutics
8.8 deCode Genetics (Amgen)
8.9 Illumina
8.10 Genelex
8.11 Myriad
8.12 Nodality
8.13 Qiagen

9. PERSONALIZED MEDICINE INDUSTRY PRODUCTS AND KITS

9.1 23andme
9.2 Affymetrix
9.3 Astex Pharmaceuticals
9.4 Atossa Genetics
  9.4.1 Mammary Aspirate Specimen Cytology Test (MASCT)
  9.4.2 ForeCYTE Breast Health Test (SM)
  9.4.3 ArgusCYTE Breast Health Test(SM)
  9.4.4 FullCYTE Breast Health Test
  9.4.5 NextCYTE Breast Health Test
9.5 Celera (Quest Diagnostics)
  9.5.1 ViroSeq HIV-1 Genotyping System
  9.5.2 ViroSeq HIV-1 Integrase Assay
  9.5.3 ViroSeq HCV Assay
  9.5.4 ViroSeq HBV Assay
  9.5.5 Cystic Fibrosis Genotyping Assay
  9.5.6 LDL-S3GGE Test
  9.5.7 HDL-S10GGE Test
  9.5.8 KIF6-StatinCheckTM Genotype Test
  9.5.9p21-EarlyMICheckTM Genotype Test
  9.5.10 LPA-AspirinCheckTM Genotype Test
  9.5.11 AlleleSEQR HLA PCR/Sequencing Kits
  9.5.12 m2000 RealTime PCR System
  9.5.13 CEGA -16 Instrument
9.6 deCode Genetics
  9.6.1 deCodeT2 Genetic Test
  9.6.2 deCODE Breast Cancer
  9.6.3 deCODE Prostate Cancer
  9.6.4 deCODE AF
  9.6.5 deCODE Glaucoma
  9.6.6 deCODE MI
  9.6.7 deCODE Complete
  9.6.8 deCODE Cancer
  9.6.9 deCODE Cardio
  9.6.10 deCODE Services
9.7 Illumina
  9.7.1 Illumina HiSeq 2000/1000
  9.7.2 Genome Analyzer IIx
  9.7.3 Illumina MiSeq
  9.7.4 Illumina HiScanHQ
  9.7.5 Illumina HiScan and iScan Array
9.8 Genelex
  9.8.1 You Script
9.9 Myriad Genetics
  9.9.1 BRACAnalysis
  9.9.2 COLARIS/COLARIS AP
  9.9.3 MELARIS
  9.9.4 PANEXIA
  9.9.5 OnDose
  9.9.6 PREZEON
  9.9.7 THERAGUIDE 5FU
  9.9.8 Prolaris
9.10 Nodility
9.11 Qiagen
  9.11.1 Genotyping Products
  9.11.2 QIAsymphony Platform

10. PERSONALIZED MEDICINE MARKET ANALYSIS

10.1 General Overview
10.2 Personalized Medicine Market Forecast
10.3 Personalized Medical Care Market Forecast
10.4 Personalized Medicine -Nutrition and Wellness Sub-Market Forecast
10.5 Personalized Medicine -Diagnostic and Therapeutic Sub-Market Forecast
10.6 Global Personalized Medical Technology Market Forecast
10.7 Global Personalized Medicine Sub-market Growth Forecast
10.8 Molecular Diagnostics Market
10.9 Consumer Genomics Market
10.10 Market Participant Analysis
  10.10.1 23andme
  10.10.2 Affymetrix
  10.10.3 Astex Pharmaceuticals
  10.10.4 Atossa Genetics
  10.10.5 Celera (Quest Diagnostics)
  10.10.6 Celldex Therapeutics
  10.10.7 deCode Genetics (Amgen)
  10.10.8 Illumina
  10.10.9 Genelex
  10.10.10 Myriad
  10.10.11 Nodality
  10.10.12 Qiagen
  10.10.13 bioMerieux

11. STRENGTHS AND ADVANTAGES OF PERSONALIZED MEDICINE

11.1 Sequencing of the Human Genome in 2000
11.2 Improving Patient Care and Reducing Side Effects
11.3 Personalized Medicine will Reduce Healthcare Costs
11.4 FDA Advances in Personalized Medicine Regulation
11.5 Advancing Technologies
  11.5.1 Next Generation Sequencing
11.6 Industry Investing in Pharmacogenomics
11.7 Consumer Genomics and POC Market
11.8 Oncology a Driving Force of Personalized Medicine

12. RESTRAINTS OF THE PERSONALIZED MEDICINE MARKET

12.1 Lack of Sufficient Regulation
12.2 Lack of Sufficient Genotypic Linkage Studies to Disease Phenotype
12.3 Reimbursement Issues

13. PERSONALIZED MEDICINE AND REGULATORY POLICIES

13.1 Regulation
13.2 Genetic Information Non-discrimination Act (GINA)
13.3 FDA Advancements on Genetic Testing Approval
13.4 FDA- New Models to Assess Gene Therapy Safety
13.5 FDA- Companion Diagnostics
13.6 FDA - Partnership in Applied Comparative Effectiveness Science (PACES) Initiative

14. FINAL SUMMARY AND FUTURE PERSPECTIVES

List Of Tables

LIST OF TABLES

Table 2.1: Quick Facts: Personalized Medicine
Table 2.2: Genetic Mutations that Predispose Individuals to Disease
Table 2.3: Potential Applications of Pharmacogenetics and Pharmacogenomics in Personalized Medicine
Table 2.4: Main Cytochrome P450 Enzymes Involved in Drug Metabolism
Table 2.5: QUICK FACTS: Rapid & Slow Metabolizer Phenotypes
Table 2.6: Population Frequency of Cytochrome P450(CYP) 2C19 Metabolizer Types
Table 2.7: Population Frequency of Cytochrome P450 (CYP) Metabolizer Types
Table 2.8: Depression Medications Affected by Genetic Mutations
Table 2.9: Cardiovascular Medications Affected by Genetic Mutations
Table 2.10: Cancer Medications that may be Affected by Genetic Mutations
Table 2.11: Diabetes Medications Affected by Genetic Mutations
Table 2.12: Anti-Epileptic Drugs Affected by Genetic Mutations
Table 2.13: Anti-Retroviral Drugs Affected by Genetic Mutations
Table 2.14: Anti-Reflux/Ulcer Drugs Affected by Genetic Mutations
Table 2.15: List of Therapeutics According to Cytochrome P450 Subtype Metabolism
Table 2.16: Cytochrome (CYP) P450 Drug-Interactions Inhibitor List
Table 2.17: Cytochrome (CYP) P450 Drug-Interactions Inducer List
Table 2.18: QUICK FACTs - Main Aims of Pharmacogenomics
Table 2.19: How Pharmacogenomics has Influenced the Top Ten Selling Drugs Globally
Table 2.20: Advantages, Disadvantages and Cost of Popular Genotyping Methods
Table 2.21: QUICK FACTS - Top Ten Pharmacogenomics Tests9
Table 2.22: QUICK FACTS - FDA Accepted Pharmacogenomic Biomarkers
Table 2.23: QUICK FACTS - Benefits of Single Base Primer Extension in Pharmacogenetics
Table 2.24: Future Applications of Ultra-High Throughput Sequencing
Table 2.25: QUICK FACTS - Comparison of Genotyping Techniques
Table 2.26: Problems associated with Microarray Sequencing
Table 2.27: QUICK-FACTS - Top Ten Genetic Findings of 2010 by 23andMe
Table 2.28: FDA Companion Diagnostics Device List: In Vitro and Imaging Tools
Table 2.29: Important Strategies for a Successful Companion Diagnostic Launch
Table 3.1: Predicted Warfarin Concentrations depending on CYP2C9 and VKORC1 Genotype
Table 3.2: QUICKFACTS - Top Five Most Frequent Cancers in Men and Women, Globally
Table 3.3: QUICKFACTs - Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer per Country, Worldwide
Table 3.4: QUICK-FACTS - Types of Diagnostic Tests Available to Determine HER2 Status in Breast Cancer Patients
Table 3.5: Validated HER2 Tests for Cancer
Table 3.6: QUICK FACTS - Advantages and limitations of IHC HER2 testing applied to breast cancer
Table 3.7: In-Situ Hybridization Determination of HER2 Expression by PathVysion and HER2 FISH pharmDxTM
Table 3.8: HER2 CISH Determination
Table 3.9: Validated FISH Kits for HER2 Testing in Breast Cancer
Table 3.10: Validated SISH Kits for HER2 Testing in Breast Cancer
Table 3.11: Validated CISH Kits for HER2 Testing in Breast Cancer
Table 3.12: Advantages and limitations of ISH techniques applied to HER2 testing in breast cancer
Table 3.13: QUICK FACTs- Prevalence of Deleterious Mutations in BRCA1 and BRCA2 Genes
Table 3.14: QUICK FACTs- prevalence of deleterious mutations in BRCA1 and BRCA2 in individuals of Ashkenazi Ancestry
Table 3.15: QUICK FACTs- Risk Factors for Hereditary Breast and Ovarian Cancer (HBOC)
Table 3.17: QUICKFACTs- BRACAnalysis Panel of Assays
Table 3.18: The Prolaris Score for Prostate Cancer
Table 4.1: QUICKFACTs - Objectives of the Personalized Medicine Coalition
Table 4.2: Current Personalized Medicine Coalition Members
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.
Table 4.4: Minimum Definition of a clinically Actionable Variant
Table 4.5: Minimum Criteria for Whole Genome Analysis in Clinical Laboratory Improvement Amendments Laboratory of Genomic Pathology, Clinical Whole Genome Analysis
Table 5.1: Public Funding Bodies for Pharmacogenetic/Pharmacogenomic Research
Table 5.2: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Drug Development and Diagnostics
Table 5.3: European Companies Involved in Pharmacogenomics/Pharmacogenetics Drug Development and Diagnostics
Table 5.4: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Diagnostics
Table 5.5: European & Other Companies Involved in Pharmacogenomics/Pharmacogenetics Diagnostics
Table 5.6: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Services
Table 5.7: European/Other Companies Involved in Pharmacogenomics/Pharmacogenetics Services
Table 5.8: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Tools Kits and Software
Table 5.9: European Companies Involved in Pharmacogenomics/Pharmacogenetics Tools Kits and Software
Table 5.10: North American Companies with Minor interest in Pharmacogenomics/Pharmacogenetics
Table 5.11: European/Other Companies with Minor interest in Pharmacogenomics/Pharmacogenetics
Table 5.12: Large US Companies with Investment into Pharmacogenomics/Pharmacogenetics
Table 5.13: Large European Companies with Investment into Pharmacogenomics/Pharmacogenetics
Table 5.14: Large Japanese Companies with Investment into Pharmacogenomics/Pharmacogenetics
Table 5.15: Top Ten Biological Areas of Interest in Pharmacogenetics/Pharmacogenomics
Table 5.16: Top International Pharmacogenetic/Pharmacogenomic Research Institutions
Table 5.17: Top European Pharmacogenetic/Pharmacogenomic Research Institutions
Table 6.1: QUICK FACTs- Variation of Reimbursement Policies for HER2 and KRAS Testing in Europe
Table 6.2: Pharmaceutical Companies Providing Subsidization of Diagnostic Personalized Medicine Tests in Europe
Table 6.3: QUICKFACTs - Challenges Within Personalized Medicine Market in Europe
Table 6.4: QUICKFACTS- Function of the European network for Health Technology Assessment (EUnetHTA) Organisation
Table 6.5: European network for Health Technology Assessment (EUnetHTA) Partners
Table 6.6: European network for Health Technology Assessment (EUnetHTA) Associates
Table 6.7: Diagnostics Guidance Assessment by the National Institute for Health and Clinical Excellence (NICE)
Table 6.8: Current Diagnostics Guidance in Development by the Diagnostics Access Program, UK
Table 6.9: Published Diagnostics Guidance by the Diagnostics Access Program, UK
Table 6.10: Medical Technologies Guidance Assessment by the National Institute for Health and Clinical Excellence (NICE)
Table 6.11: Published Medical Technologies Guidance by the National Institute for Health and Clinical Excellence (NICE)
Table 6.12: Published Medical Technologies Guidance in Development by the National Institute for Health and Clinical Excellence (NICE)
Table 6.13: QUICK FACTs - Key Challenges to Personalized Medicine
Table 6.14: QUICKFACTs - Personalized Medicine - Translation into Medical Applications
Table 7.1: QUICK FACTS - Major Market Trends in Personalized Medicine
Table 7.2: Collaboration Strategies Required between Industry, Payers and Governments for a Productive Personalized Medicine Market
Table 7.3: QUICK FACTs - Business Model Recommendations for Diagnostic, Pharmaceutical and Biotechnology Companies
Table 7.4: QUICK FACTs - Business Model Recommendations for Providers. Provider Systems and Academic Medical Centres
Table 7.5: QUICK FACTS Business Model Recommendations for Payers
Table 7.6: QUICK FACTs - Business Model Recommendations for Governments
Table 7.7: QUICK FACTs - Non-Healthcare Companies with Potential to enter the Personalized Medicine Market
Table 7.8: Hurdles of Personalised Medicine with Respect to Cost-Effectiveness
Table 8.1: Patent Listing of Affymetrix Array technology
Table 8.2: Patent Listing of Affymetrix Genotyping Technology
Table 8.3: Patent Listing of Affymetrix Array technology
Table 8.4: Patent Listing of Affymetrix Genotyping Technology
Table 8.5 Astex Pharmaceuticals Pipeline Portfolio
Table 8.6: Astex Pharmaceuticals Pipeline Portfolio Funded Completely by Partner Companies
Table 8.7: Potential Business Partnerships of Celldex Therapeutics
Table 8.8: Illumina Core Technologies
Table 8.9: Illumina Core Technology Applications
Table 8.10: Illumina Instrument Product Portfolio
Table 8.11: Illumina Assay Product Portfolio
Table 8.12: Genetic Test Panel Available from Genelex for Research Institutions and Clinical Trials
Table 8.13: Pre-Clinical, Clinical and Commercial Applications of SCNP by Nodality
Table 8.14: Qiagen Timeline of Events, 1994-2012
Table 8.15: QUICKFACTs - Range of Product Groups from Qiagen
Table 9.1: 23andMe Disease Risk Genetic Test Panel
Table 9.2: 23andMe Carrier Status Genetic Test Panel
Table 9.3: 23andMe Drug Response Genetic Marker Test Panel
Table 9.4: 23andMe Genetic Traits Test Panel
Table 9.5: QUICKFACTs - Product Overview of Affymetrix
Table 9.6: Microarray Products by Affymetrix
Table 9.7: Affymetrix Research Services Laboratory (ARSL) Premier Services
Table 9.8: Genetic Applications of Axiom Technology by Affymetrix
Table 9.9: Range of Small Molecule Therapeutics Available from Astex Pharmaceuticals
Table 9.10: Panel of cystic fibrosis transmembrane conductance regulator (CFTR) mutations screened for in Celera Cystic Fibrosis Genotyping Assay
Table 9.11: Genetic Tests Available from BHL/Celera
Table 9.12: Panel of BHL Clinical Diagnostic Tests
Table 9.13: Features of the m2000 RealTime PCR System by Celera
Table 9.14: Genetic Diagnostic Tests Available from deCode Genetics
Table 9.15: Type 2 Diabetes risk range and distribution according to continental ancestry as Determined by deCodeT2 Genetic Test
Table 9.16: Genetic Mutations Identified by the deCODE MI Test in a European Population
Table 9.17: Genetic Mutations Identified by the deCODE MI Test in an East Asian Population
Table 9.18: Disease States that are Included in the deCODE Complete Genetic Screen
Table 9.19: Panel of Diseases Screened for in the deCODE Cancer Test
Table 9.20: Panel of Cardiovascular Diseases in the deCODE Cardio Test
Table 9.21: deCODE Genetics Genotyping and Sequencing Service
Table 9.22: deCODE Genetics Data Management, Protection and Storage Service
Table 9.23: deCODE Genetics Sequence Inputation and Data Analysis Service
Table 9.24: Illumina HiSeq 2500/1500 Performance Parameters9
Table 9.25: Illumina HiSeq 2000/1000 Performance Parameters9
Table 9.26: Genome Analyzer IIx Performance Parameters
Table 9.27: Illumina MiSeq Product Specifications
Table 9.28: Illumina HiScanHQ Product Specifications
Table 9.29: Illumina HiScan and iScan Array Product Applications
Table 9.30: Illumina iScan Array Kits
Table 9.31: Panel of Genetic Screens Available from Genelex
Table 9.32: Drug Sensitivity Screens Available from Genelex
Table 9.33: Predictive Genetic Tests Available from Myriad
Table 9.34: Services offered with BRACAnalysis Testing from Myriad
Table 9.35: Advantages of BRACAnalysis Testing
Table 9.36: COLARIS Test Range by Myriad
Table 9.37: COLARIS AP Test Range by Myriad
Table 9.38: MELARIS Test Range from Myriad
Table 9.39 Personalized Medicine Tests from Myriad
Table 9.40: OnDose Testing Procedure from Myriad
Table 9.41: Qiagen Genotyping Products for Sample Collection, stabilization and Storage
Table 9.42: Qiagen Genotyping Products for Genomic DNA Isolation and Purification
Table 9.43: Qiagen Genotyping Products for PCR Based Genotyping Analysis
Table 9.44: Qiagen Products for Genotyping Analysis
Table 9.45: Qiagen Genotyping Products for PCR Detection
Table 9.46: Qiagen Assays for Genetic Analysis
Table 9.47: Qiagen Pyrosequencing-Based Genetic Analysis Products
Table 9.48: Specifications and Features of Qiagen’s QIAsymphony and QIAsymphony RGQ
Table 10.1: QUICK FACTs - Submarkets within the Personalized Medicine Technology Market
Table 10.2: Drug Classes Investigated by 23andMe using genome wide association studies
Table 10.3: Acquisition Profile of Affymetrix
Table 10.4: Genetic Applications of Axiom Technology by Affymetrix
Table 10.5 Diversified Business Units of Affymetrix
Table 10.6: Affymetrix AgBio Microarray Portfolio
Table 10.7: Celera (Quest Diagnostics) Historic Operating (Loss) (US$) – Laboratory Services and Products 2008-2010
Table 10.8: Diagnostic Test Product Categories Manufactured by BHL/Celera and Exclusively Distributed by Abbott
Table 10.9: Celldex Therapeutics R&D Expenses ($) 2010-2012
Table 10.10: Price Listing of Genelex Familial Genetic Tests
Table 10.11: Myriad - Core Business Decisions and Impact on Industry 2012
Table 10.12: Future Test Portfolio of Myriad
Table 10.13: Nodality’s Single Cell Network Profiling (SCNP) Technology as a Systems Based Biology Approach to Drug Discovery and Validation
Table 10.14: BioMerieux Immunodiagnostic Product Portfolio
Table 10.15: BioMerieux Microbiology Product Portfolio
Table 10.16: BioMerieux Molecular Diagnostic Product Portfolio
Table 11.1: QUICK FACTS: Strengths and Advantages of Genotyping Techniques
Table 11.2: QUICK FACTS: Strengths, Drivers and Advantages of Personalized Medicine Market
Table 12.1: QUICKFACTs: Restraints of Personalized Medicine Market
Table 13.1: QUICK FACTS - Summary of Clinical Laboratory Improvement Amendments (CLIA)
Table 13.2: Clinical Laboratory Improvement Amendments (CLIA) Testing Categories
Table 13.3: QUICK FACTS - Test Features required prior to FDA Approval and Clearance
Table 13.4: Impact of Genetic Information Non-discrimination Act (GINA) on Healthcare Companies and Health Plans
Table 13.5: Impact of Genetic Information Non-discrimination Act (GINA) on US Employers, employment agencies, labor organizations and training programs
Table 13.6: QUICK FACTS - FDA Commitment to the Personalized Medicine Industry
Table 13.7: Objectives of the ‘Advancing Regulatory Science at FDA: A Strategic Plan’
Table 13.8: QUICKFACTS - Implementation Strategy of the FDA to Advance Regulatory Science - Develop better Models of Human Adverse response
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
Table 13.10: QUICKFACTS - Implementation Strategy of the FDA to Advance Regulatory Science - Use and develop computational methods and in silico modelling

List Of Figures

LIST OF FIGURES

Figure 2.1: QUICK FACTS - Elements of Personalized Genomic Medicine
Figure 2.2: Identification of Good and Non-Responders in a Patient Population
Figure 2.3: Pharmacodynamic and Pharmacokinetic Examples of Drug Targets and Drug metabolism in Pharmacogenomics
Figure 2.4: QUICK FACTS - Flow Diagram of Pharmacogenetic Analysis
Figure 2.5: Primer Based Base Extension in Pharmacogenetics
Figure 2.6: Genetic Mutation Detection by Hybridization
Figure 2.7: Ligation based SNP Detection
Figure 2.8: New-Generation Sequencing: Pyrosequencing
Figure 3.1: QUICK FACTS - Warfarin Metabolism and Response
Figure 3.2: QUICK FACTS - Percentage Frequency of CYP2C9 and VKORC1 mutations in Caucasian, African-American and Asian Populations
Figure 3.3: QUICK FACTS: Anti-EGFR Therapy and KRAS Mutations
Figure 3.4: KRAS and BRAF Genetic Tests Available from Asuragen
Figure 3.5: Global Incidence and Mortality of Cancer in Women
Figure 3.6: Cancer Deaths in Women, Globally according to Cancer Type
Figure 3.7: Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer Globally
Figure 3.8: HER2 Testing Algorithm for Breast Cancer
Figure 3.9: HER2 Cellular Signalling
Figure 3.10: QUICKFACTs - Herceptin – Mechanism of Action
Figure 3.11: BRCA Mutation Increases the Risk of Breast and Ovarian Cancer
Figure 3.12: Proactive Cancer Management and Preventative Measures Reduces the Risks of Developing BRCA-associated Breast and Ovarian Cancer
Figure 4.1: Integration of Multiple components for a Personalized Medicine Healthcare System
Figure 4.2: Workflow Diagram illustrating Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology
Figure 4.3: Hypothetical Flow Diagram of a Patient through the Genomic Pathology Clinical Laboratory
Figure 5.1: Personalized Medicine Scheme Interaction with Industry, Regulatory Bodies and Funding Agencies
Figure 5.2: Number of Publically Funded Pharmacogenetic and Pharmacogenomic Research Teams Internationally
Figure 6.1: Adverse Drug Reactions are the Fourth Leading Cause of Death
Figure 6.2: Efficacy Rate of Major Disease Types with Standard Treatment
Figure 6.3: The In Vitro Diagnostic Market in Europe
Figure 6.4: QUICK FACTS: Organization of the European network for Health Technology Assessment (EUnetHTA)
Figure 6.5: Key Differences in Reimbursement Policy Approaches for Oncology Diagnostics and Therapeutics in Europe and the US
Figure 6.6: Flow Diagram of the German Healthcare System and Key Agencies
Figure 6.7: German Reimbursement Arrangement, Process and Implications
Figure 7.1: Annual Healthcare Expenditure for Major Industrial Nations
Figure 7.2: Estimated Life Expectancy from Birth for Major Industrialized Countries
Figure 8.1: Celldex Therapeutics Product Pipeline
Figure 8.2: Single Cell Network Profiling (SCNP) Technology by Nodality
Figure 8.3: Developed Functional Assays that Nodality has explored using new SCNP Technology
Figure 9.1: Flow Diagram of Celera CEGA -16 Instrument for Cystic Fibrosis Gene Analysis
Figure 9.2: Percentage of Individual Populations who have an Increased Risk of Developing Type 2 Diabetes as Determined Using the deCodeT2 Genetic Test
Figure 9.3: Illumina New Generation Sequencing Technology Workflow Station
Figure 10.1: Combined Personalized Medicine Market in the US, 2009-2015
Figure 10.2: Core Personalized Medicine Sub-Market Growth Forecast 2009-2015
Figure 10.3: Personalized Medical Care Sub-Market Growth Forecast 2009-2015
Figure 10.4: Nutrition and Wellness Sub-market of Personalized Medicine Growth Forecast 2009-2015
Figure 10.5: Diagnostic and Therapeutic Personalized Medicine Market Growth Projection in the US, 2009-2015
Figure 10.6: Global Market Personalized Medicine Technology Growth Forecast 2009-2015
Figure 10.7: Global Personalized Sub-market Growth Forecast 2009-2014
Figure 10.8: Personalized Medicine Sub-Market Share (Percentage) 2009
Figure 10.9: Personalized Medicine Sub-Market Share (Percentage) 2014
Figure 10.10: Global Molecular Diagnostics Predicted Market Share 2015
Figure 10.11: Global Molecular Diagnostics Market Projection 2015
Figure 10.12: Private Funding Gained by 23andMe 2007-2012
Figure 10.13: Affymetrix Revenue by Business Segment (Percentage), 2013
Figure 10.14: Affymetrix Revenue by Business Segment (Percentage), 2012
Figure 10.15: Affymetrix Total Revenue 2007-2013
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
Figure 10.18: Affymetrix Revenue Derived from Outside the US, 2009-2012
Figure 10.19: Affymetrix Revenue Derived from the US, 2009-2012
Figure 10.20: Affymetrix Net Loss, 2009-2012
Figure 10.21: Affymetrix Research and Development Funding, 2009-2012
Figure 10.22: Affymetrix Revenue Generated within USA (Percentage) 2010-2012
Figure 10.23: Astex Pharmaceuticals Priority Pipeline Products SGI-110 and AT13387 by Indication, Clinical Phase and Timeline
Figure 10.24: Astex Pharmaceuticals Revenue Generated 2008-2012
Figure 10.25: Astex Pharmaceuticals Net Income 2009-2012
Figure 10.26: Atossa Genetics Total Revenue (US$) 2011, 2012
Figure 10.27: Atossa Genetics Revenue (US$) Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing, 2012
Figure 10.28: Atossa Genetics Percentage Revenue Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing, 2012
Figure 10.29: Quest Diagnostics Revenue ($ Billions) 2008-2013
Figure 10.30: Quest Diagnostics Operating Revenue ($ Billions) 2008-2013
Figure 10.31: Quest Diagnostics Net Income ($ Billions) 2008-2013
Figure 10.32: Celera (Quest Diagnostics) Historic Revenue Generated 2008-2010
Figure 10.33: Celera (Quest Diagnostics) Historic Gross Margin Generated 2008-2010
Figure 10.34: Celera (Quest Diagnostics) Historic Revenue Generated– Laboratory Services and Products 2008-2010
Figure 10.35: Celera (Quest Diagnostics) Historic Revenue (%) Generated by Distribution Agreement with Abbott 2008-2010
Figure 10.36: Celera (Quest Diagnostics) Historic Research and Development Spending 2008-2010
Figure 10.37: deCode Genetics Historic Net Loss Incurred 2004-2008
Figure 10.38: Illumina Revenue Generated ($ Billions) 2010-2013
Figure 10.39: Illumina Net Income Generated ($ Billions) 2010-2013
Figure 10.40: Myriad Revenue Generated 2007-2014
Figure 10.41: Operating Income Generated by Myriad 2007-2014
Figure 10.42: Myriad Revenue Generated by Molecular Diagnostic Testing and Companion Diagnostic Services, 2012/2013
Figure 10.43: Future Molecular Diagnostic Pipeline of Myriad
Figure 10.44: Customer Profile of Qiagen – Percentage of Net Sales 2012/2013
Figure 10.45: Qiagen Global Net Sales 2007-2013
Figure 10.46: Qiagen Operating Income 2007-2013
Figure 10.47: Qiagen Global Net Income 2007-2013
Figure 11.1: Percentage Oncology (Lung, Colorectal, Breast, Prostate) Patients Undergoing Next Generation Sequencing Testing in the US, 2018
Figure 11.2: Pipeline and On-market Oncology (Lung, Breast, Colorectal, Prostate) Therapeutics Directed Against Specific Mutations, 2013