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

Thursday, June 20, 2013 Corporate News
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Reportlinker.com announces that a new market research report is available in its catalogue:

Personalized Medicine Market - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment http://www.reportlinker.com/p01361264/Personalized-Medicine-Market---A-Strategic-Analysis-of-Industry-Trends-Technologies-Participants-and-Environment.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Genomics
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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 239 tables & figures.
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The personalized medicine (global) market is presented as follows:

• By Company (e.g., 23andMe, AFFYMETRIX, ATOSSA GENETICS, NODALITY, CELERA, MYRIAD)• By Geography (US, UK, EU)• By Segment (Targeted therapeutics, 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• Celldex Therapeutics• deCode Genetics• 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 environmentThis 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 activityThis detailed report is supported with 73 figures, 166 tables and profiles the main pharmacos in personalized medicine.

Table of Contents

1.0 Executive Summary1.1 Objectives of Report1.2 Scope of Study1.3 Data Sources and Methodology1.4 Key Findings and Observations2.0 Introduction2.1 Pharmacogenetics2.2 How Personalized Medicine Monitoring can Reduce Adverse Drug Reactions2.3 Pharmacogenetic Study Challenges 2.4 Pharmacogenomics2.5 Applications of Pharmacogenomics2.5.1 Pharmacogenomics: Improving the Safety of Medications2.5.1.1 Adverse Drug Reactions2.5.1.2 Pharmacogenomics: Improving the Efficacy of Therapeutics2.6 Pharmacogenetic Analysis2.6.1 Single Base Primer Extension2.6.2 Primer Based Base Extension2.6.3 Hybridization Based SNP Analysis2.6.4 Ligation Based Approach2.6.5 New-Generation Sequencing Technologies2.6.6 Ultra-High Throughput Sequencing

3.0 Personalized Medicine Therapeutics and Companion Diagnostics3.1 CYP2C9 and VKORC1 mutations and Warfarin Response3.2 HLA-B*5701 and Abacavir Response3.3 KRAS Mutations3.3.1 Erbitux 3.3.2 Vectibix3.4 Herceptin and Breast Cancer3.5 BRACAnalysis3.5.1 Comprehensive BRACAnalysis3.5.2 BRACAnalysis Rearrangement Test (BART)3.5.3 Single Site BRACAnalysis3.5.4 Multisite 3 BRACAnalysis 3.6 Oncotype Dx Test

4.0 Personalized Medicine and Integration into the Healthcare System4.1 The Personalized Medicine Coalition4.2 Personalized Medicine and the Healthcare System4.3 Clinical Application of Personalized Medicine4.4 Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology

5.0 Private and Public Funding and Personalized Medicine Reimbursement 5.1 International Research and Development Personalized Medicine Activity5.1.1 Publically Funded Personalized Medicine Research5.1.2 Privately Funded Personalized Medicine Research5.2 Popular Biological Targets/Pathways in Pharmacogenetic/Pharmacogenomic Research5.3 Equitable Payer Reimbursement5.3.1 Molecular Diagnostic Payments in Personalized Medicine5.3.1.1 RVU-CPT-ICD Coding System5.3.2 Laboratory Service Payments in Personalized Medicine5.3.3 Revisions to Current Payment System5.4 Biorepositories and Biobanks5.5 Intellectual Property and Personalized Medicine

6.0 European Personalized Medicine Market – Payments and Investment6.1 Personalized Medicine and The European Market6.2 European Investment in Personalized Medicine6.3 Gaining Market Penetration in the EU6.4 Personalized Medicine Regulation and Reimbursement in the UK6.5 CE-marked Personalized Medicine/Diagnostic Tests in the UK6.6 Personalized Medicine Regulation in Germany6.7 Personalized Medicine Regulation in France6.8 Personalized Medicine Regulation in Spain6.9 The Personalized Medicine Regulation in Italy6.10 Challenges of Future Personalized Medicine Development

7.0 Personalized Medicine –Business Model Analysis7.1 New Business Model Required for Personalized Medicine7.2 Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies7.3 Business Model Strategies for Providers. Provider Systems and Academic Medical Centres7.4 Business Model Strategies for Payers7.5 Business Model Strategies for Governments7.6 Introduction of Non-Health Companies to the Personalized Medicine Market7.7 Change to the Big Pharma Business Model7.8 Cost-effectiveness and Business Value of Personalized Medicine7.9 Comparative Effectiveness Research in Personalized Medicine

8.0 Personalized Medicine Main Industry Players8.1 23andMe8.2 Affymetrix8.3 Astex Pharmaceuticals8.4 Atossa Genetics8.5 CuraGen8.6 Celera Corporation8.7 Celldex Therapeutics8.8 deCode Genetics8.9 Genelex8.10 Myriad 8.11 Nodality8.12 Qiagen

9.0 Personalized Medicine Industry Products and Kits9.1 23andme9.2 Affymetrix9.3 Astex Pharmaceuticals9.4 Atossa Genetics9.4.1 Mammary Aspirate Specimen Cytology Test (MASCT™)9.4.2 ForeCYTE Breast Health Test (SM)9.4.3 ArgusCYTE Breast Health Test(SM)9.5 Celera9.5.1 ViroSeq HIV-1 Genotyping System9.5.2 ViroSeq HIV-1 Integrase Assay9.5.3 ViroSeq HCV Assay9.5.4 ViroSeq HBV Assay9.5.5 Cystic Fibrosis Genotyping Assay9.5.6 LDL-S3GGE Test9.5.7 HDL-S10GGE Test9.5.8 KIF6-StatinCheckTM Genotype Test9.5.9 9p21-EarlyMICheckTM Genotype Test9.5.10 LPA-AspirinCheckTM Genotype Test9.5.11 AlleleSEQR HLA PCR/Sequencing Kits9.5.12 m2000 RealTime PCR System9.5.13 CEGA -16™ Instrument9.6 deCode Genetics9.6.1 deCodeT2 Genetic Test9.6.2 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 Services9.7 Genelex9.7.1 You Script™9.8 Myriad Genetics9.8.1 BRACAnalysis9.8.2 COLARIS/COLARIS AP9.8.3 MELARIS9.8.4 PANEXIA9.8.5 OnDose9.8.6 PREZEON™9.8.7 THERAGUIDE 5FU9.8.8 Prolaris9.9 Nodility9.10 Qiagen9.10.1 Genotyping Products9.10.2 QIAsymphony Platform

10.0 Personalized Medicine Market Analysis10.1 General Overview10.2 Personalized Medicine Market Forecast10.3 Personalized Medical Care Market Forecast10.4 Personalized Medicine -Nutrition and Wellness Sub-Market Forecast10.5 Personalized Medicine -Diagnostic and Therapeutic Sub-Market Forecast10.6 Global Personalized Medical Technology Market Forecast10.7 Global Personalized Medicine Sub-market Growth Forecast10.8 Molecular Diagnostics Market10.9 Consumer Genomics Market10.10 Market Participant Analysis10.10.1 23andme10.10.2 Affymetrix 10.10.3 Atossa Genetics10.10.4 Celera10.10.5 deCode Genetics10.10.6 Illumina10.10.7 Genelex10.10.8 Myriad 10.10.9 Nodality10.10.10 Qiagen

11.0 Strengths and Advantages of Personalized Medicine11.1 Sequencing of the Human Genome in 200011.2 Improving Patient Care and Reducing Side Effects11.3 Personalized Medicine will Reduce Healthcare Costs11.4 FDA Advances in Personalized Medicine Regulation11.5 Advancing Technologies11.6 Industry is Investing in Pharmacogenomics11.7 Consumer Genomics and POC Market12.0 Restraints of the Personalized Medicine Market12.1 Lack of Sufficient Regulation12.2 Lack of Sufficient Genotypic Linkage Studies to Disease Phenotype12.3 Reimbursement Issues13.0 Personalized Medicine and Regulatory Policies13.1 Regulation13.2 Genetic Information Non-discrimination Act (GINA)13.3 FDA Advancements on Genetic Testing Approval13.4 FDA- New Models to Assess Gene Therapy Safety13.5 FDA- Companion Diagnostics13.7 FDA - Partnership in Applied Comparative Effectiveness Science (PACES) Initiative14.0 Final Summary and Future Perspectives

List of Tables

Table 2.1: Quick Facts: Personalized MedicineTable 2.2: Genetic Mutations that Predispose Individuals to DiseaseTable 2.3: Potential Applications of Pharmacogenetics and Pharmacogenomics in Personalized MedicineTable 2.4: Main Cytochrome P450 Enzymes Involved in Drug MetabolismTable 2.5: QUICK FACTS: Rapid & Slow Metabolizer Phenotypes Table 2.6: Population Frequency of Cytochrome P450(CYP) 2C19 Metabolizer TypesTable 2.7: Population Frequency of Cytochrome P450 (CYP) Metabolizer TypesTable 2.8: Depression Medications Affected by Genetic MutationsTable 2.9: Cardiovascular Medications Affected by Genetic MutationsTable 2.10: Cancer Medications that may be Affected by Genetic MutationsTable 2.11: Diabetes Medications Affected by Genetic MutationsTable 2.12: Anti-Epileptic Drugs Affected by Genetic MutationsTable 2.13: Anti-Retroviral Drugs Affected by Genetic MutationsTable 2.14: Anti-Reflux/Ulcer Drugs Affected by Genetic MutationsTable 2.15: List of Therapeutics According to Cytochrome P450 Subtype MetabolismTable 2.16: Cytochrome (CYP) P450 Drug-Interactions Inhibitor ListTable 2.17: Cytochrome (CYP) P450 Drug-Interactions Inducer ListTable 2.18: QUICK FACTs - Main Aims of PharmacogenomicsTable 2.19: How Pharmacogenomics has Influenced the Top Ten Selling Drugs GloballyTable 2.20: Advantages, Disadvantages and Cost of Popular Genotyping MethodsTable 2.21: QUICK FACTS - Top Ten Pharmacogenomics TestsTable 2.22: QUICK FACTS - FDA Accepted Pharmacogenomic Biomarkers Table 2.23: QUICK FACTS - Benefits of Single Base Primer Extension in PharmacogeneticsTable 2.24: Future Applications of Ultra-High Throughput SequencingTable 2.25: QUICK FACTS - Comparison of Genotyping TechniquesTable 2.26: Problems associated with Microarray SequencingTable 2.27: QUICK-FACTS - Top Ten Genetic Findings of 2010 by 23andMeTable 3.1: Predicted Warfarin Concentrations depending on CYP2C9 and VKORC1 GenotypeTable 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, WorldwideTable 3.4: QUICK-FACTS - Types of Diagnostic Tests Available to Determine HER2 Status in Breast Cancer PatientsTable 3.5: Validated HER2 Tests for CancerTable 3.6: QUICK FACTS - Advantages and limitations of IHC HER2 testing applied to breast cancerTable 3.7: In-Situ Hybridization Determination of HER2 Expression by PathVysion and HER2 FISH pharmDxTMTable 3.8: HER2 CISH DeterminationTable 3.9: Validated FISH Kits for HER2 Testing in Breast CancerTable 3.10: Validated SISH Kits for HER2 Testing in Breast CancerTable 3.11: Validated CISH Kits for HER2 Testing in Breast CancerTable 3.12: Advantages and limitations of ISH techniques applied to HER2 testing in breast cancerTable 3.13: QUICK FACTs- Prevalence of Deleterious Mutations in BRCA1 and BRCA2 GenesTable 3.14: QUICK FACTs- prevalence of deleterious mutations in BRCA1 and BRCA2 in individuals of Ashkenazi AncestryTable 3.15: QUICK FACTs- Risk Factors for Hereditary Breast and Ovarian Cancer (HBOC)Table 3.17: QUICKFACTs- BRACAnalysis Panel of AssaysTable 4.1: QUICKFACTs - Objectives of the Personalized Medicine CoalitionTable 4.2: Current Personalized Medicine Coalition MembersTable 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 VariantTable 4.5: Minimum Criteria for Whole Genome Analysis in Clinical Laboratory Improvement Amendments Laboratory of Genomic Pathology, Clinical Whole Genome AnalysisTable 5.1: Public Funding Bodies for Pharmacogenetic/Pharmacogenomic ResearchTable 5.2: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Drug Development and DiagnosticsTable 5.3: European Companies Involved in Pharmacogenomics/Pharmacogenetics Drug Development and DiagnosticsTable 5.4: North American Companies Involved in Pharmacogenomics/Pharmacogenetics DiagnosticsTable 5.5: European & Other Companies Involved in Pharmacogenomics/PharmacogeneticsDiagnosticsTable 5.6: North American Companies Involved in Pharmacogenomics/Pharmacogenetics ServicesTable 5.7: European/Other Companies Involved in Pharmacogenomics/Pharmacogenetics ServicesTable 5.8: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Tools Kits and SoftwareTable 5.9: European Companies Involved in Pharmacogenomics/Pharmacogenetics Tools Kits and SoftwareTable 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/PharmacogeneticsTable 5.13: Large European Companies with Investment into Pharmacogenomics/PharmacogeneticsTable 5.14: Large Japanese Companies with Investment into Pharmacogenomics/PharmacogeneticsTable 5.15: Top Ten Biological Areas of Interest in Pharmacogenetics/Pharmacogenomics Table 5.16: Top International Pharmacogenetic/Pharmacogenomic Research InstitutionsTable 5.17: Top European Pharmacogenetic/Pharmacogenomic Research Institutions Table 6.1: QUICK FACTs- Variation of Reimbursement Policies for HER2 and KRAS Testing in EuropeTable 6.2: Pharmaceutical Companies Providing Subsidization of Diagnostic Personalized Medicine Tests in EuropeTable 6.3: QUICKFACTs - Challenges Within Personalized Medicine Market in EuropeTable 6.4: QUICKFACTS- Function of the European network for Health Technology Assessment (EUnetHTA) OrganisationTable 6.5: European network for Health Technology Assessment (EUnetHTA) PartnersTable 6.6: European network for Health Technology Assessment (EUnetHTA) AssociatesTable 6.7: QUICK FACTs - Reimbursement Challenges to Personalized MedicineTable 6.8: Diagnostics Guidance Assessment by the National Institute for Health and Clinical Excellence (NICE)Table 6.9: Current Diagnostics Guidance in Development by the Diagnostics Access Program, UKTable 6.10: Published Diagnostics Guidance by the Diagnostics Access Program, UKTable 6.11: Medical Technologies Guidance Assessment by the National Institute for Health and Clinical Excellence (NICE)Table 6.12: Published Medical Technologies Guidance by the National Institute for Health and Clinical Excellence (NICE)Table 6.13: Published Medical Technologies Guidance in Development by the National Institute for Health and Clinical Excellence (NICE)Table 6.14: QUICK FACTs - Key Challenges to Personalized Medicine Table 6.15: QUICKFACTs - Personalized Medicine - Translation into Medical ApplicationsTable 7.1: QUICK FACTS - Major Market Trends in Personalized MedicineTable 7.2: Collaboration Strategies Required between Industry, Payers and Governments for a Productive Personalized Medicine MarketTable 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 CentresTable 7.5: QUICK FACTS Business Model Recommendations for PayersTable 7.6: QUICK FACTs - Business Model Recommendations for GovernmentsTable 7.7: QUICK FACTs - Non-Healthcare Companies with Potential to enter the Personalized Medicine MarketTable 7.8: Hurdles of Personalised Medicine with Respect to Cost-EffectivenessTable 8.1: Patent Listing of Affymetrix Array technologyTable 8.2: Patent Listing of Affymetrix Genotyping TechnologyTable 8.3: Patent Listing of Affymetrix Expression and Profiling TechnologyTable 8.4: Advantages of Astex Pharmaceuticals Pyramid™ Fragment-Drug-Discovery SystemTable 8.5: Potential Business Partnerships of Celldex TherapeuticsTable 8.6: Genetic Test Panel Available from Genelex for Research Institutions and Clinical TrialsTable 8.7: Pre-Clinical, Clinical and Commercial Applications of SCNP by NodalityTable 8.8: Qiagen Timeline of Events, 1994-2012Table 8.9: QUICKFACTs - Range of Product Groups from QiagenTable 9.1: 23andme Disease Risk Genetic Test PanelTable 9.2: 23andme Carrier Status Genetic Test PanelTable 9.3: 23andme Drug Response Genetic Marker Test PanelTable 9.4: 23andme Genetic Traits Test PanelTable 9.5: QUICKFACTs - Product Overview of AffymetrixTable 9.6: Microarray Products by AffymetrixTable 9.7: Affymetrix Research Services Laboratory (ARSL) Premier ServicesTable 9.8: Genetic Applications of Axiom Technology by AffymetrixTable 9.9: Range of Small Molecule Therapeutics Available from Astex PharmaceuticalsTable 9.10: Panel of cystic fibrosis transmembrane conductance regulator (CFTR) mutations screened for in Celera Cystic Fibrosis Genotyping AssayTable 9.11: Genetic Tests Available from BHL/CeleraTable 9.12: Panel of BHL Clinical Diagnostic TestsTable 9.13: Features of the m2000 RealTime PCR System by Celera Table 9.14: Genetic Diagnostic Tests Available from deCode GeneticsTable 9.15: Type 2 Diabetes risk range and distribution according to continental ancestry as Determined by deCodeT2 Genetic TestTable 9.16: Genetic Mutations Identified by the deCODE MI™ Test in a European PopulationTable 9.17: Genetic Mutations Identified by the deCODE MI™ Test in an East Asian PopulationTable 9.18: Disease States that are Included in the deCODE Complete™ Genetic ScreenTable 9.19: Panel of Diseases Screened for in the deCODE Cancer™ TestTable 9.20: Panel of Cardiovascular Diseases in the deCODE Cardio™ TestTable 9.21: deCODE Genetics Genotyping and Sequencing ServiceTable 9.22: deCODE Genetics Data Management, Protection and Storage ServiceTable 9.23: deCODE Genetics Sequence Inputation and Data Analysis ServiceTable 9.24: Panel of Genetic Screens Available from GenelexTable 9.25: Drug Sensitivity Screens Available from GenelexTable 9.26: Predictive Genetic Tests Available from Myriad Table 9.27: Services offered with BRACAnalysis Testing from MyriadTable 9.28: Advantages of BRACAnalysis TestingTable 9.29: COLARIS Test Range by MyriadTable 9.30: COLARIS AP Test Range by MyriadTable 9.31: MELARIS Test Range from MyriadTable 9.32: Personalized Medicine Tests from MyriadTable 9.33: OnDose Testing Procedure from MyriadTable 9.34: Qiagen Genotyping Products for Sample Collection, stabilization and StorageTable 9.35: Qiagen Genotyping Products for Genomic DNA Isolation and PurificationTable 9.36: Qiagen Genotyping Products for PCR Based Genotyping AnalysisTable 9.37 Qiagen Products for Genotyping AnalysisTable 9.38: Qiagen Genotyping Products for PCR DetectionTable 9.39: Qiagen Assays for Genetic AnalysisTable 9.40: Qiagen Pyrosequencing-Based Genetic Analysis ProductsTable 9.41: Specifications and Features of Qiagen's QIAsymphony and QIAsymphony RGQTable 10.1: QUICK FACTs - Submarkets within the Personalized Medicine Technology MarketTable 10.2: Drug Classes Investigated by 23andme using genome wide association studiesTable 10.3: QUICKFACTs- Acquisition Profile of AffymetrixTable 10.4: Genetic Applications of Axiom Technology by AffymetrixTable 10.5: Diversified Business Units of AffymetrixTable 10.6: Operating (Loss) of Celera (US$) – Laboratory Services and Products 2008-2010Table 10.7: Diagnostic Test Product Categories Manufactured by BHL/Celera and Exclusively Distributed by AbbottTable 10.8: Price Listing of Genelex Familial Genetic TestsTable 10.9: Myriad - Core Business Decisions and Impact on Industry 2011Table 10.10: Future Test Portfolio of MyriadTable 11.1: QUICK FACTS: Strengths and Advantages of Genotyping TechniquesTable 12.1: QUICKFACTs: Restraints of Personalized Medicine MarketTable 13.1: QUICK FACTS - Summary of Clinical Laboratory Improvement Amendments (CLIA)Table 13.2: Clinical Laboratory Improvement Amendments (CLIA) Testing CategoriesTable 13.3: QUICK FACTS - Test Features required prior to FDA Approval and ClearanceTable 13.4: Impact of Genetic Information Non-discrimination Act (GINA) on Healthcare Companies and Health PlansTable 13.5: Impact of Genetic Information Non-discrimination Act (GINA) on US Employers, employment agencies, labor organizations and training programsTable 13.6: QUICK FACTS - FDA Commitment to the Personalized Medicine IndustryTable 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 evaluationsTable 13.10: QUICKFACTS - Implementation Strategy of the FDA to Advance Regulatory Science - Use and develop computational methods and in silico modelling

List of FiguresFigure 2.1: QUICK FACTS - Elements of Personalized Genomic MedicineFigure 2.2: Identification of Good and Non-Responders in a Patient PopulationFigure 2.3: Pharmacodynamic and Pharmacokinetic Examples of Drug Targets and Drug metabolism in PharmacogenomicsFigure 2.4: QUICK FACTS - Flow Diagram of Pharmacogenetic AnalysisFigure 2.5: Primer Based Base Extension in PharmacogeneticsFigure 2.6: Genetic Mutation Detection by HybridizationFigure 2.7: Ligation based SNP DetectionFigure 2.8: New-Generation Sequencing: PyrosequencingFigure 3.1: QUICK FACTS - Warfarin Metabolism and ResponseFigure 3.2: QUICK FACTS - Percentage Frequency of CYP2C9 and VKORC1 mutations in Caucasian, African-American and Asian PopulationsFigure 3.3: QUICK FACTS: Anti-EGFR Therapy and KRAS MutationsFigure 3.4: KRAS and BRAF Genetic Tests Available from AsuragenFigure 3.5: Global Incidence and Mortality of Cancer in WomenFigure 3.6: Cancer Deaths in Women, Globally according to Cancer TypeFigure 3.7: Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer GloballyFigure 3.8: HER2 Testing Algorithm for Breast CancerFigure 3.9: HER2 Cellular SignallingFigure 3.10: QUICKFACTs - Herceptin – Mechanism of ActionFigure 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 CancerFigure 4.1: Integration of Multiple components for a Personalized Medicine Healthcare SystemFigure 4.2: Workflow Diagram illustrating Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic PathologyFigure 4.3: Hypothetical Flow Diagram of a Patient through the Genomic Pathology Clinical LaboratoryFigure 5.1: Personalized Medicine Scheme Interaction with Industry, Regulatory Bodies and Funding AgenciesFigure 5.2: Number of Publically Funded Pharmacogenetic and Pharmacogenomic Research Teams InternationallyFigure 6.1: Adverse Drug Reactions are the Fourth Leading Cause of DeathFigure 6.2: Efficacy Rate of Major Disease Types with Standard TreatmentFigure 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 USFigure 6.6: Flow Diagram of the German Healthcare System and Key AgenciesFigure 6.7: German Reimbursement Arrangement, Process and ImplicationsFigure 7.1: Annual Healthcare Expenditure for Major Industrial NationsFigure 7.2: Estimated Life Expectancy from Birth for Major Industrialized CountriesFigure 8.1: Single Cell Network Profiling (SCNP) Technology by NodalityFigure 8.2: Developed Functional Assays that Nodality has explored using new SCNP TechnologyFigure 9.1: Flow Diagram of Celera CEGA -16™ Instrument for Cystic Fibrosis Gene AnalysisFigure 9.2: Percentage of Individual Populations who have an Increased Risk of Developing Type 2 Diabetes as Determined Using the deCodeT2 Genetic TestFigure 10.1: Combined Personalized Medicine Market in the US, 2009-2015Figure 10.2: Core Personalized Medicine Sub-Market Growth Forecast 2009-2015Figure 10.3: Personalized Medical Care Sub-Market Growth Forecast 2009-2015Figure 10.4: Nutrition and Wellness Sub-market of Personalized Medicine Growth Forecast 2009-2015Figure 10.5: Diagnostic and Therapeutic Personalized Medicine Market Growth Projection in the, 2009-2015Figure 10.6: Global Market Personalized Medicine Technology Growth Forecast 2009-2015Figure 10.7: Global Personalized Medicine Sub-market Growth Forecast 2009-2014Figure 10.8: Personalized Medicine Sub-Market Share (Percentage) 2009 Figure 10.9: Personalized Medicine Sub-Market Share (Percentage) 2014Figure 10.10: Global Molecular Diagnostics Predicted Market Share 2015Figure 10.11: Global Molecular Diagnostics Market Projection 2015Figure 10.12: Private Funding Gained by 23andme 2007-2011Figure 10.13: Affymetrix Total Revenue 2007-2011Figure 10.14: Affymetrix Revenue Derived from Outside the US, 2009-2011Figure 10.15: Affymetrix Revenue Derived from the US, 2009-2011Figure 10.16: Affymetrix Net Loss, 2009-2011Figure 10.17: Research and Development Funding, Affymetrix 2009-2011Figure 10.18: Revenue Generated by Celera 2008-2010Figure 10.19: Gross Margin Generated by Celera 2008-2010Figure 10.20: Revenue Generated by Celera – Laboratory Services and Products 2008-2010Figure 10.21: Celera- Percentage Revenue Generated by Distribution Agreement with AbbottFigure 10.22: Celera - Research and Development Spending 2008-2010Figure 10.23: Comparison of Cumulative Shareholder Returns with the NASDAQ Composite Index and NASDAQ Biotechnology Index 2008-2010 Figure 10.24: Net Loss Incurred by deCode Genetics 2004-2008Figure 10.25: Revenue Generated by Myriad 2007-2011Figure 10.26: Income Generated by Myriad 2007-2011Figure 10.27: Future Molecular Diagnostic Pipeline of MyriadFigure 10.28: Customer Profile of Qiagen – Percentage of Net Sales 2011Figure 10.29: Qiagen Global Net Sales 2007-2011Figure 10.30: Qiagen Operating Income 2007-2011Figure 10.31: Qiagen Global Net Income 2007-2011

Companies Mentioned

• 23andMe• Affymetrix• Astex Pharmaceuticals• Atossa Genetics• CuraGen• Celera Corporation• Celldex Therapeutics• deCode Genetics• Genelex• Myriad • Nodality• Qiagen

To order this report:Genomics Industry: Personalized Medicine Market - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment

Contact Clare: [email protected]   US:(339) 368 6001 Intl:+1 339 368 6001

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