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

Kelly Scientific Publications
Published Date » 2014-03-01
No. Of Pages » 224
 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...
Table of Content

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

2.0 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 Adverse Drug Reactions 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

3.0 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

4.0 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

5.0 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 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

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

7.0 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

8.0 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
8.7 Celldex Therapeutics
8.8 deCode Genetics
8.9 Genelex
8.10 Myriad
8.11 Nodality
8.12 Qiagen

9.0 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)
9.5 Celera
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
9.5.9 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 Genelex
9.7.1 You Script™
9.8 Myriad Genetics
9.8.1 BRACAnalysis 
9.8.3 MELARIS 
9.8.4 PANEXIA 
9.8.5 OnDose 
9.8.6 PREZEON™
9.8.8 Prolaris 
9.9 Nodility
9.10 Qiagen
9.10.1 Genotyping Products
9.10.2 QIAsymphony Platform

10.0 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  Atossa Genetics
10.10.4  Celera
10.10.5  deCode Genetics
10.10.6  Illumina
10.10.7  Genelex
10.10.8  Myriad
10.10.9  Nodality
10.10.10 Qiagen

11.0 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
11.6 Industry is Investing in Pharmacogenomics
11.7 Consumer Genomics and POC Market

12.0 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

13.0 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
13.7 FDA - Partnership in Applied Comparative Effectiveness Science (PACES) Initiative

14.0 Final Summary and Future Perspectives

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 Tests
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 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 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
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: QUICK FACTs - Reimbursement Challenges to Personalized Medicine
Table 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, UK
Table 6.10: Published Diagnostics Guidance by the Diagnostics Access Program, UK
Table 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 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 Expression and Profiling Technology
Table 8.4: Advantages of Astex Pharmaceuticals Pyramid™ Fragment-Drug-Discovery System
Table 8.5: Potential Business Partnerships of Celldex Therapeutics
Table 8.6: Genetic Test Panel Available from Genelex for Research Institutions and Clinical Trials
Table 8.7: Pre-Clinical, Clinical and Commercial Applications of SCNP by Nodality
Table 8.8: Qiagen Timeline of Events, 1994-2012
Table 8.9: 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: Panel of Genetic Screens Available from Genelex
Table 9.25: Drug Sensitivity Screens Available from Genelex
Table 9.26: Predictive Genetic Tests Available from Myriad
Table 9.27: Services offered with BRACAnalysis  Testing from Myriad
Table 9.28: Advantages of BRACAnalysis  Testing
Table 9.29: COLARIS  Test Range by Myriad
Table 9.30: COLARIS AP  Test Range by Myriad
Table 9.31: MELARIS  Test Range from Myriad
Table 9.32: Personalized Medicine Tests from Myriad
Table 9.33: OnDose  Testing Procedure from Myriad
Table 9.34: Qiagen Genotyping Products for Sample Collection, stabilization and Storage
Table 9.35: Qiagen Genotyping Products for Genomic DNA Isolation and Purification
Table 9.36: Qiagen Genotyping Products for PCR Based Genotyping Analysis
Table 9.37 Qiagen Products for Genotyping Analysis
Table 9.38: Qiagen Genotyping Products for PCR Detection
Table 9.39: Qiagen Assays for Genetic Analysis
Table 9.40: Qiagen Pyrosequencing-Based Genetic Analysis Products
Table 9.41: 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: QUICKFACTs- 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: Operating (Loss) of Celera (US$) – Laboratory Services and Products 2008-2010
Table 10.7: Diagnostic Test Product Categories Manufactured by BHL/Celera and Exclusively Distributed by Abbott
Table 10.8: Price Listing of Genelex Familial Genetic Tests
Table 10.9: Myriad - Core Business Decisions and Impact on Industry 2011
Table 10.10: Future Test Portfolio of Myriad
Table 11.1: QUICK FACTS: Strengths and Advantages of Genotyping Techniques
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

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: Single Cell Network Profiling (SCNP) Technology by Nodality
Figure 8.2: 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 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, 2009-2015
Figure 10.6: Global Market Personalized Medicine Technology Growth Forecast 2009-2015
Figure 10.7: Global Personalized Medicine 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 2007-2011
Figure 10.13: Affymetrix Total Revenue 2007-2011
Figure 10.14: Affymetrix Revenue Derived from Outside the US, 2009-2011
Figure 10.15: Affymetrix Revenue Derived from the US, 2009-2011
Figure 10.16: Affymetrix Net Loss, 2009-2011
Figure 10.17: Research and Development Funding, Affymetrix 2009-2011
Figure 10.18: Revenue Generated by Celera 2008-2010
Figure 10.19: Gross Margin Generated by Celera 2008-2010
Figure 10.20: Revenue Generated by Celera – Laboratory Services and Products 2008-2010
Figure 10.21: Celera- Percentage Revenue Generated by Distribution Agreement with Abbott
Figure 10.22: Celera - Research and Development Spending 2008-2010
Figure 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 2004-2008
Figure 10.25: Revenue Generated by Myriad 2007-2011
Figure 10.26: Income Generated by Myriad 2007-2011
Figure 10.27: Future Molecular Diagnostic Pipeline of Myriad
Figure 10.28: Customer Profile of Qiagen – Percentage of Net Sales 2011
Figure 10.29: Qiagen Global Net Sales 2007-2011
Figure 10.30: Qiagen Operating Income 2007-2011
Figure 10.31: Qiagen Global Net Income 2007-2011

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Strides Arcolab Bags USFDA Approval for Transplant Drug
Jul 24, 2014  
Indian pharmaceutical company Strides Arcolab has received the approval of the USFDA to sell its transplant drug Tacrolimus in the US market. The capsule is an immune-suppressant that is used for preventing organ rejection that may occur in transplant surgeries of organs such as kidneys, heart or liver in some patients.  USFDA has allowed the sale of the tablets in 5 mg, 1 mg and 0.5...