Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market to 2021- Strategic Analysis of Industry Trends, Technologies, Participants, and Environment

  • ID: 4238697
  • Report
  • 397 pages
  • Kelly Scientific Publications
1 of 6


  • 23andMe
  • Astex Pharmaceuticals
  • Claritas Genomics
  • Genelex
  • Life Technologies
  • Novartis MDx
  • MORE

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 over 360 tables & figures over 397 pages. The personalized medicine (global & USA) market is presented as follows:

By Segment (Targeted therapeutics, Companion Diagnostics, Liquid Biopsies)
By Sub-market (Companion diagnostic, targeted cancer therapeutic, medical technology, pharmacogenomics, consumer genomics, molecular diagnostics, liquid biopsy)
By Therapy (Cancer, Cardiovascular, Infectious Disease)

Key Opinion Leaders that contributed to interview questions within the report include:

  • Iain D. Miller, PhD, MBA, Founder & CEO, Healthcare Strategies Group
  • Stephen Finn, MBBS, PhD, Associate Professor, Cancer Molecular Diagnostic Laboratory, Consultant Histopathologist and Head of Histopathology, St James’s Hospital and Trinity College Dublin, Ireland
  • Ronald Przygodzki, MD, Director, Genomic Medicine Implementation at U.S. Department of Veterans Affairs, Washington DC
  • Elaine Kenny, PhD, Founder, Elda Biotech, Dublin 2, Ireland
  • Chad Clark, Co-President and Chief Operating Officer, Precision for Medicine
  • Tobias Guennel, PhD, Principal, Biomarker and IVD Analytics, Precision for Medicine
  • David Parker, PhD, Vice President, Integrated Market Access, Precision for Medicine
  • Deborah Phippard, PhD, Vice President, Research, Precision for Medicine
  • Judi Smith, MS, Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine

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

  • 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
  • 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 (USA, UK, Germany, France, Spain, Italy)
  • CE-marked Personalized Medicine/Diagnostic Tests
  • FDA Advances in Personalized Medicine Regulation

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

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 (CEOs, VPs, Business Development, C-Suite)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 360 figures and tables over 397 pages and profiles the main pharmacos in personalized medicine.

Note: Product cover images may vary from those shown
2 of 6


  • 23andMe
  • Astex Pharmaceuticals
  • Claritas Genomics
  • Genelex
  • Life Technologies
  • Novartis MDx
  • MORE

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                               
1.4.1    CYP2C9 and VKORC1 mutations and Warfarin Response                   
1.4.2    KRAS Mutations                                       
1.4.3    Herceptin® and Breast Cancer                               
1.4.4    BRACAnalysis®                                       
1.4.5    Oncotype Dx Test                                   
1.4.6    Public and Private Funding for Personalized Medical Research                   
1.4.7    New Business Model Required for Personalized Medicine                   
1.4.8    Cost-effectiveness and Business Value of Personalized Medicine               
1.4.9    Personalized Medicine Market                               
1.4.10    Personalized Medicine Oncology Therapeutics & Diagnostics Market               
1.4.11    Personalized Medicine Cardiovascular Therapeutics Market                   
1.4.12    PharmacoGenomics/PharmacoGenetics Market Analysis                   
1.4.13    Liquid Biopsy Market Analysis                               

2.0    Introduction and Background                               
2.1    Genetics Explained in Five Minutes                               
2.1.1    Why is the Central Dogma of Molecular Biology Important in Personalized Medicine?       
2.1.2    Genetic Mutations Explained                               
2.1.3    What is the Difference between Genotype and Phenotype?                   
2.1.4    Why do we Need to Look at Genetic Diversity with Respect to Personalized Medicine?       
2.2     Introduction to Personalized Medicine                           
2.3    Pharmacogenetics                                   
2.4    How Personalized Medicine Monitoring can Reduce Adverse Drug Reactions           
2.5    Pharmacogenetic Study Challenges                            
2.6    Pharmacogenomics                                   
2.7    Applications of Pharmacogenomics                               
2.7.1    Pharmacogenomics: Improving the Safety of Medications              Adverse Drug Reactions                              Pharmacogenomics: Improving the Efficacy of Therapeutics                   
2.7.2    Vioxx Disaster Could have been Prevented with Personalized Medicine               
2.8    Pharmacogenetic Analysis                                   
2.8.1    Single Base Primer Extension                               
2.8.2    Primer Based Base Extension                               
2.8.3    Hybridization Based SNP Analysis                               
2.8.4    Ligation Based Approach                                   
2.8.5    New-Generation Sequencing Technologies                           
2.8.6    Ultra-High Throughput Sequencing                               
2.9    Companion Diagnostics                                   
2.9.1    Companion Diagnostic Deals                               
2.10    Selected Personalized Medicine Drugs by Biomarker and Indication               
2.11    Selected Personalized Medicine Test/Kit According to Therapeutic and Indication        
2.12     Targeted Cancer Therapy                                   
2.13    What Percentage of Cancer Patients Could be Treated by Targeted Therapy?           
2.14    Liquid Biopsies                                       
2.14.1    CANCER-ID Project                                   
2.14.2    Challenges for Liquid Biopsies                               
2.15    Tumor Genetic Heterogeneity                               
2.15.1    Introduction                                       
2.15.2    Clonal Evolution – How Phylogenetic Analysis is Aiding Personalized Medicine           
2.15.3    Therapeutic Resistance                                   
2.15.4    Tumor Immunogenicity                                   
2.15.5    Tumor Neo-Antigen Production                               
2.15.6    Sampling Tumor Heterogeneity with Liquid Biopsies                       
2.15.7    How Does Tumor Heterogeneity Impact Personalized Medicine?               
2.15.8    Summary                                       
2.16    How Next Generation Functional Diagnostics is Helping Personalized Medicine           

3.0    Personalized Medicine Targeted Therapeutics and Associated 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                                   
3.11    Cobas® EGFR Mutation Test (Roche)                           
3.12    Prolaris Prostate Cancer Test                               
3.13    ALK and Non-Small Cell Lung Cancer                           
3.13.1    ALK-Fusion Testing                                   
3.13.2    VYSIS ALK Break Apart FISH Probe Kit                           
3.13.3    VENTANA ALK (D5F3) CDx Assay                           
3.13.4    ResponseDx: Lung™                                   

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     Overview of Reimbursement Policies in Europe                       
6.4    Gaining Market Penetration in the EU                           
6.5    Personalized (Stratified) Medicine Regulation and Reimbursement in the UK           
6.5.1    Precision Medicine Catapult                               
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                           
6.8.1    R&D UNICANCER France                               
6.9    Personalized Medicine Regulation in Spain                           
6.10    The Personalized Medicine Regulation in Italy                       
6.11    Challenges of Future Personalized Medicine Development in Europe               

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                   
7.10    Reimbursement -  Coverage and Payment Policy                       

8.0       Personalized Medicine Main Industry Players           
8.1    23andMe                                       
8.1.1    Key Products                                       
8.2    Abbott Laboratories                                   
8.2.1    Abbott Molecular Inc.                                   
8.3    Admera Health (GENEWIZ)                               
8.3.1    Products and Kits                                       
8.3.2    PGxOne                                           
8.3.3    OncoGxOne                                       
8.3.4    OncoGxOne Plus                                    
8.3.5    FloraCheck                                       
8.3.6    EGFR & KRAS Clinical Sequencing                           
8.4    Agena Biosciences (Sequenom)                               
8.4.1    MassARRAY System                                   
8.4.2    Acquisition of Sequenom’s Bioscience Business by Agena Biosciences               
8.5    Affymetrix                                        
8.5.1    Products and Kits                                       
8.6    Agendia                                           
8.7    Alere                                           
8.8    Amgen Inc.                                       
8.8.1    Vectibix (panitumumab)                                   
8.8.2    Blinatumomab (Blincyto)                                   
8.8.3    Rilotumumab                                       
8.9    Astex Pharmaceuticals                                   
8.9.1    Products and Kits                                       
8.10    AstraZeneca                                       
8.10.1    Iressa                                           
8.10.2    Tagrisso AZD9291 (Osimertinib)                               
8.11    Atossa Genetics                                       
8.11.1    Mammary Aspirate Specimen Cytology Test (MASCT™)                   
8.11.2    ForeCYTE Breast Health Test (SM)                           
8.11.3    ArgusCYTE Breast Health Test(SM)                           
8.11.4    FullCYTE Breast Health Test                               
8.12    Becton Dickinson                                       
8.12.1    Key Products                                       
8.13    BioMerieux                                       
8.13.1    Key Products                                       
8.14    BioRad                                           
8.15    Bristol-Myers Squibb Company                               
8.15.1    Erbitux (cetuximab)                                   
8.15.2    OPDIVO (nivolumab)                                   
8.15.3    Yervoy (ipilimumab)                                   
8.16    Cancer Genetics                                       
8.16.1    Key Products                                       
8.17    Celera Corporation (Quest Diagnostics)                           
8.17    Key Products                                       
8.17.1    ViroSeq® HIV-1 Genotyping System                           
8.17.2    ViroSeq® HIV-1 Integrase Assay                               
8.17.3    ViroSeq® HCV Assay                                   
8.17.4    ViroSeq® HBV Assay                                   
8.17.5    Cystic Fibrosis Genotyping Assay                               
8.17.6    LDL-S3GGE® Test                                   
8.17.7    HDL-S10GGE® Test                                   
8.17.8    KIF6-StatinCheckTM Genotype Test                           
8.17.9   LPA-AspirinCheckTM Genotype Test                           
8.17.10                 9p21-EarlyMICheckTM Genotype Test                       
8.17.11        AlleleSEQR® HLA PCR/Sequencing Kits                       
8.17.12        m2000® RealTime PCR System                           
8.17.13        CEGA -16™ Instrument                               
8.18    Celldex Therapeutics                                   
8.19      Cephid                                       
8.20    Claritas Genomics                                   
8.20.1    Products and Kits                                       
8.20.2    ClariFocus Exome for Pediatric Neurology                           
8.21    CuraGen                                       
8.22      deCode Genetics (Amgen)                                       
8.22.1                deCodeT2 Genetic Test                               
8.22.2                deCODE Breast Cancer™                               
8.22.3                    deCODE Prostate Cancer™                           
8.22.4        deCODE AF™                                   
8.22.5        deCODE Glaucoma™                               
8.22.6        deCODE MI™                                   
8.22.7        deCODE Complete™                               
8.22.8        deCODE Cancer™                               
8.22.9        deCODE Cardio™                               
8.22.10        deCODE Services                               
8.23    EDP Biotech                                       
8.24    ELDA BioTech                                       
8.25    Eisai                                           
8.26    Foundation Medicine                                   
8.26.1    FoundationOne                                       
8.26.2    FoundationOne Heme                                   
8.27    HalioDx                                           
8.28    Human Longevity Inc (Cypher Genomics)                           
8.29    Ikonisys                                           
8.30     Illumina                                           
8.30.1    Illumina HiSeq 2000/1000                                   
8.30.2    Genome Analyzer IIx                                   
8.30.3    Illumina MiSeq                                       
8.30.4    Illumina HiScanHQ                                   
8.30.5    Illumina HiScan and iScan Array                               
8.31     Intergenetics                                       
8.32    Genelex                                           
8.32.1        You Script™                                   
8.33    Johnson & Johnson (Janssen)                               
8.34    LabCorp (Covance)                                   
8.34.1    Covance and M2Gen Partnership                               
8.35    Integrated Oncology                                   
8.35.1    Main Products                                       
8.36    Merck & Co. Inc.                                   
8.36.1    Main Products                                       
8.37    MDx Health                                       
8.38    MolecularMD Corporation                               
8.39    Monogram Biosciences                                   
8.40    Myriad                                            
8.40.1    Key Products                                       
8.40.2    COLARIS®/COLARIS AP®                               
8.40.3    MELARIS®                                       
8.40.4    PANEXIA®                                       
8.40.5    OnDose®                                       
8.40.6    PREZEON™                                       
8.40.7    THERAGUIDE® 5FU                                   
8.40.8    Prolaris®                                       
8.41    Nanostring Technologies                                   
8.42    Nodality                                           
8.42.1    Products and Kits                                       
8.43    Novartis                                           
8.43.1    Novartis Molecular Diagnostics                               
8.43.2    Novartis Oncology                                   
8.44    Orion Genomics                                       
8.45    Oxford BioTherapeutics                                   
8.46    Pfizer                                           
8.46.1    Pfizer Merger with Allergan                               
8.46.2    Pfizers Oncology Strategy                                   
8.46.3    Pfizer’s Personalized Healthcare Strategy                                      
8.47    Qiagen                                           
8.47.1    Key Products                                       
8.47.2    Genotyping Products                                   
8.47.3    QIAsymphony Platform                                   
8.48    Roche                                           
8.49    Roche Diagnostics                                   
8.49.1    Roche Acquisition of Ventana Medical Systems                        
8.49.2    Roche’s Personalized Medicine Strategy                           
8.49.3    Avastin (Bevacizumab)                                   
8.49.4    Herceptin (Trastuzumab)                                   
8.49.5    Kadcyla (Trastuzumabum emtansinum)                           
8.49.6    Perjeta (Pertuzumab)                                   
8.49.7  MabThera/Rituximab                                   
8.49.8    Tarceva                                           
8.50    Sanofi                                           
8.50.1    Sanofi’s Personalized Medicine Strategy                           
8.51    Siemens Healthcare                                   
8.51.1    Companion Diagnostic Development at the Siemens Clinical Laboratory (SCL)           
8.52    Takeda                                           
8.52.1    Takeda’s to Discover Therapeutic Targets in the Microbiome                   
8.52.2    Millennium: The Takeda Oncology Company                       
8.53    Thermo Fisher Scientific                                   
8.53.1    ThermoFisher’s Personalized Healthcare Strategy                       
8.53.2    ThermoFisher’s Involvement in the NCI-MATCH Trial                   
8.54    Transgenomic                                       
8.55    Vertex Pharmaceuticals                                   
8.55.1    Orkambi (lumacaftor/ivacaftor)                               
8.55.2    Kalydeco  (ivacaftor)                                   
9.0    Personalized Medicine Market Analysis                           
9.1    Companion Diagnostic and Targeted Therapeutic Market                    
9.1.1    Global OncologyTherapeutic Market                           
9.1.2    Targeted Therapeutics – Oncology                               
9.1.3    Top Ten Companies in Oncology Drug Sales to 2021                       
9.1.4    Top Five Oncology Drugs to 2021                               
9.1.5    Global Oncology Market by Cancer Type                           
9.1.6    Oncology Targeted Therapeutics Market Analysis to 2021                   
9.1.7    Companion Diagnostic Assays – Oncology                           
9.2    Cardiovascular Targeted Therapeutics Market to 2021                   
9.2.1    Cardiovascular Companion Diagnostics Market to 2021                   
9.3    Infectious Disease Targeted Therapeutics Market to  2021                   
9.3.1    Infectious Disease Diagnostic Assay Market to 2021                                             
9.4    Global Personalized Medical Technology Market                        
9.5    Global Personalized Medicine Sub-Market Growth                        
9.6    PharmacoGenomics/PharmacoGenetics Market Analysis to 2021               
9.7    Molecular Diagnostics Market to 2021                           
9.8    Consumer Genomics Market                               
9.9    Liquid Biopsy Market to 2021                               
9.10    Major Player Profit Margin Analysis                           
9.11    Select Market Participant Case Study Analysis                       
9.11.1        23andme                                   
9.11.2        Affymetrix                                    
9.11.3        Astex Pharmaceuticals                               
9.11.4        Atossa Genetics                                   
9.11.5        Celera (Quest Diagnostics)                           
9.11.6        Celldex Therapeutics                               
9.11.7        deCode Genetics (Amgen)                               
9.11.8        Illumina                                       
9.11.9        Genelex                                       
9.11.10        Myriad                                        
9.11.11        Nodality                                       
9.11.12        Qiagen                                       
9.11.13        bioMerieux                                   

10.0    Strengths and Advantages of Personalized Medicine                   
10.1    Sequencing of the Human Genome in 2000                           
10.2    Improving Patient Care and Reducing Side Effects                       
10.3    Personalized Medicine will Reduce Healthcare Costs                       
10.4    FDA Advances in Personalized Medicine Regulation                       
10.5    Advancing Technologies                                   
10.5.1     Next Generation Sequencing                               
10.6    Industry Investing in Pharmacogenomics                           
10.7    Consumer Genomics and POC Market                           
10.8    Oncology a Driving Force of Personalized Medicine                       

11.0    Restraints of the Personalized Medicine Market                       
11.1    Lack of Sufficient Regulation                               
11.2    Lack of Sufficient Genotypic Linkage Studies to Disease Phenotype               
11.3    Reimbursement Issues                                   

12.0    Personalized Medicine and Regulatory Policies                       
12.1    Regulation by the Centres for Medicare and Medicaid Services (CMS) and US Food and Drug Administration (FDA)                                   
12.2    Genetic Information Non-discrimination Act (GINA)                       
12.3    FDA Advancements on Genetic Testing Approval                       
12.4    FDA- New Models to Assess Gene Therapy Safety                       
12.5    FDA- Companion Diagnostics                               
12.6    FDA - Partnership in Applied Comparative Effectiveness Science (PACES) Initiative       
12.7    National Institutes of Health Genetic Testing Registry                   

13.0    Final Summary and Future Perspectives                           
13.1    Re-cap of Personalized Medicine in 2016                           

14.0    Interviews with Key Opinion Leaders                           
Iain D. Miller
-  PhD
-  MBA
-  Founder & CEO
-  Healthcare Strategies Group
Stephen Finn
-  PhD
-  Associate Professor
-  Cancer Molecular Diagnostic Laboratory
-  Consultant Histopathologist and Head of Histopathology
-  St James’s Hospital and Trinity College Dublin
-  Ireland
Ronald Przygodzki
-  MD
-  Director
-  Genomic Medicine Implementation at U.S. Dept Veterans Affairs
-  Washington DC
Elaine Kenny
-  PhD
-  Founder
-  Elda Biotech
-  Dublin
-  Ireland
Chad Clark
-  Co-President and Chief Operating Officer
-  Precision for Medicine
Tobias Guennel
-  PhD
-  Principal
-  Biomarker and IVD Analytics
-  Precision for Medicine
David Parker
-  PhD
-  Vice President
-  Integrated Market Access
-  Precision for Medicine
Deborah Phippard
-  PhD
-  Vice President
-  Research
-  Precision for Medicine
Judi Smith
-  MS
-  Vice President
-  In Vitro Diagnostics Regulatory and Quality
-  Precision for Medicine

List of Tables

Table 2.1:     Glossary: Common Terms Used in Genetics and Personalized Medicine           
Table 2.2:     Types of Genetic Markers used as Biomarkers in Personalized Medicine       
Table 2.3:     Genetic Disease Associated with the Ashkenazi Jew Population           
Table 2.4:     Disease Types Associated with Specific Populations                   
Table 2.5:    Personalized Medicine                               
Table 2.6:    Genetic Mutations that Predispose Individuals to Disease               
Table 2.7:    Potential Applications of Pharmacogenetics/genomics in Personalized Medicine       
Table 2.8:    Main Cytochrome P450 Enzymes Involved in Drug Metabolism           
Table 2.9:    Rapid & Slow Metabolizer Phenotypes                        
Table 2.10:    Population Frequency of Cytochrome P450(CYP) 2C19 Metabolizer Types       
Table 2.11    Population Frequency of Cytochrome P450 (CYP) Metabolizer Types           
Table 2.12    Depression Medications Affected by Genetic Mutations               
Table 2.13    Cardiovascular Medications Affected by Genetic Mutations               
Table 2.14:    Cancer Medications that may be Affected by Genetic Mutations           
Table 2.15:    Diabetes Medications Affected by Genetic Mutations                   
Table 2.16:    Anti-Epileptic Drugs Affected by Genetic Mutations                   
Table 2.17:    Anti-Retroviral Drugs Affected by Genetic Mutations                   
Table 2.18:    Anti-Reflux/Ulcer Drugs Affected by Genetic Mutations               
Table 2.19:    List of Therapeutics According to Cytochrome P450 Subtype Metabolism       
Table 2.20:    Cytochrome (CYP) P450 Drug-Interactions Inhibitor List               
Table 2.21:    Cytochrome (CYP) P450 Drug-Interactions Inducer List               
Table 2.22:    Main Aims of Pharmacogenomics                           
Table 2.23:    How Pharmacogenomics has Influenced the Top Ten Selling Drugs Globally       
Table 2.24:    Advantages
-  Disadvantages and Cost of Popular Genotyping Methods           
Table 2.25:    Top Ten Pharmacogenomics Tests                           
Table 2.26:    FDA Accepted Pharmacogenomic Biomarkers                    
Table 2.27:    Benefits of Single Base Primer Extension in Pharmacogenetics               
Table 2.28:    Future Applications of Ultra-High Throughput Sequencing               
Table 2.29:    Comparison of Genotyping Techniques                       
Table 2.30:    Problems associated with Microarray Sequencing                   
Table 2.31:    Top Ten Genetic Findings by 23andMe                       
Table 2.32:     EMA Approved Drugs that Require Companion Diagnostics               
Table 2.33:    FDA Approved Drugs that Require Companion Diagnostics                 
Table 2.34:    FDA Companion Diagnostics Device List: In Vitro and Imaging Tools           
Table 2.35:    Important Strategies for a Successful Companion Diagnostic Launch           
Table 2.36:     Selected Personalized Medicine Drugs by Biomarker and Indication           
Table 2.37:     Selected Personalized Medicine Test/Kit According to Therapeutic and Indication   
Table 2.38:     Targeted Cancer Therapeutics by Tumor Type -  Target & Detection Method Available   
Table 2.39:     FDA Approved Targeted Therapies and Approved Indications for Solid Tumors       
Table 2.40:     List of all Academic and Industry Partners of CANCER-ID Consortium           
Table 2.41:     Scientific Advisory Board Members of CANCER-ID                   
Table 2.42:     Details of Tumor Heterogeneity- Intratumor -  Interpatient -  Inter/intrametastatic       
Table 2.43:     Polyclonal Genetic Mechanisms of Therapy Resistance by Tumor Type and Study    

Table 3.1    Predicted Warfarin Concentrations depending on CYP2C9 and VKORC1 Genotype   
Table 3.2    Top Five Most Frequent Cancers in Men and Women -  Globally            
Table 3.3    Estimated Age-Standardised Incidence Rate of Breast Cancer per Country -  Worldwide   
Table 3.4    Diagnostic Tests Available to Determine HER2 Status in Breast Cancer Patients        
Table 3.5    Validated HER2 Tests for Cancer                           
Table 3.6:    Advantages and limitations of IHC HER2 testing applied to breast cancer       
Table 3.7:    In-SituHybridization Determination HER2 Expression: PathVysion® and HER2 FISH pharmDx                                   
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:    Prevalence of Deleterious Mutations in BRCA1 and BRCA2 Genes           
Table 3.14:    Prevalence of Deleterious Mutations in BRCA1 and BRCA2 in Individuals of Ashkenazi Ancestry                                     
Table 3.15:    Risk Factors for Hereditary Breast  and Ovarian Cancer (HBOC)           
Table 3.17:    BRACAnalysis® Panel of Assays                           
Table 3.18:     The Prolaris Score for Prostate Cancer                        

Table 4.1:    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:    American Companies Involved in Pharmacogenomics/genetics Drug Development & Diagnostics                                   
Table 5.3:    European Companies Involved in Pharmacogenomics/genetics Drug Development & Diagnostics                                   
Table 5.4:     North American Companies Involved in Pharmacogenomics/genetics Services       
Table 5.5:     European/Other Companies Involved in Pharmacogenomics/genetics Services       
Table 5.6:    American Companies Involved in Pharmacogenomics/genetics Tools Kits & Software   
Table 5.7:    European Companies Involved in Pharmacogenomics/genetics Tools Kits & Software   
Table 5.8:    North American Companies with Minor interest in Pharmacogenomics/genetics        
Table 5.9:    European/Other Companies with Minor interest in Pharmacogenomics/genetics        
Table 5.10:     North American Companies with Minor interest in Pharmacogenomics/genetics       
Table 5.11:     European/Other Companies with Minor interest in Pharmacogenomics/genetics       
Table 5.12:     Large US Companies with Investment into Pharmacogenomics/genetics           
Table 5.13:     Large European Companies with Investment into Pharmacogenomics/genetics       
Table 5.14:    Large Japanese Companies with Investment into Pharmacogenomics/genetics       
Table 5.15:     Top Ten Biological Areas of Interest in Pharmacogenetics/genomics            
Table 5.16:     Top International Pharmacogenetic/Pharmacogenomic Research Institutions       
Table 5.17:     Top European Pharmacogenetic/Pharmacogenomic Research Institutions       

Table 6.1:    Variation of Reimbursement Policies for HER2 & KRAS Testing in Europe       
Table 6.2:    Pharma Providing Subsidization of Personalized Medicine Tests in Europe       
Table 6.3:    Challenges Within Personalized Medicine Market in Europe               
Table 6.4:    Function of the European network for Health Technology Assessment 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 Health Clinical Excellence    
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 NICE               
Table 6.11:    Published Medical Technologies Guidance by NICE                   
Table 6.12:    Published Medical Technologies Guidance in Development NICE           
Table 6.13    Precision Medicine Catapult Tools to Aid Market Entry               
Table 6.14    Key Challenges to Personalized Medicine                        
Table 6.15:     Strategic Objectives of French Comprehensive Cancer Centers within UNICANCER   
Table 6.16:    Key Challenges to Personalized Medicine                        
Table 6.17:    Personalized Medicine - Translation into Medical Applications           

Table 7.1:    Major Market Trends in Personalized Medicine                   
Table 7.2:        Collaboration Strategies Required between Industry -  Payers & Governments        
Table 7.3:    Business Model Recommendations: Diagnostic -  Pharma& Biotech Companies        
Table 7.4:    Business Model Recommendations: Providers. Provider Systems & Medical Centres   
Table 7.5:    Business Model Recommendations for Payers                   
Table 7.6:    Business Model Recommendations for Governments                   
Table 7.7:    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:    23andMe Disease Risk Genetic Test Panel                       
Table 8.2:    23andMe Carrier Status Genetic Test Panel                       
Table 8.3:    23andMe Drug Response Genetic Marker Test Panel                   
Table 8.4:    23andMe Genetic Traits Test Panel                           
Table 8.5:    Admera Health Commercial Drug List that are Covered by the PGxOne Assay       
Table 8.6:    Admera Health PGxOne Gene & Variant List -  Therapeutic Area & Endorsing Agency   
Table 8.7:    Patent Listing of Affymetrix Array technology                   
Table 8.8:    Patent Listing of Affymetrix Genotyping Technology                   
Table 8.9:    Patent Listing of Affymetrix Expression and Profiling Technology           
Table 8.10:    Product Overview of Affymetrix                           
Table 8.11:    Microarray Products by Affymetrix                           
Table 8.12:    Affymetrix Research Services Laboratory (ARSL) Premier Services           
Table 8.13:    Genetic Applications of Axiom® Technology by Affymetrix               
Table 8.14:    Amgen’s Product Pipeline                               
Table 8.15:    Selected Programs in Pivotal Trial (Phase III) or Development -  Amgen           
Table 8.16    Advantages of Astex Pharmaceuticals                       
Table 8.17:    Astex Pharmaceuticals Pipeline Portfolio                        
Table 8.18:    Astex Pharmaceuticals Pipeline Portfolio Funded Completely by Partner Companies   
Table 8.19:    Range of Small Molecule Therapeutics Available from Astex Pharmaceuticals       
Table 8.20:    Biomarkers by Cancer Type Offered by bioMerieux                   
Table 8.21:    Cancer Genetics Product Portfolio Flow Cytometry Based Assays           
Table 8.22:    Cancer Genetics Product Portfolio FISH Based Assays               
Table 8.23:    Cancer Genetics Product Portfolio Molecular Diagnostics Based Assays       
Table 8.24:    Cancer Genetics Product Portfolio Complete™ Test Program               
Table 8.25:    Select One Clinical Trial Services                           
Table 8.26:    Panel of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutations Screened for in Celera Cystic Fibrosis Genotyping Assay               
Table 8.27:    Genetic Tests Available from BHL/Celera                       
Table 8.28:    Panel of BHL Clinical Diagnostic Tests                       
Table 8.29:    Features of the m2000® RealTime PCR System by Celera                
Table 8.30:    Potential Business Partnerships of Celldex Therapeutics               
Table 8.31:          Cephid Product Portfolio to 2019 in the US                       
Table 8.32:          Cephid Product Portfolio to 2019 Internationally                   
Table 8.33:    Claritas Genomics Genetic Test Portfolio -  by Gene                   
Table 8.34:    Genetic Diagnostic Tests Available from deCode Genetics               
Table 8.35:    Type 2 Diabetes risk range and distribution according to continental ancestry as Determined by deCodeT2 Genetic Test                               
Table 8.36:    Genetic Mutations Identified by the deCODE MI™ Test in a European Population   
Table 8.37:    Genetic Mutations Identified by the deCODE MI™ Test in an East Asian Population   
Table 8.38:    Disease States that are Included in the deCODE Complete™ Genetic Screen       
Table 8.39:    Panel of Diseases Screened for in the deCODE Cancer™ Test               
Table 8.40:    Panel of Cardiovascular Diseases in the deCODE Cardio™ Test           
Table 8.41:    deCODE Genetics Genotyping and Sequencing Service               
Table 8.42:    deCODE Genetics Data Management - Protection and Storage Service           
Table 8.43:    deCODE Genetics Sequence Inputation and Data Analysis Service           
Table 8.44:    FoundationOne Current Gene List                           
Table 8.45:    FoundationOne Heme Gene List                           
Table 8.46:    Foundation Medicine Company-Sponsored Clinical Trials                
Table 8.47:    Illumina Core Technologies                           
Table 8.48    Illumina Core Technology Applications                       
Table 8.49    Illumina Instrument Product Portfolio                       
Table 8.50    Illumina Assay Product Portfolio                           
Table 8.51    Illumina HiSeq 2500/1500  Performance Parameters                   
Table 8.52    Illumina HiSeq 2000/1000 Performance Parameters                   
Table 8.53    Genome Analyzer IIx Performance Parameters                   
Table 8.54    Illumina MiSeq Product Specifications                        
Table 8.55    Illumina HiScanHQ Product Specifications                       
Table 8.56    Illumina HiScan and iScan Array Product Applications               
Table 8.57    Illumina HiScan and iScan Array Kits                       
Table 8.58    Clinical Applications of Diagnostic Tests Offered by Intergenetics           
Table 8.59    Genetic Test Panel Available from Genelex for Research Institutions and Clinical Trials   
Table 8.60    Panel of Genetic Screens Available from Genelex                   
Table 8.61    Drug Sensitivity Screens Available from Genelex                   
Table 8.62    Integrated Oncology Cancer Test Portfolio                       
Table 8.63    Biopharma Merck’s Key Product Range                       
Table 8.64    Molecular MD Biomarker Assays by Platform and Method Used           
Table 8.65    MolecularMD Test Panels by Next Generation Sequencing -  Molecular Targeted Therapy             Management and Pathway Analysis                           
Table 8.66    MolecularMD Companion Diagnostic Development Capabilities           
Table 8.67    Monogram Biosciences  HIV Genotypic and Phenotypic Test Portfolio           
Table 8.68    Predictive Genetic Tests Available from Myriad                    
Table 8.69    Services offered with BRACAnalysis® Testing from Myriad               
Table 8.70    Advantages of BRACAnalysis® Testing                       
Table 8.71    COLARIS® Test Range by Myriad                           
Table 8.72    COLARIS AP® Test Range by Myriad                       
Table 8.73    MELARIS® Test Range from Myriad                       
Table 8.74    Personalized Medicine Tests from Myriad                       
Table 8.75    OnDose® Testing Procedure from Myriad                       
Table 8.76    Nanostring Technologies nCounter Workflow Platform Product Portfolio       
Table 8.77    Pre-Clinical -  Clinical and Commercial Applications of SCNP by Nodality       
Table 8.78    Novartis Oncology Key Personalized Medicine Drug Targets               
Table 8.79    Orion Genomics Collaboration and Commercial Agreements               
Table 8.80    Oxford BioTherapeutics Main Technologies in Cancer Targeting           
Table 8.81    Oxford BioTherapeutics Product Pipeline Portfolio by Development Stage       
Table 8.82    Pfizer Key Branded Products                            
Table 8.83    Pfizer Oncology Targets and Technologies                       
Table 8.84    Pfizer Early Stage Pipeline Oncology Portfolio                   
Table 8.85    Qiagen Timeline of Events -  1994-2012                       
Table 8.86    Range of Product Groups from Qiagen                       
Table 8.87    Qiagen Genotyping Products for Sample Collection -  stabilization and Storage       
Table 8.88    Qiagen Genotyping Products for Genomic DNA Isolation and Purification       
Table 8.89    Qiagen Genotyping Products for PCR Based Genotyping Analysis           
Table 8.90    Qiagen Products for Genotyping Analysis                       
Table 8.91    Qiagen Genotyping Products for PCR Detection                   
Table 8.92    Qiagen Assays for Genetic Analysis                       
Table 8.93    Qiagen Pyrosequencing-Based Genetic Analysis Products               
Table 8.94    Specifications and Features of Qiagen’s QIAsymphony and QIAsymphony RGQ       
Table 8.95    Roches Personalized Medicine Products by Patient Stage                
Table 8.96    ThermoFisher Scientific Clinical Assays and Technologies for Personalized Healthcare   
Table 8.97    Transgenomic Technology Platforms                       
Table 8.98    Transgenomic Partnerships and Collaborations                   

Table 9.1    Global Market for Oncology Drugs by Geography/Country -  Through 2021       
Table 9.2    Top Ten Companies in Oncology Sales Forecast 2013 – 2021               
Table 9.3    Top Five Oncology Drugs -  Through 2021                       
Table 9.4     Submarkets within the Personalized Medicine Technology Market           
Table 9.5     Global Market for Liquid Biopsy by Region (North America
-  Europe
-  RoW)
-  to 2021   
Table 9.6    Operating Profit Margin Analysis for Selected Players in the PM Industry       
Table 9.7    Personalized Medicine Industry Segments and Companies Analysed           
Table 9.8:     Drug Classes Investigated by 23andMe Using Genome Wide Association Studies   
Table 9.9:     Acquisition Profile of Affymetrix                           
Table 9.10:     Genetic Applications of Axiom® Technology by Affymetrix               
Table 9.11:    Diversified Business Units of Affymetrix                       
Table 9.12:     Affymetrix AgBio Microarray Portfolio                       
Table 9.13:     Celera (Quest Diagnostics) Historic Operating (Loss) Laboratory Services & Products    
Table 9.14:     Diagnostic Test Product Manufactured by BHL/Celera & Distributed by Abbott       
Table 9.15:     Celldex Therapeutics R&D Expenses ($ Thousands) 2010-2012           
Table 9.16:     Price Listing of Genelex Familial Genetic Tests                   
Table 9.17:     Myriad - Core Business Decisions and Impact on Industry                
Table 9.18:     Future Test Portfolio of Myriad                           
Table 9.19:     Nodality’s Single Cell Network Profiling (SCNP) for Drug Discovery & Validation   
Table 9.20:     BioMerieux Immunodiagnostic Product Portfolio                   
Table 9.21:     BioMerieux Microbiology Product Portfolio                       
Table 9.22:     BioMerieux Molecular Diagnostic Product Portfolio                   

Table 10.1:    Strengths and Advantages of Genotyping Techniques                   
Table 10.2:     Strengths -  Drivers and Advantages of Personalized Medicine Market          

Table 11.1:    Restraints of Personalized Medicine Market                       

Table 12.1:    Summary of Clinical Laboratory Improvement Amendments (CLIA)                    
Table 12.2:    Clinical Laboratory Improvement Amendments (CLIA) Testing Categories       
Table 12.3:    Test Features required prior to FDA Approval and Clearance               
Table 12.4:     Impact of Genetic Information Non-discrimination Act (GINA) on Healthcare Companies & Health Plans                                   
Table 12.5:    Impact of Genetic Information Non-discrimination Act (GINA) on US Employers
-  employment agencies
-  labor organizations and training programs           
Table 12.6:    FDA Commitment to the Personalized Medicine Industry               
Table 12.7:    Objectives of the ‘Advancing Regulatory Science at FDA: A Strategic Plan’       
Table 12.8:     FDA Policy & Guidance Recommendations                       
Table 12.9:     Implementation Strategy of the FDA to Advance Regulatory Science - Develop better Models of Human Adverse response                           
Table 12.10:    Implementation Strategy of the FDA to Advance Regulatory Science - Identify and evaluate biomarkers and endpoints that can be used in non-clinical & clinical evaluations       
Table 12.11:     Implementation Strategy of the FDA to Advance Regulatory Science - Use and develop computational methods and in silico modelling                   
Table 12.12:     National Institutes of Health Genetic Testing Registry Test Information                              

Table 13.1     2015 Targeted Therapeutic  and Companion Diagnostic FDA Drug Approvals       

List of Figures

Figure 2.1:     DNA
-  Histones and Chromosomes                           
Figure 2.2:     DNA is Composed of Four Nucleotide Bases                   
Figure 2.3:     The Central Dogma of Molecular Biology – How DNA Encodes Protein       
Figure 2.4:    How Research
-  Technology
-  Regulation
-  Clinical Implementation and Legislation Integrates into Personalized Medicine                           
Figure 2.5    Identification of Good and Non-Responders in a Patient Population           
Figure 2.6    Pharmacodynamic and Pharmacokinetic Examples of Drug Targets and Drug metabolism in Pharmacogenomics                               
Figure 2.7    Flow Diagram of Pharmacogenetic Analysis                       
Figure 2.8:    Primer Based Base Extension in Pharmacogenetics                   
Figure 2.9:    Genetic Mutation Detection by Hybridization                   
Figure 2.10:    Ligation based SNP Detection                           
Figure 2.11    New-Generation Sequencing: Pyrosequencing                   
Figure 2.12    Number of Companion Diagnostic Deals Signed on a Yearly Basis           
Figure 2.13    Percentage of Cancer Patients with Genetic Mutations that could be Treated by Targeted Therapy                                       
Figure 2.14     Detection of Cell Free cfDNA in Cancer Patients – Timeline of Events           
Figure 2.15    Cell Free Nucleic Acids Present in Blood from Cancer Patients           
Figure 2.16    Detection of cfDNA and its Alterations in Different Forms of Cancer           
Figure 2.17     CANCER-ID Consortium Global Location of Collaborators               
Figure 2.18     CANCER-ID Consortium Work Package Outline                   
Figure 2.19     Use of Tumor Educated Blood Platelet mRNA Expression Levels in Liquid Biopsies   
Figure 2.20    Types of Tumor Heterogeneity- Intratumor
-  Interpatient
-  Inter/intrametastatic       
Figure 2.21     Tumor Clonal Evolution as Depicted in a Phylogenetic Tree               
Figure 2.22    Mechanisms of Resistance to Targeted Therapies (Vemurafenib
-  Crizotinib
-  EGFR MAbs
-  Imatinib)                               
Figure 2.23    Next Generation Functional Diagnostics in Cancer                   

Figure 3.1:    Warfarin Metabolism and Response                       
Figure 3.2:     Percentage Frequency of CYP2C9 and VKORC1 mutations in Caucasian
-  African-American and Asian Populations                               
Figure 3.3:    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 10
- 000 of Breast Cancer Globally   
Figure 3.8:    HER2 Testing Algorithm for Breast Cancer                       
Figure 3.9:    HER2 Cellular Signalling                               
Figure 3.10:    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 3.13:    ALK Cellular and Nuclear Signalling Pathway                   
Figure 3.14:    ALK-Positive Cancers by Fusion Protein -  ALK expression & Point Mutations       

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 & 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:    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 6.8:     Key Information about UNICANCER France                   
Figure 6.9:     Strategic Flow Diagram of UNICANCER France and its Operations           

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    Flow Diagram of Celera CEGA -16™ Instrument for Cystic Fibrosis Gene Analysis   
Figure 8.2            Celldex Therapeutics Product Pipeline                       
Figure 8.3    Percentage of Individual Populations who have an Increased Risk of Developing Type 2 Diabetes as Determined Using the deCodeT2 Genetic Test               
Figure 8.4    FoundationOne and FoundationOne Heme Platforms                   
Figure 8.5    Tumor Microenvironment Showing Infiltrating Immune Cells               
Figure 8.6    HalioDx ImmunoScore System                           
Figure 8.7    Human Longevity Inc (Cypher Genomics) Mantis Technology Platform           
Figure 8.8    Illumina New Generation Sequencing Technology Workflow Station           
Figure 8.9    Monogram Biosciences HIV Assay Porfolio Timeline                   
Figure 8.10    Single Cell Network Profiling (SCNP) Technology by Nodality           
Figure 8.11    Developed Functional Assays that Nodality has explored using SCNP Technology   
Figure 8.12    Sanofi Late Stage Product Pipeline                           
Figure 8.13    Sanofi Pipeline Products in Stage I                           
Figure 8.14    Sanofi Pipeline Products in Stage II                           
Figure 8.15    Takeda Pipeline Portfolio of Oncology and Gastrointestinal Therapeutics       
Figure 8.16    Millenium Takeda Oncology Development Pipeline                   
Figure 8.17    Vertex Pharmaceuticals Cystic Fibrosis
-  Oncology
-  Pain & Influenza Pipeline Products   

Figure 9.1    Personalized Targeted Therapeutic Sales Revenue
-  All Indications                  
Figure 9.2    Personalized Targeted Therapeutic Market
-  All Indications
-  2014-2021           
Figure 9.3    Companion Diagnostic and Targeted Therapeutic Personalized Medicine Market Growth   
Figure 9.4    Companion Diagnostic Market 2014-2021                       
Figure 9.5    Combined Targeted Therapeutic and Companion Diagnostic Market
-  2014-2021       
Figure 9.6    Global Market for Oncology Drugs by Geography/Country
-  Through 2021       
Figure 9.7    Global Oncology Drug Sales by Top Five Companies
-  Through 2021           
Figure 9.8    Top Five Oncology Drugs
-  Through 2021                       
Figure 9.9    Global Oncology Market by Cancer Type                           
Figure 9.10    Global Personalized Medicine Oncology Therapeutics Forecast 2014-2021       
Figure 9.11    HER-2 Positive Breast Cancer Therapeutic Market Forecast 2014-2021           
Figure 9.12    Personalized Medicine Oncology Therapeutic Market Forecast 2014-2021       
Figure 9.13    Personalized Medicine Branded Oncology Therapeutics Market Share 2016       
Figure 9.14    Personalized Medicine Branded Oncology Therapeutics Market Share 2021       
Figure 9.15    Top Pharma Companies Revenue from Targeted Therapeutics in Oncology       
Figure 9.16    Global Cancer Companion Diagnostics Market 2014-2021               
Figure 9.17    Most Popular Proteomic and Genomic Technologies Performed by End-Users       
Figure 9.18    Oncogenic Biomarker Share of Total Personalized Medicine Biomarker Space       
Figure 9.19    Oncogenic Biomarker Market Distribution by Cancer Type               
- Figure 9.20    Personalized Medicine Branded Cardiovascular Therapeutic Market 2014-2021       
Figure 9.21    Personalized Medicine Branded Cardiovascular Therapeutics Market Forecast 2014-2021   
Figure 9.22    Cardiovascular Companion Diagnostics Market Forecast 2014-2021           
Figure 9.23    Personalized Medicine Branded Infectious Disease Therapeutics Market 2014-2021   
Figure 9.24    Gilead Sciences Sovaldi and Harvoni Sales Revenue 2014-2021           
Figure 9.25    HIV and Hepatitis Diagnostic Assay Market Growth 2014 to 2021           
Figure 9.26    Global Market Personalized Medicine Technology Growth 2009-2015           
Figure 9.27    Global Personalized Sub-market Growth 2015                   
Figure 9.28    Personalized Medicine Sub-Market Share (Percentage) 2009               
Figure 9.29    Personalized Medicine Sub-Market Share (Percentage) 2014               
Figure 9.30    Global Genomic Testing Market Forecast 2014-2021                   
Figure 9.31    Pharmacogenetics Market Forecast 2014-2021                   
Figure 9.32    Global Molecular Diagnostics Predicted Market Share (%) 2015           
Figure 9.33    Global Molecular Diagnostics Market (US$) 2015                   
Figure 9.34    Global Market for Molecular Diagnostics through 2021               
Figure 9.35    Global Market for Liquid Biopsy by Geography (North America
-  Europe
-  RoW)
-  Through 2021                                       
Figure 9.36    Average Operating Profit Margin Analysis for Selected Players in the Personalized Medicine Industry                                        
Figure 9.37    Oncology
-  Infectious Disease
-  Cardiovascular and Genomic Submarket Operating Profit Margins                                       
Figure 9.38    Personalized Medicine Oncology Submarket Operating Profit Margin Analysis       
Figure 9.39    Personalized Medicine Infectious Disease Submarket Operating Profit Margin Analysis   
Figure 9.40    Personalized Medicine Cardiovascular Submarket Operating Profit Margin Analysis   
Figure 9.41    Personalized Medicine Genomics Submarket Operating Profit Margin Analysis       
Figure 9.42     Private Funding Gained by 23andMe                                
Figure 9.43     Affymetrix Revenue by Business Segment (Percentage)               
Figure 9.44     Affymetrix Revenue From Affymetrix Core and eBioscience (Percentage)       
Figure 9.45     Affymetrix Total Revenue                                        
Figure 9.46     Affymetrix Revenue by Product Division – Consumables
-  Instruments                    
Figure 9.47     Affymetrix Core Product Sales – Gene Expression
-  Genetic Analysis & Clinical Applications and Life Science Reagents                                         
Figure 9.48    Affymetrix Revenue Derived from Outside the US                      
Figure 9.49     Affymetrix Revenue Derived from the US                                   
Figure 9.50     Affymetrix Net Loss                                      
Figure 9.51     Affymetrix Research and Development Funding                   
Figure 9.52     Affymetrix Revenue Generated within USA (Percentage)                
Figure 9.53     Astex Pharmaceuticals Priority Pipeline Products SGI-110 and AT13387 by Indication
-  Clinical Phase and Timeline                           
Figure 9.54     Astex Pharmaceuticals Revenue Generated                        
Figure 9.55     Astex Pharmaceuticals Net Income                            
Figure 9.56     Atossa Genetics Total Revenue (US$)                        
Figure 9.57     Atossa Genetics Revenue (US$) Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing                               
Figure 9.58     Atossa Genetics Percentage Revenue Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing                           
Figure 9.59     Quest Diagnostics Revenue ($ Billions)                        
Figure 9.60     Quest Diagnostics Operating Revenue ($ Billions)                    
Figure 9.61     Quest Diagnostics Net Income ($ Billions)                        
Figure 9.62     Celera (Quest Diagnostics) Historic Revenue Generated                
Figure 9.63     Celera (Quest Diagnostics) Historic Gross Margin Generated                
Figure 9.64     Celera (Quest Diagnostics) Historic Revenue Generated– Laboratory Services and Products                                    
Figure 9.65     Celera (Quest Diagnostics) Historic Revenue (%) Generated by Distribution Agreement with Abbott                                        
Figure 9.66    Celera (Quest Diagnostics) Historic Research and Development Spending        
Figure 9.67     deCode Genetics Historic Net Loss Incurred                        
Figure 9.68     Illumina Revenue Generated ($ Billions)                        
Figure 9.69     Illumina Net Income Generated ($ Billions)                        
Figure 9.70     Myriad Revenue Generated                            
Figure 9.71     Operating Income Generated by Myriad                        
Figure 9.72     Myriad Revenue Generated by Molecular Diagnostic Testing and Pharmaceutical and Clinical (Companion Diagnostic) Services                        
Figure 9.73     Future Molecular Diagnostic Pipeline of Myriad                   
Figure 9.74     Customer Profile of Qiagen – Percentage of Net Sales                
Figure 9.75     Qiagen Global Net Sales                                
Figure 9.76     Qiagen Operating Income                                
Figure 9.77     Qiagen Global Net Income                            

Figure 10.1:    Percentage Oncology (Lung
-  Colorectal
-  Breast
-  Prostate) Patients Undergoing Next Generation Sequencing Testing in the US
-  2018                              
Figure 10.2:     Pipeline and On-market Oncology (Lung
-  Breast
-  Colorectal
-  Prostate) Therapeutics Directed Against Specific Mutations

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  • 23andMe
  • Abbott Laboratories
  • Abbott Molecular Inc.
  • Admera Health (GENEWIZ)
  • Affymetrix
  • Agendia
  • Alere
  • Amgen
  • Astex Pharmaceuticals
  • AstraZeneca
  • Atossa Genetics
  • Becton Dickenson
  • bioMerieux
  • BristolMyersSquibb
  • Cancer Genetics
  • Celera (Quest Diagnostics)
  • Celldex Therapeutics
  • Claritas Genomics
  • CuraGen
  • Danaher (Leica Biosystems)
  • deCode Genetics (Amgen)
  • EDP Biotech
  • ELDA BioTech
  • Eisai
  • Eli Lilly
  • Foundation Medicine
  • Genelex
  • GlaxoSmithKline
  • HalioDx
  • Human Longevity Inc (Cypher Genomics)
  • Ikonisys
  • Illumina
  • InterGenetics
  • Johnson & Johnson
  • LabCorp
  • Life Technologies
  • MDxHealth
  • Merck
  • MolecularMD Corporation
  • Monogram Biosciences
  • Myriad
  • NanoString Technologies
  • Nodality
  • Novartis MDx
  • Orion Genomics
  • Oxford BioTherapeutics
  • Pfizer
  • Qiagen
  • Roche Molecular Diagnostics
  • Sanofi
  • SensiGen
  • Siemens Healthcare Diagnostics
  • Takeda
  • Thermo Fisher Scientific
  • Transgenomic
  • Ventana (Roche)
  • Vermillion (Ciphergen)
  • Vertex Pharmaceuticals
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The methodology is available for download below.
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