Table of Content

Table of Contents
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 Summary
1.4.2 New Therapies and Companion Diagnostics Launched
1.4.3 Public and Private Funding for Personalized Medical Research
1.4.4 Personalized Medicine Market Forecast
1.4.5 Personalized Medicine Oncology Therapeutics & Diagnostics Market
1.4.6 Personalized Medicine Cardiovascular Therapeutics Market
1.4.7 Personalized Medicine Infection Disease Market
1.4.8 Personalized Medicine Geographical Market Share Analysis
1.4.9 Profit Margin Analysis on Major Players
1.4.10 Future of Personalized Medicine
2.0 Introduction to Precision/Personalized Medicine
2.1 Genetics Basis of Personalized Medicine
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
2.7.1.1 Adverse Drug Reactions
2.7.1.2 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 Introduction
2.9.1 Introduction
2.9.2 Companion Diagnostics in Clinical Trials
2.9.3 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™
3.13.5 FoundationOne CDx
3.13.6 Oncomine DX Target 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
5.3.1.1 RVU-CPT-ICD Coding System
5.3.2 Laboratory Service Payments in Personalized Medicine
5.3.3 Revisions to Current Payment System
5.4 Biorepositories and Biobanks
5.5 Intellectual Property and Personalized Medicine
6.0 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
8.3.7 LiquidGx
8.3.8 AtheroGxOne
8.3.9 CardioGxOne
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)
8.10.3 Lynparza (Olaparib)
8.10.4 Infinzi (Durvalumab)
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
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)
8.17.1 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
8.26.3 FoundationOne Liquid
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
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)
8.55.3 Symdeko/Symkevi
9.0 Personalized Medicine Market Analysis
9.1 Companion Diagnostic and Targeted Therapeutic Market
9.1.1 Global Oncology Therapeutic Market
9.1.2 Targeted Therapeutics – Oncology
9.1.3 Top Companies in Oncology Drug Sales to 2025
9.1.4 Top Oncology Drugs to 2025
9.1.5 Global Oncology Market by Cancer Type
9.1.6 Oncology Targeted Therapeutics Market Analysis to 2025
9.1.7 Companion Diagnostic Assays – Oncology Market to 2025
9.2 Cardiovascular Targeted Therapeutics Market to 2025
9.2.1 Cardiovascular Companion Diagnostics Market to 2025
9.3 Infectious Disease Targeted Therapeutics Market to 2025
9.3.1 Infectious Disease Diagnostic Assay Market to 2025
9.4 Global Personalized Medicine Market Geographical Analysis to 2025
9.5 Major Player Profit Margin Analysis
9.6 Select Market Participant Case Study Analysis
9.6.1 Affymetrix
9.6.2 Astex Pharmaceuticals
9.6.3 Quest Diagnostics
9.6.4 Celldex Therapeutics
9.6.5 deCode Genetics (Amgen)
9.6.6 Illumina
9.6.7 Genelex
9.6.8 Myriad
9.6.9 Qiagen
9.6.10 bioMerieux
10.0 Strengths and Advantages of Personalized Medicine
10.1 Sequencing of the Human Genome
10.2 Improving Patient Care and Reducing Side Effects
10.3 Personalized Medicine will Reduce Healthcare Costs
10.4 FDA and Global Regulatory Advances
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
14.0 Interviews with Key Opinion Leaders
• 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.
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: Selected EMA Approved Drugs that Require Companion Diagnostics
Table 2.33: Selected 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 Types of 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 8.52 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 – Oncology and Precision Medicine
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 2025
Table 9.2 Top Ten Companies in Oncology Sales Forecast 2017 – 2025
Table 9.3 Top Oncology Drugs, Through 2025
Table 9.4 Submarkets within the Personalized Medicine Technology Market
Table 9.5 Global Market for Liquid Biopsy by Region (North America, Europe, RoW)
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: Acquisition Profile of Affymetrix
Table 9.9: Genetic Applications of Axiom® Technology by Affymetrix
Table 9.10: Diversified Business Units of Affymetrix
Table 9.11: Affymetrix AgBio Microarray Portfolio
Table 9.12: Genelex Individual Gene Panel
Table 9.13: Myriad - Core Business Decisions and Impact on Industry
Table 9.14: Current Test Portfolio of Myriad
Table 9.15: BioMerieux Immunodiagnostic Product Portfolio
Table 9.16: BioMerieux Microbiology Product Portfolio
Table 9.17: 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 Select 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 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
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 by Select Companies, All
Indications
Figure 9.2 Personalized Targeted Therapeutic Market, All Indications, 2019-2025
Figure 9.3 Companion Diagnostic and Targeted Therapeutic Personalized Medicine
Market Growth 2019-2025
Figure 9.4 Personalized Companion Diagnostic Market 2019-2025
Figure 9.5 Combined Targeted Therapeutic and Companion Diagnostic Market, 2019-
2025
Figure 9.6 Global Market for Oncology Drugs by Geography/Country, Through 2025
Figure 9.7 Global Oncology Companies Revenue, Through 2025
Figure 9.8 Top Oncology Drugs, Through 2025
Figure 9.9 Global Oncology Market by Cancer Type 2019-2025
 
Figure 9.10 Global Personalized Medicine Oncology Therapeutics Forecast 2019-2025
Figure 9.11 HER-2 Positive Breast Cancer Therapeutic Market Forecast to 2025
Figure 9.12 Personalized Medicine Oncology Therapeutic Market Forecast 2019-2025
Figure 9.13 Personalized Medicine Branded Oncology Therapeutics Market Share 2019
Figure 9.14 Personalized Medicine Branded Oncology Therapeutics Market Share 2025
Figure 9.15 Top Pharma Companies Revenue from Targeted Therapeutics in Oncology
Figure 9.16 Global Cancer Companion Diagnostics Market 2019-2025
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 2019-2025
Figure 9.21 Personalized Medicine Branded Cardiovascular Therapeutics Market Forecast
2019-2025
Figure 9.22 Cardiovascular Companion Diagnostics Market Forecast 2019-2025
Figure 9.23 Personalized Medicine Branded Infectious Disease Therapeutics Market 2019-
2025
Figure 9.24 Select Personalized Medicine Infectious Disease Therapeutics Sales Revenue
Forecast 2019-2025
Figure 9.25 HIV and Hepatitis Diagnostic Assay Market Growth 2019 to 2025
Figure 9.26 Market Share by Geographic Region ($ Billions) 2019-2025
Figure 9.27 Percentage Geographical Breakdown of Total Personalized Medicine Market
2019 and 2025
Figure 9.28 Average Operating Profit Margin Analysis for Selected Players in the
Personalized Medicine Industry
Figure 9.29 Affymetrix Revenue by Business Segment (Percentage)
Figure 9.30 Affymetrix Revenue From Affymetrix Core and eBioscience (Percentage)
Figure 9.31 Astex Pharmaceuticals Priority Pipeline Products
Figure 9.32 Quest Diagnostics Revenue ($ Billions)
Figure 9.33 Quest Diagnostics Routine Clinical Test Revenue 2017-2019
Figure 9.34 Quest Diagnostics Gene-Based and Esoteric Test Revenue 2017-2019
Figure 9.35 Quest Diagnostics Anatomic Pathology Test Revenue 2017-2019
Figure 9.36 Illumina Revenue Generated ($ Billions)
Figure 9.37 Illumina Sequencing Consumables Income Generated ($ Billions)
Figure 9.37: Illumina Microarray Consumables Income Generated ($ Billions)
Figure 9.38 Myriad Revenue Generated
Figure 9.39 Operating Income Generated by Myriad
Figure 9.40 Myriad Revenue Generated by Molecular Diagnostic Testing and
Pharmaceutical and Clinical (Companion Diagnostic) Services
Figure 9.41 Myriad Hereditary Cancer Test Revenue
Figure 9.42 Myriad EndoPredict, Polaris, Vectra, Prenatal and GeneSight Revenue
Figure 9.43 Customer Profile of Qiagen – Percentage of Net Sales
Figure 9.44 Qiagen Global Net Sales
Figure 9.45 Qiagen Operating Income
Figure 9.46 Qiagen Global Net Income/Loss
Figure 10.1 The Future of Personalized Medicine
Figure 10.2: Percentage Oncology (Lung, Colorectal, Breast, Prostate) Patients Undergoing
Next Generation Sequencing Testing in the US
Figure 10.3: Pipeline and On-market Oncology (Lung, Breast, Colorectal, Prostate)
Therapeutics Directed Against Specific Mutations
Figure 13.1 Personalized Medicine Percentage of FDA Approvals 2014-2019