Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market to 2025- Strategic Analysis of Industry Trends, Technologies, Participants, and Environment
“Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market: Strategic Analysis of Industry Trends, Technologies, Participants, and Environment ” by Kelly Scientific Publications is a comprehensive report and financial forecast to 2025 on the precision medicine industry and its impact on the health system. This report tackles the growing market interest in pharmacogenomics, targeted therapeutics, companion diagnostics and the associated market environment.
In 2019, 11 personalized therapeutics gained approval from the the FDA’s Center for Drug Evaluation and Research (CDER) including a gene therapy and a small interfering ribonucleic acid (siRNA) based therapy. Over 20% of all new approvals in 2019 were personalized therapeutics and in 2018 alone, 42% were personalized medicines (25 agents). This was an increase from 34% in 2017 and 27% in 2016. Individualized, targeted or personalized medicine aims to increase the efficacy of therapeutics via genetic testing and companion diagnostics. Personalized therapeutics and associated companion diagnostics will be more specific and effective thereby giving pharma/biotech companies a significant advantage to recuperate R&D costs. Personalized medicine will reduce the frequency of adverse drug reactions and therefore have a dramatic impact on health economics. Developmental and diagnostic companies will benefit from lower discovery and commercialization costs and more specific market subtypes.
This report describes the current technologies that are propelling the personalized medicine and companion diagnostic market. It examines the current genetic diagnostic tests and companion diagnostic assays that are in use by the medical and pharmaceutical industry today. Current developments in personalized medicine and the pharmacogenomics revolution are discussed. The emerging trends that appear in key markets such as the US, UK, Germany and France are elucidated and analysed. This study reveals market figures of the overall personalized medicine market and also sub-market figures.
The study also provides a comprehensive financial and product review of key players in the personalized medicine industry. Strategic drivers and restraints of this market are revealed and market opportunities and challenges are identified.
In summary, the personalized therapeutic and associated companion diagnostic market have huge opportunities for growth. This industry is revolutionizing the healthcare system and will improve therapeutic effectiveness and reduce the severity of adverse effects. It has enormous potential for investment and the emergence of genetic-based in vitro diagnostics. 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 470 pages. The personalized medicine market is presented as follows:
In 2019, 11 personalized therapeutics gained approval from the the FDA’s Center for Drug Evaluation and Research (CDER) including a gene therapy and a small interfering ribonucleic acid (siRNA) based therapy. Over 20% of all new approvals in 2019 were personalized therapeutics and in 2018 alone, 42% were personalized medicines (25 agents). This was an increase from 34% in 2017 and 27% in 2016. Individualized, targeted or personalized medicine aims to increase the efficacy of therapeutics via genetic testing and companion diagnostics. Personalized therapeutics and associated companion diagnostics will be more specific and effective thereby giving pharma/biotech companies a significant advantage to recuperate R&D costs. Personalized medicine will reduce the frequency of adverse drug reactions and therefore have a dramatic impact on health economics. Developmental and diagnostic companies will benefit from lower discovery and commercialization costs and more specific market subtypes.
This report describes the current technologies that are propelling the personalized medicine and companion diagnostic market. It examines the current genetic diagnostic tests and companion diagnostic assays that are in use by the medical and pharmaceutical industry today. Current developments in personalized medicine and the pharmacogenomics revolution are discussed. The emerging trends that appear in key markets such as the US, UK, Germany and France are elucidated and analysed. This study reveals market figures of the overall personalized medicine market and also sub-market figures.
The study also provides a comprehensive financial and product review of key players in the personalized medicine industry. Strategic drivers and restraints of this market are revealed and market opportunities and challenges are identified.
In summary, the personalized therapeutic and associated companion diagnostic market have huge opportunities for growth. This industry is revolutionizing the healthcare system and will improve therapeutic effectiveness and reduce the severity of adverse effects. It has enormous potential for investment and the emergence of genetic-based in vitro diagnostics. 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 470 pages. The personalized medicine market is presented as follows:
- By Company (e.g., QIAGEN, AFFYMETRIX, ATOSSA GENETICS, NODALITY, deCode /Amgen, CELERA, MYRIAD)
- By Segment (Targeted therapeutics, Companion Diagnostics)
- By Sub-market (Cancer, Cardiovascular, Infectious Disease)
- By Geography (North America, Europe, RoW)
- 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
- Cost-effectiveness and Business Value of Personalized Medicine
- Consumer genomics and POC market
- Therapeutics and Companion Diagnostics (e.g., BRAC Analysis, Oncotype Dx, KRAS Mutations)
- Comprehensive Account of Company Product Portfolios & Kits
- 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 (US, UK, Germany, France, Spain, Italy)
- CE-Marked Personalized Medicine/Diagnostic Tests
- FDA Advances in Personalized Medicine Regulation
- 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)
- Foundation Medicin
- EDP Biotech
- Eli Lilly
- ELDA BioTech
- Eisai
- Genelex
- GlaxoSmithKline
- Human Longevity Inc (Cypher Genomics)
- HalioDx
- Ikonisys
- Illumina
- InterGenetics
- Johnson & Johnson
- LabCorp
- Life Technologies
- Merck
- MDxHealth
- MolecularMD Corporation
- Monogram Biosciences
- Myriad
- Nodality
- Novartis MDx
- Orion Genomics
- Oxford BioTherapeutics
- NanoString Technologies
- Pfizer
- Qiagen
- Roche Molecular Diagnostics
- Sanofi
- SensiGen
- Siemens Healthcare Diagnostics
- Takeda
- Thermo Fisher Scientific
- Transgenomic
- Ventana (Roche)
- Vermillion (Ciphergen)
- Vertex Pharmaceutical
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 KRASMutations
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
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 KRASMutations
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 BRCA1and BRCA2Genes
Table 3.14: Prevalence of Deleterious Mutations in BRCA1and BRCA2in 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 Oncology Phase III Product Pipeline
Table 8.15: Selected Programs in Pivotal Trial (Phase III) or Development, Amgen
Table 8.16 Advantages of Astex Pharmaceuticals Pyramid Fragment-Drug-Discovery System
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 in the US
Table 8.32: Cephid Product Portfolio 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 State 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 – 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 1
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 BRCA1and BRCA2Genes
Table 3.14: Prevalence of Deleterious Mutations in BRCA1and BRCA2in 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 Oncology Phase III Product Pipeline
Table 8.15: Selected Programs in Pivotal Trial (Phase III) or Development, Amgen
Table 8.16 Advantages of Astex Pharmaceuticals Pyramid Fragment-Drug-Discovery System
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 in the US
Table 8.32: Cephid Product Portfolio 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 State 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 – 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 1
“Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market 2015 Strategic Analysis of Industry Trends, Technologies, Participants, and Environment” by Kelly Scientific Publications is a comprehensive report on the personalized medicine industry and its impact on the health system. This report tackles the growing market interest in pharmacogenomics, targeted therapeutics, companion diagnostics and the associated market environment.
Individualized, targeted or personalized medicine aims to increase the efficacy of therapeutics via genetic testing and companion diagnostics. Personalized therapeutics and associated companion diagnostics will be more specific and effective thereby giving pharma/biotech companies a significant advantage to recuperate R&D costs. Personalized medicine will reduce the frequency of adverse drug reactions and therefore have a dramatic impact on health economics. Developmental and diagnostic companies will benefit from lower discovery and commercialization costs and more specific market subtypes.
This report describes the current technologies that are propelling the personalized medicine and companion diagnostic market. It examines the current genetic diagnostic tests and companion diagnostic assays that are in use by the medical and pharmaceutical industry today. Current developments in personalized medicine and the pharmacogenomics revolution are discussed. The emerging trends that appear in key markets such as the US, UK, Germany and France are elucidated and analysed. This study reveals market figures of the overall personalized medicine market and also sub-market figures.
The study also provides a comprehensive financial and product review of key players in the personalized medicine industry. Strategic drivers and restraints of this market are revealed and market opportunities and challenges are identified.
In summary, the personalized medicine and associated companion diagnostic market have huge opportunities for growth. This industry will revolutionize the healthcare system and will improve therapeutic effectiveness and reduce the severity of adverse effects. It has enormous potential for investment and the emergence of genetic-based in vitro diagnostics.
