Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market to 2025- Strategic Analysis of Industry Trends, Technologies, Participants, and Environment

Abstract
“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:

•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)

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

•Company Financials, Sales & Revenue Figures
•Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies
•Business Model Strategies for Providers, Provider Systems and Academic Medical Centres
•Business Model Strategies for Payers & Governments
•Private and Public Funding and Personalized Medicine Reimbursement
•Revisions to Current Payment Systems and Intellectual Property
•How to Gain Market Penetration
•Cost-effectiveness and Business Value of Personalized Medicine
•Consumer genomics and POC market
•Therapeutics and Companion Diagnostics (e.g., BRAC Analysis, Oncotype Dx, KRAS Mutations)
•Comprehensive Account of Company Product Portfolios & Kits

SWOT, Economic & Regulatory Environment specifics include:

•Key Strengths, Weaknesses and Threats Influencing Leading Player Position within the Market
•Technologies Driving the Market (e.g., New-Generation Sequencing Technologies, Ultra-High Throughput Sequencing)
•Top Fastest Growing Market Segments and Emerging Opportunities
•Top Pharmaceutical Companies within the IPM by Market Share and Revenue
•Comprehensive Product Portfolios, R&D Activity and Pipeline Therapeutics
•M&A Activity and Future Strategies of Top Personalized Medicine Pharmacos
•Personalized Medicine Regulation (US, UK, Germany, France, Spain, Italy)
•CE-Marked Personalized Medicine/Diagnostic Tests


•FDA Advances in Personalized Medicine Regulation

This report highlights a number of significant players and influential company’s and gives details of their operations, products, financials and business strategy.



•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 Medicine
•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


Updates on the Personalized medicine, targeted therapeutic and companion diagnostic space have been included in this latest edition to include cutting edge material from international conferences, workshops and symposia.

Content
1.0 Executive Summary
1.1 Objectives of Report
1.2 Scope of Study
1.3 Data Sources and Methodology
1.4 Key Findings and Observations
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
2.9.2 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-StatinCheck TM Genotype Test
8.17.9 LPA-AspirinCheck TM Genotype Test
8.17.10 9p21-EarlyMICheck TM 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