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

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Date: 01-May-2017
No. of pages: 397

Description

This is a comprehensive account of the market size, segmentation, key players, SWOT analysis, influential technologies, and business and economic environments. The report is supported by over 360 tables & figures over 397 pages. The personalized medicine (global & USA) market is presented as follows:


  • By Company (e.g., Qiagen, AFFYMETRIX, ATOSSA GENETICS, NODALITY, deCode /Amgen, CELERA, MYRIAD)

  • By Segment (Targeted therapeutics, Companion Diagnostics, Liquid Biopsies)

  • By Sub-market (Companion diagnostic, targeted cancer therapeutic, medical technology, pharmacogenomics, consumer genomics, molecular diagnostics, liquid biopsy) By Therapy (Cancer, Cardiovascular, Infectious Disease)


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


  • Iain D. Miller, PhD, MBA, Founder & CEO, Healthcare Strategies Group

  • Stephen Finn, MBBS, PhD, Associate Professor, Cancer Molecular Diagnostic Laboratory, Consultant Histopathologist and Head of Histopathology, St James’s Hospital and Trinity College Dublin, Ireland

  • Ronald Przygodzki, MD, Director, Genomic Medicine Implementation at U.S. Department of Veterans Affairs, Washington DC

  • Elaine Kenny, PhD, Founder, Elda Biotech, Dublin 2, Ireland

  • Chad Clark, Co-President and Chief Operating Officer, Precision for Medicine

  • Tobias Guennel, PhD, Principal, Biomarker and IVD Analytics, Precision for Medicine

  • David Parker, PhD, Vice President, Integrated Market Access, Precision for Medicine

  • Deborah Phippard, PhD, Vice President, Research, Precision for Medicine

  • Judi Smith, MS, Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine


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


  • Company financials, sales & revenue figures

  • Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies

  • Business Model Strategies for Providers. Provider Systems and Academic Medical Centres

  • Business Model Strategies for Payers & Governments

  • Private and Public Funding and Personalized Medicine Reimbursement

  • Revisions to Current Payment Systems and intellectual property

  • How to Gain Market Penetration in the EU

  • Cost-effectiveness and Business Value of Personalized Medicine

  • Therapeutics and Companion Diagnostics (e.g., BRAC Analysis, Oncotype Dx , KRAS Mutations)

  • Comprehensive account of company product portfolios & kits


SWOT, Economic & Regulatory Environment specifics include:


  • Key strengths, weaknesses and threats influencing leading player position within the market

  • Technologies driving the market (e.g., New-Generation Sequencing Technologies, Ultra-High Throughput Sequencing)

  • Top fastest growing market segments and emerging opportunities

  • Top pharmaceutical companies within the IPM by market share and revenue

  • Comprehensive product portfolios, R&D activity and pipeline therapeutics

  • M&A activity and future strategies of top personalized medicine pharmacos

  • Personalized Medicine Regulation (USA, UK, Germany, France, Spain, Italy)

  • CE-marked Personalized Medicine/Diagnostic Tests

  • FDA Advances in Personalized Medicine Regulation


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


  • 23andMe

  • Abbott Laboratories

  • Abbott Molecular Inc.

  • Admera Health (GENEWIZ)

  • Affymetrix

  • Agendia

  • Alere

  • Amgen

  • Astex Pharmaceuticals

  • AstraZeneca

  • Atossa Genetics

  • Becton Dickenson

  • bioMerieux

  • BristolMyersSquibb

  • Cancer Genetics

  • Celera (Quest Diagnostics)

  • Celldex Therapeutics  

  • Claritas Genomics

  • CuraGen

  • Danaher (Leica Biosystems)

  • •  deCode Genetics (Amgen)

  • 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 Pharmaceuticals


 What you will gain:


  • An in-depth understanding of the global personalized medicine market and it’s environment

  • Current market facts, figures and product lines of key players in the industry

  • Emerging trends in key markets such as the US, UK, Germany and France

  • Knowledge of how the personalized medicine market will integrate into the global healthcare market

  • Technical insights into new generation sequencing technologies and ultra-high throughput sequencing

  • Updates on bioinformatics, high throughput systems, genetic analysis kits, companion diagnostics and future technologies

  • FDA approved pharmacogenetic tests and recognized biomarkers

  • Information on key government and regulatory policies

  • Strategies on how to adapt and restructure current business models to this industry


This report tackles key concerns to the personalized medicine market such as:


  • Lack of regulatory policy and legislation in the US and Europe

  • Reimbursement schemes and payers concerns

  • Transition of investigational diagnostic assays and therapeutics to clinical practice

  • Direct to consumer (DTC) test kits and implications for the public


Who should read this report?


  • Pharmaceutical, biotechnology and diagnostic companies (CEOs, VPs, Business Development, C-Suite)with an interest in personalized medicine

  • Industry professionals and business strategists will discover key information to propel their policies

  • Investors will gain inside information to dominant players in the industry and future forecasts

  • Scientists will get a business perspective and industry insight into how scientific breakthroughs influence the market environment


This report will tell you if the companies mentioned are:


  • Strong, competitive players

  • Pooling their resources for specific growth and therapeutic areas

  • Investing strategically in R&D

  • Have a history of strategic M&A activity


This detailed report is supported with 360 figures and tables over 397 pages and profiles the main pharmacos in personalized medicine.


  • Benefits of Investing in our Cutting-Edge Reports:

  • Clients receive complementary content* with mid-level and enterprise wide licences

  • Post-sale complementary consultation with senior expert analyst is included

  • Use of tables and figures in your own reports and presentations is permitted

  • Each report provides straight-talking strategic analysis & sector intelligence

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Executive Summary

Kelly Scientific forecasts that the companion diagnostic and targeted therapeutic submarkets of the personalized medicine industry were worth $113 billion in 2016, and will hit over $162 billion by 2021 with a CAGR of 8.74%. The total personalised therapeutic market, for all indications, will be worth $x billion by 2021, with a CAGR of x%. Currently it is estimated that the companion diagnostic segment is worth $x billion globally, mainly coming from oncology, cardiovascular and infectious disease (HIV/HCV) tests. This is set to rise vertically over the next five years and by 2021 will be worth over $x billion, with a CAGR of x%.

This study details a comprehensive financial and strategic review of key players in the personalized medicine industry. Significant drivers and restraints of this market are revealed and market opportunities and challenges are identified. Disruptive technologies that are propelling the personalized medicine and companion diagnostic market are scrutinized. 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 with respect to companion diagnostics, targeted cancer therapeutics, medical technologies, pharmacogenomics, consumer genomics, molecular diagnostics and liquid biopsies.  Specific indication markets are also included such as cancer, cardiovascular and infectious disease.

The report provides value and growth of the global personal therapeutics market from 2017-2021. Also historic figures back to 2014 are given to illustrate growth. As the personal targeted therapeutics market is part of the overall personalized medicine market, the companion diagnostics market is also included in the report

The report goes into detail regarding different indications, mainly oncology drugs as these hold most market share, and also cardiovascular and infectious disease markets.

It contains specific data for both the targeted therapeutic and companion diagnostic sections of the personalized medicine market.

These sections are then further divided into indications – Oncology, Cardiovascular and Infectious Disease

The report also analyses the market with regards to major players such as GSK, Amgen, Sanofi, Novartis, Janssen, BMS, Pfizer, AstraZeneca, Roche.

To give an comprehensive view of how the PM market relates to associated markets, a number of these are analysed and forecast to 2021 (medical technology, pharmacogenomics, consumer genomics, molecular diagnostics, liquid biopsy).

For example, data from the targeted therapeutics section includes the following specifics:


  • Targeted Therapeutic Sales Revenue, All Indications (by Company, GSK, Amgen, Sanofi, Novartis, Janssen, BMS, Pfizer, AstraZeneca, Roche).

  • Global Targeted Therapeutic Market, All Indications, Forecast 2014-2021

  • Global Oncology Targeted Therapeutics Forecast 2014-2021

  • HER-2 Positive Breast Cancer Targeted Therapeutic Market Forecast 2014-2021

  • Oncology Targeted Therapeutic Market Forecast By Drug  2014-2021 (Herceptin Erbitux Gilotrif Gleevec Mekinist Tafinlar Zelboraf Tarceva Xalkori Zelboraf Kadcyla Perjeta Adcetris Xeloda Afinitor, Faslodex Iressa, Revlimid Avastin Alimta)

  • Branded Oncology Therapeutics Market Share 2014-2021 (Herceptin Erbitux Gleevec Tarceva Kadcyla Perjeta Xeloda Afinitor Revlimid Avastin Alimta)

  • Top Pharma Companies Revenue from Targeted Therapeutics in Oncology (Roche, Novartis, Janssen, BMS, AstraZeneca, Sanofi, GSK, Pfizer, Amgen, Eli Lilly)

  • Branded Cardiovascular Targeted Therapeutic Total Market 2014-2021

  • Branded Cardiovascular Targeted Therapeutics Market Forecast by Drug 2014-2021 (Metoprolol, Bidil, Plavix, Carvedilol)

  • Infectious Disease Targeted Therapeutics Market to 2014 - 2021

  • Branded Infectious Disease Targeted Therapeutics Market by Drug 2014-2021 (Incivek, Pegasys, Selzentry, Ziagen, Sovaldi, Harvoni)


Similarly, data for the companion diagnostic section is given.

Personalized Medicine Targeted Therapeutics – Oncology

In order to get an in depth understanding of the oncology therapeutics section within the personalized medicine market it is important to initially review the global oncology therapeutics market. Oncology continues to be an area of high unmet need and product revenue potential. Oncology is the largest global therapeutic area, with global sales of $x billion in 2016; that is anticipated to reach $x billion by 2021. Increasing cancer prevalence globally is a major driver of the market, and this is further underlined by more sensitive diagnostics and screening methods. The predicted revenue growth in the oncology space is reinforced by increasing cancer prevalence, as well as advances in diagnosis methods and screening programs. The current trend is that patients are advancing to 2nd, 3rd and 4th line therapy regimes, and so this progression further expands the market.

A significant driver of revenue growth is the cost of oncology therapeutics and biologics. For example, Yervoy (BMS) annual costs are $x for four doses. Another example is Dendreon’s Provenge which has an annual cost of $x for three doses. This significant increase in the price of oncology therapeutics has expanded the market, even though price reductions have been fought for by payers.

Targeted Cancer Therapeutics

Targeted cancer therapeutic sales have significantly risen in the recent past with a x% increase from 2013 to 2014 alone. The global oncology market is currently booming and one of the main reasons for this increase is the dramatic rise in the number of prescribed targeted therapies. The market is also growing in size as the cost of targeted therapeutics is high. This is due to longer treatment times, increased investment and development costs. Targeted therapeutics also are, by definition,  designed to treat smaller cohorts of patients, albeit more effectively. Therefore, pharmaco’s need to recoup costs via pricing.

Two major targeted therapeutics on the market are Roche’s melanoma agent Zelboraf and Pfizer’s lung cancer agent Xalkori. Zelboraf (vemurafenib) is a MEK inhibitor indicated for skin cancer and in FY2013 reached $x million. Xalkori (crizotinib) is indicated in patients positive for an ALK mutation and has an annual sale figure of €x million.

Top Ten Companies in Oncology Drug Sales

Roche Holdings continues to occupy its first position in oncology market. The company’s sales performance was driven by HER 2-positive breast cancer therapies. Globally, it is the largest maker of cancer treatments and mainly focuses on biologic drugs. Most of its cancer drugs are developed by California-based Genentech, a pioneer in biologic therapies that Roche acquired in 2009. Worldwide sales of Herceptin, that is about to lose patent protection year, rose 9%. But sales of Perjeta and Kadcyla, two follow-on therapies, increased by triple-digit percentages, drawing attention to the company’s success in developing successor products. Roche is pinning its hopes on follow-on products to preserve its place in the market once generic competition, known as biosimilars, begin to appear. These biologic therapies usually have higher margins than conventional drugs and are more difficult to copy.

Bristol-Myers Squibb’s overall sales rose by about x% only, but its cancer immunotherapy drugs witnessed huge sales gains. Its Yervoy, a skin-cancer immunotherapy, leaped x% to $x million in the fourth quarter, while Opdivo, another skin-cancer drug approved in late December 2014, contributed sales of $x million. The company’s sales of leukemia drug Sprycel rose x% to $x million in 2016.

Celgene Corporation has reported that its revenue rose in the most recent period, driven by sales growth of its key cancer treatment, particularly in the U.S. The company expects 2015 to be an important year for Revlimid, a blockbuster blood-cancer drug, which will be tested in trials for treatment of a kind of lymphoma. The FDA is expected to decide whether the drug can be used to treat newly diagnosed multiple myeloma. Regulatory bodies in the U.S. and the E.U. are making key decisions on the drug. Revlimid sales increased x% to $x billion in the most recent quarter, as market share expanded along with the duration of therapy. U.S. sales of the drug grew by x% while international sales increased x%.

The personalized medicine, targeted therapeutic 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.

Countries Covered


  • Global

  • US

  • UK

  • France

  • Germany

  • Spain

  • Italy

  • Europe

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

Table of Contents

1.0 Executive Summary 18
1.1 Objectives of Report 18
1.2 Scope of Study 20
1.3 Data Sources and Methodology 20
1.4 Key Findings and Observations 20
1.4.1 CYP2C9 and VKORC1 mutations and Warfarin Response 21
1.4.2 KRAS Mutations 21
1.4.3 Herceptin® and Breast Cancer 21
1.4.4 BRACAnalysis® 21
1.4.5 Oncotype Dx Test 21
1.4.6 Public and Private Funding for Personalized Medical Research 22
1.4.7 New Business Model Required for Personalized Medicine 22
1.4.8 Cost-effectiveness and Business Value of Personalized Medicine 22
1.4.9 Personalized Medicine Market 22
1.4.10 Personalized Medicine Oncology Therapeutics & Diagnostics Market 23
1.4.11 Personalized Medicine Cardiovascular Therapeutics Market 23
1.4.12 PharmacoGenomics/PharmacoGenetics Market Analysis 23
1.4.13 Liquid Biopsy Market Analysis 23

2.0 Introduction and Background 24
2.1 Genetics Explained in Five Minutes 24
2.1.1 Why is the Central Dogma of Molecular Biology Important in Personalized Medicine? 25
2.1.2 Genetic Mutations Explained 26
2.1.3 What is the Difference between Genotype and Phenotype? 27
2.1.4 Why do we Need to Look at Genetic Diversity with Respect to Personalized Medicine? 27
2.2 Introduction to Personalized Medicine 29
2.3 Pharmacogenetics 30
2.4 How Personalized Medicine Monitoring can Reduce Adverse Drug Reactions 38
2.5 Pharmacogenetic Study Challenges 38
2.6 Pharmacogenomics 38
2.7 Applications of Pharmacogenomics 39
2.7.1 Pharmacogenomics: Improving the Safety of Medications 39
2.7.1.1 Adverse Drug Reactions 39
2.7.1.2 Pharmacogenomics: Improving the Efficacy of Therapeutics 40
2.7.2 Vioxx Disaster Could have been Prevented with Personalized Medicine 44
2.8 Pharmacogenetic Analysis 44
2.8.1 Single Base Primer Extension 45
2.8.2 Primer Based Base Extension 45
2.8.3 Hybridization Based SNP Analysis 46
2.8.4 Ligation Based Approach 46
2.8.5 New-Generation Sequencing Technologies 46
2.8.6 Ultra-High Throughput Sequencing 47
2.9 Companion Diagnostics 49
2.9.1 Companion Diagnostic Deals 56
2.10 Selected Personalized Medicine Drugs by Biomarker and Indication 59
2.11 Selected Personalized Medicine Test/Kit According to Therapeutic and Indication 70
2.12 Targeted Cancer Therapy 77
2.13 What Percentage of Cancer Patients Could be Treated by Targeted Therapy? 80
2.14 Liquid Biopsies 80
2.14.1 CANCER-ID Project 83
2.14.2 Challenges for Liquid Biopsies 85
2.15 Tumor Genetic Heterogeneity 86
2.15.1 Introduction 86
2.15.2 Clonal Evolution – How Phylogenetic Analysis is Aiding Personalized Medicine 87
2.15.3 Therapeutic Resistance 88
2.15.4 Tumor Immunogenicity 90
2.15.5 Tumor Neo-Antigen Production 90
2.15.6 Sampling Tumor Heterogeneity with Liquid Biopsies 90
2.15.7 How Does Tumor Heterogeneity Impact Personalized Medicine? 91
2.15.8 Summary 91
2.16 How Next Generation Functional Diagnostics is Helping Personalized Medicine 91

3.0 Personalized Medicine Targeted Therapeutics and Associated Companion Diagnostics 93
3.1 CYP2C9 and VKORC1 mutations and Warfarin Response 93
3.2 HLA-B*5701 and Abacavir Response 94
3.3 KRAS Mutations 95
3.3.1 Erbitux 96
3.3.2 Vectibix 96
3.4 Herceptin® and Breast Cancer 96
3.5 BRACAnalysis® 105
3.5.1 Comprehensive BRACAnalysis® 108
3.5.2 BRACAnalysis® Rearrangement Test (BART) 108
3.5.3 Single Site BRACAnalysis® 108
3.5.4 Multisite 3 BRACAnalysis® 108
3.6 Oncotype Dx Test 109
3.7 Therascreen® EGFR RGQ PCR Kit 109
3.8 Therascreen KRAS RGQ PCR System 109
3.9 Therascreen® IDH1/2 test 109
3.10 THxID™ -BRAF Kit 110
3.11 Cobas® EGFR Mutation Test (Roche) 110
3.12 Prolaris Prostate Cancer Test 110
3.13 ALK and Non-Small Cell Lung Cancer 111
3.13.1 ALK-Fusion Testing 111
3.13.2 VYSIS ALK Break Apart FISH Probe Kit 111
3.13.3 VENTANA ALK (D5F3) CDx Assay 111
3.13.4 ResponseDx: Lung™ 112

4.0 Personalized Medicine and Integration into the Healthcare System 114
4.1 The Personalized Medicine Coalition 114
4.2 Personalized Medicine and the Healthcare System 116
4.3 Clinical Application of Personalized Medicine 116
4.4 Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology 117

5.0 Private and Public Funding and Personalized Medicine Reimbursement 119
5.1 International Research and Development Personalized Medicine Activity 119
5.1.1 Publically Funded Personalized Medicine Research 119
5.1.2 Privately Funded Personalized Medicine Research 120
5.2 Popular Biological Targets/Pathways in Pharmacogenetic/Pharmacogenomic Research 125
5.3 Equitable Payer Reimbursement 127
5.3.1 Molecular Diagnostic Payments in Personalized Medicine 127
5.3.1.1 RVU-CPT-ICD Coding System 127
5.3.2 Laboratory Service Payments in Personalized Medicine 127
5.3.3 Revisions to Current Payment System 127
5.4 Biorepositories and Biobanks 127
5.5 Intellectual Property and Personalized Medicine 128

6.0 European Personalized Medicine Market – Payments and Investment 129
6.1 Personalized Medicine and The European Market 129
6.2 European Investment in Personalized Medicine 130
6.3 Overview of Reimbursement Policies in Europe 130
6.4 Gaining Market Penetration in the EU 131
6.5 Personalized (Stratified) Medicine Regulation and Reimbursement in the UK 136
6.5.1 Precision Medicine Catapult 141
6.6 CE-marked Personalized Medicine/Diagnostic Tests in the UK 141
6.7 Personalized Medicine Regulation in Germany 142
6.8 Personalized Medicine Regulation in France 143
6.8.1 R&D UNICANCER France 144
6.9 Personalized Medicine Regulation in Spain 146
6.10 The Personalized Medicine Regulation in Italy 146
6.11 Challenges of Future Personalized Medicine Development in Europe 146

7.0 Personalized Medicine –Business Model Analysis 148
7.1 New Business Model Required for Personalized Medicine 148
7.2 Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies 148
7.3 Business Model Strategies for Providers. Provider Systems and Academic Medical Centres 149
7.4 Business Model Strategies for Payers 149
7.5 Business Model Strategies for Governments 150
7.6 Introduction of Non-Health Companies to the Personalized Medicine Market 150
7.7 Change to the Big Pharma Business Model 151
7.8 Cost-effectiveness and Business Value of Personalized Medicine 151
7.9 Comparative Effectiveness Research in Personalized Medicine 152
7.10 Reimbursement, Coverage and Payment Policy 152

8.0 Personalized Medicine Main Industry Players 155
8.1 23andMe 155
8.1.1 Key Products 156
8.2 Abbott Laboratories 164
8.2.1 Abbott Molecular Inc. 164
8.3 Admera Health (GENEWIZ) 164
8.3.1 Products and Kits 165
8.3.2 PGxOne 165
8.3.3 OncoGxOne 168
8.3.4 OncoGxOne Plus 168
8.3.5 FloraCheck 168
8.3.6 EGFR & KRAS Clinical Sequencing 168
8.4 Agena Biosciences (Sequenom) 168
8.4.1 MassARRAY System 168
8.4.2 Acquisition of Sequenom’s Bioscience Business by Agena Biosciences 169
8.5 Affymetrix 170
8.5.1 Products and Kits 172
8.6 Agendia 173
8.7 Alere 173
8.8 Amgen Inc. 174
8.8.1 Vectibix (panitumumab) 175
8.8.2 Blinatumomab (Blincyto) 175
8.8.3 Rilotumumab 175
8.9 Astex Pharmaceuticals 176
8.9.1 Products and Kits 178
8.10 AstraZeneca 179
8.10.1 Iressa 179
8.10.2 Tagrisso AZD9291 (Osimertinib) 179
8.11 Atossa Genetics 180
8.11.1 Mammary Aspirate Specimen Cytology Test (MASCT™) 181
8.11.2 ForeCYTE Breast Health Test (SM) 181
8.11.3 ArgusCYTE Breast Health Test(SM) 181
8.11.4 FullCYTE Breast Health Test 181
8.12 Becton Dickinson 181
8.12.1 Key Products 181
8.13 BioMerieux 183
8.13.1 Key Products 183
8.14 BioRad 184
8.15 Bristol-Myers Squibb Company 185
8.15.1 Erbitux (cetuximab) 186
8.15.2 OPDIVO (nivolumab) 186
8.15.3 Yervoy (ipilimumab) 186
8.16 Cancer Genetics 186
8.16.1 Key Products 186
8.17 Celera Corporation (Quest Diagnostics) 191
8.17 Key Products 191
8.17.1 ViroSeq® HIV-1 Genotyping System 191
8.17.2 ViroSeq® HIV-1 Integrase Assay 192
8.17.3 ViroSeq® HCV Assay 192
8.17.4 ViroSeq® HBV Assay 192
8.17.5 Cystic Fibrosis Genotyping Assay 192
8.17.6 LDL-S3GGE® Test 193
8.17.7 HDL-S10GGE® Test 193
8.17.8 KIF6-StatinCheckTM Genotype Test 193
8.17.9 LPA-AspirinCheckTM Genotype Test 193
8.17.10 9p21-EarlyMICheckTM Genotype Test 193
8.17.11 AlleleSEQR® HLA PCR/Sequencing Kits 193
8.17.12 m2000® RealTime PCR System 194
8.17.13 CEGA -16™ Instrument 195
8.18 Celldex Therapeutics 195
8.19 Cephid 197
8.20 Claritas Genomics 198
8.20.1 Products and Kits 198
8.20.2 ClariFocus Exome for Pediatric Neurology 199
8.21 CuraGen 199
8.22 deCode Genetics (Amgen) 199
8.22.1 deCodeT2 Genetic Test 200
8.22.2 deCODE Breast Cancer™ 201
8.22.3 deCODE Prostate Cancer™ 201
8.22.4 deCODE AF™ 202
8.22.5 deCODE Glaucoma™ 202
8.22.6 deCODE MI™ 202
8.22.7 deCODE Complete™ 203
8.22.8 deCODE Cancer™ 203
8.22.9 deCODE Cardio™ 204
8.22.10 deCODE Services 204
8.23 EDP Biotech 205
8.24 ELDA BioTech 205
8.25 Eisai 205
8.26 Foundation Medicine 206
8.26.1 FoundationOne 207
8.26.2 FoundationOne Heme 208
8.27 HalioDx 212
8.28 Human Longevity Inc (Cypher Genomics) 213
8.29 Ikonisys 214
8.30 Illumina 214
8.30.1 Illumina HiSeq 2000/1000 215
8.30.2 Genome Analyzer IIx 217
8.30.3 Illumina MiSeq 218
8.30.4 Illumina HiScanHQ 219
8.30.5 Illumina HiScan and iScan Array 219
8.31 Intergenetics 220
8.32 Genelex 221
8.32.1 You Script™ 222
8.33 Johnson & Johnson (Janssen) 223
8.34 LabCorp (Covance) 225
8.34.1 Covance and M2Gen Partnership 226
8.35 Integrated Oncology 227
8.35.1 Main Products 227
8.36 Merck & Co., Inc. 229
8.36.1 Main Products 229
8.37 MDx Health 231
8.38 MolecularMD Corporation 233
8.39 Monogram Biosciences 234
8.40 Myriad 236
8.40.1 Key Products 237
8.40.2 COLARIS®/COLARIS AP® 238
8.40.3 MELARIS® 239
8.40.4 PANEXIA® 239
8.40.5 OnDose® 239
8.40.6 PREZEON™ 240
8.40.7 THERAGUIDE® 5FU 240
8.40.8 Prolaris® 240
8.41 Nanostring Technologies 240
8.42 Nodality 242
8.42.1 Products and Kits 244
8.43 Novartis 244
8.43.1 Novartis Molecular Diagnostics 244
8.43.2 Novartis Oncology 245
8.44 Orion Genomics 246
8.45 Oxford BioTherapeutics 247
8.46 Pfizer 249
8.46.1 Pfizer Merger with Allergan 249
8.46.2 Pfizers Oncology Strategy 250
8.46.3 Pfizer’s Personalized Healthcare Strategy 251
8.47 Qiagen 253
8.47.1 Key Products 255
8.47.2 Genotyping Products 256
8.47.3 QIAsymphony Platform 259
8.48 Roche 260
8.49 Roche Diagnostics 260
8.49.1 Roche Acquisition of Ventana Medical Systems 262
8.49.2 Roche’s Personalized Medicine Strategy 263
8.49.3 Avastin (Bevacizumab) 264
8.49.4 Herceptin (Trastuzumab) 264
8.49.5 Kadcyla (Trastuzumabum emtansinum) 265
8.49.6 Perjeta (Pertuzumab) 265
8.49.7 MabThera/Rituximab 265
8.49.8 Tarceva 265
8.50 Sanofi 265
8.50.1 Sanofi’s Personalized Medicine Strategy 268
8.51 Siemens Healthcare 268
8.51.1 Companion Diagnostic Development at the Siemens Clinical Laboratory (SCL) 269
8.52 Takeda 269
8.52.1 Takeda’s to Discover Therapeutic Targets in the Microbiome 270
8.52.2 Millennium: The Takeda Oncology Company 272
8.53 Thermo Fisher Scientific 273
8.53.1 ThermoFisher’s Personalized Healthcare Strategy 273
8.53.2 ThermoFisher’s Involvement in the NCI-MATCH Trial 274
8.54 Transgenomic 274
8.55 Vertex Pharmaceuticals 277
8.55.1 Orkambi (lumacaftor/ivacaftor) 277
8.55.2 Kalydeco (ivacaftor) 277

9.0 Personalized Medicine Market Analysis 280
9.1 Companion Diagnostic and Targeted Therapeutic Market 280
9.1.1 Global OncologyTherapeutic Market 283
9.1.2 Targeted Therapeutics – Oncology 284
9.1.3 Top Ten Companies in Oncology Drug Sales to 2021 284
9.1.4 Top Five Oncology Drugs to 2021 286
9.1.5 Global Oncology Market by Cancer Type 287
9.1.6 Oncology Targeted Therapeutics Market Analysis to 2021 288
9.1.7 Companion Diagnostic Assays – Oncology 292
9.2 Cardiovascular Targeted Therapeutics Market to 2021 294
9.2.1 Cardiovascular Companion Diagnostics Market to 2021 296
9.3 Infectious Disease Targeted Therapeutics Market to 2021 298
9.3.1 Infectious Disease Diagnostic Assay Market to 2021 300
9.4 Global Personalized Medical Technology Market 301
9.5 Global Personalized Medicine Sub-Market Growth 302
9.6 PharmacoGenomics/PharmacoGenetics Market Analysis to 2021 303
9.7 Molecular Diagnostics Market to 2021 304
9.8 Consumer Genomics Market 307
9.9 Liquid Biopsy Market to 2021 307
9.10 Major Player Profit Margin Analysis 309
9.11 Select Market Participant Case Study Analysis 314
9.11.1 23andme 314
9.11.2 Affymetrix 316
9.11.3 Astex Pharmaceuticals 326
9.11.4 Atossa Genetics 329
9.11.5 Celera (Quest Diagnostics) 332
9.11.6 Celldex Therapeutics 337
9.11.7 deCode Genetics (Amgen) 339
9.11.8 Illumina 340
9.11.9 Genelex 343
9.11.10 Myriad 343
9.11.11 Nodality 347
9.11.12 Qiagen 349
9.11.13 bioMerieux 353

10.0 Strengths and Advantages of Personalized Medicine 362
10.1 Sequencing of the Human Genome in 2000 362
10.2 Improving Patient Care and Reducing Side Effects 362
10.3 Personalized Medicine will Reduce Healthcare Costs 362
10.4 FDA Advances in Personalized Medicine Regulation 362
10.5 Advancing Technologies 363
10.5.1 Next Generation Sequencing 363
10.6 Industry Investing in Pharmacogenomics 364
10.7 Consumer Genomics and POC Market 364
10.8 Oncology a Driving Force of Personalized Medicine 365

11.0 Restraints of the Personalized Medicine Market 366
11.1 Lack of Sufficient Regulation 366
11.2 Lack of Sufficient Genotypic Linkage Studies to Disease Phenotype 367
11.3 Reimbursement Issues 367

12.0 Personalized Medicine and Regulatory Policies 369
12.1 Regulation by the Centres for Medicare and Medicaid Services (CMS) and US Food and Drug Administration (FDA) 369
12.2 Genetic Information Non-discrimination Act (GINA) 371
12.3 FDA Advancements on Genetic Testing Approval 372
12.4 FDA- New Models to Assess Gene Therapy Safety 374
12.5 FDA- Companion Diagnostics 374
12.6 FDA - Partnership in Applied Comparative Effectiveness Science (PACES) Initiative 375
12.7 National Institutes of Health Genetic Testing Registry 375

13.0 Final Summary and Future Perspectives 376
13.1 Re-cap of Personalized Medicine in 2016 377

14.0 Interviews with Key Opinion Leaders 379
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 26
Table 2.2: Types of Genetic Markers used as Biomarkers in Personalized Medicine 27
Table 2.3: Genetic Disease Associated with the Ashkenazi Jew Population 27
Table 2.4: Disease Types Associated with Specific Populations 28
Table 2.5: Personalized Medicine 30
Table 2.6: Genetic Mutations that Predispose Individuals to Disease 31
Table 2.7: Potential Applications of Pharmacogenetics/genomics in Personalized Medicine 31
Table 2.8: Main Cytochrome P450 Enzymes Involved in Drug Metabolism 31
Table 2.9: Rapid & Slow Metabolizer Phenotypes 32
Table 2.10: Population Frequency of Cytochrome P450(CYP) 2C19 Metabolizer Types 33
Table 2.11 Population Frequency of Cytochrome P450 (CYP) Metabolizer Types 33
Table 2.12 Depression Medications Affected by Genetic Mutations 33
Table 2.13 Cardiovascular Medications Affected by Genetic Mutations 34
Table 2.14: Cancer Medications that may be Affected by Genetic Mutations 35
Table 2.15: Diabetes Medications Affected by Genetic Mutations 35
Table 2.16: Anti-Epileptic Drugs Affected by Genetic Mutations 35
Table 2.17: Anti-Retroviral Drugs Affected by Genetic Mutations 35
Table 2.18: Anti-Reflux/Ulcer Drugs Affected by Genetic Mutations 35
Table 2.19: List of Therapeutics According to Cytochrome P450 Subtype Metabolism 36
Table 2.20: Cytochrome (CYP) P450 Drug-Interactions Inhibitor List 37
Table 2.21: Cytochrome (CYP) P450 Drug-Interactions Inducer List 37
Table 2.22: Main Aims of Pharmacogenomics 38
Table 2.23: How Pharmacogenomics has Influenced the Top Ten Selling Drugs Globally 40
Table 2.24: Advantages, Disadvantages and Cost of Popular Genotyping Methods 40
Table 2.25: Top Ten Pharmacogenomics Tests 41
Table 2.26: FDA Accepted Pharmacogenomic Biomarkers 41
Table 2.27: Benefits of Single Base Primer Extension in Pharmacogenetics 48
Table 2.28: Future Applications of Ultra-High Throughput Sequencing 48
Table 2.29: Comparison of Genotyping Techniques 48
Table 2.30: Problems associated with Microarray Sequencing 48
Table 2.31: Top Ten Genetic Findings by 23andMe 48
Table 2.32: EMA Approved Drugs that Require Companion Diagnostics 49
Table 2.33: FDA Approved Drugs that Require Companion Diagnostics 50
Table 2.34: FDA Companion Diagnostics Device List: In Vitro and Imaging Tools 50
Table 2.35: Important Strategies for a Successful Companion Diagnostic Launch 56
Table 2.36: Selected Personalized Medicine Drugs by Biomarker and Indication 59
Table 2.37: Selected Personalized Medicine Test/Kit According to Therapeutic and Indication 70
Table 2.38: Targeted Cancer Therapeutics by Tumor Type, Target & Detection Method Available 77
Table 2.39: FDA Approved Targeted Therapies and Approved Indications for Solid Tumors 78
Table 2.40: List of all Academic and Industry Partners of CANCER-ID Consortium 83
Table 2.41: Scientific Advisory Board Members of CANCER-ID 83
Table 2.42: Details of Tumor Heterogeneity- Intratumor, Interpatient, Inter/intrametastatic 87
Table 2.43: Polyclonal Genetic Mechanisms of Therapy Resistance by Tumor Type and Study 89
Table 3.1 Predicted Warfarin Concentrations depending on CYP2C9 and VKORC1 Genotype 94
Table 3.2 Top Five Most Frequent Cancers in Men and Women, Globally 97
Table 3.3 Estimated Age-Standardised Incidence Rate of Breast Cancer per Country, Worldwide 99
Table 3.4 Diagnostic Tests Available to Determine HER2 Status in Breast Cancer Patients 102
Table 3.5 Validated HER2 Tests for Cancer 102
Table 3.6: Advantages and limitations of IHC HER2 testing applied to breast cancer 104
Table 3.7: In-SituHybridizationDetermination HER2 Expression: PathVysion® and HER2 FISH pharmDx 104
Table 3.8: HER2 CISH Determination 104
Table 3.9: Validated FISH Kits for HER2 Testing in Breast Cancer 104
Table 3.10: Validated SISH Kits for HER2 Testing in Breast Cancer 104
Table 3.11: Validated CISH Kits for HER2 Testing in Breast Cancer 105
Table 3.12: Advantages and limitations of ISH techniques applied to HER2 testing in breast cancer 105
Table 3.13: Prevalence of Deleterious Mutations in BRCA1 and BRCA2 Genes 106
Table 3.14: Prevalence of Deleterious Mutations in BRCA1 and BRCA2 in Individuals of Ashkenazi Ancestry 106
Table 3.15: Risk Factors for Hereditary Breast and Ovarian Cancer (HBOC) 107
Table 3.17: BRACAnalysis® Panel of Assays 108
Table 3.18: The Prolaris Score for Prostate Cancer 110
Table 4.1: Objectives of the Personalized Medicine Coalition 114
Table 4.2: Current Personalized Medicine Coalition Members 114
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. 116
Table 4.4: Minimum Definition of a clinically Actionable Variant 117
Table 4.5: Minimum Criteria for Whole Genome Analysis in Clinical Laboratory Improvement Amendments Laboratory of Genomic Pathology, Clinical Whole Genome Analysis 118
Table 5.1: Public Funding Bodies for Pharmacogenetic/Pharmacogenomic Research 120
Table 5.2: American Companies Involved in Pharmacogenomics/genetics Drug Development & Diagnostics 121
Table 5.3: European Companies Involved in Pharmacogenomics/genetics Drug Development & Diagnostics 121
Table 5.4: North American Companies Involved in Pharmacogenomics/genetics Services 121
Table 5.5: European/Other Companies Involved in Pharmacogenomics/genetics Services 122
Table 5.6: American Companies Involved in Pharmacogenomics/genetics Tools Kits & Software 122
Table 5.7: European Companies Involved in Pharmacogenomics/genetics Tools Kits & Software 122
Table 5.8: North American Companies with Minor interest in Pharmacogenomics/genetics 123
Table 5.9: European/Other Companies with Minor interest in Pharmacogenomics/genetics 123
Table 5.10: North American Companies with Minor interest in Pharmacogenomics/genetics 123
Table 5.11: European/Other Companies with Minor interest in Pharmacogenomics/genetics 124
Table 5.12: Large US Companies with Investment into Pharmacogenomics/genetics 124
Table 5.13: Large European Companies with Investment into Pharmacogenomics/genetics 125
Table 5.14: Large Japanese Companies with Investment into Pharmacogenomics/genetics 125
Table 5.15: Top Ten Biological Areas of Interest in Pharmacogenetics/genomics 126
Table 5.16: Top International Pharmacogenetic/Pharmacogenomic Research Institutions 126
Table 5.17: Top European Pharmacogenetic/Pharmacogenomic Research Institutions 126
Table 6.1: Variation of Reimbursement Policies for HER2 & KRAS Testing in Europe 130
Table 6.2: Pharma Providing Subsidization of Personalized Medicine Tests in Europe 131
Table 6.3: Challenges Within Personalized Medicine Market in Europe 132
Table 6.4: Function of the European network for Health Technology Assessment Organisation 133
Table 6.5: European network for Health Technology Assessment (EUnetHTA) Partners 135
Table 6.6: European network for Health Technology Assessment (EUnetHTA) Associates 137
Table 6.7: Diagnostics Guidance Assessment by the National Institute Health Clinical Excellence 137
Table 6.8: Current Diagnostics Guidance in Development by the Diagnostics Access Program, UK 138
Table 6.9: Published Diagnostics Guidance by the Diagnostics Access Program, UK 139
Table 6.10: Medical Technologies Guidance Assessment by NICE 139
Table 6.11: Published Medical Technologies Guidance by NICE 140
Table 6.12: Published Medical Technologies Guidance in Development NICE 140
Table 6.13 Precision Medicine Catapult Tools to Aid Market Entry 141
Table 6.14 Key Challenges to Personalized Medicine 141
Table 6.15: Strategic Objectives of French Comprehensive Cancer Centers within UNICANCER 145
Table 6.16: Key Challenges to Personalized Medicine 146
Table 6.17: Personalized Medicine - Translation into Medical Applications 147
Table 7.1: Major Market Trends in Personalized Medicine 148
Table 7.2: Collaboration Strategies Required between Industry, Payers & Governments 148
Table 7.3: Business Model Recommendations: Diagnostic, Pharma& Biotech Companies 149
Table 7.4: Business Model Recommendations: Providers. Provider Systems & Medical Centres 149
Table 7.5: Business Model Recommendations for Payers 150
Table 7.6: Business Model Recommendations for Governments 150
Table 7.7: Non-Healthcare Companies with Potential to enter the Personalized Medicine Market 151
Table 7.8: Hurdles of Personalised Medicine with Respect to Cost-Effectiveness 152
Table 8.1: 23andMe Disease Risk Genetic Test Panel 156
Table 8.2: 23andMe Carrier Status Genetic Test Panel 160
Table 8.3: 23andMe Drug Response Genetic Marker Test Panel 162
Table 8.4: 23andMe Genetic Traits Test Panel 162
Table 8.5: Admera Health Commercial Drug List that are Covered by the PGxOne Assay 165
Table 8.6: Admera Health PGxOne Gene & Variant List, Therapeutic Area & Endorsing Agency 167
Table 8.7: Patent Listing of Affymetrix Array technology 170
Table 8.8: Patent Listing of Affymetrix Genotyping Technology 171
Table 8.9: Patent Listing of Affymetrix Expression and Profiling Technology 172
Table 8.10: Product Overview of Affymetrix 172
Table 8.11: Microarray Products by Affymetrix 172
Table 8.12: Affymetrix Research Services Laboratory (ARSL) Premier Services 173
Table 8.13: Genetic Applications of Axiom® Technology by Affymetrix 173
Table 8.14: Amgen’s Product Pipeline 175
Table 8.15: Selected Programs in Pivotal Trial (Phase III) or Development, Amgen 175
Table 8.16 Advantages of Astex Pharmaceuticals 176
Table 8.17: Astex Pharmaceuticals Pipeline Portfolio 177
Table 8.18: Astex Pharmaceuticals Pipeline Portfolio Funded Completely by Partner Companies 178
Table 8.19: Range of Small Molecule Therapeutics Available from Astex Pharmaceuticals 178
Table 8.20: Biomarkers by Cancer Type Offered by bioMerieux 184
Table 8.21: Cancer Genetics Product Portfolio Flow Cytometry Based Assays 187
Table 8.22: Cancer Genetics Product Portfolio FISH Based Assays 187
Table 8.23: Cancer Genetics Product Portfolio Molecular Diagnostics Based Assays 188
Table 8.24: Cancer Genetics Product Portfolio Complete™ Test Program 189
Table 8.25: Select One Clinical Trial Services 190
Table 8.26: Panel of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutations Screened for in Celera Cystic Fibrosis Genotyping Assay 192
Table 8.27: Genetic Tests Available from BHL/Celera 194
Table 8.28: Panel of BHL Clinical Diagnostic Tests 194
Table 8.29: Features of the m2000® RealTime PCR System by Celera 194
Table 8.30: Potential Business Partnerships of Celldex Therapeutics 196
Table 8.31: Cephid Product Portfolio to 2019 in the US 197
Table 8.32: Cephid Product Portfolio to 2019 Internationally 198
Table 8.33: Claritas Genomics Genetic Test Portfolio, by Gene 199
Table 8.34: Genetic Diagnostic Tests Available from deCode Genetics 200
Table 8.35: Type 2 Diabetes risk range and distribution according to continental ancestry as Determined by deCodeT2 Genetic Test 201
Table 8.36: Genetic Mutations Identified by the deCODE MI™ Test in a European Population 202
Table 8.37: Genetic Mutations Identified by the deCODE MI™ Test in an East Asian Population 202
Table 8.38: Disease States that are Included in the deCODE Complete™ Genetic Screen 202
Table 8.39: Panel of Diseases Screened for in the deCODE Cancer™ Test 203
Table 8.40: Panel of Cardiovascular Diseases in the deCODE Cardio™ Test 203
Table 8.41: deCODE Genetics Genotyping and Sequencing Service 204
Table 8.42: deCODE Genetics Data Management, Protection and Storage Service 204
Table 8.43: deCODE Genetics Sequence Inputation and Data Analysis Service 205
Table 8.44: FoundationOne Current Gene List 207
Table 8.45: FoundationOne Heme Gene List 209
Table 8.46: Foundation Medicine Company-Sponsored Clinical Trials 211
Table 8.47: Illumina Core Technologies 213
Table 8.48 Illumina Core Technology Applications 215
Table 8.49 Illumina Instrument Product Portfolio 215
Table 8.50 Illumina Assay Product Portfolio 215
Table 8.51 Illumina HiSeq 2500/1500 Performance Parameters 216
Table 8.52 Illumina HiSeq 2000/1000 Performance Parameters 216
Table 8.53 Genome Analyzer IIx Performance Parameters 217
Table 8.54 Illumina MiSeq Product Specifications 218
Table 8.55 Illumina HiScanHQ Product Specifications 219
Table 8.56 Illumina HiScan and iScan Array Product Applications 219
Table 8.57 Illumina HiScan and iScan Array Kits 220
Table 8.58 Clinical Applications of Diagnostic Tests Offered by Intergenetics 221
Table 8.59 Genetic Test Panel Available from Genelex for Research Institutions and Clinical Trials 221
Table 8.60 Panel of Genetic Screens Available from Genelex 222
Table 8.61 Drug Sensitivity Screens Available from Genelex 222
Table 8.62 Integrated Oncology Cancer Test Portfolio 228
Table 8.63 Biopharma Merck’s Key Product Range 230
Table 8.64 Molecular MD Biomarker Assays by Platform and Method Used 233
Table 8.65 MolecularMD Test Panels by Next Generation Sequencing, Molecular Targeted Therapy Management and Pathway Analysis 234
Table 8.66 MolecularMD Companion Diagnostic Development Capabilities 234
Table 8.67 Monogram Biosciences HIV Genotypic and Phenotypic Test Portfolio 235
Table 8.68 Predictive Genetic Tests Available from Myriad 237
Table 8.69 Services offered with BRACAnalysis® Testing from Myriad 238
Table 8.70 Advantages of BRACAnalysis® Testing 238
Table 8.71 COLARIS® Test Range by Myriad 238
Table 8.72 COLARIS AP® Test Range by Myriad 239
Table 8.73 MELARIS® Test Range from Myriad 239
Table 8.74 Personalized Medicine Tests from Myriad 239
Table 8.75 OnDose® Testing Procedure from Myriad 240
Table 8.76 Nanostring Technologies nCounter Workflow Platform Product Portfolio 241
Table 8.77 Pre-Clinical, Clinical and Commercial Applications of SCNP by Nodality 243
Table 8.78 Novartis Oncology Key Personalized Medicine Drug Targets 246
Table 8.79 Orion Genomics Collaboration and Commercial Agreements 247
Table 8.80 Oxford BioTherapeutics Main Technologies in Cancer Targeting 248
Table 8.81 Oxford BioTherapeutics Product Pipeline Portfolio by Development Stage 248
Table 8.82 Pfizer Key Branded Products 249
Table 8.83 Pfizer Oncology Targets and Technologies 250
Table 8.84 Pfizer Early Stage Pipeline Oncology Portfolio 251
Table 8.85 Qiagen Timeline of Events, 1994-2012 253
Table 8.86 Range of Product Groups from Qiagen 255
Table 8.87 Qiagen Genotyping Products for Sample Collection, stabilization and Storage 256
Table 8.88 Qiagen Genotyping Products for Genomic DNA Isolation and Purification 256
Table 8.89 Qiagen Genotyping Products for PCR Based Genotyping Analysis 256
Table 8.90 Qiagen Products for Genotyping Analysis 257
Table 8.91 Qiagen Genotyping Products for PCR Detection 257
Table 8.92 Qiagen Assays for Genetic Analysis 258
Table 8.93 Qiagen Pyrosequencing-Based Genetic Analysis Products 258
Table 8.94 Specifications and Features of Qiagen’s QIAsymphony and QIAsymphony RGQ 259
Table 8.95 Roches Personalized Medicine Products by Patient Stage 263
Table 8.96 ThermoFisher Scientific Clinical Assays and Technologies for Personalized Healthcare 275
Table 8.97 Transgenomic Technology Platforms 276
Table 8.98 Transgenomic Partnerships and Collaborations 277
Table 9.1 Global Market for Oncology Drugs by Geography/Country, Through 2021 283
Table 9.2 Top Ten Companies in Oncology Sales Forecast 2013 – 2021 285
Table 9.3 Top Five Oncology Drugs, Through 2021 286
Table 9.4 Submarkets within the Personalized Medicine Technology Market 301
Table 9.5 Global Market for Liquid Biopsy by Region (North America, Europe, RoW), to 2021 308
Table 9.6 Operating Profit Margin Analysis for Selected Players in the PM Industry 310
Table 9.7 Personalized Medicine Industry Segments and Companies Analysed 311
Table 9.8: Drug Classes Investigated by 23andMe Using Genome Wide Association Studies 315
Table 9.9: Acquisition Profile of Affymetrix 317
Table 9.10: Genetic Applications of Axiom® Technology by Affymetrix 317
Table 9.11: Diversified Business Units of Affymetrix 318
Table 9.12: Affymetrix AgBio Microarray Portfolio 319
Table 9.13: Celera (Quest Diagnostics) Historic Operating (Loss) Laboratory Services & Products 336
Table 9.14: Diagnostic Test Product Manufactured by BHL/Celera & Distributed by Abbott 336
Table 9.15: Celldex Therapeutics R&D Expenses ($ Thousands) 2010-2012 339
Table 9.16: Price Listing of Genelex Familial Genetic Tests 343
Table 9.17: Myriad - Core Business Decisions and Impact on Industry 347
Table 9.18: Future Test Portfolio of Myriad 347
Table 9.19: Nodality’s Single Cell Network Profiling (SCNP) for Drug Discovery & Validation 349
Table 9.20: BioMerieux Immunodiagnostic Product Portfolio 355
Table 9.21: BioMerieux Microbiology Product Portfolio 357
Table 9.22: BioMerieux Molecular Diagnostic Product Portfolio 359
Table 10.1: Strengths and Advantages of Genotyping Techniques 363
Table 10.2: Strengths, Drivers and Advantages of Personalized Medicine Market 365
Table 11.1: Restraints of Personalized Medicine Market 368
Table 12.1: Summary of Clinical Laboratory Improvement Amendments (CLIA) 370
Table 12.2: Clinical Laboratory Improvement Amendments (CLIA) Testing Categories 370
Table 12.3: Test Features required prior to FDA Approval and Clearance 370
Table 12.4: Impact of Genetic Information Non-discrimination Act (GINA) on Healthcare Companies & Health Plans 371
Table 12.5: Impact of Genetic Information Non-discrimination Act (GINA) on US Employers, employment agencies, labor organizations and training programs 371
Table 12.6: FDA Commitment to the Personalized Medicine Industry 371
Table 12.7: Objectives of the ‘Advancing Regulatory Science at FDA: A Strategic Plan’ 372
Table 12.8: FDA Policy & Guidance Recommendations 372
Table 12.9: Implementation Strategy of the FDA to Advance Regulatory Science - Develop better Models of Human Adverse response 373
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 373
Table 12.11: Implementation Strategy of the FDA to Advance Regulatory Science - Use and develop computational methods and in silico modelling 373
Table 12.12: National Institutes of Health Genetic Testing Registry Test Information 375
Table 13.1 2015 Targeted Therapeutic and Companion Diagnostic FDA Drug Approvals 378

List of Figures

Figure 2.1: DNA, Histones and Chromosomes 24
Figure 2.2: DNA is Composed of Four Nucleotide Bases 25
Figure 2.3: The Central Dogma of Molecular Biology – How DNA Encodes Protein 26
Figure 2.4: How Research, Technology, Regulation, Clinical Implementation and Legislation Integrates into Personalized Medicine 29
Figure 2.5 Identification of Good and Non-Responders in a Patient Population 32
Figure 2.6 Pharmacodynamic and Pharmacokinetic Examples of Drug Targets and Drug metabolism in Pharmacogenomics 39
Figure 2.7 Flow Diagram of Pharmacogenetic Analysis 43
Figure 2.8: Primer Based Base Extension in Pharmacogenetics 45
Figure 2.9: Genetic Mutation Detection by Hybridization 46
Figure 2.10: Ligation based SNP Detection 47
Figure 2.11 New-Generation Sequencing: Pyrosequencing 47
Figure 2.12 Number of Companion Diagnostic Deals Signed on a Yearly Basis 57
Figure 2.13 Percentage of Cancer Patients with Genetic Mutations that could be Treated by Targeted Therapy 80
Figure 2.14 Detection of Cell Free cfDNA in Cancer Patients – Timeline of Events 81
Figure 2.15 Cell Free Nucleic Acids Present in Blood from Cancer Patients 81
Figure 2.16 Detection of cfDNA and its Alterations in Different Forms of Cancer 82
Figure 2.17 CANCER-ID Consortium Global Location of Collaborators 84
Figure 2.18 CANCER-ID Consortium Work Package Outline 85
Figure 2.19 Use of Tumor Educated Blood Platelet mRNA Expression Levels in Liquid Biopsies 86
Figure 2.20 Types of Tumor Heterogeneity- Intratumor, Interpatient, Inter/intrametastatic 87
Figure 2.21 Tumor Clonal Evolution as Depicted in a Phylogenetic Tree 87
Figure 2.22 Mechanisms of Resistance to Targeted Therapies (Vemurafenib, Crizotinib, EGFR MAbs, EGFR TKIs, Imatinib) 88
Figure 2.23 Next Generation Functional Diagnostics in Cancer 88
Figure 3.1: Warfarin Metabolism and Response 93
Figure 3.2: Percentage Frequency of CYP2C9 and VKORC1 mutations in Caucasian, African-American and Asian Populations 94
Figure 3.3: Anti-EGFR Therapy and KRAS Mutations 95
Figure 3.4: KRAS and BRAF Genetic Tests Available from Asuragen 96
Figure 3.5: Global Incidence and Mortality of Cancer in Women 97
Figure 3.6: Cancer Deaths in Women, Globally according to Cancer Type 98
Figure 3.7: Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer Globally 98
Figure 3.8: HER2 Testing Algorithm for Breast Cancer 102
Figure 3.9: HER2 Cellular Signalling 103
Figure 3.10: Herceptin – Mechanism of Action 103
Figure 3.11: BRCA Mutation Increases the Risk of Breast and Ovarian Cancer 107
Figure 3.12: Proactive Cancer Management and Preventative Measures Reduces the Risks of Developing BRCA-associated Breast and Ovarian Cancer 108
Figure 3.13: ALK Cellular and Nuclear Signalling Pathway 112
Figure 3.14: ALK-Positive Cancers by Fusion Protein, ALK expression & Point Mutations 113
Figure 4.1: Integration of Multiple components for a Personalized Medicine Healthcare System 115
Figure 4.2: Workflow Diagram illustrating Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology 117
Figure 4.3: Hypothetical Flow Diagram of a Patient & the Genomic Pathology Clinical Laboratory 118
Figure 5.1: Personalized Medicine Scheme Interaction with Industry, Regulatory Bodies and Funding Agencies 119
Figure 5.2: Number of Publically Funded Pharmacogenetic and Pharmacogenomic Research Teams Internationally 120
Figure 6.1: Adverse Drug Reactions are the Fourth Leading Cause of Death 129
Figure 6.2: Efficacy Rate of Major Disease Types with Standard Treatment 129
Figure 6.3: The In Vitro Diagnostic Market in Europe 132
Figure 6.4: Organization of the European network for Health Technology Assessment (EUnetHTA) 133
Figure 6.5: Key Differences in Reimbursement Policy Approaches for Oncology Diagnostics and Therapeutics in Europe and the US 138
Figure 6.6: Flow Diagram of the German Healthcare System and Key Agencies 142
Figure 6.7: German Reimbursement Arrangement, Process and Implications 143
Figure 6.8: Key Information about UNICANCER France 144
Figure 6.9: Strategic Flow Diagram of UNICANCER France and its Operations 145
Figure 7.1: Annual Healthcare Expenditure for Major Industrial Nations 153
Figure 7.2: Estimated Life Expectancy from Birth for Major Industrialized Countries 154
Figure 8.1 Flow Diagram of Celera CEGA -16™ Instrument for Cystic Fibrosis Gene Analysis 195
Figure 8.2 Celldex Therapeutics Product Pipeline 196
Figure 8.3 Percentage of Individual Populations who have an Increased Risk of Developing Type 2 Diabetes as Determined Using the deCodeT2 Genetic Test 201
Figure 8.4 FoundationOne and FoundationOne Heme Platforms 209
Figure 8.5 Tumor Microenvironment Showing Infiltrating Immune Cells 212
Figure 8.6 HalioDx ImmunoScore System 213
Figure 8.7 Human Longevity Inc (Cypher Genomics) Mantis Technology Platform 213
Figure 8.8 Illumina New Generation Sequencing Technology Workflow Station 216
Figure 8.9 Monogram Biosciences HIV Assay Porfolio Timeline 236
Figure 8.10 Single Cell Network Profiling (SCNP) Technology by Nodality 242
Figure 8.11 Developed Functional Assays that Nodality has explored using SCNP Technology 243
Figure 8.12 Sanofi Late Stage Product Pipeline 266
Figure 8.13 Sanofi Pipeline Products in Stage I 267
Figure 8.14 Sanofi Pipeline Products in Stage II 267
Figure 8.15 Takeda Pipeline Portfolio of Oncology and Gastrointestinal Therapeutics 271
Figure 8.16 Millenium Takeda Oncology Development Pipeline 272
Figure 8.17 Vertex Pharmaceuticals Cystic Fibrosis, Oncology, Pain & Influenza Pipeline Products 279
Figure 9.1 Personalized Targeted Therapeutic Sales Revenue, All Indications 280
Figure 9.2 Personalized Targeted Therapeutic Market, All Indications, 2014-2021 281
Figure 9.3 Companion Diagnostic and Targeted Therapeutic Personalized Medicine Market Growth 282
Figure 9.4 Companion Diagnostic Market 2014-2021 282
Figure 9.5 Combined Targeted Therapeutic and Companion Diagnostic Market, 2014-2021 283
Figure 9.6 Global Market for Oncology Drugs by Geography/Country, Through 2021 284
Figure 9.7 Global Oncology Drug Sales by Top Five Companies, Through 2021 286
Figure 9.8 Top Five Oncology Drugs, Through 2021 287
Figure 9.9 Global Oncology Market by Cancer Type 287
Figure 9.10 Global Personalized Medicine Oncology Therapeutics Forecast 2014-2021 288
Figure 9.11 HER-2 Positive Breast Cancer Therapeutic Market Forecast 2014-2021 289
Figure 9.12 Personalized Medicine Oncology Therapeutic Market Forecast 2014-2021 290
Figure 9.13 Personalized Medicine Branded Oncology Therapeutics Market Share 2016 290
Figure 9.14 Personalized Medicine Branded Oncology Therapeutics Market Share 2021 291
Figure 9.15 Top Pharma Companies Revenue from Targeted Therapeutics in Oncology 291
Figure 9.16 Global Cancer Companion Diagnostics Market 2014-2021 292
Figure 9.17 Most Popular Proteomic and Genomic Technologies Performed by End-Users 293
Figure 9.18 Oncogenic Biomarker Share of Total Personalized Medicine Biomarker Space 294
Figure 9.19 Oncogenic Biomarker Market Distribution by Cancer Type 294
Figure 9.20 Personalized Medicine Branded Cardiovascular Therapeutic Market 2014-2021 295
Figure 9.21 Personalized Medicine Branded Cardiovascular Therapeutics Market Forecast 2014-2021 295
Figure 9.22 Cardiovascular Companion Diagnostics Market Forecast 2014-2021 296
Figure 9.23 Personalized Medicine Branded Infectious Disease Therapeutics Market 2014-2021 298
Figure 9.24 Gilead Sciences Sovaldi and Harvoni Sales Revenue 2014-2021 299
Figure 9.25 HIV and Hepatitis Diagnostic Assay Market Growth 2014 to 2021 300
Figure 9.26 Global Market Personalized Medicine Technology Growth 2009-2015 301
Figure 9.27 Global Personalized Sub-market Growth 2015 302
Figure 9.28 Personalized Medicine Sub-Market Share (Percentage) 2009 302
Figure 9.29 Personalized Medicine Sub-Market Share (Percentage) 2014 303
Figure 9.30 Global Genomic Testing Market Forecast 2014-2021 303
Figure 9.31 Pharmacogenetics Market Forecast 2014-2021 304
Figure 9.32 Global Molecular Diagnostics Predicted Market Share (%) 2015 306
Figure 9.33 Global Molecular Diagnostics Market (US$) 2015 306
Figure 9.34 Global Market for Molecular Diagnostics through 2021 307
Figure 9.35 Global Market for Liquid Biopsy by Geography (North America, Europe, RoW), Through 2021 308
Figure 9.36 Average Operating Profit Margin Analysis for Selected Players in the Personalized Medicine Industry 309
Figure 9.37 Oncology, Infectious Disease, Cardiovascular and Genomic Submarket Operating Profit Margins 311
Figure 9.38 Personalized Medicine Oncology Submarket Operating Profit Margin Analysis 312
Figure 9.39 Personalized Medicine Infectious Disease Submarket Operating Profit Margin Analysis 312
Figure 9.40 Personalized Medicine Cardiovascular Submarket Operating Profit Margin Analysis 313
Figure 9.41 Personalized Medicine Genomics Submarket Operating Profit Margin Analysis 313
Figure 9.42 Private Funding Gained by 23andMe 314
Figure 9.43 Affymetrix Revenue by Business Segment (Percentage) 321
Figure 9.44 Affymetrix Revenue From Affymetrix Core and eBioscience (Percentage) 321
Figure 9.45 Affymetrix Total Revenue 322
Figure 9.46 Affymetrix Revenue by Product Division – Consumables, Instruments 322
Figure 9.47 Affymetrix Core Product Sales – Gene Expression, Genetic Analysis & Clinical Applications and Life Science Reagents 323
Figure 9.48 Affymetrix Revenue Derived from Outside the US 323
Figure 9.49 Affymetrix Revenue Derived from the US 324
Figure 9.50 Affymetrix Net Loss 324
Figure 9.51 Affymetrix Research and Development Funding 325
Figure 9.52 Affymetrix Revenue Generated within USA (Percentage) 325
Figure 9.53 Astex Pharmaceuticals Priority Pipeline Products SGI-110 and AT13387 by Indication, Clinical Phase and Timeline 326
Figure 9.54 Astex Pharmaceuticals Revenue Generated 328
Figure 9.55 Astex Pharmaceuticals Net Income 328
Figure 9.56 Atossa Genetics Total Revenue (US$) 330
Figure 9.57 Atossa Genetics Revenue (US$) Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing 331
Figure 9.58 Atossa Genetics Percentage Revenue Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing 331
Figure 9.59 Quest Diagnostics Revenue ($ Billions) 332
Figure 9.60 Quest Diagnostics Operating Revenue ($ Billions) 334
Figure 9.61 Quest Diagnostics Net Income ($ Billions) 334
Figure 9.62 Celera (Quest Diagnostics) Historic Revenue Generated 335
Figure 9.63 Celera (Quest Diagnostics) Historic Gross Margin Generated 335
Figure 9.64 Celera (Quest Diagnostics) Historic Revenue Generated– Laboratory Services and Products 335
Figure 9.65 Celera (Quest Diagnostics) Historic Revenue (%) Generated by Distribution Agreement with Abbott 336
Figure 9.66 Celera (Quest Diagnostics) Historic Research and Development Spending 337
Figure 9.67 deCode Genetics Historic Net Loss Incurred 340
Figure 9.68 Illumina Revenue Generated ($ Billions) 342
Figure 9.69 Illumina Net Income Generated ($ Billions) 342
Figure 9.70 Myriad Revenue Generated 346
Figure 9.71 Operating Income Generated by Myriad 346
Figure 9.72 Myriad Revenue Generated by Molecular Diagnostic Testing and Pharmaceutical and Clinical (Companion Diagnostic) Services 347
Figure 9.73 Future Molecular Diagnostic Pipeline of Myriad 348
Figure 9.74 Customer Profile of Qiagen – Percentage of Net Sales 353
Figure 9.75 Qiagen Global Net Sales 353
Figure 9.76 Qiagen Operating Income 353
Figure 9.77 Qiagen Global Net Income 354
Figure 10.1: Percentage Oncology (Lung, Colorectal, Breast, Prostate) Patients Undergoing Next Generation Sequencing Testing in the US, 2018 364
Figure 10.2: Pipeline and On-market Oncology (Lung, Breast, Colorectal, Prostate) Therapeutics Directed Against Specific Mutations 365

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