Personalized Medicine, Targeted Therapeutics & Companion Diagnostic Market to 2021

4,500.0013,500.00

Published May 2017

Personalized Medicine: Targeted Therapeutics & Companion Diagnostic Market- A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment to 2021” provides a comprehensive account of the market size, market forecast, segmentation, key players, SWOT analysis, influential technologies, and business and economic environments.

For Sample Pages Download Here or email deirdre@kellysci.com for more info

Clear

Description

Personalized Medicine. Targeted Therapeutics and Companion Diagnostic Market- A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment to 2021” (published May 2017)

 

Download sample pages Here or email deirdre@kellysci.com for more info
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%.

Advancing technologies within the liquid biopsy market is also driving the market and will see strategic growth over the next five years with a CAGR of 20.6%. The two segments of the liquid biopsy market are tumor cell enrichment products and tumor cell detection technologies.

 

Individualized, targeted or personalized medicine aims to increase the efficacy of therapeutics via genetic testing and companion diagnostics. Personalized therapeutics and associated companion diagnostics are more specific and effective thereby giving pharma/biotech companies a significant advantage to recuperate R&D costs. Personalized medicine reduces the frequency of adverse drug reactions and therefore has a dramatic impact on health economics. Developmental and diagnostic companies benefit from lower discovery and commercialization costs and more specific market subtypes.

 

This new report gives 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 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 (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, 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
  • 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 (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.

  • 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

 

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.

 

Who should read this report?

  • Pharmaceutical, biotechnology and diagnostic companies 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 over 365 tables & figures over 397 pages and profiles the main pharmacos in personalized medicine.

 

Table of Contents

Table of Contents

Executive Summary 

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

1.4.2       KRAS Mutations

1.4.3       Herceptin® and Breast Cancer

1.4.4       BRACAnalysis®

1.4.5       Oncotype Dx Test

1.4.6       Public and Private Funding for Personalized Medical Research

1.4.7       New Business Model Required for Personalized Medicine

1.4.8       Cost-effectiveness and Business Value of Personalized Medicine

1.4.9       Personalized Medicine Market

1.4.10     Personalized Medicine Oncology Therapeutics & Diagnostics Market

1.4.11     Personalized Medicine Cardiovascular Therapeutics Market

1.4.12     PharmacoGenomics/PharmacoGenetics Market Analysis

1.4.13     Liquid Biopsy Market Analysis

 

2.0          Introduction and Background                                                                                                                       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 2020                                                                                 284

9.1.4       Top Five Oncology Drugs to 2020                                                                                                                  286

9.1.5       Global Oncology Market by Cancer Type                                                                                                      287

9.1.6       Oncology Targeted Therapeutics Market Analysis to 2020                                                                        288

9.1.7       Companion Diagnostic Assays – Oncology                                                                                                   292

9.2          Cardiovascular Targeted Therapeutics Market to 2019                                                                               294

9.2.1       Cardiovascular Companion Diagnostics Market to 2020                                                                            296

9.3          Infectious Disease Targeted Therapeutics Market to  2019                                                                        298

9.3.1       Infectious Disease Diagnostic Assay Market to2019                                                                                   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 2019                                                            303

9.7          Molecular Diagnostics Market to 2020                                                                                                           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 2015                                                                                                      377

 

 

 

 

Reviews

There are no reviews yet.

Be the first to review “Personalized Medicine, Targeted Therapeutics & Companion Diagnostic Market to 2021”

You may also like…