Personalized Medicine and Companion Diagnostic Market - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment"

 

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Abstract

 
"Personalized Medicine and Companion Diagnostic Market - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment" by Kelly Scientific Publications is a cutting-edge comprehensive report on the personalized medicine industry and its impact on the health system. This report tackles the growing market interest in pharmacogenomics, companion diagnostics and the associated market environment.

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

This report describes the current technologies that are propelling the personalized medicine and companion diagnostic market. It examines the current genetic diagnostic tests and companion diagnostic assays that are in use by the medical and pharmaceutical industry today. Current developments in personalized medicine and the pharmacogenomics revolution are discussed. The emerging trends that appear in key markets such as the US, UK, Germany and France are elucidated and analysed. This study reveals market figures of the overall personalized medicine market and also sub-market figures. Forecast projections and future growth rates are provided to give the reader a forthcoming perspective of this growing industry.

The study also provides a comprehensive financial and product review of key players in the personalized medicine industry. Strategic drivers and restraints of this market are revealed and market opportunities and challenges are identified.

In summary, the personalized medicine and associated companion diagnostic market have huge opportunities for growth. This industry will revolutionize the healthcare system and will improve therapeutic effectiveness and reduce the severity of adverse effects. It has enormous potential for investment and the emergence of genetic-based in vitro diagnostics.
 

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 263 tables & figures over 224 pages. The personalized medicine (global) market is presented as follows:

o By Company (e.g., 23andMe, AFFYMETRIX, ATOSSA GENETICS, NODALITY, deCode /Amgen, CELERA, MYRIAD)
o By Geography (US, UK, EU)
o By Segment (Targeted therapeutics, Companion Diagnostics, Esoteric tests, Esoteric lab services)
o By Sub-market (Companion diagnostics & therapeutic, nutrition & wellness, medical technology, pharmacogenomics, consumer genomics)

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

o Up-to-date company financials, sales & revenue figures
o Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies
o Business Model Strategies for Providers. Provider Systems and Academic Medical Centres
o Business Model Strategies for Payers & Governments
o Private and Public Funding and Personalized Medicine Reimbursement
o Revisions to Current Payment Systems and intellectual property
o How to Gain Market Penetration in the EU
o Cost-effectiveness and Business Value of Personalized Medicine
o Consumer genomics and POC market
o Therapeutics and Companion Diagnostics (e.g., BRAC Analysis, Oncotype Dx , KRAS Mutations)
o Comprehensive account of company product portfolios & kits

SWOT, Economic & Regulatory Environment specifics include:

o Key strengths, weaknesses and threats influencing leading player position within the market
o Technologies driving the market (e.g., New-Generation Sequencing Technologies, Ultra-High Throughput Sequencing)
o Top fastest growing market segments and emerging opportunities
o Top pharmaceutical companies within the IPM by market share and revenue
o Comprehensive product portfolios, R&D activity and pipeline therapeutics
o M&A activity and future strategies of top personalized medicine pharmacos
o Personalized Medicine Regulation (UK, Germany, France, Spain, Italy)
o CE-marked Personalized Medicine/Diagnostic Tests
o FDA Advances in Personalized Medicine Regulation

 

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Report Source Information

Supplied by: Research and Experts 
Date Published: 2014-05-01 

Report: Personalized Medicine and Companion Diagnostic Market - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment"

 

Contents

List of Tables

Table 2.1: Quick Facts: Personalized Medicine 18
Table 2.2: Genetic Mutations that Predispose Individuals to Disease 19
Table 2.3: Potential Applications of Pharmacogenetics and Pharmacogenomics in Personalized Medicine 19
Table 2.4: Main Cytochrome P450 Enzymes Involved in Drug Metabolism 19
Table 2.5: QUICK FACTS: Rapid & Slow Metabolizer Phenotypes 20
Table 2.6: Population Frequency of Cytochrome P450(CYP) 2C19 Metabolizer Types 21
Table 2.7: Population Frequency of Cytochrome P450 (CYP) Metabolizer Types 21
Table 2.8: Depression Medications Affected by Genetic Mutations 21
Table 2.9: Cardiovascular Medications Affected by Genetic Mutations 22
Table 2.10: Cancer Medications that may be Affected by Genetic Mutations 22
Table 2.11: Diabetes Medications Affected by Genetic Mutations 23
Table 2.12: Anti-Epileptic Drugs Affected by Genetic Mutations 23
Table 2.13: Anti-Retroviral Drugs Affected by Genetic Mutations 23
Table 2.14: Anti-Reflux/Ulcer Drugs Affected by Genetic Mutations 23
Table 2.15: List of Therapeutics According to Cytochrome P450 Subtype Metabolism 24
Table 2.16: Cytochrome (CYP) P450 Drug-Interactions Inhibitor List 25
Table 2.17: Cytochrome (CYP) P450 Drug-Interactions Inducer List 25
Table 2.18: QUICK FACTs - Main Aims of Pharmacogenomics 26
Table 2.19: How Pharmacogenomics has Influenced the Top Ten Selling Drugs Globally 28
Table 2.20: Advantages, Disadvantages and Cost of Popular Genotyping Methods 28
Table 2.21: QUICK FACTS - Top Ten Pharmacogenomics Tests 29
Table 2.22: QUICK FACTS - FDA Accepted Pharmacogenomic Biomarkers 29
Table 2.23: QUICK FACTS - Benefits of Single Base Primer Extension in Pharmacogenetics 32
Table 2.24: Future Applications of Ultra-High Throughput Sequencing 36
Table 2.25: QUICK FACTS - Comparison of Genotyping Techniques 36
Table 2.26: Problems associated with Microarray Sequencing 36
Table 2.27: QUICK-FACTS - Top Ten Genetic Findings of 2010 by 23andMe 36
Table 2.28: FDA Companion Diagnostics Device List: In Vitro and Imaging Tools 37
Table 2.29: Important Strategies for a Successful Companion Diagnostic Launch 43
Table 3.1: Predicted Warfarin Concentrations depending on CYP2C9 and VKORC1 Genotype 45
Table 3.2: QUICKFACTS - Top Five Most Frequent Cancers in Men and Women, Globally 48
Table 3.3: QUICKFACTs - Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer per Country, Worldwide 50
Table 3.4: QUICK-FACTS - Types of Diagnostic Tests Available to Determine HER2 Status in Breast Cancer Patients 55
Table 3.5: Validated HER2 Tests for Cancer 57
Table 3.6: QUICK FACTS - Advantages and limitations of IHC HER2 testing applied to breast cancer 57
Table 3.7: In-Situ Hybridization Determination of HER2 Expression by PathVysion and HER2 FISH pharmDxTM 58
Table 3.8: HER2 CISH Determination 58
Table 3.9: Validated FISH Kits for HER2 Testing in Breast Cancer 58
Table 3.10: Validated SISH Kits for HER2 Testing in Breast Cancer 58
Table 3.11: Validated CISH Kits for HER2 Testing in Breast Cancer 58
Table 3.12: Advantages and limitations of ISH techniques applied to HER2 testing in breast cancer 59
Table 3.13: QUICK FACTs- Prevalence of Deleterious Mutations in BRCA1 and BRCA2 Genes 59
Table 3.14: QUICK FACTs- prevalence of deleterious mutations in BRCA1 and BRCA2 in individuals of Ashkenazi Ancestry 60
Table 3.15: QUICK FACTs- Risk Factors for Hereditary Breast and Ovarian Cancer (HBOC) 61
Table 3.17: QUICKFACTs- BRACAnalysis Panel of Assays 62
Table 3.18: The Prolaris Score for Prostate Cancer 64
Table 4.1: QUICKFACTs - Objectives of the Personalized Medicine Coalition 65
Table 4.2: Current Personalized Medicine Coalition Members 65
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. 67
Table 4.4: Minimum Definition of a clinically Actionable Variant 68
Table 4.5: Minimum Criteria for Whole Genome Analysis in Clinical Laboratory Improvement Amendments Laboratory of Genomic Pathology, Clinical Whole Genome Analysis 69
Table 5.1: Public Funding Bodies for Pharmacogenetic/Pharmacogenomic Research 71
Table 5.2: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Drug Development and Diagnostics 72
Table 5.3: European Companies Involved in Pharmacogenomics/Pharmacogenetics Drug Development and Diagnostics 72
Table 5.4: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Diagnostics 72
Table 5.5: European & Other Companies Involved in Pharmacogenomics/Pharmacogenetics
Diagnostics 73
Table 5.6: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Services 73
Table 5.7: European/Other Companies Involved in Pharmacogenomics/Pharmacogenetics Services 73
Table 5.8: North American Companies Involved in Pharmacogenomics/Pharmacogenetics Tools Kits and Software 74
Table 5.9: European Companies Involved in Pharmacogenomics/Pharmacogenetics Tools Kits and Software 74
Table 5.10: North American Companies with Minor interest in Pharmacogenomics/Pharmacogenetics 74
Table 5.11: European/Other Companies with Minor interest in Pharmacogenomics/Pharmacogenetics 75
Table 5.12: Large US Companies with Investment into Pharmacogenomics/Pharmacogenetics 75
Table 5.13: Large European Companies with Investment into Pharmacogenomics/Pharmacogenetics 76
Table 5.14: Large Japanese Companies with Investment into Pharmacogenomics/Pharmacogenetics 76
Table 5.15: Top Ten Biological Areas of Interest in Pharmacogenetics/Pharmacogenomics 76
Table 5.16: Top International Pharmacogenetic/Pharmacogenomic Research Institutions 77
Table 5.17: Top European Pharmacogenetic/Pharmacogenomic Research Institutions 77
Table 6.1: QUICK FACTs- Variation of Reimbursement Policies for HER2 and KRAS Testing in Europe 81
Table 6.2: Pharmaceutical Companies Providing Subsidization of Diagnostic Personalized Medicine Tests in Europe 82
Table 6.3: QUICKFACTs - Challenges Within Personalized Medicine Market in Europe 83
Table 6.4: QUICKFACTS- Function of the European network for Health Technology Assessment (EUnetHTA) Organisation 83
Table 6.5: European network for Health Technology Assessment (EUnetHTA) Partners 84
Table 6.6: European network for Health Technology Assessment (EUnetHTA) Associates 86
Table 6.7: Diagnostics Guidance Assessment by the National Institute for Health and Clinical Excellence (NICE) 88
Table 6.8: Current Diagnostics Guidance in Development by the Diagnostics Access Program, UK 89
Table 6.9: Published Diagnostics Guidance by the Diagnostics Access Program, UK 90
Table 6.10: Medical Technologies Guidance Assessment by the National Institute for Health and Clinical Excellence (NICE) 90
Table 6.11: Published Medical Technologies Guidance by the National Institute for Health and Clinical Excellence (NICE) 91
Table 6.12: Published Medical Technologies Guidance in Development by the National Institute for Health and Clinical Excellence (NICE) 91
Table 6.13: QUICK FACTs - Key Challenges to Personalized Medicine 95
Table 6.14: QUICKFACTs - Personalized Medicine - Translation into Medical Applications 95
Table 7.1: QUICK FACTS - Major Market Trends in Personalized Medicine 96
Table 7.2: Collaboration Strategies Required between Industry, Payers and Governments for a Productive Personalized Medicine Market 96
Table 7.3: QUICK FACTs - Business Model Recommendations for Diagnostic, Pharmaceutical and Biotechnology Companies 97
Table 7.4: QUICK FACTs - Business Model Recommendations for Providers. Provider Systems and Academic Medical Centres 97
Table 7.5: QUICK FACTS Business Model Recommendations for Payers 98
Table 7.6: QUICK FACTs - Business Model Recommendations for Governments 98
Table 7.7: QUICK FACTs - Non-Healthcare Companies with Potential to enter the Personalized Medicine Market 99
Table 7.8: Hurdles of Personalised Medicine with Respect to Cost-Effectiveness 100
Table 8.1: Patent Listing of Affymetrix Array technology 104
Table 8.2: Patent Listing of Affymetrix Genotyping Technology 104
Table 8.3: Patent Listing of Affymetrix Array technology 105
Table 8.4: Patent Listing of Affymetrix Genotyping Technology 106
Table 8.5 Astex Pharmaceuticals Pipeline Portfolio 106
Table 8.6: Astex Pharmaceuticals Pipeline Portfolio Funded Completely by Partner Companies 107
Table 8.7: Potential Business Partnerships of Celldex Therapeutics 109
Table 8.8: Illumina Core Technologies 111
Table 8.9: Illumina Core Technology Applications 111
Table 8.10: Illumina Instrument Product Portfolio 112
Table 8.11: Illumina Assay Product Portfolio 112
Table 8.12: Genetic Test Panel Available from Genelex for Research Institutions and Clinical Trials 113
Table 8.13: Pre-Clinical, Clinical and Commercial Applications of SCNP by Nodality 116
Table 8.14: Qiagen Timeline of Events, 1994-2012 116
Table 8.15: QUICKFACTs - Range of Product Groups from Qiagen 118
Table 9.1: 23andMe Disease Risk Genetic Test Panel 119
Table 9.2: 23andMe Carrier Status Genetic Test Panel 122
Table 9.3: 23andMe Drug Response Genetic Marker Test Panel 124
Table 9.4: 23andMe Genetic Traits Test Panel 124
Table 9.5: QUICKFACTs - Product Overview of Affymetrix 126
Table 9.6: Microarray Products by Affymetrix 126
Table 9.7: Affymetrix Research Services Laboratory (ARSL) Premier Services 127
Table 9.8: Genetic Applications of Axiom Technology by Affymetrix 127
Table 9.9: Range of Small Molecule Therapeutics Available from Astex Pharmaceuticals 127
Table 9.10: Panel of cystic fibrosis transmembrane conductance regulator (CFTR) mutations screened for in Celera Cystic Fibrosis Genotyping Assay 130
Table 9.11: Genetic Tests Available from BHL/Celera 132
Table 9.12: Panel of BHL Clinical Diagnostic Tests 132
Table 9.13: Features of the m2000 RealTime PCR System by Celera 132
Table 9.14: Genetic Diagnostic Tests Available from deCode Genetics 133
Table 9.15: Type 2 Diabetes risk range and distribution according to continental ancestry as Determined by deCodeT2 Genetic Test 134
Table 9.16: Genetic Mutations Identified by the deCODE MI(TM) Test in a European Population 135
Table 9.17: Genetic Mutations Identified by the deCODE MI(TM) Test in an East Asian Population 136
Table 9.18: Disease States that are Included in the deCODE Complete(TM) Genetic Screen 136
Table 9.19: Panel of Diseases Screened for in the deCODE Cancer(TM) Test 137
Table 9.20: Panel of Cardiovascular Diseases in the deCODE Cardio(TM) Test 137
Table 9.21: deCODE Genetics Genotyping and Sequencing Service 137
Table 9.22: deCODE Genetics Data Management, Protection and Storage Service 138
Table 9.23: deCODE Genetics Sequence Inputation and Data Analysis Service 138
Table 9.24: Illumina HiSeq 2500/1500 Performance Parameters 139
Table 9.25: Illumina HiSeq 2000/1000 Performance Parameters 139
Table 9.26: Genome Analyzer IIx Performance Parameters 140
Table 9.27: Illumina MiSeq Product Specifications 141
Table 9.28: Illumina HiScanHQ Product Specifications 142
Table 9.29: Illumina HiScan and iScan Array Product Applications 142
Table 9.30: Illumina iScan Array Kits 142
Table 9.31: Panel of Genetic Screens Available from Genelex 144
Table 9.32: Drug Sensitivity Screens Available from Genelex 144
Table 9.33: Predictive Genetic Tests Available from Myriad 145
Table 9.34: Services offered with BRACAnalysis Testing from Myriad 145
Table 9.35: Advantages of BRACAnalysis Testing 146
Table 9.36: COLARIS Test Range by Myriad 146
Table 9.37: COLARIS AP Test Range by Myriad 147
Table 9.38: MELARIS Test Range from Myriad 147
Table 9.39 Personalized Medicine Tests from Myriad 147
Table 9.40: OnDose Testing Procedure from Myriad 148
Table 9.41: Qiagen Genotyping Products for Sample Collection, stabilization and Storage 149
Table 9.42: Qiagen Genotyping Products for Genomic DNA Isolation and Purification 149
Table 9.43: Qiagen Genotyping Products for PCR Based Genotyping Analysis 150
Table 9.44: Qiagen Products for Genotyping Analysis 150
Table 9.45: Qiagen Genotyping Products for PCR Detection 151
Table 9.46: Qiagen Assays for Genetic Analysis 151
Table 9.47: Qiagen Pyrosequencing-Based Genetic Analysis Products 151
Table 9.48: Specifications and Features of Qiagen's QIAsymphony and QIAsymphony RGQ 152
Table 10.1: QUICK FACTs - Submarkets within the Personalized Medicine Technology Market 157
Table 10.2: Drug Classes Investigated by 23andMe using genome wide association studies 162
Table 10.3: Acquisition Profile of Affymetrix 164
Table 10.4: Genetic Applications of Axiom Technology by Affymetrix 164
Table 10.5 Diversified Business Units of Affymetrix 165
Table 10.6: Affymetrix AgBio Microarray Portfolio 167
Table 10.7: Celera (Quest Diagnostics) Historic Operating (Loss) (US$) - Laboratory Services and
Products 2008-2010 183
Table 10.8: Diagnostic Test Product Categories Manufactured by BHL/Celera and Exclusively Distributed by Abbott 183
Table 10.9: Celldex Therapeutics R&D Expenses ($) 2010-2012 186
Table 10.10: Price Listing of Genelex Familial Genetic Tests 191
Table 10.11: Myriad - Core Business Decisions and Impact on Industry 2012 195
Table 10.12: Future Test Portfolio of Myriad 195
Table 10.13: Nodality's Single Cell Network Profiling (SCNP) Technology as a Systems Based Biology Approach to Drug Discovery and Validation 197
Table 10.14: BioMerieux Immunodiagnostic Product Portfolio 202
Table 10.15: BioMerieux Microbiology Product Portfolio 204
Table 10.16: BioMerieux Molecular Diagnostic Product Portfolio 206
Table 11.1: QUICK FACTS: Strengths and Advantages of Genotyping Techniques 211
Table 11.2: QUICK FACTS: Strengths, Drivers and Advantages of Personalized Medicine Market 213
Table 12.1: QUICKFACTs: Restraints of Personalized Medicine Market 216
Table 13.1: QUICK FACTS - Summary of Clinical Laboratory Improvement Amendments (CLIA) 217
Table 13.2: Clinical Laboratory Improvement Amendments (CLIA) Testing Categories 218
Table 13.3: QUICK FACTS - Test Features required prior to FDA Approval and Clearance 218
Table 13.4: Impact of Genetic Information Non-discrimination Act (GINA) on Healthcare Companies and Health Plans 219
Table 13.5: Impact of Genetic Information Non-discrimination Act (GINA) on US Employers, employment agencies, labor organizations and training programs 219
Table 13.6: QUICK FACTS - FDA Commitment to the Personalized Medicine Industry 220
Table 13.7: Objectives of the 'Advancing Regulatory Science at FDA: A Strategic Plan' 220
Table 13.8: QUICKFACTS - Implementation Strategy of the FDA to Advance Regulatory Science - Develop better Models of Human Adverse response 221
Table 13.9: QUICKFACTS - Implementation Strategy of the FDA to Advance Regulatory Science - Identify and evaluate biomarkers and endpoints that can be used in non-clinical and clinical evaluations 221
Table 13.10: QUICKFACTS - Implementation Strategy of the FDA to Advance Regulatory Science - Use and develop computational methods and in silico modelling 221














List of Figures

Figure 2.1: QUICK FACTS - Elements of Personalized Genomic Medicine 17
Figure 2.2: Identification of Good and Non-Responders in a Patient Population 20
Figure 2.3: Pharmacodynamic and Pharmacokinetic Examples of Drug Targets and Drug metabolism in Pharmacogenomics 27
Figure 2.4: QUICK FACTS - Flow Diagram of Pharmacogenetic Analysis 32
Figure 2.5: Primer Based Base Extension in Pharmacogenetics 33
Figure 2.6: Genetic Mutation Detection by Hybridization 34
Figure 2.7: Ligation based SNP Detection 34
Figure 2.8: New-Generation Sequencing: Pyrosequencing 35
Figure 3.1: QUICK FACTS - Warfarin Metabolism and Response 44
Figure 3.2: QUICK FACTS - Percentage Frequency of CYP2C9 and VKORC1 mutations in Caucasian, African-American and Asian Populations 45
Figure 3.3: QUICK FACTS: Anti-EGFR Therapy and KRAS Mutations 46
Figure 3.4: KRAS and BRAF Genetic Tests Available from Asuragen 47
Figure 3.5: Global Incidence and Mortality of Cancer in Women 48
Figure 3.6: Cancer Deaths in Women, Globally according to Cancer Type 49
Figure 3.7: Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer Globally 49
Figure 3.8: HER2 Testing Algorithm for Breast Cancer 56
Figure 3.9: HER2 Cellular Signalling 56
Figure 3.10: QUICKFACTs - Herceptin - Mechanism of Action 57
Figure 3.11: BRCA Mutation Increases the Risk of Breast and Ovarian Cancer 61
Figure 3.12: Proactive Cancer Management and Preventative Measures Reduces the Risks of Developing BRCA-associated Breast and Ovarian Cancer 61
Figure 4.1: Integration of Multiple components for a Personalized Medicine Healthcare System 66
Figure 4.2: Workflow Diagram illustrating Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology 68
Figure 4.3: Hypothetical Flow Diagram of a Patient through the Genomic Pathology Clinical Laboratory 69
Figure 5.1: Personalized Medicine Scheme Interaction with Industry, Regulatory Bodies and Funding Agencies 70
Figure 5.2: Number of Publically Funded Pharmacogenetic and Pharmacogenomic Research Teams Internationally 71
Figure 6.1: Adverse Drug Reactions are the Fourth Leading Cause of Death 80
Figure 6.2: Efficacy Rate of Major Disease Types with Standard Treatment 80
Figure 6.3: The In Vitro Diagnostic Market in Europe 83
Figure 6.4: QUICK FACTS: Organization of the European network for Health Technology Assessment (EUnetHTA) 84
Figure 6.5: Key Differences in Reimbursement Policy Approaches for Oncology Diagnostics and Therapeutics in Europe and the US 89
Figure 6.6: Flow Diagram of the German Healthcare System and Key Agencies 93
Figure 6.7: German Reimbursement Arrangement, Process and Implications 93
Figure 7.1: Annual Healthcare Expenditure for Major Industrial Nations 101
Figure 7.2: Estimated Life Expectancy from Birth for Major Industrialized Countries 101
Figure 8.1: Celldex Therapeutics Product Pipeline 110
Figure 8.2: Single Cell Network Profiling (SCNP) Technology by Nodality 115
Figure 8.3: Developed Functional Assays that Nodality has explored using new SCNP Technology 115
Figure 9.1: Flow Diagram of Celera CEGA -16(TM) Instrument for Cystic Fibrosis Gene Analysis 133
Figure 9.2: Percentage of Individual Populations who have an Increased Risk of Developing Type 2 Diabetes as Determined Using the deCodeT2 Genetic Test 134
Figure 9.3: Illumina New Generation Sequencing Technology Workflow Station 138
Figure 10.1: Combined Personalized Medicine Market in the US, 2009-2015 155
Figure 10.2: Core Personalized Medicine Sub-Market Growth Forecast 2009-2015 155
Figure 10.3: Personalized Medical Care Sub-Market Growth Forecast 2009-2015 156
Figure 10.4: Nutrition and Wellness Sub-market of Personalized Medicine Growth Forecast 2009-2015 156
Figure 10.5: Diagnostic and Therapeutic Personalized Medicine Market Growth Projection in the US, 2009-2015 157
Figure 10.6: Global Market Personalized Medicine Technology Growth Forecast 2009-2015 158
Figure 10.7: Global Personalized Sub-market Growth Forecast 2009-2014 158
Figure 10.8: Personalized Medicine Sub-Market Share (Percentage) 2009 159
Figure 10.9: Personalized Medicine Sub-Market Share (Percentage) 2014 159
Figure 10.10: Global Molecular Diagnostics Predicted Market Share 2015 160
Figure 10.11: Global Molecular Diagnostics Market Projection 2015 160
Figure 10.12: Private Funding Gained by 23andMe 2007-2012 161
Figure 10.13: Affymetrix Revenue by Business Segment (Percentage), 2013 168
Figure 10.14: Affymetrix Revenue by Business Segment (Percentage), 2012 168
Figure 10.15: Affymetrix Total Revenue 2007-2013 169
Figure 10.16: Affymetrix Revenue by Product Division - Consumables, Instruments 2010-2012 169
Figure 10.17: Affymetrix Core Product Sales - Gene Expression, Genetic Analysis & Clinical Application and Life Science Reagents, 2011-2012 170
Figure 10.18: Affymetrix Revenue Derived from Outside the US, 2009-2012 170
Figure 10.19: Affymetrix Revenue Derived from the US, 2009-2012 171
Figure 10.20: Affymetrix Net Loss, 2009-2012 171
Figure 10.21: Affymetrix Research and Development Funding, 2009-2012 172
Figure 10.22: Affymetrix Revenue Generated within USA (Percentage) 2010-2012 172
Figure 10.23: Astex Pharmaceuticals Priority Pipeline Products SGI-110 and AT13387 by Indication, Clinical Phase and Timeline 173
Figure 10.24: Astex Pharmaceuticals Revenue Generated 2008-2012 175
Figure 10.25: Astex Pharmaceuticals Net Income 2009-2012 175
Figure 10.26: Atossa Genetics Total Revenue (US$) 2011, 2012 177
Figure 10.27: Atossa Genetics Revenue (US$) Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing, 2012 178
Figure 10.28: Atossa Genetics Percentage Revenue Generated by MASCT Sales and ForeCYTE & ArgusCYTE Diagnostic Testing, 2012 178
Figure 10.29: Quest Diagnostics Revenue ($ Billions) 2008-2013 180
Figure 10.30: Quest Diagnostics Operating Revenue ($ Billions) 2008-2013 181
Figure 10.31: Quest Diagnostics Net Income ($ Billions) 2008-2013 181
Figure 10.32: Celera (Quest Diagnostics) Historic Revenue Generated 2008-2010 182
Figure 10.33: Celera (Quest Diagnostics) Historic Gross Margin Generated 2008-2010 182
Figure 10.34: Celera (Quest Diagnostics) Historic Revenue Generated- Laboratory Services and Products 2008-2010 183
Figure 10.35: Celera (Quest Diagnostics) Historic Revenue (%) Generated by Distribution Agreement with Abbott 2008-2010 184
Figure 10.36: Celera (Quest Diagnostics) Historic Research and Development Spending 2008-2010 184
Figure 10.37: deCode Genetics Historic Net Loss Incurred 2004-2008 188
Figure 10.38: Illumina Revenue Generated ($ Billions) 2010-2013 190
Figure 10.39: Illumina Net Income Generated ($ Billions) 2010-2013 190
Figure 10.40: Myriad Revenue Generated 2007-2014 194
Figure 10.41: Operating Income Generated by Myriad 2007-2014 194
Figure 10.42: Myriad Revenue Generated by Molecular Diagnostic Testing and Companion Diagnostic
Services, 2012/2013 195
Figure 10.43: Future Molecular Diagnostic Pipeline of Myriad 196
Figure 10.44: Customer Profile of Qiagen - Percentage of Net Sales 2012/2013 200
Figure 10.45: Qiagen Global Net Sales 2007-2013 201
Figure 10.46: Qiagen Operating Income 2007-2013 201
Figure 10.47: Qiagen Global Net Income 2007-2013 202
Figure 11.1: Percentage Oncology (Lung, Colorectal, Breast, Prostate) Patients Undergoing Next Generation Sequencing Testing in the US, 2018 212
Figure 11.2: Pipeline and On-market Oncology (Lung, Breast, Colorectal, Prostate) Therapeutics Directed Against Specific Mutations, 2013 214



 

Scope

What you will gain:

o An in-depth understanding of the global personalized medicine market and it's environment
o Current market facts, figures and product lines of key players in the industry
o Emerging trends in key markets such as the US, UK, Germany and France
o Knowledge of how the personalized medicine market will integrate into the global healthcare market
o Technical insights into new generation sequencing technologies and ultra-high throughput sequencing
o Updates on bioinformatics, high throughput systems, genetic analysis kits, companion diagnostics and future technologies
o FDA approved pharmacogenetic tests and recognized biomarkers
o Information on key government and regulatory policies
o Strategies on how to adapt and restructure current business models to this industry

 

Highlights

The personalized medicine and associated companion diagnostic market have huge opportunities for growth. This industry will revolutionize the healthcare system and will improve therapeutic effectiveness and reduce the severity of adverse effects. It has enormous potential for investment and the emergence of genetic-based in vitro diagnostics.

 

Classification

Language Code: EN 
Region: Global 
Report Type: Industry Report 
Industry: Life Sciences 
Sector: Pharmaceutical Manufacturing 
Pages: 224 

Companies Featured

o 23andMe o Affymetrix o Astex Pharmaceuticals o Atossa Genetics o CuraGen o Celera Corporation (Quest Diagnostics) o Celldex Therapeutics o deCode Genetics (Amgen) o Illumina o Genelex o Myriad o Nodality o Qiagen

 

Reasons to buy this report

This report tackles key concerns to the personalized medicine market such as:
o Lack of regulatory policy and legislation in the US and Europe
o Reimbursement schemes and payers concerns
o Transition of investigational diagnostic assays and therapeutics to clinical practice
o Direct to consumer (DTC) test kits and implications for the public

Who should read this report?
o Pharmaceutical, biotechnology and diagnostic companies with an interest in personalized medicine
o Industry professionals and business strategists will discover key information to propel their policies
o Investors will gain inside information to dominant players in the industry and future forecasts
o Scientists will get a business perspective and industry insight into how scientific breakthroughs influence the market environment

 

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Personalized Medicine and Companion Diagnostic Market - A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment"

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Branch ID: 1591

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Global

The global economy is the economy of all the world's countries. The total world population now stands at over 7 billion and the global unemployment rate is 9% with approximately half the world's population paid less than $2 a day. 

The global economy is picking up again after five years of uncertaintity and slow economic growth. The IMF is predicting global growth of 3.7% in 2014 rising to 3.9% in 2015. However, much uncertainity remains. Low inflation in developed economies means that these economies take longer to deal with debt burdens and are at increases risk of deflation. 

The second half of 2013 saw growth in the US and European economies (particularly UK, Germany and France).  

Growth in the US has been helped by cheaper energy from fracking , renewables and more oil and gas exploration. This cheaper energy is bring manufacturing jobs back to the US and helping to boost domestic demand. Recent winter weather conditions have hampered growth in the construction sector and have slowed demand in the construction equipment sector which saw exports drop by 25% in 2013. Growth should pick up in this sector with continued federal investment in infrastructure, new residential house builds and refurbishment and the energy boom.

In Europe growth is expected to be uneven with growth being slow in stressed economies such as Portugal and Greece but confidence picking up in UK, Ireland and even Spain showing some improvement.

Developing economies such as China and India will continue to have strong growth in 2014 and 2015. China has benefitted from increased investment with the Chinese govenment now focused on quality growth of 7.5% in 2014. India which is less reliant on exports expects growth of 5.4% in 2014 and 6.4% in 2015.

Much uncertainity still remains in the global economy with greater optimism needed to stabilise growth.

Links

World Bank

IMF (International Monetary Fund)

 

 

Zones

Regional zones

 

Country

Countries

 

Industry Sector Information

Taxonomy

Branch ID: 525

Taxonomy Location

The taxonomy on the left shows the ancestors of the Pharmaceutical Manufacturing node. This provides an insight into parent categories that may provide reports or articles that may compliment this report. The number in brackets after the node name indicates the number of reports that Research and Experts currently have in the parent category.

Clicking on a parent category will present the list of reports in the parent node in a separate window.

Pharmaceutical Manufacturing

The pharmaceutical manufacturing industry manufactures drugs for use as medications. The global pharmaceutical manufacturing industry has experienced huge change in the last ten years with many drugs coming off patent. Finding new markets for drugs is critical for the future of the pharma industry.

Companies need to use quality well researched information which will give them the insights required to make strategic decisions.

Research and Experts provide reports which analyse key players in the market place, identify market size globally and regionally and look at trends currently driving decisions in the industry.

Associations

Association of the British Pharmaceutical Industry

 

 

Pharmaceuticals

According to the World Health Organisation the global pharmaceuticals market is worth US$300 billion a year and is expected to rise to US$400 billion within three years. Of the top ten global pharmaceutical companies six are US based and four are European. 

2014 promises to be a good year for the pharmaceutical industry with companies benefitting from the impact of the Affordable Care Act in the US, benefits from emerging market opportunities and disease trends.  Pharmaceutical companies however need to be prepared to negotiate with more sophisticated strategic purchasing professionals now working for many healthcare bodies. Purchasers are looking for greater value for money in todays difficult economic climate.

The Research and Experts platform is the place to start your research when looking for key intelligence on the pharmaceutical industry. 

Useful Links

The Association of the British Pharmaceutical Association

The World Health Organisation - The Pharmaceutical Industry

The International Federation of Pharmaceutical Manufacturers & Associations 

Pharmaceuticals

Life Sciences

The Life Sciences industry includes biotechnology, healthcare, pharmaceuticals, medical devices and diagnostics. The industry is dominated by US companies requiring considerable investment in research and development to stay competitive.  While US companies dominate this space, competition is emerging from smaller companies in Europe and Asia. 

Companies trying to stay competitive or enter new markets in life sciences consult our reports. For example, Plimsoll, in their recent review of global antibiotic manufacturers have reviewed 150 of the largest manufacturers including analysis of  ANTIBIOTICE SA, BAYER HEALTHCARE MANUFACTURING SRL and CIPLA LTD. 

Our reports are a requirement for companies looking for the best competitive intelligence in the life sciences sector providing information on market size, rankings, best trading partners and financial analysis. 

Useful Links

Analytical Life Sciences and Diagnostics Association

German Life Sciences Association

 

Life Sciences

Industry

Industries

 

 

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