On 18 September 2014: Email ID-Tel No - 91 2241236650 Published by

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Global and USA Cancer Biomarker Market to 2018
(Identification, Technologies, Market Analysis, Competitor
Profiles, Companion Diagnostic Co-Development, Business
Strategies, Industry Trends, and Pipeline Analysis)
On 18
th
September 2014

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
280 tables & figures over 232 pages. The oncology biomarker (globaland USA) market is
presented as follows:
By Company (e.g., 23andMe, AFFYMETRIX, ATOSSA GENETICS, NODALITY, deCode /Amgen,
CELERA, MYRIAD, FOUNDATION MEDICINE, GENOMIC HEALTH)
By Geography (Global, US)
By Sub-market (Global Biomarker Market, Cancer Biomarker Market, Global Cancer Profiling
Technology Market )
A wealth of financial data & business strategy information is provided including:
Up-to-date company financials, sales & revenue figures
Revenue and market forecasts up to 2018

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Tel No- 91 2241236650

Business model strategies for diagnostic, pharmaceutical and biotechnology companies
Therapeutics and Companion Diagnostics (e.g., BRAC Analysis, Oncotype Dx , KRAS Mutations)
Comprehensive account of company product financials, 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 cancer biomarker market
Comprehensive product portfolios, R&D activity and pipeline therapeutics
M&A activity and future strategies of top companies
Approved biomarker companion diagnostic tests
High demand and Unmet Need Enhances the Global Biomarker Market
FDA Support Increases Biomarker Development
More Streamlined Clinical Trials
Significant Growth of High-Impact Oncogenic Biomarker Research
Advancements in Discovery Technologies
Challenges of the Oncogenic Biomarker Market
Variability of Biomarkers within Different Cancer Subtypes
Integration of Genomics and Biomarker Diagnostics into the Healthcare System
Ethical Considerations

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This report highlights a number of significant Indian pharmacos and gives details of their
operations, products, financials and business strategy.
23andMe
Affymetrix
Ambry Genetics
Astex Pharmaceuticals
Atossa Genetics
BioMerieux
CuraGen
Celera Corporation (Quest Diagnostics)
Celldex Therapeutics
deCode Genetics (Amgen)
Foundation Medicine
Illumina
Genelex
Genomic Health
Myriad
Nodality
OriGene Technologies
Randox
Qiagen
"GLOBAL & USA CANCER BIOMARKER MARKET to 2018 (Identification, Technologies, Market
Analysis, Competitor Profiles, Companion Diagnostic Co-development, Business Strategies,
Industry Trends, and Pipeline Analysis) by Kelly Scientific Publications is a comprehensive
report on the cancer biomarker industry and its impact on the health system. This report
tackles the growing market interest in oncogenic biomarkers, personalized medicine,
companion diagnostics and the associated market environment.
Cancer biomarkers are molecular or genetic moieties (e.g., cells, proteins/peptides, genetic
mutations, gene products, enzymes, or hormones) that not only are readily identifiable, but
easily quantified in the lab setting. They function primarily to identify or correlate significantly
with the severity or occurrence of a certain disease state. The rise in number of oncogenic
biomarkers over the last number of years has massive potential in the healthcare industry and
serves to propel both the personalized medicine and companion diagnostic markets.

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One of the most import aspects of biomarkers is their use to diagnose and assess the progress
of disease states in patients. As quantitative markers, these agents also offer the ability to
monitor response to certain drug treatments and so are important in the area of personalized
medicine.
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 cancer biomarker 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 the global market and the most developed market (US) are
elucidated and analysed. This study reveals market figures of the overall biomarker market and
the cancer biomarker space (2013-2018). 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, business strategy and product review of key
players in the cancer biomarker industry. Strategic drivers and restraints of this market are
revealed and market opportunities and challenges are identified.
In summary, the cancer biomarker 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.

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Other industries we cover:
Advertising and Media
Automotive and Parts
Consumer Goods
Healthcare and Medical
Finance and Banking
Food and Beverages
Travel and Tourism
Textiles and Clothing
SWOT Analysis
Table of Content
1.0 Executive Summary 13
1.1 Objectives of Report 13
1.2 Data Sources and Methodology 15
1.3 Key Findings and Observations 15
1.3.1 What Makes Cancer Biomarkers so Important for the Healthcare Industry? 15
1.3.2 What Technologies are Used to Identify Novel Biomarkers? 16
1.3.3 Increase in Cancer Prevalence is Propelling the Oncogenic Biomarker Market 16
1.3.4 Global and US Economic Impact of Cancer 16
1.3.5 How Cancer Biomarkers are Revolutionizing Cancer Treatment 17
1.3.6 What are the most Significant and Strategic Cancer Biomarkers? 17
1.3.7 Global Biomarker Test Market Analysis 18
1.3.8 Global Cancer Biomarker Market Analysis 18

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1.3.9 Oncology Biomarker Market Main Industry Players 19
1.3.10 Drivers, Restraints, Opportunities and Challenges of the Cancer Biomarker Market 19
2.0 Global Burden of Cancer 20
2.1 Global Cancer Statistics 20
2.2 Lung Cancer Globally 25
2.3 Lung Cancer Mutation Analysis 28
2.4 Colorectal (Bowel) Cancer Globally 29
2.5 Prostate Cancer Globally 31
2.6 Breast Cancer Globally 33
2.7 Global Economic Impact of Cancer 39
2.8 Cancer in the USA 40
2.9 Breast Cancer in the US 43
2.10 Lung Cancer in the US 44
2.11 Colorectal Cancer in the US 45
2.12 Prostate Cancer in the US 50
2.13 Skin Cancer in the US 52
3.0 Oncogenic Biomarkers An Overview 54
3.1 Biomarker Discovery to Clinical Validation 56
3.2 Specific Technologies Used in Biomarker Discovery 57
3.2.1 Proteomics 57

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3.2.2 Mass Spectrometry Based Technologies 57
3.2.3 Principles of Diagnostic Mass Spectrometry 58
3.2.4 Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) 58
3.2.5 Nano LC-MS/MS 59
3.2.6 MALDI-TOF 59
3.3 Glycomics 60
3.4 Metabolomics 61
3.5 Peptidomics 62
3.5.1 Enzyme-Linked Immunosorbent Assay (ELISA) 62
3.6 Selected (Multiple) Reaction Monitoring 66
3.7 DNA Based Techniques 67
3.7.1 Microarrays 67
3.7.2 Small Molecule Real Time (SMRT) DNA Sequencing 69
3.7.3 Digital PCR 69
3.7.4 Next Generation Sequencing 70
3.7.5 Second-Generation Sequencing Platforms 71
3.7.6 Whole Genome Sequencing 71
3.7.7 Epigenomics 72
3.7.8 Bioinformatics and Next Generation Sequencing 72
3.7.9 Third Generation Sequencing 72

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4.0 Biomarker Validation 73
4.1 Introduction 73
4.2 Phases of Biomarker Validation 73
4.3 Biomarker Validation and Clinical Trials 75
5.0 Current and Prospective Oncogenic Biomarkers 77
5.1 Catalogue of Somatic Mutations in Cancer (COSMIC) 77
5.2 P53 Transcription Factor Oncogenic Mutations 78
5.2.1 Current Clinical Trials Investigating P53 as an Oncogenic Biomarker 83
5.3 Epidermal Growth Factor Receptor (EGFR) 84
5.3.1 EGFR-Activating and Resistance Mutations 85
5.3.2 Clinically Validated Resistance Mechanisms to EGFR Inhibitors 86
5.3.3 Current Strategies to Defeat Resistance to EGFR-Mediated Cancer Therapeutics 87
5.4 BRCA- Mutant Cancers 87
5.5 PARP-Inhibitors are Making a Comeback 90
5.5.1 Olaparib A Pipeline PARP-Inhibitor 90
5.5.2 Niraparib (MK4827) in Phase III trials 91
5.5.3 Rucaparib 91
5.5.4 Veliparib 91
5.5.5 Novel Biomarkers in the PARP-Inhibitor Response Pathway 92
5.6 PTEN Current Leader in Pipeline Onocogenic Biomarkers 92

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5.7 Ataxia Telangiectasia Mutated (ATM) A Pipeline Target 93
5.8 TMPRSS2-ERG A Promising Prostate Cancer Biomarker 94
5.9 MiR-17/92 Cluster The Oncomir with Biomarker Potential 95
5.9.1 Altered MiR-17/92 Expression Correlates with Cancer Pathogenesis 95
5.9.2 MiR-17/92 Cluster and Colorectal Cancer 96
5.9.3 MiR-17/92 Cluster and Breast Cancer 96
5.9.4 MiR-17/92 Cluster and Ovarian Cancer 97
5.9.5 MiR-17/92 Cluster and Lung Cancer 97
5.9.6 MiR-17/92 Cluster and Renal Cancer 97
5.9.7 MiR-17/92 Cluster and Head and Neck Cancer 97
5.9.8 MiR-17/92 Cluster and Pancreatic Cancer 97
5.9.9 MiR-17/92 Cluster and Liver Cancer 98
5.9.10 MiR-17/92 Cluster and Acute Myeloid Leukaemia 98
5.9.11 MiR-17/92 Cluster and B-Cell Lymphoma 98
5.9.12 MiR-17/92 Cluster and B-Cell Chronic Lymphocytic Leukemia 98
5.9.13 Transcriptional Regulators of MiR-17/92 Cluster 98
5.9.14 Significant Molecular Targets of MiR-17/92 99

6.0 Cancer Biomarker Test Market Analysis 2013-2018 101
6.1 Economic Burden of Cancer Worldwide 101

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6.2 Economic Burden of Cancer in the US 101
6.3 Global Biomarker Test Market Analysis 102
6.4 Oncology Biomarkers Dominate the Biomarker Market 103
6.5 Global Cancer Profiling Technology Market 105
6.6 Global Cancer Biomarker Market Analysis 105
6.7 Market Share of Oncology Market Within Total Biomarker Market 108
6.8 US Cancer Biomarker Market 108
6.9 Oncology Biomarker Market is Fuelled by Year-on-Year Expansion of Research Publications
109
6.10 Proteomic and Genomic Technologies are Preferred as Methods of Detection by End-Users
114

7.0 Oncology Biomarker Market Main Industry Players 115
7.1 23andMe 115
7.2 Affymetrix 116
7.3 Ambry Genetics 118
7.4 Astex Pharmaceuticals 119
7.5 Atossa Genetics 121
7.6 CuraGen 122
7.7 Celera Corporation (Quest Diagnostics) 122
7.8 Celldex Therapeutics 122

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7.9 deCode Genetics (Amgen) 124
7.10 Foundation Medicine 124
7.11 Illumina 125
7.12 Genelex 126
7.13 Genomic Health 126
7.14 Myriad 126
7.15 Nodality 127
7.16 OriGene Technologies 130
7.17 Randox 130
7.18 Qiagen 131

8.0 Oncology Biomarker Market Products and Kits 133
8.1 Oncology Companion Diagnostic Tests 133
8.1.1 HER2 Tests in Breast Cancer Patients 133
8.2 23andMe 135
8.3 Affymetrix 139
8.4 Ambry Genetics 140
8.4.1 BRCAPlus 140
8.4.2 BreastNext 141
8.4.3 CancerNext 141

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8.4.4 ColoNext 141
8.4.5 OvaNext 142
8.4.6 PancNext 142
8.4.7 RenalNext 142
8.4.8 Hereditary Diffuse Gastric Cancer Test 145
8.5 Astex Pharmaceuticals 150
8.6.1 Mammary Aspirate Specimen Cytology Test (MASCT) 150
8.6.2 ForeCYTE Breast Health Test (SM) 150
8.6.3 ArgusCYTE Breast Health Test(SM) 151
8.6.4 FullCYTE Breast Health Test 151
8.6.5 NextCYTE Breast Health Test 151
8.7 BioMerieux 151
8.7.1 THxID -BRAF Kit 151
8.8 Celera (Quest Diagnostics) 151
8.9 deCode Genetics 153
8.9.1 deCODE Breast Cancer 153
8.9.2 deCODE Prostate Cancer 153
8.9.3 deCODE AF 153
8.9.4 deCODE Complete 153

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8.9.5 deCODE Cancer 154
8.9.6 deCODE Services 154
8.10.1 FoundationOne 155
8.10.2 FoundationOne Heme 155
8.11 Illumina 157
8.11.1 Illumina New-Generation Sequencing Technology 157
8.11.2 Illumina HiSeq 2500/1500 158
8.11.3 Illumina HiSeq 2000/1000 158
8.11.4 Genome Analyzer IIx 159
8.11.5 Illumina MiSeq 159
8.11.6 Illumina HiScanHQ 159
8.11.7 Illumina HiScan and iScan Array 159
8.12 Genelex 160
8.13.1 Oncotype DX Breast Cancer Test 160
8.13.2 Oncotype DX Colon Cancer Test 161
8.13.3 Oncotype DX Prostate Cancer Assay 161
8.14 Myriad Genetics 163
8.14.1 BRACAnalysis 163

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8.14.2 Comprehensive BRACAnalysis 165
8.14.3 BRACAnalysis Rearrangement Test (BART) 165
8.14.4 Single Site BRACAnalysis 165
8.14.5 Multisite 3 BRACAnalysis 165
8.14.6 COLARIS/COLARIS AP 166
8.14.7 MELARIS 166
8.14.8 PANEXIA 166
8.14.9 OnDose 167
8.14.10 PREZEON 167
8.14.11 THERAGUIDE 5FU 167
8.14.12 Prolaris 167
8.15 Nodility 168
8.16 OriGene 168
8.16.1 TissueScan Cancer cDNA Arrays 168
8.17 Randox 172
8.17.1 Tumor PSA Marker Array 172
8.17.2 Tumor Marker Array 3 172
8.17.3 KRAS/ BRAF/PIK3CA Array 172
8.18 Qiagen 173
8.18.1 Genotyping Products 173

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8.18.2 QIAsymphony Platform 175
8.18.3 Therascreen EGFR RGQ PCR Kit 176
8.18.4 Therascreen KRAS RGQ PCR System 176
8.18.5 Therascreen IDH1/2 test 176
8.19 Roche 177
8.19.1 Cobas EGFR Mutation Test 177

9.0 Market Participant Financial and Business Strategy Analysis 178
9.1 23andMe 178
9.2 Affymetrix 180
9.3 Astex Pharmaceuticals (Otuska Pharamceutical) 189
9.5 BioMerieux 195
9.6 Celera (Quest Diagnostics) 200
9.7 Celldex Therapeutics 206
9.8 deCode Genetics (Amgen) 207
9.10 Illumina 210
9.11 Genelex 213

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9.13 Myriad 214
9.14 Nodality 218
9.15 Qiagen 220

10.0 Objective Business and Strategic Analysis of the Cancer Biomarker Market 225
10.1 Drivers of Oncogenic Biomarker Market 225
10.1.1 High demand and Unmet Need Enhances the Global Biomarker Market 225
10.1.2 Biomarkers are Highly Specific Diagnostic and Prognostic Clinical Tools 225
10.1.3 Increasing Cancer Prevalence Globally 226
10.1.4 FDA Support Increases Biomarker Development 226
10.1.5 More Streamlined Clinical Trials 227
10.1.6 Significant Growth of High-Impact Oncogenic Biomarker Research 227
10.1.7 Advancements in Discovery Technologies 227
10.2 Challenges of the Oncogenic Biomarker Market 228
10.2.1 Variability of Biomarkers within Different Cancer Subtypes 228
10.2.2 Integration of Genomics and Biomarker Diagnostics into the Healthcare System 228
10.2.3 Ethical Considerations 228
10.3 Restraints of the Cancer Biomarker Market 229
10.3.1 Initial Investment into Biomarker Discovery and Development 229
10.3.2 Are Biomarkers Profitable for Smaller Companies? 229

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10.4 Opportunities for the Cancer Biomarker Market 230
10.4.1 Personalized Medicine Market Opportunities 230
10.4.2 Companion Diagnostics 230

List Of Tables

Table 2.1: QUICKFACTs- Top Five Most Frequent Cancers in Men and Women, Globally 20
Table 2.2: Main Clinical Stages of Lung Cancer 26
Table 2.3: Current Therapeutic Options for Lung Cancer 27
Table 2.4: QUICKFACTs- Estimated Age-Standardised Incidence Rate per 100,000 of Breast
Cancer per Country, Worldwide 37
Table 2.5: Risk Factors of Colorectal Cancer 47

Table 3.1: Important Advantages of Using Biomarkers as Diagnostic Tools 54
Table 3.2: Biomarkers in Early Drug Development and Decision Making 54
Table 3.3: Biomarkers in Later Drug Development and Decision Making 55
Table 3.4: Functions of Biomarkers within the Healthcare Setting 55
Table 3.5: Ideal Attributes of Clinical Oncogenic Biomarkers 56
Table 3.6: Main Technologies Used in the Discovery of Biomarkers 56
Table 3.7: Proteomic Technologies Used in Biomarker Discovery 57

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Table 3.8: Types of Cancer Aided Diagnostically by Mass Spectrometry 58
Table 3.9: Recommendations for Use of MALDI-TOF MS in Cancer Diagnostics 60
Table 3.10: Metabolomic Discovered Potential Oncogenic Biomarkers 62
Table 3.11: Cancer Biomarkers in Clinical Practice Using ELISA Technology 64
Table 3.12: Putative Cancer Biomarkers that can be Detected using ELISA Technology 64
Table 3.13: Advantages of Selected (Multiple) Reaction Monitoring Technique in Biomarker
Discovery 67
Table 3.14: Major Advantages of Microarray Assays 67
Table 3.15: Applications of Microarrays 67
Table 3.16: Applications of Microarray Technology in Cancer Diagnostics 68
Table 3.17: Commercially Available Microarray Kits for Cancer Diagnostics 68
Table 3.18: Recommendations for Use of Microarrays in Cancer Diagnostics 69
Table 3.19: Digital PCR in Comparison to Real-time PCR and Traditional PCR 70
Table 3.20: Advantages of Digital PCR 70
Table 3.21: Applications of Digital PCR 70
Table 4.1: Current General Classes of Biomarker Assay as Defined by the American Association
of Pharmaceutical Scientists 73
Table 4.2: Comparison of Validative Properties of Different Bioassay Classes 73
Table 5.1: Catalogue of Somatic Mutations in Cancer (COSMIC) Current Statistics 77
Table 5.2: Important Genetic Oncogenic Biomarkers and Their Application in Treatment 78
Table 5.3: P53 Somatic Mutation Prevalence by Tumor Site 80

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Table 5.4: P53 Germline Mutation Prevalence by Tumor Site 81
Table 5.5: List of P53 Down-regulated Gene Targets 82
Table 5.6: List of P53 Up-regulated Gene Targets 82
Table 5.7: Positive Regulators of Epidermal Growth Factor Receptor (EGFR) Activity 84
Table 5.8: Types of Cancer Associated with EGFR Over-expression 85
Table 5.9: EGFR-Activating and Resistance Mutations Identified in Lung Adenocarcinoma 86
Table 5.10: Current Next Generation EGFR Inhibitors that Target the T790M Mutation 87
Table 5.11: Prevalence of Deleterious Mutations in BRCA1 and BRCA2 Genes 87
Table 5.12: Prevalence of Deleterious Mutations in BRCA1 and BRCA2 in Individuals of
Ashkenazi Ancestry 88
Table 5.13: Risk Factors for Hereditary Breast and Ovarian Cancer (HBOC) 89
Table 5.14: PARP Inhibitors in Late-Stage Development 90
Table 5.15: Novel and Potential Biomarkers Within the PARP-Inhibitor Response Pathway 92
Table 5.16: Negative Regulators of PTEN Protein Expression 92
Table 5.17: Positive Regulators of PTEN Protein Expression 92
Table 5.18: ATM Molecular Targets and Protein Interactions 94
Table 5.19: Key Facts Regarding MiR-17/92 Cluster 95
Table 5.20: Expression Levels of Individual MiR-17/92 Biomarkers in Cancer, Cardiovascular
Disease, Alzheimers, Multiple Sclerosis, Aging and Normal Development 96
Table 5.21: Functional and Validated Positive Regulators of MiR-17/92 98
Table 5.22: Functional and Validated Negative Regulators of MiR-17/92 99

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Table 5.23: Potential Regulators of MiR-17/92 99
Table 5.24: Cellular Signal Transduction Pathways Regulated by the MiR-17/92 Cluster 99
Table 5.25: Specific Cell Death Protein Targets of the MiR-17/92 Cluster 100
Table 5.26: Specific Cell Cycle Arrest Protein Targets of the MiR-17/92 Cluster 100
Table 5.27: Specific Cell Cycle Regulation Protein Targets of the MiR-17/92 Cluster 100
Table 5.28: Specific Heart and Lung Development Protein Targets of the MiR-17/92 Cluster 100
Table 5.29: Specific Cell Proliferation Protein Targets of the MiR-17/92 Cluster 100

Table 6.1: Global Biomarker Market Worth (Billions) and CAGR (%) 2011-2018 102
Table 6.2: Main Diagnostic Areas Within Oncology Biomarker Market 103
Table 6.3: Future Diagnostic Areas With High Potential Within Oncology Biomarker Market 103
Table 6.4: Global Cancer Profiling Technology Market Worth (Billions) and CAGR 2013-2018 105
Table 6.5: Global Cancer Biomarker Market Worth (Billions) and CAGR (%) 2009-2018 106
Table 6.6: USA Cancer Biomarker Market Share Compared to Global Biomarker Market 2013-
2018 108
Table 6.7: Main Sub-Sets of Oncogenic Biomarker Research Published 2008-2013 109

Table 7.1: Patent Listing of Affymetrix Array technology 117
Table 7.2: Patent Listing of Affymetrix Genotyping Technology 117
Table 7.3: Patent Listing of Affymetrix Expression and Profiling Technology 118

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Table 7.4: Advantages of Astex Pharmaceuticals Pyramid Fragment-Drug-Discovery System 119
Table 7.5: Astex Pharmaceuticals Pipeline Portfolio 120
Table 7.6: Astex Pharmaceuticals Pipeline Portfolio Funded Completely by Partner Companies
120
Table 7.7: Potential Business Partnerships of Celldex Therapeutics 123
Table 7.8: Illumina Core Technologies 125
Table 7.9: Illumina Core Technology Applications 125
Table 7.10: Illumina Instrument Product Portfolio 125
Table 7.11: Illumina Assay Product Portfolio 125
Table 7.12: Genetic Test Panel Available from Genelex for Research Institutions and Clinical
Trials 126
Table 7.13: Pre-Clinical, Clinical and Commercial Applications of SCNP by Nodality 130
Table 7.14: Qiagen Timeline of Events, 1994-2012 131
Table 7.15: QUICKFACTs - Range of Product Groups from Qiagen 132

Table 8.1: Types of Diagnostic Tests Available to Determine HER2 Status in Breast Cancer
Patients 133
Table 8.2: Validated HER2 Tests for Cancer 134
Table 8.3: Advantages and Limitations of IHC HER2 testing applied to breast cancer 134
Table 8.4: In-Situ Hybridization Determination of HER2 Expression by PathVysion and HER2 FISH
pharmDxTM 134
Table 8.5: HER2 CISH Determination 135

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Table 8.7: Validated FISH Kits for HER2 Testing in Breast Cancer 135
Table 8.8: Validated SISH Kits for HER2 Testing in Breast Cancer 135
Table 8.9: Validated CISH Kits for HER2 Testing in Breast Cancer 135
Table 8.10: Advantages and Limitations of ISH Techniques Applied to HER2 Testing in Breast
Cancer 135
Table 8.11: 23andMe Disease Risk Genetic Test Panel 136
Table 8.12: 23andMe Carrier Status Genetic Test Panel 137
Table 8.13: 23andMe Drug Response Genetic Marker Test Panel 138
Table 8.14: 23andMe Genetic Traits Test Panel 138
Table 8.15: QUICKFACTs - Product Overview of Affymetrix 139
Table 8.16: Microarray Products by Affymetrix 140
Table 8.17: Affymetrix Research Services Laboratory (ARSL) Premier Services 140
Table 8.18: Genetic Applications of Axiom Technology by Affymetrix 140
Table 8.19: Clinical Diagnostic Test Kits Available from Ambry Genetics 143
Table 8.20: Ambry Genetics Cancer Test Portfolio and Genetic Biomarkers 143
Table 8.21: Ambry Genetics Comprehensive List of Genetic Tests by Disease and Genetic
Biomarkers 143
Table 8.22: Ambry Genetics BRCA1

List Of Figures

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Figure 2.1: Global Cancer Statistics Key Facts 20
Figure 2.2: Number of Lung, Breast and Colorectal Cancer Diagnoses Globally, 2012 21
Figure 2.3: Percentage of Lung, Breast and Colorectal Cancer Diagnoses Globally, 2012 21
Figure 2.4: Number of Lung, Liver and Stomach Cancer Deaths Globally, 2012 22
Figure 2.5: Percentage of Lung, Liver and Stomach Cancer Deaths Globally, 2012 22
Figure 2.6: Global Cancer Incidence, Men 2012 (per 100,000) 23
Figure 2.7: Global Cancer Mortality, Men 2012 (per 100,000) 23
Figure 2.8: Global Cancer Incidence, Women 2012 (per 100,000) 24
Figure 2.9: Global Cancer Mortality, Women 2012 (per 100,000) 24
Figure 2.10: Number (Millions) of Smokers (Men and Women) in China, Russia, India, the UK
and USA 25
Figure 2.11: Incidence and Mortality Rates of Global Lung Cancer (Male and Female) 27
Figure 2.12: Incidence and Mortality Rates of Global Colorectal Cancer (Male and Female) 30
Figure 2.13: Incidence and Mortality Rates of Global Prostate Cancer 32
Figure 2.14: Global Incidence and Mortality of All Cancer Types (excl non-melanoma skin-
cancer) per 100,000, Male and Female 34
Figure 2.15: Combined Global Prostate, Breast, Colorectal, Lung and Bladder Cancer Incidence
and Mortality by Male and Female 35
Figure 2.16: Cancer Deaths in Women, Globally according to Cancer Type 36
Figure 2.17: Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer Globally
36
Figure 2.18: Top Three Cancers Leading to Global Economic Burden of Cancer ($ Billion) 40

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Figure 2.19: Top 20 Cancers in the USA, Adults (Male and Female) 41
Figure 2.20: Top Adult Male Cancers, USA, Estimated Five Year Prevalence 2012-2017 42
Figure 2.21: Top Adult Female Cancers, USA, Estimated Five Year Prevalence 2012-2017 42
Figure 2.22: US Age Adjusted Cancer Death Rates Per 100,000 (Male) by Cancer Type, 1930-
2009 43
Figure 2.23: US Age Adjusted Cancer Death Rates Per 100,000 (Female) by Cancer Type, 1930-
2009 43
Figure 2.24: Incidence and Mortality of Lung Cancer (Male) Patients in the Americas 44
Figure 2.25: Incidence and Mortality of Lung Cancer (Female) Patients in the Americas 45
Figure 2.26: Incidence and Mortality of Colorectal Cancer (Male and Female) Patients in the
Americas 47
Figure 2.27: Colorectal Cancer Incidence Rates (per 100,000) by Race/Ethnicity and Sex, USA 48
Figure 2.28: Colorectal Cancer Death Rates (per 100,000) by Race/Ethnicity and Sex, USA 48
Figure 2.29: Colorectal Cancer Incidence Rates (per 100,000) by State, USA 48
Figure 2.30: Colorectal Cancer Mortality Rates (per 100,000) by State, USA 49
Figure 2.31: Adults Aged 5075 Years (%) That are Up-to-Date with Colorectal Test Screening, by
State, United States 49
Figure 2.32: Incidence and Mortality of Prostate Cancer (Male) Patients in the Americas 51
Figure 2.33: Incidence and Mortality of Melanoma (Male and Female) Patients in the Americas
53

Figure 3.1: Integration of Oncogenic Biomarker Data to Cancer Diagnosis and Clinical Decisions
55

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Figure 3.2: Influence of Biomarker Market on R&D, Molecular Diagnostics, Emerging Diagnostics
and Independent Clinical Molecular Diagnostic Services 55
Figure 3.3: Biomarker Discovery to Clinical Assay Development and Validation Process 56
Figure 3.4: Mass Spectrometry Based Technologies in Oncogenic Biomarker Discovery 57
Figure 3.5: Principles of Enzyme-Linked Immunosorbant Assay (ELISA) 63
Figure 4.1: The Different Phases of Fit-For-Purpose Biomarker Validation 74
Figure 4.2: Biomarker Validation Using ELISA Technique 75
Figure 5.1: Frequency of Genetic Mutation by Cancer Subtype 77
Figure 5.2: Oncogenic Biomarker P53 Signalling Pathway: Activators, Effectors, Inhibitors and
Cellular Outcomes 79
Figure 5.3: P53 Somatic Mutation Prevalence by Tumor Site 80
Figure 5.4: P53 Germline Mutation Prevalence by Tumor Site 81
Figure 5.5: EGFR Signalling Pathways and Potential Biomarker Proteins 85
Figure 5.6: Clinically Validated Resistance Mechanisms to EGFR Inhibitors 86
Figure 5.7: BRCA Mutation Increases the Risk of Breast and Ovarian Cancer 89
Figure 5.8: Proactive Cancer Management and Preventative Measures Reduces the Risks of
Developing BRCA-associated Breast and Ovarian Cancer 89
Figure 6.1: Economic Burden of Cancer in the US, Direct and Indirect Costs ($ billion) 101
Figure 6.2: Economic Burden of Cancer in the US, Direct and Indirect Costs (%) 102
Figure 6.3: Global Biomarker Market Worth (Billions) and CAGR (%) 2011-2018 103
Figure 6.4: Oncogenic Biomarker Share of Total Personalized Medicine Biomarker Space 104
Figure 6.5: Oncogenic Biomarker Market Distribution by Cancer Type 104

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Figure 6.6: Global Cancer Profiling Technology Market Worth (Billions) and CAGR 2013-2018
105
Figure 6.7: Global Cancer Biomarker Market Worth (Billions) and CAGR (%) 2009-2018 106
Figure 6.8: Global Oncology Biomarker Market as a Percentage of Total Biomarker Market
2013-2018 108
Figure 6.9: USA Cancer Biomarker Market Share Compared to Global Biomarker Market 2013-
2018 109
Figure 6.10: Number of Peer-Reviewed Publications in the Area of Oncology Biomarker
Research 2008-2013 110
Figure 6.11: Number of Peer-Reviewed Publications ion Oncogenes within Oncogenic Biomarker
Research 2008-2013 110
Figure 6.12: Number of Peer-Reviewed Publications on MicroRNAs Within Oncology Biomarker
Research 2008-2013 111
Figure 6.13: Number of Peer-Reviewed Publications on Epigenetic Modifications Within
Oncology Biomarker Research 2008-2013 111
Figure 6.14: Number of Peer-Reviewed Publications by the National Cancer Institute Within
Figure 6.15: Number of Peer-Reviewed Publications on Tumor Suppressor Genes Within
Figure 6.16: Number of Peer-Reviewed Publications on incRNA Within Oncology Biomarker
Research 2008-2013 113
Figure 6.17: Most Popular Proteomic and Genomic Technologies Performed by End-Users 114
Figure 7.1: Celldex Therapeutics Product Pipeline 123
Figure 7.2: Single Cell Network Profiling (SCNP) Technology by Nodality 129
Figure 7.3: Developed Functional Assays that Nodality has explored using new SCNP Technology
129

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Figure 8.1: HER2 Testing Algorithm for Breast Cancer 133
Figure 8.2: HER2 Cellular Signalling 133
Figure 8.3: QUICKFACTS: Herceptin Mechanism of Action 134
Figure 8.4: Illumina New Generation Sequencing Technology Workflow Station 157
Figure 8.5: Genomic Health Studies Used in the Development of the DCIS Score Algorithm 160
Figure 8.6: Genomic Health Gene Panel Used for Oncotype DX Breast Cancer Test 161
Figure 8.7: Genomic Health Gene Panel Used for Oncotype DX Colon Cancer Test 161
Figure 8.8: Genomic Health Oncotype DX Prostate Cancer Test Development Process 162
Figure 8.9: Genomic Health Gene Panel Used for Oncotype DX Prostate Cancer Test 162
Figure 8.10: OriGenes TissueScan Cancer cDNA Array Sequence of Analysis 169
Figure 9.1: Private Funding Gained by 23andMe 2007-2012 178
Figure 9.2: Affymetrix Revenue by Business Segment (Percentage), 2013 184
Figure 9.3: Affymetrix Revenue by Business Segment (Percentage), 2013 184
Figure 9.4: Affymetrix Total Revenue 2007-2013 185
Figure 9.5: Affymetrix Revenue by Product Division Consumables, Instruments 2010-2012 186
Figure 9.6: Affymetrix Core Product Sales Gene Expression, Genetic Analysis & Clinical
Applications and Life Science Reagents, 2011-2012 186
Figure 9.7: Affymetrix Revenue Derived from Outside the US, 2009-2012 187
Figure 9.8: Affymet

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