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This BCC Research report reviews the status of next generation cancer diagnostic technologies and assays, and assesses their global growth potential over a five-year period from 2014 to 2019. Influencing factors, including cancer diagnostic needs, regulatory trends, industry structure and patent status are also discussed.

Use this report to:
- Review the status of next generation cancer diagnostic technologies and assays, and assess their global growth potential over a five-year period from 2014 to 2019.
- Analyze the key trends, markets and industry dynamics to provide a useful basis for corporate decision making.
- Study the market analysis and forecast from 2014 through 2019 by cancer indication, analysis type performed and diagnostic function.
- Gain insight into innovative technology platforms that provide more sensitive, accurate and rapid diagnostic tools for oncologists to use when treating cancer patients.

Highlights
- BCC Research estimates the global market for next generation cancer diagnostic as $1.6 billion in 2013. This indication is expected to reach $1.8 billion in 2014 and $10 billion
in 2019, registering a compound annual growth (CAGR) of 42.6% over the next five years.
- Solid tumors, excluding sex-related tumors as a segment will grow from $742.9 million in 2014 to nearly $4.6 billion by 2019 at a 44% CAGR for the period 2014-2019.
- Blood-born cancers is the largest segment of the global market for next generation cancer diagnostic and it is expected to reach $140.2 million in 2014 and $1.4 billion by 2019, increasing at a CAGR of 60.2% from 2014 through 2019.

INTRODUCTION

STUDY GOALS AND OBJECTIVES
The objective of this study is to review the status of next generation cancer diagnostic technologies and assays, and assess their global growth potential over a five-year period from 2014 to 2019. Particularly focus is placed on characterizing the markets for the key next generation platforms: real-time polymerase chain reaction (RT-PCR), DNA
microarrays, lab-on-a-chip (LOAC), protein microarrays, next generation capture methods (e.g., circulating tumor cells, exosomes, cell-free DNA/RNA), multiplexed conventional and next generation sequencing (NGS). A main focus of this report is genomic, epigenomic, proteomic and cellular analysis, in which the majority of cancer diagnostic sales occur. The main objective is to present a comprehensive review of next generation platforms by cancer indication to assess the industry’s future market potential.

REASONS FOR DOING THE STUDY
Cancer is a collection of diseases caused by genetic malfunctions. The ongoing discovery of new genomic and proteomic information since the completion of the Human Genome Project is leading to the discovery of new disease biomarkers. These biomarkers can be correlated with cancer initiation and progression. There has also been tremendous scientific progress in novel analysis technologies, including LOAC, RT-PCR, high-density microarrays, NGS, cellular capture and identification and multiplexed assays. These technological forces are merging with unmet cancer diagnostic needs to create favorable conditions for future commercial growth. Thus, it is particularly timely to review the market opportunities and future growth of specific cancer diagnostic market segments.

The next generation cancer diagnostic industry is a relatively small but growing segment of the in vitro diagnostic industry. Some tests are already established, including in cervical cancer screening, colorectal cancer and breast cancer prognostics. A significant number of new assays using innovative platforms are in the diagnostic pipeline. Companies seeking to exploit the growth in this industry must understand the various next generation platforms and their development status for each cancer indication.
Given the emerging nature of this industry, it is timely to analyze the key trends, markets and industry dynamics to provide a useful basis for corporate decision making.

INTENDED AUDIENCE
BCC Research has compiled a study of the main next generation platforms that will be important in key end-user segments. These cancer diagnostic markets are analyzed by
indication (e.g., breast, colorectal, prostate), type of analysis (e.g., gene expression, genotyping, cytogenetic), technology platform (e.g., NGS, LOAC, DNA microarray), and
diagnostic function (e.g., screening/early detection, prognosis, monitoring/recurrence, companion diagnostic). This report examines the next generation diagnostic technologies, forces driving industry growth, product types, key market applications, companies, corporate alliances, future market potential and global markets for the period 2013 through 2019. It analyzes industry dynamics, including each of the distinct industry subsegments, as well as recent corporate acquisitions and alliances.

This study will be of particular interest to companies in:
- In vitro diagnostics.
- Pharmaceuticals.
- Biotechnology.
- Nanomaterials.
- Life sciences tools and reagents.
- Medical devices.
- DNA sequencing.
- DNA microarrays.
- Protein microarrays.
- Biochips.
- Lab-on-a-chip.
- PCR.
- Clinical laboratories.
- Bioinformatics.

SCOPE AND FORMAT
The study scope includes the major next generation formats that are likely to become commercialized within the next five years. Each technology format is analyzed to
determine its market status, impact on future market segments and projected growth from 2014 through 2019. Technology issues and forces driving the market are discussed.
Influencing factors, including cancer diagnostic needs, regulatory trends, industry structure and patent status are also discussed. BCC Research examines companies in the industry, corporate alliances and assay consumption by indication. More than 130 companies participating in the industry are profiled in this report.

METHODOLOGY
BCC Research presents an analysis of each of the key market segments that will be commercially important during the next five years: RT-PCR, DNA microarrays, protein
microarrays, LOAC, next generation capture, NGS, and multiplexed conventional. Based on this analysis, potential applications of next generation platforms in each of the major market segments and their forecast market value for 2014 through 2019 will be evaluated. For each technology platform, this report provides a market analysis and forecast from 2014 through 2019 by cancer indication, analysis type performed and diagnostic function. For each analysis type (e.g., detection, early screening), the market size by cancer indication is forecast. For selected key cancer indications, a detailed forecast of the next generation technology formats is provided. Finally, the overall next generation cancer diagnostic market by geographical region is provided.

INFORMATION SOURCES
Both primary and secondary information sources were used in preparing this study. BCC Research surveyed life science companies and research institutions to obtain data
for this study. Research tools, diagnostics, drug firms, and leading research institutions were included. In addition, data from secondary sources, including industry, trade and
government organizations, were used.

Table Of Contents

Next Generation Cancer Diagnostics: Technologies and Global Markets
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
INTENDED AUDIENCE 2
SCOPE AND FORMAT 3
METHODOLOGY 3
INFORMATION SOURCES 4
RELATED BCC RESEARCH REPORTS 4
ANALYST'S CREDENTIALS 4
BCC RESEARCH WEBSITE 5
DISCLAIMER 5
CHAPTER 2 SUMMARY 7
SUMMARY TABLE GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 7
SUMMARY FIGURE GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY
INDICATION, 2013-2019 ($ MILLIONS) 7
CHAPTER 3 OVERVIEW 11
INTRODUCTION 11
TABLE 1 REPORT SCOPE 11
NEXT GENERATION CANCER DIAGNOSTIC MARKETING POTENTIAL 12
TABLE 2 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 12
DRIVING FORCES 13
TABLE 3 CANCER DIAGNOSTIC MARKET DRIVING FORCES, THROUGH 2019 13
PLATFORMS 14
PRODUCT LIFECYCLE STATUS 15
TABLE 4 DIAGNOSTIC PRODUCT LIFECYCLE STATUS, 2014 15
INDUSTRY 16
TABLE 5 NEXT GENERATION CANCER DIAGNOSTIC INDUSTRY, 2014 16
CHAPTER 4 NEXT GENERATION CANCER DIAGNOSTIC TECHNOLOGIES 19
DIAGNOSTICS OVERVIEW 19
TABLE 6 DIAGNOSTIC MARKET SEGMENTS 19
TABLE 7 NEXT GENERATION CANCER DIAGNOSTIC PLATFORMS, 2014-2019 20
TECHNOLOGY OVERVIEW 20
TABLE 8 ANALYSIS PLATFORMS AND BIOMARKER TYPES 20
GENETIC ANALYSIS 21
FIGURE 1 DNA, MRNA AND GENETIC VARIATION 21
GENETIC ANALYSIS TECHNOLOGIES 23
TABLE 9 SCOPE OF KEY GENOMIC ANALYSIS TECHNOLOGIES, 2014 23
TABLE 10 GENETIC ANALYSIS TECHNOLOGY PLATFORM COMPARISON 25
EPIGENETIC ANALYSIS 26
PARADIGM CHANGE 26
TABLE 11 EPIGENETICS WITHIN THE MOLECULAR BIOLOGY PARADIGM 27
DNA METHYLATION ANALYSIS 27
FIGURE 2 EPIGENETIC CHANGES TO DNA AFFECTING GENE EXPRESSION 28
CIRCULATING TUMOR CELL ANALYSIS 28
TABLE 12 CIRCULATING TUMOR CAPTURE METHODS 29
TABLE 13 CIRCULATING TUMOR CAPTURE IDENTIFICATION METHODS 30
PROTEOMIC ANALYSIS 30
NEXT GENERATION CANCER DIAGNOSTIC TECHNOLOGY PLATFORMS 31
DNA MICROARRAYS 31
TABLE 14 DNA MICROARRAY TECHNOLOGIES 31
PROTEIN MICROARRAYS 32
TABLE 15 PROTEIN MICROARRAY PLATFORMS 32
LAB-ON-A-CHIP 33
TABLE 16 LAB-ON-A-CHIP TYPES 34
In Vitro Proteomics 34
Electrophoresis on a Chip 34
Structural Proteomics 35
PCR on a Chip 35
Immunoassays on a Chip 36
REAL-TIME POLYMERASE CHAIN REACTION 36
TABLE 17 CONVENTIONAL END-POINT REAL-TIME POLYMERASE CHAIN REACTION
DETECTION PROBLEMS 37
TABLE 18 REAL-TIME POLYMERASE CHAIN REACTION CANCER DIAGNOSTIC
APPLICATIONS 38
NEXT GENERATION SEQUENCING PLATFORMS 38
TABLE 19 NEXT GENERATION SEQUENCING TECHNOLOGIES 38
TABLE 20 ROCHE NEXT GENERATION SEQUENCING WORKFLOW, 2014 38
TABLE 21 ILLUMINA NEXT GENERATION SEQUENCING WORKFLOW, 2014 40
TABLE 22 LIFE TECHNOLOGIES NEXT GENERATION SEQUENCING WORKFLOW,
2014 41
BENCHTOP SEQUENCERS 41
TABLE 23 BENCHTOP SEQUENCER PLATFORMS, 2014 42
NEXT GENERATION SEQUENCING IN THE CLINICAL SETTING 43
TABLE 24 GENETIC TESTING EVOLUTION 43
TABLE 25 KEY NEAR- TO MID-TERM SEGMENTS FOR NEXT GENERATION
SEQUENCING DIAGNOSTICS, 2014-2019 44
CHAPTER 5 NEXT GENERATION CANCER DIAGNOSTIC APPLICATIONS 47
INTRODUCTION 47
TABLE 26 NEXT GENERATION DIAGNOSTIC PARADIGM SHIFT, 2000-2020 47
BIOMARKER DISCOVERY DRIVING GROWTH 48
TABLE 27 BIOMARKERS USED IN NEXT GENERATION DIAGNOSTICS 48
CLINICAL ACCEPTANCE OF A NEW DIAGNOSTIC ASSAY 50
TABLE 28 DNA MICROARRAY DIAGNOSTIC TEST ADOPTION RATE 50
MOLECULAR DIAGNOSTICS 51
INTRODUCTION 51
MARKET PENETRATION CHALLENGES 52
TABLE 29 COMPARISON OF DNA-BASED MDX PLATFORMS 53
TABLE 30 FACTORS AFFECTING PENETRATION OF NEXT GENERATION FORMATS
INTO THE MDX MARKET 54
MARKET SEGMENTS 56
TEST SENSITIVITY AND SPECIFICITY 57
FIGURE 3 SENSITIVITY AND SPECIFICITY 57
REGULATORY STATUS 58
STATUS OF NEXT GENERATION DIAGNOSTICS BY INDICATION 60
CANCER OVERVIEW 60
TABLE 31 U.S. INCIDENCE AND DEATHS FOR SELECTED CANCERS, 2010 AND 2013
(NUMBER) 60
BLADDER CANCER 61
TABLE 32 BLADDER CANCER NEXT GENERATION DIAGNOSTIC TESTS, 2014 61
BRAIN CANCER 62
TABLE 33 BRAIN CANCER NEXT GENERATION DIAGNOSTIC TESTS, 2014 62
BREAST CANCER 63
Breast Cancer Screening 63
Prognosis and Pharmacogenetics Tests 64
TABLE 34 U.S. ANNUAL BREAST CANCER TREATMENT DECISIONS BY CANCER
CLASSIFICATION, 2014 (NUMBER) 65
Breast Cancer MDx Platforms 65
TABLE 35 BREAST CANCER MDX TECHNOLOGY PLATFORMS, 2014 66
Status of Next generation Breast Cancer Tests 67
TABLE 36 NEXT GENERATION BREAST CANCER TESTS, 2014 67
Breast Cancer Early Detection and Screening Tests 69
Breast Cancer Risk Tests 69
Response to Chemotherapy, Recurrence Probability and Subtyping 70
CERVICAL CANCER 73
TABLE 37 NEXT GENERATION HUMAN PAPILLOMA VIRUS AND CERVICAL CANCER
TESTS, 2014 75
COLORECTAL CANCER 78
Conventional Colorectal Cancer Screening Tests 78
TABLE 38 COLORECTAL CANCER SCREENING AND DIAGNOSTIC TESTS, 2014 79
Next Generation Colorectal Cancer Diagnostics Tests 80
TABLE 39 NEXT GENERATION DIAGNOSTIC TESTS FOR COLORECTAL CANCER,
2014 80
CANCER OF UNKNOWN PRIMARY 84
TABLE 40 CANCER OF UNKNOWN PRIMARY NEXT GENERATION DIAGNOSTIC TESTS,
2014 85
GASTRIC CANCER 87
TABLE 41 GASTRIC AND STOMACH CANCER NEXT GENERATION DIAGNOSTIC
TESTS, 2014 87
KIDNEY CANCER 88
TABLE 42 NEXT GENERATION KIDNEY CANCER DIAGNOSTIC TESTS, 2014 88
LEUKEMIA 89
TABLE 43 NEXT GENERATION LEUKEMIA AND MYELOMA DIAGNOSTIC TESTS, 2014 89
LIVER CANCER 93
TABLE 44 NEXT GENERATION LIVER CANCER DIAGNOSTIC TESTS, 2014 93
LUNG CANCER 94
TABLE 45 FIVE-YEAR SURVIVAL RATES FOR NON-SMALL CELL LUNG CANCER, 2014
(%) 94
TABLE 46 NEXT GENERATION LUNG CANCER DIAGNOSTIC TESTS, 2014 95
LYMPHOMAS 98
TABLE 47 NEXT GENERATION LYMPHOMA CANCER DIAGNOSTIC TESTS, 2014 98
MELANOMA 99
TABLE 48 NEXT GENERATION MELANOMA DIAGNOSTIC TESTS, 2014 100
OVARIAN CANCER 101
TABLE 49 OVARIAN CANCER EARLY SCREENING TESTS 101
TABLE 50 NEXT GENERATION OVARIAN CANCER DIAGNOSTIC TESTS, 2014 103
PAN-CANCER 105
TABLE 51 NEXT GENERATION PAN-CANCER DIAGNOSTIC TESTS, 2014 105
PANCREATIC CANCER 108
TABLE 52 NEXT GENERATION PANCREATIC CANCER DIAGNOSTIC TESTS, 2014 108
PROSTATE CANCER 109
TABLE 53 NEXT GENERATION PROSTATE CANCER DIAGNOSTIC TESTS, 2014 109
THYROID CANCER 112
TABLE 54 NEXT GENERATION THYROID CANCER DIAGNOSTIC TESTS, 2014 113
NEXT GENERATION CANCER DIAGNOSTIC TEST SUMMARY 114
TABLE 55 NEXT GENERATION DIAGNOSTIC TEST SUMMARY BY INDICATION AND
TECHNOLOGY, 2014 114
CHAPTER 6 INDUSTRY DYNAMICS 117
ACQUISITIONS 117
TABLE 56 ACQUISITIONS IN NEXT GENERATION CANCER DIAGNOSTICS INDUSTRY,
2012-2014 117
STRATEGIC ALLIANCES 118
TABLE 57 NEXT GENERATION CANCER DIAGNOSTIC STRATEGIC ALLIANCES,
2012-2014 119
CIRCULATING TUMOR CELL DIAGNOSTIC INDUSTRY 124
TABLE 58 CIRCULATING TUMOR CELL INDUSTRY, 2014 124
DNA MICROARRAY DIAGNOSTIC INDUSTRY 129
TABLE 59 DNA MICROARRAY INDUSTRY, 2014 130
NEXT GENERATION SEQUENCING INSTRUMENT INDUSTRY 131
TABLE 60 NEXT GENERATION SEQUENCING INSTRUMENT COMPANIES:
COMMERCIAL PHASE, 2014 131
CLINICAL LABORATORY NEXT GENERATION SEQUENCING INDUSTRY 133
TABLE 61 LEADING U.S. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS
LABORATORIES WITH NEXT-GENERATION SEQUENCING DIAGNOSTICS, 2014 133
LAB-ON-A-CHIP NEXT GENERATION CANCER DIAGNOSTIC INDUSTRY 135
TABLE 62 NEXT GENERATION LAB-ON-A-CHIP CANCER DIAGNOSTIC INDUSTRY,
2014 135
RT-PCR NEXT GENERATION CANCER DIAGNOSTIC INDUSTRY 137
TABLE 63 NEXT GENERATION RT-PCR CANCER DIAGNOSTIC INDUSTRY, 2014 137
CHAPTER 7 NEXT GENERATION CANCER DIAGNOSTIC MARKETS 140
INDUSTRY GROWTH DRIVING FORCES 140
TABLE 64 CANCER DIAGNOSTIC MARKET DRIVING FORCES, 2014-2019 140
LIFE SCIENCE RESEARCH AND DEVELOPMENT FUNDING GROWTH 140
TARGETED MEDICINE DEVELOPMENT 141
EARLY CANCER DETECTION DEMAND 141
AGING POPULATIONS IN DEVELOPED REGIONS OF THE WORLD 142
INNOVATIVE DIAGNOSTIC TESTING FORMAT DEMAND 142
ONGOING DISCOVERIES IN GENOMICS 142
GENE AND SINGLE NUCLEOTIDE POLYMORPHISM DISEASE ASSOCIATION
DISCOVERY 142
MARKET SUMMARY 143
MARKET BY TECHNOLOGY PLATFORM 143
TABLE 65 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 143
MARKET BY ANALYSIS TYPE 144
TABLE 66 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY ANALYSIS
TYPE, THROUGH 2019 ($ MILLIONS) 144
MARKET BY INDICATION 145
TABLE 67 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 145
Bladder Cancer 146
Brain Cancer 146
Breast Cancer 147
Cervical Cancer 147
Colorectal Cancer 148
Cancer of Unknown Primary 148
Gastric Cancer 148
Kidney Cancer 149
Leukemia 150
Liver Cancer 150
Lung Cancer 151
Lymphoma 151
Melanoma 152
Ovarian Cancer 152
Pan-Cancer 153
Pancreatic Cancer 154
Prostate Cancer 154
Thyroid Cancer 155
MARKET BY DIAGNOSTIC FUNCTION 155
TABLE 68 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY FUNCTION,
THROUGH 2019 ($ MILLIONS) 155
MARKETS BY TECHNOLOGY FORMAT 156
DNA MICROARRAY MARKET 156
TABLE 69 GLOBAL DNA MICROARRAY CANCER DIAGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 156
PROTEIN MICROARRAY MARKET 158
TABLE 70 GLOBAL PROTEIN MICROARRAY CANCER DIAGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 158
LAB-ON-A-CHIP MARKET 159
TABLE 71 GLOBAL LAB-ON-A-CHIP CANCER DIAGNOSTIC MARKET BY INDICATION,
THROUGH 2019 ($ MILLIONS) 159
RT-PCR MARKET 160
TABLE 72 GLOBAL RT-PCR CANCER DIAGNOSTIC MARKET BY INDICATION,
THROUGH 2019 ($ MILLIONS) 160
NEXT GENERATION SEQUENCING MARKET 162
TABLE 73 GLOBAL NEXT GENERATION SEQUENCING CANCER DIAGNOSTIC MARKET
BY INDICATION, THROUGH 2019 ($ MILLIONS) 162
NEXT GENERATION CAPTURE MARKET 163
TABLE 74 GLOBAL NEXT GENERATION CAPTURE CANCER DIAGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 164
MULTIPLEX CONVENTIONAL MARKET 165
TABLE 75 GLOBAL MULTIPLEX CONVENTIONAL CANCER DIAGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 165
MARKETS BY DIAGNOSTIC FUNCTION 166
RISK MARKET 166
TABLE 76 GLOBAL NEXT GENERATION CANCER RISK MARKET BY INDICATION,
THROUGH 2019 ($ MILLIONS) 166
SCREENING MARKET 167
TABLE 77 GLOBAL NEXT GENERATION CANCER SCREENING MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 167
PROGNOSTIC MARKET 168
TABLE 78 GLOBAL NEXT GENERATION CANCER PROGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 169
MONITORING MARKET 170
TABLE 79 GLOBAL NEXT GENERATION CANCER MONITORING MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 170
COMPANION DIAGNOSTIC MARKET 171
TABLE 80 GLOBAL NEXT GENERATION CANCER COMPANION DIAGNOSTIC MARKET
BY INDICATION, THROUGH 2019 ($ MILLIONS) 172
MARKETS FOR KEY INDICATIONS BY TECHNOLOGY PLATFORM 172
BREAST CANCER MARKET 172
TABLE 81 GLOBAL NEXT GENERATION BREAST CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 173
CERVICAL CANCER MARKET 174
TABLE 82 GLOBAL NEXT GENERATION CERVICAL CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 174
COLORECTAL CANCER MARKET 174
TABLE 83 GLOBAL NEXT GENERATION COLORECTAL CANCER DIAGNOSTIC MARKET
BY TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 175
CANCER OF UNKNOWN PRIMARY (CUP) MARKET 175
TABLE 84 GLOBAL NEXT GENERATION CANCER OF UNKNOWN PRIMARY (CUP)
DIAGNOSTIC MARKET BY TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 176
LEUKEMIA MARKET 176
TABLE 85 GLOBAL NEXT GENERATION LEUKEMIA DIAGNOSTIC MARKET BY
TECHNOLOGY FORMAT, THROUGH 2015 ($ MILLIONS) 177
LUNG CANCER MARKET 178
TABLE 86 GLOBAL NEXT GENERATION LUNG CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 178
LYMPHOMA MARKET 179
TABLE 87 GLOBAL NEXT GENERATION LYMPHOMA DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 179
PAN-CANCER MARKET 179
TABLE 88 GLOBAL NEXT GENERATION PAN-CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 180
TABLE 89 GENOME COVERAGE OF REPRESENTATIVE NEXT GENERATION
SEQUENCING PAN-CANCER TESTS, 2014 180
PROSTATE CANCER MARKET 181
TABLE 90 GLOBAL NEXT GENERATION PROSTATE CANCER DIAGNOSTIC MARKET
BY TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 181
NEXT GENERATION CANCER DIAGNOSTIC REGIONAL MARKET 182
TABLE 91 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC BY REGION, THROUGH
2019 ($ MILLIONS) 182
CHAPTER 8 PATENTS 185
MICROARRAY PATENTS 185
TABLE 92 DNA MICROARRAY-RELATED PATENTS BY REGION, 2002-2012 185
TABLE 93 MICROARRAY-RELATED PROTEOMICS PATENTS BY REGION, 2002-2012 186
LAB-ON-A-CHIP PATENTS 186
TABLE 94 LAB-ON-A-CHIP-RELATED PROTEOMIC PATENTS BY REGION, 2002-2012 187
RT-PCR PATENTS 187
TABLE 95 ISSUED RT-PCR-RELATED PATENTS BY REGION, 2002-2012 188
CIRCULATING TUMOR CELL PATENTS 188
TABLE 96 ISSUED CIRCULATING TUMOR CELL-RELATED PATENTS BY REGION,
2002-2012 188
CLINICAL NEXT GENERATION SEQUENCING PATENTS 189
TABLE 97 CLINICAL NEXT GENERATION SEQUENCING-RELATED SEQUENCING
PATENTS, 2002-2012 189
CLINICAL NEXT GENERATION SEQUENCING PATENTS BY INDICATION 189
TABLE 98 CLINICAL NEXT GENERATION SEQUENCING-RELATED PATENTS BY
INDICATION, 2002-2012 190
CHAPTER 9 COMPANY PROFILES 192
20/20 GENE SYSTEMS INC. 192
ABBOTT LABORATORIES 193
ABTECH SCIENTIFIC INC. 193
ADAPTIVE BIOTECHNOLOGIES INC. 194
ADNAGEN GMBH 195
ADVANCED CELL DIAGNOSTICS INC. 195
AFFYMETRIX INC. 195
AGENDIA NV 197
TABLE 99 AGENDIA MICROARRAY-BASED DIAGNOSTICS PIPELINE, 2014 198
AGILENT TECHNOLOGIES INC. 199
ALLEGRO DIAGNOSTICS INC. 200
ALMAC GROUP LTD. 201
AMBRY GENETICS 202
APPISTRY INC. 203
ARPEGGI INC. 203
ARRAYIT CORP. 204
ASTRID BIOSCIENCE GMBH 204
ASURAGEN INC. 205
AUTOGENOMICS INC. 205
AXELA BIOSENSORS 205
AYANDA BIOSYSTEMS SA 206
BGI 207
BIOCARTIS SA 208
BIOCEPT INC. 209
TABLE 100 CANCERS 209
BIODESIX INC. 210
BIOLOGICAL DYNAMICS INC. 210
BIOTHERANOSTICS 211
BIOTIME INC. 212
BOREAL GENOMICS 212
CANCER GENETICS INC. 213
CARIS LIFE SCIENCES 214
CASTLE BIOSCIENCES INC. 215
CEPHEID 215
CHRONIX BIOMEDICAL INC. 216
CIRCADIAN TECHNOLOGIES 216
COMBIMATRIX MOLECULAR DIAGNOSTICS INC. 217
CVERGENX 218
DECODE GENETICS 218
DIAGNOPLEX SA 219
DIAXONHIT 219
EPIC SCIENCES INC. 220
EXACT SCIENCES CORP. 220
EXIQON A/S 221
EXOSOME SCIENCES INC. 221
EXOSOME DIAGNOSTICS INC. 222
EVENTUS DIAGNOSTICS INC. 222
FOUNDATION MEDICINE 223
FUSION GENOMICS CORP. 224
GATC BIOTECH AG 225
GE HEALTHCARE 225
GENALYTE INC. 226
GENEDX INC. 226
GENENEWS 227
GENERA BIOSYSTEMS LIMITED 228
GENETIC TECHNOLOGIES LTD. 229
GENOMIC HEALTH INC. 229
GIGAGEN INC. 230
GUARDANT HEALTH INC. 231
HEALTHLINX LIMITED 231
HOLOGIC INC. 232
HUMAN LONGEVITY INC. 233
ILLUMINA INC. 233
INSIGHT GENETICS INC. 236
INTEGRAGEN SA 237
INVITAE 237
IRIS BIOTECHNOLOGIES INC. 238
IRIS INTERNATIONAL INC. 238
JOHNSON and JOHNSON 239
LABORATORY CORP. OF AMERICA INC. 239
LABORATORY FOR MOLECULAR MEDICINE 240
LIFE TECHNOLOGIES INC. 241
MAGARRAY INC. 243
MAVEN BIOTECHNOLOGIES 243
MD ANDERSON CANCER CENTER 243
MDX HEALTH S.A. 244
MED BIOGENE INC. 244
MEDGENOME LABS PVT. LTD. 245
METAMARK GENETICS INC. 245
MINGYUAN MEDICARE DEVELOPMENT COMPANY LTD. 245
MIRA DX 246
MITOMICS INC. 246
MYRIAD GENETICS INC. 247
NANOIVD INC. 248
NANOSTRING TECHNOLOGIES INC. 248
NATURALNANO INC. 249
NEOGENOMICS LABORATORIES 249
NEWGENE LIMITED 249
TABLE 101 NEWGENE CANCER TESTS 250
NEXUS DX INC. 251
NOVARTIS AG 251
NUCLEA BIOTECHNOLOGIES INC. 252
NUVERA BIOSCIENCES 252
ONCODNA SA 253
ONCOLYS BIOPHARMA INC. 253
ONCOSPIRE GENOMICS 254
OPKO HEALTH INC. 254
OXFORD GENE TECHNOLOGY 255
PARADIGM 256
PERKIN ELMER INC. 256
PERSONAL GENOME DIAGNOSTICS 259
PGXL LABORATORIES 259
PHILIPS ELECTRONICS NV 260
PHYSICIAN'S CHOICE LABORATORY SERVICES 260
PREVENTIONGENETICS INC. 260
QIAGEN 261
QIAGEN MARSEILLE 262
QUANTUMDX 263
QUEST DIAGNOSTICS 264
RAINDANCE TECHNOLOGIES INC. 265
RANDOX LABORATORIES, LTD. 267
RESPONSE GENETICS INC. 267
RHEONIX 268
ROCHE HOLDING AG 268
ROSETTA GENOMICS INC. 269
TABLE 102 ROSETTA'S DIAGNOSTIC TESTS, 2014 269
SEQUENTA INC. 271
SIGNAL GENETICS LLC 272
SIGNATURE DIAGNOSTICS AG 273
SISTEMAS GENOMICOS, SL 274
SKYLINEDX B.V. 274
SOFTGENETICS LLC 275
SOMALOGIC INC. 275
STRAND LIFE SCIENCES 276
SYAPSE 276
SYSMEX CORP. 277
THERMO FISHER SCIENTIFIC INC. 277
TRANSGENOMIC INC. 278
TROVAGENE INC. 279
VERACYTE 280
VERISANTE TECHNOLOGY INC. 281
VITATEX INC. 282
VOLITIONRX LTD. 282
XAGENIC INC. 283
LIST OF TABLES
SUMMARY TABLE GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 7
TABLE 1 REPORT SCOPE 11
TABLE 2 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 12
TABLE 3 CANCER DIAGNOSTIC MARKET DRIVING FORCES, THROUGH 2019 13
TABLE 4 DIAGNOSTIC PRODUCT LIFECYCLE STATUS, 2014 15
TABLE 5 NEXT GENERATION CANCER DIAGNOSTIC INDUSTRY, 2014 16
TABLE 6 DIAGNOSTIC MARKET SEGMENTS 19
TABLE 7 NEXT GENERATION CANCER DIAGNOSTIC PLATFORMS, 2014-2019 20
TABLE 8 ANALYSIS PLATFORMS AND BIOMARKER TYPES 20
TABLE 9 SCOPE OF KEY GENOMIC ANALYSIS TECHNOLOGIES, 2014 23
TABLE 10 GENETIC ANALYSIS TECHNOLOGY PLATFORM COMPARISON 25
TABLE 11 EPIGENETICS WITHIN THE MOLECULAR BIOLOGY PARADIGM 27
TABLE 12 CIRCULATING TUMOR CAPTURE METHODS 29
TABLE 13 CIRCULATING TUMOR CAPTURE IDENTIFICATION METHODS 30
TABLE 14 DNA MICROARRAY TECHNOLOGIES 31
TABLE 15 PROTEIN MICROARRAY PLATFORMS 32
TABLE 16 LAB-ON-A-CHIP TYPES 34
TABLE 17 CONVENTIONAL END-POINT REAL-TIME POLYMERASE CHAIN REACTION
DETECTION PROBLEMS 37
TABLE 18 REAL-TIME POLYMERASE CHAIN REACTION CANCER DIAGNOSTIC
APPLICATIONS 38
TABLE 19 NEXT GENERATION SEQUENCING TECHNOLOGIES 38
TABLE 20 ROCHE NEXT GENERATION SEQUENCING WORKFLOW, 2014 38
TABLE 21 ILLUMINA NEXT GENERATION SEQUENCING WORKFLOW, 2014 40
TABLE 22 LIFE TECHNOLOGIES NEXT GENERATION SEQUENCING WORKFLOW, 2014 41
TABLE 23 BENCHTOP SEQUENCER PLATFORMS, 2014 42
TABLE 24 GENETIC TESTING EVOLUTION 43
TABLE 25 KEY NEAR- TO MID-TERM SEGMENTS FOR NEXT GENERATION
SEQUENCING DIAGNOSTICS, 2014-2019 44
TABLE 26 NEXT GENERATION DIAGNOSTIC PARADIGM SHIFT, 2000-2020 47
TABLE 27 BIOMARKERS USED IN NEXT GENERATION DIAGNOSTICS 48
TABLE 28 DNA MICROARRAY DIAGNOSTIC TEST ADOPTION RATE 50
TABLE 29 COMPARISON OF DNA-BASED MDX PLATFORMS 53
TABLE 30 FACTORS AFFECTING PENETRATION OF NEXT GENERATION FORMATS
INTO THE MDX MARKET 54
TABLE 31 U.S. INCIDENCE AND DEATHS FOR SELECTED CANCERS, 2010 AND 2013
(NUMBER) 60
TABLE 32 BLADDER CANCER NEXT GENERATION DIAGNOSTIC TESTS, 2014 61
TABLE 33 BRAIN CANCER NEXT GENERATION DIAGNOSTIC TESTS, 2014 62
TABLE 34 U.S. ANNUAL BREAST CANCER TREATMENT DECISIONS BY CANCER
CLASSIFICATION, 2014 (NUMBER) 65
TABLE 35 BREAST CANCER MDX TECHNOLOGY PLATFORMS, 2014 66
TABLE 36 NEXT GENERATION BREAST CANCER TESTS, 2014 67
TABLE 37 NEXT GENERATION HUMAN PAPILLOMA VIRUS AND CERVICAL CANCER
TESTS, 2014 75
TABLE 38 COLORECTAL CANCER SCREENING AND DIAGNOSTIC TESTS, 2014 79
TABLE 39 NEXT GENERATION DIAGNOSTIC TESTS FOR COLORECTAL CANCER, 2014 80
TABLE 40 CANCER OF UNKNOWN PRIMARY NEXT GENERATION DIAGNOSTIC TESTS,
2014 85
TABLE 41 GASTRIC AND STOMACH CANCER NEXT GENERATION DIAGNOSTIC TESTS,
2014 87
TABLE 42 NEXT GENERATION KIDNEY CANCER DIAGNOSTIC TESTS, 2014 88
TABLE 43 NEXT GENERATION LEUKEMIA AND MYELOMA DIAGNOSTIC TESTS, 2014 89
TABLE 44 NEXT GENERATION LIVER CANCER DIAGNOSTIC TESTS, 2014 93
TABLE 45 FIVE-YEAR SURVIVAL RATES FOR NON-SMALL CELL LUNG CANCER, 2014
(%) 94
TABLE 46 NEXT GENERATION LUNG CANCER DIAGNOSTIC TESTS, 2014 95
TABLE 47 NEXT GENERATION LYMPHOMA CANCER DIAGNOSTIC TESTS, 2014 98
TABLE 48 NEXT GENERATION MELANOMA DIAGNOSTIC TESTS, 2014 100
TABLE 49 OVARIAN CANCER EARLY SCREENING TESTS 101
TABLE 50 NEXT GENERATION OVARIAN CANCER DIAGNOSTIC TESTS, 2014 103
TABLE 51 NEXT GENERATION PAN-CANCER DIAGNOSTIC TESTS, 2014 105
TABLE 52 NEXT GENERATION PANCREATIC CANCER DIAGNOSTIC TESTS, 2014 108
TABLE 53 NEXT GENERATION PROSTATE CANCER DIAGNOSTIC TESTS, 2014 109
TABLE 54 NEXT GENERATION THYROID CANCER DIAGNOSTIC TESTS, 2014 113
TABLE 55 NEXT GENERATION DIAGNOSTIC TEST SUMMARY BY INDICATION AND
TECHNOLOGY, 2014 114
TABLE 56 ACQUISITIONS IN NEXT GENERATION CANCER DIAGNOSTICS INDUSTRY,
2012-2014 117
TABLE 57 NEXT GENERATION CANCER DIAGNOSTIC STRATEGIC ALLIANCES,
2012-2014 119
TABLE 58 CIRCULATING TUMOR CELL INDUSTRY, 2014 124
TABLE 59 DNA MICROARRAY INDUSTRY, 2014 130
TABLE 60 NEXT GENERATION SEQUENCING INSTRUMENT COMPANIES: COMMERCIAL
PHASE, 2014 131
TABLE 61 LEADING U.S. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS
LABORATORIES WITH NEXT-GENERATION SEQUENCING DIAGNOSTICS, 2014 133
TABLE 62 NEXT GENERATION LAB-ON-A-CHIP CANCER DIAGNOSTIC INDUSTRY, 2014 135
TABLE 63 NEXT GENERATION RT-PCR CANCER DIAGNOSTIC INDUSTRY, 2014 137
TABLE 64 CANCER DIAGNOSTIC MARKET DRIVING FORCES, 2014-2019 140
TABLE 65 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 143
TABLE 66 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY ANALYSIS
TYPE, THROUGH 2019 ($ MILLIONS) 144
TABLE 67 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY INDICATION,
THROUGH 2019 ($ MILLIONS) 145
TABLE 68 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY FUNCTION,
THROUGH 2019 ($ MILLIONS) 155
TABLE 69 GLOBAL DNA MICROARRAY CANCER DIAGNOSTIC MARKET BY INDICATION,
THROUGH 2019 ($ MILLIONS) 156
TABLE 70 GLOBAL PROTEIN MICROARRAY CANCER DIAGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 158
TABLE 71 GLOBAL LAB-ON-A-CHIP CANCER DIAGNOSTIC MARKET BY INDICATION,
THROUGH 2019 ($ MILLIONS) 159
TABLE 72 GLOBAL RT-PCR CANCER DIAGNOSTIC MARKET BY INDICATION, THROUGH
2019 ($ MILLIONS) 160
TABLE 73 GLOBAL NEXT GENERATION SEQUENCING CANCER DIAGNOSTIC MARKET
BY INDICATION, THROUGH 2019 ($ MILLIONS) 162
TABLE 74 GLOBAL NEXT GENERATION CAPTURE CANCER DIAGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 164
TABLE 75 GLOBAL MULTIPLEX CONVENTIONAL CANCER DIAGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 165
TABLE 76 GLOBAL NEXT GENERATION CANCER RISK MARKET BY INDICATION,
THROUGH 2019 ($ MILLIONS) 166
TABLE 77 GLOBAL NEXT GENERATION CANCER SCREENING MARKET BY INDICATION,
THROUGH 2019 ($ MILLIONS) 167
TABLE 78 GLOBAL NEXT GENERATION CANCER PROGNOSTIC MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 169
TABLE 79 GLOBAL NEXT GENERATION CANCER MONITORING MARKET BY
INDICATION, THROUGH 2019 ($ MILLIONS) 170
TABLE 80 GLOBAL NEXT GENERATION CANCER COMPANION DIAGNOSTIC MARKET
BY INDICATION, THROUGH 2019 ($ MILLIONS) 172
TABLE 81 GLOBAL NEXT GENERATION BREAST CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 173
TABLE 82 GLOBAL NEXT GENERATION CERVICAL CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 174
TABLE 83 GLOBAL NEXT GENERATION COLORECTAL CANCER DIAGNOSTIC MARKET
BY TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 175
TABLE 84 GLOBAL NEXT GENERATION CANCER OF UNKNOWN PRIMARY (CUP)
DIAGNOSTIC MARKET BY TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 176
TABLE 85 GLOBAL NEXT GENERATION LEUKEMIA DIAGNOSTIC MARKET BY
TECHNOLOGY FORMAT, THROUGH 2015 ($ MILLIONS) 177
TABLE 86 GLOBAL NEXT GENERATION LUNG CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 178
TABLE 87 GLOBAL NEXT GENERATION LYMPHOMA DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 179
TABLE 88 GLOBAL NEXT GENERATION PAN-CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 180
TABLE 89 GENOME COVERAGE OF REPRESENTATIVE NEXT GENERATION
SEQUENCING PAN-CANCER TESTS, 2014 180
TABLE 90 GLOBAL NEXT GENERATION PROSTATE CANCER DIAGNOSTIC MARKET BY
TECHNOLOGY PLATFORM, THROUGH 2019 ($ MILLIONS) 181
TABLE 91 GLOBAL NEXT GENERATION CANCER DIAGNOSTIC BY REGION, THROUGH
2019 ($ MILLIONS) 182
TABLE 92 DNA MICROARRAY-RELATED PATENTS BY REGION, 2002-2012 185
TABLE 93 MICROARRAY-RELATED PROTEOMICS PATENTS BY REGION, 2002-2012 186
TABLE 94 LAB-ON-A-CHIP-RELATED PROTEOMIC PATENTS BY REGION, 2002-2012 187
TABLE 95 ISSUED RT-PCR-RELATED PATENTS BY REGION, 2002-2012 188
TABLE 96 ISSUED CIRCULATING TUMOR CELL-RELATED PATENTS BY REGION,
2002-2012 188
TABLE 97 CLINICAL NEXT GENERATION SEQUENCING-RELATED SEQUENCING
PATENTS, 2002-2012 189
TABLE 98 CLINICAL NEXT GENERATION SEQUENCING-RELATED PATENTS BY
INDICATION, 2002-2012 190
TABLE 99 AGENDIA MICROARRAY-BASED DIAGNOSTICS PIPELINE, 2014 198
TABLE 100 CANCERS 209
TABLE 101 NEWGENE CANCER TESTS 250
TABLE 102 ROSETTA'S DIAGNOSTIC TESTS, 2014 269
LIST OF FIGURES
SUMMARY FIGURE GLOBAL NEXT GENERATION CANCER DIAGNOSTIC MARKET BY
INDICATION, 2013-2019 ($ MILLIONS) 7
FIGURE 1 DNA, MRNA AND GENETIC VARIATION 21
FIGURE 2 EPIGENETIC CHANGES TO DNA AFFECTING GENE EXPRESSION 28
FIGURE 3 SENSITIVITY AND SPECIFICITY 57

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