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This BCC Research report provides a comprehensive discussion of NGS technologies, clinical applications, industry structure, important clinical sequencing initiatives, global markets, patent status and companies. Market data covers the years 2014, 2015 and 2020.

Use this report to:
- Identify the main sequencing technologies and learn why genetic variation is important in clinical testing.
- Examine the global NGS diagnostic markets, characterized and quantified by disease type, test complexity, test purpose and geography.
- Focus on the top research initiatives that are contributing to clinical NGS applications.
- Learn about the main industry acquisitions and strategic alliances from 2013 through 2015, including key alliance trends.

Highlights
- The global clinical next-generation sequencing (NGS) market was valued at $886.1 million in 2014. This market is expected to grow at a compound annual growth rate (CAGR) of 31.3%, from $997.1 million in 2015 to nearly $3.9 billion by 2020.
- NGS-based diagnostic market for reproductive health applications is expected to increase from $572.9 million in 2015 to $1.7 billion by 2020, at a CAGR of 24.8% from 2015 to 2020.
- The global market for NGS-based cancer applications is expected to grow at a CAGR of 34.7%, from $206.3 million in 2015 to $915.7 million by 2020.

Introduction & Scope

INTRODUCTION

STUDY GOALS AND OBJECTIVES
BCC Research’s goal for this study is to provide an in-depth analysis of the clinical next-generation sequencing (NGS) industry, an emerging industry with enormous
market potential. The approach of analyzing the industry is taken in terms of workflow (e.g., sequencers, sequence capture, informatics) and key indications where NGS
diagnostics will have market share by 2020. BCC Research examines the markets for NGS diagnostics for the years 2014, 2015 and 2020. The global NGS diagnostic markets are characterized and quantified by disease indication, test complexity, test purpose and geography. Market segments that provide exceptional growth opportunities include cancer, rare genetic diseases and reproductive health. The report provides a comprehensive discussion of NGS technologies, clinical applications, industry structure, important clinical sequencing initiatives, global markets, patent status and companies. The report is designed to aid companies in their strategic planning efforts for clinical genetic testing.

REASONS FOR DOING THE STUDY
The Human Genome Project (HGP) moved DNA sequencing technology to the forefront of life science research as a genetic analysis tool. The HGP relied heavily on Sanger
sequencing by capillary electrophoresis to decipher the DNA sequence of the bases in the human genome. The HGP led to significant improvements in the efficiency and costs of DNA sequencing. During this time period, the sequencing industry consolidated, resulting in one dominant company, Applied Biosystems (now Thermo Fisher Scientific).

Beginning in 2005, the launch of next-generation sequencing technologies radically changed the structure of the industry and opened up exciting new market applications.
The costs of sequencing have rapidly reduced to the point where it is now feasible for complex NGS tests to be priced in the range of other multiplex genetic tests. As a result, opportunities emerged in clinical applications that are currently reaching fruition. The NGS clinical market is beginning to establish a foothold in the molecular diagnostic industry and holds great commercial promise. More than 85 clinical laboratories are now offering NGS-based testing services. For many applications, the clinical benefits have been proven. At the same time, payers and insurance companies are beginning to provide coverage for these tests, further enhancing their commercial potential. The outstanding growth potential for NGS diagnostics makes it particularly timely to update an earlier report, published in 2013.

CONTRIBUTION OF THE STUDY AND INTENDED AUDIENCE
This report fills a gap in the industry by focusing solely on clinical applications run on next-generation sequencing instruments. Because this industry shows great promise,
information about the market will be particularly useful to companies and other institutions. The report provides a roadmap for understanding the ways in which next-generation sequencing will be used in the diagnostic business during the next five years. It is a useful guide for strategic and business planning, as well as for learning about the impact new sequencing technologies will have in clinical diagnostics. This market report will be useful to many companies involved in the clinical, genetic testing and sequencing industries. It will be particularly valuable for companies in such industries as life science research tools, NGS instruments, molecular diagnostics, informatics clinical laboratories, pharmaceutical, biotechnology, microfluidics, lab-on-a-chip and sample preparation.

SCOPE AND FORMAT
The scope of the report includes clinical NGS technologies, applications, industries, initiatives, patents and companies. The markets for NGS-based diagnostics are given
for the years 2014, 2015 and 2020. This report reviews the main sequencing technologies and explains why genetic variation is important in clinical testing. It then discusses some of the top research initiatives that are contributing to clinical NGS applications. Market driving forces are also discussed. The report examines the markets by test complexity, indication and test purpose. Test complexity refers to the multiplexing (e.g., the number of genes covered) and coverage (e.g., the extent to which the genome is covered) of the test. Examining the market by test complexity provides valuable insight into which products (e.g., sample preparation, NGS instrument, informatics) will be in demand in the future. The report provides market data and forecasts for NGS diagnostics by specific applications, including those for cancer, rare diseases, complex disorders and reproductive health.

Specific geographic markets are discussed, including North America, Europe, China, Japan and the rest of the world. Market data covers the years 2014, 2015 and 2020.
Industry sectors analyzed include NGS instruments, target enrichment, informatics, clinical laboratory testing services, reproductive health diagnostics, HLA typing, liquid
biopsy, immune sequencing and fusion diagnostics. More than 170 companies in the clinical NGS industry are profiled in this report. BCC Research provides a summary of the main industry acquisitions and strategic alliances from 2013 through 2015, including key alliance trends.

METHODOLOGY
Both primary and secondary research methodologies were used in preparing this study. BCC Research examined each of the key end-user market segments that will be
commercially important during the next five years: cancer, rare genetic disorders, complex disorders and reproductive health. Based on this analysis, the current and future applications of NGS technologies are evaluated in each of the major clinical market segments and sales revenues are forecast for 2015 through 2020. Based on analysis of both secondary and primary market sources, as well as the key trends in the industry, the report provides the current and projected market size for the various clinical NGS segments for the years 2014, 2015 and 2020.

Table Of Contents

Next-Generation Sequencing: Emerging Clinical Applications and Global Markets
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
CONTRIBUTION OF THE STUDY AND INTENDED AUDIENCE 3
SCOPE AND FORMAT 3
METHODOLOGY 4
INFORMATION SOURCES 4
ANALYST'S CREDENTIALS 4
RELATED BCC RESEARCH REPORTS 5
BCC RESEARCH WEBSITE 5
DISCLAIMER 5
CHAPTER 2 EXECUTIVE SUMMARY 7
SUMMARY TABLE GLOBAL CLINICAL NEXT-GENERATION SEQUENCING MARKET BY
DISEASE CLASS, THROUGH 2020 ($ MILLIONS) 8
SUMMARY FIGURE GLOBAL CLINICAL NEXT-GENERATION SEQUENCING MARKET BY
DISEASE CLASS, 2014-2020 ($ MILLIONS) 8
CHAPTER 3 OVERVIEW 11
INTRODUCTION 11
TABLE 1 REPORT SCOPE 11
CLINICAL NGS MARKETS 11
TABLE 2 GLOBAL NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY
DISEASE TYPE, THROUGH 2020 ($ MILLIONS) 12
CLINICAL NGS GROWTH DRIVING FORCES 13
TECHNOLOGY DRIVERS 13
TABLE 3 KEY TECHNOLOGY DRIVERS FOR CLINICAL NEXT-GENERATION
SEQUENCING 13
MARKET DRIVERS 14
TABLE 4 CLINICAL NEXT-GENERATION SEQUENCING MARKET DRIVING FORCES 15
CLINICAL NGS APPLICATIONS 16
TABLE 5 CLINICAL NEXT-GENERATION SEQUENCING APPLICATION STATUS 16
CLINICAL NGS INDUSTRY 17
TABLE 6 KEY DIAGNOSTIC NEXT-GENERATION SEQUENCING INDUSTRY
PARTICIPANTS BY SECTOR 17
CHAPTER 4 TECHNOLOGIES 20
IMPORTANCE OF DNA 20
TABLE 7 DNA CHEMICAL BUILDING BLOCKS 20
TABLE 8 DNA TRANSLATION AND TRANSCRIPTION 20
TABLE 9 LONG-RANGE DNA STRUCTURE 21
GENETIC VARIATION AND ANALYSIS 22
TABLE 10 GENETIC VARIANT TYPES 22
GENETIC ANALYSIS TECHNOLOGIES 23
TABLE 11 IMPORTANT MOLECULAR DIAGNOSTIC PLATFORMS 24
NGS IN CLINICAL APPLICATIONS 25
TABLE 12 GENETIC TESTING EVOLUTION 25
TABLE 13 MARKET SEGMENTS FOR NEXT-GENERATION SEQUENCING DIAGNOSTICS 26
NGS TECHNOLOGIES 27
HISTORY OF DNA SEQUENCING 27
TABLE 14 DNA SEQUENCING HISTORICAL TIMELINE, 1977-2015 28
TABLE 15 SEQUENCING TECHNOLOGY DEVELOPMENT, 1990-2020 33
FIGURE 1 EFFECT OF NEW SEQUENCING TECHNOLOGIES ON COST TO SEQUENCE A
SINGLE HUMAN GENOME, 2001-2014 [3] ($/GENOME) 34
SANGER SEQUENCING TECHNOLOGY 35
TABLE 16 SANGER SEQUENCING SUMMARY 35
TABLE 17 SANGER SEQUENCING IMPROVEMENTS 36
NGS PLATFORMS 36
TABLE 18 NEXT-GENERATION SEQUENCING TECHNOLOGIES 37
TABLE 19 ROCHE NEXT-GENERATION SEQUENCING WORKFLOW 37
TABLE 20 ILLUMINA NEXT-GENERATION SEQUENCING WORKFLOW 38
TABLE 21 LIFE TECHNOLOGIES NEXT-GENERATION SEQUENCING WORKFLOW 39
BENCHTOP SEQUENCERS 40
TABLE 22 BENCHTOP SEQUENCER PLATFORMS 40
NANOPORE SEQUENCING TECHNOLOGIES 41
INFORMATICS TECHNOLOGIES 42
TABLE 23 NEXT-GENERATION SEQUENCING BIOINFORMATICS WORKFLOW 42
BASE CALLING 43
MAPPING TO A REFERENCE SEQUENCE 43
TABLE 24 SEQUENCE ANNOTATION STEPS 44
VARIANT ANALYSIS 45
FUTURE TECHNOLOGY CHALLENGES 46
TABLE 25 FUTURE CHALLENGES FOR IMPLEMENTING CLINICAL NEXT-GENERATION
SEQUENCING 46
CHAPTER 5 TOP 10 CLINICAL NGS INITIATIVES 49
TABLE 26 TOP 10 CLINICAL NEXT-GENERATION SEQUENCING PROJECTS 49
ACTIONABLE GENOME CONSORTIUM 50
BABYSEQ 50
CANCER MOON SHOTS PROGRAM 50
CLINGEN 50
LUNG-MAP 51
MATCHMAKER EXCHANGE 51
MILLION VETERAN PROGRAM 51
MEDSEQ 52
PRECISION MEDICINE 52
PROMPT 52
CHAPTER 6 CLINICAL NGS APPLICATIONS 54
INTRODUCTION 54
TABLE 27 CLINICAL NEXT-GENERATION SEQUENCING, NEAR TO MID-TERM
APPLICATIONS 54
CANCER APPLICATIONS 55
TABLE 28 CANCER APPLICATIONS 55
MENDELIAN DISORDERS APPLICATIONS 57
TABLE 29 MENDELIAN DISORDERS APPLICATIONS 57
REPRODUCTIVE HEALTH APPLICATIONS 58
TABLE 30 SCREENING APPLICATIONS 58
TABLE 31 ETHICAL ISSUES ASSOCIATED WITH PRENATAL AND NEWBORN
SCREENING 60
INFECTIOUS DISEASE APPLICATIONS 61
TABLE 32 INFECTIOUS DISEASE APPLICATIONS 62
COMPLEX DISORDERS APPLICATIONS 63
TABLE 33 COMPLEX DISORDER APPLICATIONS 64
CHAPTER 7 CLINICAL NGS INDUSTRY 67
INTRODUCTION 67
TABLE 34 KEY SEGMENTS WITHIN THE NEXT-GENERATION SEQUENCING CLINICAL
INDUSTRY 67
NGS INSTRUMENT INDUSTRY 68
TABLE 35 NEXT-GENERATION SEQUENCING INSTRUMENT COMPANIES SUMMARY 68
NGS TARGET ENRICHMENT INDUSTRY 71
TABLE 36 NEXT-GENERATION SEQUENCING-BASED TARGET ENRICHMENT
INDUSTRY 71
NGS CLINICAL INFORMATICS INDUSTRY 72
TABLE 37 NEXT-GENERATION SEQUENCING CLINICAL INFORMATICS COMPANY
POSITIONING 73
NGS CLINICAL LABORATORY TESTING SERVICES INDUSTRY 75
TABLE 38 NGS CLINICAL LABORATORY TESTING SERVICES INDUSTRY 75
INDIA'S CLINICAL SEQUENCING INDUSTRY 78
TABLE 39 INDIA NGS CLINICAL SEQUENCING COMPETITIVE POSITIONING 78
REPRODUCTIVE HEALTH DIAGNOSTICS INDUSTRY 79
NONINVASIVE PRENATAL TESTING INDUSTRY 79
TABLE 40 NGS NIPT INDUSTRY 80
TABLE 41 GLOBAL NGS-BASED NONINVASIVE PRENATAL DIAGNOSTIC MARKET
SHARE BY TEST, 2014 (%) 84
TABLE 42 GERMANY NGS-BASED NONINVASIVE PRENATAL DIAGNOSTIC
COMPETITIVE SITUATION 85
PREIMPLANTATION GENETICS DIAGNOSIS/SCREENING INDUSTRY 87
TABLE 43 PREIMPLANTATION DIAGNOSTICS PLATFORMS 87
TABLE 44 PREIMPLANTATION GENETIC SCREENING AND DIAGNOSIS INDUSTRY 88
LIQUID BIOPSY INDUSTRY 91
TABLE 45 NGS-BASED LIQUID BIOPSY INDUSTRY 92
HLA TYPING INDUSTRY 94
TABLE 46 NGS-BASED HLA TYPING INDUSTRY COMPETITORS 95
IMMUNE SEQUENCING INDUSTRY 97
TABLE 47 IMMUNE SYSTEM PROFILING INDUSTRY 97
NGS GENE FUSION DIAGNOSTICS INDUSTRY 98
TABLE 48 NGS-BASED GENE FUSION DIAGNOSTICS INDUSTRY 99
CLINICAL NGS INDUSTRY ACQUISITIONS AND STRATEGIC ALLIANCES 100
ACQUISITIONS 100
TABLE 49 CLINICAL NEXT-GENERATION SEQUENCING INDUSTRY ACQUISITIONS,
2013- MARCH 2015 100
STRATEGIC ALLIANCES 104
TABLE 50 CLINICAL NEXT-GENERATION SEQUENCING STRATEGIC ALLIANCES,
2013-MARCH 2015 105
CHAPTER 8 NGS DIAGNOSTICS MARKETS 119
GROWTH DRIVING FORCES 119
TABLE 51 CLINICAL NEXT-GENERATION SEQUENCING KEY GROWTH DRIVING
FORCES, THROUGH 2020 119
TABLE 52 CLINICAL NGS STAKEHOLDERS ACTIVITY 121
GLOBAL NGS DIAGNOSTIC MARKET 122
TABLE 53 GLOBAL NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY TEST
COMPLEXITY, THROUGH 2020 ($ MILLIONS) 123
TABLE 54 GLOBAL NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY TEST
PURPOSE, THROUGH 2020 ($ MILLIONS) 124
NGS CANCER DIAGNOSTIC MARKETS 126
TABLE 55 GLOBAL NEXT-GENERATION SEQUENCING CANCER DIAGNOSTIC MARKET
BY SEGMENT, THROUGH 2020 ($ MILLIONS) 126
TABLE 56 GLOBAL NEXT-GENERATION SEQUENCING CANCER DIAGNOSTIC MARKET
BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 129
NGS Cancer Diagnosis Market 130
NGS Cancer Screening Market 130
NGS Cancer Monitoring Market 130
NGS Cancer Therapy Guidance Market 131
Companion Diagnostics 132
TABLE 57 RECENT NGS-BASED COMPANION DIAGNOSTICS ACTIVITIES 132
Thyroid and Leukemia Update 134
NGS Cancer Market by Test Complexity 134
TABLE 58 GLOBAL CANCER NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET
BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 135
TABLE 59 MULTI-GENE NGS-BASED HEMATOLOGICAL TESTS 137
NGS CARDIOLOGY DIAGNOSTIC MARKETS 137
TABLE 60 GLOBAL NEXT-GENERATION SEQUENCING CARDIOVASCULAR
DIAGNOSTIC MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 138
TABLE 61 DILATED CARDIOMYOPATHY TEST PROVIDERS 139
TABLE 62 GLOBAL NEXT-GENERATION SEQUENCING CARDIOLOGY DIAGNOSTIC
MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 140
NGS MENDELIAN DISORDERS DIAGNOSTIC MARKETS 140
TABLE 63 GLOBAL NEXT-GENERATION SEQUENCING MENDELIAN DISORDER
DIAGNOSTIC MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 142
TABLE 64 GLOBAL NEXT-GENERATION SEQUENCING MENDELIAN DISORDER
DIAGNOSTIC MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 143
NGS METABOLIC/IMMUNE DISORDER DIAGNOSTIC MARKETS 145
TABLE 65 GLOBAL NEXT-GENERATION SEQUENCING METABOLIC AND IMMUNE
DISORDER DIAGNOSTIC MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 146
TABLE 66 MULTIPLE SCLEROSIS DIAGNOSTIC TECHNOLOGIES 146
TABLE 67 GLOBAL NEXT-GENERATION SEQUENCING METABOLIC AND IMMUNE
DISORDER DIAGNOSTIC MARKET BY TEST COMPLEXITY, THROUGH 2020 ($
MILLIONS)
147
NGS NEUROLOGY DIAGNOSTIC MARKETS 148
TABLE 68 GLOBAL NEXT-GENERATION SEQUENCING NEUROLOGY DIAGNOSTIC
MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 148
TABLE 69 GLOBAL NEXT-GENERATION SEQUENCING NEUROLOGY DIAGNOSTIC
MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 149
NGS REPRODUCTIVE HEALTH DIAGNOSTIC MARKETS 150
Newborn Screening Diagnostic Market 150
TABLE 70 GLOBAL NEXT-GENERATION SEQUENCING NEWBORN SCREENING
DIAGNOSTIC MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 151
TABLE 71 GLOBAL NEXT-GENERATION SEQUENCING NEWBORN SCREENING
DIAGNOSTIC MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 152
Prenatal Screening Diagnostic Market 153
TABLE 72 GLOBAL NEXT-GENERATION SEQUENCING PRENATAL DIAGNOSTIC
MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 154
TABLE 73 GLOBAL NEXT-GENERATION SEQUENCING PRENATAL DIAGNOSTIC
MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 156
Preimplantation Diagnostic Market 157
TABLE 74 GLOBAL NEXT-GENERATION SEQUENCING PREIMPLANTATION
DIAGNOSTIC MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 157
TABLE 75 GLOBAL NEXT-GENERATION SEQUENCING PREIMPLANTATION
DIAGNOSTIC MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 158
NGS FOOD-BORNE ILLNESS DIAGNOSTIC MARKET 159
TABLE 76 GLOBAL NEXT-GENERATION SEQUENCING FOOD-BORNE ILLNESS
DIAGNOSTIC MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 160
TABLE 77 GLOBAL NEXT-GENERATION SEQUENCING FOOD-BORNE ILLNESS
DIAGNOSTIC MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 160
TABLE 78 NGS IN INFECTIOUS DISEASE DIAGNOSTICS 161
NGS HLA TYPING DIAGNOSTIC MARKET 161
TABLE 79 GLOBAL NEXT-GENERATION SEQUENCING HLA TYPING DIAGNOSTIC
MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 162
TABLE 80 GLOBAL NEXT-GENERATION SEQUENCING HLA TYPING DIAGNOSTIC
MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 164
NGS DIAGNOSTIC MARKETS BY REGION 165
TABLE 81 GLOBAL NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY
REGION, THROUGH 2020 ($ MILLIONS) 165
NORTH AMERICA 165
TABLE 82 NORTH AMERICAN NEXT-GENERATION SEQUENCING DIAGNOSTIC
MARKET BY APPLICATION, THROUGH 2020 ($ MILLIONS) 166
EUROPE 166
TABLE 83 EUROPEAN NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 167
CHINA 168
TABLE 84 CHINA NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 169
JAPAN 170
TABLE 85 JAPANESE NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 170
REST OF WORLD 171
TABLE 86 REST OF WORLD NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET
BY APPLICATION, THROUGH 2020 ($ MILLIONS) 171
CHAPTER 9 PATENTS 174
CLINICAL NGS PATENTS 174
TABLE 87 CLINICAL NEXT-GENERATION SEQUENCING PATENTS, 2004-2014 174
CLINICAL NGS PATENTS BY INDICATION 174
TABLE 88 CLINICAL NEXT-GENERATION SEQUENCING PATENTS BY INDICATION,
2004-2014 175
STATUS OF MYRIAD'S BRCA PATENTS 175
SEQUENOM AND ILLUMINA NIPT PATENT POOL 176
CHAPTER 10 COMPANY PROFILES 179
10X GENOMICS 179
14M GENOMICS LTD. 179
23ANDME INC. 180
TABLE 89 DATA NEEDS 180
ADAPTIVE BIOTECHNOLOGIES INC. 181
ADMERA HEALTH 182
AGILENT TECHNOLOGIES INC. 183
ALMAC GROUP LTD. 184
AMARANTUS BIOSCIENCE HOLDINGS INC. 185
AMBRY GENETICS 185
APPISTRY INC. 186
ARUP LABORATORIES 187
ASSUREX HEALTH 187
ASTRIDBIO TECHNOLOGIES KFT. 187
ASURAGEN INC. 188
ATHENA DIAGNOSTICS INC. 189
ATRECA INC. 189
BASE4 INNOVATION LTD. 190
BAYLOR MIRACA GENETICS LABORATORIES INC. 191
BECTON, DICKINSON AND CO. 191
BERRY GENOMICS CO. LTD. 192
BGI SHENZHEN 193
BIOARRAY SL 195
BIODESIX INC. 195
BIOINNOVATION SOLUTIONS SA 196
BIO-RAD LABORATORIES INC. 197
BIOTHERANOSTICS INC. 198
BLUEPRINT GENETICS 198
BOREAL GENOMICS 199
CAREDX INC. 199
CARIS LIFE SCIENCES 200
CEGAT GMBH 200
CELLULAR RESEARCH INC. 201
CENTOGENE AG 201
CERGENTIS BV 202
CHRONIX BIOMEDICAL 202
CLARITAS GENOMICS INC. 202
CLEVELAND CLINICAL LABORATORIES 203
COFACTOR GENOMICS INC. 203
CORIELL LIFE SCIENCES INC. 203
CORRELAGEN DIAGNOSTICS INC. 204
COUNSYL INC. 205
COURTAGEN LIFE SCIENCES INC. 205
CYNVENIO BIOSYSTEMS INC. 206
CYPHER GENOMICS INC. 206
DANAHER CORP. 207
DIPLOID 208
DIRECTED GENOMICS LLC 208
DNA ELECTRONICS LTD. 209
DNA LINK INC. 210
DNANEXUS INC. 210
ELECTRONIC BIOSCIENCES 211
ESPERITE NV 211
EUROFINS GENOMICS 212
EXOSOME DIAGNOSTICS INC. 212
EXPRESSION ANALYSIS INC. 213
FOUNDATION MEDICINE 214
FUSION GENOMICS CORP. 215
GATC BIOTECH AG 216
GE HEALTHCARE 216
GENAPSYS INC. 217
GENDX BV 217
GENE BY GENE LTD. 218
GENEDX INC. 219
GENEPEEKS INC. 220
GENOLOGICS LIFE SCIENCES SOFTWARE 220
GENOMATIX SOFTWARE GMBH 221
GENOMEDX 221
GENOMEQUEST INC. 222
GENOMIC EXPRESSION 223
GENOMIC HEALTH INC. 223
GENOMONCOLOGY 224
GENOSPACE 224
GIGAGEN INC. 225
GOLDEN HELIX 226
GOOD START GENETICS INC. 226
HISTOGENETICS LLC 227
HTG MOLECULAR DIAGNOSTICS INC. 228
ILLUMINA INC. 228
TABLE 90 NEW PLATFORMS INTRODUCED BY ILLUMINA IN 2015 229
INNOVATIONS EXCHANGE PTE. LTD. 233
INTELLIMEDIX 233
INTERPACE DIAGNOSTICS LLC 234
INVITAE 234
INVIVOSCRIBE TECHNOLOGIES INC. 235
IREPERTOIRE INC. 235
KAILOS GENETICS 236
KELLBENX INC. 236
KEW GROUP INC. 237
KNOME INC. 237
LABORATORY CORPORATION OF AMERICA INC. 238
LABORATORY FOR MOLECULAR MEDICINE 239
LASERGEN INC. 240
LEUCINE RICH BIO 240
LIFECODE INC. 241
LUMENOGIX INC. 241
MACROGEN INC. 242
MAVERIX BIOMICS INC. 242
MAYO MEDICAL LABORATORIES 242
MEDGENOME LABS PVT. LTD. 243
MEDICAL DIAGNOSTIC LABORATORIES LLC 243
MEDOMICS LLC 244
MERCK KGAA 245
MIRATI THERAPEUTICS 245
MOGENE CLINICAL DIAGNOSTICS 245
MOLECULAR HEALTH GMBH 246
MOLECULARMD CORP. 246
MRIGLOBAL RESEARCH INSTITUTE 247
MULTIPLICOM NV 247
MYRIAD GENETICS INC. 248
NABSYS INC. 249
NANTHEALTH 250
NATERA INC. 250
NEOGENOMICS INC. 251
NEW ENGLAND BIOLABS 252
NEWGENE LTD. 252
NEW ONCOLOGY AG 253
N-OF-ONE INC. 253
NOVARTIS AG 254
NUGEN TECHNOLOGIES INC. 255
OMICIA INC. 256
OMIXON BIOCOMPUTING KFT 256
ONCODNA SA 257
OXFORD GENE TECHNOLOGY 258
OXFORD NANOPORE TECHNOLOGIES LTD. 259
PACIFIC BIOSCIENCES OF CALIFORNIA INC. 260
PARABASE GENOMICS 262
PARSEQ LAB 262
PATHOGENETIX 263
PATHWAY GENOMICS CORP. 264
PERKINELMER INC. 264
PERSONAL GENOME DIAGNOSTICS INC. 266
PERSONAL GENOMICS INC. 267
PERSONALIS INC. 268
PICOSEQ 268
POPULATION GENETICS TECHNOLOGIES LTD. 269
TABLE 91 SENSITIVITY TO DETECT DRUG RESISTANT MUTATIONS IN VIRUSES (%) 270
PORTABLE GENOMICS LLC 271
PREMAITHA HEALTH PLC 271
PRENETICS 272
PRESSURE BIOSCIENCES INC. 272
PREVENTIONGENETICS INC. 274
QIAGEN NV 274
QUANTAPORE INC. 276
QUANTUMDX GROUP 277
QUEST DIAGNOSTICS 278
RAINDANCE TECHNOLOGIES INC. 279
REAL TIME GENOMICS INC. 280
REPROGENETICS 280
RESPONSE GENETICS INC. 281
ROCHE HOLDING AG 281
TABLE 92 COMMERCIAL SEQUENCER COMPETITIVE POSITIONING 283
ROSWELL PARK CANCER INSTITUTE 284
SCIGENOM LABS 285
SELAH GENOMICS 285
SENGENICS INTERNATIONAL PTE LTD. 285
SEQUENOM INC. 286
SEVEN BRIDGES GENOMICS INC. 287
SISTEMAS GENOMICOS SL 288
SOFTGENETICS LLC 288
SOPHIA GENETICS 289
STATION X INC. 289
STRAND LIFE SCIENCES 290
STRATOS GENOMICS INC. 290
SUNDANCE DIAGNOSTICS INC. 291
SUPRATECH MICROPATH LABORATORY and RESEARCH INSTITUTE 291
SYAPSE 292
SYMBIODX 292
THERMO FISHER SCIENTIFIC INC. 293
TRANSGENOMIC INC. 294
TROVAGENE INC. 295
VELA DIAGNOSTICS 296
WAFERGEN BIOSYSTEMS INC. 297
TABLE 93 WAFERGEN STRATEGIC ALLIANCES 297
WARP DRIVE BIO LLC 298
YIKON GENOMICS CO. LTD. 299
ZS GENETICS INC. 299

LIST OF TABLES
SUMMARY TABLE GLOBAL CLINICAL NEXT-GENERATION SEQUENCING MARKET BY
DISEASE CLASS, THROUGH 2020 ($ MILLIONS) 8
TABLE 1 REPORT SCOPE 11
TABLE 2 GLOBAL NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY
DISEASE TYPE, THROUGH 2020 ($ MILLIONS) 12
TABLE 3 KEY TECHNOLOGY DRIVERS FOR CLINICAL NEXT-GENERATION
SEQUENCING 13
TABLE 4 CLINICAL NEXT-GENERATION SEQUENCING MARKET DRIVING FORCES 15
TABLE 5 CLINICAL NEXT-GENERATION SEQUENCING APPLICATION STATUS 16
TABLE 6 KEY DIAGNOSTIC NEXT-GENERATION SEQUENCING INDUSTRY
PARTICIPANTS BY SECTOR 17
TABLE 7 DNA CHEMICAL BUILDING BLOCKS 20
TABLE 8 DNA TRANSLATION AND TRANSCRIPTION 20
TABLE 9 LONG-RANGE DNA STRUCTURE 21
TABLE 10 GENETIC VARIANT TYPES 22
TABLE 11 IMPORTANT MOLECULAR DIAGNOSTIC PLATFORMS 24
TABLE 12 GENETIC TESTING EVOLUTION 25
TABLE 13 MARKET SEGMENTS FOR NEXT-GENERATION SEQUENCING DIAGNOSTICS 26
TABLE 14 DNA SEQUENCING HISTORICAL TIMELINE, 1977-2015 28
TABLE 15 SEQUENCING TECHNOLOGY DEVELOPMENT, 1990-2020 33
TABLE 16 SANGER SEQUENCING SUMMARY 35
TABLE 17 SANGER SEQUENCING IMPROVEMENTS 36
TABLE 18 NEXT-GENERATION SEQUENCING TECHNOLOGIES 37
TABLE 19 ROCHE NEXT-GENERATION SEQUENCING WORKFLOW 37
TABLE 20 ILLUMINA NEXT-GENERATION SEQUENCING WORKFLOW 38
TABLE 21 LIFE TECHNOLOGIES NEXT-GENERATION SEQUENCING WORKFLOW 39
TABLE 22 BENCHTOP SEQUENCER PLATFORMS 40
TABLE 23 NEXT-GENERATION SEQUENCING BIOINFORMATICS WORKFLOW 42
TABLE 24 SEQUENCE ANNOTATION STEPS 44
TABLE 25 FUTURE CHALLENGES FOR IMPLEMENTING CLINICAL NEXT-GENERATION
SEQUENCING 46
TABLE 26 TOP 10 CLINICAL NEXT-GENERATION SEQUENCING PROJECTS 49
TABLE 27 CLINICAL NEXT-GENERATION SEQUENCING, NEAR TO MID-TERM
APPLICATIONS 54
TABLE 28 CANCER APPLICATIONS 55
TABLE 29 MENDELIAN DISORDERS APPLICATIONS 57
TABLE 30 SCREENING APPLICATIONS 58
TABLE 31 ETHICAL ISSUES ASSOCIATED WITH PRENATAL AND NEWBORN
SCREENING 60
TABLE 32 INFECTIOUS DISEASE APPLICATIONS 62
TABLE 33 COMPLEX DISORDER APPLICATIONS 64
TABLE 34 KEY SEGMENTS WITHIN THE NEXT-GENERATION SEQUENCING CLINICAL
INDUSTRY 67
TABLE 35 NEXT-GENERATION SEQUENCING INSTRUMENT COMPANIES SUMMARY 68
TABLE 36 NEXT-GENERATION SEQUENCING-BASED TARGET ENRICHMENT INDUSTRY 71
TABLE 37 NEXT-GENERATION SEQUENCING CLINICAL INFORMATICS COMPANY
POSITIONING 73
TABLE 38 NGS CLINICAL LABORATORY TESTING SERVICES INDUSTRY 75
TABLE 39 INDIA NGS CLINICAL SEQUENCING COMPETITIVE POSITIONING 78
TABLE 40 NGS NIPT INDUSTRY 80
TABLE 41 GLOBAL NGS-BASED NONINVASIVE PRENATAL DIAGNOSTIC MARKET
SHARE BY TEST, 2014 (%) 84
TABLE 42 GERMANY NGS-BASED NONINVASIVE PRENATAL DIAGNOSTIC
COMPETITIVE SITUATION 85
TABLE 43 PREIMPLANTATION DIAGNOSTICS PLATFORMS 87
TABLE 44 PREIMPLANTATION GENETIC SCREENING AND DIAGNOSIS INDUSTRY 88
TABLE 45 NGS-BASED LIQUID BIOPSY INDUSTRY 92
TABLE 46 NGS-BASED HLA TYPING INDUSTRY COMPETITORS 95
TABLE 47 IMMUNE SYSTEM PROFILING INDUSTRY 97
TABLE 48 NGS-BASED GENE FUSION DIAGNOSTICS INDUSTRY 99
TABLE 49 CLINICAL NEXT-GENERATION SEQUENCING INDUSTRY ACQUISITIONS,
2013- MARCH 2015 100
TABLE 50 CLINICAL NEXT-GENERATION SEQUENCING STRATEGIC ALLIANCES,
2013-MARCH 2015 105
TABLE 51 CLINICAL NEXT-GENERATION SEQUENCING KEY GROWTH DRIVING
FORCES, THROUGH 2020 119
TABLE 52 CLINICAL NGS STAKEHOLDERS ACTIVITY 121
TABLE 53 GLOBAL NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY TEST
COMPLEXITY, THROUGH 2020 ($ MILLIONS) 123
TABLE 54 GLOBAL NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY TEST
PURPOSE, THROUGH 2020 ($ MILLIONS) 124
TABLE 55 GLOBAL NEXT-GENERATION SEQUENCING CANCER DIAGNOSTIC MARKET
BY SEGMENT, THROUGH 2020 ($ MILLIONS) 126
TABLE 56 GLOBAL NEXT-GENERATION SEQUENCING CANCER DIAGNOSTIC MARKET
BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 129
TABLE 57 RECENT NGS-BASED COMPANION DIAGNOSTICS ACTIVITIES 132
TABLE 58 GLOBAL CANCER NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET
BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 135
TABLE 59 MULTI-GENE NGS-BASED HEMATOLOGICAL TESTS 137
TABLE 60 GLOBAL NEXT-GENERATION SEQUENCING CARDIOVASCULAR DIAGNOSTIC
MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 138
TABLE 61 DILATED CARDIOMYOPATHY TEST PROVIDERS 139
TABLE 62 GLOBAL NEXT-GENERATION SEQUENCING CARDIOLOGY DIAGNOSTIC
MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 140
TABLE 63 GLOBAL NEXT-GENERATION SEQUENCING MENDELIAN DISORDER
DIAGNOSTIC MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 142
TABLE 64 GLOBAL NEXT-GENERATION SEQUENCING MENDELIAN DISORDER
DIAGNOSTIC MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 143
TABLE 65 GLOBAL NEXT-GENERATION SEQUENCING METABOLIC AND IMMUNE
DISORDER DIAGNOSTIC MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 146
TABLE 66 MULTIPLE SCLEROSIS DIAGNOSTIC TECHNOLOGIES 146
TABLE 67 GLOBAL NEXT-GENERATION SEQUENCING METABOLIC AND IMMUNE
DISORDER DIAGNOSTIC MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 147
TABLE 68 GLOBAL NEXT-GENERATION SEQUENCING NEUROLOGY DIAGNOSTIC
MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 148
TABLE 69 GLOBAL NEXT-GENERATION SEQUENCING NEUROLOGY DIAGNOSTIC
MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 149
TABLE 70 GLOBAL NEXT-GENERATION SEQUENCING NEWBORN SCREENING
DIAGNOSTIC MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 151
TABLE 71 GLOBAL NEXT-GENERATION SEQUENCING NEWBORN SCREENING
DIAGNOSTIC MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 152
TABLE 72 GLOBAL NEXT-GENERATION SEQUENCING PRENATAL DIAGNOSTIC
MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 154
TABLE 73 GLOBAL NEXT-GENERATION SEQUENCING PRENATAL DIAGNOSTIC
MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 156
TABLE 74 GLOBAL NEXT-GENERATION SEQUENCING PREIMPLANTATION DIAGNOSTIC
MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 157
TABLE 75 GLOBAL NEXT-GENERATION SEQUENCING PREIMPLANTATION DIAGNOSTIC
MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 158
TABLE 76 GLOBAL NEXT-GENERATION SEQUENCING FOOD-BORNE ILLNESS
DIAGNOSTIC MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 160
TABLE 77 GLOBAL NEXT-GENERATION SEQUENCING FOOD-BORNE ILLNESS
DIAGNOSTIC MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 160
TABLE 78 NGS IN INFECTIOUS DISEASE DIAGNOSTICS 161
TABLE 79 GLOBAL NEXT-GENERATION SEQUENCING HLA TYPING DIAGNOSTIC
MARKET BY TEST PURPOSE, THROUGH 2020 ($ MILLIONS) 162
TABLE 80 GLOBAL NEXT-GENERATION SEQUENCING HLA TYPING DIAGNOSTIC
MARKET BY TEST COMPLEXITY, THROUGH 2020 ($ MILLIONS) 164
TABLE 81 GLOBAL NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY
REGION, THROUGH 2020 ($ MILLIONS) 165
TABLE 82 NORTH AMERICAN NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET
BY APPLICATION, THROUGH 2020 ($ MILLIONS) 166
TABLE 83 EUROPEAN NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 167
TABLE 84 CHINA NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 169
TABLE 85 JAPANESE NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 170
TABLE 86 REST OF WORLD NEXT-GENERATION SEQUENCING DIAGNOSTIC MARKET
BY APPLICATION, THROUGH 2020 ($ MILLIONS) 171
TABLE 87 CLINICAL NEXT-GENERATION SEQUENCING PATENTS, 2004-2014 174
TABLE 88 CLINICAL NEXT-GENERATION SEQUENCING PATENTS BY INDICATION,
2004-2014 175
TABLE 89 DATA NEEDS 180
TABLE 90 NEW PLATFORMS INTRODUCED BY ILLUMINA IN 2015 229
TABLE 91 SENSITIVITY TO DETECT DRUG RESISTANT MUTATIONS IN VIRUSES (%) 270
TABLE 92 COMMERCIAL SEQUENCER COMPETITIVE POSITIONING 283
TABLE 93 WAFERGEN STRATEGIC ALLIANCES 297

LIST OF FIGURES
SUMMARY FIGURE GLOBAL CLINICAL NEXT-GENERATION SEQUENCING MARKET BY
DISEASE CLASS, 2014-2020 ($ MILLIONS) 8
FIGURE 1 EFFECT OF NEW SEQUENCING TECHNOLOGIES ON COST TO SEQUENCE A
SINGLE HUMAN GENOME, 2001-2014 [3] ($/GENOME) 34

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