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DNA Sequencing: Emerging Technologies and Applications

  • May 2016
  • -
  • BCC Research
  • -
  • 357 pages

This BCC Research report provides a comprehensive discussion of sequencing technologies, market applications, industry structure, important clinical sequencing initiatives, global markets, and companies. Sales forecasts are provided from 2015 through 2020.

Use this report to:

Analyze the next-generation sequencing industry and market, as well as Sanger and emerging sequencing.
Explore strong growth opportunities including benchtop and handheld sequencing instruments, clinical diagnostics and applied sequencing services, etc.
Discuss sequencing technologies, market applications, industry structure, important clinical sequencing initiatives, global markets, patent status and companies.
Evaluate key industry trends and company activities, as well as market dynamics.

Highlights

The global market for sequencing products has grown to $5.9 billion in 2015 from $5.3 billion in 2014. The market is expected to grow at a five-year compound annual growth rate (CAGR) of 18.7% from 2015 to 2020, reaching nearly $13.8 billion by 2020.
The market for sequencing instruments, reagents and consumables in the sequencing industry is expected to grow from $3.0 billion in 2015 to $4.7 billion in 2020, increasing at a CAGR of 9.5% for the period 2015-2020.
The global market for sequencing services in the sequencing industry is expected to grow from $2.9 billion in 2015 to $9.1 billion in 2020, increasing at a CAGR of 26.0% for the period 2015-2020.

STUDY GOALS AND OBJECTIVES

BCC Research’s goal for this study is to provide an in-depth analysis of the sequencing industry, an important industry in life sciences with enormous market potential. The approach for analyzing the industry is taken in terms of workflow (e.g., sequencers, sequence capture, informatics) and key applications (e.g., research, applied, services, sample prep, informatics) in which sequencing will have market share by 2020.

BCC Research examines the markets for sequencing products and services for the years 2014, 2015 and 2020.
Emphasis is placed on the global next-generation sequencing (NGS) diagnostic markets, which are characterized and quantified by disease indication, test complexity, test purpose and geography.

Sequencing market segments that provide strong growth opportunities include benchtop and handheld sequencing instruments; clinical diagnostics (e.g., oncology, transplant, reproductive health); and applied sequencing services (e.g., agriculture, consumer, forensics).

The report provides a comprehensive discussion of sequencing technologies, market 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 accessing sequencing industry opportunities.

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 Life Technologies).

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 dropped 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 for sequencing products and services are emerging in diverse applications ranging, for example, from clinical diagnostics to agriculture genetic testing markets.

The clinical value of sequencing has been shown for many applications, and several launched tests are having commercial success. This shows that both patients and physicians are recognizing the value of NGS tests. New product formats, including liquid biopsy and single cell sequencing, are being introduced.

At the same time, payors and insurance companies are beginning to provide coverage for these tests, further enhancing their commercial potential.
The continuing emphasis in the industry on precision medicine is helping to pave the way for sequencing systems. Examples of this include the Precision Medicine Program in the U.S., which will sequence more than one million people to identify genomic drivers of cancer, and the recent declaration of precision medicine as a focus for China’s 13 Five Year Plan for 2016 to 2020.

These technical and market factors are driving this market, so that it is now timely to re-examine the sequencing markets with this updated report.

Table Of Contents

DNA Sequencing: Emerging Technologies and Applications
CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
INTENDED AUDIENCE 3
SCOPE AND FORMAT OF REPORT 3
METHODOLOGY 4
INFORMATION SOURCES 5
RELATED BCC RESEARCH REPORTS 5
ANALYST'S CREDENTIALS 5
BCC RESEARCH WEBSITE 5
DISCLAIMER 6
CHAPTER 2 EXECUTIVE SUMMARY 8
SUMMARY TABLE GLOBAL SEQUENCING MARKET BY PRODUCT TYPE, THROUGH
2020 ($ MILLIONS) 8
SUMMARY FIGURE GLOBAL SEQUENCING MARKET BY PRODUCT TYPE, 2014-2020
($ MILLIONS) 8
CHAPTER 3 OVERVIEW 12
INTRODUCTION 12
TABLE 1 ARRAY OF WORKFLOW PRODUCTS AND SERVICES 12
SEQUENCING MARKET 13
TABLE 2 GLOBAL SEQUENCING MARKET BY DELIVERED FORMAT, THROUGH 2020
($ MILLIONS) 13
TABLE 3 KEY DRIVING FORCES FOR SEQUENCING INDUSTRY GROWTH 15
SEQUENCING PRODUCTS 16
SEQUENCING INSTRUMENTS AND CONSUMABLES 17
SAMPLE PREPARATION REAGENTS AND KITS 17
BIOINFORMATICS 17
SEQUENCING SERVICES 17
SEQUENCING PRODUCT LIFE CYCLE STATUS 17
TABLE 4 LIFE CYCLE OF DNA SEQUENCING TYPES 18
NEXT-GENERATION SEQUENCING INDUSTRY 18
TABLE 5 SUMMARY OF NEXT-GENERATION SEQUENCING INDUSTRY SECTORS 18
CHAPTER 4 TECHNOLOGIES 21
IMPORTANCE OF DNA 21
TABLE 6 DNA CHEMICAL BUILDING BLOCKS 21
TABLE 7 PROCESS OF DNA TRANSLATION AND TRANSCRIPTION 21
TABLE 8 LONG-RANGE DNA STRUCTURE 22
GENETIC VARIATION AND ANALYSIS 23
TABLE 9 DIFFERENT TYPES OF GENETIC VARIANTS 23
GENETIC ANALYSIS TECHNOLOGIES 24
TABLE 10 IMPORTANT MOLECULAR DIAGNOSTIC PLATFORMS, BY COMPANY 24
SEQUENCING IN CLINICAL APPLICATIONS 25
TABLE 11 EVOLUTION OF GENETIC TESTING 25
TABLE 12 KEY NEAR- TO MID-TERM SEGMENTS FOR NEXT-GENERATION
SEQUENCING DIAGNOSTICS 27
SEQUENCING TECHNOLOGIES 28
HISTORY OF DNA SEQUENCING 28
TABLE 13 HISTORICAL TIMELINE OF DNA SEQUENCING 28
TABLE 14 SEQUENCING TECHNOLOGY DEVELOPMENT, 1990-2020 34
TABLE 15 COST TO SEQUENCE A SINGLE HUMAN GENOME, 2001-2015 ($) 34
SANGER SEQUENCING TECHNOLOGY 35
TABLE 16 SANGER SEQUENCING SUMMARY 35
TABLE 17 SANGER SEQUENCING IMPROVEMENTS 36
NEXT-GENERATION SEQUENCING PLATFORMS 36
TABLE 18 NEXT-GENERATION SEQUENCING TECHNOLOGIES 36
TABLE 19 ROCHE NEXT-GENERATION SEQUENCING WORKFLOW STEPS 37
TABLE 20 ILLUMINA NEXT-GENERATION SEQUENCING WORKFLOW STEPS 38
TABLE 21 LIFE TECHNOLOGIES NEXT-GENERATION SEQUENCING WORKFLOW
STEPS 39
BENCHTOP SEQUENCERS 39
TABLE 22 BENCHTOP AND HANDHELD SEQUENCER PLATFORMS, 2010-2015 40
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 44
CLINICAL SEQUENCING TECHNOLOGY CHALLENGES 45
TABLE 25 FUTURE CHALLENGES FOR IMPLEMENTING CLINICAL NEXT-GENERATION
SEQUENCING 45
CLINICAL NGS INITIATIVES 46
TABLE 26 KEY CLINICAL NGS PROJECTS 46
100K GENOMES PROJECT 47
ACTIONABLE GENOME CONSORTIUM 48
BABYSEQ 48
CANCER MOON SHOTS PROGRAM 48
CLINGEN 48
CSER 49
DECIPHERING DEVELOPMENTAL DISORDERS PROJECT 49
EMERGE 49
GENOME KOREA 49
LUNG-MAP 49
MATCHMAKER EXCHANGE 50
MILLION VETERAN PROGRAM 50
MEDSEQ 50
PRECISION MEDICINE 51
PROMPT 51
UK10K 51
CHAPTER 5 DNA SEQUENCING APPLICATIONS 54
INTRODUCTION 54
TABLE 27 GENOME SEQUENCING PROJECTS, 2005 AND 2015 54
GENETIC ANALYSIS 55
TABLE 28 COMPARISON OF GENETIC ANALYSIS FORMATS 56
TABLE 29 APPLICATIONS OF SEQUENCING ANALYSIS 57
TABLE 30 REQUIREMENTS FOR DE NOVO VS. RESEQUENCING 58
DE NOVO WHOLE GENOME SEQUENCING 59
RESEQUENCING 59
WHOLE GENOME RESEQUENCING 60
TARGETED RESEQUENCING 61
SEQ-BASED METHODS 61
TABLE 31 GENETIC ANALYSIS APPLICATIONS UTILIZING MICROARRAYS OR
SEQUENCING PLATFORMS 62
CHIPSEQ 62
TABLE 32 COMPARISON OF SEQUENCING WITH MICROARRAYS FOR CHIP
APPLICATIONS 63
DNASE-SEQ 63
RNA-SEQ 63
TABLE 33 COMPARISON OF SEQUENCING AND MICROARRAYS FOR GENE
EXPRESSION ANALYSIS 64
METHYL-SEQ 65
STRUCTURAL VARIATION STUDIES 66
COMPLEMENTARY SEQUENCING AND MICROARRAY PLATFORMS 66
SEQUENCING END-USE APPLICATIONS 67
RESEARCH 67
CONSUMER SEQUENCING 69
TABLE 34 COMPARISON OF GENETIC ANALYSIS PLATFORMS 69
AGRICULTURAL SEQUENCING 70
TABLE 35 IMPACT OF SEQUENCING ON AGRICULTURAL PRODUCT CLASSES 71
MICROBIAL SEQUENCING 72
TABLE 36 KEY APPLICATIONS IN MICROBIAL SEQUENCING 72
FORENSICS SEQUENCING 73
TABLE 37 KEY APPLICATIONS IN FORENSICS/HUMAN IDENTITY SEQUENCING 73
CHAPTER 6 CLINICAL SEQUENCING APPLICATIONS 76
INTRODUCTION 76
TABLE 38 CLINICAL NEXT-GENERATION SEQUENCING, NEAR-TO MID-TERM
APPLICATIONS 76
CANCER APPLICATIONS 77
TABLE 39 MAJOR CANCER APPLICATIONS FOR NGS DIAGNOSTICS 77
MENDELIAN DISORDERS APPLICATION 79
TABLE 40 MENDELIAN DISORDERS APPLICATION 80
REPRODUCTIVE HEALTH APPLICATIONS 81
TABLE 41 SCREENING APPLICATIONS 81
TABLE 42 ETHICAL ISSUES ASSOCIATED WITH PRENATAL AND NEWBORN
SCREENING 83
INFECTIOUS DISEASE APPLICATIONS 84
TABLE 43 INFECTIOUS DISEASE APPLICATIONS 84
COMPLEX DISORDERS APPLICATIONS 86
TABLE 44 COMPLEX DISORDERS APPLICATIONS 87
CHAPTER 7 SEQUENCING INDUSTRY 90
INTRODUCTION 90
TABLE 45 KEY SEGMENTS AND TRENDS IN THE SEQUENCING INDUSTRY 90
NGS INSTRUMENT INDUSTRY 91
TABLE 46 NEXT-GENERATION SEQUENCING INSTRUMENT COMPANIES 91
DROPLET DIGITAL PCR INDUSTRY 94
TABLE 47 ADVANTAGES OF DROPLET DIGITAL PCR 95
TABLE 48 DROPLET DIGITAL PCR INDUSTRY 95
TARGET ENRICHMENT AND AMPLIFICATION INDUSTRY 96
TABLE 49 TARGET ENRICHMENT INDUSTRY 96
SPECIALIZED DNA POLYMERASE INDUSTRY 98
TABLE 50 SPECIALIZED DNA POLYMERASE INDUSTRY 98
NONINVASIVE PRENATAL TESTING INDUSTRY 99
TABLE 51 KEY COMPANIES IN THE NGS NIPT INDUSTRY 99
TABLE 52 GLOBAL NIPT MARKET BY REGION, COMPANY AND NUMBER OF TESTS,
2015 103
TABLE 53 GERMAN COMPANIES INVOLVED IN NGS-BASED NONINVASIVE PRENATAL
DIAGNOSTICS 104
PREIMPLANTATION GENETICS DIAGNOSIS AND SCREENING INDUSTRY 106
TABLE 54 PREIMPLANTATION DIAGNOSTICS PLATFORMS 107
TABLE 55 PREIMPLANTATION GENETIC SCREENING AND DIAGNOSIS INDUSTRY 108
LIQUID BIOPSY INDUSTRY 111
TABLE 56 COMPANIES IN THE LIQUID BIOPSY INDUSTRY AND THEIR FOCUS 112
IMMUNE SYSTEM PROFILING INDUSTRY 119
TABLE 57 COMPANIES IN THE IMMUNE SYSTEM PROFILING INDUSTRY 120
NEXT-GENERATION SEQUENCING CLINICAL INFORMATICS INDUSTRY 121
TABLE 58 NEXT-GENERATION SEQUENCING CLINICAL INFORMATICS COMPANY
POSITIONING 121
HLA TYPING INDUSTRY 123
TABLE 59 NGS-BASED HLA TYPING INDUSTRY COMPANIES 123
THIRD-GENERATION SEQUENCING INDUSTRY 126
TABLE 60 SUMMARY OF 3GS INDUSTRY 126
DIRECT-TO-CONSUMER GENETIC TESTING INDUSTRY 128
TABLE 61 KEY COMPANIES IN THE DIRECT-TO-CONSUMER GENETIC TESTING
INDUSTRY 129
ACQUISITIONS AND STRATEGIC ALLIANCES 131
SEQUENCING INDUSTRY ACQUISITIONS 132
TABLE 62 SEQUENCING INDUSTRY ACQUISITIONS 2014-2015 132
SEQUENCING INDUSTRY STRATEGIC ALLIANCES 137
TABLE 63 SEQUENCING INDUSTRY STRATEGIC ALLIANCES 2014-2016 137
CHAPTER 8 SEQUENCING MARKETS 159
FORCES DRIVING GROWTH 159
TABLE 64 KEY DRIVERS OF GROWTH FOR THE SEQUENCING INDUSTRY 159
SEQUENCING MARKET SUMMARY 161
TABLE 65 GLOBAL SEQUENCING MARKET BY DELIVERED FORMAT, THROUGH 2020
($ MILLIONS) 162
SEQUENCING INSTRUMENTS AND CONSUMABLES MARKET 164
TABLE 66 GLOBAL MARKET FOR SEQUENCING INSTRUMENTS AND CONSUMABLES
BY PRODUCT TYPE, THROUGH 2020 ($ MILLIONS) 164
SEQUENCING INSTRUMENTS AND CONSUMABLES BY PLATFORM 165
TABLE 67 GLOBAL MARKET FOR SEQUENCING INSTRUMENTS AND CONSUMABLES
BY PLATFORM, THROUGH 2020 ($ MILLIONS) 165
TABLE 68 COMPANIES MIGRATING TO NGS FOR HIV TESTING 167
NGS INSTRUMENTS AND CONSUMABLES BY PLATFORM 168
TABLE 69 GLOBAL MARKET FOR SEQUENCING INSTRUMENTS AND CONSUMABLES
BY SEQUENCER PLATFORM, THROUGH 2020 ($ MILLIONS) 168
SEQUENCING SAMPLE PREP MARKET 169
TABLE 70 GLOBAL SEQUENCING SAMPLE PREP MARKET BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 170
SEQUENCING INFORMATICS MARKET 171
TABLE 71 GLOBAL SEQUENCING INFORMATICS MARKET BY SOFTWARE FUNCTION,
THROUGH 2020 ($ MILLIONS) 171
SEQUENCING SERVICES MARKET 172
TABLE 72 GLOBAL SEQUENCING SERVICES MARKET BY END USER, THROUGH 2020
($ MILLIONS) 172
SEQUENCING SERVICES MARKET BY GENOME TYPE 174
TABLE 73 GLOBAL SEQUENCING SERVICES MARKET BY GENOME TYPE, THROUGH
2020 ($ MILLIONS) 174
APPLIED SEQUENCING SERVICES MARKET 175
TABLE 74 GLOBAL MARKET FOR APPLIED SEQUENCING SERVICES BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 175
Agriculture Sequencing 175
Consumer Sequencing 176
Forensics Sequencing 177
Microbiology Sequencing 178
TABLE 75 GLOBAL AGRICULTURE SEQUENCING SERVICES MARKET BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 179
TABLE 76 SEQUENCING IMPACT ON AGRICULTURAL PRODUCT CLASSES 180
CLINICAL SEQUENCING MARKET 181
TABLE 77 GLOBAL CLINICAL SEQUENCING MARKET BY INDICATION, THROUGH
2020 181
TABLE 78 GLOBAL CLINICAL SEQUENCING MARKET BY TEST COMPLEXITY,
THROUGH 2020 ($ MILLIONS) 183
TABLE 79 GLOBAL CLINICAL SEQUENCING MARKET BY TEST PURPOSE, THROUGH
2020 ($ MILLIONS) 185
CLINICAL SEQUENCING CANCER MARKET 186
TABLE 80 GLOBAL CLINICAL SEQUENCING CANCER MARKET BY INDICATION,
THROUGH 2020 ($ MILLIONS) 186
TABLE 81 GLOBAL CLINICAL SEQUENCING CANCER MARKET BY TEST PURPOSE,
THROUGH 2020 ($ MILLIONS) 189
TABLE 82 SCREENING METHODS FOR EARLY CANCER DETECTION 190
TABLE 83 GLOBAL CLINICAL SEQUENCING CANCER MARKET BY TEST COMPLEXITY,
THROUGH 2020 ($ MILLIONS) 192
REPRODUCTIVE HEALTH MARKET 193
TABLE 84 GLOBAL MARKET FOR REPRODUCTIVE HEALTH SEQUENCING BY TEST
APPLICATION, THROUGH 2020 ($ MILLIONS) 193
NIPT MARKET 194
TABLE 85 GLOBAL NIPT MARKET BY RISK TYPE, THROUGH 2020 ($ MILLIONS) 194
IVF MARKET 196
NEWBORN SCREENING MARKET 197
CARRIER SCREENING MARKET 198
TABLE 86 GLOBAL REPRODUCTIVE HEALTH SEQUENCING MARKET BY TEST
COMPLEXITY, THROUGH 2020 ($ MILLIONS) 198
TRANSPLANT MARKET 199
TABLE 87 GLOBAL TRANSPLANT SEQUENCING MARKET BY TEST PURPOSE,
THROUGH 2020 ($ MILLIONS) 200
TABLE 88 GLOBAL TRANSPLANT SEQUENCING MARKET BY TEST COMPLEXITY,
THROUGH 2020 ($ MILLIONS) 202
TABLE 89 GLOBAL MARKET FOR SEQUENCING TRANSPLANT MONITORING BY
ORGAN TYPE, THROUGH 2020 ($ MILLIONS) 203
TABLE 90 TRANSPLANT PROCEDURES PERFORMED IN THE U.S., 2015 203
MICROBIOLOGY MARKET 205
TABLE 91 GLOBAL MICROBIOLOGY SEQUENCING MARKET BY END USER, THROUGH
2020 ($ MILLIONS) 205
INFORMATICS MARKET 206
TABLE 92 GLOBAL INFORMATICS SEQUENCING MARKET BY SOFTWARE FUNCTION,
THROUGH 2020 ($ MILLIONS) 206
REGIONAL MARKET 207
TABLE 93 GLOBAL SEQUENCING MARKET BY REGION, THROUGH 2020 ($ MILLIONS) 207
TABLE 94 GLOBAL CANCER DIAGNOSTICS MARKET BY REGION, THROUGH 2020 ($
MILLIONS) 210
TABLE 95 GLOBAL MARKET FOR REPRODUCTIVE HEALTH SEQUENCING BY REGION,
THROUGH 2020 ($ MILLIONS) 211
TABLE 96 GLOBAL TRANSPLANT DIAGNOSTICS MARKET BY REGION, THROUGH
2020 ($ MILLIONS) 213
CHAPTER 9 SEQUENCING PATENTS 215
CLINICAL NGS PATENTS 215
TABLE 97 CLINICAL NEXT-GENERATION SEQUENCING PATENTS, 2005-2015 (NO. OF
PATENTS) 215
CLINICAL NGS PATENTS BY INDICATION 215
TABLE 98 CLINICAL NEXT-GENERATION SEQUENCING PATENTS BY INDICATION,
2005-2015 216
CELL-FREE DNA PATENTS 216
TABLE 99 CELL-FREE DNA PATENTS BY REGION, 2005-2015 217
SEQUENCING-RELATED PATENT ISSUES 217
TABLE 100 STATUS OF SEQUENCING-RELATED PATENT DISPUTES 217
CHAPTER 10 COMPANY PROFILES 221
10X GENOMICS 221
23ANDME INC. 221
TABLE 101 23ANDME DATA NEEDS 222
ACCURAGEN 223
ADAPTIVE BIOTECHNOLOGIES INC. 224
ADICON CLINICAL LABORATORIES 225
ADMERA HEALTH 225
AGILENT TECHNOLOGIES INC. 226
ALMAC GROUP LTD. 228
ALTHEA DX 229
AMARANTUS BIOSCIENCE HOLDINGS INC. 229
TABLE 102 MULTIPLE SCLEROSIS DIAGNOSTIC WORKFLOW 230
AMBRY GENETICS 230
ANNOROAD GENE TECHNOLOGY 231
APPISTRY INC. 232
ARCHERDX 232
ARUP LABORATORIES 233
ASTRIDBIO TECHNOLOGIES KFT. 233
ASSUREX HEALTH 234
ASURAGEN INC. 234
ATHENA DIAGNOSTICS INC. 235
ATRECA INC. 236
BASE4 INNOVATION LTD. 236
BAYLOR MIRACA GENETICS LABORATORIES INC. 237
BECTON, DICKINSON AND CO. 237
BECKMAN COULTER 239
BERRY GENOMICS CO. LTD. 239
BGI SHENZHEN 240
BIOCARTIS NV 242
BIOCEPT INC. 242
BIO.LOGIS GMBH 243
BIOINNOVATION SOLUTIONS 244
BIOMATTERS LTD. 245
BIO-RAD LABORATORIES INC. 245
BIOTHERANOSTICS INC. 246
BLUEPRINT GENETICS 246
BOREAL GENOMICS 247
CAMBRIDGE EPIGENETIX LTD. 247
TABLE 103 COMPANIES IN THE EPIGENETIC SEQUENCING INDUSTRY 248
CAREDX INC. 248
CARIS LIFE SCIENCES 248
CEGAT GMBH 249
CELL MICROSYSTEMS INC. 250
CELLULAR RESEARCH INC. 251
CELSEE DIAGNOSTICS 251
CENTOGENE AG 252
CERGENTIS BV 252
CHRONIX BIOMEDICAL 253
CIRCULOGENE THERANOSTICS 253
CLARITAS GENOMICS INC. 254
CLONTECH LABORATORIES INC. 254
COFACTOR GENOMICS INC. 254
COLOR GENOMICS 255
CORIELL LIFE SCIENCES INC. 255
CORRELAGEN DIAGNOSTICS INC. 256
COUNSYL INC. 257
COURTAGEN LIFE SCIENCES INC. 257
CYNVENIO BIOSYSTEMS INC. 258
DANAHER CORP. 258
DARUI BIOTECHNOLOGY CO. LTD. 259
DIAGNOMICS 259
DIAN DIAGNOSTICS 260
DIPLOID 260
DNA ELECTRONICS LTD. 261
DNA LINK INC. 262
DNANEXUS INC. 262
EAGLE GENOMICS LTD. 263
ELECTRONIC BIOSCIENCES 263
EPIC SCIENCES 263
ESPERITE NV 264
EUROFINS GENOMICS 265
EXIQON A/S 266
EXOSOME DIAGNOSTICS INC. 266
EXPRESSION ANALYSIS INC. 268
FOUNDATION MEDICINE 268
FLUXION BIOSCIENCES INC. 269
FULL GENOMES CORP. 270
FUSION GENOMICS CORP. 270
GATC BIOTECH AG 271
GE HEALTHCARE 271
GENAPSYS INC. 272
GENDX BV 272
GENE BY GENE LTD. 273
GENEDX INC. 274
GENEPEEKS INC. 275
GENEWIZ INC. 275
GENOMATIX SOFTWARE GMBH 276
GENOMEDX BIOSCIENCES 276
GENOMIC EXPRESSION 277
GENOMIC HEALTH INC. 277
GENOME PROFILING LLC 278
GENOMNIA SRL 279
GENOMONCOLOGY 279
GENOSPACE 280
GIGAGEN INC. 280
GOOD START GENETICS INC. 281
GOLDEN HELIX 282
GRAIL 283
GUARDANT HEALTH INC. 283
GUARDIOME 284
HELIX OPCO LLC 284
HISTOGENETICS LLC 285
HTG MOLECULAR DIAGNOSTICS INC. 285
HUMAN LONGEVITY INC. 286
ILLUMINA INC. 287
TABLE 104 NEW PLATFORMS INTRODUCED BY ILLUMINA, 2015 287
INTELLIMEDIX 291
INTERPACE DIAGNOSTICS LLC 291
TABLE 105 MOLECULAR THYROID NODULE CLASSIFIER TEST COMPANY
POSITIONING 292
INVITAE 292
INVIVOSCRIBE TECHNOLOGIES INC. 293
IREPERTOIRE INC. 294
KAILOS GENETICS 294
KAPA BIOSYSTEMS INC. 295
KELLBENX INC. 295
KEW GROUP INC. 296
KINGMED DIAGNOSTICS CENTER CO. LTD. 297
LABORATORY CORP. OF AMERICA INC. 297
LABORATORY FOR MOLECULAR MEDICINE 299
LASERGEN INC. 299
LEUCINE RICH BIO 300
LUMENOGIX INC. 300
MACROGEN INC. 301
MAPMYGENOME 301
MAVERIX BIOMICS INC. 302
MAYO MEDICAL LABORATORIES 302
MDX HEALTH INC. 303
MEDGENOME LABS PVT. LTD. 303
MEDOMICS LLC 304
MERCK KGAA 305
MICROSYNTH AG 305
MIINOME INC. 306
MIRATI THERAPEUTICS 306
MOGENE DX 307
MOLECULAR HEALTH GMBH 307
MOLECULARMD CORP. 307
MRIGLOBAL RESEARCH INSTITUTE 308
MULTIPLICOM NV 308
MYRIAD GENETICS INC. 309
NATERA INC. 311
NEOGENOMICS INC. 311
NEW ENGLAND BIOLABS 312
NEWGENE LTD. 313
NEW ONCOLOGY AG 314
N-OF-ONE INC. 314
NOVARTIS AG 315
NOVOGENE BIOINFORMATICS TECHNOLOGY CO. LTD. 317
NUGEN TECHNOLOGIES INC. 317
NXT-DX 318
OMICIA INC. 318
OMIXON BIOCOMPUTING KFT 319
ONCODNA SA 319
ONCOSPIRE GENOMICS 321
ONEOME 321
OXFORD GENE TECHNOLOGY 321
OXFORD NANOPORE TECHNOLOGIES LTD. 322
PACIFIC BIOSCIENCES OF CALIFORNIA INC. 323
PAIRNOMIX INC. 324
PARABASE GENOMICS 325
PARSEQ LAB 325
PATHWAY GENOMICS CORP. 326
PERKINELMER INC. 327
PERSONAL GENOME DIAGNOSTICS INC. 328
PERSONAL GENOMICS INC. 329
PERSONALIS INC. 330
PICOSEQ 331
POPULATION GENETICS TECHNOLOGIES LTD. 331
TABLE 106 SENSITIVITY TO DETECT DRUG-RESISTANT MUTATIONS IN VIRUSES (%) 332
PORTABLE GENOMICS LLC 333
POSITIVE BIOSCIENCE 333
PREMAITHA HEALTH PLC 334
PRENETICS 335
PRESSURE BIOSCIENCES INC. 335
PREVENTIONGENETICS INC. 336
QIAGEN NV 337
QUANTAPORE INC. 339
QUANTUMDX 339
QUEST DIAGNOSTICS 340
RAINDANCE TECHNOLOGIES INC. 340
RARECELLS SAS 342
RARECYTE INC. 342
REAL TIME GENOMICS INC. 342
REPROGENETICS 343
RESOLUTION BIOSCIENCE INC. 343
ROCHE HOLDING AG 344
TABLE 107 COMMERCIAL SEQUENCER COMPETITIVE POSITIONING 345
RUBICON GENOMICS 347
SALVEO DX 348
SCREENCELL 348
SCIGENOM LABS 348
SELAH GENOMICS 349
SENGENICS INTERNATIONAL PTE LTD. 349
SEQUENOM INC. 350
SEVEN BRIDGES GENOMICS INC. 351
SILICON BIOSYSTEMS 352
SISTEMAS GENOMICOS SL 352
SOFTGENETICS LLC 353
SOPHIA GENETICS 353
SPIRAL GENETICS INC. 354
STATION X INC. 354
STRAND LIFE SCIENCES 354
STRATEC BIOMEDICAL AG 355
STRATOS GENOMICS INC. 355
SUNDANCE DIAGNOSTICS INC. 356
SURE GENOMICS INC. 356
SYAPSE INC. 356
SYGNIS AG 357
SYMBIODX 357
SYSMEX INOSTICS GMBH 358
TAI DIAGNOSTICS INC. 358
THERMO FISHER SCIENTIFIC INC. 358
THORNE DIAGNOSTICS INC. 360
TRANSGENOMIC INC. 360
TROVAGENE INC. 361
TUTE GENOMICS INC. 362
TWO PORE GUYS INC. 362
UBIQUITY GENOMICS INC. 363
VELA DIAGNOSTICS 363
WAFERGEN BIO-SYSTEMS INC. 363
TABLE 108 WAFERGEN STRATEGIC ALLIANCES 364
WARP DRIVE BIO LLC 365
XCELL BIOSCIENCES INC. 365
YIKON GENOMICS CO. LTD. 366
ZINXIN PHARMACEUTICAL INDUSTRIAL CO LTD. 366
ZS GENETICS INC. 367
ZYMO RESEARCH CORP. 367

LIST OF TABLES

SUMMARY TABLE GLOBAL SEQUENCING MARKET BY PRODUCT TYPE, THROUGH
2020 ($ MILLIONS) 8
TABLE 1 ARRAY OF WORKFLOW PRODUCTS AND SERVICES 12
TABLE 2 GLOBAL SEQUENCING MARKET BY DELIVERED FORMAT, THROUGH 2020 ($
MILLIONS) 13
TABLE 3 KEY DRIVING FORCES FOR SEQUENCING INDUSTRY GROWTH 15
TABLE 4 LIFE CYCLE OF DNA SEQUENCING TYPES 18
TABLE 5 SUMMARY OF NEXT-GENERATION SEQUENCING INDUSTRY SECTORS 18
TABLE 6 DNA CHEMICAL BUILDING BLOCKS 21
TABLE 7 PROCESS OF DNA TRANSLATION AND TRANSCRIPTION 21
TABLE 8 LONG-RANGE DNA STRUCTURE 22
TABLE 9 DIFFERENT TYPES OF GENETIC VARIANTS 23
TABLE 10 IMPORTANT MOLECULAR DIAGNOSTIC PLATFORMS, BY COMPANY 24
TABLE 11 EVOLUTION OF GENETIC TESTING 25
TABLE 12 KEY NEAR- TO MID-TERM SEGMENTS FOR NEXT-GENERATION
SEQUENCING DIAGNOSTICS 27
TABLE 13 HISTORICAL TIMELINE OF DNA SEQUENCING 28
TABLE 14 SEQUENCING TECHNOLOGY DEVELOPMENT, 1990-2020 34
TABLE 15 COST TO SEQUENCE A SINGLE HUMAN GENOME, 2001-2015 ($) 34
TABLE 16 SANGER SEQUENCING SUMMARY 35
TABLE 17 SANGER SEQUENCING IMPROVEMENTS 36
TABLE 18 NEXT-GENERATION SEQUENCING TECHNOLOGIES 36
TABLE 19 ROCHE NEXT-GENERATION SEQUENCING WORKFLOW STEPS 37
TABLE 20 ILLUMINA NEXT-GENERATION SEQUENCING WORKFLOW STEPS 38
TABLE 21 LIFE TECHNOLOGIES NEXT-GENERATION SEQUENCING WORKFLOW STEPS 39
TABLE 22 BENCHTOP AND HANDHELD SEQUENCER PLATFORMS, 2010-2015 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 45
TABLE 26 KEY CLINICAL NGS PROJECTS 46
TABLE 27 GENOME SEQUENCING PROJECTS, 2005 AND 2015 54
TABLE 28 COMPARISON OF GENETIC ANALYSIS FORMATS 56
TABLE 29 APPLICATIONS OF SEQUENCING ANALYSIS 57
TABLE 30 REQUIREMENTS FOR DE NOVO VS. RESEQUENCING 58
TABLE 31 GENETIC ANALYSIS APPLICATIONS UTILIZING MICROARRAYS OR
SEQUENCING PLATFORMS 62
TABLE 32 COMPARISON OF SEQUENCING WITH MICROARRAYS FOR CHIP
APPLICATIONS 63
TABLE 33 COMPARISON OF SEQUENCING AND MICROARRAYS FOR GENE
EXPRESSION ANALYSIS 64
TABLE 34 COMPARISON OF GENETIC ANALYSIS PLATFORMS 69
TABLE 35 IMPACT OF SEQUENCING ON AGRICULTURAL PRODUCT CLASSES 71
TABLE 36 KEY APPLICATIONS IN MICROBIAL SEQUENCING 72
TABLE 37 KEY APPLICATIONS IN FORENSICS/HUMAN IDENTITY SEQUENCING 73
TABLE 38 CLINICAL NEXT-GENERATION SEQUENCING, NEAR-TO MID-TERM
APPLICATIONS 76
TABLE 39 MAJOR CANCER APPLICATIONS FOR NGS DIAGNOSTICS 77
TABLE 40 MENDELIAN DISORDERS APPLICATION 80
TABLE 41 SCREENING APPLICATIONS 81
TABLE 42 ETHICAL ISSUES ASSOCIATED WITH PRENATAL AND NEWBORN
SCREENING 83
TABLE 43 INFECTIOUS DISEASE APPLICATIONS 84
TABLE 44 COMPLEX DISORDERS APPLICATIONS 87
TABLE 45 KEY SEGMENTS AND TRENDS IN THE SEQUENCING INDUSTRY 90
TABLE 46 NEXT-GENERATION SEQUENCING INSTRUMENT COMPANIES 91
TABLE 47 ADVANTAGES OF DROPLET DIGITAL PCR 95
TABLE 48 DROPLET DIGITAL PCR INDUSTRY 95
TABLE 49 TARGET ENRICHMENT INDUSTRY 96
TABLE 50 SPECIALIZED DNA POLYMERASE INDUSTRY 98
TABLE 51 KEY COMPANIES IN THE NGS NIPT INDUSTRY 99
TABLE 52 GLOBAL NIPT MARKET BY REGION, COMPANY AND NUMBER OF TESTS,
2015 103
TABLE 53 GERMAN COMPANIES INVOLVED IN NGS-BASED NONINVASIVE PRENATAL
DIAGNOSTICS 104
TABLE 54 PREIMPLANTATION DIAGNOSTICS PLATFORMS 107
TABLE 55 PREIMPLANTATION GENETIC SCREENING AND DIAGNOSIS INDUSTRY 108
TABLE 56 COMPANIES IN THE LIQUID BIOPSY INDUSTRY AND THEIR FOCUS 112
TABLE 57 COMPANIES IN THE IMMUNE SYSTEM PROFILING INDUSTRY 120
TABLE 58 NEXT-GENERATION SEQUENCING CLINICAL INFORMATICS COMPANY
POSITIONING 121
TABLE 59 NGS-BASED HLA TYPING INDUSTRY COMPANIES 123
TABLE 60 SUMMARY OF 3GS INDUSTRY 126
TABLE 61 KEY COMPANIES IN THE DIRECT-TO-CONSUMER GENETIC TESTING
INDUSTRY 129
TABLE 62 SEQUENCING INDUSTRY ACQUISITIONS 2014-2015 132
TABLE 63 SEQUENCING INDUSTRY STRATEGIC ALLIANCES 2014-2016 137
TABLE 64 KEY DRIVERS OF GROWTH FOR THE SEQUENCING INDUSTRY 159
TABLE 65 GLOBAL SEQUENCING MARKET BY DELIVERED FORMAT, THROUGH 2020
($ MILLIONS) 162
TABLE 66 GLOBAL MARKET FOR SEQUENCING INSTRUMENTS AND CONSUMABLES
BY PRODUCT TYPE, THROUGH 2020 ($ MILLIONS) 164
TABLE 67 GLOBAL MARKET FOR SEQUENCING INSTRUMENTS AND CONSUMABLES
BY PLATFORM, THROUGH 2020 ($ MILLIONS) 165
TABLE 68 COMPANIES MIGRATING TO NGS FOR HIV TESTING 167
TABLE 69 GLOBAL MARKET FOR SEQUENCING INSTRUMENTS AND CONSUMABLES
BY SEQUENCER PLATFORM, THROUGH 2020 ($ MILLIONS) 168
TABLE 70 GLOBAL SEQUENCING SAMPLE PREP MARKET BY APPLICATION, THROUGH
2020 ($ MILLIONS) 170
TABLE 71 GLOBAL SEQUENCING INFORMATICS MARKET BY SOFTWARE FUNCTION,
THROUGH 2020 ($ MILLIONS) 171
TABLE 72 GLOBAL SEQUENCING SERVICES MARKET BY END USER, THROUGH 2020
($ MILLIONS) 172
TABLE 73 GLOBAL SEQUENCING SERVICES MARKET BY GENOME TYPE, THROUGH
2020 ($ MILLIONS) 174
TABLE 74 GLOBAL MARKET FOR APPLIED SEQUENCING SERVICES BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 175
TABLE 75 GLOBAL AGRICULTURE SEQUENCING SERVICES MARKET BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 179
TABLE 76 SEQUENCING IMPACT ON AGRICULTURAL PRODUCT CLASSES 180
TABLE 77 GLOBAL CLINICAL SEQUENCING MARKET BY INDICATION, THROUGH 2020 181
TABLE 78 GLOBAL CLINICAL SEQUENCING MARKET BY TEST COMPLEXITY, THROUGH
2020 ($ MILLIONS) 183
TABLE 79 GLOBAL CLINICAL SEQUENCING MARKET BY TEST PURPOSE, THROUGH
2020 ($ MILLIONS) 185
TABLE 80 GLOBAL CLINICAL SEQUENCING CANCER MARKET BY INDICATION,
THROUGH 2020 ($ MILLIONS) 186
TABLE 81 GLOBAL CLINICAL SEQUENCING CANCER MARKET BY TEST PURPOSE,
THROUGH 2020 ($ MILLIONS) 189
TABLE 82 SCREENING METHODS FOR EARLY CANCER DETECTION 190
TABLE 83 GLOBAL CLINICAL SEQUENCING CANCER MARKET BY TEST COMPLEXITY,
THROUGH 2020 ($ MILLIONS) 192
TABLE 84 GLOBAL MARKET FOR REPRODUCTIVE HEALTH SEQUENCING BY TEST
APPLICATION, THROUGH 2020 ($ MILLIONS) 193
TABLE 85 GLOBAL NIPT MARKET BY RISK TYPE, THROUGH 2020 ($ MILLIONS) 194
TABLE 86 GLOBAL REPRODUCTIVE HEALTH SEQUENCING MARKET BY TEST
COMPLEXITY, THROUGH 2020 ($ MILLIONS) 198
TABLE 87 GLOBAL TRANSPLANT SEQUENCING MARKET BY TEST PURPOSE,
THROUGH 2020 ($ MILLIONS) 200
TABLE 88 GLOBAL TRANSPLANT SEQUENCING MARKET BY TEST COMPLEXITY,
THROUGH 2020 ($ MILLIONS) 202
TABLE 89 GLOBAL MARKET FOR SEQUENCING TRANSPLANT MONITORING BY ORGAN
TYPE, THROUGH 2020 ($ MILLIONS) 203
TABLE 90 TRANSPLANT PROCEDURES PERFORMED IN THE U.S., 2015 203
TABLE 91 GLOBAL MICROBIOLOGY SEQUENCING MARKET BY END USER, THROUGH
2020 ($ MILLIONS) 205
TABLE 92 GLOBAL INFORMATICS SEQUENCING MARKET BY SOFTWARE FUNCTION,
THROUGH 2020 ($ MILLIONS) 206
TABLE 93 GLOBAL SEQUENCING MARKET BY REGION, THROUGH 2020 ($ MILLIONS) 207
TABLE 94 GLOBAL CANCER DIAGNOSTICS MARKET BY REGION, THROUGH 2020 ($
MILLIONS) 210
TABLE 95 GLOBAL MARKET FOR REPRODUCTIVE HEALTH SEQUENCING BY REGION,
THROUGH 2020 ($ MILLIONS) 211
TABLE 96 GLOBAL TRANSPLANT DIAGNOSTICS MARKET BY REGION, THROUGH 2020
($ MILLIONS) 213
TABLE 97 CLINICAL NEXT-GENERATION SEQUENCING PATENTS, 2005-2015 (NO. OF
PATENTS) 215
TABLE 98 CLINICAL NEXT-GENERATION SEQUENCING PATENTS BY INDICATION,
2005-2015 216
TABLE 99 CELL-FREE DNA PATENTS BY REGION, 2005-2015 217
TABLE 100 STATUS OF SEQUENCING-RELATED PATENT DISPUTES 217
TABLE 101 23ANDME DATA NEEDS 222
TABLE 102 MULTIPLE SCLEROSIS DIAGNOSTIC WORKFLOW 230
TABLE 103 COMPANIES IN THE EPIGENETIC SEQUENCING INDUSTRY 248
TABLE 104 NEW PLATFORMS INTRODUCED BY ILLUMINA, 2015 287
TABLE 105 MOLECULAR THYROID NODULE CLASSIFIER TEST COMPANY POSITIONING 292
TABLE 106 SENSITIVITY TO DETECT DRUG-RESISTANT MUTATIONS IN VIRUSES (%) 332
TABLE 107 COMMERCIAL SEQUENCER COMPETITIVE POSITIONING 345
TABLE 108 WAFERGEN STRATEGIC ALLIANCES 364

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