1. Market Research
  2. > Diagnostics Market Trends
  3. > Molecular Diagnostics: Technologies and Global Markets

Molecular Diagnostics: Technologies and Global Markets

  • June 2015
  • -
  • BCC Research
  • -
  • 179 pages

BCC Research’s goal in conducting this study is to determine the current status of the DNA diagnostics industry and to assess its growth potential over a five-year period from 2015 to 2020.

Use this report to:
- Receive comprehensive analysis of the current molecular diagnostics market and its future direction.
- Analyze developments and their impact on the DNA diagnostics business.
- Evaluate scientific challenges and advances including the latest trends in molecular diagnostics market.

Highlights
- The global molecular diagnostics market was valued at almost $21.7 billion in 2014. The total market is projected to grow at a compound annual growth rate (CAGR) of 12.5% from 2015 through 2020 to reach nearly $25.2 billion by 2015 and $45.2 billion by 2020.
- The market for polymerase chain reaction (PCR)-based diagnostic assays totaled nearly $10.1 billion in 2014. This market is projected to grow at a CAGR of 11.1% from 2015 to 2020, to reach nearly $11.5 billion by 2015 and $19.4 billion by 2020.
- The biochip or lab-on-a-chip market totaled nearly $2.5 billion in 2014. It is projected to increase at a CAGR of 16.5% to reach $3 billion by 2015 and nearly $6.5 billion by 2020.

Introduction & Scope

INTRODUCTION

STUDY GOALS AND OBJECTIVES
BCC Research’s goal in conducting this study is to determine the current status of the DNA diagnostics industry and to assess its growth potential over a five-year period
from 2015 to 2020. We are particularly interested in the markets for DNA microarrays, polymerase chain reaction (PCR)-based assays, fluorescent in situ hybridization and
biochips. In addition, we are interested in the market for DNA assays for specific clinical applications. For each we examine the technology, development process, market penetration and projected market for each diagnostic assay through 2020. Our key objective is to present a comprehensive analysis of the current market and its
future direction.

REASONS FOR DOING THE STUDY
DNA-based assays continue to move from research settings into the clinic; therefore, they represent one of the fastest-growing segments of diagnostics. We are interested
in the innovations in microarrays, PCR assays, biochips and other common technologies for DNA detection as they are modified for routine clinical use. As nucleic
acid testing becomes routine, a number of related issues have come to the fore, including government regulation, reimbursement through insurance, and patient confidentiality and other legal ramifications. These developments and their impact on the DNA diagnostics business are also covered in this report.

SCOPE OF REPORT
This study examines the global market for assays used to detect specific nucleic acid sequences in medical and life sciences applications. While the goal of all DNA-based
diagnostic assays is similar, several different technologies can be employed. BCC Research analyzes each technology in detail, determines major players and current
market status and presents forecasts of growth over the next five years. Scientific challenges and advances including the latest trends are emphasized. We examine
government regulations, major collaborations, recent patents and factors affecting the industry globally. In addition, we examine new directions for DNA diagnostic
technologies and emerging applications in clinical diagnostics.

INTENDED AUDIENCE
This study will be of interest to technology and business professionals in the pharmaceutical, healthcare, genomics and biotechnology industries. Business development professionals, market analysts, consultants and investors working in medical biotechnology will also find this report valuable.

METHODOLOGY AND INFORMATION SOURCES
The market assessments provided have been assembled based on publicly available information up to and including April 2015. The base year for this report is 2010 and
forecast data are provided through 2020. Market figures are based on current dollars, and inflation is not computed into the projection figures. The information contained in
this report has been assembled from both primary and secondary data sources. Primary research was conducted via telephone interviews with industry professionals,
research scientists, physician-researchers and laboratory heads to discover the most recent developments in their fields of interest. Secondary data were collected via a
comprehensive search of the peer-reviewed scientific literature, clinical trial reports and databases, industry trade media, company websites, annual reports and industry
press releases.

Table Of Contents

Molecular Diagnostics: Technologies and Global Markets
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
SCOPE OF REPORT 2
INTENDED AUDIENCE 2
METHODOLOGY AND INFORMATION SOURCES 3
ANALYST'S CREDENTIALS 3
RELATED BCC RESEARCH REPORTS 3
BCC RESEARCH WEBSITE 4
DISCLAIMER 4
CHAPTER 2 SUMMARY 6
FORECASTS 6
SUMMARY TABLE GLOBAL MARKET FOR MOLECULAR DIAGNOSTICS BY
TECHNOLOGY, THROUGH 2020 ($ MILLIONS) 6
SUMMARY FIGURE GLOBAL MARKET FOR MOLECULAR DIAGNOSTICS BY
TECHNOLOGY, 2012-2020 ($ MILLIONS) 6
VENDORS 7
CHAPTER 3 OVERVIEW 9
OVERVIEW 9
INTRODUCTION TO GENOMIC DIAGNOSTICS 9
EXPRESSION PROFILING AND DISEASE 11
EXPRESSION PROFILING AND INFECTIOUS DISEASE 12
DNA SEQUENCING FOR GENOTYPING AND DIAGNOSIS 12
CLINICAL PHARMACOLOGY 13
MUTATION DETECTION AND GENOTYPING FOR SPECIFIC GENES 13
IDENTIFICATION OF NEW DISEASE GENES 13
CHAPTER 4 REGULATIONS AND FINANCE 15
OVERVIEW 15
INSURANCE 15
FOOD AND DRUG ADMINISTRATION GUIDELINES 16
INTERNAL STANDARDS FOR DNA DIAGNOSTICS 17
TABLE 1 MINIMUM INFORMATION ABOUT A MICROARRAY EXPERIMENT - MIAME 2.0 18
TABLE 2 MICROARRAY QUALITY CONTROL (MAQC) PROJECT 19
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) 20
TABLE 3 U.S. LABORATORIES CLIA-CERTIFIED FOR MOLECULAR DIAGNOSTICS AND
NUMBER OF DISEASE TESTS, 2012 21
FIGURE 1 GROWTH IN CLINICAL LABORATORY SITES AND DISEASE TESTING,
1993-2015 21
TABLE 4 GENETIC TESTING PROCEDURES PERFORMED IN U.S. BY TYPE, 2015 22
PERSONALIZED MEDICINES AND COMPANION DIAGNOSTICS 23
FDA GUIDELINES FOR IN VITRO COMPANION DIAGNOSTICS 24
Definition and Use of an IVD Companion Diagnostic Device 24
Review and Approval of IVD Companion Diagnostic Devices and
Therapeutic Products 25
Novel Therapeutic Products 25
Approval of a Therapeutic Product without an Approved IVD
Companion Diagnostic Device 25
General Policies 26
FDA-APPROVED COMPANION DIAGNOSTICS 27
TABLE 5 FDA-APPROVED IN VITRO COMPANION DIAGNOSTIC DEVICES AS OF DEC.
23, 2014 28
TABLE 6 FDA-APPROVED IN VITRO COMPANION DIAGNOSTIC DEVICES, AS OF
DECEMBER 2012 34
PHARMACOGENOMICS RESEARCH NETWORK 42
TABLE 7 CURRENT PGRN-RIKEN CGM COLLABORATIVE STUDIES 43
CHAPTER 5 COMMERCIAL MARKET TRENDS 50
MARKET CONDITIONS 50
HEALTHCARE, HOSPITALS, DOCTORS, GREATER REGULATION AND NEED
FOR INSURANCE REIMBURSEMENT 50
NEW REQUIREMENTS FOR SUCCESS 50
SALES AND MARKETING 50
MEDICAL AFFAIRS 51
REGULATORY COMPLIANCE 51
REIMBURSEMENT 51
ALLIANCES AND MERGERS 52
TABLE 8 DIAGNOSTICS MANUFACTURER MERGERS AND ACQUISITIONS, 2004-2014 52
CHAPTER 6 MARKET FOR MOLECULAR DIAGNOSTICS BY TECHNOLOGY 56
OVERVIEW 56
DESCRIPTION 56
REVENUES AND FORECASTS 57
TABLE 9 GLOBAL MARKET FOR MOLECULAR DIAGNOSTICS BY TECHNOLOGY,
THROUGH 2020 ($ MILLIONS) 57
TABLE 10 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
TECHNOLOGY, 2015 (%) 57
FIGURE 2 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
TECHNOLOGY, 2015 (%) 57
MANUFACTURERS 58
TABLE 11 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
MANUFACTURER, 2015 (%) 59
FIGURE 3 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
MANUFACTURER, 2015 (%) 59
MICROARRAY 60
DESCRIPTION 60
Planar 60
Bead 60
REVENUES AND FORECASTS 61
TABLE 12 GLOBAL MICROARRAY MARKET FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 61
TABLE 13 GLOBAL MICROARRAY MARKET SHARE FOR MOLECULAR DIAGNOSTICS
BY APPLICATION, 2015 (%) 62
FIGURE 4 GLOBAL MICROARRAY MARKET SHARE FOR MOLECULAR DIAGNOSTICS
BY APPLICATION, 2015 (%) 62
MANUFACTURERS AND PRODUCTS 63
Planar 63
TABLE 14 MAJOR SUPPLIERS OF PLANAR DNA MICROARRAYS 63
Bead 64
TABLE 15 MAJOR SUPPLIERS OF BEAD MICROARRAYS 64
PCR 64
DESCRIPTION 64
REVENUES AND FORECASTS 65
TABLE 16 GLOBAL PCR MARKET FOR MOLECULAR DIAGNOSTICS BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 65
TABLE 17 GLOBAL PCR MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 66
FIGURE 5 GLOBAL PCR MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 66
MANUFACTURERS AND PRODUCTS 66
TABLE 18 GLOBAL PCR MARKET SHARE BY MANUFACTURER, 2015 (%) 67
IN SITU HYBRIDIZATION (ISH) 67
DESCRIPTION 67
Labeling Techniques 68
Applications of In Situ Hybridization 68
FIBER FISH 69
HER2 FISH TESTING 70
REVENUES AND FORECASTS 71
TABLE 19 GLOBAL ISH MARKET FOR MOLECULAR DIAGNOSTICS BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 71
TABLE 20 GLOBAL ISH MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 72
FIGURE 6 GLOBAL ISH MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 72
LAB-ON-A-CHIP/BIOCHIPS 72
DESCRIPTION 72
Microfluidic Devices 74
PRODUCT DEVELOPMENT 75
REVENUES AND FORECASTS 76
TABLE 21 GLOBAL LAB-ON-A-CHIP/BIOCHIP MARKET FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, THROUGH 2020 ($ MILLIONS) 76
TABLE 22 GLOBAL LAB-ON-A-CHIP/BIOCHIP MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 76
FIGURE 7 GLOBAL LAB-ON-A-CHIP/BIOCHIP MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 77
EMERGING AND OTHER DIAGNOSTIC TECHNOLOGIES 77
DESCRIPTION 77
The Trend toward Single-Cell Measurements 78
Genetic Typing of Single Cells 78
Single-Cell Sequencing 78
Copy Number Variations in Single Cells 78
Combined Immunotyping and Single-Cell Expression Analysis 78
Diagnosing the Epigenome 79
REVENUES AND FORECASTS 79
TABLE 23 GLOBAL EMERGING/OTHER MOLECULAR DIAGNOSTICS MARKET BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 79
TABLE 24 GLOBAL EMERGING/OTHER MOLECULAR DIAGNOSTICS MARKET SHARE
BY APPLICATION, 2015 (%) 80
CHAPTER 7 MARKETS FOR MOLECULAR DIAGNOSTICS BY APPLICATION AND
PRODUCTS 82
OVERVIEW 82
DESCRIPTION 82
REVENUES AND FORECASTS 82
TABLE 25 GLOBAL MARKET FOR MOLECULAR DIAGNOSTICS BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 82
TABLE 26 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 83
FIGURE 8 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 83
PRE-/POSTNATAL GENETIC SCREENING 84
DESCRIPTION 84
Carrier Screening 84
Prenatal Diagnostic Testing 85
Amniocentesis 85
Chorionic Villus Sampling 85
Genetic Counseling 86
Preimplantation Diagnosis 87
Newborn Screening 87
REVENUES AND FORECASTS 88
TABLE 27 GLOBAL PRE/POSTNATAL SCREENING MARKET FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, THROUGH 2020 ($ MILLIONS) 88
TABLE 28 GLOBAL PRE/POSTNATAL SCREENING MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 88
FIGURE 9 GLOBAL PRE/POSTNATAL SCREENING MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 88
INFECTIOUS DISEASE DIAGNOSTICS 89
DESCRIPTION 89
REVENUES AND FORECASTS 90
TABLE 29 GLOBAL INFECTIOUS DISEASES MARKET FOR MOLECULAR DIAGNOSTICS
BY APPLICATION, THROUGH 2020 ($ MILLIONS) 91
TABLE 30 GLOBAL INFECTIOUS DISEASE SCREENING MARKET SHARE FOR
MOLECULAR DIAGNOSTICS BY APPLICATION, 2015 (%) 91
FIGURE 10 GLOBAL INFECTIOUS DISEASE SCREENIN MARKET SHARE FOR
MOLECULAR DIAGNOSTICS BY APPLICATION, 2015 (%) 91
ONCOLOGY DIAGNOSTICS 92
DESCRIPTION 92
Leukemias 92
Chronic Myeloid Leukemia 93
Genetic Marker of Chronic Myeloid Leukemia 93
REVENUES AND FORECASTS 94
TABLE 31 GLOBAL ONCOLOGY MARKET FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 94
TABLE 32 GLOBAL ONCOLOGY MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 95
FIGURE 11 GLOBAL ONCOLOGY MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 95
IDENTITY DIAGNOSTICS, FORENSICS AND PATERNITY 95
DESCRIPTION 95
Paternity Testing 96
Technology 96
Accreditation 96
Legal Issues 96
Veterinary Identity Testing 97
REVENUES AND FORECASTS 97
TABLE 33 GLOBAL IDENTITY TESTING MARKET FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 98
TABLE 34 GLOBAL IDENTITY TESTING MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 98
FIGURE 12 GLOBAL IDENTITY TESTING MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 98
PHARMACOGENOMICS/OTHER APPLICATIONS 99
DESCRIPTION 99
REVENUES AND FORECASTS 102
TABLE 35 GLOBAL PHARMACOGENOMICS AND OTHER MARKET FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, THROUGH 2020 ($ MILLIONS) 103
TABLE 36 GLOBAL PHARMACOGENOMICS AND OTHER MARKET SHARE FOR
MOLECULAR DIAGNOSTICS BY APPLICATION, 2015 (%) 103
CHAPTER 8 PATENT ANALYSIS 105
PCR 105
TABLE 37 SELECTED PCR PATENTS GRANTED FROM JANUARY 2013 TO JANUARY
2015 105
REAL TIME PCR DETECTION OF RESPIRATORY SYNCYTIAL VIRUS 107
NUCLEIC ACID AMPLIFICATION PRIMERS FOR PCR-BASED CLONALITY STUDIES 107
QUANTITATIVE MULTIPLEX METHYLATION SPECIFIC PCR METHOD- CMETHDNA,
REAGENTS, AND ITS USE 107
REAL-TIME PCR DETECTION OF STREPTOCOCCUS PYOGENES 108
REAL-TIME PCR FOR THE DETECTION OF PATHOGENS 108
QUANTITATIVE MULTIPLEX METHYLATION-SPECIFIC PCR 109
REAL-TIME PCR DETECTION OF MYCOBACTERIUM TUBERCULOSIS COMPLEX 109
REAL TIME PCR DETECTION OF M. TUBERCULOSIS RESISTANT/SUSCEPTIBLE TO
RIFAMPICIN AND/OR ISONIAZID 109
ABSOLUTE PCR QUANTIFICATION 110
COMPOSITIONS AND METHOD FOR MEASURING AND CALIBRATING
AMPLIFICATION BIAS IN MULTIPLEXED PCR REACTIONS 110
REAL-TIME PCR DETECTION OF SEASONAL INFLUENZA H1, H3 AND B SUBTYPES 110
MULTIMODAL PCR TARGET DETECTION 111
COMPOSITION TO OVERCOME INHIBITORS IN PCR AND GROWTH CULTURES 111
MAGNETIC IMMUNO DIGITAL PCR ASSAY 111
CUTOFF POINT DELTA CT. METHOD FOR HER2 PCR TESTING IN BREAST CANCER 112
METHODS AND COMPOSITIONS FOR PCR USING BLOCKED AND UNIVERSAL
PRIMERS 112
PCR ASSAYS AND REAGENTS FOR MOLECULAR DETECTION OF INFECTIOUS
AGENTS 112
RANDOM HOMOZYGOUS GENE PERTURBATION (RHGP) WITH THERMAL
ASSYMETRIC INTERLACED (TAIL)-PCR 113
MICRO RNA-BASED METHODS AND COMPOSITIONS FOR THE DIAGNOSIS,
PROGNOSIS AND TREATMENT OF OVARIAN CANCER USING A REAL-TIME PCR
PLATFORM
113
PCR METHODS FOR CHARACTERIZING THE 5' UNTRANSLATED REGION OF THE
FMR1 AND FMR2 GENES 114
MULTIPLEX PCR-BASED TESTING OF CUTANEOUS SQUAMOUS CELL CARCINOMA
AND PSEUDOEPITHELIOMATOUS HYPERPLASIA AND METHODS FOR
DISTINGUISHING THE SAME
114
IDENTIFICATION OF ANTIGEN-SPECIFIC ADAPTIVE IMMUNE RESPONSES USING
ARM-PCR AND HIGH-THROUGHPUT SEQUENCING 114
QUANTITATIVE MULTIPLEX METHYLATION-SPECIFIC PCR 115
PCR DIAGNOSTICS OF DERMATOPHYTES AND OTHER PATHOGENIC FUNGI 115
HIGHLY MULTIPLEX PCR METHODS AND COMPOSITIONS 115
SINGLE TUBE QUANTITATIVE POLYMERASE CHAIN REACTION (PCR) 116
HIGHLY MULTIPLEX PCR METHODS AND COMPOSITIONS 116
IDENTIFICATION OF LINKAGE USING MULTIPLEX DIGITAL PCR 116
METHODS AND COMPOSITIONS TO ENABLE MULTIPLEX COLD-PCR 117
METHODS OF DIAGNOSING DISEASE USING OVERLAP EXTENSION PCR 117
HOT-START DIGITAL PCR 117
METHOD FOR DETECTION, DIFFERENTIATION AND QUANTIFICATION OF T CELL
POPULATIONS BY WAY OF REVERSE TRANSCRIPTION QUANTITATIVE REAL TIME
PCR (RT-QPCR) TECHNOLOGY
118
NDM-1 POLYMERASE CHAIN REACTION (PCR) ASSAY 118
DETECTION OF MICRO METASTASIS OF MELANOMA AND BREAST CANCER IN
PARAFFIN-EMBEDDED TUMOR DRAINING LYMPH NODES BY MULTIMARKER
QUANTITATIVE RT-PCR
118
LATE-PCR 119
HEMOMOSAIC: HIGH-THROUGHPUT TECHNIQUE FOR RARE CELL DETECTION IN
LIQUID SAMPLES BY MASSIVELY MULTIPLEXED PCR IN A PHOTOLITHOGRAPHIC
MATRIX
119
SERIAL QUANTITATIVE PCR ASSAY FOR DETECTION, SPECIES-DISCRIMINATION
AND QUANTIFICATION OF LEISHMANIA SPP. IN HUMAN SAMPLES 120
GENE DETECTING METHODS WITHOUT USING PCR 120
HIGHLY MULTIPLEX PCR METHODS AND COMPOSITIONS 120
PROCESS FOR DETECTION OF MULTIDRUG RESISTANT TUBERCULOSIS USING
REAL-TIME PCR AND HIGH RESOLUTION MELT ANALYSIS 121
ISOFORMS OF THE HUMAN SST5 RECEPTOR ORIGINATED BY ALTERNATIVE
SPLICING AND OLIGONUCLEOTIDE PAIRS TO DETECT THEM BY PCR 121
REAL TIME PCR ASSAY FOR DETECTION OF BACTERIAL RESPIRATORY
PATHOGENS 121
METHODS AND COMPOSITIONS RELATED TO CONTINUOUS FLOW THERMAL
GRADIENT PCR 122
METHOD FOR DETECTING MORE THAN ONE TARGET IN A PCR-BASED
APPROACH APPLYING AN UN-SPECIFIC DYE WHICH IS NOT INTERFERING WITH
THE EMISSION OF FLUOROPHORE-LABELED PROBES
122
MICROARRAY 123
TABLE 38 SELECTED MICROARRAY PATENTS GRANTED, JANUARY 2013 TO MAY
2015 123
METHODS AND SYSTEMS FOR MANUFACTURE OF MICROARRAY ASSAY SYSTEMS,
CONDUCTING MICROFLUIDIC ASSAYS, AND MONITORING AND SCANNING TO
OBTAIN MICROFLUIDIC ASSAY RESULTS
124
SYMMETRICALLY BRANCHED POLYMER CONJUGATES AND MICROARRAY ASSAYS 124
TWO-DIMENSIONAL PHOTONIC CRYSTAL MICROARRAY MEASUREMENT METHOD
AND APPARATUS FOR HIGHLY-SENSITIVE LABEL-FREE MULTIPLE ANALYTE
SENSING, BIOSENSING, AND DIAGNOSTIC ASSAY
124
SOURCE CONTROLLED DECODABLE MICROARRAY SYSTEM AND METHODS FOR
USE 125
MICROARRAY BASED SAMPLE DETECTION SYSTEM 125
MICROARRAY FABRICATION SYSTEM AND METHOD 125
MICROARRAY FOR DETECTING VIABLE ORGANISMS 126
SERUM-BASED MIRNA MICROARRAY AND ITS USE IN DIAGNOSIS AND
TREATMENT OF BARRETT'S ESOPHAGUS (BE) AND ESOPHAGEAL
ADENOCARCINOMA (EAC)
126
LUMINOPHORE-LABELED MOLECULES COUPLED WITH PARTICLES FOR
MICROARRAY-BASED ASSAYS 126
Y-SHAPED PROBE AND VARIANT THEREOF, AND DNA MICROARRAY, KIT AND
GENETIC ANALYSIS METHOD USING THE SAME 127
MICROARRAY-BASED ASSAY INTEGRATED WITH PARTICLES FOR ANALYZING
MOLECULAR INTERACTIONS 127
MICROARRAY FABRICATION SYSTEM AND METHOD 128
ALLERGEN MICROARRAY 128
PHOTONIC CRYSTAL MICROARRAY LAYOUTS FOR ENHANCED SENSITIVITY AND
SPECIFICITY OF LABEL-FREE MULTIPLE ANALYTE SENSING, BIOSENSING AND
DIAGNOSTIC ASSAY
128
ISH 129
TABLE 39 SELECTED ISH PATENTS GRANTED, JANUARY 2013 TO MAY 2015 129
CELL PREPARATIONS AND CELL SUPPORTS AND THEIR USE IN THERANOSIS 129
ULTRA SENSITIVE METHOD FOR IN SITU DETECTION OF NUCLEIC ACIDS 129
BACH2 REPRESSION IN CELLS 130
IN SITU HYBRIDIZATION METHOD AND BUFFER 130
BIOCHIP 131
TABLE 40 SELECTED BIOCHIP PATENTS GRANTED, JANUARY 2013 TO MAY 2015 131
BIOCHIP AND TARGET DNA QUANTITATIVE METHOD 131
UNITARY BIOCHIP PROVIDING SAMPLE-IN TO RESULTS-OUT PROCESSING AND
METHODS OF MANUFACTURE 132
BIOCHIP AND FABRICATION THEREOF 132
UNITARY BIOCHIP PROVIDING SAMPLE-IN TO RESULTS-OUT PROCESSING AND
METHODS OF MANUFACTURE 132
BIOCHIP ASSEMBLY AND ASSAY METHOD THEREOF 133
BIOCHIP 133
CHAPTER 9 COMPANY PROFILES 135
ABBOTT MOLECULAR 135
PRODUCT CATEGORIES 136
PARTNERSHIPS 136
ADVANDX INC. 136
AFFYMETRIX INC. 137
PRODUCTS 138
Agrigenomics Genotyping Solutions 138
Chromogenic RNA in situ Hybridization 138
Fluorescence RNA in situ Hybridization 139
AGILENT TECHNOLOGIES INC. 139
PRODUCTS 140
PCR/qPCR 140
AUTOGENOMICS INC. 142
PRODUCTS 143
BECKMAN COULTER INC. (OWNED BY DANAHER) 143
PRODUCTS 144
Pipeline 144
BECTON DICKINSON AND COMPANY 144
BIOMERIEUX SA 145
PRODUCTS 147
Argene Molecular Biology Range 147
BIO-RAD LABORATORIES 148
LIFE SCIENCE RESEARCH 148
CLINICAL DIAGNOSTICS 149
PRODUCTS 149
Amplification/PCR 149
Digital PCR 149
PrimePCR Assays and Panels 149
Real-Time PCR Detection Systems 149
Thermal Cyclers 149
PX1 PCR Plate Sealer 149
PCR Reagents 150
PCR Plastic Consumables 150
Amplification Software 150
Nucleic Acid Sample Preparation and Purification 150
CALIPER LIFE SCIENCES INC. 150
PRODUCTS 151
Microfluidics, Laboratory Automation and Liquid Handling 151
THE CARLYLE GROUP 151
CEPHEID 152
PRODUCTS 153
CURAGEN CORP. (ACQUIRED BY CELLDEX) 154
DECODE GENETICS 154
PRODUCTS AND SERVICES 155
DNA DIAGNOSTICS CENTER 155
SERVICES 155
ELITECH GROUP 157
EMD MILLIPORE 157
PRODUCTS 158
EUROGENTEC (OWNED BY KANEKA CORP.) 158
PRODUCTS 159
SERVICES 159
EXACT SCIENCES CORP. 160
GE HEALTHCARE 160
HOLOGIC INC. 161
PRODUCTS 162
HTG MOLECULAR DIAGNOSTICS 163
SERVICES 164
PRODUCTS 164
ILLUMINA 164
PRODUCTS 165
LABORATORY CORP. OF AMERICA (LABCORP) 165
LIFE TECHNOLOGIES 166
PRODUCTS 166
LUMINEX CORP 167
PRODUCTS 167
xMAP technology 167
xTAG Technology 168
MultiCode Technology 168
MICRONICS INC. 168
PRODUCTS 169
MYRIAD GENETICS 169
PRODUCTS 170
PRODUCTS IN DEVELOPMENT 171
NOVARTIS MOLECULAR DIAGNOSTICS 171
PRODUCTS 172
Development Strategy 172
Novartis Diagnostics Division Products 172
OXFORD GENE TECHNOLOGY IP LTD. 173
PRODUCTS 173
PATHOGENETIX 174
PROMEGA 175
QIAGEN N.V. 176
PRODUCTS 176
COMPANION DIAGNOSTICS 177
QUEST DIAGNOSTICS 178
PRODUCTS 178
IN DEVELOPMENT 178
ROCHE 179
TABLE 41 ROCHE-COMPANION DIAGNOSTICS PIPELINE JOINT ONCOLOGY PHARMA
AND DIAGNOSTICS 181
SAVYON DIAGNOSTICS 181
PRODUCTS 181
SEQUENOM INC. 182
PRODUCTS 183
APPLICATIONS 183
SIEMENS 184
SORENSON GENOMICS INC. 185
THERMO FISHER SCIENTIFIC INC. 185
TRANSGENOMIC INC. 186
PRODUCTS AND PIPELINES 187
Genetic Testing Services 187
In Development 188

LIST OF TABLES
SUMMARY TABLE GLOBAL MARKET FOR MOLECULAR DIAGNOSTICS BY TECHNOLOGY,
THROUGH 2020 ($ MILLIONS) 6
TABLE 1 MINIMUM INFORMATION ABOUT A MICROARRAY EXPERIMENT - MIAME 2.0 18
TABLE 2 MICROARRAY QUALITY CONTROL (MAQC) PROJECT 19
TABLE 3 U.S. LABORATORIES CLIA-CERTIFIED FOR MOLECULAR DIAGNOSTICS AND
NUMBER OF DISEASE TESTS, 2012 21
TABLE 4 GENETIC TESTING PROCEDURES PERFORMED IN U.S. BY TYPE, 2015 22
TABLE 5 FDA-APPROVED IN VITRO COMPANION DIAGNOSTIC DEVICES AS OF DEC.
23, 2014 28
TABLE 6 FDA-APPROVED IN VITRO COMPANION DIAGNOSTIC DEVICES, AS OF
DECEMBER 2012 34
TABLE 7 CURRENT PGRN-RIKEN CGM COLLABORATIVE STUDIES 43
TABLE 8 DIAGNOSTICS MANUFACTURER MERGERS AND ACQUISITIONS, 2004-2014 52
TABLE 9 GLOBAL MARKET FOR MOLECULAR DIAGNOSTICS BY TECHNOLOGY,
THROUGH 2020 ($ MILLIONS) 57
TABLE 10 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY TECHNOLOGY,
2015 (%) 57
TABLE 11 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
MANUFACTURER, 2015 (%) 59
TABLE 12 GLOBAL MICROARRAY MARKET FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 61
TABLE 13 GLOBAL MICROARRAY MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 62
TABLE 14 MAJOR SUPPLIERS OF PLANAR DNA MICROARRAYS 63
TABLE 15 MAJOR SUPPLIERS OF BEAD MICROARRAYS 64
TABLE 16 GLOBAL PCR MARKET FOR MOLECULAR DIAGNOSTICS BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 65
TABLE 17 GLOBAL PCR MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 66
TABLE 18 GLOBAL PCR MARKET SHARE BY MANUFACTURER, 2015 (%) 67
TABLE 19 GLOBAL ISH MARKET FOR MOLECULAR DIAGNOSTICS BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 71
TABLE 20 GLOBAL ISH MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 72
TABLE 21 GLOBAL LAB-ON-A-CHIP/BIOCHIP MARKET FOR MOLECULAR DIAGNOSTICS
BY APPLICATION, THROUGH 2020 ($ MILLIONS) 76
TABLE 22 GLOBAL LAB-ON-A-CHIP/BIOCHIP MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 76
TABLE 23 GLOBAL EMERGING/OTHER MOLECULAR DIAGNOSTICS MARKET BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 79
TABLE 24 GLOBAL EMERGING/OTHER MOLECULAR DIAGNOSTICS MARKET SHARE BY
APPLICATION, 2015 (%) 80
TABLE 25 GLOBAL MARKET FOR MOLECULAR DIAGNOSTICS BY APPLICATION,
THROUGH 2020 ($ MILLIONS) 82
TABLE 26 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY APPLICATION,
2015 (%) 83
TABLE 27 GLOBAL PRE/POSTNATAL SCREENING MARKET FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, THROUGH 2020 ($ MILLIONS) 88
TABLE 28 GLOBAL PRE/POSTNATAL SCREENING MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 88
TABLE 29 GLOBAL INFECTIOUS DISEASES MARKET FOR MOLECULAR DIAGNOSTICS
BY APPLICATION, THROUGH 2020 ($ MILLIONS) 91
TABLE 30 GLOBAL INFECTIOUS DISEASE SCREENING MARKET SHARE FOR
MOLECULAR DIAGNOSTICS BY APPLICATION, 2015 (%) 91
TABLE 31 GLOBAL ONCOLOGY MARKET FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 94
TABLE 32 GLOBAL ONCOLOGY MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 95
TABLE 33 GLOBAL IDENTITY TESTING MARKET FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, THROUGH 2020 ($ MILLIONS) 98
TABLE 34 GLOBAL IDENTITY TESTING MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 98
TABLE 35 GLOBAL PHARMACOGENOMICS AND OTHER MARKET FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, THROUGH 2020 ($ MILLIONS) 103
TABLE 36 GLOBAL PHARMACOGENOMICS AND OTHER MARKET SHARE FOR
MOLECULAR DIAGNOSTICS BY APPLICATION, 2015 (%) 103
TABLE 37 SELECTED PCR PATENTS GRANTED FROM JANUARY 2013 TO JANUARY
2015 105
TABLE 38 SELECTED MICROARRAY PATENTS GRANTED, JANUARY 2013 TO MAY 2015 123
TABLE 39 SELECTED ISH PATENTS GRANTED, JANUARY 2013 TO MAY 2015 129
TABLE 40 SELECTED BIOCHIP PATENTS GRANTED, JANUARY 2013 TO MAY 2015 131
TABLE 41 ROCHE-COMPANION DIAGNOSTICS PIPELINE JOINT ONCOLOGY PHARMA
AND DIAGNOSTICS 181

LIST OF FIGURES
SUMMARY FIGURE GLOBAL MARKET FOR MOLECULAR DIAGNOSTICS BY
TECHNOLOGY, 2012-2020 ($ MILLIONS) 6
FIGURE 1 GROWTH IN CLINICAL LABORATORY SITES AND DISEASE TESTING,
1993-2015 21
FIGURE 2 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY TECHNOLOGY,
2015 (%) 57
FIGURE 3 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
MANUFACTURER, 2015 (%) 59
FIGURE 4 GLOBAL MICROARRAY MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 62
FIGURE 5 GLOBAL PCR MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 66
FIGURE 6 GLOBAL ISH MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 72
FIGURE 7 GLOBAL LAB-ON-A-CHIP/BIOCHIP MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 77
FIGURE 8 GLOBAL MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY APPLICATION,
2015 (%) 83
FIGURE 9 GLOBAL PRE/POSTNATAL SCREENING MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 88
FIGURE 10 GLOBAL INFECTIOUS DISEASE SCREENIN MARKET SHARE FOR
MOLECULAR DIAGNOSTICS BY APPLICATION, 2015 (%) 91
FIGURE 11 GLOBAL ONCOLOGY MARKET SHARE FOR MOLECULAR DIAGNOSTICS BY
APPLICATION, 2015 (%) 95
FIGURE 12 GLOBAL IDENTITY TESTING MARKET SHARE FOR MOLECULAR
DIAGNOSTICS BY APPLICATION, 2015 (%) 98

View This Report »

Find all the market research you need - instantly, in one place.

+1.2 Million Research Documents & Statistics +200,000 Trusted Public Sources 350 Industries With Global Coverage

24/7 Customer Support

Talk to Louis

+1 718 618 4302

Purchase Reports From Reputable Market Research Publishers

2015-2019 Global Automated Microbiology Market: US, Europe, Japan--Molecular Diagnostics, Microbial Identification, Antibiotic Susceptibility, Blood Culture, Urine Screening, Immunodiagnostics--Emerging Opportunities for Instrument and Reagent Suppliers--

2015-2019 Global Automated Microbiology Market: US, Europe, Japan--Molecular Diagnostics, Microbial Identification, Antibiotic Susceptibility, Blood Culture, Urine Screening, Immunodiagnostics--Emerging Opportunities for Instrument and Reagent Suppliers--

  • $ 22 400
  • Industry report
  • July 2015
  • by Venture Planning Group

Complete report $35,500.  DataPack (test volumes, sales forecasts, supplier shares) $22,400. “2015-2019 Global Automated Microbiology Market: US, Europe, Japan” is a new seven-country strategic ...

2015 Automated Microbiology Market-- A Global Strategic Outlook: Molecular Diagnostics, Microbial Identification, Antibiotic Susceptibility, Blood Culture, Urine Screening, Immunodiagnostics

2015 Automated Microbiology Market-- A Global Strategic Outlook: Molecular Diagnostics, Microbial Identification, Antibiotic Susceptibility, Blood Culture, Urine Screening, Immunodiagnostics

  • $ 22 400
  • Industry report
  • May 2015
  • by Venture Planning Group

Complete report $35,500.  DataPack (test volumes, sales forecasts, supplier shares) $22,400. “2015 Global Automated Microbiology Market” is a new seven-country strategic analysis of the major business ...

2015-2019 Global Automated Microbiology Market: US, Europe, Japan--Molecular Diagnostics, Microbial Identification, Antibiotic Susceptibility, Blood Culture, Urine Screening, Immunodiagnostics--Competitive Strategies, Supplier Shares

2015-2019 Global Automated Microbiology Market: US, Europe, Japan--Molecular Diagnostics, Microbial Identification, Antibiotic Susceptibility, Blood Culture, Urine Screening, Immunodiagnostics--Competitive Strategies, Supplier Shares

  • $ 22 400
  • Industry report
  • July 2015
  • by Venture Planning Group

Complete report $35,500.  DataPack (test volumes, sales forecasts, supplier shares) $22,400. “2015-2019 Global Automated Microbiology Market: US, Europe, Japan--Molecular Diagnostics, Microbial Identification, ...


ReportLinker is an award-winning market research solution that finds, filters and organizes the latest industry data so you get all the market research you need - quickly, in one place.