Molecular Diagnostics: Technologies and Global Markets

  • March 2013
  • -
  • BCC Research
  • -
  • 180 pages

REPORT SCOPE

INTRODUCTION

STUDY GOALS AND OBJECTIVES

BCC’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 2013 to 2018. We are particularly interested in the markets for DNA microarrays, 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 2018. 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 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 worldwide. 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, health care, 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 January 2013. The base year for this report is 2010 and forecast data are provided through 2018. 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 was 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.

ANALYST CREDENTIALS

Jon Evans has been involved in business development and research for the medical industry since 1984. Mr. Evans’ career includes four years as a diagnostic systems sales representative and more than 15 years in market research and strategy analysis with Fortune 500 clients. He has developed expertise in assessing the unique business development challenges facing firms in the medical industry and designing strategies to optimize market performance. Mr. Evans received a BS in biology from Rutgers University in 1983, and an MBA in business analysis from San Francisco State University in 1989.

REPORT HIGHLIGHTS

This report provides:
• An overview of the global market for molecular diagnostics.
• Analyses of global market trends, with data from 2010 through 2012, estimates for 2013, and projections of compound annual growth rates (CAGRs) through 2018.
• Discussion of related issues, such as government regulation, reimbursement through insurance, patient confidentiality, and other legal ramifications.
• Identification of scientific challenges and advances, including the latest trends.
• Comprehensive company profiles and a patent analysis.

Table Of Contents

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 CREDENTIALS 3
RELATED BCC REPORTS 3
BCC ONLINE SERVICES 4
DISCLAIMER 4

CHAPTER 2 SUMMARY 6
FORECASTS 6
SUMMARY TABLE TOTAL GLOBAL MOLECULAR DIAGNOSTICS MARKET,
THROUGH 2018 ($ MILLIONS) 6
SUMMARY FIGURE TOTAL GLOBAL MOLECULAR DIAGNOSTICS MARKET,
2010-2018 ($ 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 12
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 18
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,
1993-2011 21
PERSONALIZED MEDICINES AND COMPANION DIAGNOSTICS 22
FDA GUIDELINES FOR IN VITRO COMPANION DIAGNOSTICS 23
Definition and Use of an IVD Companion Diagnostic Device 23
Review and Approval of IVD Companion Diagnostic Devices and
Therapeutic Products 23
Novel Therapeutic Products 24
Approval of a Therapeutic Product without an Approved IVD
Companion Diagnostic Device 24
General Policies 25
FDA APPROVED COMPANION DIAGNOSTICS 26
TABLE 4 FDA-APPROVED IN VITRO COMPANION DIAGNOSTIC DEVICES AS OF
DECEMBER 2012 26
PHARMACOGENOMICS RESEARCH NETWORK 35
TABLE 5 PGRN-RIKEN CGM COLLABORATIVE STUDIES UNDERWAY 36

CHAPTER 5 COMMERCIAL MARKET TRENDS 43
MARKET CONDITIONS 43
HEALTHCARE, HOSPITALS, DOCTORS, GREATER REGULATION AND
NEED FOR INSURANCE REIMBURSEMENT 43
NEW REQUIREMENTS FOR SUCCESS 43
SALES AND MARKETING 43
MEDICAL AFFAIRS 44
REGULATORY COMPLIANCE 44
REIMBURSEMENT 44
ALLIANCES AND MERGERS 45
TABLE 6 DIAGNOSTICS MANUFACTURER MERGERS AND ACQUISITIONS,
2004-2012 45

CHAPTER 6 MARKET FOR MOLECULAR DIAGNOSTICS BY TECHNOLOGY 48
OVERVIEW 48
DESCRIPTION 48
REVENUES AND FORECASTS 49
TABLE 7 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS BY
TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 49
TABLE 8 GLOBAL DNA DIAGNOSTICS MARKET BY PRODUCT SHARE, 2013 (%) 49
FIGURE 2 GLOBAL DNA DIAGNOSTICS MARKET BY PRODUCT SHARE, 2013
(%) 49
MANUFACTURERS 50
TABLE 9 GLOBAL MOLECULAR DIAGNOSTICS MANUFACTURERS BY MARKET
SHARE, 2012 (%) 50
FIGURE 3 GLOBAL MOLECULAR DIAGNOSTICS MANUFACTURERS BY
MARKET SHARE, 2012 (%) 51
MICROARRAY 51
DESCRIPTION 51
Planar 51
Bead 52
REVENUES AND FORECASTS 52
TABLE 10 GLOBAL MICROARRAY MARKET FORECAST FOR DNA
DIAGNOSTICS BY TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 53
TABLE 11 GLOBAL MICROARRAY MARKET BY PRODUCT SHARE, 2013 (%) 53
FIGURE 4 GLOBAL MICROARRAY MARKET BY PRODUCT SHARE, 2013 (%) 54
MANUFACTURERS AND PRODUCTS 54
Planar 54
TABLE 12 MAJOR SUPPLIERS OF PLANAR DNA MICROARRAYS 54
Bead 55
TABLE 13 MAJOR SUPPLIERS OF BEAD MICROARRAYS 55
PCR 55
DESCRIPTION 55
REVENUES AND FORECASTS 56
TABLE 14 GLOBAL PCR MARKET FORECAST FOR DNA DIAGNOSTICS BY
TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 57
TABLE 15 GLOBAL PCR MARKET BY PRODUCT SHARE, 2013 (%) 57
FIGURE 5 GLOBAL PCR MARKET BY PRODUCT SHARE, 2013 (%) 58
MANUFACTURERS AND PRODUCTS 58
TABLE 16 PCR MANUFACTURER MARKET SHARE, 2012 (%) 59
IN SITU HYBRIDIZATION (ISH) 59
DESCRIPTION 59
Labeling Techniques 59
Applications of In Situ Hybridization 60
FIBER FISH 61
HER-2 FISH TESTING 62
REVENUES AND FORECASTS 63
TABLE 17 GLOBAL ISH MARKET FORECAST FOR DNA DIAGNOSTICS BY
TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 63
TABLE 18 GLOBAL ISH PRODUCTS BY MARKET SHARE, 2013 (%) 64
FIGURE 6 GLOBAL ISH PRODUCTS BY MARKET SHARE, 2013 (%) 64
LAB-ON-A-CHIP/BIOCHIPS 64
DESCRIPTION 64
Microfluidic Devices 66
PRODUCT DEVELOPMENT 67
REVENUES AND FORECASTS 68
TABLE 19 GLOBAL MARKET FORECAST FOR LAB-ON-A-CHIP/BIOCHIPS BY
TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 68
TABLE 20 GLOBAL LAB-ON-A-CHIP/BIOCHIP PRODUCTS BY MARKET SHARE,
2013 (%) 69
FIGURE 7 GLOBAL LAB-ON-A-CHIP/BIOCHIP PRODUCTS BY MARKET SHARE,
2013 (%) 69
EMERGING AND OTHER DIAGNOSTIC TECHNOLOGIES 69
DESCRIPTION 69
The Trend toward Single Cell Measurements 70
Genetic Typing of Single Cells 70
Single Cell Sequencing 70
Copy Number Variations in Single Cells 70
Combined Immunotyping and Single-Cell Expression Analysis 70
Diagnosing the Epigenome 70
REVENUES AND FORECASTS 71
TABLE 21 GLOBAL EMERGING/OTHER DNA DIAGNOSTICS MARKET
FORECAST BY TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 71
TABLE 22 GLOBAL EMERGING MOLECULAR DIAGNOSTICS MARKET BY
PRODUCT SHARE, 2013 (%) 71

CHAPTER 7 MARKETS FOR MOLECULAR DIAGNOSTICS BY APPLICATION AND
PRODUCTS 73
OVERVIEW 73
DESCRIPTION 73
REVENUES AND FORECASTS 73
TABLE 23 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS BY
APPLICATION, THROUGH 2018 ($ MILLIONS) 74
TABLE 24 GLOBAL MOLECULAR DIAGNOSTICS BY APPLICATION MARKET
SHARE, 2013 (%) 74
FIGURE 8 GLOBAL MOLECULAR DIAGNOSTICS BY APPLICATION MARKET
SHARE, 2013 (%) 75
PRE/POSTNATAL GENETIC SCREENING 75
DESCRIPTION 75
Carrier Screening 76
Prenatal Diagnostic Testing 76
Amniocentesis 77
Chorionic Villus Sampling (CVS) 77
Genetic Counseling 77
Preimplantation Diagnosis 78
Newborn Screening 78
REVENUES AND FORECASTS 79
TABLE 25 GLOBAL PRE/POSTNATAL SCREENING MARKET FORECAST FOR
DNA DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) 79
TABLE 26 GLOBAL PRE/POSTNATAL SCREENING MARKET BY PRODUCT
SHARE, 2013 (%) 80
FIGURE 9 GLOBAL PRE/POSTNATAL SCREENING MARKET BY PRODUCT
SHARE, 2013 (%) 80
INFECTIOUS DISEASE DIAGNOSTICS 80
DESCRIPTION 80
REVENUES AND FORECASTS 82
TABLE 27 GLOBAL INFECTIOUS DISEASES MARKET FORECAST FOR DNA
DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) 82
TABLE 28 GLOBAL INFECTIOUS DISEASE SCREENING MARKET BY PRODUCT
SHARE, 2013 (%) 82
FIGURE 10 GLOBAL INFECTIOUS DISEASE SCREENING MARKET BY
PRODUCT SHARE, 2013 (%) 82
ONCOLOGY DIAGNOSTICS 83
DESCRIPTION 83
Leukemias 83
Chronic Myeloid Leukemia (CML) 83
Genetic Marker of CML 84
REVENUES AND FORECASTS 85
TABLE 29 GLOBAL ONCOLOGY MARKET FORECAST FOR DNA DIAGNOSTICS
BY APPLICATION, THROUGH 2018 ($ MILLIONS) 85
TABLE 30 GLOBAL ONCOLOGY SCREENING MARKET BY PRODUCT SHARE,
2013 (%) 85
FIGURE 11 GLOBAL ONCOLOGY SCREENING MARKET BY PRODUCT SHARE,
2013 (%) 85
IDENTITY DIAGNOSTICS, FORENSICS AND PATERNITY 86
DESCRIPTION 86
Paternity Testing 86
Technology 86
Accreditation 87
Legal Issues 87
Veterinary Identity Testing 88
REVENUES AND FORECASTS 88
TABLE 31 GLOBAL IDENTITY TESTING MARKET FORECAST FOR DNA
DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) 88
TABLE 32 GLOBAL IDENTITY SCREENING MARKET BY PRODUCT SHARE,
2012 (%) 88
FIGURE 12 GLOBAL IDENTITY SCREENING MARKET BY PRODUCT SHARE,
2013 (%) 88
PHARMACOGENOMICS/OTHER APPLICATIONS 89
DESCRIPTION 89
REVENUES AND FORECASTS 92
TABLE 33 GLOBAL PHARMACOGENOMICS AND OTHER MARKET FORECAST
FOR DNA DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) 93
TABLE 34 GLOBAL PHARMACOGENOMIC SCREENING MARKET BY PRODUCT
SHARE, 2013 (%) 93

CHAPTER 8 PATENT ANALYSIS 95
PCR 95
TABLE 35 SELECTED PCR PATENTS GRANTED FROM 2011 TO 2012 95
METHOD FOR DETECTION OF MUTANT ALLELES COMBINING REAL
TIME PCR AND REMS-PCR 96
REAL-TIME PCR POINT MUTATION ASSAYS FOR DETECTING HIV-1
RESISTANCE TO ANTIVIRAL DRUGS 97
SYSTEMS AND METHODS FOR MULTIPLEX ANALYSIS OF PCR IN
REAL TIME 98
DETECTION OF SALMONELLA BY REAL-TIME MULTIPLEX PCR 98
METHODS AND COMPOSITIONS RELATED TO CONTINUOUS FLOW
THERMAL GRADIENT PCR 99
METHOD FOR DETECTION OF HCV AT THE REAL TIME PCR WITH
INTERCALATING DYE 99
REAL-TIME PCR OF TARGETS ON A MICRO-ARRAY 100
DETERMINATION OF ELBOW VALUES FOR PCR FOR PARABOLIC
SHAPED CURVES 101
METHOD FOR DETECTION AND MULTIPLE, SIMULTANEOUS
QUANTIFICATION OF PATHOGENS BY MEANS OF REAL-TIME
POLYMERASE CHAIN REACTION 101
REUSABLE PCR AMPLIFICATION SYSTEM AND METHOD 103
EFFICIENT ALGORITHM FOR PCR TESTING OF BLOOD SAMPLES 103
METHOD OF PRODUCING AMPLIFICATION PRODUCT BY PCR AND
USAGE THEREOF 104
SYSTEM FOR MULTI COLOR REAL TIME PCR 104
METHOD FOR MEASURING THE NUMBER OF ORAL LACTOBACILLUS,
AND A PCR PRIMERS-PROBE SET USED FOR THE SAME 105
RAPID ONE-STEP REVERSE TRANSCRIPTASE PCR 106
PCR METHOD FOR IDENTIFYING A SEROTYPE OF KLEBSIELLA
PNEUMONIAE BY USING CPS REGION PRIMERS AND APPLICATION
THEREOF 106
POLYMERASE CHAIN REACTION (PCR) METHOD FOR AMPLIFYING A
DNA TEMPLATE 107
QUANTITATIVE MULTIPLEX METHYLATION-SPECIFIC PCR 108
METHOD FOR SINGLE NUCLEOTIDE POLYMORPHISM AND
MUTATION DETECTION USING REAL TIME POLYMERASE CHAIN
REACTION MICROARRAY 109
MULTIPLEX Q-PCR ARRAYS 109
REAL-TIME PCR POINT MUTATION ASSAYS FOR DETECTING HIV-1
RESISTANCE TO ANTIVIRAL DRUGS 110
AUTOMATIC THRESHOLD SETTING AND BASELINE DETERMINATION
FOR REAL-TIME PCR 111
AMPLICON RESCUE MULTIPLEX POLYMERASE CHAIN REACTION
FOR AMPLIFICATION OF MULTIPLE TARGETS 111
PCR PROCESS AND ARRANGEMENT FOR DNA AMPLIFICATION
USING DRY REAGENTS 112
PCR ELBOW DETERMINATION USING CURVATURE ANALYSIS OF A
DOUBLE SIGMOID 113
SYSTEMS AND METHODS FOR DETERMINING REAL-TIME PCR CYCLE
THRESHOLDS USING CLUSTER ANALYSIS 113
SYSTEMS AND METHODS FOR MULTIPLEX ANALYSIS OF PCR IN
REAL TIME 114
DETECTION OF AMPLICON CONTAMINATION DURING PCR
EXHIBITING TWO DIFFERENT ANNEALING TEMPERATURES 115
DETECTION OF MICRO METASTASIS OF MELANOMA AND BREAST
CANCER IN PARAFFIN-EMBEDDED TUMOR DRAINING LYMPH NODES
BY MULTIMARKER QUANTITATIVE RT-PCR 116
METHOD OF PERFORMING PCR AMPLIFICATION ON A MICROARRAY 117
COMPOSITIONS AND METHODS FOR REVERSE
TRANSCRIPTASE-POLYMERASE CHAIN REACTION (RT-PCR) 118
IDENTIFICATION OF CELL CULTURE CONTAMINANTS AMONG
MOLLICUTES SPECIES BY A PCR BASED ASSAY 118
POLYMERASE CHAIN REACTION SYSTEM USING MAGNETIC BEADS
FOR ANALYZING A SAMPLE THAT INCLUDES NUCLEIC ACID 119
METHOD FOR THE SIMULTANEOUS AMPLIFICATION OF MULTIPLE
SEQUENCES IN A PCR REACTION AND MARKING THEREOF 120
ARRAY 121
TABLE 36 SELECTED MICRO-ARRAY PATENTS GRANTED FROM 2011 TO 2012 121
MICROARRAY FOR DETECTION OF THE DELETION OF EXON 3 OF
THE G-CSF GENE 121
MICROARRAY DEVICES HAVING CONTROLLABLE REACTION VOLUME 122
PHOTONIC CRYSTAL MICROARRAY DEVICE FOR LABEL-FREE
MULTIPLE ANALYTE SENSING, BIOSENSING AND DIAGNOSTIC
ASSAY CHIPS 122
PROSTATE CANCER-RELATED COMPOSITIONS, METHODS AND KITS
BASED ON DNA MICROARRAY PROTEOMICS PLATFORMS 124
METHODS, MICROARRAY, AND KITS FOR DETECTION OF DRUG
RESISTANCE GENES IN GRAM-NEGATIVE BACTERIA 124
MICROARRAY-MEDIATED DIAGNOSIS OF HERPES VIRUS INFECTION
BY MONITORING HOST'S DIFFERENTIAL GENE EXPRESSION UPON
INFECTION 125
METHOD FOR SINGLE NUCLEOTIDE POLYMORPHISM AND
MUTATION DETECTION USING REAL TIME POLYMERASE CHAIN
REACTION MICROARRAY 126
MICROARRAY SYNTHESIS AND ASSEMBLY OF GENE-LENGTH
POLYNUCLEOTIDES 126
APPARATUS FOR MICROARRAY BINDING SENSORS HAVING
BIOLOGICAL PROBE MATERIALS USING CARBON NANOTUBE
TRANSISTORS 127
SINGLE NUCLEOTIDE POLYMORPHISM GENOTYPING DETECTION
VIA THE REAL-TIME INVADER ASSAY MICROARRAY PLATFORM 128
METHOD OF FORMING POLYMERIC MICROARRAY SUPPORT 128
CELLULAR MICROARRAY AND ITS MICROFABRICATION METHOD 129
MULTIPLEXED LATERAL FLOW MICROARRAY ASSAY FOR DETECTION
OF CITRUS PATHOGENS XYLELLA FASTIDIOSA AND XANTHOMONAS
AXONOPODIS PV CITRI 130
METHOD OF PERFORMING PCR AMPLIFICATION ON A MICROARRAY 130
ISH 131
TABLE 37 SELECTED ISH PATENTS GRANTED FROM 2011 TO 2012 131
DIAGNOSTIC HISTOPATHOLOGY USING MULTIPLEX GENE
EXPRESSION FISH 132
AUTOMATIC IMAGE ANALYSIS AND QUANTIFICATION FOR
FLUORESCENCE IN SITU HYBRIDIZATION 132
POLYMERIC CARRIERS FOR IMMUNOHISTOCHEMISTRY AND IN SITU
HYBRIDIZATION 133
METHODS OF ANALYZING CHROMOSOMAL TRANSLOCATIONS
USING FLUORESCENCE IN SITU HYBRIDIZATION (FISH) 133
AUTOMATED CANCER DIAGNOSTIC METHODS USING FISH 134
BIOCHIPS 135
TABLE 38 SELECTED BIOCHIP/LOAC PATENTS GRANTED FROM 2011 TO 2012 135
NANOPARTICLE BIOCHIP SUBSTRATES 135
BIOCHIP ANALYSIS SYSTEM 136
METHOD AND APPARATUS FOR DETECTING BIO-CHIP BY USING
PHASE-CHANGE 137
DNA BIOCHIP AND METHODS OF USE 138
EMERGING TECHNOLOGIES 138
TABLE 39 SELECTED EMERGING MOLECULAR DIAGNOSTIC PATENTS
GRANTED FROM 2011 TO 2012 139

CHAPTER 9 COMPANY PROFILES 142
ABBOTT MOLECULAR 142
ADVANDX, INC. 143
AFFYMETRIX, INC. 144
AGILENT TECHNOLOGIES, INC. 145
AUTOGENOMICS, INC. 148
BECKMAN COULTER INC. (DANAHER-OWNER) 149
BECTON DICKINSON AND COMPANY 150
BIOMERIEUX SA 151
BIO-RAD LABORATORIES 153
CALIPER LIFE SCIENCES, INC. 155
CEPHEID 156
CURAGEN CORP. (ACQUIRED BY CELLDEX) 157
DECODE GENETICS 157
DNA DIAGNOSTICS CENTER 158
ELITECH GROUP 160
EMD MILLIPORE 160
EUROGENTEC (OWNED BY KANEKA CORP.) 161
EXACT SCIENCES CORP. 163
GE HEALTHCARE 164
HOLOGIC, INC. 164
HTG MOLECULAR DIAGNOSTICS 166
ILLUMINA 167
LABORATORY CORPORATION OF AMERICA (LABCORP) 168
LIFE TECHNOLOGIES 169
LUMINEX CORP 170
MICRONICS, INC. 171
MYRIAD GENETICS 172
NOVARTIS MOLECULAR DIAGNOSTICS 174
OXFORD GENE TECHNOLOGY IP LTD. 175
PATHOGENETIX 177
PROMEGA 177
QIAGEN N.V. 178
QUEST DIAGNOSTICS 180
ROCHE 181
TABLE 40 ROCHE - COMPANION DIAGNOSTICS PIPELINE JOINT ONCOLOGY
PHARMA AND DIAGNOSTICS 182
SAVYON DIAGNOSTICS 183
SEQUENOM INC. 184
SIEMENS 185
SORENSON GENOMICS, INC. 186
THERMO FISHER SCIENTIFIC, INC. 187
TRANSGENOMIC INC. 187



LIST OF TABLES

SUMMARY TABLE TOTAL GLOBAL MOLECULAR DIAGNOSTICS MARKET,
THROUGH 2018 ($ MILLIONS) 6
TABLE 1 MINIMUM INFORMATION ABOUT A MICROARRAY EXPERIMENT -
MIAME 2.0 18
TABLE 2 MICROARRAY QUALITY CONTROL (MAQC) PROJECT 18
TABLE 3 U.S. LABORATORIES CLIA-CERTIFIED FOR MOLECULAR
DIAGNOSTICS AND NUMBER OF DISEASE TESTS, 2012 21
TABLE 4 FDA-APPROVED IN VITRO COMPANION DIAGNOSTIC DEVICES AS OF
DECEMBER 2012 26
TABLE 5 PGRN-RIKEN CGM COLLABORATIVE STUDIES UNDERWAY 36
TABLE 6 DIAGNOSTICS MANUFACTURER MERGERS AND ACQUISITIONS,
2004-2012 45
TABLE 7 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS BY
TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 49
TABLE 8 GLOBAL DNA DIAGNOSTICS MARKET BY PRODUCT SHARE, 2013 (%) 49
TABLE 9 GLOBAL MOLECULAR DIAGNOSTICS MANUFACTURERS BY MARKET
SHARE, 2012 (%) 50
TABLE 10 GLOBAL MICROARRAY MARKET FORECAST FOR DNA DIAGNOSTICS
BY TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 53
TABLE 11 GLOBAL MICROARRAY MARKET BY PRODUCT SHARE, 2013 (%) 53
TABLE 12 MAJOR SUPPLIERS OF PLANAR DNA MICROARRAYS 54
TABLE 13 MAJOR SUPPLIERS OF BEAD MICROARRAYS 55
TABLE 14 GLOBAL PCR MARKET FORECAST FOR DNA DIAGNOSTICS BY
TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 57
TABLE 15 GLOBAL PCR MARKET BY PRODUCT SHARE, 2013 (%) 57
TABLE 16 PCR MANUFACTURER MARKET SHARE, 2012 (%) 59
TABLE 17 GLOBAL ISH MARKET FORECAST FOR DNA DIAGNOSTICS BY
TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 63
TABLE 18 GLOBAL ISH PRODUCTS BY MARKET SHARE, 2013 (%) 64
TABLE 19 GLOBAL MARKET FORECAST FOR LAB-ON-A-CHIP/BIOCHIPS BY
TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 68
TABLE 20 GLOBAL LAB-ON-A-CHIP/BIOCHIP PRODUCTS BY MARKET SHARE,
2013 (%) 69
TABLE 21 GLOBAL EMERGING/OTHER DNA DIAGNOSTICS MARKET FORECAST
BY TECHNOLOGY, THROUGH 2018 ($ MILLIONS) 71
TABLE 22 GLOBAL EMERGING MOLECULAR DIAGNOSTICS MARKET BY
PRODUCT SHARE, 2013 (%) 71
TABLE 23 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS BY
APPLICATION, THROUGH 2018 ($ MILLIONS) 74
TABLE 24 GLOBAL MOLECULAR DIAGNOSTICS BY APPLICATION MARKET
SHARE, 2013 (%) 74
TABLE 25 GLOBAL PRE/POSTNATAL SCREENING MARKET FORECAST FOR
DNA DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) 79
TABLE 26 GLOBAL PRE/POSTNATAL SCREENING MARKET BY PRODUCT SHARE,
2013 (%) 80
TABLE 27 GLOBAL INFECTIOUS DISEASES MARKET FORECAST FOR DNA
DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) 82
TABLE 28 GLOBAL INFECTIOUS DISEASE SCREENING MARKET BY PRODUCT
SHARE, 2013 (%) 82
TABLE 29 GLOBAL ONCOLOGY MARKET FORECAST FOR DNA DIAGNOSTICS BY
APPLICATION, THROUGH 2018 ($ MILLIONS) 85
TABLE 30 GLOBAL ONCOLOGY SCREENING MARKET BY PRODUCT SHARE,
2013 (%) 85
TABLE 31 GLOBAL IDENTITY TESTING MARKET FORECAST FOR DNA
DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) 88
TABLE 32 GLOBAL IDENTITY SCREENING MARKET BY PRODUCT SHARE, 2012
(%) 88
TABLE 33 GLOBAL PHARMACOGENOMICS AND OTHER MARKET FORECAST
FOR DNA DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) 93
TABLE 34 GLOBAL PHARMACOGENOMIC SCREENING MARKET BY PRODUCT
SHARE, 2013 (%) 93
TABLE 35 SELECTED PCR PATENTS GRANTED FROM 2011 TO 2012 95
TABLE 36 SELECTED MICRO-ARRAY PATENTS GRANTED FROM 2011 TO 2012 121
TABLE 37 SELECTED ISH PATENTS GRANTED FROM 2011 TO 2012 131
TABLE 38 SELECTED BIOCHIP/LOAC PATENTS GRANTED FROM 2011 TO 2012 135
TABLE 39 SELECTED EMERGING MOLECULAR DIAGNOSTIC PATENTS
GRANTED FROM 2011 TO 2012 139
TABLE 40 ROCHE - COMPANION DIAGNOSTICS PIPELINE JOINT ONCOLOGY
PHARMA AND DIAGNOSTICS 182
SUMMARY FIGURE TOTAL GLOBAL MOLECULAR DIAGNOSTICS MARKET,
2010-2018 ($ MILLIONS) 6




LIST OF FIGURES

FIGURE 1 GROWTH IN CLINICAL LABORATORY SITES AND DISEASE TESTING,
1993-2011 21
FIGURE 2 GLOBAL DNA DIAGNOSTICS MARKET BY PRODUCT SHARE, 2013 (%) 49
FIGURE 3 GLOBAL MOLECULAR DIAGNOSTICS MANUFACTURERS BY MARKET
SHARE, 2012 (%) 51
FIGURE 4 GLOBAL MICROARRAY MARKET BY PRODUCT SHARE, 2013 (%) 54
FIGURE 5 GLOBAL PCR MARKET BY PRODUCT SHARE, 2013 (%) 58
FIGURE 6 GLOBAL ISH PRODUCTS BY MARKET SHARE, 2013 (%) 64
FIGURE 7 GLOBAL LAB-ON-A-CHIP/BIOCHIP PRODUCTS BY MARKET SHARE,
2013 (%) 69
FIGURE 8 GLOBAL MOLECULAR DIAGNOSTICS BY APPLICATION MARKET
SHARE, 2013 (%) 75
FIGURE 9 GLOBAL PRE/POSTNATAL SCREENING MARKET BY PRODUCT
SHARE, 2013 (%) 80
FIGURE 10 GLOBAL INFECTIOUS DISEASE SCREENING MARKET BY PRODUCT
SHARE, 2013 (%) 82
FIGURE 11 GLOBAL ONCOLOGY SCREENING MARKET BY PRODUCT SHARE,
2013 (%) 85
FIGURE 12 GLOBAL IDENTITY SCREENING MARKET BY PRODUCT SHARE,
2013 (%) 88

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