MOLECULAR DIAGNOSTICS: TECHNOLOGIES AND GLOBAL MARKETS. BIO063B March Jon Evans Project Analyst ISBN:

Transcription

1 MOLECULAR DIAGNOSTICS: TECHNOLOGIES AND GLOBAL MARKETS BIO063B March 2013 Jon Evans Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA , Custom Reports: carol.laverty@bccresearch.com

2 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) SUMMARY FIGURE TOTAL GLOBAL MOLECULAR DIAGNOSTICS MARKET, ($ MILLIONS) VENDORS 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 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 FIGURE 1 GROWTH IN CLINICAL LABORATORY SITES AND DISEASE TESTING, 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

3 Novel Therapeutic Products 24 Approval of a Therapeutic Product without an Approved IVD Companion Diagnostic Device General Policies 25 FDA APPROVED COMPANION DIAGNOSTICS 26 TABLE 4 FDA-APPROVED IN VITRO COMPANION DIAGNOSTIC DEVICES AS OF DECEMBER 2012 PHARMACOGENOMICS RESEARCH NETWORK 35 TABLE 5 PGRN-RIKEN CGM COLLABORATIVE STUDIES UNDERWAY CHAPTER 5 COMMERCIAL MARKET TRENDS 43 MARKET CONDITIONS 43 HEALTHCARE, HOSPITALS, DOCTORS, GREATER REGULATION AND NEED FOR INSURANCE REIMBURSEMENT 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, 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 TABLE 8 GLOBAL DNA DIAGNOSTICS MARKET BY PRODUCT 49 FIGURE 2 GLOBAL DNA DIAGNOSTICS MARKET BY PRODUCT SHARE, 2013 (%) MANUFACTURERS 50 TABLE 9 GLOBAL MOLECULAR DIAGNOSTICS MANUFACTURERS BY MARKET SHARE, 2012 (%) FIGURE 3 GLOBAL MOLECULAR DIAGNOSTICS MANUFACTURERS BY MARKET SHARE, 2012 (%) MICROARRAY 51 DESCRIPTION 51 Planar 51 Bead 52 REVENUES AND FORECASTS 52 TABLE 10 GLOBAL MICROARRAY MARKET FORECAST FOR DNA DIAGNOSTICS BY TABLE 11 GLOBAL MICROARRAY MARKET BY PRODUCT 53 FIGURE 4 GLOBAL MICROARRAY MARKET BY PRODUCT 54 MANUFACTURERS AND PRODUCTS 54 Planar 54 TABLE 12 MAJOR SUPPLIERS OF PLANAR DNA MICROARRAYS

4 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 TABLE 15 GLOBAL PCR MARKET BY PRODUCT 57 FIGURE 5 GLOBAL PCR MARKET BY PRODUCT 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 TABLE 18 GLOBAL ISH PRODUCTS BY MARKET 64 FIGURE 6 GLOBAL ISH PRODUCTS BY MARKET 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 TABLE 20 GLOBAL LAB-ON-A-CHIP/BIOCHIP PRODUCTS BY MARKET SHARE, FIGURE 7 GLOBAL LAB-ON-A-CHIP/BIOCHIP PRODUCTS BY MARKET SHARE, 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 TABLE 22 GLOBAL EMERGING MOLECULAR DIAGNOSTICS MARKET BY PRODUCT CHAPTER 7 MARKETS FOR MOLECULAR DIAGNOSTICS BY APPLICATION AND PRODUCTS 73

5 OVERVIEW 73 DESCRIPTION 73 REVENUES AND FORECASTS 73 TABLE 23 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) TABLE 24 GLOBAL MOLECULAR DIAGNOSTICS BY APPLICATION MARKET FIGURE 8 GLOBAL MOLECULAR DIAGNOSTICS BY APPLICATION MARKET 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) TABLE 26 GLOBAL PRE/POSTNATAL SCREENING MARKET BY PRODUCT FIGURE 9 GLOBAL PRE/POSTNATAL SCREENING MARKET BY PRODUCT 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) TABLE 28 GLOBAL INFECTIOUS DISEASE SCREENING MARKET BY PRODUCT FIGURE 10 GLOBAL INFECTIOUS DISEASE SCREENING MARKET BY PRODUCT 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) TABLE 30 GLOBAL ONCOLOGY SCREENING MARKET BY PRODUCT SHARE, FIGURE 11 GLOBAL ONCOLOGY SCREENING MARKET BY PRODUCT SHARE, IDENTITY DIAGNOSTICS, FORENSICS AND PATERNITY 86 DESCRIPTION 86 Paternity Testing 86 Technology

6 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) TABLE 32 GLOBAL IDENTITY SCREENING MARKET BY PRODUCT SHARE, 2012 (%) FIGURE 12 GLOBAL IDENTITY SCREENING MARKET BY PRODUCT SHARE, 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) TABLE 34 GLOBAL PHARMACOGENOMIC SCREENING MARKET BY PRODUCT CHAPTER 8 PATENT ANALYSIS 95 PCR 95 TABLE 35 SELECTED PCR PATENTS GRANTED FROM 2011 TO METHOD FOR DETECTION OF MUTANT ALLELES COMBINING REAL TIME PCR AND REMS-PCR REAL-TIME PCR POINT MUTATION ASSAYS FOR DETECTING HIV-1 RESISTANCE TO ANTIVIRAL DRUGS SYSTEMS AND METHODS FOR MULTIPLEX ANALYSIS OF PCR IN REAL TIME DETECTION OF SALMONELLA BY REAL-TIME MULTIPLEX PCR 98 METHODS AND COMPOSITIONS RELATED TO CONTINUOUS FLOW THERMAL GRADIENT PCR METHOD FOR DETECTION OF HCV AT THE REAL TIME PCR WITH INTERCALATING DYE REAL-TIME PCR OF TARGETS ON A MICRO-ARRAY 100 DETERMINATION OF ELBOW VALUES FOR PCR FOR PARABOLIC SHAPED CURVES METHOD FOR DETECTION AND MULTIPLE, SIMULTANEOUS QUANTIFICATION OF PATHOGENS BY MEANS OF REAL-TIME POLYMERASE CHAIN REACTION 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 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 RAPID ONE-STEP REVERSE TRANSCRIPTASE PCR 106 PCR METHOD FOR IDENTIFYING A SEROTYPE OF KLEBSIELLA PNEUMONIAE BY USING CPS REGION PRIMERS AND APPLICATION THEREOF POLYMERASE CHAIN REACTION (PCR) METHOD FOR AMPLIFYING A DNA TEMPLATE

7 QUANTITATIVE MULTIPLEX METHYLATION-SPECIFIC PCR 108 METHOD FOR SINGLE NUCLEOTIDE POLYMORPHISM AND MUTATION DETECTION USING REAL TIME POLYMERASE CHAIN REACTION MICROARRAY MULTIPLEX Q-PCR ARRAYS 109 REAL-TIME PCR POINT MUTATION ASSAYS FOR DETECTING HIV-1 RESISTANCE TO ANTIVIRAL DRUGS AUTOMATIC THRESHOLD SETTING AND BASELINE DETERMINATION FOR REAL-TIME PCR AMPLICON RESCUE MULTIPLEX POLYMERASE CHAIN REACTION FOR AMPLIFICATION OF MULTIPLE TARGETS PCR PROCESS AND ARRANGEMENT FOR DNA AMPLIFICATION USING DRY REAGENTS PCR ELBOW DETERMINATION USING CURVATURE ANALYSIS OF A DOUBLE SIGMOID SYSTEMS AND METHODS FOR DETERMINING REAL-TIME PCR CYCLE THRESHOLDS USING CLUSTER ANALYSIS SYSTEMS AND METHODS FOR MULTIPLEX ANALYSIS OF PCR IN REAL TIME DETECTION OF AMPLICON CONTAMINATION DURING PCR EXHIBITING TWO DIFFERENT ANNEALING TEMPERATURES DETECTION OF MICRO METASTASIS OF MELANOMA AND BREAST CANCER IN PARAFFIN-EMBEDDED TUMOR DRAINING LYMPH NODES BY MULTIMARKER QUANTITATIVE RT-PCR METHOD OF PERFORMING PCR AMPLIFICATION ON A MICROARRAY 117 COMPOSITIONS AND METHODS FOR REVERSE TRANSCRIPTASE-POLYMERASE CHAIN REACTION (RT-PCR) IDENTIFICATION OF CELL CULTURE CONTAMINANTS AMONG MOLLICUTES SPECIES BY A PCR BASED ASSAY POLYMERASE CHAIN REACTION SYSTEM USING MAGNETIC BEADS FOR ANALYZING A SAMPLE THAT INCLUDES NUCLEIC ACID METHOD FOR THE SIMULTANEOUS AMPLIFICATION OF MULTIPLE SEQUENCES IN A PCR REACTION AND MARKING THEREOF ARRAY 121 TABLE 36 SELECTED MICRO-ARRAY PATENTS GRANTED FROM 2011 TO MICROARRAY FOR DETECTION OF THE DELETION OF EXON 3 OF THE G-CSF GENE MICROARRAY DEVICES HAVING CONTROLLABLE REACTION VOLUME 122 PHOTONIC CRYSTAL MICROARRAY DEVICE FOR LABEL-FREE MULTIPLE ANALYTE SENSING, BIOSENSING AND DIAGNOSTIC ASSAY CHIPS PROSTATE CANCER-RELATED COMPOSITIONS, METHODS AND KITS BASED ON DNA MICROARRAY PROTEOMICS PLATFORMS METHODS, MICROARRAY, AND KITS FOR DETECTION OF DRUG RESISTANCE GENES IN GRAM-NEGATIVE BACTERIA MICROARRAY-MEDIATED DIAGNOSIS OF HERPES VIRUS INFECTION BY MONITORING HOST'S DIFFERENTIAL GENE EXPRESSION UPON INFECTION METHOD FOR SINGLE NUCLEOTIDE POLYMORPHISM AND MUTATION DETECTION USING REAL TIME POLYMERASE CHAIN REACTION MICROARRAY

8 MICROARRAY SYNTHESIS AND ASSEMBLY OF GENE-LENGTH POLYNUCLEOTIDES APPARATUS FOR MICROARRAY BINDING SENSORS HAVING BIOLOGICAL PROBE MATERIALS USING CARBON NANOTUBE TRANSISTORS SINGLE NUCLEOTIDE POLYMORPHISM GENOTYPING DETECTION VIA THE REAL-TIME INVADER ASSAY MICROARRAY PLATFORM 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 METHOD OF PERFORMING PCR AMPLIFICATION ON A MICROARRAY 130 ISH 131 TABLE 37 SELECTED ISH PATENTS GRANTED FROM 2011 TO DIAGNOSTIC HISTOPATHOLOGY USING MULTIPLEX GENE EXPRESSION FISH AUTOMATIC IMAGE ANALYSIS AND QUANTIFICATION FOR FLUORESCENCE IN SITU HYBRIDIZATION POLYMERIC CARRIERS FOR IMMUNOHISTOCHEMISTRY AND IN SITU HYBRIDIZATION METHODS OF ANALYZING CHROMOSOMAL TRANSLOCATIONS USING FLUORESCENCE IN SITU HYBRIDIZATION (FISH) AUTOMATED CANCER DIAGNOSTIC METHODS USING FISH 134 BIOCHIPS 135 TABLE 38 SELECTED BIOCHIP/LOAC PATENTS GRANTED FROM 2011 TO NANOPARTICLE BIOCHIP SUBSTRATES 135 BIOCHIP ANALYSIS SYSTEM 136 METHOD AND APPARATUS FOR DETECTING BIO-CHIP BY USING PHASE-CHANGE DNA BIOCHIP AND METHODS OF USE 138 EMERGING TECHNOLOGIES 138 TABLE 39 SELECTED EMERGING MOLECULAR DIAGNOSTIC PATENTS GRANTED FROM 2011 TO 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

9 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 SAVYON DIAGNOSTICS 183 SEQUENOM INC. 184 SIEMENS 185 SORENSON GENOMICS, INC. 186 THERMO FISHER SCIENTIFIC, INC. 187 TRANSGENOMIC INC

10 LIST OF TABLES TABLE HEADING SUMMARY TABLE TOTAL GLOBAL MOLECULAR DIAGNOSTICS MARKET, THROUGH 2018 ($ MILLIONS) TABLE 1 MINIMUM INFORMATION ABOUT A MICROARRAY EXPERIMENT - MIAME 2.0 TABLE 2 MICROARRAY QUALITY CONTROL (MAQC) PROJECT 18 TABLE 3 U.S. LABORATORIES CLIA-CERTIFIED FOR MOLECULAR DIAGNOSTICS AND NUMBER OF DISEASE TESTS, 2012 TABLE 4 FDA-APPROVED IN VITRO COMPANION DIAGNOSTIC DEVICES AS OF DECEMBER 2012 TABLE 5 PGRN-RIKEN CGM COLLABORATIVE STUDIES UNDERWAY 36 TABLE 6 DIAGNOSTICS MANUFACTURER MERGERS AND ACQUISITIONS, TABLE 7 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS BY TABLE 8 GLOBAL DNA DIAGNOSTICS MARKET BY PRODUCT 49 TABLE 9 GLOBAL MOLECULAR DIAGNOSTICS MANUFACTURERS BY MARKET SHARE, 2012 (%) TABLE 10 GLOBAL MICROARRAY MARKET FORECAST FOR DNA DIAGNOSTICS BY TABLE 11 GLOBAL MICROARRAY MARKET BY PRODUCT 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 TABLE 15 GLOBAL PCR MARKET BY PRODUCT 57 TABLE 16 PCR MANUFACTURER MARKET SHARE, 2012 (%) 59 TABLE 17 GLOBAL ISH MARKET FORECAST FOR DNA DIAGNOSTICS BY TABLE 18 GLOBAL ISH PRODUCTS BY MARKET 64 TABLE 19 GLOBAL MARKET FORECAST FOR LAB-ON-A-CHIP/BIOCHIPS BY TABLE 20 GLOBAL LAB-ON-A-CHIP/BIOCHIP PRODUCTS BY MARKET SHARE, TABLE 21 GLOBAL EMERGING/OTHER DNA DIAGNOSTICS MARKET FORECAST BY TABLE 22 GLOBAL EMERGING MOLECULAR DIAGNOSTICS MARKET BY PRODUCT TABLE 23 GLOBAL MARKET FORECAST FOR DNA DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) TABLE 24 GLOBAL MOLECULAR DIAGNOSTICS BY APPLICATION MARKET TABLE 25 GLOBAL PRE/POSTNATAL SCREENING MARKET FORECAST FOR DNA DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) TABLE 26 GLOBAL PRE/POSTNATAL SCREENING MARKET BY PRODUCT SHARE, TABLE 27 GLOBAL INFECTIOUS DISEASES MARKET FORECAST FOR DNA DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) TABLE 28 GLOBAL INFECTIOUS DISEASE SCREENING MARKET BY PRODUCT

11 TABLE HEADING TABLE 29 GLOBAL ONCOLOGY MARKET FORECAST FOR DNA DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) TABLE 30 GLOBAL ONCOLOGY SCREENING MARKET BY PRODUCT SHARE, TABLE 31 GLOBAL IDENTITY TESTING MARKET FORECAST FOR DNA DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) TABLE 32 GLOBAL IDENTITY SCREENING MARKET BY PRODUCT SHARE, 2012 (%) TABLE 33 GLOBAL PHARMACOGENOMICS AND OTHER MARKET FORECAST FOR DNA DIAGNOSTICS BY APPLICATION, THROUGH 2018 ($ MILLIONS) TABLE 34 GLOBAL PHARMACOGENOMIC SCREENING MARKET BY PRODUCT TABLE 35 SELECTED PCR PATENTS GRANTED FROM 2011 TO TABLE 36 SELECTED MICRO-ARRAY PATENTS GRANTED FROM 2011 TO TABLE 37 SELECTED ISH PATENTS GRANTED FROM 2011 TO TABLE 38 SELECTED BIOCHIP/LOAC PATENTS GRANTED FROM 2011 TO TABLE 39 SELECTED EMERGING MOLECULAR DIAGNOSTIC PATENTS GRANTED FROM 2011 TO 2012 TABLE 40 ROCHE - COMPANION DIAGNOSTICS PIPELINE JOINT ONCOLOGY PHARMA AND DIAGNOSTICS

12 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE TOTAL GLOBAL MOLECULAR DIAGNOSTICS MARKET, ($ MILLIONS) FIGURE 1 GROWTH IN CLINICAL LABORATORY SITES AND DISEASE TESTING, FIGURE 2 GLOBAL DNA DIAGNOSTICS MARKET BY PRODUCT 49 FIGURE 3 GLOBAL MOLECULAR DIAGNOSTICS MANUFACTURERS BY MARKET SHARE, 2012 (%) FIGURE 4 GLOBAL MICROARRAY MARKET BY PRODUCT 54 FIGURE 5 GLOBAL PCR MARKET BY PRODUCT 58 FIGURE 6 GLOBAL ISH PRODUCTS BY MARKET 64 FIGURE 7 GLOBAL LAB-ON-A-CHIP/BIOCHIP PRODUCTS BY MARKET SHARE, FIGURE 8 GLOBAL MOLECULAR DIAGNOSTICS BY APPLICATION MARKET FIGURE 9 GLOBAL PRE/POSTNATAL SCREENING MARKET BY PRODUCT FIGURE 10 GLOBAL INFECTIOUS DISEASE SCREENING MARKET BY PRODUCT FIGURE 11 GLOBAL ONCOLOGY SCREENING MARKET BY PRODUCT SHARE, FIGURE 12 GLOBAL IDENTITY SCREENING MARKET BY PRODUCT SHARE,