POLYMERASE CHAIN REACTION (PCR) TECHNOLOGIES AND GLOBAL MARKETS BIO087C August 2016 Shalini Shahani Dewan Project Analyst ISBN: 1-62296-333-4 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215 (toll-free within the USA), or (+1) 781-489-7301 www.bccresearch.com information@bccresearch.com
TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY GOALS AND OBJECTIVES 2 REASONS FOR DOING THIS STUDY 2 INTENDED AUDIENCE 2 SCOPE OF THE STUDY 2 METHODOLOGY 3 INFORMATION SOURCES 3 ANALYSTS' CREDENTIALS 3 RELATED BCC RESEARCH REPORTS 4 BCC RESEARCH WEBSITE 4 DISCLAIMER 5 CHAPTER 2 EXECUTIVE SUMMARY 7 SUMMARY TABLE GLOBAL MARKET FOR PCR PRODUCTS BY REGION, THROUGH 2021 ($ SUMMARY FIGURE 8 8 CHAPTER 3 OVERVIEW 10 POLYMERASE CHAIN REACTION 10 EVOLUTION OF PCR 10 TABLE 1 EVOLUTION OF PCR TECHNOLOGY 11 PRINCIPLES OF PCR 11 INSTRUMENTS AND COMPONENTS OF PCR 12 INSTRUMENTS 12 TARGET DNA 12 PRIMERS 12 ENZYME AND ENZYME CONCENTRATION 13 BUFFERS 13 MAGNESIUM CONCENTRATION 13 DEOXYRIBONUCLEOSIDE TRIPHOSPHATES 13 TYPES OF PCR 13 REVERSE TRANSCRIPTION PCR 14 NESTED PCR 14 HOT START AND TOUCHDOWN PCR 15 INVERSE PCR 15 MULTIPLEX PCR 15 QUANTITATIVE PCR 15 TRADITIONAL PCR VS. REAL-TIME PCR 16 TABLE 2 TRADITIONAL VS. REAL-TIME PCR 16 DESIGN OF PRIMER FOR PCR 17 PRIMER SELECTION 17 PRIMER LENGTH 17 MELTING TEMPERATURE 17 SPECIFICITY 18 G/C CONTENT AND POLYPYRIMIDINE (T, C) OR POLYPURINE (A, G) STRETCHES 18
3' END SEQUENCE 18 PCR QUANTIFICATION METHODS 18 ABSOLUTE QUANTIFICATION 18 Standard Curve Method 18 Digital PCR 19 RELATIVE QUANTIFICATION 19 COMPONENTS OF QUANTITATIVE PCR 19 DNA BINDING DYES 20 TABLE 3 ADVANTAGES AND DISADVANTAGES OF DYE-BASED DETECTION 20 PROBES IN QPCR 20 Linear Probes 21 Structured Probes 21 Molecular Beacon Probes 21 Scorpion Probes 21 CONTROLS FOR QUANTITATIVE PCR EXPERIMENTS 22 APPLICATIONS OF PCR 22 TABLE 4 KEY APPLICATIONS OF PCR TECHNOLOGY 23 THE HUMAN GENOME PROJECT AND PCR 23 CHAPTER 4 REGULATORY APPROVALS 25 GENERAL CONTROLS 25 SPECIAL CONTROLS 25 PREMARKET APPROVAL 25 TABLE 5 NEW APPROVALS OF PCR DEVICES AND KITS BY PREMARKET APPROVAL, 2013- JANUARY 2016 NEW APPROVALS OF PCR MACHINES AND KITS BY 510(K) CLEARANCES FROM 2013- JANUARY 2016 TABLE 6 NEW APPROVALS OF PCR DEVICES AND KITS BY 510(K) CLEARANCES, 2013- JANUARY 2016 RECALLS 31 TABLE 7 RECALLS OF DEVICES, FROM 2013 TO JANUARY 2016 31 26 27 27 CHAPTER 5 NEW DEVELOPMENTS 34 NEW PRODUCT LAUNCHES 34 TABLE 8 NEW PCR PRODUCTS FROM TOP MANUFACTURERS, 2013 JANUARY 2016 34 ALTERNATIVE TECHNOLOGIES TO PCR-BASED ANALYTICAL METHODS 37 LAMP 37 MAP 38 NASBA 38 TMA 39 MERGERS AND ACQUISITIONS 39 TABLE 9 MERGERS AND ACQUISITIONS OF TOP PCR COMPANIES, 2013-JANUARY 2016 39 CHAPTER 6 MARKET ANALYSIS 42 MARKET BY PRODUCT TYPE 42 MARKET OVERVIEW 42 MARKET REVENUE 43
TABLE 10 GLOBAL MARKET FOR PCR PRODUCTS BY TYPE, THROUGH 2021 ($ FIGURE 1 GLOBAL MARKET FOR PCR PRODUCTS BY TYPE, 2014-2021 ($ 44 MARKET SHARE 44 TABLE 11 GLOBAL MARKET SHARE OF PCR PRODUCTS BY TYPE, 2015 (%) 44 FIGURE 2 GLOBAL MARKET SHARE OF PCR PRODUCTS BY TYPE, 2015 (%) 45 INSTRUMENT MARKET BY TYPE AND REGION 45 Market Overview 46 Market Revenue by Type 46 TABLE 12 GLOBAL MARKET FOR PCR INSTRUMENTS BY TYPE, THROUGH 2021 ($ FIGURE 3 GLOBAL MARKET FOR PCR INSTRUMENTS BY TYPE, 2014-2021 ($ Market Revenue by Region 47 TABLE 13 GLOBAL MARKET FOR PCR INSTRUMENTS BY REGION,THROUGH 2021 ($ FIGURE 4 GLOBAL MARKET FOR PCR INSTRUMENTS BY REGION, 2014-2021 ($ Thermal Cyclers 48 Market Overview 48 Market Revenue 49 TABLE 14 GLOBAL MARKET FOR THERMAL CYCLERS BY REGION, THROUGH 2021 ($ FIGURE 5 GLOBAL MARKET FOR THERMAL CYCLERS BY REGION, 2014-2021 ($ Real-time PCR Instruments 50 Market Overview 50 Market Revenue 51 TABLE 15 GLOBAL MARKET FOR REAL-TIME PCR INSTRUMENTS BY REGION, THROUGH 2021 ($ FIGURE 6 GLOBAL MARKET FOR REAL-TIME PCR INSTRUMENTS BY REGION, 2014-2021 ($ MARKET FOR REAGENTS AND CONSUMABLES BY TYPE AND REGION 52 Market Overview 52 Market Revenue by Type 53 TABLE 16 GLOBAL MARKET FOR PCR REAGENTS AND CONSUMABLES BY TYPE, THROUGH 2021 ($ FIGURE 7 GLOBAL MARKET FOR PCR REAGENTS AND CONSUMABLES BY TYPE, 2014-2021 ($ Market Revenue by Region 54 TABLE 17 GLOBAL MARKET FOR PCR REAGENTS AND CONSUMABLES BY REGION, THROUGH 2021 ($ FIGURE 8 GLOBAL MARKET FOR PCR REAGENTS AND CONSUMABLES BY REGION, 2014-2021 ($ Individual Reagents 56 Market Overview 57 Market Revenue by Type 57 TABLE 18 GLOBAL MARKET FOR PCR INDIVIDUAL REAGENTS BY TYPE, THROUGH 2021 ($ 44 47 47 48 48 49 49 51 51 54 54 55 55 58
FIGURE 9 GLOBAL MARKET FOR PCR INDIVIDUAL REAGENTS BY TYPE, 2014-2021 ($ Market Revenue by Region 59 TABLE 19 GLOBAL MARKET FOR PCR INDIVIDUAL REAGENTS BY REGION, THROUGH 2021 ($ FIGURE 10 GLOBAL MARKET FOR PCR INDIVIDUAL REAGENTS BY REGION, 2014-2021 ($ Master Mixes and Reagent Kits 60 Market Overview 60 Market Revenue 61 TABLE 20 GLOBAL MARKET FOR PCR MASTER MIXES/ REAGENT KITS BY REGION, THROUGH 2021 ($ FIGURE 11 GLOBAL MARKET FOR PCR MASTER MIXES/REAGENT KITS BY REGION, 2014-2021 ($ Other Reagents 62 Market Overview 62 Market Revenue 62 TABLE 21 GLOBAL MARKET FOR OTHER REAGENTS BY REGION, THROUGH 2021 ($ FIGURE 12 GLOBAL MARKET FOR OTHER REAGENTS BY REGION, 2014-2021 ($ Consumables 63 Market Overview 64 Market Revenue 64 TABLE 22 GLOBAL MARKET FOR CONSUMABLES BY REGION, THROUGH 2021 ($ FIGURE 13 GLOBAL MARKET FOR CONSUMABLES BY REGION, 2014-2021 ($ PCR SOFTWARE MARKET BY TYPE AND REGION 65 Market Overview 65 Market Revenue by Type 66 TABLE 23 GLOBAL MARKET FOR PCR SOFTWARE BY TYPE, THROUGH 2021 ($ FIGURE 14 GLOBAL MARKET FOR PCR SOFTWARE BY TYPE, 2014-2021 ($ 66 Market Revenue by Region 67 TABLE 24 GLOBAL MARKET FOR PCR SOFTWARE BY REGION, THROUGH 2021 ($ FIGURE 15 GLOBAL MARKET FOR PCR SOFTWARE BY REGION, 2014-2021 ($ Primer Design and Sequencing Software 68 Market Overview 68 Market Revenue 69 TABLE 25 GLOBAL MARKET FOR PRIMER DESIGN AND SEQUENCING SOFTWARE BY REGION, THROUGH 2021 ($ FIGURE 16 GLOBAL MARKET FOR PRIMER DESIGN AND SEQUENCING SOFTWARE BY REGION, 2014-2021 ($ PCR Analyzer Software 70 Market Overview 70 Market Revenue 70 58 59 59 61 61 63 63 64 64 66 67 68 69 69
TABLE 26 GLOBAL MARKET FOR PCR ANALYZER SOFTWARE BY REGION, THROUGH 2021 ($ FIGURE 17 GLOBAL MARKET FOR PCR ANALYZER SOFTWARE BY REGION, 2014-2021 ($ Other Software Markets 71 Market Overview 72 Market Revenue 72 TABLE 27 GLOBAL MARKET FOR OTHER SOFTWARE BY REGION, THROUGH 2021 ($ FIGURE 18 GLOBAL MARKET FOR OTHER SOFTWARE BY REGION, 2014-2021 ($ SERVICES MARKET 73 Market Overview 73 Market Revenue 74 TABLE 28 GLOBAL MARKET FOR PCR SERVICES BY REGION, THROUGH 2021 ($ FIGURE 19 GLOBAL MARKET FOR PCR SERVICES BY REGION, 2014-2021 ($ 71 71 72 73 74 74 CHAPTER 7 INDUSTRY STRUCTURE 76 PCR INSTRUMENTS 76 MARKET LEADERS 76 TABLE 29 LEADING MANUFACTURERS/SUPPLIERS OF PCR INSTRUMENTS, 2015 76 MARKET SHARE 77 TABLE 30 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR INSTRUMENTS, 2015 (%) FIGURE 20 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR INSTRUMENTS, 2015 (%) REAGENTS AND CONSUMABLES 78 MARKET LEADERS 78 TABLE 31 LEADING MANUFACTURERS/SUPPLIERS OF PCR REAGENTS AND CONSUMABLES, 2015 MARKET SHARE 81 TABLE 32 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR REAGENTS AND CONSUMABLES, 2015 (%) FIGURE 21 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR REAGENTS AND CONSUMABLES, 2015 (%) PCR SOFTWARE 82 MARKET LEADERS 82 TABLE 33 LEADING MANUFACTURERS/SUPPLIERS OF PCR SOFTWARE, 2015 83 MARKET SHARE 83 TABLE 34 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR SOFTWARE, 2015 (%) FIGURE 22 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR SOFTWARE, 2015 (%) 77 77 78 81 82 84 84 CHAPTER 8 MARKET BY APPLICATION AND TECHNOLOGY 86 MARKET BY TECHNOLOGY 86 MARKET OVERVIEW 86 MARKET REVENUE 87
TABLE 35 GLOBAL MARKET FOR PCR TECHNOLOGY BY TYPE, THROUGH 2021 ($ FIGURE 23 GLOBAL MARKET FOR PCR TECHNOLOGY BY TYPE, 2014-2021 ($ MARKET SHARE 88 TABLE 36 GLOBAL MARKET SHARE OF PCR TECHNOLOGY BY TYPE, 2015 (%) 88 FIGURE 24 GLOBAL MARKET SHARE OF PCR TECHNOLOGY BY TYPE, 2015 (%) 89 REAL-TIME PCR 89 Market Overview 90 Market Revenue 90 TABLE 37 GLOBAL MARKET FOR REAL-TIME PCR TECHNOLOGY BY REGION, THROUGH 2021 ($ FIGURE 25 GLOBAL MARKET FOR REAL-TIME PCR TECHNOLOGY BY REGION, 2014-2021 ($ REVERSE TRANSCRIPTASE PCR 91 Market Overview 92 Market Revenue 92 TABLE 38 GLOBAL MARKET FOR REVERSE TRANSCRIPTASE PCR TECHNOLOGY BY REGION, THROUGH 2021 ($ FIGURE 26 GLOBAL MARKET FOR REVERSE TRANSCRIPTASE PCR TECHNOLOGY, BY REGION, 2014-2021 ($ INVERSE AND STANDARD PCR 93 Market Overview 93 Market Revenue 94 TABLE 39 GLOBAL MARKET FOR INVERSE AND STANDARD PCR TECHNOLOGY BY REGION, THROUGH 2021 ($ FIGURE 27 GLOBAL MARKET FOR INVERSE AND STANDARD PCR TECHNOLOGY BY REGION, 2014-2021 ($ ASSEMBLY AND NESTED PCR 95 Market Overview 95 Market Revenue 95 TABLE 40 GLOBAL MARKET FOR ASSEMBLY AND NESTED PCR TECHNOLOGY BY REGION, THROUGH 2021 ($ FIGURE 28 GLOBAL MARKET FOR ASSEMBLY AND NESTED PCR TECHNOLOGY BY REGION, 2014-2021 ($ HOT START AND TOUCHDOWN PCR 96 Market Overview 97 Market Revenue 97 TABLE 41 GLOBAL MARKET FOR HOT START AND TOUCHDOWN PCR TECHNOLOGY BY REGION, THROUGH 2021 ($ FIGURE 29 GLOBAL MARKET FOR HOT START AND TOUCHDOWN PCR TECHNOLOGY BY REGION, 2014-2021 ($ MULTIPLEX PCR AND OTHER PCR 98 Market Overview 98 Market Revenue 99 TABLE 42 GLOBAL MARKET FOR MULTIPLEX AND OTHER PCR TECHNOLOGIES BY REGION, THROUGH 2021 ($ FIGURE 30 GLOBAL MARKET FOR MULTIPLEX AND OTHER PCR TECHNOLOGIES BY REGION, 2014-2021 ($ MARKET BY APPLICATION 100 88 88 91 91 92 93 94 94 96 96 97 98 99 99
MARKET OVERVIEW 100 MARKET REVENUE 101 TABLE 43 GLOBAL MARKET FOR PCR PRODUCTS BY APPLICATION, THROUGH 2021 ($ FIGURE 31 GLOBAL MARKET FOR PCR PRODUCTS BY APPLICATION, 2014-2021 ($ MARKET SHARE 102 TABLE 44 GLOBAL MARKET SHARE OF PCR PRODUCTS BY APPLICATION, 2015 (%) 102 FIGURE 32 GLOBAL MARKET SHARE OF PCR PRODUCTS BY APPLICATION, 2015 (%) 102 RESEARCH APPLICATIONS 102 Market Overview 103 Market Revenue by Type 103 TABLE 45 GLOBAL MARKET FOR PCR PRODUCTS FOR RESEARCH APPLICATIONS BY TYPE, THROUGH 2021 ($ FIGURE 33 GLOBAL MARKET FOR PCR PRODUCTS FOR RESEARCH APPLICATIONS BY TYPE, 2014-2021 ($ Market Revenue by Region 105 TABLE 46 GLOBAL MARKET FOR PCR PRODUCTS FOR RESEARCH APPLICATIONS BY REGION, THROUGH 2021 ($ FIGURE 34 GLOBAL MARKET FOR PCR PRODUCTS FOR RESEARCH APPLICATIONS BY REGION, 2014-2021 ($ DNA Cloning 106 Market Overview 106 Market Revenue 106 TABLE 47 GLOBAL MARKET FOR DNA CLONING BY REGION, THROUGH 2021 ($ FIGURE 35 GLOBAL MARKET FOR DNA CLONING BY REGION, 2014-2021 ($ Gene Expression and Genetic Mapping 107 Market Overview 108 Market Revenue 108 TABLE 48 GLOBAL MARKET FOR GENE EXPRESSION AND GENETIC MAPPING BY REGION, THROUGH 2021 ($ FIGURE 36 GLOBAL MARKET FOR GENE EXPRESSION AND GENETIC MAPPING BY REGION, 2014-2021 ($ Genotyping 109 Market Overview 110 Market Revenue 110 TABLE 49 GLOBAL MARKET FOR GENOTYPING BY REGION, THROUGH 2021 ($ FIGURE 37 GLOBAL MARKET FOR GENOTYPING BY REGION, 2014-2021 ($ 111 DNA Sequencing 111 Market Overview 112 Market Revenue 112 TABLE 50 GLOBAL MARKET FOR DNA SEQUENCING BY REGION, THROUGH 2021 ($ FIGURE 38 GLOBAL MARKET FOR DNA SEQUENCING BY REGION, 2014-2021 ($ Forensic Science 113 Market Overview 114 101 101 104 104 105 105 107 107 109 109 111 113 113
Market Revenue 114 TABLE 51 GLOBAL MARKET FOR FORENSIC SCIENCE BY REGION, THROUGH 2021 ($ FIGURE 39 GLOBAL MARKET FOR FORENSIC SCIENCE BY REGION, 2014-2021 ($ Bioinformatics 115 Market Overview 116 Market Revenue 116 TABLE 52 GLOBAL MARKET FOR BIOINFORMATICS BY REGION, THROUGH 2021 ($ FIGURE 40 GLOBAL MARKET FOR BIOINFORMATICS BY REGION, 2014-2021 ($ Other Research Applications 117 Market Overview 117 Market Revenue 117 TABLE 53 GLOBAL MARKET FOR OTHER RESEARCH BY REGION, THROUGH 2021 ($ FIGURE 41 GLOBAL MARKET FOR OTHER RESEARCH BY REGION, 2014-2021 ($ CLINICAL APPLICATIONS 118 Market Overview 119 Market Revenue by Type 119 TABLE 54 GLOBAL MARKET FOR PCR PRODUCTS FOR CLINICAL RESEARCH APPLICATIONS BY TYPE, THROUGH 2021 ($ FIGURE 42 GLOBAL MARKET FOR PCR PRODUCTS FOR CLINICAL RESEARCH APPLICATIONS BY TYPE, 2014-2021 ($ Market Revenue by Region 121 TABLE 55 GLOBAL MARKET FOR PCR PRODUCTS FOR CLINICAL RESEARCH APPLICATIONS BY REGION, THROUGH 2021 ($ FIGURE 43 GLOBAL MARKET FOR PCR PRODUCTS FOR CLINICAL RESEARCH APPLICATIONS BY REGION, 2014-2021 ($ Infectious Disease Diagnosis 122 Market Overview 122 Market Revenue 123 TABLE 56 GLOBAL MARKET FOR INFECTIOUS DISEASE DIAGNOSIS BY REGION, THROUGH 2021 ($ FIGURE 44 GLOBAL MARKET FOR INFECTIOUS DISEASE DIAGNOSIS BY REGION, 2014-2021 ($ Genetic Testing 124 Market Overview 124 Market Revenue 125 TABLE 57 GLOBAL MARKET FOR GENETIC TESTING BY REGION, THROUGH 2021 ($ FIGURE 45 GLOBAL MARKET FOR GENETIC TESTING BY REGION, 2014-2021 ($ Cancer Therapy Determination 126 Market Overview 126 Market Revenue 127 TABLE 58 GLOBAL MARKET FOR CANCER THERAPY BY REGION, THROUGH 2021 ($ 115 115 116 117 118 118 120 120 121 121 123 123 125 125 127
FIGURE 46 GLOBAL MARKET FOR CANCER THERAPY BY REGION, 2014-2021 ($ Blood Screening 128 Market Overview 128 Market Revenue 128 TABLE 59 GLOBAL MARKET FOR BLOOD SCREENING BY REGION, THROUGH 2021 ($ FIGURE 47 GLOBAL MARKET FOR BLOOD SCREENING BY REGION, 2014-2021 ($ Tissue Typing 129 Market Overview 129 Market Revenue 130 TABLE 60 GLOBAL MARKET FOR TISSUE TYPING BY REGION, THROUGH 2021 ($ FIGURE 48 GLOBAL MARKET FOR TISSUE TYPING BY REGION, 2014-2021 ($ Prenatal Diagnosis 131 Market Overview 131 Market Revenue 131 TABLE 61 GLOBAL MARKET FOR PRENATAL DIAGNOSIS BY REGION, THROUGH 2021 ($ FIGURE 49 GLOBAL MARKET FOR PRENATAL DIAGNOSIS BY REGION, 2014-2021 ($ OTHER PCR APPLICATIONS 132 Market Overview 133 Market Revenue 133 TABLE 62 GLOBAL MARKET FOR OTHER PCR APPLICATION BY REGION, THROUGH 2021 ($ FIGURE 50 GLOBAL MARKET FOR OTHER PCR APPLICATION BY REGION, 2014-2021 ($ 127 128 129 130 130 131 132 133 133 CHAPTER 9 PATENT ANALYSIS 136 PATENTS BY YEAR 136 TABLE 63 NUMBER OF PATENTS BY YEAR, JANUARY 2013-JANUARY 2016 137 FIGURE 51 NUMBER OF PATENTS BY YEAR, JANUARY 2013-JANUARY 2016 137 PATENTS BY TYPE 137 TABLE 64 NUMBER OF PATENTS BY TYPE, JANUARY 2013-JANUARY 2016 137 FIGURE 52 NUMBER OF PATENTS BY TYPE, JANUARY 2013-JANUARY 2016 137 PATENTS BY COMPANY 138 TABLE 65 NUMBER OF PATENTS BY COMPANY, JANUARY 2013-JANUARY 2016 138 PATENTS BY COUNTRY 139 TABLE 66 NUMBER OF PATENTS BY COUNTRY, JANUARY 2013-JANUARY 2016 140 TABLE 67 PATENT SHARES BY COUNTRY, JANUARY 2013-JANUARY 2016 (NO./%) 140 FIGURE 53 PATENT SHARES BY COUNTRY, JANUARY 2013-JANUARY 2016 (%) 140 PATENTS BY ASSIGNEE 141 TABLE 68 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2013-JANUARY 2016 141 FIGURE 54 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2013-JANUARY 2016 141 CHAPTER 10 CURRENT SITUATION 144
FACTORS AFFECTING THE PCR MARKET 144 DRIVERS 144 Growth in Proteomics and Genomics 144 Product Launches and Increased Technology Adoption 145 Prevalence of Chronic Diseases and Growth in the Molecular Diagnostic Industry Broad Range of Applications 146 RESTRAINTS AND CHALLENGES 146 Product Prices 146 Lack of Trained Professionals 146 Lack of Awareness 146 Development of Alternative Technologies 147 OPPORTUNITIES 147 145 CHAPTER 11 COMPANY PROFILES 149 ABBOTT LABORATORIES 149 AFFYMETRIX INC. 149 AGILENT TECHNOLOGIES INC. 150 ALPHAHELIX MOLECULAR DIAGNOSTICS AB 150 AMPLICON EXPRESS INC. 151 ANASPEC INC. (EUROGENTEC GROUP) 151 BECKMAN COULTER INC. 151 BECTON, DICKINSON & CO. 152 BIOLINE GMBH 152 BIONEER CORP. 153 BIOFIRE DIAGNOSTICS LLC 153 BIO-RAD LABORATORIES INC. 154 COMPLETE GENOMICS INC. 154 ELITECH GROUP MOLECULAR DIAGNOSTICS 155 EPPENDORF AG 156 EXIQON 156 F. HOFFMAN-LA ROCHE LTD. 157 GE ELECTRIC HEALTHCARE LIFE SCIENCES. 157 KAPA BIOSYSTEMS INC. 158 LUCIGEN CORP. 158 LUMINEX CORP. 159 NEW ENGLAND BIOLABS 159 PROMEGA CORP. 159 QIAGEN N.V. 160 QUANTA BIOSCIENCES INC. 160 SIGMA-ALDRICH CORP. 161 TAKARA BIO INC. 161 THERMO FISHER SCIENTIFIC INC. 162 CHAPTER 12 APPENDIX I-ABBREVIATIONS 165 ABBREVIATIONS 165
LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL MARKET FOR PCR PRODUCTS BY REGION, THROUGH 2021 ($ TABLE 1 EVOLUTION OF PCR TECHNOLOGY 11 TABLE 2 TRADITIONAL VS. REAL-TIME PCR 16 TABLE 3 ADVANTAGES AND DISADVANTAGES OF DYE-BASED DETECTION 20 TABLE 4 KEY APPLICATIONS OF PCR TECHNOLOGY 23 TABLE 5 NEW APPROVALS OF PCR DEVICES AND KITS BY PREMARKET APPROVAL, 2013- JANUARY 2016 TABLE 6 NEW APPROVALS OF PCR DEVICES AND KITS BY 510(K) CLEARANCES, 2013- JANUARY 2016 TABLE 7 RECALLS OF DEVICES, FROM 2013 TO JANUARY 2016 31 TABLE 8 NEW PCR PRODUCTS FROM TOP MANUFACTURERS, 2013 JANUARY 2016 34 TABLE 9 MERGERS AND ACQUISITIONS OF TOP PCR COMPANIES, 2013-JANUARY 2016 TABLE 10 GLOBAL MARKET FOR PCR PRODUCTS BY TYPE, THROUGH 2021 ($ TABLE 11 GLOBAL MARKET SHARE OF PCR PRODUCTS BY TYPE, 2015 (%) 44 TABLE 12 GLOBAL MARKET FOR PCR INSTRUMENTS BY TYPE, THROUGH 2021 ($ TABLE 13 GLOBAL MARKET FOR PCR INSTRUMENTS BY REGION,THROUGH 2021 ($ TABLE 14 GLOBAL MARKET FOR THERMAL CYCLERS BY REGION, THROUGH 2021 ($ TABLE 15 GLOBAL MARKET FOR REAL-TIME PCR INSTRUMENTS BY REGION, THROUGH 2021 ($ TABLE 16 GLOBAL MARKET FOR PCR REAGENTS AND CONSUMABLES BY TYPE, THROUGH 2021 ($ TABLE 17 GLOBAL MARKET FOR PCR REAGENTS AND CONSUMABLES BY REGION, THROUGH 2021 ($ TABLE 18 GLOBAL MARKET FOR PCR INDIVIDUAL REAGENTS BY TYPE, THROUGH 2021 ($ TABLE 19 GLOBAL MARKET FOR PCR INDIVIDUAL REAGENTS BY REGION, THROUGH 2021 ($ TABLE 20 GLOBAL MARKET FOR PCR MASTER MIXES/ REAGENT KITS BY REGION, THROUGH 2021 ($ TABLE 21 GLOBAL MARKET FOR OTHER REAGENTS BY REGION, THROUGH 2021 ($ TABLE 22 GLOBAL MARKET FOR CONSUMABLES BY REGION, THROUGH 2021 ($ TABLE 23 GLOBAL MARKET FOR PCR SOFTWARE BY TYPE, THROUGH 2021 ($ TABLE 24 GLOBAL MARKET FOR PCR SOFTWARE BY REGION, THROUGH 2021 ($ TABLE 25 GLOBAL MARKET FOR PRIMER DESIGN AND SEQUENCING SOFTWARE BY REGION, THROUGH 2021 ($ TABLE 26 GLOBAL MARKET FOR PCR ANALYZER SOFTWARE BY REGION, THROUGH 2021 ($ TABLE 27 GLOBAL MARKET FOR OTHER SOFTWARE BY REGION, THROUGH 2021 ($ TABLE 28 GLOBAL MARKET FOR PCR SERVICES BY REGION, THROUGH 2021 ($ 8 26 27 39 44 47 48 49 51 54 55 58 59 61 63 64 66 67 69 71 72 74
TABLE HEADING TABLE 29 LEADING MANUFACTURERS/SUPPLIERS OF PCR INSTRUMENTS, 2015 76 TABLE 30 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR INSTRUMENTS, 2015 (%) TABLE 31 LEADING MANUFACTURERS/SUPPLIERS OF PCR REAGENTS AND CONSUMABLES, 2015 TABLE 32 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR REAGENTS AND CONSUMABLES, 2015 (%) TABLE 33 LEADING MANUFACTURERS/SUPPLIERS OF PCR SOFTWARE, 2015 83 TABLE 34 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR SOFTWARE, 2015 (%) TABLE 35 GLOBAL MARKET FOR PCR TECHNOLOGY BY TYPE, THROUGH 2021 ($ TABLE 36 GLOBAL MARKET SHARE OF PCR TECHNOLOGY BY TYPE, 2015 (%) 88 TABLE 37 GLOBAL MARKET FOR REAL-TIME PCR TECHNOLOGY BY REGION, THROUGH 2021 ($ TABLE 38 GLOBAL MARKET FOR REVERSE TRANSCRIPTASE PCR TECHNOLOGY BY REGION, THROUGH 2021 ($ TABLE 39 GLOBAL MARKET FOR INVERSE AND STANDARD PCR TECHNOLOGY BY REGION, THROUGH 2021 ($ TABLE 40 GLOBAL MARKET FOR ASSEMBLY AND NESTED PCR TECHNOLOGY BY REGION, THROUGH 2021 ($ TABLE 41 GLOBAL MARKET FOR HOT START AND TOUCHDOWN PCR TECHNOLOGY BY REGION, THROUGH 2021 ($ TABLE 42 GLOBAL MARKET FOR MULTIPLEX AND OTHER PCR TECHNOLOGIES BY REGION, THROUGH 2021 ($ TABLE 43 GLOBAL MARKET FOR PCR PRODUCTS BY APPLICATION, THROUGH 2021 ($ TABLE 44 GLOBAL MARKET SHARE OF PCR PRODUCTS BY APPLICATION, 2015 (%) 102 TABLE 45 GLOBAL MARKET FOR PCR PRODUCTS FOR RESEARCH APPLICATIONS BY TYPE, THROUGH 2021 ($ TABLE 46 GLOBAL MARKET FOR PCR PRODUCTS FOR RESEARCH APPLICATIONS BY REGION, THROUGH 2021 ($ TABLE 47 GLOBAL MARKET FOR DNA CLONING BY REGION, THROUGH 2021 ($ TABLE 48 GLOBAL MARKET FOR GENE EXPRESSION AND GENETIC MAPPING BY REGION, THROUGH 2021 ($ TABLE 49 GLOBAL MARKET FOR GENOTYPING BY REGION, THROUGH 2021 ($ TABLE 50 GLOBAL MARKET FOR DNA SEQUENCING BY REGION, THROUGH 2021 ($ TABLE 51 GLOBAL MARKET FOR FORENSIC SCIENCE BY REGION, THROUGH 2021 ($ TABLE 52 GLOBAL MARKET FOR BIOINFORMATICS BY REGION, THROUGH 2021 ($ TABLE 53 GLOBAL MARKET FOR OTHER RESEARCH BY REGION, THROUGH 2021 ($ TABLE 54 GLOBAL MARKET FOR PCR PRODUCTS FOR CLINICAL RESEARCH APPLICATIONS BY TYPE, THROUGH 2021 ($ TABLE 55 GLOBAL MARKET FOR PCR PRODUCTS FOR CLINICAL RESEARCH APPLICATIONS BY REGION, THROUGH 2021 ($ TABLE 56 GLOBAL MARKET FOR INFECTIOUS DISEASE DIAGNOSIS BY REGION, THROUGH 2021 ($ 77 78 81 84 88 91 92 94 96 97 99 101 104 105 107 109 111 113 115 116 118 120 121 123
TABLE HEADING TABLE 57 GLOBAL MARKET FOR GENETIC TESTING BY REGION, THROUGH 2021 ($ TABLE 58 GLOBAL MARKET FOR CANCER THERAPY BY REGION, THROUGH 2021 ($ TABLE 59 GLOBAL MARKET FOR BLOOD SCREENING BY REGION, THROUGH 2021 ($ TABLE 60 GLOBAL MARKET FOR TISSUE TYPING BY REGION, THROUGH 2021 ($ TABLE 61 GLOBAL MARKET FOR PRENATAL DIAGNOSIS BY REGION, THROUGH 2021 ($ TABLE 62 GLOBAL MARKET FOR OTHER PCR APPLICATION BY REGION, THROUGH 2021 ($ TABLE 63 NUMBER OF PATENTS BY YEAR, JANUARY 2013-JANUARY 2016 137 TABLE 64 NUMBER OF PATENTS BY TYPE, JANUARY 2013-JANUARY 2016 137 TABLE 65 NUMBER OF PATENTS BY COMPANY, JANUARY 2013-JANUARY 2016 138 TABLE 66 NUMBER OF PATENTS BY COUNTRY, JANUARY 2013-JANUARY 2016 140 TABLE 67 PATENT SHARES BY COUNTRY, JANUARY 2013-JANUARY 2016 (NO./%) 140 TABLE 68 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2013-JANUARY 2016 141 125 127 128 130 131 133
LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE 8 FIGURE 1 GLOBAL MARKET FOR PCR PRODUCTS BY TYPE, 2014-2021 ($ 44 FIGURE 2 GLOBAL MARKET SHARE OF PCR PRODUCTS BY TYPE, 2015 (%) 45 FIGURE 3 GLOBAL MARKET FOR PCR INSTRUMENTS BY TYPE, 2014-2021 ($ FIGURE 4 GLOBAL MARKET FOR PCR INSTRUMENTS BY REGION, 2014-2021 ($ FIGURE 5 GLOBAL MARKET FOR THERMAL CYCLERS BY REGION, 2014-2021 ($ FIGURE 6 GLOBAL MARKET FOR REAL-TIME PCR INSTRUMENTS BY REGION, 2014-2021 ($ FIGURE 7 GLOBAL MARKET FOR PCR REAGENTS AND CONSUMABLES BY TYPE, 2014-2021 ($ FIGURE 8 GLOBAL MARKET FOR PCR REAGENTS AND CONSUMABLES BY REGION, 2014-2021 ($ FIGURE 9 GLOBAL MARKET FOR PCR INDIVIDUAL REAGENTS BY TYPE, 2014-2021 ($ FIGURE 10 GLOBAL MARKET FOR PCR INDIVIDUAL REAGENTS BY REGION, 2014-2021 ($ FIGURE 11 GLOBAL MARKET FOR PCR MASTER MIXES/REAGENT KITS BY REGION, 2014-2021 ($ FIGURE 12 GLOBAL MARKET FOR OTHER REAGENTS BY REGION, 2014-2021 ($ FIGURE 13 GLOBAL MARKET FOR CONSUMABLES BY REGION, 2014-2021 ($ FIGURE 14 GLOBAL MARKET FOR PCR SOFTWARE BY TYPE, 2014-2021 ($ 66 FIGURE 15 GLOBAL MARKET FOR PCR SOFTWARE BY REGION, 2014-2021 ($ FIGURE 16 GLOBAL MARKET FOR PRIMER DESIGN AND SEQUENCING SOFTWARE BY REGION, 2014-2021 ($ FIGURE 17 GLOBAL MARKET FOR PCR ANALYZER SOFTWARE BY REGION, 2014-2021 ($ FIGURE 18 GLOBAL MARKET FOR OTHER SOFTWARE BY REGION, 2014-2021 ($ FIGURE 19 GLOBAL MARKET FOR PCR SERVICES BY REGION, 2014-2021 ($ 74 FIGURE 20 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR INSTRUMENTS, 2015 (%) FIGURE 21 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR REAGENTS AND CONSUMABLES, 2015 (%) FIGURE 22 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS OF PCR SOFTWARE, 2015 (%) FIGURE 23 GLOBAL MARKET FOR PCR TECHNOLOGY BY TYPE, 2014-2021 ($ FIGURE 24 GLOBAL MARKET SHARE OF PCR TECHNOLOGY BY TYPE, 2015 (%) 89 FIGURE 25 GLOBAL MARKET FOR REAL-TIME PCR TECHNOLOGY BY REGION, 2014-2021 ($ FIGURE 26 GLOBAL MARKET FOR REVERSE TRANSCRIPTASE PCR TECHNOLOGY, BY REGION, 2014-2021 ($ FIGURE 27 GLOBAL MARKET FOR INVERSE AND STANDARD PCR TECHNOLOGY BY REGION, 2014-2021 ($ 47 48 49 51 54 55 58 59 61 63 64 68 69 71 73 77 82 84 88 91 93 94
FIGURE TITLE FIGURE 28 GLOBAL MARKET FOR ASSEMBLY AND NESTED PCR TECHNOLOGY BY REGION, 2014-2021 ($ FIGURE 29 GLOBAL MARKET FOR HOT START AND TOUCHDOWN PCR TECHNOLOGY BY REGION, 2014-2021 ($ FIGURE 30 GLOBAL MARKET FOR MULTIPLEX AND OTHER PCR TECHNOLOGIES BY REGION, 2014-2021 ($ FIGURE 31 GLOBAL MARKET FOR PCR PRODUCTS BY APPLICATION, 2014-2021 ($ FIGURE 32 GLOBAL MARKET SHARE OF PCR PRODUCTS BY APPLICATION, 2015 (%) 102 FIGURE 33 GLOBAL MARKET FOR PCR PRODUCTS FOR RESEARCH APPLICATIONS BY TYPE, 2014-2021 ($ FIGURE 34 GLOBAL MARKET FOR PCR PRODUCTS FOR RESEARCH APPLICATIONS BY REGION, 2014-2021 ($ FIGURE 35 GLOBAL MARKET FOR DNA CLONING BY REGION, 2014-2021 ($ 107 FIGURE 36 GLOBAL MARKET FOR GENE EXPRESSION AND GENETIC MAPPING BY REGION, 2014-2021 ($ FIGURE 37 GLOBAL MARKET FOR GENOTYPING BY REGION, 2014-2021 ($ 111 FIGURE 38 GLOBAL MARKET FOR DNA SEQUENCING BY REGION, 2014-2021 ($ FIGURE 39 GLOBAL MARKET FOR FORENSIC SCIENCE BY REGION, 2014-2021 ($ FIGURE 40 GLOBAL MARKET FOR BIOINFORMATICS BY REGION, 2014-2021 ($ FIGURE 41 GLOBAL MARKET FOR OTHER RESEARCH BY REGION, 2014-2021 ($ FIGURE 42 GLOBAL MARKET FOR PCR PRODUCTS FOR CLINICAL RESEARCH APPLICATIONS BY TYPE, 2014-2021 ($ FIGURE 43 GLOBAL MARKET FOR PCR PRODUCTS FOR CLINICAL RESEARCH APPLICATIONS BY REGION, 2014-2021 ($ FIGURE 44 GLOBAL MARKET FOR INFECTIOUS DISEASE DIAGNOSIS BY REGION, 2014-2021 ($ FIGURE 45 GLOBAL MARKET FOR GENETIC TESTING BY REGION, 2014-2021 ($ FIGURE 46 GLOBAL MARKET FOR CANCER THERAPY BY REGION, 2014-2021 ($ FIGURE 47 GLOBAL MARKET FOR BLOOD SCREENING BY REGION, 2014-2021 ($ FIGURE 48 GLOBAL MARKET FOR TISSUE TYPING BY REGION, 2014-2021 ($ FIGURE 49 GLOBAL MARKET FOR PRENATAL DIAGNOSIS BY REGION, 2014-2021 ($ FIGURE 50 GLOBAL MARKET FOR OTHER PCR APPLICATION BY REGION, 2014-2021 ($ FIGURE 51 NUMBER OF PATENTS BY YEAR, JANUARY 2013-JANUARY 2016 137 FIGURE 52 NUMBER OF PATENTS BY TYPE, JANUARY 2013-JANUARY 2016 137 FIGURE 53 PATENT SHARES BY COUNTRY, JANUARY 2013-JANUARY 2016 (%) 140 FIGURE 54 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2013-JANUARY 2016 141 96 98 99 101 104 105 109 113 115 117 118 120 121 123 125 127 129 130 132 133