IN VITRO DIAGNOSTICS: TECHNOLOGIES AND GLOBAL MARKETS

IN VITRO DIAGNOSTICS: TECHNOLOGIES AND GLOBAL MARKETS HLC186A November 2015 Sangeetha Prabakar Project Analyst ISBN: 1-62296-178-1 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 CONTRIBUTION OF THE STUDY AND FOR WHOM 3 SCOPE OF REPORT 3 METHODOLOGY 4 ANALYST'S CREDENTIALS 4 RELATED BCC RESEARCH REPORTS 5 BCC RESEARCH WEBSITE 5 DISCLAIMER 5 CHAPTER 2 SUMMARY 7 INTRODUCTION 7 GLOBAL MARKET TRENDS 7 SUMMARY TABLE GLOBAL IVD MARKET BY REGION, THROUGH 2020 ($ 8 SUMMARY FIGURE GLOBAL IVD MARKET BY REGION, 2013-2020 ($ 9 CHAPTER 3 MARKET LANDSCAPE 11 MARKET OVERVIEW AND SEGMENTATION 11 FIGURE 1 MARKET SEGMENTATION 11 KEY FINDINGS 11 FACTORS INFLUENCING THE GLOBAL IVD MARKET 13 DRIVERS 13 Need for Disease Detection before Appearance of Symptoms 13 Need to Identify the Right Patients for Drug Therapy 13 Need for Faster Real-Time Tests that Enable Personalized Treatment 13 Point-of-Care Tests that Minimize Dependency on Lab Testing 14 Improving Healthcare Budgets Drive Demand for IVD in Emerging Markets Rising Aging Population and Global Incidence of Chronic Diseases 14 Discovery of New Biomarkers and Advances in Molecular Techniques 15 Public and Environmental Health Monitoring Requires the Use of IVDs for Faster Diagnosis and Treatment RESTRAINTS 16 Declining Reimbursement for IVDs in Europe Reduces Growth 16 U.S. Medical Device Tax Reduces Profits for Manufacturers 16 Stringent Regulatory Framework to Stifle the Growth of IVD Market 16 High R&D and Marketing Costs 17 Regulatory Disparities and the Expansion of Laboratory-developed Tests REGULATORY LANDSCAPE 18 IVD REGULATIONS IN NORTH AMERICA 18 U.S. 18 TABLE 1 TYPES OF DIAGNOSTIC TESTS AND HOW THEY ARE REGULATED 18 Canada 19 IVD REGULATIONS IN EUROPE 19 14 15 17

IVD REGULATIONS IN ASIA 20 Japan 20 China 20 India 21 Australia and New Zealand 21 Malaysia 22 Singapore 22 TABLE 2 CHANGES IN IVD REGULATIONS IN ASIA 23 IVD REGULATIONS IN LAAM 23 Brazil 23 Mexico 24 Israel 25 Saudi Arabia 25 South Africa 25 CHAPTER 4 GLOBAL IVD MARKET BY SUBCATEGORIES 28 INTRODUCTION 28 DESCRIPTION 28 IMMUNOCHEMISTRY 28 POC TESTING 28 MOLECULAR DIAGNOSTICS 28 HEMATOLOGY 28 CLINICAL MICROBIOLOGY 29 TISSUE DIAGNOSTICS 29 TRENDS IN IVD SEGMENTS 29 TABLE 3 GLOBAL IVD MARKET BY SEGMENT, THROUGH 2020 ($ 30 FIGURE 2 GLOBAL IVD MARKET BY SEGMENT, 2013-2020 ($ 30 FIGURE 3 GLOBAL IVD MARKET SHARE BY SEGMENT, 2014 (%) 31 COMPETITIVE STRUCTURE 31 MARKET SHARE ANALYSIS 31 TABLE 4 MAJOR IVD MARKET COMPANIES, 2014 ($ 32 FIGURE 4 MARKET SHARE OF MAJOR IVD MARKET COMPANIES, 2014 (%) 33 CHAPTER 5 GLOBAL IMMUNOCHEMISTRY MARKET 35 APPLICATIONS 37 BLOOD GAS, ELECTROLYTES AND METABOLITES (BGEM) 37 ENDOCRINE 37 INFECTIOUS DISEASES 37 CANCER 38 URINALYSIS 38 DIABETES 38 CARDIOLOGY 39 BLOOD SCREENING 39 OTHERS 40 TABLE 5 GLOBAL IMMUNOCHEMISTRY MARKET BY APPLICATION THROUGH 2020 ($ FIGURE 5 GLOBAL IMMUNOCHEMISTRY MARKET SHARE BY APPLICATION, 2014 (%) 40 40

TABLE 6 GLOBAL IMMUNOCHEMISTRY MARKET BY REGION, THROUGH 2020 ($ FIGURE 6 GLOBAL IMMUNOCHEMISTRY MARKET BY REGION, 2013-2020 ($ 42 42 CHAPTER 6 GLOBAL POC TESTING MARKET 44 APPLICATIONS 45 GLUCOSE TESTING 45 BGEM 46 CARDIAC MARKER TESTING 46 INFECTIOUS DISEASE TESTING 46 PREGNANCY AND FERTILITY TESTING 46 DRUG AND ALCOHOL ABUSE TESTING 47 HEMATOLOGY AND HEMOSTASIS TESTING 47 CHOLESTEROL TESTING 47 URINE CHEMISTRY TESTING 48 TUMOR MARKER TESTING 48 OTHER POC TESTING 48 TABLE 7 GLOBAL POC TESTING MARKET BY APPLICATION, THROUGH 2020 ($ FIGURE 7 GLOBAL POC TESTING MARKET BY APPLICATION, 2013-2020 ($ 49 FIGURE 8 GLOBAL POC TESTING MARKET SHARE BY APPLICATION, 2014 (%) 49 TABLE 8 GLOBAL POC TESTING MARKET BY REGION, THROUGH 2020 ($ 51 FIGURE 9 GLOBAL POC TESTING MARKET BY REGION, 2013-2020 ($ 51 49 CHAPTER 7 GLOBAL HEMATOLOGY MARKET 53 APPLICATIONS 55 ROUTINE HEMATOLOGY TESTS 55 HEMOSTASIS 56 TABLE 9 GLOBAL HEMATOLOGY MARKET BY APPLICATION, THROUGH 2020 ($ FIGURE 10 GLOBAL HEMATOLOGY MARKET BY APPLICATION, 2013-2020 ($ FIGURE 11 GLOBAL HEMATOLOGY MARKET SHARE BY APPLICATION, 2014 (%) 57 FIGURE 12 GLOBAL HEMATOLOGY MARKET SHARE BY TECHNIQUE, 2014 (%) 58 FIGURE 13 GLOBAL HEMATOLOGY MARKET SHARE BY TECHNIQUE, 2014 (%) 58 TABLE 10 GLOBAL HEMATOLOGY MARKET BY REGION, THROUGH 2020 ($ FIGURE 14 GLOBAL HEMATOLOGY MARKET BY REGION, 2013-2020 ($ 59 56 56 59 CHAPTER 8 GLOBAL MOLECULAR DIAGNOSTICS MARKET 61 APPLICATIONS 63 INFECTIOUS DISEASES 63 BLOOD SCREENING 63 ONCOLOGY 63 GENETIC TESTING 64 OTHERS (COMPANION DIAGNOSTICS, PRENATAL GENETIC TESTS AND RARE DISEASES) 65

TABLE 11 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY APPLICATION THROUGH 2020 ($ FIGURE 15 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY APPLICATION, 2013-2020 ($ FIGURE 16 GLOBAL MOLECULAR DIAGNOSTICS MARKET SHARE BY APPLICATION, 2014 (%) FIGURE 17 GLOBAL INFECTIOUS DISEASE MOLECULAR DIAGNOSTICS MARKET SHARE BY DISEASE, 2014 (%) FIGURE 18 COMPANION DIAGNOSTIC TESTS BY YEAR APPROVED, 1994-2014 (NO. OF TESTS) TABLE 12 COMPANION DIAGNOSTIC TESTS MANUFACTURERS BY NUMBER OF TESTS, 2013 TABLE 13 FDA-APPROVED NUCLEIC ACID BASED TESTS FOR GENETIC CONDITIONS 69 TABLE 14 FDA-APPROVED COMPANION DIAGNOSTIC TESTS 71 TABLE 15 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY REGION, THROUGH 2020 ($ FIGURE 19 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY REGION, 2013-2020 ($ 65 65 66 67 68 69 73 73 CHAPTER 9 GLOBAL CLINICAL MICROBIOLOGY MARKET 75 APPLICATIONS 76 BLOOD CULTURE 76 GENERAL CULTURE (URINE/SALIVA/STOOL/SPUTUM/CSF AND OTHER BODY FLUIDS) IDENTIFICATION AND ANTIBIOTIC SUSCEPTIBILITY TESTING 77 TABLE 16 GLOBAL CLINICAL MICROBIOLOGY MARKET BY APPLICATION, THROUGH 2020 ($ FIGURE 20 GLOBAL CLINICAL MICROBIOLOGY MARKET BY APPLICATION, 2013-2020 ($ FIGURE 21 GLOBAL CLINICAL MICROBIOLOGY MARKET SHARE BY APPLICATION, 2014 (%) TABLE 17 GLOBAL CLINICAL MICROBIOLOGY MARKET BY REGION, THROUGH 2020 ($ FIGURE 22 GLOBAL CLINICAL MICROBIOLOGY MARKET BY REGION, 2013-2020 ($ 77 77 77 78 79 79 CHAPTER 10 GLOBAL TISSUE DIAGNOSTICS MARKET 81 APPLICATIONS 82 CANCER DIAGNOSIS 82 TISSUE TYPING 83 PATHOGEN DETECTION 83 TABLE 18 GLOBAL TISSUE DIAGNOSTICS MARKET BY APPLICATION, THROUGH 2020 ($ FIGURE 23 GLOBAL TISSUE DIAGNOSTICS MARKET BY APPLICATION, 2013-2020 ($ FIGURE 24 GLOBAL TISSUE DIAGNOSTICS MARKET SHARE BY APPLICATION, 2014 (%) TABLE 19 GLOBAL TISSUE DIAGNOSTICS MARKET BY REGION, THROUGH 2020 ($ FIGURE 25 GLOBAL TISSUE DIAGNOSTICS MARKET BY REGION, 2013-2020 ($ 84 84 85 85 85

CHAPTER 11 GLOBAL IVD MARKET BY END USERS 88 INTRODUCTION 88 TRENDS 88 FIGURE 26 GLOBAL IVD MARKET SHARE BY END USER, 2014 (%) 89 CHAPTER 12 GLOBAL IVD MARKET PRODUCTS 91 INTRODUCTION 91 TRENDS 91 FIGURE 27 GLOBAL IVD MARKET SHARE BY PRODUCT TYPE, 2014 (%) 92 CHAPTER 13 REGIONAL ANALYSIS 95 INTRODUCTION 95 NORTH AMERICA 95 EUROPE 95 ASIA 96 LAAM 96 INTERNATIONAL HEALTH EXPENDITURE AND TRENDS 96 FIGURE 28 TOTAL HEALTH EXPENDITURE AS A PERCENTAGE OF GDP FOR THE TOP INDUSTRIALIZED ECONOMIES, 2010 (%) TABLE 20 GLOBAL IVD MARKET BY REGION, THROUGH 2020 ($ 98 FIGURE 29 GLOBAL IVD MARKET SHARE BY REGION, 2014 (%) 99 NORTH AMERICA 99 TABLE 21 NORTH AMERICA IVD MARKET BY COUNTRY, THROUGH 2020 ($ FIGURE 30 NORTH AMERICA IVD MARKET SHARE BY COUNTRY, 2014 (%) 100 TABLE 22 NORTH AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($ U.S. 101 TABLE 23 U.S. IVD MARKET BY SEGMENT, THROUGH 2020 ($ 102 CANADA 102 TABLE 24 CANADA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 102 EUROPE 103 WESTERN EUROPE (WE) 103 CENTRAL AND EASTERN EUROPE (CEE) 103 TABLE 25 EUROPE IVD MARKET BY COUNTRY, THROUGH 2020 ($ 104 FIGURE 31 EUROPE IVD MARKET SHARE BY COUNTRY, 2014 (%) 104 FIGURE 32 WE IVD MARKET SHARE BY COUNTRY, 2014 (%) 105 FIGURE 33 CEE IVD MARKET SHARE BY COUNTRY, 2014 (%) 106 TABLE 26 EUROPE IVD MARKET BY SEGMENT, THROUGH 2020 ($ 107 WESTERN EUROPE 107 GERMANY 107 TABLE 27 GERMANY IVD MARKET BY SEGMENT, THROUGH 2020 ($ 108 FRANCE 108 TABLE 28 FRANCE IVD MARKET BY SEGMENT, THROUGH 2020 ($ 108 ITALY 109 TABLE 29 ITALY IVD MARKET BY SEGMENT, THROUGH 2020 ($ 109 SPAIN 109 97 100 101

TABLE 30 SPAIN IVD MARKET BY SEGMENT, THROUGH 2020 ($ 110 U.K. 110 TABLE 31 U.K. IVD MARKET BY SEGMENT, THROUGH 2020 ($ 110 OTHERS 111 TABLE 32 OTHERS IVD MARKET BY SEGMENT, THROUGH 2020 ($ 111 CENTRAL AND EASTERN EUROPE 112 TURKEY 112 TABLE 33 TURKEY IVD MARKET BY SEGMENT, THROUGH 2020 ($ 112 RUSSIA 112 TABLE 34 RUSSIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 113 POLAND 113 TABLE 35 POLAND IVD MARKET BY SEGMENT, THROUGH 2020 ($ 113 GREECE 114 TABLE 36 GREECE IVD MARKET BY SEGMENT, THROUGH 2020 ($ 114 CZECH REPUBLIC 114 TABLE 37 CZECH REPUBLIC IVD MARKET BY SEGMENT, THROUGH 2020 ($ OTHERS 115 TABLE 38 OTHERS IVD MARKET BY SEGMENT, THROUGH 2020 ($ 115 ASIA 116 TABLE 39 ASIA IVD MARKET BY COUNTRY, THROUGH 2020 ($ 116 FIGURE 34 ASIA IVD MARKET SHARE BY COUNTRY, 2013-2020 (%) 116 TABLE 40 ASIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 118 JAPAN 118 TABLE 41 JAPAN IVD MARKET BY SEGMENT, THROUGH 2020 ($ 119 CHINA 119 TABLE 42 CHINA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 120 AUSTRALIA 120 TABLE 43 AUSTRALIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 121 INDIA 121 TABLE 44 INDIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 123 SOUTH KOREA 123 TABLE 45 SOUTH KOREA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 124 TAIWAN 124 TABLE 46 TAIWAN IVD MARKET BY SEGMENT, THROUGH 2020 ($ 125 REST OF ASIA 125 TABLE 47 REST OF ASIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 125 LATIN AMERICA, AFRICA AND MIDDLE EAST (LAAM) 126 TABLE 48 LAAM IVD MARKET BY REGION, THROUGH 2020 ($ 127 TABLE 49 LAAM IVD MARKET BY SEGMENT, THROUGH 2020 ($ 127 LATIN AMERICA 127 TABLE 50 LATIN AMERICA IVD MARKET BY COUNTRY, THROUGH 2020 ($ 128 FIGURE 35 LATIN AMERICA IVD MARKET SHARE BY COUNTRY, 2014 (%) 128 TABLE 51 LATIN AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 129 BRAZIL 129 TABLE 52 BRAZIL IVD MARKET BY SEGMENT, THROUGH 2020 ($ 130 MEXICO 130 TABLE 53 MEXICO IVD MARKET BY SEGMENT, THROUGH 2020 ($ 131 115

REST OF LATIN AMERICA 131 TABLE 54 REST OF LATIN AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($ MIDDLE EAST AND AFRICA (MEA) 132 TABLE 55 MIDDLE EAST AND AFRICA IVD MARKET BY REGION, THROUGH 2020 ($ FIGURE 36 MIDDLE EAST AND AFRICA IVD MARKET SHARE BY REGION, 2014 (%) 133 TABLE 56 MIDDLE EAST AND AFRICA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 131 133 134 CHAPTER 14 EMERGING GLOBAL TECHNOLOGY TRENDS AND DEVELOPMENTS 136 TRENDS 136 INDUSTRY DEVELOPMENTS 137 RAPID FINGER PRICK EBOLA TEST 137 ROCHE DIAGNOSTICS' ELECSYS HTLV-I/II 137 HIV COMBO ASSAY 138 BLOOD-BASED GENETIC ASSAY 138 PORTABLE MOLECULAR DIAGNOSTICS SYSTEM GENEXPERT OMNI 138 NEW INSTRUMENTS AND ASSAYS AT AACC 2015 138 INOVA DIAGNOSTICS' QUANTA FLASH ASSAYS 139 LEADCARE PLUS CLINICAL LEAD ANALYZER 139 DIAGNOSTIC TEST TO DIFFERENTIATE BETWEEN TYPES OF HIV INFECTIONS IMMUNOCHEMICAL POC TESTING IN FIVE MINUTES 140 ASSAYS FOR DETECTING FOODBORNE PATHOGENS 140 TEST TO DETECT PATHOGENIC C. DIFFICILE 140 MOLECULAR DIAGNOSTIC TESTS FOR ONCOLOGY 141 RAPID DIAGNOSTIC TEST FOR MALARIA 141 EMERGING APPROACHES TO DIAGNOSIS OF MALARIA 141 TABLE 57 EMERGING APPROACHES TO MALARIA DIAGNOSIS 142 MALARIA IVD TECHNOLOGIES IN DEVELOPMENT 142 TABLE 58 MALARIA DIAGNOSTIC TECHNOLOGIES UNDER DEVELOPMENT 143 TABLE 59 IVD PRODUCT APPROVALS, 2014-2015 144 ACADEMIC RESEARCH AND DEVELOPMENT 151 RAPID TECHNIQUE TO DETECT DISEASE-CAUSING DNA 151 SALIVA TEST TO PREDICT ALZHEIMER'S DISEASE 151 MOBILE DNA TEST FOR CHLAMYDIA 151 BLOOD TEST FOR VIRAL INFECTIONS 152 RAPID IVD FOR DENGUE 152 139 CHAPTER 15 TECHNOLOGY DEVELOPMENT OPPORTUNITIES IN IVD INDUSTRY 154 OPPORTUNITY AREAS 154 IVD FOR NEGLECTED INFECTIOUS DISEASES 154 PORTABLE DEVICES COMPATIBLE WITH SIMPLE DETECTION PLATFORMS 154 CHEMISTRY-BASED PORTABLE ANALYZERS 155 IMPROVED SAMPLE PRESERVATION TECHNOLOGIES 155 NEW DETECTION TECHNOLOGIES 156 ALTERNATIVE TECHNOLOGIES TO PCR 157

KEY BIOMARKERS FOR DISEASES OF THE DEVELOPING WORLD 158 FIGURE 37 BIOMARKER RELATED PUBLICATIONS, 2009-2014 (NO. OF PUBLICATIONS) FIGURE 38 BIOMARKER-BASED TESTS CLEARED BY 510(K), 2009-2014 (NO. OF BIOMARKER-BASED TESTS) TABLE 60 BIOMARKER-BASED TESTS RELEASED PER COMPANY, 2013 (NO. OF TESTS) FIGURE 39 BIOMARKERS IN FDA-CLEARED TESTS, 2010-2014 (NO. OF TESTS CLEARED) MICROFLUIDIC PLATFORM BASED POC TESTS FOR REMOTE SETTINGS 162 COMBINING MULTIPLE DETECTION TECHNOLOGIES INTO A SINGLE INSTRUMENT 158 160 160 161 163 CHAPTER 16 FUNDING ANALYSIS AND INDUSTRY ACTIVITY 166 PUBLIC FUNDING 166 EUROPE 166 U.S. 166 FIGURE 40 NCI'S FUNDING SHARE FOR IVDS AND VARIOUS OTHER DISCIPLINES, 2014 (%) SWISS-BASED SERI FUNDS EBOLA DIAGNOSTICS WORK BY FIND 168 EUROPEAN UNION AWARD FOR FABPULOUS BV FOR CARDIAC IVD 168 PRIVATE FUNDING 168 CANADIAN START-UP XAGENIC RECEIVES SERIES B VC FUNDING 168 BLOOD-BASED IVD FOR CANCER 169 OPTICS-BASED IVD 169 IVD FOR LIVER DISEASES 169 DNA-BASED IVD FOR PRENATAL AND CANCER TESTING 169 IVD FOR ORAL CANCER 170 IVD FOR BLADDER CANCER 170 TESTS FOR INFECTIOUS DISEASES AND CANCERS 170 TAIWAN-BASED MOLECULAR DIAGNOSTICS FIRM RECEIVES PRIVATE FUNDING MERGERS AND ACQUISITIONS 171 FIGURE 41 IVD MERGERS AND ACQUISITIONS, 2012-2015 (NO. OF DEALS) 172 FIGURE 42 SHARE OF MERGERS AND ACQUISITIONS BY CATEGORY, 2012-2015 (%) 172 TABLE 61 MERGERS AND ACQUISITIONS, 2012-JUNE 2015 173 167 171 CHAPTER 17 PATENT LANDSCAPE 181 FIGURE 43 PATENTS BY PUBLICATION DATE, 2012-JUNE 2015 182 FIGURE 44 PATENTS BY SUBSEGMENT AND PUBLICATION DATE, 2012 JUNE 2015 IMMUNOASSAYS 183 FIGURE 45 IMMUNOASSAYS PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 CLINICAL CHEMISTRY 184 FIGURE 46 CLINICAL CHEMISTRY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 POC TESTING 185 FIGURE 47 POCT PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 186 182 184 185

MOLECULAR DIAGNOSTICS 187 FIGURE 48 MOLECULAR DIAGNOSTICS PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 MICROBIOLOGY 188 FIGURE 49 MICROBIOLOGY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015* HEMATOLOGY 189 FIGURE 50 HEMATOLOGY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 TISSUE DIAGNOSTICS 190 FIGURE 51 TISSUE DIAGNOSTICS PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 187 188 189 190 CHAPTER 18 COMPANY PROFILES 193 ABBOTT DIAGNOSTICS INC. 193 GEOGRAPHIC REACH 193 GLOBAL REACH 193 SALES AND MARKETING 193 STRATEGY 194 ALERE SAN DIEGO INC. 194 GEOGRAPHIC REACH 194 SALES AND MARKETING 195 STRATEGY 195 BAYER DIABETES CARE (NOW PART OF PANASONIC HEALTHCARE) 195 BECKMAN COULTER (PART OF DANAHER) 196 GEOGRAPHIC REACH 196 OPERATIONS 196 SALES AND MARKETING 197 STRATEGY 197 BECTON DICKINSON 197 STRATEGY 198 BIOMERIEUX 198 GLOBAL REACH 198 SALES AND MARKETING 199 STRATEGY 199 BIORAD 199 SALES AND MARKETING 200 ELITECH GROUP 200 HOLOGIC INC. 200 SALES AND MARKETING 201 KEM-EN-TEC DIAGNOSTICS A/S 201 ORTHO CLINICAL DIAGNOSTICS 202 ROCHE DIAGNOSTICS CORP. 202 GEOGRAPHIC REACH 203 SALES AND MARKETING 203 FINANCIAL PERFORMANCE 203 STRATEGY 203 SIEMENS HEALTHCARE DIAGNOSTICS INC. 204

GEOGRAPHIC REACH 204 SALES AND MARKETING 204 STRATEGY 205 SYSMEX 205 THERMO FISHER SCIENTIFIC INC. 205 STRATEGY 206 TRANSASIA BIO-MEDICALS 206 WERFEN GROUP 207 CHAPTER 19 APPENDIX 209 LIST OF IVD MARKET PARTICIPANTS 209 LIST OF ABBREVIATIONS 210

LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL IVD MARKET BY REGION, THROUGH 2020 ($ 8 TABLE 1 TYPES OF DIAGNOSTIC TESTS AND HOW THEY ARE REGULATED 18 TABLE 2 CHANGES IN IVD REGULATIONS IN ASIA 23 TABLE 3 GLOBAL IVD MARKET BY SEGMENT, THROUGH 2020 ($ 30 TABLE 4 MAJOR IVD MARKET COMPANIES, 2014 ($ 32 TABLE 5 GLOBAL IMMUNOCHEMISTRY MARKET BY APPLICATION THROUGH 2020 ($ TABLE 6 GLOBAL IMMUNOCHEMISTRY MARKET BY REGION, THROUGH 2020 ($ TABLE 7 GLOBAL POC TESTING MARKET BY APPLICATION, THROUGH 2020 ($ TABLE 8 GLOBAL POC TESTING MARKET BY REGION, THROUGH 2020 ($ 51 TABLE 9 GLOBAL HEMATOLOGY MARKET BY APPLICATION, THROUGH 2020 ($ TABLE 10 GLOBAL HEMATOLOGY MARKET BY REGION, THROUGH 2020 ($ 59 TABLE 11 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY APPLICATION THROUGH 2020 ($ TABLE 12 COMPANION DIAGNOSTIC TESTS MANUFACTURERS BY NUMBER OF TESTS, 2013 TABLE 13 FDA-APPROVED NUCLEIC ACID BASED TESTS FOR GENETIC CONDITIONS 69 TABLE 14 FDA-APPROVED COMPANION DIAGNOSTIC TESTS 71 TABLE 15 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY REGION, THROUGH 2020 ($ TABLE 16 GLOBAL CLINICAL MICROBIOLOGY MARKET BY APPLICATION, THROUGH 2020 ($ TABLE 17 GLOBAL CLINICAL MICROBIOLOGY MARKET BY REGION, THROUGH 2020 ($ TABLE 18 GLOBAL TISSUE DIAGNOSTICS MARKET BY APPLICATION, THROUGH 2020 ($ TABLE 19 GLOBAL TISSUE DIAGNOSTICS MARKET BY REGION, THROUGH 2020 ($ TABLE 20 GLOBAL IVD MARKET BY REGION, THROUGH 2020 ($ 98 TABLE 21 NORTH AMERICA IVD MARKET BY COUNTRY, THROUGH 2020 ($ 100 TABLE 22 NORTH AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 101 TABLE 23 U.S. IVD MARKET BY SEGMENT, THROUGH 2020 ($ 102 TABLE 24 CANADA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 102 TABLE 25 EUROPE IVD MARKET BY COUNTRY, THROUGH 2020 ($ 104 TABLE 26 EUROPE IVD MARKET BY SEGMENT, THROUGH 2020 ($ 107 TABLE 27 GERMANY IVD MARKET BY SEGMENT, THROUGH 2020 ($ 108 TABLE 28 FRANCE IVD MARKET BY SEGMENT, THROUGH 2020 ($ 108 TABLE 29 ITALY IVD MARKET BY SEGMENT, THROUGH 2020 ($ 109 TABLE 30 SPAIN IVD MARKET BY SEGMENT, THROUGH 2020 ($ 110 TABLE 31 U.K. IVD MARKET BY SEGMENT, THROUGH 2020 ($ 110 TABLE 32 OTHERS IVD MARKET BY SEGMENT, THROUGH 2020 ($ 111 TABLE 33 TURKEY IVD MARKET BY SEGMENT, THROUGH 2020 ($ 112 TABLE 34 RUSSIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 113 TABLE 35 POLAND IVD MARKET BY SEGMENT, THROUGH 2020 ($ 113 TABLE 36 GREECE IVD MARKET BY SEGMENT, THROUGH 2020 ($ 114 TABLE 37 CZECH REPUBLIC IVD MARKET BY SEGMENT, THROUGH 2020 ($ 115 40 42 49 56 65 69 73 77 79 84 85

TABLE HEADING TABLE 38 OTHERS IVD MARKET BY SEGMENT, THROUGH 2020 ($ 115 TABLE 39 ASIA IVD MARKET BY COUNTRY, THROUGH 2020 ($ 116 TABLE 40 ASIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 118 TABLE 41 JAPAN IVD MARKET BY SEGMENT, THROUGH 2020 ($ 119 TABLE 42 CHINA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 120 TABLE 43 AUSTRALIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 121 TABLE 44 INDIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 123 TABLE 45 SOUTH KOREA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 124 TABLE 46 TAIWAN IVD MARKET BY SEGMENT, THROUGH 2020 ($ 125 TABLE 47 REST OF ASIA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 125 TABLE 48 LAAM IVD MARKET BY REGION, THROUGH 2020 ($ 127 TABLE 49 LAAM IVD MARKET BY SEGMENT, THROUGH 2020 ($ 127 TABLE 50 LATIN AMERICA IVD MARKET BY COUNTRY, THROUGH 2020 ($ 128 TABLE 51 LATIN AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($ 129 TABLE 52 BRAZIL IVD MARKET BY SEGMENT, THROUGH 2020 ($ 130 TABLE 53 MEXICO IVD MARKET BY SEGMENT, THROUGH 2020 ($ 131 TABLE 54 REST OF LATIN AMERICA IVD MARKET BY SEGMENT, THROUGH 2020 ($ TABLE 55 MIDDLE EAST AND AFRICA IVD MARKET BY REGION, THROUGH 2020 ($ TABLE 56 MIDDLE EAST AND AFRICA IVD MARKET BY SEGMENT, THROUGH 2020 ($ TABLE 57 EMERGING APPROACHES TO MALARIA DIAGNOSIS 142 TABLE 58 MALARIA DIAGNOSTIC TECHNOLOGIES UNDER DEVELOPMENT 143 TABLE 59 IVD PRODUCT APPROVALS, 2014-2015 144 TABLE 60 BIOMARKER-BASED TESTS RELEASED PER COMPANY, 2013 (NO. OF TESTS) 160 TABLE 61 MERGERS AND ACQUISITIONS, 2012-JUNE 2015 173 131 133 134

LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL IVD MARKET BY REGION, 2013-2020 ($ 9 FIGURE 1 MARKET SEGMENTATION 11 FIGURE 2 GLOBAL IVD MARKET BY SEGMENT, 2013-2020 ($ 30 FIGURE 3 GLOBAL IVD MARKET SHARE BY SEGMENT, 2014 (%) 31 FIGURE 4 MARKET SHARE OF MAJOR IVD MARKET COMPANIES, 2014 (%) 33 FIGURE 5 GLOBAL IMMUNOCHEMISTRY MARKET SHARE BY APPLICATION, 2014 (%) 40 FIGURE 6 GLOBAL IMMUNOCHEMISTRY MARKET BY REGION, 2013-2020 ($ 42 FIGURE 7 GLOBAL POC TESTING MARKET BY APPLICATION, 2013-2020 ($ 49 FIGURE 8 GLOBAL POC TESTING MARKET SHARE BY APPLICATION, 2014 (%) 49 FIGURE 9 GLOBAL POC TESTING MARKET BY REGION, 2013-2020 ($ 51 FIGURE 10 GLOBAL HEMATOLOGY MARKET BY APPLICATION, 2013-2020 ($ 56 FIGURE 11 GLOBAL HEMATOLOGY MARKET SHARE BY APPLICATION, 2014 (%) 57 FIGURE 12 GLOBAL HEMATOLOGY MARKET SHARE BY TECHNIQUE, 2014 (%) 58 FIGURE 13 GLOBAL HEMATOLOGY MARKET SHARE BY TECHNIQUE, 2014 (%) 58 FIGURE 14 GLOBAL HEMATOLOGY MARKET BY REGION, 2013-2020 ($ 59 FIGURE 15 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY APPLICATION, 2013-2020 ($ FIGURE 16 GLOBAL MOLECULAR DIAGNOSTICS MARKET SHARE BY APPLICATION, 2014 (%) FIGURE 17 GLOBAL INFECTIOUS DISEASE MOLECULAR DIAGNOSTICS MARKET SHARE BY DISEASE, 2014 (%) FIGURE 18 COMPANION DIAGNOSTIC TESTS BY YEAR APPROVED, 1994-2014 (NO. OF TESTS) FIGURE 19 GLOBAL MOLECULAR DIAGNOSTICS MARKET BY REGION, 2013-2020 ($ FIGURE 20 GLOBAL CLINICAL MICROBIOLOGY MARKET BY APPLICATION, 2013-2020 ($ FIGURE 21 GLOBAL CLINICAL MICROBIOLOGY MARKET SHARE BY APPLICATION, 2014 (%) FIGURE 22 GLOBAL CLINICAL MICROBIOLOGY MARKET BY REGION, 2013-2020 ($ FIGURE 23 GLOBAL TISSUE DIAGNOSTICS MARKET BY APPLICATION, 2013-2020 ($ FIGURE 24 GLOBAL TISSUE DIAGNOSTICS MARKET SHARE BY APPLICATION, 2014 (%) 85 FIGURE 25 GLOBAL TISSUE DIAGNOSTICS MARKET BY REGION, 2013-2020 ($ FIGURE 26 GLOBAL IVD MARKET SHARE BY END USER, 2014 (%) 89 FIGURE 27 GLOBAL IVD MARKET SHARE BY PRODUCT TYPE, 2014 (%) 92 FIGURE 28 TOTAL HEALTH EXPENDITURE AS A PERCENTAGE OF GDP FOR THE TOP INDUSTRIALIZED ECONOMIES, 2010 (%) FIGURE 29 GLOBAL IVD MARKET SHARE BY REGION, 2014 (%) 99 FIGURE 30 NORTH AMERICA IVD MARKET SHARE BY COUNTRY, 2014 (%) 100 FIGURE 31 EUROPE IVD MARKET SHARE BY COUNTRY, 2014 (%) 104 FIGURE 32 WE IVD MARKET SHARE BY COUNTRY, 2014 (%) 105 FIGURE 33 CEE IVD MARKET SHARE BY COUNTRY, 2014 (%) 106 FIGURE 34 ASIA IVD MARKET SHARE BY COUNTRY, 2013-2020 (%) 116 FIGURE 35 LATIN AMERICA IVD MARKET SHARE BY COUNTRY, 2014 (%) 128 FIGURE 36 MIDDLE EAST AND AFRICA IVD MARKET SHARE BY REGION, 2014 (%) 133 FIGURE 37 BIOMARKER RELATED PUBLICATIONS, 2009-2014 (NO. OF PUBLICATIONS) 158 65 66 67 68 73 77 78 79 84 85 97

FIGURE TITLE FIGURE 38 BIOMARKER-BASED TESTS CLEARED BY 510(K), 2009-2014 (NO. OF BIOMARKER-BASED TESTS) FIGURE 39 BIOMARKERS IN FDA-CLEARED TESTS, 2010-2014 (NO. OF TESTS CLEARED) FIGURE 40 NCI'S FUNDING SHARE FOR IVDS AND VARIOUS OTHER DISCIPLINES, 2014 (%) FIGURE 41 IVD MERGERS AND ACQUISITIONS, 2012-2015 (NO. OF DEALS) 172 FIGURE 42 SHARE OF MERGERS AND ACQUISITIONS BY CATEGORY, 2012-2015 (%) 172 FIGURE 43 PATENTS BY PUBLICATION DATE, 2012-JUNE 2015 182 FIGURE 44 PATENTS BY SUBSEGMENT AND PUBLICATION DATE, 2012 JUNE 2015 FIGURE 45 IMMUNOASSAYS PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 FIGURE 46 CLINICAL CHEMISTRY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 FIGURE 47 POCT PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 186 FIGURE 48 MOLECULAR DIAGNOSTICS PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 FIGURE 49 MICROBIOLOGY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015* FIGURE 50 HEMATOLOGY PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 FIGURE 51 TISSUE DIAGNOSTICS PATENT DISTRIBUTION BY SECTOR, 2011-JUNE 2015 160 161 167 182 184 185 187 188 189 190