TABLE OF CONTENTS
1 INTRODUCTION 53
1.1 OBJECTIVES OF THE STUDY 53
1.2 MARKET DEFINITION 53
1.3 OVERVIEW OF NORTH AMERICA ACUTE MYELOID LEUKEMIA DIAGNOSTICS MARKET 53
1.4 LIMITATIONS 55
1.5 MARKETS COVERED 56
2 MARKET SEGMENTATION 59
2.1 MARKETS COVERED 59
2.2 GEOGRAPHICAL SCOPE 60
2.3 YEARS CONSIDERED FOR THE STUDY 61
2.4 CURRENCY AND PRICING 61
2.5 DBMR TRIPOD DATA VALIDATION MODEL 62
2.6 MULTIVARIATE MODELLING 65
2.7 PRODUCT TYPE LIFELINE CURVE 65
2.8 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 66
2.9 DBMR MARKET POSITION GRID 67
2.10 MARKET END USER COVERAGE GRID 69
2.11 VENDOR SHARE ANALYSIS 70
2.12 SECONDARY SOURCES 71
2.13 ASSUMPTIONS 71
3 EXECUTIVE SUMMARY 72
4 PREMIUM INSIGHTS 75
4.1 PESTEL ANALYSIS 76
4.2 PORTER'S 5 FORCES 77
5 NORTH AMERICA ACUTE MYELOID LEUKEMIA DIAGNOSTICS MARKET, REGULATIONS 78
5.1 REGULATORY SCENARIO IN THE U.S. 78
5.2 REGULATORY SCENARIO IN AUSTRALIA 79
5.3 REGULATORY SCENARIO IN JAPAN 79
5.4 REGULATORY SCENARIO IN CHINA 79
6 MARKET OVERVIEW 81
6.1 DRIVERS 83
6.1.1 GROWING PREVALENCE OF LEUKEMIA CANCER 83
6.1.2 NOVEL TECHNOLOGICAL ADVANCEMENTS IN LEUKEMIA DIAGNOSTICS 85
6.1.3 RISING PREFERENCE FOR PREVENTIVE HEALTH CHECK-UPS 85
6.1.4 INCREASE IN AWARENESS REGARDING LEUKEMIA CANCER 86
6.2 RESTRAINTS 87
6.2.1 STRICT REGULATIONS AND STANDARDS FOR THE APPROVAL AND COMMERCIALIZATION OF LEUKEMIA DIAGNOSTIC PRODUCTS 87
6.2.2 LATE DIAGNOSIS AND POOR PROGNOSIS OF LEUKEMIA 87
6.3 OPPORTUNITIES 88
6.3.1 INCREASE IN DIAGNOSTIC PRODUCTS FOR LEUKEMIA 88
6.3.2 RISE IN HEALTHCARE EXPENDITURE FOR CANCER DIAGNOSIS AND TREATMENT 88
6.3.3 GOVERNMENT INITIATIVES TOWARD CANCER DIAGNOSTICS 89
6.4 CHALLENGES 90
6.4.1 INCREASED COST, SAFETY, AND CONVENIENCE ISSUES 90
6.4.2 LACK OF SKILLED AND CERTIFIED PROFESSIONALS 90
7 NORTH AMERICA ACUTE MYELOID LEUKEMIA DIAGNOSTICS MARKET, BY PRODUCT TYPE 91
7.1 OVERVIEW 92
7.2 INSTRUMENTS 95
7.2.1 BIOPSY INSTRUMENTS 96
7.2.1.1 BONE MARROW BIOPSY 96
7.2.1.2 NEEDLE BIOPSY 96
7.2.1.3 SURGICAL BIOPSY 96
7.2.1.4 OTHERS 97
7.2.2 PATHOLOGY-BASED INSTRUMENTS 97
7.2.2.1 PCR INSTRUMENTS 97
7.2.2.2 SLIDE STAINING SYSTEMS 97
7.2.2.3 TISSUE PROCESSING SYSTEMS 97
7.2.2.4 CELL PROCESSORS 97
7.2.2.5 OTHER PATHOLOGY-BASED INSTRUMENTS 98
7.2.3 IMAGING INSTRUMENTS 98
7.2.3.1 ULTRASOUND SYSTEMS 98
7.2.3.2 CT SYSTEMS 98
7.2.3.3 MRI SYSTEMS 98
7.2.3.4 OTHERS 98
7.2.4 OTHERS 98
7.3 CONSUMABLES & ACCESSORIES 99
7.3.1 KITS 100
7.3.1.1 PCR KITS 100
7.3.1.2 DNA POLYMERASE KITS 100
7.3.1.3 NUCLEIC ACID ISOLATION KITS 100
7.3.1.4 OTHERS 101
7.3.2 REAGENTS 101
7.3.2.1 ASSAYS 101
7.3.2.2 BUFFERS 101
7.3.2.3 PRIMERS 101
7.3.2.4 OTHERS 101
7.3.3 PROBES 102
7.3.4 OTHER CONSUMABLES 102
8 NORTH AMERICA ACUTE MYELOID LEUKEMIA DIAGNOSTICS MARKET, BY TEST TYPE 103
8.1 OVERVIEW 104
8.2 BLOOD TEST 107
8.2.1 COMPLETE BLOOD COUNT (CBC) 108
8.2.2 BLOOD CHEMISTRY TESTS 108
8.2.3 OTHERS 108
8.3 IMAGING TEST 108
8.3.1 COMPUTED TOMOGRAPHY (CT) SCAN 109
8.3.2 MRI 109
8.3.3 POSITRON EMISSION TOMOGRAPHY (PET) SCAN 110
8.3.4 OTHERS 110
8.4 BONE MARROW TESTS 110
8.4.1 BONE MARROW ASPIRATE 111
8.4.2 BONE MARROW BIOPSY 111
8.4.3 OTHERS 111
8.5 GENETIC TESTS 111
8.5.1 FLUORESCENCE IN SITU HYBRIDIZATION (FISH) 112
8.5.2 KARYOTYPING 112
8.5.3 OTHERS 112
8.6 BIOMARKER TEST 112
8.6.1 GENETIC ACUTE MYELOID LEUKEMIA (AML) BIOMARKER 113
8.6.2 EPIGENETIC ACUTE MYELOID LEUKEMIA (AML) BIOMARKER 113
8.6.3 PROTEOMIC ACUTE MYELOID LEUKEMIA (AML) BIOMARKER 114
8.7 IMMUNOPHENOTYPING 114
8.7.1 FLOW CYTOMETRY 115
8.7.2 IMMUNOHISTOCHEMISTRY 115
8.7.3 OTHERS 115
8.8 OTHERS 115
9 NORTH AMERICA ACUTE MYELOID LEUKEMIA DIAGNOSTICS MARKET, BY CANCER TYPE 117
9.1 OVERVIEW 118
9.2 MYELOBLASTIC (M0) 121
9.3 MYELOBLASTIC (M1) 121
9.4 MYELOBLASTIC (M2) 122
9.5 PROMYELOCYTIC (M3) 123
9.6 MYELOMONOCYTIC (M4) 124
9.7 MONOCYTIC (M5) 124
9.8 ERYTHROLEUKEMIA (M6) 125
9.9 MEGAKARYOCYTIC (M7) 126
10 NORTH AMERICA ACUTE MYELOID LEUKEMIA DIAGNOSTICS MARKET, BY AGE GROUP 127
10.1 OVERVIEW 128
10.2 65 AND ABOVE 131
10.3 30-65 131
10.4 BELOW 21 132
10.5 21-29 133
11 NORTH AMERICA ACUTE MYELOID LEUKEMIA DIAGNOSTICS MARKET, BY GENDER 135
11.1 OVERVIEW 136
11.2 MALE 139
11.3 FEMALE 139
12 NORTH AMERICA ACUTE MYELOID LEUKEMIA DIAGNOSTICS MARKET, BY END USER 141
12.1 OVERVIEW 142
12.2 HOSPITALS 145
12.3 ASSOCIATED LABS 145
12.4 INDEPENDENT DIAGNOSTIC LABORATORIES 146
12.5 DIAGNOSTIC IMAGING CENTERS 147
12.6 CANCER RESEARCH INSTITUTES 147
12.7 OTHERS 148
13 NORTH AMERICA ACUTE MYELOID LEUKEMIA DIAGNOSTICS MARKET, BY DISTRIBUTION CHANNEL 150
13.1 OVERVIEW 151
13.2 DIRECT TENDER 154
13.3 RETAIL SALES 154
14 NORTH AMERICA ACUTE MYELOID LEUKEMIA DIAGNOSTICS MARKET, BY REGION 156
14.1 NORTH AMERICA 157
14.1.1 U.S. 168
14.1.2 CANADA 174
14.1.3 MEXICO 180
15 NORTH AMERICA ACUTE MYELOID LEUKEMIA DIAGNOSTICS MARKET: COMPANY LANDSCAPE 186
15.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 186
16 SWOT ANALYSIS 187
17 COMPANY PROFILE 188
17.1 CANON MEDICAL SYSTEMS CORPORATION. 188
17.1.1 COMPANY SNAPSHOT 188
17.1.2 REVENUE ANALYSIS 188
17.1.3 COMPANY SHARE ANALYSIS 189
17.1.4 PRODUCT PORTFOLIO 189
17.1.5 RECENT DEVELOPMENT 189
17.2 SYSMEX CORPORATION 190
17.2.1 COMPANY SNAPSHOT 190
17.2.2 REVENUE ANALYSIS 190
17.2.3 COMPANY SHARE ANALYSIS 191
17.2.4 PRODUCT PORTFOLIO 191
17.2.5 RECENT DEVELOPMENT 191
17.3 EPIGENOMICS AG. 192
17.3.1 COMPANY SNAPSHOT 192
17.3.2 REVENUE ANALYSIS 192
17.3.3 COMPANY SHARE ANALYSIS 193
17.3.4 PRODUCT PORTFOLIO 193
17.3.5 RECENT DEVELOPMENT 193
17.4 MYRIAD GENETICS, INC.. 194
17.4.1 COMPANY SNAPSHOT 194
17.4.2 REVENUE ANALYSIS 194
17.4.3 COMPANY SHARE ANALYSIS 195
17.4.4 PRODUCT PORTFOLIO 195
17.4.5 RECENT DEVELOPMENT 195
17.5 F. HOFFMANN- LA ROCHE LTD 196
17.5.1 COMPANY SNAPSHOT 196
17.5.2 REVENUE ANALYSIS 196
17.5.3 COMPANY SHARE ANALYSIS 197
17.5.4 PRODUCT PORTFOLIO 197
17.5.5 RECENT DEVELOPMENT 197
17.6 ABBOTT 198
17.6.1 COMPANY SNAPSHOT 198
17.6.2 REVENUE ANALYSIS 198
17.6.3 PRODUCT PORTFOLIO 199
17.6.4 RECENT DEVELOPMENT 199
17.7 AGILENT TECHNOLOGIES, INC. 200
17.7.1 COMPANY SNAPSHOT 200
17.7.2 REVENUE ANALYSIS 200
17.7.3 PRODUCT PORTFOLIO 201
17.7.4 RECENT DEVELOPMENT 201
17.8 BD 202
17.8.1 COMPANY SNAPSHOT 202
17.8.2 REVENUE ANALYSIS 202
17.8.3 PRODUCT PORTFOLIO 203
17.8.4 RECENT DEVELOPMENT 203
17.9 BIOMERIEUX 204
17.9.1 COMPANY SNAPSHOT 204
17.9.2 PRODUCT PORTFOLIO 204
17.9.3 RECENT DEVELOPMENT 204
17.10 BIO-RAD LABORATORIES, INC. 205
17.10.1 COMPANY SNAPSHOT 205
17.10.2 REVENUE ANALYSIS 205
17.10.3 PRODUCT PORTFOLIO 206
17.10.4 RECENT DEVELOPMENT 206
17.11 DIASORIN S.P.A. 207
17.11.1 COMPANY SNAPSHOT 207
17.11.2 REVENUE ANALYSIS 207
17.11.3 PRODUCT PORTFOLIO 208
17.11.4 RECENT DEVELOPMENTS 208
17.12 EXACT SCIENCES CORPORATION 209
17.12.1 COMPANY SNAPSHOT 209
17.12.2 REVENUE ANALYSIS 209
17.12.3 PRODUCT PORTFOLIO 210
17.12.4 RECENT DEVELOPMENTS 210
17.13 FONAR CORP. 211
17.13.1 COMPANY SNAPSHOT 211
17.13.2 REVENUE ANALYSIS 211
17.13.3 PRODUCT PORTFOLIO 212
17.13.4 RECENT DEVELOPMENT 212
17.14 HOLOGIC INC. 213
17.14.1 COMPANY SNAPSHOT 213
17.14.2 REVENUE ANALYSIS 213
17.14.3 PRODUCT PORTFOLIO 214
17.14.4 RECENT DEVELOPMENT 214
17.15 ILLUMINA, INC. 215
17.15.1 COMPANY SNAPSHOT 215
17.15.2 REVENUE ANALYSIS 215
17.15.3 PRODUCT PORTFOLIO 216
17.15.4 RECENT DEVELOPMENT 216
17.16 KONINKLIJKE PHILIPS N.V. 217
17.16.1 COMPANY SNAPSHOT 217
17.16.2 REVENUE ANALYSIS 217
17.16.3 PRODUCT PORTFOLIO 218
17.16.4 RECENT DEVELOPMENT 218
17.17 MEDONICA CO. LTD 219
17.17.1 COMPANY SNAPSHOT 219
17.17.2 PRODUCT PORTFOLIO 219
17.17.3 RECENT DEVELOPMENT 219
17.18 MERCK KGAA 220
17.18.1 COMPANY SNAPSHOT 220
17.18.2 REVENUE ANALYSIS 220
17.18.3 PRODUCT PORTFOLIO 221
17.18.4 RECENT DEVELOPMENTS 221
17.19 MINFOUND MEDICAL SYSTEMS CO., LTD 222
17.19.1 COMPANY SNAPSHOT 222
17.19.2 PRODUCT PORTFOLIO 222
17.19.3 RECENT DEVELOPMENT 222
17.20 PLEXBIO 223
17.20.1 COMPANY SNAPSHOT 223
17.20.2 PRODUCT PORTFOLIO 223
17.20.3 RECENT DEVELOPMENTS 223

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