TABLE OF CONTENTS
1 INTRODUCTION 65
1.1 OBJECTIVES OF THE STUDY 65
1.2 MARKET DEFINITION 65
1.3 OVERVIEW OF THE NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET 65
1.4 CURRENCY AND PRICING 67
1.5 LIMITATIONS 67
1.6 MARKETS COVERED 67
2 MARKET SEGMENTATION 72
2.1 MARKETS COVERED 72
2.2 GEOGRAPHICAL SCOPE 73
2.3 YEARS CONSIDERED FOR THE STUDY 74
2.4 DBMR TRIPOD DATA VALIDATION MODEL 75
2.5 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 78
2.6 MULTIVARIATE MODELLING 79
2.7 TEST TYPE SEGMENT LIFELINE CURVE 79
2.8 MARKET END USER COVERAGE GRID 80
2.9 DBMR MARKET POSITION GRID 81
2.10 VENDOR SHARE ANALYSIS 82
2.11 SECONDARY SOURCES 83
2.12 ASSUMPTIONS 83
3 EXECUTIVE SUMMARY 84
4 PREMIUM INSIGHTS 87
4.1 PESTEL ANALYSIS 88
4.2 PORTER'S FIVE FORCES MODEL 89
5 INDUSTRY INSIGHTS 90
6 NUMBER OF LABS 92
6.1 NUMBER OF LABS IN MIDDLE EASTERN COUNTRIES 92
6.2 NUMBER OF LABS IN EUROPE 92
7 REGULATIONS OF THE NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET 94
7.1 U.S. 94
8 MARKET OVERVIEW 95
8.1 DRIVERS 97
8.1.1 INCREASING DEMAND FOR PERSONALIZED MEDICINE 97
8.1.2 ADVANCEMENTS IN MOLECULAR DIAGNOSTICS 97
8.1.3 GROWING PREVALENCE OF CHRONIC DISEASES 97
8.1.4 INCREASING AWARENESS AND ACCEPTANCE TOWARDS THE ASSISTANCES OF LDTS 98
8.2 RESTRAINTS 98
8.2.1 STRINGENT QUALITY CONTROL AND STANDARDIZATION FOR LDTS 98
8.2.2 STRICT REGULATORY GUIDELINES REGARDING LDTS 99
8.3 OPPORTUNITIES 99
8.3.1 INCREASING DEMAND FOR PRECISION MEDICINE AND TARGETED THERAPY 99
8.3.2 ENHANCED HEALTHCARE SUBSTRUCTURE 100
8.4 CHALLENGES 100
8.4.1 DEPRIVED DATA INTERPRETATION AND INTEGRATION 100
8.4.2 COMPLEX LABORATORY PROCESSES 101
9 NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY TEST TYPE 102
9.1 OVERVIEW 103
9.2 CLINICAL CHEMISTRY AND IMMUNOLOGY 106
9.2.1 GLUCOSE 107
9.2.1.1 GLUCOSE CHALLENGE TEST 107
9.2.1.2 ORAL GLUCOSE TOLERANCE TEST (OGTT) 107
9.2.2 PROTHROMBIN 108
9.2.3 METABOLIC PANEL 108
9.2.3.1 BASIC 108
9.2.3.2 COMPREHENSIVE 108
9.2.4 LIPID PANEL 108
9.2.5 LIVER PANEL 108
9.2.5.1 ALP TEST (ALKALINE PHOSPHATE) 109
9.2.5.2 ALT TEST (ALKALINE TRANSMINASE) 109
9.2.5.3 AST TEST (ASPARTATE AMINOTRANSFERASE) 109
9.2.5.4 GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST 109
9.2.6 THYROID STIMULATING HORMONE 109
9.2.7 URINALYSIS 109
9.2.7.1 RED BLOOD CELL URINE TEST 110
9.2.7.2 GLUCOSE URINE TEST 110
9.2.7.3 PROTEIN URINE TEST 110
9.2.7.4 URINE PH LEVEL 110
9.2.7.5 KETONES URINE TEST 110
9.2.7.6 BILIBURIN URINE TEST 110
9.2.7.7 URINE SPECIFIC GRAVITY TEST 111
9.2.8 OTHERS 111
9.3 CRITICAL CARE 111
9.3.1 CARBOXYHAEMOGLOBIN TEST 112
9.3.2 PH TEST 112
9.3.3 POTASSIUM TEST 112
9.3.4 SODIUM TEST 112
9.3.5 METHEMOGLOBIN TEST 112
9.3.6 LACTATE TEST 112
9.3.7 OTHERS 113
9.4 HAEMATOLOGY 113
9.4.1 COMPLETE BLOOD COUNT (CBC) 114
9.4.1.1 WHITE BLOOD CELL COUNT (WBC) 114
9.4.1.2 RED BLOOD CELL COUNT (RBC) 114
9.4.2 PLATELET COUNT 114
9.4.3 BLOOD PROTEIN TESTING 115
9.4.4 OTHERS 115
9.5 MOLECULAR DIAGNOSTIC 115
9.5.1 SAMPLE TYPE 116
9.5.1.1 BLOOD 116
9.5.1.2 URINE 116
9.5.1.3 TISSUE 116
9.5.1.4 CEREBROSPINAL FLUID (CSF) 116
9.5.1.5 OTHERS 116
9.5.2 THERAPEUTIC AREA 116
9.5.2.1 INFECTIONS 117
9.5.2.2 GENETIC DISORDERS 117
9.5.2.3 ONCOLOGY/CANCER 117
9.5.2.4 AUTOIMMUNE DISEASE 117
9.5.2.5 UROLOGY 117
9.5.2.6 GYNECOLOGY 117
9.5.2.7 OTHERS 117
9.5.3 TECHNOLOGY 118
9.5.3.1 POLYMERASE CHAIN REACTION (PCR) 118
9.5.3.2 NEXT-GENERATION SEQUENCING (NGS) 118
9.5.3.3 FLUORESCENCE IN SITU HYBRIDIZATION (FISH) 118
9.5.3.4 SANGER SEQUENCING 118
9.5.3.5 MICROARRAYS 118
9.5.3.6 MASS SPECTROMETRY 119
9.5.3.7 ISOTHERMAL AMPLIFICATION 119
9.5.4 END USER 119
9.5.4.1 HOSPITAL-BASED LABS 119
9.5.4.2 STAND-ALONE LABS 119
9.5.4.3 DIAGNOSTIC CHAINS 119
9.5.4.4 ACADEMIC INSTITUTES 120
9.5.4.5 CLINICAL RESEARCH ORGANIZATIONS 120
9.5.4.6 SPECIALTY DIAGNOSTIC CENTERS 120
9.5.4.7 OTHERS 120
9.6 MICROBIOLOGY 120
9.6.1 MICROSCOPY 121
9.6.2 CULTURE 121
9.6.3 ANTIMICROBIAL SUSCEPTIBILITY TEST 121
9.6.4 OTHERS 121
9.7 OTHER TEST 122
9.7.1 DRUGS OF ABUSE TESTING 123
9.7.2 HEPATITIS 123
9.7.3 HUMAN IMMUNODEFICIENCY VIRUSES (HIV) 123
9.7.4 MALARIA 123
9.7.5 TUBERCULOSIS 123
9.7.6 HUMAN PAPILLOMAVIRUS (HPV) 123
9.7.7 OTHERS 124
10 NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY PRODUCT TYPE 125
10.1 OVERVIEW 126
10.2 CONSUMABLES 129
10.2.1 PANELS 129
10.2.2 REAGENT AND KITS 130
10.2.3 OTHERS 130
10.3 ANALYZERS AND INSTRUMENTS 130
10.3.1 FULLY-AUTOMATED INSTRUMENTS 131
10.3.2 SEMI-AUTOMATED INSTRUMENTS 131
10.3.3 OTHERS 131
10.4 ACCESSORIES 131
11 NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY SAMPLE TYPE 133
11.1 OVERVIEW 134
11.2 BLOOD 137
11.3 URINE 137
11.4 TISSUE 138
11.5 CEREBROSPINAL FLUID (CSF) 138
11.6 OTHERS 139
12 NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY THERAPEUTIC AREA 141
12.1 OVERVIEW 142
12.2 INFECTIONS 145
12.2.1 METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) 146
12.2.2 CLOSTRIDIUM DIFFICILE 146
12.2.3 VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE) 146
12.2.4 CARBAPENEM-RESISTANT BACTERIA 146
12.2.5 FLU 146
12.2.6 RESPIRATORY SYNCYTIAL VIRUS (RSV) 147
12.2.7 CANDIDA 147
12.2.8 TUBERCULOSIS AND DRUG-RESISTANT TBA 147
12.2.9 MENINGITIS 147
12.2.10 GASTROINTESTINAL PANEL TESTING 147
12.2.11 CHLAMYDIA 147
12.2.12 GONORRHEA 147
12.2.13 HIV 147
12.2.14 HEPATITIS B 147
12.2.15 HEPATITIS C 147
12.2.16 OTHER INFECTIOUS DISEASES 147
12.3 GENETIC DISORDERS 148
12.3.1 NEW BORN SCREENING 148
12.3.2 PREDICTIVE AND PRESYMPTOMATIC TESTING 149
12.3.3 OTHER GENETIC TESTING 149
12.4 ONCOLOGY/CANCER 149
12.4.1 BREAST CANCER 150
12.4.2 PROSTATE CANCER 150
12.4.3 COLORECTAL CANCER 150
12.4.4 CERVICAL CANCER 150
12.4.5 KIDNEY CANCER 150
12.4.6 LIVER CANCER 150
12.4.7 BLOOD CANCER 150
12.4.8 LUNG CANCER 151
12.4.9 OTHER CANCER 151
12.5 AUTOIMMUNE DISEASE 151
12.6 UROLOGY 151
12.7 GYNECOLOGY 152
12.8 OTHERS 153
13 NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY GENDER 154
13.1 OVERVIEW 155
13.2 MALE 158
13.3 FEMALE 158
14 NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY AGE GROUP 160
14.1 OVERVIEW 161
14.2 GERIATRICS 164
14.3 ADULT 164
14.4 PEDIATRICS 165
15 NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY END USER 166
15.1 OVERVIEW 167
15.2 HOSPITAL-BASED LABS 170
15.3 STAND ALONE LABS 170
15.4 DIAGNOSTIC CHAINS 171
15.5 ACADEMIC INSTITUTES 172
15.6 CLINICAL RESEARCH ORGANISTAION 172
15.7 SPECIALTY DIAGNOSTIC 173
15.8 OTHERS 174
16 NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY DISTRIBUTION CHANNEL 175
16.1 OVERVIEW 176
16.2 DIRECT TENDER 179
16.3 RETAIL SALES 179
16.4 THIRD PARTY DISTRIBUTORS 180
16.5 OTHERS 181
17 NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY REGION 182
17.1 NORTH AMERICA 183
17.1.1 U.S. 198
17.1.2 CANADA 207
17.1.3 MEXICO 216
18 NORTH AMERICA LABORATORY-DEVELOPED TESTS (LDTS) MARKET, COMPANY LANDSCAPE 225
18.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 225
19 COMPANY PROFILES 226
19.1 F. HOFFMANN-LA ROCHE LTD. 226
19.1.1 COMPANY SNAPSHOT 226
19.1.2 REVENUE ANALYSIS 226
19.1.3 COMPANY SHARE ANALYSIS 227
19.1.4 PRODUCT PORTFOLIO 227
19.1.5 RECENT DEVELOPMENT 227
19.2 BIOMRIEUX 228
19.2.1 COMPANY SNAPSHOT 228
19.2.2 REVENUE ANALYSIS 228
19.2.3 COMPANY SHARE ANALYSIS 229
19.2.4 PRODUCT PORTFOLIO 229
19.2.5 RECENT DEVELOPMENTS 229
19.3 SYSMEX CORPORATION 230
19.3.1 COMPANY SNAPSHOT 230
19.3.2 REVENUE ANALYSIS 230
19.3.3 COMPANY SHARE ANALYSIS 231
19.3.4 PRODUCT PORTFOLIO 231
19.3.5 RECENT DEVELOPMENT 231
19.4 BIOMERICA. 232
19.4.1 COMPANY SNAPSHOT 232
19.4.2 REVENUE ANALYSIS 232
19.4.3 COMPANY SHARE ANALYSIS 233
19.4.4 PRODUCT PORTFOLIO 233
19.4.5 RECENT DEVELOPMENT 233
19.5 BIO-RAD LABORATORIES, INC 234
19.5.1 COMPANY SNAPSHOT 234
19.5.2 REVENUE ANALYSIS 234
19.5.3 COMPANY SHARE ANALYSIS 235
19.5.4 PRODUCT PORTFOLIO 235
19.5.5 RECENT DEVELOPMENT 235
19.6 23ANDME, INC. 236
19.6.1 COMPANY SNAPSHOT 236
19.6.2 REVENUE ANALYSIS 236
19.6.3 PRODUCT PORTFOLIO 237
19.6.4 RECENT DEVELOPMENTS 237

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