TABLE OF CONTENTS
1 INTRODUCTION 66
1.1 OBJECTIVES OF THE STUDY 66
1.2 MARKET DEFINITION 66
1.3 OVERVIEW OF THE EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET 66
1.4 CURRENCY AND PRICING 68
1.5 LIMITATIONS 68
1.6 MARKETS COVERED 68
2 MARKET SEGMENTATION 73
2.1 MARKETS COVERED 73
2.2 GEOGRAPHICAL SCOPE 74
2.3 YEARS CONSIDERED FOR THE STUDY 75
2.4 DBMR TRIPOD DATA VALIDATION MODEL 76
2.5 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 79
2.6 MULTIVARIATE MODELLING 80
2.7 TEST TYPE SEGMENT LIFELINE CURVE 80
2.8 MARKET END USER COVERAGE GRID 81
2.9 DBMR MARKET POSITION GRID 82
2.10 VENDOR SHARE ANALYSIS 83
2.11 SECONDARY SOURCES 84
2.12 ASSUMPTIONS 84
3 EXECUTIVE SUMMARY 85
4 PREMIUM INSIGHTS 88
4.1 PESTEL ANALYSIS 89
4.2 PORTER'S FIVE FORCES MODEL 90
5 INDUSTRY INSIGHTS 91
6 NUMBER OF LABS 93
6.1 NUMBER OF LABS IN MIDDLE EASTERN COUNTRIES 93
6.2 NUMBER OF LABS IN EUROPE 93
7 REGULATIONS OF THE EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET 95
7.1 EUROPE 95
8 MARKET OVERVIEW 96
8.1 DRIVERS 98
8.1.1 INCREASING DEMAND FOR PERSONALIZED MEDICINE 98
8.1.2 ADVANCEMENTS IN MOLECULAR DIAGNOSTICS 98
8.1.3 GROWING PREVALENCE OF CHRONIC DISEASES 98
8.1.4 INCREASING AWARENESS AND ACCEPTANCE TOWARDS THE ASSISTANCES OF LDTS 99
8.2 RESTRAINTS 99
8.2.1 STRINGENT QUALITY CONTROL AND STANDARDIZATION FOR LDTS 99
8.2.2 STRICT REGULATORY GUIDELINES REGARDING LDTS 100
8.3 OPPORTUNITIES 100
8.3.1 INCREASING DEMAND FOR PRECISION MEDICINE AND TARGETED THERAPY 100
8.3.2 ENHANCED HEALTHCARE SUBSTRUCTURE 101
8.4 CHALLENGES 101
8.4.1 DEPRIVED DATA INTERPRETATION AND INTEGRATION 101
8.4.2 COMPLEX LABORATORY PROCESSES 102
9 EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY TEST TYPE 103
9.1 OVERVIEW 104
9.2 CLINICAL CHEMISTRY AND IMMUNOLOGY 107
9.2.1 GLUCOSE 108
9.2.1.1 GLUCOSE CHALLENGE TEST 108
9.2.1.2 ORAL GLUCOSE TOLERANCE TEST (OGTT) 108
9.2.2 PROTHROMBIN 109
9.2.3 METABOLIC PANEL 109
9.2.3.1 BASIC 109
9.2.3.2 COMPREHENSIVE 109
9.2.4 LIPID PANEL 109
9.2.5 LIVER PANEL 109
9.2.5.1 ALP TEST (ALKALINE PHOSPHATE) 110
9.2.5.2 ALT TEST (ALKALINE TRANSMINASE) 110
9.2.5.3 AST TEST (ASPARTATE AMINOTRANSFERASE) 110
9.2.5.4 GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST 110
9.2.6 THYROID STIMULATING HORMONE 110
9.2.7 URINALYSIS 110
9.2.7.1 RED BLOOD CELL URINE TEST 111
9.2.7.2 GLUCOSE URINE TEST 111
9.2.7.3 PROTEIN URINE TEST 111
9.2.7.4 URINE PH LEVEL 111
9.2.7.5 KETONES URINE TEST 111
9.2.7.6 BILIBURIN URINE TEST 111
9.2.7.7 URINE SPECIFIC GRAVITY TEST 112
9.2.8 OTHERS 112
9.3 CRITICAL CARE 112
9.3.1 CARBOXYHAEMOGLOBIN TEST 113
9.3.2 PH TEST 113
9.3.3 POTASSIUM TEST 113
9.3.4 SODIUM TEST 113
9.3.5 METHEMOGLOBIN TEST 113
9.3.6 LACTATE TEST 113
9.3.7 OTHERS 114
9.4 HAEMATOLOGY 114
9.4.1 COMPLETE BLOOD COUNT (CBC) 115
9.4.1.1 WHITE BLOOD CELL COUNT (WBC) 115
9.4.1.2 RED BLOOD CELL COUNT (RBC) 115
9.4.2 PLATELET COUNT 115
9.4.3 BLOOD PROTEIN TESTING 116
9.4.4 OTHERS 116
9.5 MOLECULAR DIAGNOSTIC 116
9.5.1 SAMPLE TYPE 117
9.5.1.1 BLOOD 117
9.5.1.2 URINE 117
9.5.1.3 TISSUE 117
9.5.1.4 CEREBROSPINAL FLUID (CSF) 117
9.5.1.5 OTHERS 117
9.5.2 THERAPEUTIC AREA 117
9.5.2.1 INFECTIONS 118
9.5.2.2 GENETIC DISORDERS 118
9.5.2.3 ONCOLOGY/CANCER 118
9.5.2.4 AUTOIMMUNE DISEASE 118
9.5.2.5 UROLOGY 118
9.5.2.6 GYNECOLOGY 118
9.5.2.7 OTHERS 118
9.5.3 TECHNOLOGY 119
9.5.3.1 POLYMERASE CHAIN REACTION (PCR) 119
9.5.3.2 NEXT-GENERATION SEQUENCING (NGS) 119
9.5.3.3 FLUORESCENCE IN SITU HYBRIDIZATION (FISH) 119
9.5.3.4 SANGER SEQUENCING 119
9.5.3.5 MICROARRAYS 119
9.5.3.6 MASS SPECTROMETRY 120
9.5.3.7 ISOTHERMAL AMPLIFICATION 120
9.5.4 END USER 120
9.5.4.1 HOSPITAL-BASED LABS 120
9.5.4.2 STAND-ALONE LABS 120
9.5.4.3 DIAGNOSTIC CHAINS 120
9.5.4.4 ACADEMIC INSTITUTES 121
9.5.4.5 CLINICAL RESEARCH ORGANIZATIONS 121
9.5.4.6 SPECIALTY DIAGNOSTIC CENTERS 121
9.5.4.7 OTHERS 121
9.6 MICROBIOLOGY 121
9.6.1 MICROSCOPY 122
9.6.2 CULTURE 122
9.6.3 ANTIMICROBIAL SUSCEPTIBILITY TEST 122
9.6.4 OTHERS 122
9.7 OTHER TEST 123
9.7.1 DRUGS OF ABUSE TESTING 124
9.7.2 HEPATITIS 124
9.7.3 HUMAN IMMUNODEFICIENCY VIRUSES (HIV) 124
9.7.4 MALARIA 124
9.7.5 TUBERCULOSIS 124
9.7.6 HUMAN PAPILLOMAVIRUS (HPV) 124
9.7.7 OTHERS 125
10 EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY PRODUCT TYPE 126
10.1 OVERVIEW 127
10.2 CONSUMABLES 130
10.2.1 PANELS 130
10.2.2 REAGENT AND KITS 131
10.2.3 OTHERS 131
10.3 ANALYZERS AND INSTRUMENTS 131
10.3.1 FULLY-AUTOMATED INSTRUMENTS 132
10.3.2 SEMI-AUTOMATED INSTRUMENTS 132
10.3.3 OTHERS 132
10.4 ACCESSORIES 132
11 EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY SAMPLE TYPE 134
11.1 OVERVIEW 135
11.2 BLOOD 138
11.3 URINE 138
11.4 TISSUE 139
11.5 CEREBROSPINAL FLUID (CSF) 139
11.6 OTHERS 140
12 EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY THERAPEUTIC AREA 142
12.1 OVERVIEW 143
12.2 INFECTIONS 146
12.2.1 METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) 147
12.2.2 CLOSTRIDIUM DIFFICILE 147
12.2.3 VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE) 147
12.2.4 CARBAPENEM-RESISTANT BACTERIA 147
12.2.5 FLU 147
12.2.6 RESPIRATORY SYNCYTIAL VIRUS (RSV) 148
12.2.7 CANDIDA 148
12.2.8 TUBERCULOSIS AND DRUG-RESISTANT TBA 148
12.2.9 MENINGITIS 148
12.2.10 GASTROINTESTINAL PANEL TESTING 148
12.2.11 CHLAMYDIA 148
12.2.12 GONORRHEA 148
12.2.13 HIV 148
12.2.14 HEPATITIS B 148
12.2.15 HEPATITIS C 148
12.2.16 OTHER INFECTIOUS DISEASES 148
12.3 GENETIC DISORDERS 149
12.3.1 NEW BORN SCREENING 149
12.3.2 PREDICTIVE AND PRESYMPTOMATIC TESTING 150
12.3.3 OTHER GENETIC TESTING 150
12.4 ONCOLOGY/CANCER 150
12.4.1 BREAST CANCER 151
12.4.2 PROSTATE CANCER 151
12.4.3 COLORECTAL CANCER 151
12.4.4 CERVICAL CANCER 151
12.4.5 KIDNEY CANCER 151
12.4.6 LIVER CANCER 151
12.4.7 BLOOD CANCER 151
12.4.8 LUNG CANCER 152
12.4.9 OTHER CANCER 152
12.5 AUTOIMMUNE DISEASE 152
12.6 UROLOGY 152
12.7 GYNECOLOGY 153
12.8 OTHERS 154
13 EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY GENDER 155
13.1 OVERVIEW 156
13.2 MALE 159
13.3 FEMALE 159
14 EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY AGE GROUP 161
14.1 OVERVIEW 162
14.2 GERIATRICS 165
14.3 ADULT 165
14.4 PEDIATRICS 166
15 EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY END USER 167
15.1 OVERVIEW 168
15.2 HOSPITAL-BASED LABS 171
15.3 STAND ALONE LABS 171
15.4 DIAGNOSTIC CHAINS 172
15.5 ACADEMIC INSTITUTES 173
15.6 CLINICAL RESEARCH ORGANISTAION 173
15.7 SPECIALTY DIAGNOSTIC 174
15.8 OTHERS 175
16 EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY DISTRIBUTION CHANNEL 176
16.1 OVERVIEW 177
16.2 DIRECT TENDER 180
16.3 RETAIL SALES 180
16.4 THIRD PARTY DISTRIBUTORS 181
16.5 OTHERS 182
17 EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY REGION 183
17.1 EUROPE 184
17.1.1 GERMANY 199
17.1.2 U.K. 208
17.1.3 FRANCE 217
17.1.4 ITALY 226
17.1.5 RUSSIA 235
17.1.6 SPAIN 244
17.1.7 NETHERLANDS 253
17.1.8 SWITZERLAND 262
17.1.9 BELGIUM 271
17.1.10 TURKEY 280
17.1.11 REST OF EUROPE 289
18 EUROPE LABORATORY-DEVELOPED TESTS (LDTS) MARKET, COMPANY LANDSCAPE 290
18.1 COMPANY SHARE ANALYSIS: EUROPE 290
19 COMPANY PROFILES 291
19.1 F. HOFFMANN-LA ROCHE LTD. 291
19.1.1 COMPANY SNAPSHOT 291
19.1.2 REVENUE ANALYSIS 291
19.1.3 COMPANY SHARE ANALYSIS 292
19.1.4 PRODUCT PORTFOLIO 292
19.1.5 RECENT DEVELOPMENT 292
19.2 BIOMRIEUX 293
19.2.1 COMPANY SNAPSHOT 293
19.2.2 REVENUE ANALYSIS 293
19.2.3 COMPANY SHARE ANALYSIS 294
19.2.4 PRODUCT PORTFOLIO 294
19.2.5 RECENT DEVELOPMENTS 294
19.3 SYSMEX CORPORATION 295
19.3.1 COMPANY SNAPSHOT 295
19.3.2 REVENUE ANALYSIS 295
19.3.3 COMPANY SHARE ANALYSIS 296
19.3.4 PRODUCT PORTFOLIO 296
19.3.5 RECENT DEVELOPMENT 296
19.4 BIOMERICA. 297
19.4.1 COMPANY SNAPSHOT 297
19.4.2 REVENUE ANALYSIS 297
19.4.3 COMPANY SHARE ANALYSIS 298
19.4.4 PRODUCT PORTFOLIO 298
19.4.5 RECENT DEVELOPMENT 298

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