laboratory-developed tests (ldts) market

Global Laboratory-Developed Tests (LDTs) Market - Industry Trends and Forecast to 2030

  • Published Date: 2023-08-18
  • Report ID: 145566
  • Pages: 250
  • Format: prudent report format

The Global Laboratory-Developed Tests (LDTs) Market is expected to reach USD 41,521.83 Million by 2030 from USD 18,411.29 Million in 2022, growing at a CAGR of 10.7% during the forecast period of 2023 to 2030.

Market Segmentation

Global Laboratory-Developed Tests (LDTs) Market, By Test Type (Clinical Chemistry and Immunology, Critical Care, Hematology, Molecular Diagnostics, Microbiology, and Other Test), Product Type (Consumables, Analyzers and Instruments, and Accessories), Sample Type (Blood, Urine, Tissue, Cerebrospinal Fluid (CSF), and Others), Therapeutic Area (Infections, Genetic Disorders, Oncology/Cancer, Autoimmune Disease, Urology, Gynecology, and Others), Gender (Male, and Female), Age Group (Geriatrics, Adult, and Pediatric), End Users (Hospital-Based Labs, Stand-Alone Labs, Diagnostic Chains, Academic Institutes, Clinical Research Organizations, Specialty Diagnostic Centers, and Others), Distribution Channel (Direct Tender, Retail Sales, Third Party Distributors, and Others), Region (North America, Europe, Asia-Pacific, South America, Middle East and Africa) - Industry Trends and Forecast to 2030

Overview of Global Laboratory-Developed Tests (LDTs) Market Dynamics

Drivers

Increasing demand for personalized medicines
Advancements in molecular diagnostics

Restraint

Stringent quality control and standardization for LDTs
Opportunity

Increasing demand for precision medicine and targeted therapy
Market Players
Some of the major market players operating in the global Laboratory-Developed Tests (LDTs) market are:
F. Hoffmann-La Roche Ltd
bioMrieux, Inc.
Sysmex Corporation
Biomerica, Inc.
Bio-Rad Laboratories, Inc.
Abbott
Siemens Medical Solutions USA, Inc.
Quest Diagnostics Incorporated
QIAGEN
Eurofins Scientific
Biodesix.
Hologic, Inc.
Guardant Health
OPKO Health, Inc.
BD
Beckman Coulter, Inc.
NeoGenomics Laboratories.
Seegene Inc.
Ambry Genetics
BGI
23andMe, Inc.
Milab Scientific
Admera Health
Agendia


TABLE OF CONTENTS
1 INTRODUCTION 67
1.1 OBJECTIVES OF THE STUDY 67
1.2 MARKET DEFINITION 67
1.3 OVERVIEW OF THE GLOBAL LABORATORY-DEVELOPED TESTS (LDTS) MARKET 67
1.4 CURRENCY AND PRICING 69
1.5 LIMITATIONS 69
1.6 MARKETS COVERED 69
2 MARKET SEGMENTATION 74
2.1 MARKETS COVERED 74
2.2 GEOGRAPHICAL SCOPE 75
2.3 YEARS CONSIDERED FOR THE STUDY 76
2.4 DBMR TRIPOD DATA VALIDATION MODEL 77
2.5 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 80
2.6 MULTIVARIATE MODELLING 81
2.7 TEST TYPE SEGMENT LIFELINE CURVE 81
2.8 MARKET END USER COVERAGE GRID 82
2.9 DBMR MARKET POSITION GRID 83
2.10 VENDOR SHARE ANALYSIS 84
2.11 SECONDARY SOURCES 85
2.12 ASSUMPTIONS 85
3 EXECUTIVE SUMMARY 86
4 PREMIUM INSIGHTS 89
4.1 PESTEL ANALYSIS 92
4.2 PORTER'S FIVE FORCES MODEL 93
5 INDUSTRY INSIGHTS 94
6 NUMBER OF LABS 96
6.1 NUMBER OF LABS IN MIDDLE EASTERN COUNTRIES 96
6.2 NUMBER OF LABS IN EUROPE 96
7 REGULATIONS OF THE GLOBAL LABORATORY-DEVELOPED TESTS (LDTS) MARKET 98
7.1 U.S. 98
7.2 EUROPE 98
7.3 SINGAPORE 99
7.4 CHINA 99
7.5 SOUTH AFRICA 100
8 MARKET OVERVIEW 101
8.1 DRIVERS 103
8.1.1 INCREASING DEMAND FOR PERSONALIZED MEDICINE 103
8.1.2 ADVANCEMENTS IN MOLECULAR DIAGNOSTICS 103
8.1.3 GROWING PREVALENCE OF CHRONIC DISEASES 103
8.1.4 INCREASING AWARENESS AND ACCEPTANCE TOWARDS THE ASSISTANCES OF LDTS 104
8.2 RESTRAINTS 104
8.2.1 STRINGENT QUALITY CONTROL AND STANDARDIZATION FOR LDTS 104
8.2.2 STRICT REGULATORY GUIDELINES REGARDING LDTS 105
8.3 OPPORTUNITIES 105
8.3.1 INCREASING DEMAND FOR PRECISION MEDICINE AND TARGETED THERAPY 105
8.3.2 ENHANCED HEALTHCARE SUBSTRUCTURE 106
8.4 CHALLENGES 106
8.4.1 DEPRIVED DATA INTERPRETATION AND INTEGRATION 106
8.4.2 COMPLEX LABORATORY PROCESSES 107
9 GLOBAL LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY TEST TYPE 108
9.1 OVERVIEW 109
9.2 CLINICAL CHEMISTRY AND IMMUNOLOGY 112
9.2.1 GLUCOSE 113
9.2.1.1 GLUCOSE CHALLENGE TEST 113
9.2.1.2 ORAL GLUCOSE TOLERANCE TEST (OGTT) 113
9.2.2 PROTHROMBIN 114
9.2.3 METABOLIC PANEL 114
9.2.3.1 BASIC 114
9.2.3.2 COMPREHENSIVE 114
9.2.4 LIPID PANEL 114
9.2.5 LIVER PANEL 114
9.2.5.1 ALP TEST (ALKALINE PHOSPHATE) 115
9.2.5.2 ALT TEST (ALKALINE TRANSMINASE) 115
9.2.5.3 AST TEST (ASPARTATE AMINOTRANSFERASE) 115
9.2.5.4 GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST 115
9.2.6 THYROID STIMULATING HORMONE 115
9.2.7 URINALYSIS 115
9.2.7.1 RED BLOOD CELL URINE TEST 116
9.2.7.2 GLUCOSE URINE TEST 116
9.2.7.3 PROTEIN URINE TEST 116
9.2.7.4 URINE PH LEVEL 116
9.2.7.5 KETONES URINE TEST 116
9.2.7.6 BILIBURIN URINE TEST 116
9.2.7.7 URINE SPECIFIC GRAVITY TEST 117
9.2.8 OTHERS 117
9.3 CRITICAL CARE 117
9.3.1 CARBOXYHAEMOGLOBIN TEST 118
9.3.2 PH TEST 118
9.3.3 POTASSIUM TEST 118
9.3.4 SODIUM TEST 118
9.3.5 METHEMOGLOBIN TEST 118
9.3.6 LACTATE TEST 118
9.3.7 OTHERS 119
9.4 HAEMATOLOGY 119
9.4.1 COMPLETE BLOOD COUNT (CBC) 120
9.4.1.1 WHITE BLOOD CELL COUNT (WBC) 120
9.4.1.2 RED BLOOD CELL COUNT (RBC) 120
9.4.2 PLATELET COUNT 120
9.4.3 BLOOD PROTEIN TESTING 121
9.4.4 OTHERS 121
9.5 MOLECULAR DIAGNOSTIC 121
9.5.1 SAMPLE TYPE 122
9.5.1.1 BLOOD 122
9.5.1.2 URINE 122
9.5.1.3 TISSUE 122
9.5.1.4 CEREBROSPINAL FLUID (CSF) 122
9.5.1.5 OTHERS 122
9.5.2 THERAPEUTIC AREA 122
9.5.2.1 INFECTIONS 123
9.5.2.2 GENETIC DISORDERS 123
9.5.2.3 ONCOLOGY/CANCER 123
9.5.2.4 AUTOIMMUNE DISEASE 123
9.5.2.5 UROLOGY 123
9.5.2.6 GYNECOLOGY 123
9.5.2.7 OTHERS 123
9.5.3 TECHNOLOGY 124
9.5.3.1 POLYMERASE CHAIN REACTION (PCR) 124
9.5.3.2 NEXT-GENERATION SEQUENCING (NGS) 124
9.5.3.3 FLUORESCENCE IN SITU HYBRIDIZATION (FISH) 124
9.5.3.4 SANGER SEQUENCING 124
9.5.3.5 MICROARRAYS 124
9.5.3.6 MASS SPECTROMETRY 125
9.5.3.7 ISOTHERMAL AMPLIFICATION 125
9.5.4 END USER 125
9.5.4.1 HOSPITAL-BASED LABS 125
9.5.4.2 STAND-ALONE LABS 125
9.5.4.3 DIAGNOSTIC CHAINS 125
9.5.4.4 ACADEMIC INSTITUTES 126
9.5.4.5 CLINICAL RESEARCH ORGANIZATIONS 126
9.5.4.6 SPECIALTY DIAGNOSTIC CENTERS 126
9.5.4.7 OTHERS 126
9.6 MICROBIOLOGY 126
9.6.1 MICROSCOPY 127
9.6.2 CULTURE 127
9.6.3 ANTIMICROBIAL SUSCEPTIBILITY TEST 127
9.6.4 OTHERS 127
9.7 OTHER TEST 128
9.7.1 DRUGS OF ABUSE TESTING 129
9.7.2 HEPATITIS 129
9.7.3 HUMAN IMMUNODEFICIENCY VIRUSES (HIV) 129
9.7.4 MALARIA 129
9.7.5 TUBERCULOSIS 129
9.7.6 HUMAN PAPILLOMAVIRUS (HPV) 129
9.7.7 OTHERS 130
10 GLOBAL LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY PRODUCT TYPE 131
10.1 OVERVIEW 132
10.2 CONSUMABLES 135
10.2.1 PANELS 135
10.2.2 REAGENT AND KITS 136
10.2.3 OTHERS 136
10.3 ANALYZERS AND INSTRUMENTS 136
10.3.1 FULLY-AUTOMATED INSTRUMENTS 137
10.3.2 SEMI-AUTOMATED INSTRUMENTS 137
10.3.3 OTHERS 137
10.4 ACCESSORIES 137
11 GLOBAL LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY SAMPLE TYPE 139
11.1 OVERVIEW 140
11.2 BLOOD 143
11.3 URINE 143
11.4 TISSUE 144
11.5 CEREBROSPINAL FLUID (CSF) 144
11.6 OTHERS 145
12 GLOBAL LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY THERAPEUTIC AREA 147
12.1 OVERVIEW 148
12.2 INFECTIONS 151
12.2.1 METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) 152
12.2.2 CLOSTRIDIUM DIFFICILE 152
12.2.3 VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE) 152
12.2.4 CARBAPENEM-RESISTANT BACTERIA 152
12.2.5 FLU 152
12.2.6 RESPIRATORY SYNCYTIAL VIRUS (RSV) 153
12.2.7 CANDIDA 153
12.2.8 TUBERCULOSIS AND DRUG-RESISTANT TBA 153
12.2.9 MENINGITIS 153
12.2.10 GASTROINTESTINAL PANEL TESTING 153
12.2.11 CHLAMYDIA 153
12.2.12 GONORRHEA 153
12.2.13 HIV 153
12.2.14 HEPATITIS B 153
12.2.15 HEPATITIS C 153
12.2.16 OTHER INFECTIOUS DISEASES 153
12.3 GENETIC DISORDERS 154
12.3.1 NEW BORN SCREENING 154
12.3.2 PREDICTIVE AND PRESYMPTOMATIC TESTING 155
12.3.3 OTHER GENETIC TESTING 155
12.4 ONCOLOGY/CANCER 155
12.4.1 BREAST CANCER 156
12.4.2 PROSTATE CANCER 156
12.4.3 COLORECTAL CANCER 156
12.4.4 CERVICAL CANCER 156
12.4.5 KIDNEY CANCER 156
12.4.6 LIVER CANCER 156
12.4.7 BLOOD CANCER 156
12.4.8 LUNG CANCER 157
12.4.9 OTHER CANCER 157
12.5 AUTOIMMUNE DISEASE 157
12.6 UROLOGY 157
12.7 GYNECOLOGY 158
12.8 OTHERS 159
13 GLOBAL LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY GENDER 160
13.1 OVERVIEW 161
13.2 MALE 164
13.3 FEMALE 164
14 GLOBAL LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY AGE GROUP 166
14.1 OVERVIEW 167
14.2 GERIATRICS 170
14.3 ADULT 170
14.4 PEDIATRICS 171
15 GLOBAL LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY END USER 172
15.1 OVERVIEW 173
15.2 HOSPITAL-BASED LABS 176
15.3 STAND ALONE LABS 176
15.4 DIAGNOSTIC CHAINS 177
15.5 ACADEMIC INSTITUTES 178
15.6 CLINICAL RESEARCH ORGANISTAION 178
15.7 SPECIALTY DIAGNOSTIC 179
15.8 OTHERS 180
16 GLOBAL LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY DISTRIBUTION CHANNEL 181
16.1 OVERVIEW 182
16.2 DIRECT TENDER 185
16.3 RETAIL SALES 185
16.4 THIRD PARTY DISTRIBUTORS 186
16.5 OTHERS 187
17 GLOBAL LABORATORY-DEVELOPED TESTS (LDTS) MARKET, BY REGION 188
17.1 OVERVIEW 189
17.2 NORTH AMERICA 195
17.2.1 U.S. 210
17.2.2 CANADA 219
17.2.3 MEXICO 228
17.3 EUROPE 237
17.3.1 GERMANY 252
17.3.2 U.K. 261
17.3.3 FRANCE 270
17.3.4 ITALY 279
17.3.5 RUSSIA 288
17.3.6 SPAIN 297
17.3.7 NETHERLANDS 306
17.3.8 SWITZERLAND 315
17.3.9 BELGIUM 324
17.3.10 TURKEY 333
17.3.11 REST OF EUROPE 342
17.4 ASIA PACIFIC 343
17.4.1 CHINA 357
17.4.2 JAPAN 366
17.4.3 INDIA 375
17.4.4 AUSTRALIA 384
17.4.5 SOUTH KOREA 393
17.4.6 INDONESIA 402
17.4.7 PHILIPPINES 411
17.4.8 THAILAND 420
17.4.9 MALAYSIA 429
17.4.10 SINGAPORE 438
17.4.11 REST OF ASIA-PACIFIC 447
17.5 SOUTH AMERICA 448
17.5.1 BRAZIL 466
17.5.2 ARGENTINA 479
17.5.3 REST OF SOUTH AMERICA 492
17.6 MIDDLE EAST AND AFRICA 493
17.6.1 SAUDI ARABIA 511
17.6.2 SOUTH AFRICA 524
17.6.3 U.A.E 537
17.6.4 EGYPT 550
17.6.5 ISRAEL 563
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