Abstract
Summary
North America genetic testing market is expected to reach USD 25,045,918.59 thousand by 2031 from USD 7,381,854.06 thousand in 2023 with growing at a CAGR of 16.8% during the forecast period of 2024 to 2031.
Market Segmentation
North America Genetic Testing Market, By Type (Carrier Testing, Diagnostic Testing, New Born Screening, Predictive and Presymptomatic Testing, and Other Types), Technology (DNA sequencing, Polymerase Chain Reaction, Microarrays, Whole Genome Sequencing, Fluorescence In Situ Hybridization (FISH), and Others), Diseases (Rare Genetic Disorder, Cancer, Cystic Fibrosis, Sickle Cell Anemia, Duchenne Muscular Dystrophy, Thalassemia, Huntington’s Disease, Fragile X Syndrome, and Other Diseases), End User (Hospitals, Clinics, Diagnostic Centers, Private Clinics, Laboratory Service Providers, and Private Laboratories), By Country (U.S., Canada, and Mexico) - Industry Trends and Forecast to 2031
Overview of Global Genetic Testing Market Dynamics
Driver
• Growing prevalence of genetic disorders
Restrain
• High cost of genetic testing
Opportunity
• Strategic initiatives by the key market player
Market Players
Some of the key market players for North America genetic testing market are:
• Thermo Fisher Scientific Inc.
• Invitae Corporation
• Bio-Rad Laboratories, Inc.
• PerkinElmer Inc.
• Illumina, Inc.
• QIAGEN
• F. Hoffmann-La Roche Ltd.
• Fulgent Genetics
• Myriad Genetics, Inc.
• Abbott
• Eurofins Scientific
• Sorenson Genomics
• BIO-HELIX
• Biocartis
• Cepheid (A subsidiary of Danaher)
• PacBio
• ELITechGroup
• Genes2Me
• Eugene Labs
• Otogenetics
• Mapmygenome
• MedGenome
• BioReference
• Natera, Inc.
Table of Contents
1 INTRODUCTION 66
1.1 OBJECTIVES OF THE STUDY 66
1.2 MARKET DEFINITION 66
1.3 OVERVIEW OF THE NORTH AMERICA GENETIC TESTING MARKET 66
1.4 LIMITATIONS 68
1.5 MARKETS COVERED 68
2 MARKET SEGMENTATION 71
2.1 MARKETS COVERED 71
2.2 GEOGRAPHICAL SCOPE 72
2.3 YEARS CONSIDERED FOR THE STUDY 73
2.4 CURRENCY AND PRICING 73
2.5 DBMR TRIPOD DATA VALIDATION MODEL 74
2.6 TYPE LIFELINE CURVE 78
2.7 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 79
2.8 DBMR MARKET POSITION GRID 80
2.9 MARKET APPLICATION COVERAGE GRID 81
2.10 VENDOR SHARE ANALYSIS 82
2.11 SECONDARY SOURCES 83
2.12 ASSUMPTIONS 83
3 EXECUTIVE SUMMARY 84
4 PREMIUM INSIGHTS 86
4.1 PESTAL ANALYSIS 89
4.2 PORTERS 5 FORCES 90
4.3 EPIDEMIOLOGY 91
5 NORTH AMERICA GENETIC TESTING MARKET: REGULATIONS 92
6 MARKET OVERVIEW 94
6.1 DRIVERS 96
6.1.1 GROWING PREVALENCE OF GENETIC DISORDERS 96
6.1.2 INCREASE IN THE ADOPTION OF NEXT GENERATION SEQUENCING 96
6.1.3 WIDE PRODUCT PORTFOLIO OFFERED BY A MAJOR PLAYER 97
6.1.4 INCREASE THE TREND TOWARD PERSONALIZED MEDICATION 97
6.2 RESTRAINTS 98
6.2.1 HIGH COST OF GENETIC TESTING 98
6.2.2 CYBER SECURITY CONCERNS IN GENOMICS 99
6.3 OPPORTUNITIES 99
6.3.1 STRATEGIC INITIATIVES BY THE KEY MARKET PLAYER 99
6.3.2 TECHNOLOGICAL ADVANCEMENT IN THE FIELD OF GENETIC TESTING 100
6.3.3 INCREASING RESEARCH AND DEVELOPMENT FOR GENETIC TESTING 100
6.4 CHALLENGES 101
6.4.1 LACK OF SKILLED PROFESSIONALS TO PERFORM GENETIC TESTING 101
6.4.2 STRINGENT REGULATION POLICY FOR GENETIC TESTING 102
7 NORTH AMERICA GENETIC TESTING MARKET, BY TYPE 103
7.1 OVERVIEW 104
7.2 DIAGNOSTIC TESTING 108
7.3 PRENATAL TESTING 108
7.3.1 NON-INVASIVE SCREENING 109
- 7.3.1.1 WHOLE GENOME SEQUENCING 110
- 7.3.1.2 COUNTING OF CFDNA FRAGMENTS 110
- 7.3.1.3 OTHERS 110
7.3.2 BY CONDITION 111
- 7.3.2.1 TRISOMY 21 111
- 7.3.2.2 KLINEFELTER SYNDROME 111
- 7.3.2.3 JACOBS SYNDROME 111
- 7.3.2.4 CYSTIC FIBROSIS 111
- 7.3.2.5 TURNER SYNDROME 112
- 7.3.2.6 TRISOMY 18 112
- 7.3.2.7 HEMOPHILIA 112
- 7.3.2.8 TRISOMY 13 112
- 7.3.2.9 MICRODELETION SYNDROME 112
- 7.3.2.10 FETAL GENDER 112
- 7.3.2.11 OTHERS 112
7.3.3 BY SCREENING TYPE 113
- 7.3.3.1 CARRIER SEQUENCING 113
- 7.3.3.2 SEQUENTIAL SEQUENCING 113
7.3.4 MATERNAL SERUM QUAD SCREENING 113
7.4 NEW-BORN SCREENING 114
7.4.1 SICKLE CELL DISEASE 114
7.4.2 CONGENITAL HYPOTHYROIDISM 115
7.4.3 PHENYLKETONURINA (PKU) 115
7.4.4 GALACTOSEMIA 115
7.4.5 MAPLE SYRUP URINE DISEASE 115
7.4.6 OTHERS 115
7.5 PREDICTIVE AND PRESYMPTOMATIC TESTING 115
7.6 CARRIER TESTING 116
7.6.1 MOLECULAR SCREENING TEST 116
7.6.2 BIOCHEMICAL SCREENING TEST 117
- 7.6.2.1 EXPANDED CARRIER SCREENING 117
- 7.6.2.2 PREDESIGNED PANEL TESTING 118
- 7.6.2.3 CUSTOM-MADE PANEL TESTING 118
- 7.6.2.4 TARGETED DISEASE CARRIER SCREENING 118
- 7.6.2.4.1 HEMATOLOGICAL CONDITIONS 118
- 7.6.2.4.2 PULMONARY CONDITIONS 119
- 7.6.2.4.3 NEUROLOGICAL CONDITIONS 119
- 7.6.2.4.4 OTHER CONDITIONS 119
7.7 OTHER TYPES 119
8 NORTH AMERICA GENETIC TESTING MARKET, BY TECHNOLOGY 120
8.1 OVERVIEW 121
8.2 POLYMERASE CHAIN REACTION 124
8.2.1 REAL-TIME PCR (QPCR) 125
8.2.2 DIGITAL PCR (DPCR) 125
8.2.3 REVERSE TRANSCRIPTION PCR (RT-PCR) 125
8.2.4 HOT-START PCR 125
8.2.5 MULTIPLEX PCR 125
8.2.6 OTHER PCR 125
8.3 DNA SEQUENCING (NGS-BASED TESTING) 126
8.3.1 NEXT GENERATION SEQUENCING (NGS) 126
8.3.2 SANGER SEQUENCING (SINGLE GENE) 126
8.3.3 OTHER 127
8.4 WHOLE GENOME SEQUENCING 127
8.5 MICROARRAYS 127
8.5.1 DNA MICROARRAYS 128
8.5.2 PROTEIN MICROARRAYS 128
8.5.3 OTHER MICROARRAYS 128
8.6 FLUORESCENCE IN SITU HYBRIDIZATION (FISH) 128
8.7 OTHERS 129
9 NORTH AMERICA GENETIC TESTING MARKET, BY DISEASES 130
9.1 OVERVIEW 131
9.2 CANCER 134
9.2.1 BREAST 135
9.2.2 COLON 135
9.2.3 LUNG 135
9.2.4 PROSTATE 135
9.2.5 OTHERS 135
9.3 SICKLE CELL ANEMIA 136
9.4 THALASSEMIA 136
9.5 RARE GENETIC DISORDER 137
9.5.1 TRISOMY 21 137
9.5.2 MONOSOMY X 137
9.5.3 TRISOMY 13 138
9.5.4 MICRODELETION SYNDROME 138
9.5.5 TRISOMY 18 138
9.5.6 OTHERS 138
9.6 FRAGILE X SYNDROME 138
9.7 DUCHENNE MUSCULAR DYSTROPHY 139
9.8 HUNTINGTON'S DISEASE 139
9.9 CYSTIC FIBROSIS 140
9.10 OTHERS 140
10 NORTH AMERICA GENETIC TESTING MARKET, BY END USER 141
10.1 OVERVIEW 142
10.2 HOSPITALS 145
10.3 CLINICS 146
10.4 DIAGNOSTIC CENTERS 146
10.5 PRIVATE CLINICS 147
10.6 LABORATORY SERVICE PROVIDERS 147
10.7 PRIVATE LABORATORIES 148
11 NORTH AMERICA GENETIC TESTING MARKET, BY REGION 149
11.1 OVERVIEW 150
11.2 NORTH AMERICA 153
11.2.1 U.S 163
11.2.2 CANADA 174
11.2.3 MEXICO 185
12 NORTH AMERICA GENETIC TESTING MARKET, COMPANY LANDSCAPE 196
12.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 196
13 SWOT ANALYSIS 197
14 COMPANY PROFILES 198
14.1 ILLUMINA, INC 198
14.1.1 COMPANY SNAPSHOT 198
14.1.2 REVENUE ANALYSIS 198
14.1.3 COMPANY SHARE ANALYSIS 199
14.1.4 PRODUCT PORTFOLIO 199
14.1.5 RECENT DEVELOPMENT 200
14.2 CEPHEID 201
14.2.1 COMPANY SNAPSHOT 201
14.2.2 REVENUE ANALYSIS 201
14.2.3 COMPANY SHARE ANALYSIS 202
14.2.4 PRODUCT PORTFOLIO 202
14.2.5 RECENT DEVELOPMENT 202
14.3 FULGENT GENETICS 203
14.3.1 COMPANY SNAPSHOT 203
14.3.2 REVENUE ANALYSIS 203
14.3.3 COMPANY SHARE ANALYSIS 204
14.3.4 PRODUCT PORTFOLIO 204
14.3.5 RECENT DEVELOPMENT 205
14.4 PERKINELMER INC 206
14.4.1 COMPANY SNAPSHOT 206
14.4.2 REVENUE ANALYSIS 206
14.4.3 COMPANY SHARE ANALYSIS 207
14.4.4 PRODUCT PORTFOLIO 207
14.4.5 RECENT DEVELOPMENT 207
14.5 THERMO FISHER SCIENTIFIC INC 208
14.5.1 COMPANY SNAPSHOT 208
14.5.2 REVENUE ANALYSIS 208
14.5.3 COMPANY SHARE ANALYSIS 209
14.5.4 PRODUCT PORTFOLIO 209
14.5.5 RECENT DEVELOPMENT 210
- 14.5.5.1 COLLABORATION 210
14.6 BIOREFERENCE 211
14.6.1 COMPANY SNAPSHOT 211
14.6.2 REVENUE ANALYSIS 211
14.6.3 PRODUCT PORTFOLIO 212
14.6.4 RECENT DEVELOPMENT 212
14.7 ELITECHGROUP 213
14.7.1 COMPANY SNAPSHOT 213
14.7.2 PRODUCT PORTFOLIO 213
14.7.3 RECENT DEVELOPMENTS 214
14.8 EUROFINS SCIENTIFIC 215
14.8.1 COMPANY SNAPSHOT 215
14.8.2 REVENUE ANALYSIS 215
14.8.3 PRODUCT PORTFOLIO 216
14.8.4 RECENT DEVELOPMENT 216
14.9 INVITAE CORPORATION 217
14.9.1 COMPANY SNAPSHOT 217
14.9.2 REVENUE ANALYSIS 217
14.9.3 PRODUCT PORTFOLIO 218
14.9.4 RECENT DEVELOPMENTS 218
14.10 MYRIAD GENETICS 219
14.10.1 COMPANY SNAPSHOT 219
14.10.2 REVENUE ANALYSIS 219
14.10.3 PRODUCT PORTFOLIO 220
14.10.4 RECENT DEVELOPMENT 220
14.11 ABBOTT 221
14.11.1 COMPANY SNAPSHOT 221
14.11.2 REVENUE ANALYSIS 221
14.11.3 PRODUCT PORTFOLIO 222
14.11.4 RECENT DEVELOPMENT 222
14.12 BIOCARTIS 223
14.12.1 COMPANY SNAPSHOT 223
14.12.2 REVENUE ANALYSIS 223
14.12.3 PRODUCT PORTFOLIO 224
14.12.4 RECENT DEVELOPMENTS 224
- 14.12.4.1 PARTNERSHIP 224
14.13 BIO-HELIX 225
14.13.1 COMPANY SNAPSHOT 225
14.13.2 PRODUCT PORTFOLIO 225
14.13.3 RECENT DEVELOPMENT 225
14.14 BIO-RAD LABORATORIES, INC 226
14.14.1 COMPANY SNAPSHOT 226
14.14.2 REVENUE ANALYSIS 226
14.14.3 PRODUCT PORTFOLIO 227
14.14.4 RECENT DEVELOPMENTS 227
14.15 EUGENE LABS 228
14.15.1 COMPANY SNAPSHOT 228
14.15.2 PRODUCT PORTFOLIO 228
14.15.3 RECENT DEVELOPMENT 228
14.16 F. HOFFMANN-LA ROCHE LTD 229
14.16.1 COMPANY SNAPSHOT 229
14.16.2 REVENUE ANALYSIS (PARENT COMPANY) 229
14.16.3 PRODUCT PORTFOLIO 230
14.16.4 RECENT DEVELOPMENT 230
14.17 GENES2ME 231
14.17.1 COMPANY SNAPSHOT 231
14.17.2 PRODUCT PORTFOLIO 231
14.17.3 RECENT DEVELOPMENT 231
14.18 MAPMYGENOME 232
14.18.1 COMPANY SNAPSHOT 232
14.18.2 PRODUCT PORTFOLIO 232
14.18.3 RECENT DEVELOPMENT 233
14.19 MEDGENOME 234
14.19.1 COMPANY SNAPSHOT 234
14.19.2 PRODUCT PORTFOLIO 234
14.19.3 RECENT DEVELOPMENT 235
14.20 NATERA, INC 236
14.20.1 COMPANY SNAPSHOT 236
14.20.2 REVENUE ANALYSIS 236
14.20.3 PRODUCT PORTFOLIO 237
14.20.4 RECENT DEVELOPMENT 238
14.21 OTOGENETICS 239
14.21.1 COMPANY SNAPSHOT 239
14.21.2 PRODUCT PORTFOLIO 240
14.21.3 RECENT DEVELOPMENT 240
14.22 PACBIO 241
14.22.1 COMPANY SNAPSHOT 241
14.22.2 REVENUE ANALYSIS 241
14.22.3 PRODUCT PORTFOLIO 242
14.22.4 RECENT DEVELOPMENT 242
14.23 QIAGEN 243
14.23.1 COMPANY SNAPSHOT 243
14.23.2 REVENUE ANALYSIS 243
14.23.3 PRODUCT PORTFOLIO 244
14.23.4 RECENT DEVELOPMENT 244
14.24 SORENSON GENOMICS 245
14.24.1 COMPANY SNAPSHOT 245
14.24.2 PRODUCT PORTFOLIO 245
14.24.3 RECENT DEVELOPMENT 245
15 QUESTIONNAIRE 246
16 RELATED REPORTS 249