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NA Rapid Diagnostic Tests (RDT) Market - Industry Trends And Forecast To 2029
- Published Date: September, 2022 | Report ID: CLS-176 | No of pages: 267 | Format:
North America Rapid Diagnostic Tests (RDT) Market is projected to register a substantial CAGR of 9.8% in the forecast period of 2022 to 2029. The new market report contains data for the historic year 2020, the base year of calculation is 2021, and the forecast period is 2022 to 2029
Market Segmentation:
North America Rapid Diagnostic Tests (RDT) Market, By Product Type (Consumables and Kits, Instruments and Others), Mode (Professional Rapid Diagnostic Test Product and Over-The-Counter [OTC] Rapid Diagnostic Test Product), Technology (PCR-Based, Flow-Through Assays, Lateral Flow Immunochromatographic Assays, Agglutination Assay, Microfluidics, Substrate Technology and Others), Modality (Laboratory Based Test and Non-Laboratory Based Test), Age Group (Adult and Pediatric), Test Type (Determining Confirmation, Serological Testing and Viral Sequencing), Approach (In-Vitro Diagnostic, Molecular Diagnostic), Specimen (Swab, Blood, Urine, Saliva, Sputum and Others), Application (Infectious Disease Testing, Glucose Monitoring, Cardiology Testing, Oncology Testing, Cardiometabolic Testing, Drugs-of-Abuse Testing, Pregnancy & Fertility Testing, Toxicology Testing, Others), End User (Hospital & Clinic, Diagnostic Laboratory, Home Care Setting, Research and Academic Institutes and Others), Distribution Channel (Direct Tender, Retail Sales, Others), Country (U.S., Canada, Mexico), Industry Trends and Forecast to 2029
Some of the major factors contributing to the growth of the North America rapid diagnostic tests (RDT) market are:
Increasing healthcare expenditure
Increasing prevalence of chronic diseases
Market Players:
Some of the key market players for the North America rapid diagnostic tests (RDT) market are listed below:
Abbott
Danaher
Cellex
AdvaCare Pharma
Access Bio
Cardinal Health
Bio-Rad Laboratories, Inc.
BD
F. Hoffmann-La Roche Ltd
bioMrieux SA
InBios International, Inc.
Gnomegen LLC
QIAGEN
Quidel Corporation
Chembio Diagnostics Systems, Inc.
Siemens Healthcare Gmbh (A Subsidiary Siemens Healthineers AG)
PerkinElmer Inc.
Sekisui Diagnostics
Fujirebio (A Subsidiary of H.U. Group)
PTS Diagnostics
LamdaGen Corporation
Werfen
Nova Biomedical
Trinity Biotech
Sysmex Europe GmbH (A Subsidiary of Sysmex Corporation)
Luminex Corporation. A DiaSorin Company
TABLE OF CONTENT
TABLE OF CONTENTS
1 INTRODUCTION 54
1.1 OBJECTIVES OF THE STUDY 54
1.2 MARKET DEFINITION 54
1.3 OVERVIEW OF THE NORTH AMERICA RAPID DIAGNOSTIC TESTS (RTD) MARKET 55
1.4 CURRENCY AND PRICING 57
1.5 LIMITATIONS 57
1.6 MARKETS COVERED 57
2 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET: SEGMENTATION 62
2.1 MARKETS COVERED 62
2.2 GEOGRAPHICAL SCOPE 63
2.3 YEARS CONSIDERED FOR THE STUDY 64
2.4 DBMR TRIPOD DATA VALIDATION MODEL 65
2.5 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 68
2.6 MULTIVARIATE MODELLING 69
2.7 PRODUCT TYPE SEGMENT LIFELINE CURVE 69
2.8 DBMR MARKET POSITION GRID 70
2.9 VENDOR SHARE ANALYSIS 72
2.10 MARKET APPLICATION COVERAGE GRID 73
2.11 SECONDARY SOURCES 74
3 EXECUTIVE SUMMARY 75
4 PREMIUM INSIGHTS 78
5 MARKET OVERVIEW 79
5.1 DRIVERS 81
5.1.1 INCREASE IN INCIDENCE OF CHRONIC DISEASES 81
5.1.2 RISE IN GERIATRIC POPULATION 82
5.1.3 TECHNOLOGICAL ADVANCEMENTS IN THE RAPID DIAGNOSTIC TESTING 83
5.1.4 GOVERNMENT INITIATIVES FOR DIAGNOSIS OF INFECTIOUS DISEASES 83
5.1.5 RISE IN PRODUCT LAUNCHES 83
5.2 RESTRAINTS 84
5.2.1 HIGH COST ASSOCIATED WITH THE RAPID DIAGNOSTIC KITS 84
5.2.2 OPERATIONAL BARRIERS FACED WHILE CONDUCTING RAPID DIAGNOSTIC TESTS 84
5.2.3 PRODUCT RECALLS IN RAPID DIAGNOSTIC TESTS 85
5.2.4 LACK OF AWARENESS ABOUT RAPID DIAGNOSTIC TESTING 85
5.3 OPPORTUNITIES 85
5.3.1 STRATEGIC INITIATIVES BY THE MARKET PLAYERS 85
5.3.2 RISING GOVERNMENT FUNDING 86
5.3.3 INCREASING HEALTHCARE EXPENDITURE 86
5.4 CHALLENGES 87
5.4.1 STRINGENT REGULATORY FOR MARKET APPROVAL 87
5.4.2 LACK OF TRAINING 87
6 IMPACT OF COVID-19 ON NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET 89
6.1 IMPACT ON PRICE 89
6.2 IMPACT ON SUPPLY CHAIN 89
6.3 IMPACT ON DEMAND 90
6.4 STRATEGIC INITIATIVES BY MANUFACTURERS 90
6.5 CONCLUSION 90
7 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY PRODUCT TYPE 92
7.1 OVERVIEW 93
7.2 CONSUMABLES AND KITS 96
7.2.1 RAPID IMMUNOASSAY TEST STRIPS/CASSETTES 97
7.2.2 IMMUNOCHROMATOGRAPHIC ASSAY 97
7.2.2.1 ANTIBODY TESTS 97
7.2.2.1.1 TOTAL ANTIBODY ELISA KIT 98
7.2.2.1.2 IGM/IGG RAPID DIAGNOSTIC TEST 98
7.2.2.1.3 IGG ELISA KIT 98
7.2.2.1.4 IGM ELISA KIT 98
7.2.2.1.5 NEUTRALIZING ANTIBODY ELISA KIT 98
7.2.2.2 ANTIGEN ELISA KITS 98
7.2.2.3 SPECIMEN COLLECTION KIT 99
7.2.3 RT-PCR ASSAY KITS 99
7.2.3.1 REVERSE TRANSCRIPTION PCR (RT-PCR) 99
7.2.3.2 QUANTITATIVE REVERSE TRANSCRIPTION PCR (RT-QPCR) 99
7.2.4 OTHERS 99
7.3 INSTRUMENTS 99
7.3.1 PORTABLE 100
7.3.2 BENCHTOP 100
7.3.3 FIXED 100
7.4 OTHERS 100
8 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY MODE 102
8.1 OVERVIEW 103
8.2 PROFESSIONAL 106
8.3 OVER-THE-COUNTER [OTC] 107
9 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY TECHNOLOGY 108
9.1 OVERVIEW 109
9.2 PCR-BASED 112
9.3 FLOW-THROUGH ASSAYS 112
9.4 LATERAL FLOW IMMUNOCHROMATOGRAPHIC ASSAYS 113
9.5 AGGLUTINATION ASSAY 113
9.6 MICROFLUIDICS 114
9.6.1 PAPER-BASED MICROFLUDICS 115
9.6.2 LUCIFERASE IMMUNOPRECIPITATION SYSTEMS (LIPS) 115
9.6.3 OTHERS 115
9.7 SUBSTRATE TECHNOLOGY 115
9.8 OTHERS 116
10 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY MODALITY 117
10.1 OVERVIEW 118
10.2 LABORATORY BASED TEST 121
10.3 NON-LABORATORY BASED TEST 121
11 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY AGE GROUP 123
11.1 OVERVIEW 124
11.2 ADULT 127
11.3 PEDIATRIC 127
12 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY TEST TYPE 128
12.1 OVERVIEW 129
12.2 DETERMINING CONFIRMATION 132
12.2.1 RT-PCR ASSAY KITS 132
12.2.2 RAPID IMMUNOASSAY TEST STRIPS/CASSETTES 132
12.2.3 IMMUNOCHROMATOGRAPHIC ASSAY 133
12.2.4 OTHERS 133
12.3 SEROLOGICAL TESTING 133
12.3.1 RT-PCR ASSAY KITS 134
12.3.2 RAPID IMMUNOASSAY TEST STRIPS/CASSETTES 134
12.3.3 IMMUNOCHROMATOGRAPHIC ASSAY 134
12.3.4 OTHERS 134
12.4 VIRAL SEQUENCING 134
12.4.1 RT-PCR ASSAY KITS 135
12.4.2 RAPID IMMUNOASSAY TEST STRIPS/CASSETTES 135
12.4.3 IMMUNOCHROMATOGRAPHIC ASSAY 135
12.4.4 OTHERS 135
13 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY APPROACH 136
13.1 OVERVIEW 137
13.2 IN-VITRO DIAGNOSTIC 140
13.3 MOLECULAR DIAGNOSTIC 140
14 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY SPECIMEN 141
14.1 OVERVIEW 142
14.2 SWAB 145
14.3 BLOOD 145
14.4 URINE 146
14.5 SALIVA 146
14.6 SPUTUM 147
14.7 OTHERS 147
15 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY APPLICATION 149
15.1 OVERVIEW 150
15.2 INFECTIOUS DISEASE TESTING 153
15.2.1 VIRUS 154
15.2.2 BACTERIA 154
15.2.3 OTHERS 154
15.3 GLUCOSE MONITORING 154
15.4 CARDIOLOGY TESTING 155
15.5 ONCOLOGY TESTING 155
15.5.1 LUNG CANCER 156
15.5.2 BREAST CANCER 156
15.5.3 BLOOD CANCER 156
15.5.4 OTHERS 156
15.6 CARDIOMETABOLIC TESTING 156
15.7 DRUGS-OF-ABUSE TESTING 157
15.8 PREGNANCY & FERTILITY TESTING 157
15.9 TOXICOLOGY TESTING 158
15.10 OTHERS 158
16 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY END USER 160
16.1 OVERVIEW 161
16.2 HOSPITAL & CLINIC 163
16.3 DIAGNOSTIC LABORATORY 164
16.4 HOME CARE SETTING 165
16.5 RESEARCH AND ACADEMIC INSTITUTES 165
16.6 OTHERS 166
17 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY DISTRIBUTION CHANNEL 167
17.1 OVERVIEW 168
17.2 DIRECT TENDER 171
17.3 RETAIL SALES 171
18 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET, BY REGION 173
18.1 NORTH AMERICA 174
18.1.1 U.S. 185
18.1.2 CANADA 191
18.1.3 MEXICO 197
19 NORTH AMERICA RAPID DIAGNOSTIC TESTS (RDT) MARKET: COMPANY LANDSCAPE 203
19.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 203
20 SWOT ANALYSIS 204
21 COMPANY SHARE ANALYSIS 205
21.1 ABBOTT 205
21.1.1 COMPANY SNAPSHOT 205
21.1.2 REVENUE ANALYSIS 205
21.1.3 COMPANY SHARE ANALYSIS 206
21.1.4 PRODUCT PORTFOLIO 207
21.1.5 RECENT DEVELOPMENTS 207
21.2 F. HOFFMANN-LA ROCHE LTD 208
21.2.1 COMPANY SNAPSHOT 208
21.2.2 REVENUE ANALYSIS 208
21.2.3 COMPANY SHARE ANALYSIS 209
21.2.4 PRODUCT PORTFOLIO 210
21.2.5 RECENT DEVELOPMENTS 210
21.3 SIEMENS HEALTHCARE GMBH (A SUBSIDIARY OF SIEMENS HEALTHINEERS AG) 211
21.3.1 COMPANY SNAPSHOT 211
21.3.2 REVENUE ANALYSIS 211
21.3.3 COMPANY SHARE ANALYSIS 212
21.3.4 PRODUCT PORTFOLIO 213
21.3.5 RECENT DEVELOPMENTS 214
21.4 CARDINAL HEALTH 215
21.4.1 COMPANY SNAPSHOT 215
21.4.2 REVENUE ANALYSIS 215
21.4.3 COMPANY SHARE ANALYSIS 216
21.4.4 PRODUCT PORTFOLIO 217
21.4.5 RECENT DEVELOPMENT 217
21.5 QUIDEL CORPORATION 218
21.5.1 COMPANY SNAPSHOT 218
21.5.2 REVENUE ANALYSIS 218
21.5.3 COMPANY SHARE ANALYSIS 219
21.5.4 PRODUCT PORTFOLIO 220
21.5.5 RECENT DEVELOPMENTS 221
21.6 ADVACARE PHARMA 222
21.6.1 COMPANY SNAPSHOT 222
21.6.2 PRODUCT PORTFOLIO 222
21.6.3 RECENT DEVELOPMENT 222
21.7 ACCESS BIO 223
21.7.1 COMPANY SNAPSHOT 223
21.7.2 PRODUCT PORTFOLIO 223
21.7.3 RECENT DEVELOPMENTS 224
21.8 BD 225
21.8.1 COMPANY SNAPSHOT 225
21.8.2 REVENUE ANALYSIS 225
21.8.3 PRODUCT PORTFOLIO 226
21.8.4 RECENT DEVELOPMENTS 226
21.9 BIOMRIEUX SA 227
21.9.1 COMPANY SNAPSHOT 227
21.9.2 REVENUE ANALYSIS 227
21.9.3 PRODUCT PORTFOLIO 228
21.9.4 RECENT DEVELOPMENT 228
21.10 BIO-RAD LABORATORIES, INC. 229
21.10.1 COMPANY SNAPSHOT 229
21.10.2 REVENUE ANALYSIS 229
21.10.3 PRODUCT PORTFOLIO 230
21.10.4 RECENT DEVELOPMENTS 230
21.11 CELLEX 231
21.11.1 COMPANY SNAPSHOT 231
21.11.2 PRODUCT PORTFOLIO 231
21.11.3 RECENT DEVELOPMENTS 231
21.12 CHEMBIO DIAGNOSTICS SYSTEMS, INC. 232
21.12.1 COMPANY SNAPSHOT 232
21.12.2 REVENUE ANALYSIS 232
21.12.3 PRODUCT PORTFOLIO 233
21.12.4 RECENT DEVELOPMENTS 233
21.13 DANAHER 234
21.13.1 COMPANY SNAPSHOT 234
21.13.2 REVENUE ANALYSIS 234
21.13.3 PRODUCT PORTFOLIO 235
21.13.4 RECENT DEVELOPMENTS 235
21.14 FUJIREBIO (A SUBSIDIARY OF H.U. GROUP) 236
21.14.1 COMPANY SNAPSHOT 236
21.14.2 REVENUE ANALYSIS 236
21.14.3 PRODUCT PORTFOLIO 237
21.14.4 RECENT DEVELOPMENTS 237
21.15 GNOMEGAN LLC 238
21.15.1 COMPANY SNAPSHOT 238
21.15.2 PRODUCT PORTFOLIO 238
21.15.3 RECENT DEVELOPMENT 238
21.16 INBIOS INTERNATIONAL, INC 239
21.16.1 COMPANY SNAPSHOT 239
21.16.2 PRODUCT PORTFOLIO 239
21.16.3 RECENT DEVELOPMENTS 240
21.17 LAMDAGEN CORPORATION. 241
21.17.1 COMPANY SNAPSHOT 241
21.17.2 PRODUCT PORTFOLIO 241
21.17.3 RECENT DEVELOPMENTS 241
21.18 LUMINEX CORPORATION, A DIASORIN COMPANY 243
21.18.1 COMPANY SNAPSHOT 243
21.18.2 REVENUE ANALYSIS 243
21.18.3 PRODUCT PORTFOLIO 244
21.18.4 RECENT DEVELOPMENT 244
21.19 MEGAKOR DIAGNOSTIK GMBH 245
21.19.1 COMPANY SNAPSHOT 245
21.19.2 PRODUCT PORTFOLIO 245
21.19.3 RECENT DEVELOPMENT 245
21.20 NOVA BIOMEDICAL 246
21.20.1 COMPANY SNAPSHOT 246
21.20.2 PRODUCT PORTFOLIO 246
21.20.3 RECENT DEVELOPMENTS 247
21.21 PERKIN ELMER INC. 248
21.21.1 COMPANY SNAPSHOT 248
21.21.2 REVENUE ANALYSIS 248
21.21.3 PRODUCT PORTFOLIO 249
21.21.4 RECENT DEVELOPMENTS 250
21.22 PTS DIAGNOSTICS 251
21.22.1 COMPANY SNAPSHOT 251
21.22.2 PRODUCT PORTFOLIO 251
21.22.3 RECENT DEVELOPMENTS 252
21.23 QIAGEN 253
21.23.1 COMPANY SNAPSHOT 253
21.23.2 REVENUE ANALYSIS 253
21.23.3 PRODUCT PORTFOLIO 254
21.23.4 RECENT DEVELOPMENT 254
21.24 SEKISUI DIAGNOSTICS 255
21.24.1 COMPANY SNAPSHOT 255
21.24.2 PRODUCT PORTFOLIO 255
21.24.3 RECENT DEVELOPMENTS 256
21.25 SYSMEX EUROPE GMBH (A SUBSIDIARY OF SYSMEX CORPORATION) 257
21.25.1 COMPANY SNAPSHOT 257
21.25.2 REVENUE ANALYSIS 257
21.25.3 PRODUCT PORTFOLIO 258
21.25.4 RECENT DEVELOPMENTS 258
21.26 TRINITY BIOTECH 259
21.26.1 COMPANY SNAPSHOT 259
21.26.2 REVENUE ANALYSIS 259
21.26.3 PRODUCT PORTFOLIO 260
21.26.4 RECENT DEVELOPMENT 260
21.27 WERFEN 261
21.27.1 COMPANY SNAPSHOT 261
21.27.2 PRODUCT PORTFOLIO 261
21.27.3 RECENT DEVELOPMENT 261
22 QUESTIONNAIRE 262
23 RELATED REPORTS 267
Segmentation
Short Description
North America Rapid Diagnostic Tests (RDT) Market, By Product Type (Consumables and Kits, Instruments and Others), Mode (Professional Rapid Diagnostic Test Product and Over-The-Counter [OTC] Rapid Diagnostic Test Product), Technology (PCR-Based, Flow-Through Assays, Lateral Flow Immunochromatographic Assays, Agglutination Assay, Microfluidics, Substrate Technology and Others), Modality (Laboratory Based Test and Non-Laboratory Based Test), Age Group (Adult and Pediatric), Test Type (Determining Confirmation, Serological Testing and Viral Sequencing), Approach (In-Vitro Diagnostic, Molecular Diagnostic), Specimen (Swab, Blood, Urine, Saliva, Sputum and Others), Application (Infectious Disease Testing, Glucose Monitoring, Cardiology Testing, Oncology Testing, Cardiometabolic Testing, Drugs-of-Abuse Testing, Pregnancy & Fertility Testing, Toxicology Testing, Others), End User (Hospital & Clinic, Diagnostic Laboratory, Home Care Setting, Research and Academic Institutes and Others), Distribution Channel (Direct Tender, Retail Sales, Others), Country (U.S., Canada, Mexico), Industry Trends and Forecast to 2029
Market Definition:
The rapid diagnostic tests, also called rapid tests, are easy-to-use tests that offer quick results, usually in less than 20 minutes. Unlike other standard and conventional tests, where the diagnosis and sampling are sent to the laboratory, the results obtained from rapid diagnostic test kits are provided at the point of care. The point of care is a place where the patients get cured. The point of care can be a providers office, a clinic, or a patients own house.
The RDTs are applicable for diagnosing and testing infectious diseases such as COVID-19, cardiology diseases, oncology, pregnancy, fertility testing, toxicology testing, drugs-of-abuse testing, cardiometabolic testing, and glucose monitoring.
The currently available technological developments in rapid diagnostics testing are the reverse transcriptase-polymerase chain reaction (RT-PCR), RT-LAMP, enzyme-linked immunosorbent assay (ELISA), and Next Generation Sequencing (NGS). The developments in the testing kits provide an effective strategy to implement robust identification and diagnosis of the pathogen. The digital approach to rapid diagnostic tests allows the research team to understand and obtain, real time-results. The use of lateral flow testing is increasing, and it has to go digital for societies to get maximum benefits from it.
Market Segmentation:
The North America rapid diagnostic tests (RDT) market is categorized into eleven notable segments based on product type, mode, technology, modality, age group, test type, approach, specimen, application, end user, and distribution channel.
On the basis of product type, the North America rapid diagnostic tests (RDT) market is segmented into consumables and kits, instruments, and others
On the basis of mode, the North America rapid diagnostic tests (RDT) market is segmented into professional rapid diagnostic test product, and over-the-counter [OTC] rapid diagnostic test product
On the basis of technology, the North America rapid diagnostic tests (RDT) market is segmented into PCR-based, flow-through assays, lateral flow immunochromatographic assays, agglutination assay, microfluidics, substrate technology, and others
On the basis of modality, the North America rapid diagnostic tests (RDT) market is segmented into laboratory based test and non-laboratory based test
On the basis of age group, the North America rapid diagnostic tests (RDT) market is segmented into adult and pediatric
On the basis of test type, the North America rapid diagnostic tests (RDT) market is segmented into determining confirmation, serological testing, and viral sequencing
On the basis of approach, the North America rapid diagnostic tests (RDT) market is segmented into in-vitro diagnostic and molecular diagnostic
On the basis of specimen, the North America rapid diagnostic tests (RDT) market is segmented into swab, blood, urine, saliva, sputum, and others
On the basis of application, the North America rapid diagnostic tests (RDT) market is segmented into infectious disease testing, glucose monitoring, cardiology testing, oncology testing, cardiometabolic testing, drugs-of-abuse testing, pregnancy & fertility testing, toxicology testing, and others
On the basis of end user, the North America rapid diagnostic tests (RDT) market is segmented into hospital & clinic, diagnostic laboratory, home care setting, research and academic institutes, and others
On the basis of distribution channel, the North America rapid diagnostic tests (RDT) market is segmented into direct tender, retail sales, and others
Market Players
Some of the key market players for the North America rapid diagnostic tests (RDT) market are listed below:
Abbott
Danaher
Cellex
AdvaCare Pharma
Access Bio
Cardinal Health
Bio-Rad Laboratories, Inc.
BD
F. Hoffmann-La Roche Ltd
bioMrieux SA
InBios International, Inc.
Gnomegen LLC
QIAGEN
Quidel Corporation
Chembio Diagnostics Systems, Inc.
Siemens Healthcare Gmbh (A Subsidiary Siemens Healthineers AG)
PerkinElmer Inc.
Sekisui Diagnostics
Fujirebio (A Subsidiary of H.U. Group)
PTS Diagnostics
LamdaGen Corporation
Werfen
Nova Biomedical
Trinity Biotech
Sysmex Europe GmbH (A Subsidiary of Sysmex Corporation)
Luminex Corporation. A DiaSorin Company
Methodology
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