Short Description
North America Molecular Point of Care Testing (using NAAT) Market By Product (Instruments and Consumables & Reagents), Indication (Respiratory Infections Testing, Sexually Transmitted Infection (STI) Testing, Gastrointestinal Tract Infections Testing, and Others), End User (Laboratories, Hospitals, Clinics, Ambulatory Centers, Homecare, Assisted Living Facilities, and Others), Mode of Testing (Prescription-Based Testing and OTC Testing), Distribution Channel (Hospital Pharmacy, Retail Pharmacy, and Online Pharmacy), Country (U.S. and Canada) Industry Trends and Forecast to 2028
Market Definition:
POCT (Point of Care Testing) is characterized as testing which can be done close to the patient where a medical decision can be made immediately, including the results and monitoring. POCT devices now entering clinical use are based on nucleic acid amplification technologies (NAAT), defined here as second-generation devices. These platforms generally have improved sensitivity, typically 60 to 90%, compared to first-generation POCTs, and require portable instrumentation with a footprint of approximately 30cm x 30cm. These instruments are essentially used in molecularly detecting various disorders such as HIV, HPV, and respiratory disease through NAAT technology. NAAT is Nucleic Acid Amplification Techniques that allow the identification of pathogenic organisms by detecting their DNA or RNA.
Market Segmentation:
North America molecular point of care testing (using NAAT) market is segmented into five notable segments based on the product, indication, end user, mode of testing, and distribution channel.
On the basis of product, the North America molecular point of care testing (using NAAT) market is segmented into instruments and consumables and reagents
On the basis of indication, the North America molecular point of care testing (using NAAT) market is segmented into sexually transmitted infection (STI) testing, respiratory infection testing, gastrointestinal tract infection testing, and others
On the basis of end user, the North America molecular point of care testing (using NAAT) market is segmented into laboratories, hospitals, clinics, ambulatory centers, home care, assisted living facilities, and others
On the basis of mode of testing, the North America molecular point of care testing (using NAAT) market is segmented into prescription-based testing and OTC testing
On the basis of distribution channel, the North America molecular point of care testing (using NAAT) market is segmented into hospital pharmacy, retail pharmacy, and online pharmacy
Market Players
The key market players for North America molecular point of care testing (using NAAT) market are listed below:
SD Biosensor, Inc.
Abbott
F.Hoffmann-La Roche Ltd.
Thermo Fisher Scientific Inc
binx Health, Inc.
Lucira
Meridian Bioscience
Quantumdx Group Ltd.
BD
Biomrieux Sa
Qiagen
Quidel Corporation
Sysmex Corporation
Bio-Rad Laboratories, Inc.
Sekisui Diagnostic
Randox Laboratories Ltd.
GenMark Diagnostics
Seegene Inc.
Grifols S.A.
Wondfo
Oxford Nanopore Diagnostic
PerkinElmer Inc.
Co-Diagnostic
TABLE OF CONTENTS
1 INTRODUCTION 39
1.1 OBJECTIVES OF THE STUDY 39
1.2 MARKET DEFINITION 39
1.3 OVERVIEW OF NORTH AMERICA MOLECULAR POINT OF CARE TESTING (USING NAAT) MARKET 39
1.4 LIMITATIONS 41
1.5 MARKETS COVERED 41
2 MARKET SEGMENTATION 44
2.1 MARKETS COVERED 44
2.2 GEOGRAPHICAL SCOPE 45
2.3 YEARS CONSIDERED FOR THE STUDY 46
2.4 CURRENCY AND PRICING 46
2.5 DBMR TRIPOD DATA VALIDATION MODEL 47
2.6 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 50
2.7 MULTIVARIATE MODELLING 51
2.8 DISTRIBUTION CHANNEL LIFELINE CURVE 51
2.9 DBMR MARKET POSITION GRID 52
2.10 VENDOR SHARE ANALYSIS 54
2.11 MARKET END USER COVERAGE GRID 55
2.12 SECONDARY SOURCES 56
2.13 ASSUMPTIONS 56
3 EXECUTIVE SUMMARY 57
4 PREMIUM INSIGHTS 61
4.1 PORTERS FIVE FORCES 62
4.2 PESTEL ANALYSIS 63
4.3 ANNUAL TEST VOLUME: FOR ALL COUNTRIES 64
4.3.1 CEPHEID 64
4.3.2 THERMO FISHER SCIENTIFIC INC. 65
4.3.3 HOLOGIC, INC. 66
4.3.4 BD 67
4.3.5 F. HOFFMANN-LA ROCHE LTD 68
4.4 NUMBER OF POCT INSTRUMENTS INSTALLED IN EACH COUNTRY 69
4.5 DISTRIBUTORS 70
4.5.1 NORTH AMERICA 70
4.5.2 EUROPE 71
4.5.3 SOUTH ASIA 73
4.5.4 SOUTH EAST ASIA 74
4.5.5 MIDDLE EAST 76
4.5.6 AFRICA 77
5 REGULATORY FRAMEWORK 78
6 MARKET OVERVIEW 81
6.1 DRIVERS 83
6.1.1 INCREASING PREVALENCE OF CHRONIC DISEASES 83
6.1.2 IMPROVING DIAGNOSIS SEEKING RATE 83
6.1.3 RISING TECHNOLOGICAL ADVANCEMENTS 84
6.1.4 RISING GERIATRIC POPULATION ACROSS GLOBE 84
6.1.5 RISING PREFERENCE FOR HOMECARE TESTING 85
6.2 RESTRAINTS 86
6.2.1 PRODUCT RECALLS 86
6.2.2 HIGH COSTS OF PRODUCTS 86
6.2.3 NON-AVAILABILITY OF RELEVANT AND APPROPRIATE KITS 87
6.3 OPPORTUNITIES 87
6.3.1 STRATEGIC INITIATIVES TAKEN BY MARKET PLAYERS 87
6.3.2 RISING HEALTHCARE EXPENDITURE 88
6.3.3 PANDEMIC OUTBREAK OF COVID-19 89
6.3.4 GROWING DEMAND FOR BETTER QUALITY HEALTHCARE AND EARLY DIAGNOSIS 89
6.4 CHALLENGES 90
6.4.1 LACK OF ALIGNMENT WITH TEST RESULTS OBTAINED FROM LABORATORIES 90
6.4.2 LACK OF ACCESSIBILITY 90
7 IMPACT OF COVID-19 ON THE NORTH AMERICA MOLECULAR POINT OF CARE TESTING (USING NAAT) MARKET 92
7.1 IMPACT ON PRICE 92
7.2 IMPACT ON DEMAND 92
7.3 IMPACT ON SUPPLY CHAIN 93
7.4 KEY INITIATIVES BY MARKET PLAYERS DURING THE COVID 19 93
7.5 CONCLUSION: 94
8 NORTH AMERICA MOLECULAR POINT OF CARE TESTING (USING NAAT) MARKET, BY PRODUCT 95
8.1 OVERVIEW 96
8.2 CONSUMABLES & REAGENTS 99
8.3 INSTRUMENTS 99
8.3.1 MOBILE PLATFORM (SMALL & PORTABLE) 100
8.3.2 FACILITY-BASED PLATFORMS (LARGE POCT PLATFORM) 100
9 NORTH AMERICA MOLECULAR POINT OF CARE TESTING (USING NAAT) MARKET, BY INDICATION 101
9.1 OVERVIEW 102
9.2 RESPIRATORY INFECTIONS TESTING 105
9.2.1 COVID-19 106
9.2.2 FLU B 106
9.2.3 FLU A 106
9.2.4 RSV 106
9.2.5 TUBERCULOSIS 106
9.2.6 PNEUMONIA (PNEUMOCOCCAL PNEUMONIA) 106
9.2.7 OTHERS 107
9.3 SEXUALLY TRANSMITTED INFECTION (STI) TESTING 107
9.3.1 TV 108
9.3.2 CT 108
9.3.3 NG 108
9.3.4 HPV 108
9.3.5 HSV 108
9.3.6 MG 108
9.3.7 UU 109
9.3.8 MH 109
9.3.9 OTHERS 109
9.4 GASTROINTESTINAL TRACT INFECTIONS TESTING 109
9.4.1 GROUP B STREPTOCOCCUS 110
9.4.2 SHIGA TOXIN 110
9.4.3 H. PYLORI 110
9.5 OTHERS 111
10 NORTH AMERICA MOLECULAR POINT OF CARE TESTING (USING NAAT) MARKET, BY END USER 112
10.1 OVERVIEW 113
10.2 LABORATORIES 116
10.2.1 POLYMERASE CHAIN REACTION 117
10.2.2 ISOTHERMAL AMPLIFICATION 117
10.3 HOSPITAL 117
10.3.1 POLYMERASE CHAIN REACTION 118
10.3.2 ISOTHERMAL AMPLIFICATION 118
10.4 CLINICS 118
10.4.1 POLYMERASE CHAIN REACTION 119
10.4.2 ISOTHERMAL AMPLIFICATION 119
10.5 AMBULATORY CENTER 119
10.5.1 POLYMERASE CHAIN REACTION 120
10.5.2 ISOTHERMAL AMPLIFICATION 120
10.6 HOMECARE 120
10.6.1 POLYMERASE CHAIN REACTION 121
10.6.2 ISOTHERMAL AMPLIFICATION 121
10.7 ASSISTED LIVING FACILITIES 122
10.7.1 POLYMERASE CHAIN REACTION 122
10.7.2 ISOTHERMAL AMPLIFICATION 122
10.8 OTHERS 123
11 NORTH AMERICA MOLECULAR POINT OF CARE TESTING (USING NAAT) MARKET, BY MODE OF TESTING 124
11.1 OVERVIEW 125
11.2 PRESCRIPTION-BASED TESTING 128
11.3 OTC TESTING 129
12 NORTH AMERICA MOLECULAR POINT OF CARE TESTING (USING NAAT) MARKET, BY DISTRIBUTION CHANNEL 130
12.1 OVERVIEW 131
12.2 HOSPITAL PHARMACY 134
12.3 RETAIL PHARMACY 135
12.4 ONLINE PHARMACY 136
13 NORTH AMERICA MOLECULAR POINT OF CARE TESTING (USING NAAT) MARKET, BY REGION 137
13.1 NORTH AMERICA 138
13.1.1 U.S. 147
13.1.2 CANADA 152
14 NORTH AMERICA MOLECULAR POINT OF CARE TESTING (USING NAAT) MARKET: COMPANY LANDSCAPE 157
14.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 157
15 SWOT ANALYSIS 158
16 COMPANY PROFILE 159
16.1 DANAHER 159
16.1.1 COMPANY SNAPSHOT 159
16.1.2 REVENUE ANALYSIS 159
16.1.3 COMPANY SHARE ANALYSIS 160
16.1.4 PRODUCT PORTFOLIO 160
16.1.5 RECENT DEVELOPMENTS 161
16.2 THERMO FISHER SCIENTIFIC INC. 162
16.2.1 COMPANY SNAPSHOT 162
16.2.2 REVENUE ANALYSIS 162
16.2.3 COMPANY SHARE ANALYSIS 163
16.2.4 PRODUCT PORTFOLIO 163
16.2.5 RECENT DEVELOPMENTS 163
16.3 BD 164
16.3.1 COMPANY SNAPSHOT 164
16.3.2 REVENUE ANALYSIS 164
16.3.3 COMPANY SHARE ANALYSIS 165
16.3.4 PRODUCT PORTFOLIO 165
16.3.5 RECENT DEVELOPMENTS 165
16.4 F.HOFFMANN-LA-ROCHE LTD. 166
16.4.1 COMPANY SNAPSHOT 166
16.4.2 REVENUE ANALYSIS 166
16.4.3 COMPANY SHARE ANALYSIS 167
16.4.4 PRODUCT PORTFOLIO 167
16.4.5 RECENT DEVELOPMENTS 168
16.5 ABBOTT 169
16.5.1 COMPANY SNAPSHOT 169
16.5.2 REVENUE ANALYSIS 169
16.5.3 PRODUCT PORTFOLIO 170
16.5.4 RECENT DEVELOPMENTS 170
16.6 BINX HEALTH, INC. 171
16.6.1 COMPANY SNAPSHOT 171
16.6.2 PRODUCT PORTFOLIO 171
16.6.3 RECENT DEVELOPMENT 171
16.7 BIOMERIEUX SA 172
16.7.1 COMPANY SNAPSHOT 172
16.7.2 REVENUE ANALYSIS 172
16.7.3 PRODUCT PORTFOLIO 173
16.7.4 RECENT DEVELOPMENT 173
16.8 CO-DIAGNOSTICS, INC. 174
16.8.1 COMPANY SNAPSHOT 174
16.8.2 REVENUE ANALYSIS 174
16.8.3 PRODUCT PORTFOLIO 175
16.8.4 RECENT DEVELOPMENTS 175
16.9 GENMARK DIAGNOSTICS, INC 176
16.9.1 COMPANY SNAPSHOT 176
16.9.2 REVENUE ANALYSIS 176
16.9.3 PRODUCT PORTFOLIO 177
16.9.4 RECENT DEVELOPMENT 177
16.10 GRIFOLS, S.A. 178
16.10.1 COMPANY SNAPSHOT 178
16.10.2 REVENUE ANALYSIS 178
16.10.3 PRODUCT PORTFOLIO 179
16.10.4 RECENT DEVELOPMENT 179
16.11 LUCIRA HEALTH INC. 180
16.11.1 COMPANY SNAPSHOT 180
16.11.2 PRODUCT PORTFOLIO 180
16.11.3 RECENT DEVELOPMENTS 180
16.12 MERIDIAN BIOSCIENCE 181
16.12.1 COMPANY SNAPSHOT 181
16.12.2 REVENUE ANALYSIS 181
16.12.3 PRODUCT PORTFOLIO 182
16.12.4 RECENT DEVELOPMENTS 182
16.13 QUANTUMDX GROUP LTD. 183
16.13.1 COMPANY SNAPSHOT 183
16.13.2 PRODUCT PORTFOLIO 183
16.13.3 RECENT DEVELOPMENTS 183
16.14 QUIDEL CORPORATION 185
16.14.1 COMPANY SNAPSHOT 185
16.14.2 REVENUE ANALYSIS 185
16.14.3 PRODUCT PORTFOLIO 186
16.14.4 RECENT DEVELOPMENT 186
16.15 SD BIOSENSOR, INC. 187
16.15.1 COMPANY SNAPSHOT 187
16.15.2 PRODUCT PORTFOLIO 187
16.15.3 RECENT DEVELOPMENT 187
16.16 SEKISUI DIAGNOSTICS (A SUBSIDIARY OF SEKISUI MEDICAL) 188
16.16.1 COMPANY SNAPSHOT 188
16.16.2 PRODUCT PORTFOLIO 188
16.16.3 RECENT DEVELOPMENT 188
16.17 SYSMEX (A SUBSIDIARY OF SYSMEX CORPORATION 190
16.17.1 COMPANY SNAPSHOT 190
16.17.2 REVENUE ANALYSIS 190
16.17.3 PRODUCT PORTFOLIO 191
16.17.4 RECENT DEVELOPMENT 191
16.18 WONDFO 192
16.18.1 COMPANY SNAPSHOT 192
16.18.2 PRODUCT PORTFOLIO 192
16.18.3 RECENT DEVELOPMENT 192
17 QUESTIONNAIRE 193
18 RELATED REPORTS 196