TABLE OF CONTENTS

1 INTRODUCTION 18
1.1 OBJECTIVES OF THE STUDY 18
1.2 MARKET DEFINITION 18
1.3 MARKET SCOPE 18
1.4 MARKETS COVERED 19
1.4.1 YEARS CONSIDERED FOR THE STUDY 20
1.5 CURRENCY 20
1.6 LIMITATIONS 20
1.7 STAKEHOLDERS 20
2 RESEARCH METHODOLOGY 21
2.1 RESEARCH DATA 21
2.1.1 SECONDARY DATA 22
2.1.1.1 Secondary sources 23
2.1.2 PRIMARY DATA 23
2.1.2.1 Primary sources 25
2.1.2.2 Key Industry Insights 26
2.1.3 MARKET SIZE ESTIMATION METHODOLOGY 26
2.1.3.1 BOTTOM-UP APPROACH 27
2.1.3.2 TOP-DOWN APPROACH 27
2.1.4 RESEARCH DESIGN 28
2.1.5 MARKET DATA VALIDATION AND TRIANGULATION 29
2.1.6 ASSUMPTIONS FOR THE STUDY 30
3 EXECUTIVE SUMMARY 31
3.1 INTRODUCTION 31
4 PREMIUM INSIGHTS 35
4.1 POC DIAGNOSTICS: MARKET OVERVIEW 35
4.2 POC DIAGNOSTICS MARKET, BY PLATFORM 36
4.3 GEOGRAPHIC ANALYSIS: POC DIAGNOSTICS MARKET, BY END USER AND REGION 37
4.4 POC DIAGNOSTICS MARKET, BY PRODUCT 38
4.5 POC DIAGNOSTICS MARKET, BY PRESCRIPTION MODE 38
4.6 GEOGRAPHIC SNAPSHOT OF THE POC DIAGNOSTICS MARKET 39
 
5 MARKET OVERVIEW 40
5.1 INTRODUCTION 40
5.2 MARKET DYNAMICS 40
5.2.1 DRIVERS 42
5.2.1.1 High prevalence of infectious diseases in developing countries 42
5.2.1.2 Increasing incidence of target diseases 42
5.2.1.3 Rising usage of home-based POC devices 44
5.2.1.4 Growing government support 44
5.2.1.5 Technological advancements and new product launches 45
5.2.1.6 Growing number of regulatory approvals for novel immunoassay techniques 45
5.2.1.7 Shortage of skilled laboratory technicians 45
5.2.1.8 Rising number of CLIA-waived POC tests 46
5.2.2 RESTRAINTS 47
5.2.2.1 Product recalls: Hampering user confidence 47
5.2.2.2 Pricing pressure owing to reimbursement cuts and budget constraints 47
5.2.2.3 Stringent and time-consuming regulatory policies are significantly increasing gestation period for product launches 48
5.2.3 OPPORTUNITIES 48
5.2.3.1 Growth opportunities in emerging markets 48
5.2.3.2 Healthcare decentralization —Converting lab tests to POC tests 49
5.2.3.3 Increasing number of conferences and events 50
5.2.3.4 POC tests with multiplexing capabilities 50
5.2.4 CHALLENGES 51
5.2.4.1 Lack of alignment with definitive central lab methods 51
5.2.4.1.1 Disadvantages of POC testing over central lab methods 51
5.2.4.2 Inadequate knowledge about the use of POC devices in professional settings 51
5.2.4.3 Reluctance towards changing existing diagnostic practices 52
5.2.4.4 High cost of devices 52
5.2.5 EMERGING APPLICATIONS OF POINT-OF-CARE TESTING 52
5.2.5.1 Sepsis biomarkers 52
5.2.5.2 Stroke markers 53
5.2.5.3 Thyroid testing 54
5.2.5.4 DNA testing 54
5.2.5.5 Endocrine testing 55
 
6 POINT-OF-CARE DIAGNOSTICS MARKET, BY PRODUCT 56
6.1 INTRODUCTION 57
6.2 GLUCOSE MONITORING PRODUCTS 58
6.2.1 STRIPS 61
6.2.2 METERS 61
6.2.3 LANCETS & LANCING DEVICES 61
6.3 CARDIOMETABOLIC TESTING PRODUCTS 62
6.3.1 CARDIAC MARKER TESTING PRODUCTS 63
6.3.2 BLOOD GAS/ELECTROLYTES TESTING PRODUCTS 64
6.3.3 HBA1C TESTING PRODUCTS 66
6.4 INFECTIOUS DISEASE TESTING PRODUCTS 67
6.4.1 INFLUENZA TESTING PRODUCTS 69
6.4.2 HIV TESTING PRODUCTS 70
6.4.3 HEPATITIS C TESTING PRODUCTS 71
6.4.4 SEXUALLY TRANSMITTED DISEASE (STD) TESTING PRODUCTS 73
6.4.5 HEALTHCARE-ASSOCIATED INFECTION (HAI) TESTING PRODUCTS 74
6.4.6 RESPIRATORY INFECTION TESTING PRODUCTS 75
6.4.7 TROPICAL DISEASE TESTING PRODUCTS 76
6.4.8 OTHER INFECTIOUS DISEASE TESTING PRODUCTS 77
6.5 COAGULATION TESTING PRODUCTS 78
6.5.1 PT/INR TESTING PRODUCTS 80
6.5.2 ACTIVATED CLOTTING TIME (ACT/APTT) TESTING PRODUCTS 81
6.6 PREGNANCY AND FERTILITY TESTING PRODUCTS 82
6.6.1 PREGNANCY TESTING PRODUCTS 83
6.6.2 FERTILITY TESTING PRODUCTS 84
6.7 TUMOR/CANCER MARKER TESTING PRODUCTS 85
6.8 URINALYSIS TESTING PRODUCTS 86
6.9 CHOLESTEROL TESTING PRODUCTS 87
6.10 HEMATOLOGY TESTING PRODUCTS 89
6.11 DRUGS-OF-ABUSE TESTING PRODUCTS 90
6.12 FECAL OCCULT TESTING PRODUCTS 91
6.13 OTHER POC PRODUCTS 92
7 POINT-OF-CARE DIAGNOSTICS MARKET, BY PLATFORM 94
7.1 INTRODUCTION 95
7.2 LATERAL FLOW ASSAYS (IMMUNOCHROMATOGRAPHY TESTS) 96
7.3 DIPSTICKS 97
7.4 MICROFLUIDICS 98
7.5 MOLECULAR DIAGNOSTICS 99
7.6 IMMUNOASSAYS 100
 
8 POINT-OF-CARE DIAGNOSTICS MARKET, BY PRESCRIPTION MODE 102
8.1 INTRODUCTION 103
8.2 PRESCRIPTION-BASED TESTING 104
8.3 OTC TESTING 105
9 POINT-OF-CARE DIAGNOSTICS MARKET, BY END USER 107
9.1 INTRODUCTION 108
9.2 PROFESSIONAL DIAGNOSTIC CENTERS 109
9.2.1 OUTPATIENT HEALTHCARE & AMBULATORY CARE SETTINGS 110
9.2.2 HOSPITALS/CRITICAL CARE CENTERS 111
9.3 HOME CARE 112
9.4 RESEARCH LABORATORIES 113
9.5 OTHER END USERS 114
10 POINT-OF-CARE DIAGNOSTICS MARKET, BY REGION 116
10.1 INTRODUCTION 117
10.2 NORTH AMERICA 118
10.2.1 US 122
10.2.2 CANADA 126
10.3 EUROPE 129
10.3.1 GERMANY 133
10.3.2 FRANCE 136
10.3.3 UK 139
10.3.4 REST OF EUROPE (ROE) 142
10.4 ASIA PACIFIC 144
10.4.1 JAPAN 148
10.4.2 CHINA 151
10.4.3 INDIA 154
10.4.4 REST OF ASIA PACIFIC 157
10.5 REST OF THE WORLD (ROW) 161
10.5.1 LATIN AMERICA 163
10.5.2 MIDDLE EAST & AFRICA 165
11 COMPETITIVE LANDSCAPE 169
11.1 OVERVIEW 169
11.2 MARKET SHARE ANALYSIS, 2016 170
11.3 COMPETITIVE SCENARIO AND TRENDS 171
11.3.1 PRODUCT LAUNCHES 171
11.3.2 AGREEMENTS, PARTNERSHIPS, AND COLLABORATIONS 171
11.3.3 PRODUCT APPROVALS 172
11.3.4 ACQUISITIONS 172
12 COMPANY PROFILES 173
(Business Overview, Products Offered, Recent Developments, Mnm View)*
12.1 ABBOTT LABORATORIES 173
12.2 ACCUBIOTECH 176
12.3 BECTON, DICKINSON, AND COMPANY (BD) 179
12.4 CHEMBIO DIAGNOSTICS 182
12.5 DANAHER CORPORATION 185
12.6 EKF DIAGNOSTICS 188
12.7 INSTRUMENTATION LABORATORY (A WERFEN COMPANY) 191
12.8 JOHNSON & JOHNSON 193
12.9 NOVA BIOMEDICAL 196
12.10 PTS DIAGNOSTICS (A PART OF SINOCARE INC.) 199
12.11 QUIDEL 201
12.12 ROCHE DIAGNOSTICS (A SUBSIDIARY OF F. HOFFMANN-LA ROCHE LTD.) 204
12.13 SEKISUI DIAGNOSTICS 208
12.14 SIEMENS 211
12.15 TRINITY BIOTECH 215
*Business Overview, Products Offered, Recent Developments, Mnm View might not be captured in case of unlisted companies.
13 APPENDIX 217
13.1 DISCUSSION GUIDE 217
13.2 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 221
13.3 INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE 223
13.4 AVAILABLE CUSTOMIZATIONS 225
13.5 RELATED REPORTS 225
13.6 AUTHOR DETAILS 226