MediPoint: Point of Care Diagnostics - Global Analysis and Market Forecasts
Summary
Point-of-care testing (POCT), as known as bedside/near-patient testing is one of the most rapidly growing areas in IVD. Systems that are categorized as POC include the following -
- Disposable systems or devices, which vary from reagent test strips for a single analyte to multi-analyte reagent strips
- Small analyzers, usually hand-held devices
- Desktop analyzers are larger and include systems designed for use in clinics or small laboratories.
POCT may be performed in a variety of locations such as in secondary care including emergency departments, ambulance service, hospital wards, and intensive treatment units; and increasingly in the community and primary care including general practice (GP), health and community centers.
- $2 billion in annual global sales and growth rate of 5.3% during the forecast period; the emerging markets: China, India and Brazil, are expected to show the fastest growth.
- A number of factors, such as the increasing prevalence of infectious diseases in developing countries, the rising incidences of lifestyle diseases such as cardiac diseases and diabetes, the rising usage of home-based POC devices, expansion of test menu, and advancements in molecular testing and lab-on-chip technology are stimulating the demand for POC testing.
- The rate of POC testing adoption will be moderated by the requirement for regulatory compliance, the pressure to control cost, and the need to demonstrate clear clinical-cost benefits of POC testing over central laboratory testing.
Highlights
Key Questions Answered
- What is the current and future POC diagnostics market outlook in the developed and emerging markets? What trends are affecting the global market?
- What is the competitive landscape and market share of major players in the POC space across different regions?
- What are the key, high growth markets that IVD manufacturers should expand into? Which market segments are growing the fastest?
- What are the unmet needs with the POC tests currently on the market? How will emerging technologies such as molecular POC assays fulfil these unmet needs?
- What are the key factors influencing a physician to use POC tests? What is physician perception and market outlook of POC devices?
- What are the challenges and barriers that have hindered widespread adoption of POC devices?
Scope
- Competitive assessment: Currently marketed POC products and evolving competitive landscape
- In-depth analysis of unmet needs and adoption trends of different POC devices
- Insightful review of the key industry drivers, opportunities, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications
- Pipeline analysis: Emerging products and technologies.
- Annualized total POC diagnostics market revenue by segment and market outlooks by country from 2012-2021.
- Other key topics covered include strategic competitive assessment, market characterization, identification of unmet needs, market dynamics, and implications of the emerging technologies on the market.
Reasons to buy
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline
- Develop business strategies by understanding the trends shaping and driving the global market
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global market in the future
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage
- Track device sales in the global market from 2012-2021
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships
Table Of Contents
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 12
1.2 List of Figures 16
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 18
3 Industry Overview 19
3.1 POC Diagnostics Overview 19
3.2 Test Trends 21
3.2.1 Cardiac Markers POC Testing 21
3.2.2 Female Fertility and Pregnancy POC Testing 24
3.3 Mergers, Acquisitions, and Key Partnerships 29
4 Unmet Needs 33
4.1 Detection of Multiple Analytes 33
4.2 Sensitivity of Lateral Flow Technology 33
4.3 Analytical Quality 35
4.4 Markers for Myocardial Ischemia 35
4.5 Data Management 36
4.6 POC Diagnostics to Reduce Usage of Antibiotics 37
4.7 Cost-Effectiveness and Reimbursement 38
4.8 Gap between Physicians and Manufacturers 39
5 Market Drivers and Barriers 40
5.1 Drivers 40
5.1.1 Fast Turnaround Time 40
5.1.2 POC Molecular Testing Driving Infectious Disease POCT 40
5.1.3 Increasing Adoption of Cardiac Marker POCT 41
5.1.4 Expansion POC Testing Menu 42
5.1.5 Expansion of the Home-Testing Market 43
5.1.6 CLIA Waived Status for POCT 43
5.1.7 Rising Prevalence of Diseases 44
5.2 Barriers 44
5.2.1 Management of POCT 44
5.2.2 Competition with Laboratory Tests 45
5.2.3 Regulatory Compliance 46
5.2.4 Medical Device Excise Tax 47
6 Competitive Assessment 48
6.1 Company Share Analysis 48
6.1.1 Global 48
6.1.2 US 49
6.1.3 Europe 50
6.1.4 Asia-Pacific 51
6.2 Trends in Corporate Strategy 52
6.3 Major Players 53
6.3.1 Abbott Diagnostics 53
6.3.2 Akers Bioscience 56
6.3.3 Alere 59
6.3.4 Beckman Coulter 64
6.3.5 BioMerieux 66
6.3.6 Chembio Diagnostics 69
6.3.7 EKF Diagnostics 72
6.3.8 Meridian Bioscience 75
6.3.9 OraSure Technologies 79
6.3.10 Quidel 82
6.3.11 Radiometer Medical 86
6.3.12 Response Biomedical 89
6.3.13 Roche Diagnostics 93
6.3.14 Siemens Healthcare 97
6.3.15 Trinity Biotech 100
6.3.16 Other Companies 104
7 Pipeline Assessment 116
7.1 Overview 116
7.2 Pipeline Profiles 117
7.2.1 Cardiac Markers POCT 117
7.2.2 Female Fertility and Pregnancy POCT 118
7.2.3 Hematology POCT 118
7.2.4 Infectious Disease POCT 119
7.2.5 Immunochemistry POCT Analyzers 125
8 Market Outlook 126
8.1 By Market Segment 126
8.1.1 Global Overview 126
8.1.2 Cardiac Markers POCT 128
8.1.3 Female Fertility and Pregnancy POCT 130
8.1.4 Hematology POCT 132
8.1.5 Infectious Disease POCT 133
8.1.6 Immunochemistry POCT Analyzers 134
8.2 By Geography 136
8.2.1 Global Overview 136
8.2.2 US 139
8.2.3 France 141
8.2.4 Germany 144
8.2.5 Italy 146
8.2.6 Spain 150
8.2.7 UK 152
8.2.8 Japan 156
8.2.9 China 158
8.2.10 India 161
8.2.11 Brazil 164
9 Appendix 168
9.1 Bibliography 168
9.2 Abbreviations 172
9.3 Report Methodology 177
9.3.1 Overview 177
9.3.2 Coverage 177
9.3.3 Secondary Research 177
9.3.4 Forecasting Methodology 178
9.3.5 Primary Research — Key Opinion Leader Interviews 179
9.3.6 Primary Research - Physician and Industry Interviews 180
9.3.7 Expert Panel Validation 181
9.4 Physicians and Specialists Included in This Study 182
9.5 About the Authors 183
9.5.1 Analysts 183
9.5.2 Tyler Fletcher, Global Head of Medical Devices 184
9.6 About MediPoint 185
9.7 About GlobalData 185
9.8 Disclaimer 185
List Of Tables
1.1 List of Tables
Table 1: Advantages and Disadvantages of POCT 20
Table 2: Global Troponin POCT Volume (thousands) Forecast by Country, 2012-2021 22
Table 3: Global B-type Natriuretic Peptide POCT Volume (thousands) Forecast by Country, 2012-2021 23
Table 4: Global Follicle-Stimulating Hormone POCT Volume Forecast by Country, 2012-2021 25
Table 5: Global Luteinizing Hormone POCT Volume (thousands) Forecast by Country, 2012-2021 27
Table 6: Global Human Chorionic Gonadotropin POCT Volume (thousands) Forecast by Country, 2012-2021 28
Table 7: Mergers, Acquisitions, and Key Partnerships, 2012-2016 30
Table 8: Company Profile - Abbott Diagnostics 54
Table 9: Abbott Diagnostics’ POC Portfolio Assessment, 2015 55
Table 10: SWOT Analysis - Abbott Diagnostics 56
Table 11: Company Profile - Akers Bioscience 57
Table 12: Aker Bioscience’s POC Portfolio Assessment, 2015 58
Table 13: SWOT Analysis - Akers Bioscience 58
Table 14: Company Profile - Alere 60
Table 15: Alere’s POC Portfolio Assessment, 2015 61
Table 16: SWOT Analysis - Alere 64
Table 17: Company Profile - Beckman Coulter 65
Table 18: Beckman Coulter’s POC Portfolio Assessment, 2015 65
Table 19: SWOT Analysis - Beckman Coulter 66
Table 20: Company Profile - BioMerieux 67
Table 21: BioMerieux’s POC Portfolio Assessment, 2015 68
Table 22: SWOT Analysis - BioMerieux 69
Table 23: Company Profile - Chembio Diagnostics 70
Table 24: Chembio Diagnostics’ POC Portfolio Assessment, 2015 71
Table 25: SWOT Analysis - Chembio Diagnostics 72
Table 26: Company Profile - EKF Diagnostics 73
Table 27: EKF Diagnostics’ POC Portfolio Assessment, 2015 74
Table 28: SWOT Analysis - EKF Diagnostics 75
Table 29: Company Profile - Meridian Bioscience 77
Table 30: Meridian Bioscience’s POC Portfolio Assessment, 2015 78
Table 31: SWOT Analysis - Meridian Bioscience 79
Table 32: Company Profile - OraSure Technologies 80
Table 33: OraSure Technologies’ POC Portfolio Assessment, 2015 81
Table 34: SWOT Analysis - OraSure Technologies 81
Table 35: Company Profile - Quidel 83
Table 36: Quidel’s POC Portfolio Assessment, 2015 84
Table 37: SWOT Analysis - Quidel 86
Table 38: Company Profile - Radiometer Medical 87
Table 39: Radiometer Medical’s POC Portfolio Assessment, 2015 88
Table 40: SWOT Analysis - Radiometer Medical 89
Table 41: Company Profile - Response Biomedical 91
Table 42: Response Biomedical’s POC Portfolio Assessment, 2015 92
Table 43: SWOT Analysis - Response Biomedical 93
Table 44: Company Profile - Roche Diagnostics 95
Table 45: Roche Diagnostics’ POC Portfolio Assessment, 2015 96
Table 46: SWOT Analysis - Roche Diagnostics 97
Table 47: Company Profile - Siemens Healthcare 98
Table 48: Siemens Healthcare’s POC Portfolio Assessment, 2015 99
Table 49: SWOT Analysis - Siemens Healthcare 100
Table 50: Company Profile - Trinity Biotech 101
Table 51: Trinity Biotech’s POC Portfolio Assessment, 2015 102
Table 52: SWOT Analysis - Trinity Biotech 103
Table 53: Other POC Companies in North America, 2015 104
Table 54: Other POC Companies in Europe, 2015 111
Table 55: Other POC Companies in APAC and Other Regions, 2015 114
Table 56: Key Cardiac Markers POCT Pipelines, 2015 117
Table 57: Key Female Fertility and Pregnancy POCT Pipelines, 2015 118
Table 58: Key Hematology POCT Pipelines, 2015 118
Table 59: Key Infectious Disease POCT Pipelines, 2015 119
Table 60: Key Immunochemistry POCT Analyzer Pipelines, 2015 125
Table 61: Global POC Diagnostics Sales Forecast ($m) by Market Segment, 2012-2021 127
Table 62: Cardiac Marker POCT Sales Forecast ($m), 2012-2021 130
Table 63: Fertility and Pregnancy POCT Sales Forecast ($m), 2012-2021 131
Table 64: Hematology POCT Sales Forecast ($m), 2012-2021 132
Table 65: Infectious Disease POCT Sales Forecast ($m), 2012-2021 134
Table 66: Immunochemistry POCT Analyzers Sales Forecast ($m), 2012-2021 135
Table 67: Global POC Diagnostics Sales Forecast ($m) by Country, 2012-2021 136
Table 68: US POC Diagnostics Sales Forecast ($m), 2012-2021 140
Table 69: France POC Diagnostics Sales Forecast ($m), 2012-2021 142
Table 70: Germany POC Diagnostics Sales Forecast ($m), 2012-2021 145
Table 71: Italy POC Diagnostics Sales Forecast ($m), 2012-2021 147
Table 72: Spain POC Diagnostics Sales Forecast ($m), 2012-2021 150
Table 73: UK POC Diagnostics Sales Forecast ($m), 2012-2021 153
Table 74: Japan POC Diagnostics Sales Forecast ($m), 2012-2021 156
Table 75: China POC Diagnostics Sales Forecast ($m), 2012-2021 160
Table 76: India POC Diagnostics Sales Forecast ($m), 2012-2021 162
Table 77: Brazil POC Diagnostics Sales Forecast ($m), 2012-2021 166
Table 78: POC Diagnostics - Primary Call Count by Country 180
Lisst Of Figures
1.2 List of Figures
Figure 1: Troponin POCT Volume by Country, 2012-2021 22
Figure 2: B-type Natriuretic Peptide POCT Volume by Country, 2012-2021 24
Figure 3: Follicle-Stimulating Hormone POCT Volume by Country, 2012-2021 26
Figure 4: Luteinizing Hormone POCT Volume by Country, 2012-2021 27
Figure 5: Human Chorionic Gonadotropin POCT Volume by Country, 2012-2021 29
Figure 6: Global POC Diagnostics Market, By Company Share, 2015 49
Figure 7: US POC Diagnostics Market, By Company Share, 2015 50
Figure 8: Europe POC Diagnostics Market, By Company Share, 2015 51
Figure 9: APAC POC Diagnostics Market, By Company Share, 2015 52
Figure 10: Global POC Diagnostics Sales Forecast ($m) by Market Segment, 2012-2021 127
Figure 11: Global POC Diagnostics Market Potential by Segment, 2021 128
Figure 12: Cardiac Marker POCT Sales Forecast ($m), 2012-2021 130
Figure 13: Fertility and Pregnancy POCT Sales Forecast ($m), 2012-2021 131
Figure 14: Hematology POCT Sales Forecast ($m), 2012-2021 133
Figure 15: Infectious Disease POCT Sales Forecast ($m), 2012-2021 134
Figure 16: Immunochemistry POCT Analyzers Sales Forecast ($m), 2012-2021 135
Figure 17: Global POC Diagnostics Sales Forecast ($m), 2012-2021 137
Figure 18: Global POC Diagnostics Market Share Forecast ($m) by Country, 2015 and 2021 138
Figure 19: Global POC Diagnostics Market Potential by Country, 2021 139
Figure 20: US POC Diagnostics Sales Forecast ($m), 2012-2021 140
Figure 21: US POC Diagnostics Market Revenue Breakdown, by Segment, 2015 141
Figure 22: France POC Diagnostics Sales Forecast ($m), 2012-2021 143
Figure 23: France POC Diagnostics Market Revenue Breakdown, by Segment, 2015 144
Figure 24: Germany POC Diagnostics Sales Forecast ($m), 2012-2021 145
Figure 25: Germany POC Diagnostics Market Revenue Breakdown, by Segment, 2015 146
Figure 26: Italy POC Diagnostics Sales Forecast ($m), 2012-2021 148
Figure 27: Italy POC Diagnostics Market Revenue Breakdown, by Segment, 2015 149
Figure 28: Spain POC Diagnostics Sales Forecast ($m), 2012-2021 151
Figure 29: Spain POC Diagnostics Market Revenue Breakdown, by Segment, 2015 152
Figure 30: UK POC Diagnostics Sales Forecast ($m), 2012-2021 154
Figure 31: UK POC Diagnostics Market Revenue Breakdown, by Segment, 2015 155
Figure 32: Japan POC Diagnostics Sales Forecast ($m), 2012-2021 157
Figure 33: Japan POC Diagnostics Market Revenue Breakdown, by Segment, 2015 158
Figure 34: China POC Diagnostics Sales Forecast ($m), 2012-2021 160
Figure 35: China POC Diagnostics Market Revenue Breakdown, by Segment, 2015 161
Figure 36: India POC Diagnostics Sales Forecast ($m), 2012-2021 163
Figure 37: India POC Diagnostics Market Revenue Breakdown, by Segment, 2015 164
Figure 38: Brazil POC Diagnostics Sales Forecast ($m), 2012-2021 166
Figure 39: Brazil POC Diagnostics Market Revenue Breakdown, by Segment, 2015 167
Figure 40: POC Diagnostics - Primary Call Count by Country (N=390) 180
