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MediPoint: Infectious Disease Point of Care Testing - Global Analysis and Market Forecasts

Published By :

GlobalData

Published Date : Sep 2016

Category :

Medical Equipments

No. of Pages : 158 Pages

MediPoint: Infectious Disease Point of Care Testing - 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.

The infectious disease POCT space represents one of the fastest growing markets within the POC space. Just under $700 million in annual global sales and growth rate of 7.7% during the forecast period; the US, 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 usage of home-based POC devices, the expansion of the test menu, and technological advancements in molecular testing and lab-on-chip technology are stimulating the demand for infectious disease POCT.The rate of infectious disease POCT adoption will be moderated by the requirement for regulatory compliance, the pressure to control cost, and the need to demonstrate the clear clinical-cost benefits of POCT over central laboratory testing.

Highlights

Key Questions Answered

- What is the current and future infectious disease POCT 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 infectious disease POCT 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 infectious disease 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 infectious disease POC tests? What is physician perception and market outlook of these devices?
- What are the challenges and barriers that have hindered widespread adoption of infectious disease POC devices?

Scope

- Competitive assessment: Currently marketed infectious disease POC products and evolving competitive landscape
- In-depth analysis of unmet needs and adoption trends of different infectious disease 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 infectious disease POCT market revenue by segment and market outlooks by country from 2013-2022.
- 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

The report will enable you to -
- 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 2013-2022
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 13
1.2 List of Figures 16
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 19
3 Industry Overview 20
3.1 Infectious Disease POCT Overview 20
3.2 Reimbursement Trends 21
3.2.1 US 21
3.2.2 France 23
3.2.3 Germany 23
3.2.4 Italy 23
3.2.5 Spain 24
3.2.6 UK 24
3.2.7 Japan 24
3.2.8 China 25
3.2.9 India 25
3.2.10 Brazil 25
3.3 Mergers, Acquisitions, and Key Partnerships 27
4 Unmet Needs 30
4.1 Multiplexing 30
4.2 Sensitivity of Infectious Disease Immunoassays 30
4.3 Analytical Performance 31
4.4 Data Recording and Management 32
4.5 Infectious Disease POCT to Curb Usage of Antibiotics 33
4.6 Cost-Effectiveness Data 33
4.7 Primary Care Physician Needs 34
5 Competitive Assessment 35
5.1 Company Share Analysis 35
5.1.1 Global 35
5.2 Alere 36
5.2.1 Overview 36
5.2.2 Marketed Products Assessment 37
5.2.3 SWOT Analysis 40
5.3 Beckman Coulter 40
5.3.1 Overview 40
5.3.2 Marketed Products Assessment 41
5.3.3 SWOT Analysis 42
5.4 BioMerieux 42
5.4.1 Overview 42
5.4.2 Marketed Products Assessment 44
5.4.3 SWOT Analysis 45
5.5 Cepheid 45
5.5.1 Overview 45
5.5.2 Marketed Products Assessment 46
5.5.3 SWOT Analysis 48
5.6 Chembio Diagnostics 49
5.6.1 Overview 49
5.6.2 Marketed Products Assessment 50
5.6.3 SWOT Analysis 51
5.7 Meridian Bioscience 51
5.7.1 Overview 51
5.7.2 Marketed Products Assessment 53
5.7.3 SWOT Analysis 54
5.8 OraSure Technologies 55
5.8.1 Overview 55
5.8.2 Marketed Products Assessment 56
5.8.3 SWOT Analysis 57
5.9 Quidel 57
5.9.1 Overview 57
5.9.2 Marketed Products Assessment 59
5.9.3 SWOT Analysis 60
5.10 Roche Diagnostics 61
5.10.1 Overview 61
5.10.2 Marketed Products Assessment 62
5.10.3 SWOT Analysis 62
5.11 Trinity Biotech 63
5.11.1 Overview 63
5.11.2 Marketed Products Assessment 64
5.11.3 SWOT Analysis 65
5.12 Other Companies 66
5.12.1 North American Market Companies 66
5.12.2 European Market Companies 71
5.12.3 APAC and Other Markets Companies 73
6 Pipeline Assessment 74
6.1 Overview 74
6.2 Early Development Pipeline 75
6.3 Pre-clinical Stage Pipeline 78
6.4 Clinical Stage Pipeline 79
6.5 Products in the Approval Process 82
7 Market Outlook 83
7.1 Test Trends 83
7.1.1 HIV POCT 83
7.1.2 Influenza POCT 84
7.1.3 HBV POCT 86
7.1.4 HCV POCT 88
7.1.5 C. difficile POCT 89
7.2 Market Dynamics 90
7.2.1 Driver: Fast Turnaround Time 90
7.2.2 Driver: Emergence of Molecular Infectious Disease POCT 90
7.2.3 Driver: Expansion POCT Menu 91
7.2.4 Driver: CLIA-Waived Status for POCT 92
7.2.5 Driver: Rising Prevalence of Diseases 92
7.2.6 Barriers: Management of POCT 92
7.2.7 Barriers: Competition with Laboratory Tests 94
7.2.8 Barriers: Reimbursement 95
7.2.9 Barriers: Regulatory Compliance 96
7.3 Market Outlook By Market Segment 96
7.3.1 Global Overview 96
7.3.2 HIV POCT 99
7.3.3 Influenza POCT 101
7.3.4 HBV POCT 103
7.3.5 HCV POCT 104
7.3.6 C. difficile POCT 105
7.3.7 Molecular POCT Analyzers 106
7.4 Market Outlook By Geography 107
7.4.1 Global Overview 107
7.4.2 US 111
7.4.3 France 114
7.4.4 Germany 117
7.4.5 Italy 120
7.4.6 Spain 123
7.4.7 UK 126
7.4.8 Japan 129
7.4.9 China 132
7.4.10 India 136
7.4.11 Brazil 139
8 Appendix 142
8.1 Bibliography 142
8.2 Abbreviations 146
8.3 Report Methodology 151
8.3.1 Overview 151
8.3.2 Coverage 151
8.3.3 Secondary Research 151
8.3.4 Forecasting Methodology 152
8.3.5 Primary Research - Key Opinion Leader Interviews 153
8.3.6 Primary Research - Physician and Industry Interviews 154
8.3.7 Expert Panel Validation 154
8.4 About the Team 155
8.4.1 Analysts 155
8.4.2 Tyler Fletcher, Global Head of Medical Devices 156
8.5 About MediPoint 157
8.6 About GlobalData 157
8.7 Disclaimer 157

1.1 List of Tables
Table 1: Advantages and Disadvantages of POCT 21
Table 2: Medicare National Average of Clinical Laboratory Services Reimbursement for Infectious Disease Testing, 2014-2015 22
Table 3: Mergers, Acquisitions, and Key Partnerships, 2014-2016 27
Table 4: Company Profile - Alere 37
Table 5: Alere Infectious Disease POCT Portfolio Assessment, 2016 38
Table 6: SWOT Analysis - Alere 40
Table 7: Company Profile - Beckman Coulter 41
Table 8: Beckman Coulter Infectious Disease POCT Portfolio Assessment, 2016 41
Table 9: SWOT Analysis - Beckman Coulter 42
Table 10: Company Profile - BioMerieux 43
Table 11: BioMerieuxs Infectious Disease POCT Portfolio Assessment, 2016 44
Table 12: SWOT Analysis - BioMerieux 45
Table 13: Company Profile - Cepheid 46
Table 14: Cepheids Infectious Disease POCT Portfolio Assessment, 2016 47
Table 15: SWOT Analysis - Cepheid 48
Table 16: Company Profile - Chembio Diagnostics 49
Table 17: Chembio Diagnostics Infectious Disease POCT Portfolio Assessment, 2016 50
Table 18: SWOT Analysis - Chembio Diagnostics 51
Table 19: Company Profile - Meridian Bioscience 52
Table 20: Meridian Biosciences Infectious Disease POCT Portfolio Assessment, 2016 53
Table 21: SWOT Analysis - Meridian Bioscience 54
Table 22: Company Profile - OraSure Technologies 56
Table 23: OraSure Technologies Infectious Disease POCT Portfolio Assessment, 2016 56
Table 24: SWOT Analysis - OraSure Technologies 57
Table 25: Company Profile - Quidel 58
Table 26: Quidels Infectious Disease POCT Portfolio Assessment, 2016 59
Table 27: SWOT Analysis - Quidel 60
Table 28: Company Profile - Roche Diagnostics 61
Table 29: Roche Diagnostics Infectious Disease POCT Portfolio Assessment, 2016 62
Table 30: SWOT Analysis - Roche Diagnostics 62
Table 31: Company Profile - Trinity Biotech 63
Table 32: Trinity Biotechs Infectious Disease POCT Portfolio Assessment, 2016 64
Table 33: SWOT Analysis - Trinity Biotech 65
Table 34: Other Infectious Disease POCT Companies in North America, 2016 66
Table 35: Other Infectious Disease POCT Companies in Europe, 2016 71
Table 36: Other Infectious Disease POCT Companies in APAC and Other Regions, 2016 73
Table 37: Key Infectious Disease POCT Products in Early Development, 2016 75
Table 38: Key Infectious Disease POCT Products in Pre-clinical Stage, 2016 78
Table 39: Key Infectious Disease POCT Products in the Clinical Stage, 2016 79
Table 40: Key Infectious Disease POCT Pipelines in Approval Process, 2016 82
Table 41: Global HIV POCT Volume Forecast (thousands) by Region, 2013-2022 83
Table 42: Global Influenza POCT Volume Forecast (Thousands) by Region, 2013-2022 84
Table 43: Global HBV POCT Volume Forecast (Thousands) by Region, 2013-2022 86
Table 44: Global HCV POCT Volume Forecast (Thousands) by Region, 2013-2022 88
Table 45: Global C. difficile POCT Volume Forecast (Thousands) by Region, 2013-2022 89
Table 46: Global Infectious Disease POCT Sales Forecast ($m) by Market Segment, 2013-2022 98
Table 47: HIV POCT Sales Forecast ($m), 2013-2022 100
Table 48: Influenza POCT Sales Forecast ($m), 2013-2022 101
Table 49: HBV POCT Sales Forecast ($m), 2013-2022 103
Table 50: HCV POCT Sales Forecast ($m), 2013-2022 104
Table 51: C. difficile POCT Sales Forecast ($m), 2013-2022 105
Table 52: Molecular POCT Analyzers Sales Forecast ($m), 2013-2022 106
Table 53: Global Infectious Disease POCT Sales Forecast ($m) by Country, 2013-2022 108
Table 54: US Infectious Disease POCT Sales Forecast ($m), 2013-2022 111
Table 55: France Infectious Disease POCT Sales Forecast ($m), 2013-2022 114
Table 56: Germany Infectious Disease POCT Sales Forecast ($m), 2013-2022 117
Table 57: Italy Infectious Disease POCT Sales Forecast ($m), 2013-2022 120
Table 58: Spain Infectious Disease POCT Sales Forecast ($m), 2013-2022 123
Table 59: UK Infectious Disease POCT Sales Forecast ($m), 2013-2022 127
Table 60: Japan Infectious Disease POCT Sales Forecast ($m), 2013-2022 129
Table 61: China Infectious Disease POCT Sales Forecast ($m), 2013-2022 133
Table 62: India Infectious Disease POCT Sales Forecast ($m), 2013-2022 137
Table 63: Brazil Infectious Disease POCT Sales Forecast ($m), 2013-2022 140

1.2 List of Figures
Figure 1: Global Infectious Disease POCT Market, by Company Share, 2015 36
Figure 2: Infectious Disease POCT Pipelines, by Stage of Development, 2016 74
Figure 3: Global HIV POCT Volume Forecast (Thousands) by Region, 2013-2022 84
Figure 4: Global Influenza POCT Volume Forecast (Thousands) by Region, 2013-2022 85
Figure 5: Global HBV POCT Volume Forecast (Thousands) by Region, 2013-2022 87
Figure 6: Global HCV POCT Volume Forecast (Thousands) by Region, 2013-2022 88
Figure 7: Global C. difficile POCT Volume Forecast (Thousands) by Region, 2013-2022 89
Figure 8: Global Infectious Disease POCT Sales Forecast ($m) by Market Segment, 2013-2022 98
Figure 9: Global Infectious Disease POCT Market Share Forecast ($m) by Segment, 2015 and 2022 99
Figure 10: HIV POCT Sales Forecast ($m), 2013-2022 100
Figure 11: Influenza POCT Sales Forecast ($m), 2013-2022 102
Figure 12: HBV POCT Sales Forecast ($m), 2013-2022 103
Figure 13: HCV POCT Sales Forecast ($m), 2013-2022 104
Figure 14: C. difficile POCT Sales Forecast ($m), 2013-2022 105
Figure 15: Molecular POCT Analyzers Sales Forecast ($m), 2013-2022 107
Figure 16: Global Infectious Disease POCT Sales Forecast ($m), 2013-2022 108
Figure 17: Global Infectious Disease POCT Market Share Forecast ($m) by Country, 2015 and 2022 110
Figure 18: US Infectious Disease POCT Sales Forecast ($m), 2013-2022 112
Figure 19: US Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022 113
Figure 20: France Infectious Disease POCT Sales Forecast ($m), 2013-2022 115
Figure 21: France Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022 116
Figure 22: Germany Infectious Disease POCT Sales Forecast ($m), 2013-2022 118
Figure 23: Germany Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022 119
Figure 24: Italy Infectious Disease POCT Sales Forecast ($m), 2013-2022 121
Figure 25: Italy Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022 122
Figure 26: Spain Infectious Disease POCT Sales Forecast ($m), 2013-2022 124
Figure 27: Spain Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022 125
Figure 28: UK Infectious Disease POCT Sales Forecast ($m), 2013-2022 127
Figure 29: UK Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022 128
Figure 30: Japan Infectious Disease POCT Sales Forecast ($m), 2013-2022 130
Figure 31: Japan Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022 131
Figure 32: China Infectious Disease POCT Sales Forecast ($m), 2013-2022 134
Figure 33: China Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022 135
Figure 34: India Infectious Disease POCT Sales Forecast ($m), 2013-2022 137
Figure 35: India Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022 138
Figure 36: Brazil Infectious Disease POCT Sales Forecast ($m), 2013-2022 140
Figure 37: Brazil Infectious Disease POCT Market Share Forecast (%) by Segment, 2015 and 2022 141
Figure 38: Infectious Disease POCT - Physician Survey Count by Country (N=121) 154

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