Point of Care Coagulation Testing: World Market 2013-2023
London (PRWEB) September 30, 2013 -- Report Details
In 2011, the global point of care diagnostics market was worth $13.8bn, with high single-digit growth from the year before. Despite being a vast and mature market, there are number of sectors likely to experience fast growth during the next 10 years. Much of this growth is linked to the prevalence of a number of diseases worldwide, as well as an aging population. The preference for at home testing and its convenience will continue to drive the point of care diagnostics market.
The point of care coagulation market is one of the largest sectors in the global point of care industry. In 2011, the global POC coagulation testing market (including the sales of kits and instruments) was valued at $1.0bn. Total sales in this market are predicted to reach $1.8bn in 2017. PT/INR testing was the largest segment in the POC coagulation testing market with sales of $0.6bn in 2011.
For the past several years, four companies - Roche, International Technidyne Corporation (ITC), Abbott, and Alere - have dominated the POC PT/INR testing market. The devices currently available in the market are able to meet demand. However, there is need for improvement in technology to attract more physicians and patients to use this testing. Most of the testing for patients on anticoagulant warfarin is currently conducted in laboratories. Such patients need regular monitoring. The use of POC tests can help save a lot of time and money spent on unwanted complications arising from the use of the drug without monitoring.
The primary driver for growth will be the increasing use of anticoagulant therapy and higher adoption of self-testing kits for use at home. Anticoagulant drugs are commonly used for the treatment of thrombosis and associated disorders, including stroke, myocardial infarction and pulmonary embolism. The global epidemic of heart attack and stroke is predicted to continue and indeed worsen, from 2011 to 2023. However, market growth will slow down beyond 2017, with the launch of new oral anticoagulants in the market to replace warfarin.
Point of Care Coagulation Testing: World Market 2013-2023 provides an in-depth analysis of this segment. The report uses a wealth of research tools - including market forecasting, qualitative analyses, probing interviews with industry experts, literature searches and use of commercial databases. The report is packed with original data in tables, charts and other formats.
Why you should buy Point of Care Coagulation Testing: World Market 2013-2023
In this report, you will receive the following benefits:
•You will receive a comprehensive analysis of prospects in the point of care coagulation testing market as a whole from 2011 to 2023, including predicted market sizes, growth rates and other metrics for leading sectors
•You will receive an overall forecast for the point of care market and point of care coagulation testing market from 2012 to 2023, as well as that for the PT/INR market, with discussions and other supporting information
•You will receive an overall forecast for the anticoagulant drug market from 2012 to 2023, with comprehensive discussions and other supporting information
•You will discover revenue forecasts to 2023 for leading national markets (US, Europe, and Rest of the World), seeing growth trends
•You will receive analysis of leading companies in the point of care coagulation testing market
•You will find out where the market is heading - both technologically and commercially - from 2012 onwards
•You will discover the drivers, restraints, competition and opportunities influencing the point of care coagulation testing market
•You will identify where new opportunities lie in these sectors, with commercial opportunities and challenges discussed
•You will view opinions from our industry survey, receiving full interview transcripts.
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Table of Contents
1. Executive Summary
1.1 The Point of Care (POC) Coagulation Testing Market Review
1.2 Aims, Scope and Format of the Report
1.2.1 Chapter Outlines
1.3 Research and Analysis Methods
2. Introduction to In-Vitro Diagnostics and POC Diagnostics
2.1 What are In Vitro Diagnostic (IVD) Tests?
2.2 Classifying IVD: EDMA Classification
2.2.1 Clinical Chemistry
2.2.2 Immunochemistry
2.2.3 Haematology
2.2.4 Microbiology
2.2.5 Genetic Testing
2.3 Point of Care (POC) Diagnostics
2.3.1 Advantages and Disadvantages of POC Diagnostics
2.4 Regulation of the IVD and POC Market
2.4.1 FDA Classifications
2.4.2 FDA and CLIA Regulation of IVD and POC Tests
2.4.3 Regulation of IVD/POC Diagnostics in the EU
3. The Point of Care Diagnostics Market, 2011-2023
3.1 Point of Care Diagnostics Market, 2011
3.2 Blood Glucose Testing is the Largest Contributor to the POC Market Sales
3.3 Self Testing - Largest Segment in the POC Market by the Point of Delivery, 2011
3.4 Point of Care Diagnostics Market Forecast, 2012-2017
3.5 Point of Care Diagnostics Market Forecast, 2017-2023
4. POC Coagulation Testing Market, 2011-2023
4.1 The POC Coagulation Testing Market in 2011
4.1.1 PT/INR Monitoring is the Largest Segment in the POC Coagulation Testing Market
4.1.2 Roche Dominates the POC Coagulation Testing Market with CoaguChek XS System
4.2 Products Available in the POC Coagulation Testing Market, 2013
4.3 POC Coagulation Testing Will Witness Strong Growth to 2017
4.4 POC Coagulation Testing Market Forecast, 2017-2023
4.5 Drivers for Growth
5. The PT/INR Testing Market, 2011-2023
5.1 Patient Self Testing is the Smallest, But Fastest Growing Segment
5.2 Test Strips Generate 85% of the Sales in the PT/INR POC Testing Market
5.3 PT/INR Testing Market Forecast, 2012-2023
6. Anticoagulant Drugs Market, 2011-2023
6.1 Anticoagulants
6.1.1 Heparins
6.1.2 Vitamin K Antagonists
6.1.3 Direct Thrombin Inhibitors
6.1.4 Direct Factor Xa Inhibitors
6.2 The Anticoagulants Market in 2011
6.3 Anticoagulants Market Forecast, 2012-2023
6.4 Vitamin K Antagonists
6.4.1 The Vitamin K Antagonists Market in 2011
6.4.2 Vitamin K Antagonists: Market Sector Forecast, 2012-2023
7. Leading National Markets for POC PT/INR Testing, 2011-2023
7.1 The US is the Largest Market for POC PT/INR Testing
7.2 Coagulation Self-Monitoring: Reimbursement Status
7.3 The US Market
7.4 The European Market
7.4.1 Germany
7.4.2 The UK
7.4.3 France
7.4.4 Other European Countries
7.5 Rest of the World Markets
7.5.1 Japanese Market
7.5.2 Indian Market
8. Leading Companies in the POC PT/INR Testing Market
8.1 Four Companies Dominate the POC PT/INR Testing Market
8.2 Company Profiles
8.2.1 Roche
8.2.1.1 Global Presence
8.2.1.2 Sales and Recent Performance Analysis
8.2.1.3 Roche Diagnostics
8.2.1.4 Growing Portfolio of Coagulation Testing Products
8.2.1.5 Recent M&A Activity and Strategic Collaborations
8.2.2 Abbott Laboratories
8.2.2.1 Sales and Recent Performance Analysis
8.2.2.2 Abbott: Diagnostics Segment
8.2.2.3 Point of Care Diagnostics Products
8.2.2.4 Abbott IVD Segment: Strengths & Challenges
8.2.2.5 Abbott Diagnostics Historical Revenues, 2009-2011
8.2.2.6 Recent M&A Activity and Strategic Collaborations
8.2.2.6.1 Collaboration with GSK
8.2.2.6.2 Collaboration with Merck
8.2.2.6.3 Acquisition of STARLIMS Technologies
8.2.2.6.4 Acquisition of Ibis Biosciences
8.2.3 International Technidyne Corporation (ITC)
8.2.3.1 Overview
8.2.3.2 Products
8.2.3.3 Blood Coagulation Monitor Devices
9. Products in the Pipeline
9.1 POC Coagulation Test Systems in Development
9.1.1 Portable Coagulation Monitor, Entegrion
9.1.2 Blood Coagulation Monitor, Bio-AMD
9.1.3 Siemens-Universal Biosensors Collaboration
10. SWOT Analysis of the POC Coagulation Testing Market, 2013-2023
10.1 Strengths and Weaknesses of the Sector
10.1.1 Thrombotic Diseases: Management Rather Than Cure
10.1.2 Better Patient and Disease Management
10.1.3 Warfarin Has Been the Anticoagulant of Choice for More Than 50 Years
10.1.4 Availability of Several POC Devices
10.1.5 Availability of International Guidelines for Self-Monitoring
10.1.6 The Cost of POC Tests
10.1.7 Educating the End-Users
10.2 Opportunities and Threats
10.2.1 Consistent Technological Developments
10.2.2 Rising Disease Prevalence
10.2.3 Launch of New Class of Anticoagulants
10.2.4 Expansion into Developing National Markets and Lifestyle Diseases Will Drive the Market
10.2.5 High-Entry Barriers in the POC Blood Coagulation Testing Market
10.2.6 Medical Device Excise Tax: A Threat to the OEMs
11. Expert Opinion
11.1 Interview with Dr Frank Peacock, Professor, Associate Chair and Research Director, Baylor College of Medicine, Houston, Texas
11.1.1 Warfarin vs Novel Oral Anticoagulants
11.1.2 The Unmet Needs of the Market
11.1.3 The R&D Pipeline
11.1.4 Key Market Drivers and Restraints
11.2 Interview with Dr Jonathan L. Halperin, Professor of Medicine, Director of Clinical Cardiology Services, Zena and Michael A. Wiener Cardiovascular Institute, The Mount Sinai Medical Center, New York
11.2.1 Unmet Needs
11.2.2 New Findings
11.2.3 Warfarin Replacement
11.2.4 Areas Demanding Attention
11.2.5 Key Market Restraints
12. Conclusions
12.1 Overview of Point of Care Coagulation Testing
12.2 Commercial Drivers for the Adoption of POC Coagulation Tests
12.3 Commercial Restraints in the POC Coagulation Testing Market
12.4 Growth of POC Coagulation Testing Market from 2013 to 2023
12.5 Future Outlook and Concluding Remarks
List of Tables
Table 2.1 Advantages and Disadvantages of POC Diagnostics
Table 3.1 POC Market by Leading Segments, Sales ($bn) and Market Share (%), 2011
Table 3.2 Self Testing & Professional Testing in the POC Market ($bn), 2011
Table 3.3 World POC Diagnostics Market Forecast ($bn), 2011-2017
Table 3.4 World POC Diagnostics Market Forecast ($bn), 2017-2023
Table 4.1 Global POC Coagulation Testing Market ($m) by Marker, 2011
Table 4.2 Global POC Coagulation Testing Market ($m) by Leading Companies, 2011
Table 4.3 List of Some Products in the POC Coagulation Testing Market, 2013
Table 4.4 The POC Coagulation Testing Market Forecast ($bn), 2011-2017
Table 4.5 The POC Coagulation Testing Market Forecast ($bn), 2017-2023
Table 5.1 PT/INR POC Testing Market ($m) by Point of Use, 2011
Table 5.2 The Price of Some POC PT/INR Testing Systems, 2012
Table 5.3 PT/INR POC Testing Market ($m) by Components, 2011
Table 5.4 The PT/INR Testing Market Forecast ($m), 2011-2017
Table 5.5 The PT/INR Testing Market Forecast ($m), 2017-2023
Table 6.1 Anticoagulant Drug Market: Revenues ($m) by Class, 2011
Table 6.2 Anticoagulant Classes: Revenue Forecasts ($m), 2011-2017
Table 6.3 Anticoagulant Classes: Revenue Forecasts ($m), 2018-2023
Table 6.4 Vitamin K Antagonists: Market Sector Forecast ($m), 2011-2023
Table 6.5 The Vitamin K Antagonist Market: Drivers and Restraints, 2013-2023
Table 7.1 PT/INR POC Testing Market ($m) by Region, 2011
Table 7.2 Leading National PT/INR Testing Market Forecast ($m), 2011-2023
Table 7.3 Reimbursement for Coagulation Self-Monitoring In the US and Some European
Countries, 2011
Table 7.4 The US PT/INR Testing Market Forecast ($m), 2011-2023
Table 7.5 The European PT/INR Testing Market Forecast ($m), 2011-2023
Table 7.6 Rest of the World PT/INR Testing Market Forecast ($m), 2011-2023
Table 8.1 POC PT/INR Testing Market ($m) by Companies, 2011
Table 8.2 Roche: Key Facts, 2013
Table 8.3 Roche: Revenue ($bn) and Revenue Shares (%) by Sector, 2011
Table 8.4 Roche Diagnostics: Revenue ($bn) and Revenue Shares (%), by Region, 2011
Table 8.5 Roche Diagnostics: Revenue ($bn) and Revenue Shares (%) by Sector, 2011
Table 8.6 Abbott: Key Facts, 2013
Table 8.7 Abbott: Net Sales ($bn) & Net Sales Shares (%), By Business Segment, 2011
Table 8.8 Abbott: Net Sales ($bn) and Net Sales Shares (%), by Geographical Region, 2011
Table 8.9 Abbott Diagnostics: Net Sales ($bn) and Net Sales Shares by Sub-Segment, 2011
Table 8.10 Abbott: Diagnostics Net Sales ($bn), 2009-2011
Table 9.1 List of Some POC Coagulation Tests Under Development, 2011
Table 10.1 SWOT Analysis of the POC Coagulation Testing Market
List of Figures
Figure 3.1 Market Shares (%) of Leading Segments in the POC Diagnostics Market, 2011
Figure 3.2 Market Share (%) of Self Testing & Professional Testing in the POC Market, 2011
Figure 3.3 World POC Diagnostics Market Forecast ($bn), 2011-2017
Figure 3.4 World POC Diagnostics Market Forecast ($bn), 2017-2023
Figure 4.1 Market Share (%) of POC Coagulation Testing Market by Type of Marker, 2011
Figure 4.2 Market Share (%) of Roche in the POC Coagulation Testing Market, 2011
Figure 4.3 The POC Coagulation Testing Market Forecast ($bn), 2011-2017
Figure 4.4 The POC Coagulation Testing Market Forecast ($bn), 2017-2023
Figure 5.1 Market Share (%) of the PT/INR POC Testing Market by Point of Use, 2011
Figure 5.2 Market Share (%) of Meters and Strips in the PT/INR POC Testing Market, 2011
Figure 5.3 The PT/INR Testing Market Forecast ($m), 2011-2017
Figure 5.4 The PT/INR Testing Market Forecast ($m), 2017-2023
Figure 6.1 Anticoagulant Drugs: Market Sector Shares (%), 2011
Figure 6.2 Anticoagulant Drugs: Overall Sector Forecast ($m), 2011-2023
Figure 6.3 Anticoagulant Drugs: Market Sector Shares (%), 2023
Figure 6.4 Vitamin K Antagonists: Market Sector Forecast ($m), 2011-2023
Figure 7.1 Regional Market Share (%) of the PT/INR POC Testing Market, 2011
Figure 7.2 The US PT/INR Testing Market Forecast ($m), 2011-2023
Figure 7.3 The European PT/INR Testing Market Forecast ($m), 2011-2023
Figure 7.4 Rest of the World PT/INR Testing Market Forecast ($m), 2011-2023
Figure 8.1 Sales ($m) of Leading Companies in the POC PT/INR Testing Market, 2011
Figure 8.2 Market Share (%) of Leading Companies in the POC PT/INR Testing Market, 2011
Figure 8.3 Roche: Revenues ($bn) by Sector, 2011
Figure 8.4 Roche: Revenue Shares (%) by Industry Area, 2011
Figure 8.5 Roche Diagnostics: Revenue Shares (%) by Region, 2011
Figure 8.6 Roche Diagnostics: Revenues ($bn) by Sector, 2011
Figure 8.7 Roche Diagnostics: Revenue Share (%) by Sector, 2011
Figure 8.8 Abbott: Net Sales ($bn) By Business Segment, 2011
Figure 8.9 Abbott: Net Sales Shares (%), By Business Segment, 2011
Figure 8.10 Abbott Historical Performance: Net Sales ($bn), Net Income ($bn), Profit Margin
(%), 2007-2011
Figure 8.11 Abbott: Net Sales ($bn) by Region, 2011
Figure 8.12 Abbott: Net Sales Shares (%) by Region, 2011
Figure 8.13 Abbott Diagnostics: Net Sales ($bn) by Sub-Segment, 2011
Figure 8.14 Abbott Diagnostics: Net Sales Shares (%) by Sub-Segment, 2011
Figure 8.15 Abbott Diagnostics: Historical Margin (%) Improvement, 2007-2011
Companies Listed
Abbott
AbbVie
Alere
AntiCoagulation Europe
AntiCoagulation Self-Monitoring Alliance (ACSMA)
Atrial Fibrillation Association
Barr Pharmaceuticals
Bayer
Baylor College of Medicine [US]
Bio-AMD
Boehringer Ingelheim
Centers for Device and Radiological Health (CDRH) [US]
Centers for Disease Control and Prevention (CDC) [US]
Centers for Medicare & Medicaid Services (CMS) [US]
Children's Heart Federation
Chugai Pharmaceuticals
CoaguSense
College of American Pathologists
EIDIA
Eisai
Entegrion
European Commission
European Diagnostics Manufacturers Association (EDMA)
Food and Drug Administration (FDA) [US]
Genentech
GlaxoSmithKline
Helena Laboratories
Ibis Biosciences
Instrumentation Laboratory
International Self-Monitoring Association of Oral Anticoagulated Patients (ISMAAP)
International Technidyne Corporation
La Federación Española de Asociaciones de Anticoagulados (FEASAN)
Mechanical Heart Valve Support Group
Medtronic
Merck
Ministry of Health, Labor and Welfare (MHLW) [Japan]
Mount Sinai School of Medicine
National Health Service (NHS) [UK]
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Portola Pharmaceuticals
QuickMedical
Roche
Siemens
STARLIMS Technologies
Suyog Diagnostics
Teva
Thermo Cardiosystems
Thermo Electron Corporation
Thoratec Corporation
Transasia Bio-Medicals
Universal Biosensor (UBI)
US Department of Defense (DoD)
Ventana
Warburg Pincus
Werfen Group
World Health Organization (WHO)
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Point of Care Coagulation Testing: World Market 2013-2023
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Sarah Smith
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Sarah Smith, Research Advisor at Reportbuyer.com, +44 208 816 85 48, [email protected]
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