Aarkstore Enterprise-- Point Of Care Diagnostic Testing Sector Trendsmarket Research ...
Table of Contents :
Table of Contents :
1. Overview 6
1.1 Statement of Report 6
1.2 Scope of the Report 8
1.3 Objectives 9
1.4 Methodology 9
1.5 Executive Summary 10
2. Overview of Diagnostic Point of Care Testing 12
2.1 Key Issues in the Point of Care Diagnostic Testing Sector 12
2.1.1 Current Market Trends and Drivers 12
2.1.2 Effectiveness of POCT 13
2.1.3 New Growth Areas for POCT 14
2.1.4 Advantages of POCT in a Clinical Setting 14
2.1.5 Pricing and Reimbursement Issues 14
2.1.6 Key Customer Segments 14
2.2 Global Point of Care Marketplace 14
2.3 Shifts from Central Lab Testing to POCT 16
2.4 Geographical Distribution 16
2.5 Emerging New Technologies 17
2.6 Challenges of POCT 18
2.7 Key Issues for POCT 18
2.7.1 Locations of POCT 18
2.7.2 Hospital Lab Rapid Tests 19
2.7.3 Doctors Office Laboratory 19
2.7.4 Non-Hospital POCT 19
2.7.5 Home Monitoring 19
2.7.6 Milestones in Technology Development 20
2.7.7 Drive for Decentralization from Lab to Patient 21
2.7.8 Expanded Reimbursement 21
2.7.9 Competitive Landscape for POCT 24
2.8 The Future of POCT 24
3. POC and Rapid Testing: Market Analysis: Size, Background, Growth, Share and Competitors 25
3.1 Global POCT Market 28
3.2 U.S. Point of Care Markets 29
3.3 European POCT Market 34
3.4 Japanese POCT Market 37
4. The Place of POCT in Critical Care 38
4.1 Technological Diversity in POCT 38
4.1.1 The Wide Range of Point of Care Assays 38
4.1.2 Challenge of Testing on a Single Platform 40
4.1.3 Connectivity with Testing Platforms 42
4.1.4 Improvement in Clinical Outcomes With Use of POCT 44
4.1.5 Future Developments 44
4.2 Point of Care Addresses Critical Requirements 45
4.2.1 Needs in Critical Care Testing 45
4.2.2 Point of Care Instrument Key Elements 46
4.2.3 Key AdvancementsMenu, Quality Assurance (QA), Connectivity, Internet Access 46
4.2.4 Standardized System for All Testing Locations 48
4.3 POCT versus Central Laboratory Testing 49
4.3.1 The Financial Advantages of POCT 49
4.3.2 Is the Shift Towards Point of Care Justified? 49
4.3.3 Overall Cost Benefit 50
4.3.4 More Available Time for Clinical Practitioners 51
4.3.5 Future Policies 51
5. POCT Sector Trends and Forecasts 52
6. Business Trends in the Point of Care Sector 54
6.1 Sector Consolidation 54
6.2 Acquisition, License Agreements, Internal Development and Partnerships 55
6.3 Product Breadth in POCT 57
6.4 Companies Exiting From POCT 57
6.5 Increased Market Penetration 57
6.6 Costs of Doing Business in Europe 58
6.7 Drivers of European Diagnostics Testing 58
6.8 European Reimbursement Practices 59
6.9 Cost Containment in Europe 59
6.10 Significant Factors That Provide Competitive Advantage 59
6.11 Sales and Marketing Strategies for POCT 59
6.11.1 North American Market 60
6.11.2 International Markets 61
6.11.2.1 Europe 61
6.11.2.2 Central and South America 62
6.11.2.3 Asia/Pacific 62
7. Biotechnology Industry Trends 63
7.1 Pharmaceutical Industry Trends 63
8. Government Regulation 64
8.1 Regulatory Overview 64
8.1.1 U.S. Regulation 64
8.1.1.1 Importing Medical Devices Into The U.S. 65
8.1.1.2 Exporting Medical Devices from the U.S. 66
8.1.2 U.K. Regulations 67
8.1.3 E.U. Regulations 68
8.1.4 Japanese Regulations 70
8.1.5 Korean Regulations 70
8.2 Post Filing Regulations For Point of Care Devices 71
8.3 Exporting Unapproved POCTs 72
8.4 Analyte Specific Reagents (Home Brew Tests) 72
8.5 Medical Device Registration 72
8.6 Product Labeling 73
8.7 Punitive FDA Actions 73
8.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws 73
8.9 Impact of Regulations on the Industry 74
8.10 Minimizing Regulatory Barriers 75
8.11 Waived Testing 77
9. Limited Reimbursements by Third-Party Payers Obstruct Sales 78
9.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales 78
9.2 Reimbursement Codes Classification 78
9.3 Point of Care Product Line Reimbursement Picture 79
10. Barriers to Business 80
10.1 Concentration of Customers 80
10.2 Intense Competition From Other Companies 80
10.3 Protection of Intellectual Property Rights 80
10.4 Physician Acceptance 81
10.5 Current Levels of Market Growth for POCT Procedures May Not be Indicative of Future Growth 81
10.6 Additional Applications of Technology Platform 81
10.7 Management of Growth 82
10.8 Difficulty of Establishing a Marketing Infrastructure 82
11. Acquisition Activity 83
11.1 The Ideal Acquisition Profile 83
11.2 Markets of Interest For Acquisition of POCT 83
11.3 Key M&A Steps 83
For more information please contact :
http://www.aarkstore.com/reports/Point-of-Care-Diagnostic-Testing-Sector-Trends-1333.html
http://blogs.aarkstore.com/
From:Aarkstore Enterprise
Contact: Neel
Email: press@aarkstore.com
http://www.aarkstore.com
by: Aarkstore Enterprise
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