Aarkstore Enterprise - Positron Emission Tomography (PET) Markets

FOR IMMEDIATE RELEASE
(Free-Press-Release.com) November 4, 2011 -- Positron Emission Tomography (PET) Markets
http://www.aarkstore.com/reports/Positron-Emission-Tomography-PET-Markets-1338.html

The medical imaging segments are poised for a major new phase of growth fueled by the availability of new technology coming out of the computer and digital information technology segment. Continuous improvements in technology are resulting in a growing number of new imaging tests that combine high levels of accuracy with rapid, easy-to-use product formats. Part of that medical imaging improvement is coming from positron emission tomography (PET). PET is a scanning technique used in combination with small amounts of radio-labeled compounds to visualize the anatomy and function of the brain. The purpose of this Publications report is to describe the specific market segment of the diagnostics medical imaging market called PET scanning. This sector includes all of the generally accepted imaging activities that are currently used in PET, including equipment for PET, PET/CT, SPECT and the use of radiopharmaceuticals for imaging. It examines these clinical measurement devices and their reagents and supplies as used in hospitals and clinics. It also reviews associated clinical market segments in which PET scanning has taken a prominent role including cancer treatment, cardiology and neurology imaging markets.

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 9

2. Overview of Diagnostic Point of Care Testing 11
2.1 Key Issues in the Point of Care Diagnostic Testing Sector 11
2.1.1 Current Market Trends and Drivers 11
2.1.2 Effectiveness of POCT 12
2.1.3 New Growth Areas for POCT 13
2.1.4 Advantages of POCT in a Clinical Setting 13
2.1.5 Pricing and Reimbursement Issues 13
2.1.6 Key Customer Segments 13

2.2 Global Point of Care Marketplace 13
2.3 Shifts from Central-Lab Testing to POCT 15
2.4 Geographical Distribution 15
2.5 Emerging New Technologies 16
2.6 Challenges of POCT 17
2.7 Key Issues for POCT 17
2.7.1 Locations of POCT 17
2.7.2 Hospital Lab Rapid Tests 18
2.7.3 Doctor’s Office Laboratory 18
2.7.4 Non-Hospital POCT 18
2.7.5 Home Monitoring 19
2.7.6 Milestones in Technology Development 20
2.7.7 Drive for Decentralization from Lab to Patient 20
2.7.8 Expanded Reimbursement 20
2.7.9 Competitive Landscape for POCT 23
2.8 The Future of POCT 23

3. POC and Rapid Testing: Market Analysis: Size, Background, Growth, Share and Competitors 24
3.1 Global POCT Market 26
3.2. U.S. Point of Care Markets 27
3.3. European POCT Market 32
3.4. Japanese POCT Market 35

4. The Place of POCT in Critical Care 36
4.1 Technological Diversity in POCT 36
4.1.1 The Wide Range of Point of Care Assays 36
4.1.2 Challenge of Testing on a Single Platform 39
4.1.3 Connectivity with Testing Platforms 40
4.1.4 Improvement in Clinical Outcomes with Use of POCT 42
4.1.5 Future Developments 42

4.2 Point of Care Addresses Critical Requirements 43
4.2.1 Needs in Critical-Care Testing 43
4.2.2 Point of Care Instrument Key Elements 44
4.2.3 Key Advancements—Menu, Quality Assurance (QA), Connectivity, Internet Access 44
4.2.4 Standardized System for All Testing Locations 45
4.3 POCT Versus Central-Laboratory Testing 47
4.3.1 The Financial Advantages of POCT 47
4.3.2 Is the Shift Towards Point of Care Justified? 47
4.3.3 Overall Cost Benefit 48
4.3.4 More Available Time for Clinical Practitioners 49
4.3.5 Future Policies 49

5. POCT Sector Trends and Forecasts 50

6. Business Trends in the Point of Care Sector 52
6.1 Sector Consolidation 52
6.2 Acquisition, License Agreements, Internal Development and Partnerships 53
6.3 Product Breadth in POCT 54
6.4 Companies Exiting from POCT 54
6.5 Increased Market Penetration 55
6.6 Costs of Doing Business in Europe 56
6.7 Drivers of European Diagnostics Testing 56
6.8 European Reimbursement Practices 56
6.9 Cost Containment in Europe 56
6.10 Significant Factors that Provide Competitive Advantage 57
6.11 Sales and Marketing Strategies for POCT 57
6.11.1 North American Market 57

6.11.2 International Markets 58
6.11.2.1 Europe 59
6.11.2.2 Central and South America 59
6.11.2.3 Asia/Pacific 59

7. Biotechnology Industry Trends 61
7.1 Pharmaceutical Industry Trends 61
7.2 Acquisition, License Agreement and Partnerships 62

8. Government Regulation 65
8.1 Government Regulation 65
8.1.1 U.S. Regulation 65
8.1.1.1 Importing Medical Devices into the U.S. 66
8.1.1.2 Exporting Medical Devices from the U.S. 67
8.1.2 U.K. Regulations 68
8.1.3 E.U. Regulations 69
8.1.4 Japanese Regulations 71
8.1.5 Korean Regulations 71

8.2 Post-Filing Regulations for Point of Care Devices 72
8.3 Exporting Unapproved POCTs 73
8.4 Analyte Specific Reagents (Home-Brew Tests) 73
8.5 Medical Device Registration 73
8.6 Product Labeling 74
8.7 Punitive FDA Actions 74
8.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws 74
8.9 Impact of Regulations on the Industry 75
8.10 Minimizing Regulatory Barriers 76

9. Limited Reimbursements by Third-Party Payers Obstruct Sales 79
9.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales 79
9.2 Reimbursement Codes Classification 79

9.3 Point of Care Product Line Reimbursement Picture 80

10. Barriers to Business 81
10.1 Concentration of Customers 81
10.2 Intense Competition from Other Companies 81
10.3 Protection of Intellectual Property Rights 81
10.4 Physician Acceptance 82
10.5 Current Levels of Growth in the Market for Point of Care Diagnostic Testing Procedures May Not be Indicative of Future Growth 82
10.6 Additional Applications of Technology Platform 83
10.7 Management of Growth 83
10.8 Difficulty of Establishing a Marketing Infrastructure 83

11. Acquisition Activity 84

11.1 The Ideal Acquisition Profile 84
11.2 Markets of Interest for Acquisition of POCT 84
11.3 Key M&A Steps 84

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