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Point of Care Diagnostic Testing World Markets

  • April 2016
  • -
  • TriMark Publications
  • -
  • 449 pages

Point of care testing (POCT) enables rapid diagnostic tests to be performed while the patient is at the point of care facility where results can be obtained immediately, rather than waiting hours or even days for outside lab results to arrive. Point of care testing covers: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening. This TriMark Publications report describes latest developments in the point of care testing market segment. It examines clinical instruments, devices and reagents and supplies as utilized in near-patient environments like hospital emergency rooms, critical care units, clinics and doctor's offices. The study defines the dollar volume of point of care sales and makes five year projections--both in the U.S. and worldwide--including Europe, Asia and Latin America. It also examines in detail the point of care sector for 25 individual country markets. A detailed summary of all important instruments in each clinical market is provided with emphasis on newly introduced products. Moreover, parallel areas where rapid detection is important using hand-held devices such as rapid detection of food pathogens and infectious diseases (MRSA, herpes simplex, avian flu, West Nile virus and typhoid) are discussed. Growth moderators and developing trends in point of care applications, as well as technology platform innovations and connectivity questions are examined in detail. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the point of care market in the U.S. and worldwide. Each company is discussed in depth, with a section on its history, product lines, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market data are also included.

Table Of Contents

Point of Care Diagnostic Testing World Markets










TABLE OF CONTENTS



1. Overview 6

1.1 Statement of Report 6

1.2 Scope of the Report 8

1.3 Objectives 8

1.4 Methodology 8

1.5 Executive Summary 10



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 18

2.7.6 Milestones in Technology Development 19

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 27

3.2 U.S. Point of Care Markets 28

3.3 European POCT Market 33

3.4 Japanese POCT Market 36



4. The Place of POCT in Critical Care 37

4.1 Technological Diversity in POCT 37

4.1.1 The Wide Range of Point of Care Assays 37

4.1.2 Challenge of Testing on a Single Platform 39

4.1.3 Connectivity with Testing Platforms 41

4.1.4 Improvement in Clinical Outcomes with Use of POCT 43

4.1.5 Future Developments 43

4.2 Point of Care Addresses Critical Requirements 44

4.2.1 Needs in Critical Care Testing 44

4.2.2 Point of Care Instrument Key Elements 45

4.2.3 Key Advancements-Menu, Quality Assurance (QA), Connectivity, Internet
Access 45

4.2.4 Standardized System for All Testing Locations 46

4.3 POCT versus Central Laboratory Testing 48

4.3.1 The Financial Advantages of POCT 48

4.3.2 Is the Shift Towards Point of Care Justified? 48

4.3.3 Overall Cost Benefit 48

4.3.4 More Available Time for Clinical Practitioners 49

4.3.5 Future Policies 50



5. POCT Sector Trends and Forecasts 51



6. Business Trends in the Point of Care Sector 53

6.1 Sector Consolidation 53

6.2 Acquisition, License Agreements, Internal Development and Partnerships 54

6.3 Product Breadth in POCT 56

6.4 Companies Exiting From POCT 56

6.5 Increased Market Penetration 56

6.6 Costs of Doing Business in Europe 57

6.7 Drivers of European Diagnostics Testing 57

6.8 European Reimbursement Practices 58

6.9 Cost Containment in Europe 58

6.10 Significant Factors That Provide Competitive Advantage 58

6.11 Sales and Marketing Strategies for POCT 58

6.11.1 North American Market 59

6.11.2 International Markets 60

6.11.2.1 Europe 60

6.11.2.2 Central and South America 60

6.11.2.3 Asia/Pacific 61



7. Biotechnology Industry Trends 62

7.1 Pharmaceutical Industry Trends 62



8. Government Regulation 63

8.1 Government Regulation 63

8.1.1 U.S. Regulation 63

8.1.1.1 Importing Medical Devices into the U.S. 64

8.1.1.2 Exporting Medical Devices from the U.S. 65

8.1.2 U.K. Regulations 65

8.1.3 E.U. Regulations 67

8.1.4 Japanese Regulations 69

8.1.5 Korean Regulations 69

8.2 Post Filing Regulations for Point of Care Devices 70

8.3 Exporting Unapproved POCTs 71

8.4 Analyte Specific Reagents (Home Brew Tests) 71

8.5 Medical Device Registration 71

8.6 Product Labeling 72

8.7 Punitive FDA Actions 72

8.8 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws 72

8.9 Impact of Regulations on the Industry 73

8.10 Minimizing Regulatory Barriers 74

8.11 Waived Testing 76



9. Limited Reimbursements by Third-Party Payers Obstruct Sales 77

9.1 Third-Party Reimbursement Impact on POCT Reagents and Devices Sales 77

9.2 Reimbursement Codes Classification 77

9.3 Point of Care Product Line Reimbursement Picture 78



10. Barriers to Business 79

10.1 Concentration of Customers 79

10.2 Intense Competition from Other Companies 79

10.3 Protection of Intellectual Property Rights 79

10.4 Physician Acceptance 80

10.5 Current Levels of Market Growth for POCT Procedures May Not be Indicative
of Future Growth 80

10.6 Additional Applications of Technology Platform 80

10.7 Management of Growth 81

10.8 Difficulty of Establishing a Marketing Infrastructure 81



11. Acquisition Activity 82

11.1 The Ideal Acquisition Profile 82

11.2 Markets of Interest for Acquisition of POCT 82

11.3 Key MandA Steps 82



12. Company Profiles 83

12.1 Abaxis, Inc. 83

12.2 Abbott Diagnostics 85

12.3 Accumetrics, Inc. 87

12.4 Accurex Biomedical Pvt., Ltd. 88

12.5 Akers Bioscience (ABI) 88

12.6 Alfa Scientific Design, Inc. 89

12.7 Ambri, Ltd. 89

12.8 American Bio Medica Corp. 89

12.9 Ani Biotech 90

12.10 Apogent Technologies 91

12.11 Ark Therapeutics 91

12.12 ARKRAY 91

12.13 Atlas Genetics 92

12.14 Atonomics 92

12.15 Avox Systems 92

12.16 Axis-Shield 92

12.17 Bayer Corp. 93

12.18 Beacon Diagnostics 95

12.19 Beckman Coulter 95

12.20 Binax Corporation 100

12.21 Biomerica 100

12.22 bioMerieux Vitek, Inc. 100

12.23 BioScan Screening Systems, Inc. 100

12.24 Biosite Diagnostics 101

12.25 BioStar 101

12.26 British Biocell Holdings 101

12.27 Caliper Life Sciences 101

12.28 Calypte Biomedical 102

12.29 Cardiovascular Diagnostics 103

12.30 Chembio Diagnostics 103

12.31 Cholestech 104

12.32 CompuCyte Corporation 104

12.33 Cozart Bioscience 104

12.34 Cygnus Therapeutic Systems 104

12.35 Cytogen 104

12.36 Dade Behring 105

12.37 Daiichi Sankyo Group 105

12.38 Denka Seiken Co., Ltd. 105

12.39 Diagnostic Chemicals, Ltd. 105

12.40 EY Laboratories, Inc. 106

12.41 Enterix, Inc. 106

12.42 Focus Diagnostic, Inc. 106

12.43 GDS Technology 106

12.44 GenBio 107

12.45 Genzyme Diagnostics 107

12.46 Grant Life Sciences, Inc. 109

12.47 Gryphus Diagnostics, LLC 109

12.48 Guided Therapeutics, Inc 110

12.49 Helena Laboratories 111

12.50 Hema Diagnostic Systems 111

12.51 HemoCue, Inc. 112

12.52 Home Access Health Corp. 112

12.53 i-STAT Corporation 112

12.54 ImmunoScience, Inc. 113

12.55 Instrumentation Laboratory 114

12.56 International Medical Innovations 114

12.57 Inverness Medical Innovations 114

12.58 Johnson and Johnson 118

12.59 LifeAssays 120

12.60 LifePoint, Inc. 121

12.61 Lifestream Technologies 121

12.62 LXN Corp. (Inverness Medical Technologies) 121

12.63 Matritech 121

12.64 Medical Services International, Inc. 122

12.65 MediSense 122

12.66 Medisys 122

12.67 Medix Biochemica 122

12.68 MedMira Laboratories 123

12.69 Meretek Diagnostics Group 124

12.70 Meridian Bioscience 124

12.71 MiniMed 126

12.72 Mitsubishi Chemical USA, Inc. 127

12.73 Mitsubishi Kagaku Iatron 127

12.74 Nanogen 127

12.75 New Horizons Diagnostics 128

12.76 Nova Biomedical 129

12.77 OraSure 131

12.78 Orgenics 133

12.79 Orion Diagnostica 133

12.80 PanBio, Ltd. 134

12.81 Phamatech Corporation 134

12.82 PharmaNetics, Inc. 134

12.83 Phillips Medical Systems 134

12.84 Polymedco 135

12.85 Polymer Technology Systems 137

12.86 Princeton BioMeditech Corporation 137

12.87 Quest Diagnostics 137

12.88 Quidel 138

12.89 Radiometer 141

12.90 Response Biomedical Corp. 143

12.91 Roche Diagnostics 144

12.92 Royal Philips Electronics 147

12.93 StatSure Diagnostic Systems (Saliva Diagnostics) 148

12.94 Savyon Diagnostics 148

12.95 Selfcare, Inc. 149

12.96 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 149

12.97 Shionogi and Co., Ltd. 149

12.98 Siemens Corporation 150

12.99 Guided Therapeutics (SpectRx, Inc.) 150

12.100 Spectral Diagnostics 151

12.101 StatSure Diagnostics 151

12.102 Strategic Diagnostics 151

12.103 Sun Biomedical Laboratories 152

12.104 Thoratec/International Technidyne Corp. 152

12.105 Trinity Biotech, Plc 153

12.106 Vasamed, Inc. 155

12.107 Venkateshwara Hatcheries Pvt., Ltd. 156



13. FDA Currently Waived Tests 157





INDEX OF TABLES



Table 2.1: POCT Frequency in Hospitals 14

Table 2.2: Worldwide Distribution of IVD Testing in 2008 16

Table 2.3: Top Twelve Country IVD Testing Markets, 2007 16

Table 2.4: Competitive Landscape for Point of Care Diagnostic Testing 23

Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2008 24

Table 3.2: Number of POCTs in U.S., 2004-2012 25

Table 3.3: Overall In Vitro Diagnostic Testing Market Worldwide, 2007 26

Table 3.4: Largest Diagnostic Companies Worldwide, 2007 26

Table 3.5: Global Point of Care Revenues, 2005-2012 27

Table 3.6: Worldwide Distribution of POCT, 2008 27

Table 3.7: Professional Glucose Testing Market for POCT Worldwide, 2001-2012 28

Table 3.8: U.S. POCT Market, 2000-2012 28

Table 3.9: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location
of Analysis, 2008 29

Table 3.10: U.S. POCT by Performance Location, 2008 29

Table 3.11: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2007
30

Table 3.12: U.S. POCT Glucose Testing Market, 2003-2012 30

Table 3.13: U.S. POCT Blood Gas and Electrolytes Market Size, 2003-2012 30

Table 3.14: U.S. POCT Coagulation Market Size, 2003-2012 31

Table 3.15: U.S. POCT Cardiac Markers Market Size, 2003-2012 31

Table 3.16: U.S. POCT Dedicated Primary Care Markers Market Size, 2003-2012 31

Table 3.17: U.S. POCT Urinalysis Market Size, 2003-2012 32

Table 3.18: Manufacturer Market Share U.S. POCT Market, 2008 32

Table 3.19: Manufacturer Market Share U.S. POCT Market Glucose Testing, 2008 32

Table 3.20: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes
Market, 2008 33

Table 3.21: Manufacturer Market Share U.S. POCT Coagulation Market, 2008 33

Table 3.22: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2008 33

Table 3.23: Regional Comparison of Healthcare Spending for IVD for Eastern
Europe 34

Table 3.24: European POCT Market, 2005-2012 35

Table 3.25: European POCT Diagnostics Market, 2007 35

Table 3.26: Top Twelve Country IVD and POC Testing Markets, 2007 36

Table 3.27: Japan POCT Market, 2005-2012 36

Table 4.1: Customized Reports Must Support CAP and JCAHO Requirements 42

Table 12.1: Products Marketed by Abbott in the Diagnostic Market 86

Table 12.2: Quidel Product Sales Distribution and Sales, 2006-2008 139

Table 12.3: Key Products 146






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