A Market Opportunity Analysis for Point of Care Diagnostic Testing in European Countries

1. INTRODUCTION 7

1.1 Project Objectives 7

1.2 Geographic Scope 7

1.3 Methodology 8

1.4 Respondent Population 8

1.5 Definitions 10

Point of Care Tests 10

Glucose 10

Haemoglobin 11

Arterial blood gas & Electrolytes 11

Acid Base 12

Haemostasis 13

Homeostasis 13

Rapid Cardiac Tests 14

Drugs of Abuse 14

2. PROVISION OF HEALTH CARE 15

2.1 Switzerland 15

Primary Health Care 15

Secondary Health Care 15

2.2 Austria 16

Primary Health Care 16

Secondary Health Care 17

2.3 Italy 17

Primary Health Care 17

Secondary Health Care 17

2.4 Germany 19

Primary Health Care 19

Secondary Health Care 20

2.5 Benelux 20

Primary Health Care 20

Secondary Health Care 21

SECTION 1: POINT OF CARE TESTING

AMONGST END USERS

3 THE USE OF POINT OF CARE TESTS 23

3.1 Use of POC tests amongst GPs 23

Switzerland 24

Italy 25

Austria 26

Germany 27

Benelux 28

3.2 Use of POC tests in Hospitals 29

Switzerland 32

Italy 33

Austria 34

Germany 35

Benelux 35

Summary 37

3.3 Reasons to run Point of Care Tests 37

Switzerland 39

Italy 39

Austria 40

Germany 41

Benelux 41

Conclusion 42

3.4 Future Change in Point of Care Test Usage by End

User Prediction 43

Switzerland 43

Italy 44

Austria 46

Germany 47

Benelux 48

Conclusion 48

4. CENTRALIZATION OF HEALTH CARE SERVICES 50

Switzerland 50

Italy 50

Austria 50

Germany 50

Benelux 51

Conclusion 52

5. STORAGE OF POINT OF CARE TEST RESULTS & NEED FOR HOSPITAL SOFTWARE

Switzerland 54

Italy 55

Austria 55

Germany 56

Benelux 57

Conclusions: Healthcare IT 58

6. END USER PERCEPTION OF POC TESTS

6.1 Glucose 59

6.2 Haemoglobin 62

6.3 Arterial blood gas 62

6.4 Electrolytes 63

6.5 Haemostasis 63

6.6 Homeostasis 63

6.7 Rapid Cardiac Tests 63

6.8 Other Tests Used 64

6.9 Products in Development 65

6.10 Desired Products 66

Switzerland 66

Austria 66

Italy 66

Germany 67

Benelux 67

7. KEY FINDINGS AND CONCLUSIONS 68

SECTION II: MANUFACTURERS 69

8. MARKET PARTICIPANTS 70

8.1 Company Market Shares?by Product Type72

Glucose POCT 72

ABG/Electrolytes 73

Haemostasis POCT 74

Homeostasis POCT 75

Rapid Cardiac POCT 75

POCT IT Connectivity 76

8.2 Company Profiles 77

Abbott Laboratories 77

Bayer 77

Axis-Shield plc 78

Beckman Coulter 78

Dade Behring 79

Instrumentation Laboratory 79

A. Menarini Diagnostics 79

Radiometer 80

Roche 80

Others 80

9. MARKET SIZES FOR THE POINT OF CARE TEST MARKET 82

9.1 The Market Size by Country 83

Country totals in ? 83

Switzerland 86

Italy 87

Austria 89

Germany 91

Benelux 93

9.2 Market Size by POC Test 95

Glucose 95

Glucose Patient Self Tests 96

Urine test strips 97

Haemoglobin 97

Arterial blood gas (ABG) 98

Electrolytes 99

Acid-base 100

Haemostasis 102

Homeostasis 103

Rapid Cardiac Tests 103

Drugs of Abuse Testing 104

Infectious Diseases 105

Multiple, or Panel, Tests 106

Sample of New Products & Technologies 107

Connectivity Products 107

The E-Health Trend & Its Impact on IVD 108

IT Connectivity in the US 108

9.3 The European Union�fs IVD Directive 110

9.4 Will POC testing overcome laboratory testing 111

10. KEY MARKET PREDICTIONS EUROPE 112

11. RECOMMENDATIONS 113

11.1 Country Specific Business Recommendations113

Switzerland 113

Austria 114

Italy 114

Germany 115

Benelux 115

12. RECOMMENDATIONS FOR NEXT STEPS116

13. APPENDICES 118

13.1 Industry questionnaire 118

13.2 End User Questionnaire 122

13.3 Abbreviations 125

13.4 Selected contact numbers 126

13.5 Secondary sources of information 128