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

  • ID: 45568
  • Report
  • December 2003
  • Region: Europe
  • HBS Medical Limited
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The new report by examines the reality of point-of-care testing (POC) in European Hospitals and practices in 6 European countries and provides you with following information:

By Respondent:
- Private Practices
- Hospitals
- Industry Players

Subject of this report:

- Indication of the type and number of tests conducted by private practices & hospitals per country
- Market size in € by product segment
- Market shares by Product segment
- Market growth and forecasts by product segment and country
- Indication of data management/Software storage requirements in hospitals by country
- The future of data management software requirements in hospitals
- Opportunity analysis (also including healthcare politics)
- Trends regarding decentralized healthcare
services (policlinics, hospital outpatient)

By Country:
- Germany
- Austria
- Switzerland
- Italy
- BeNeLux
- UK

By Product:
- Glucose Testing
- Haemoglobin Testing
- Electrolyte Testing
- Acid – base metabolism
- Haemostasis
- Homeostasis
- Rapid Cardiac Testing
- Drugs of Abuse Screening

Product Value Proposition -

The study will allow the owner of the information to:
- Assess current market realities in terms of current POC test usage per country, divided by hospitals and GPs
- Position yourself in the dynamic segment of POC testing
- Identify geographic and product markets with the highest potential for sales
- Reflect the current situation not only at a specific point in time, but monitor trends over a period of time (both in terms of market participants as well as product types)
- Model market and own sales forecasts based on end-user assessments
- Reflect the expected behaviour of buyers, not just the expectations of sellers; but by the motivations of buyers.
- Understand Data Management and IT connectivity product requirements by End User
- Further Need of POC test products

The report can be disseminated to anyone in the organisation who is responsible for sales budget planning and will assist in more accurate planning, which is decisive for other budget allocation.

The use of POC tests is not very common amongst GPs in Germany. It appears that only glucose POC tests are used in all practices, while cardiac tests were mentioned only once. This may reflect the fact that GPs are seen as “family doctors” and generally consulted in case of more benign conditions, whereas patients are referred to specialists in case of serious disease.

“I think all practices run glucose, but all others are sent to a lab. I think this is representative of other GP offices in Germany.” GP

“We are not really interested in other tests, because we wouldn’t have the time to do the test. We’re very pleased with the test results of the laboratories.”, Nurse, GP Office

One reason that running glucose tests is so common is that the device is often given to the GP free of charge. The office may or may not have to pay for the test strips, depending upon any arrangements with the local pharmacy. Hence, the test is not only fast, easy to use and inexpensive, but it is also reimbursed by the patient’s health insurance. Even if the GP feels that a rapid test may not be that reliable, still it gives some indication of the blood glucose level, and it is very convenient for the patient to have the test performed quickly, right in the doctor’s office.

The doctor who mentioned using cardiac tests said, “We do Troponin-T tests (heart trouble tests) – twice a year –just test strips, only when a patient with suspected acute myocardial infarct comes in.”

Troponin T tests have been reimbursed in German practices with €11,66, but this will change with the introduction of the DRG system in 2004. Under the DRG system, reimbursement rates are based on the individual circumstances of a patient with a condition according to the diagnosis, and not on specific measures or services. Only the diagnosis will be reimbursed no matter what products, etc. are involved. It will be interesting to evaluate whether or not implementation of the DRG system will change patterns of diagnosis.

Storage of Point of Care Test Results & Need for Hospital Software

Benelux

Since GPs do not perform many POC tests they usually enter the results manually into their computer/practice management software. The situation within the hospitals is much more diverse than in other countries, because hospitals seem to have POC interfaces, although not necessarily in all departments. Three hospital respondents stated that they write the test results on paper; 1 of them lacked an EPR, but acknowledged that as soon as they have the EPR (within 4 years) they will need a POC interface. The second respondent said that they send the paper files to the central lab which has a LIS to incorporate the data into the EPR and was very frustrated about the overall situation. The third respondent said that they use paper for Glucose tests (written on paper chart -disadvantage of the Glucodevice) and software with a LIS interface which they have developed themselves for Blood Gas tests.

“[Computer] We’re implementing glucose POC in a structured way, not with
clandestine machines in departments. All data is entered via docking stations, into the patient’s file. The supplier of POC also offers the software, for example Abbott and Radiometer.” Hospital, Central Lab, Netherlands

“[Paper & computer) Yes!! An interface to the LIS! We have software for the arterial blood gas to connect to the LIS, but not for glucose. It’s a very bad situation, I am very frustrated.” Hospital Director of Lab

“[Paper] We don’t even have an EPR yet. We’ll have EPR in 4-5 years, then we will need POCT software.” Hospital, Director of A&E

“[Paper & computer] We’ve decided to implement the software. We’ll replace the
Glucodevice (Bayer) with a device suitable for use with a docking station, and use additional software. Right now, glucose is written on paper, and I’m sure that we don’t receive all of the results from all departments. Arterial blood gas uses software we developed, and results are stored directly into the LIS.” Hospital, Director of Lab, Netherlands

Market Size by POC Test

Glucose

Glucose monitoring products continue to comprise the largest segment by far of the POC testing market in Europe and worldwide. Diabetes is a chronic illness with invalidating long term complications in non controlled conditions. And POC tests accept clear benefits of a early detection and monitoring. Although glucose meters and test strips are manufactured by a large number of suppliers, the market is dominated by four major companies, including Roche Diagnostics; Bayer Diagnostics; Abbott Diagnostics and LifeScan - a unit of Johnson & Johnson. HBS Consulting forecast an average growth rate of 10%.

Glucose Patient Self Tests

The greying of the population, as well as the epidemic rise of obesity worldwide, are contributing to the burgeoning market for glucose monitors or self-testing devices, one of the fastest-growing segments in the world of in vitro diagnostics. There was a significant increase in the number of glucose self-testing devices shown at Medica ‘03. Here as well an interest exists in non-invasive glucose monitoring systems, such as MiniMed's (Sylmar, California) glucose monitoring system, Cygnus’s GlucoWatch G2® Biographer (Redwood City, California), and the GlukoMediTech AG (Witten, Germany) whose parent company is Sangui BioTech AG.

In February 2003, Sangui BioTech International Inc., in efforts to refocus, cut costs, speed up market entry and concentrate upon what it considers to be its most promising product, merged its two German subsidiary companies, GlucoMediTech AG and Sangui BioTech AG, became Sangui BioTech AG, and Sangui BioTech Inc. merged with the parent company Sangui BioTech International, Inc. In November 2003, the German subsidiary of Sangui BioTech International was registered in Germany as a GmbH, and is now Sangui BioTech GmbH, a limited liability company under German corporate law.

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1. INTRODUCTION

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 22

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 59

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’s 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
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