1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 8
2 Introduction 10
2.1 What Is This Report About? 10
3 Definitions of Markets Covered in the Report 11
3.1 Diabetes Care Devices 11
3.2 Glucose Monitoring Devices 11
3.2.1 Blood Glucose Meters 11
3.2.2 Blood Glucose Strips 11
3.3 Insulin Delivery 11
3.3.1 Insulin Pens 11
3.3.2 Insulin Syringes 12
3.3.3 Insulin Pumps 12
3.3.4 Traditional Insulin Pump Accessories 12
4 Healthcare Sector Review 13
4.1 Healthcare Expenditure 13
4.2 Healthcare Infrastructure 14
4.3 Healthcare Policy 18
5 Regulation System 20
5.1 Medical Equipment Approval Process 20
5.1.1 Classification of medical devices 20
5.1.2 Conformity Assessment Process 29
5.2 Post Market Surveillance (PMS) 32
6 Pricing and Reimbursement 33
6.1 Pricing and Reimbursement Policies 33
7 Distribution Structure 34
8 Diabetes Care Devices In Spain 35
8.1 Diabetes Care Devices, Cross Country Comparison, Revenue ($ mn), 2000-2015 35
8.2 Diabetes Care Devices, Spain, Overall Revenue ($ mn), 2000-2015 36
8.3 Diabetes Care Devices, Spain, Category Volume (Units), 2000-2015 40
8.4 Diabetes Care Devices, Spain, Company Share (2007-2008) 43
9 Glucose Monitoring In Spain 44
9.1 Glucose Monitoring Overall Revenue (2000-2015) 44
9.1.1 Blood Glucose Meters Overall Revenue (2000-2015) 46
9.2 Glucose Monitoring Overall Volume (2000-2015) 48
9.2.1 Blood Glucose Meters Overall Volume (2000-2015) 50
9.3 Glucose Monitoring Average Price (2000-2015) 51
9.4 Glucose Monitoring Distribution Share (2007-2008) 52
9.5 Glucose Monitoring, Spain, Company Share (2007-2008) 53
10 Insulin Delivery In Spain 54
10.1 Insulin Delivery Overall Revenue (2000-2015) 54
10.1.1 Insulin Pens Overall Revenue (2000-2015) 56
10.2 Insulin Delivery Overall Volume (2000-2015) 58
10.2.1 Insulin Pens Overall Volume (2000-2015) 59
10.3 Insulin Delivery Average Price (2000-2015) 61
10.4 Insulin Delivery Distribution Share (2007-2008) 62
10.5 Insulin Delivery, Spain, Company Share (2007-2008) 63
11 Overview of Key Companies in Spain Diabetes Care Devices Market 64
11.1 F. Hoffmann-La Roche Ltd. 64
11.1.1 Company Overview 64
11.1.2 Value Chain Analysis 65
11.1.3 F. Hoffmann-La Roche Ltd Pipeline Products 67
11.2 Bayer HealthCare AG 68
11.2.1 Company Overview 68
11.2.2 Value Chain Analysis 69
11.2.3 Bayer HealthCare AG Pipeline Products 71
11.3 Abbott Laboratories 72
11.3.1 Company Overview 72
11.3.2 Value Chain Analysis 73
11.3.3 Abbott Laboratories Pipeline Products 75
11.4 Becton, Dickinson and Company 77
11.4.1 Company Overview 77
11.4.2 Value Chain Analysis 77
11.5 Novo Nordisk A/S 79
11.5.1 Company Overview 79
11.5.2 Novo Nordisk A/S Pipeline Products 79
11.6 Medtronic, Inc. 81
11.6.1 Company Overview 81
11.6.2 Value Chain Analysis 82
11.6.3 Medtronic, Inc. Pipeline Products 84
11.7 Eli Lilly and Company 92
11.7.1 Company Overview 92
11.7.2 Value Chain Analysis 92
11.7.3 Eli Lilly and Company Pipeline Products 95
11.8 LifeScan, Inc. 96
11.8.1 Company Overview 96
11.8.2 LifeScan, Inc. Pipeline Products 96
11.9 ARKRAY, Inc. 98
11.9.1 Company Overview 98
11.9.2 ARKRAY, Inc. Pipeline Products 98
11.10 Terumo Corporation 100
11.10.1 Company Overview 100
11.10.2 Value Chain Analysis 100
11.11 Animas Corporation 103
11.11.1 Company Overview 103
11.12 Sanofi-Aventis 103
11.12.1 Company Overview 103
11.13 Smiths Medical 104
11.13.1 Company Overview 104
11.13.2 Value Chain Analysis 105
12 Appendix 107
12.1 Global Markets Direct Research Methodology 107
12.2 Coverage 108
12.3 Secondary Research 108
12.4 Primary Research 109
12.5 Models 109
12.6 Forecasts 110
12.7 Expert Panel Validation 110
12.8 Currency Conversion 111
12.9 Contact Us 112
12.10 Disclaimer 112
1.1 List of Tables
Table 1: Number of Doctors by Specialty in Spain, 2003-2007 15
Table 2: Number of Hospital Wards by Specialty in Spain, 2003-2007 16
Table 3: Healthcare Institutions in Spain, 2007 17
Table 4: Hospital Beds by Type in Spain, 2007 17
Table 5: Number of Healthcare Personnel in Spain, 2007 18
Table 6: Number of Selected Medical Equipment in Spain, 2007 18
Table 7: Diabetes Care Devices, Cross Country Comparison, Revenue ($ mn), 2000-2015 35
Table 8: Diabetes Care Devices, Spain, Overall Revenue ($ mn), 2000-2015 36
Table 9: Diabetes Care Devices, Spain, Cross-Category Analysis, 2000-2015 37
Table 10: Diabetes Care Devices, Spain, Overall Revenue ($ mn), Historic, 2000-2008 38
Table 11: Diabetes Care Devices, Spain, Overall Revenue ($ mn), Forecast, 2008-2015 39
Table 12: Diabetes Care Devices, Spain, Category Volume (Units), 2000-2015 40
Table 13: Diabetes Care Devices, Spain, Category Volume (Units), Historic, 2000-2008 41
Table 14: Diabetes Care Devices, Spain, Category Volume (Units), Forecast, 2008-2015 42
Table 15: Diabetes Care Devices, Spain, Company Share by Revenue ($ mn), 2007-2008 43
Table 16: Glucose Monitoring, Spain, Revenue ($ mn) by Segment, Historic, 2000-2008 44
Table 17: Glucose Monitoring, Spain, Revenue ($ mn) by Segment, Forecast, 2008-2015 45
Table 18: Blood Glucose Meters, Spain, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 46
Table 19: Blood Glucose Meters, Spain, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 47
Table 20: Glucose Monitoring, Spain, Volume (Units) by Segment, Historic, 2000-2008 48
Table 21: Glucose Monitoring, Spain, Volume (Units) by Segment, Forecast, 2008-2015 49
Table 22: Blood Glucose Meters, Spain, Volume (Units) by Sub-Segment, Historic, 2000-2008 50
Table 23: Blood Glucose Meters, Spain, Volume (Units) by Sub-Segment, Forecast, 2008-2015 50
Table 24: Glucose Monitoring, Spain, Average Price ($), Historic, 2000-2008 51
Table 25: Glucose Monitoring, Spain, Average Price ($), Forecast, 2008-2015 51
Table 26: Glucose Monitoring, Spain, Distribution Share by Revenue ($mn), 2007-2008 52
Table 27: Glucose Monitoring, Spain, Company Share by Revenue ($ mn), 2007-2008 53
Table 28: Insulin Delivery, Spain, Revenue ($ mn) by Segment, Historic, 2000-2008 54
Table 29: Insulin Delivery, Spain, Revenue ($ mn) by Segment, Forecast, 2008-2015 55
Table 30: Insulin Pens, Spain, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 56
Table 31: Insulin Pens, Spain, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 57
Table 32: Insulin Delivery, Spain, Volume (Units) by Segment, Historic, 2000-2008 58
Table 33: Insulin Delivery, Spain, Volume (Units) by Segment, Forecast, 2008-2015 58
Table 34: Insulin Pens, Spain, Volume (Units) by Sub-Segment, Historic, 2000-2008 59
Table 35: Insulin Pens, Spain, Volume (Units) by Sub-Segment, Forecast, 2008-2015 60
Table 36: Insulin Delivery, Spain, Average Price ($), Historic, 2000-2008 61
Table 37: Insulin Delivery, Spain, Average Price ($), Forecast, 2008-2015 61
Table 38: Insulin Delivery, Spain, Distribution Share by Revenue ($mn), 2007-2008 62
Table 39: Insulin Delivery, Spain, Company Share by Revenue ($ mn), 2007-2008 63
Table 40: F. Hoffmann-La Roche Ltd Pipeline Products by Equipment Type 67
Table 41: F. Hoffmann-La Roche Ltd Pipeline Products by Development Stage 67
Table 42: F. Hoffmann-La Roche Ltd Pipeline Products by Therapy Area 67
Table 43: Bayer HealthCare AG Pipeline Products by Equipment Type 71
Table 44: Bayer HealthCare AG Pipeline Products by Development Stage 71
Table 45: Bayer HealthCare AG Pipeline Products by Therapy Area 71
Table 46: Bayer HealthCare AG Pipeline Products by News Summary 71
Table 47: Abbott Laboratories Pipeline Products by Equipment Type 75
Table 48: Abbott Laboratories Pipeline Products by Development Stage 75
Table 49: Abbott Laboratories Pipeline Products by Therapy Area 75
Table 50: Abbott Laboratories Pipeline Products by Clinical Trials 76
Table 51: Abbott Laboratories Pipeline Products by News Summary 76
Table 52: Novo Nordisk A/S Pipeline Products by Equipment Type 79
Table 53: Novo Nordisk A/S Pipeline Products By Development Stage 79
Table 54: Novo Nordisk A/S Pipeline Products By Therapy Area 80
Table 55: Novo Nordisk A/S Pipeline Products By Clinical Trials 80
Table 56: Medtronic, Inc. Pipeline Products by Equipment Type 84
Table 57: Medtronic, Inc. Pipeline Products By Development Stage 86
Table 58: Medtronic, Inc. Pipeline Products By Therapy Area 88
Table 59: Medtronic, Inc. Pipeline Products By Clinical Trials 90
Table 60: Medtronic, Inc. Pipeline Products By News Summary 91
Table 61: Eli Lilly and Company Pipeline Products by Equipment Type 95
Table 62: Eli Lilly and Company Pipeline Products by Development Stage 95
Table 63: Eli Lilly and Company Pipeline Products by Therapy Area 95
Table 64: Eli Lilly and Company Pipeline Products by Clinical Trials 95
Table 65: Eli Lilly and Company Pipeline Products by News Summary 95
Table 66: LifeScan, Inc. Pipeline Products by Equipment Type 96
Table 67: LifeScan, Inc. Pipeline Products by Development Stage 96
Table 68: LifeScan, Inc. Pipeline Products by Therapy Area 96
Table 69: LifeScan, Inc. Pipeline Products by Clinical Trials 97
Table 70: LifeScan, Inc. Pipeline Products by News Summary 97
Table 71: ARKRAY, Inc. Pipeline Products by Equipment Type 98
Table 72: ARKRAY, Inc. Pipeline Products by Development Stage 98
Table 73: ARKRAY, Inc. Pipeline Products by Clinical Trials 98
Table 74: ARKRAY, Inc. Pipeline Products by News Summary 99
Table 75: USD to Local Currency, Average Exchange Rate 2008 111
1.2 List of Figures
Figure 1: Total Healthcare Expenditure in Spain, 2000 – 2006 14
Figure 2: Flowchart for Classification of Non-invasive Devices in Spain, 2007 21
Figure 3: Flowchart for Classification of Invasive Devices in Spain, 2007 22
Figure 4: Flowchart for Classification of Invasive Devices in Spain, 2007 23
Figure 5: Flowchart for Classification of Invasive Devices in Spain, 2007 24
Figure 6: Flowchart for Classification of Invasive Devices in Spain, 2007 25
Figure 7: Flowchart for Classification of Active Devices in Spain, 2007 26
Figure 8: Flowchart for Classification of Active Devices in Spain, 2007 27
Figure 9: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in Spain, 2007 28
Figure 10: Conformity Assessment of Class-I Medical Devices in Spain, 2007 29
Figure 11: Conformity Assessment of Class-IIa Medical Devices in Spain, 2007 30
Figure 12: Conformity Assessment of Class-IIb Medical Devices in Spain, 2007 31
Figure 13: Conformity Assessment of Class-III Medical Devices in Spain, 2007 32
Figure 14: Diabetes Care Devices, Cross Country Comparison, Revenue ($ mn), 2000-2015 35
Figure 15: Diabetes Care Devices, Spain, Overall Revenue ($ mn), 2000-2015 36
Figure 16: Diabetes Care Devices, Spain, Cross-Category Analysis, 2000-2015 37
Figure 17: Diabetes Care Devices, Spain, Overall Revenue ($ mn), Historic, 2000-2008 38
Figure 18: Diabetes Care Devices, Spain, Overall Revenue ($ mn), Forecast, 2008-2015 39
Figure 19: Diabetes Care Devices, Spain, Category Volume (Units), 2000-2015 40
Figure 20: Diabetes Care Devices, Spain, Category Volume (Units), Historic, 2000-2008 41
Figure 21: Diabetes Care Devices, Spain, Category Volume (Units), Forecast, 2008-2015 42
Figure 22: Diabetes Care Devices, Spain, Company Share (%), 2008 43
Figure 23: Glucose Monitoring, Spain, Revenue ($ mn) by Segment, Historic, 2000-2008 44
Figure 24: Glucose Monitoring, Spain, Revenue ($ mn) by Segment, Forecast, 2008-2015 45
Figure 25: Blood Glucose Meters, Spain, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 46
Figure 26: Blood Glucose Meters, Spain, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 47
Figure 27: Glucose Monitoring, Spain, Volume (Units) by Segment, Historic, 2000-2008 48
Figure 28: Glucose Monitoring, Spain, Volume (Units) by Segment, Forecast, 2008-2015 49
Figure 29: Glucose Monitoring, Spain, Company Share (%), 2008 53
Figure 30: Insulin Delivery, Spain, Revenue ($ mn) by Segment, Historic, 2000-2008 54
Figure 31: Insulin Delivery, Spain, Revenue ($ mn) by Segment, Forecast, 2008-2015 55
Figure 32: Insulin Pens, Spain, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 56
Figure 33: Insulin Pens, Spain, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 57
Figure 34: Insulin Pens, Spain, Volume (Units) by Sub-Segment, Historic, 2000-2008 59
Figure 35: Insulin Pens, Spain, Volume (Units) by Sub-Segment, Forecast, 2008-2015 60
Figure 36: Insulin Delivery, Spain, Company Share (%), 2008 63
Figure 37: F. Hoffmann-La Roche Ltd Value Chain Analysis 65
Figure 38: Bayer HealthCare AG Value Chain Analysis 69
Figure 39: Abbott Laboratories Value Chain Analysis 73
Figure 40: Becton, Dickinson and Company Value Chain Analysis 77
Figure 41: Medtronic, Inc. Value Chain Analysis 82
Figure 42: Eli Lilly and Company Value Chain Analysis 92
Figure 43: Terumo Corporation Value Chain Analysis 100
Figure 44: Smiths Medical Value Chain Analysis 105
Figure 45: Global Markets Direct Methodology 107