1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 8
1.2 List of Figures 10
2 Introduction 12
2.1 What Is This Report About? 12
3 Definitions of the March kets Covered in the Report 13
3.1 Patient monitoring 13
3.2 Wireless Ambulatory Telemetry Monitoring 13
3.2.1 Hospital Ambulatory 13
3.2.2 Cardiac rehabilitation 13
3.3 Multiparameter patient monitoring 13
3.3.1 Critical Care Monitors 13
3.3.2 Perioperative Care Monitors 13
3.4 Remote patient monitoring 14
3.5 Non-invasive Blood pressure monitors 14
3.5.1 Mercury sphygmomanometer 14
3.5.2 Aneroid sphygmomanometer 14
3.5.3 Automatic sphygmomanometer 14
3.6 Micro- electromechanical systems (MEMS) 14
4 Healthcare Segment Review 15
4.1 Healthcare Expenditure 15
4.2 Healthcare Infrastructure 16
4.3 Healthcare Policy 20
5 Regulation System 21
5.1 Medical Equipment Approval Process 21
5.1.1 Classification of medical devices 21
5.1.2 Conformity Assessment Process 30
5.1.2.1 Class I devices 30
5.1.2.2 Class IIa devices 31
5.1.2.3 Class IIb devices 32
5.2 Post March ket Surveillance (PMS) 33
6 Pricing and Reimbursement 34
6.1 Pricing and Reimbursement Policies 34
7 Distribution Structure 35
8 Patient Monitoring In Spain 36
8.1 Patient Monitoring Cross Country Comparison, Revenue ($ mn), from 2000 to 2015 36
8.2 Patient Monitoring, Spain, Overall Revenue ($ mn), from 2000 to 2015 37
8.3 Patient Monitoring, Spain, Overall Volume (Units), from 2000 to 2015 41
8.4 Patient Monitoring, Spain, Firms Share (2006-2007) 43
9 Micro-Electromechanical Systems In Spain 44
9.1 Micro-Electromechanical Systems Overall Revenue (from 2000 to 2015 ) 44
9.2 Micro-Electromechanical Systems Overall Volume (from 2000 to 2015 ) 46
9.3 Micro-Electromechanical Systems Average Price (from 2000 to 2015 ) 48
9.4 Micro-Electromechanical Systems Distribution Share (2007-2008) 48
9.5 Micro-Electromechanical Systems, Spain, Firms Share (2006-2007) 49
10 Multiparameter Patient Monitoring In Spain 50
10.1 Multiparameter Patient Monitoring Overall Revenue (from 2000 to 2015 ) 50
10.2 Multiparameter Patient Monitoring Overall Volume (from 2000 to 2015 ) 52
10.3 Multiparameter Patient Monitoring Average Price (from 2000 to 2015 ) 54
10.4 Multiparameter Patient Monitoring Distribution Share (2007-2008) 54
10.5 Multiparameter Patient Monitoring, Spain, Firms Share (2006-2007) 55
11 Non-Invasive Blood Pressure Monitors In Spain 56
11.1 Non-Invasive Blood Pressure Monitors Overall Revenue (from 2000 to 2015 ) 56
11.2 Non-Invasive Blood Pressure Monitors Average Price (from 2000 to 2015 ) 59
11.3 Non-Invasive Blood Pressure Monitors Distribution Share (2007-2008) 60
11.4 Non-Invasive Blood Pressure Monitors, Spain, Firms Share (2006-2007) 61
12 Remote Patient Monitoring In Spain 62
12.1 Remote Patient Monitoring Overall Revenue (from 2000 to 2015 ) 62
12.2 Remote Patient Monitoring Overall Volume (from 2000 to 2015 ) 64
12.3 Remote Patient Monitoring Average Price (from 2000 to 2015 ) 66
12.4 Remote Patient Monitoring Distribution Share (2007-2008) 66
12.5 Remote Patient Monitoring, Spain, Firms Share (2006-2007) 67
13 Wireless and Ambulatory Monitoring In Spain 68
13.1 Wireless and Ambulatory Monitoring Overall Revenue (from 2000 to 2015 ) 68
13.2 Wireless and Ambulatory Monitoring Overall Volume (from 2000 to 2015 ) 70
13.3 Wireless and Ambulatory Monitoring Average Price (from 2000 to 2015 ) 72
13.4 Wireless and Ambulatory Monitoring Distribution Share (2007-2008) 72
13.5 Wireless and Ambulatory Monitoring, Spain, Firms Share (2006-2007) 73
14 GE Healthcare Firms Profile 74
14.1 Corporate Presentation 74
15 Philips Healthcare Firms Profile 75
15.1 Corporate Presentation 75
15.2 Value Chain Analysis 76
15.2.1 Manufacturing 76
15.2.1.1 In House Manufacturing 76
15.2.1.2 Outsourcing 76
15.2.2 Product Development 77
15.2.2.1 Regulatory Approvals 77
15.2.2.2 Clinical Trials 77
15.2.2.3 Research and Development 77
15.2.3 Sales and March keting 77
15.2.3.1 Partnerships and Alliances 77
15.2.3.2 Licensing Agreements 78
15.2.3.3 E-distribution 78
16 OMRON HEALTHCARE Co., Ltd. Firms Profile 79
16.1 Corporate Presentation 79
16.2 OMRON HEALTHCARE Co., Ltd 79
16.2.1 OMRON HEALTHCARE Co., Ltd. Pipeline Products By Equipment Type 79
16.2.2 OMRON HEALTHCARE Co., Ltd. Pipeline Products by Development Stage 79
16.2.3 OMRON HEALTHCARE Co., Ltd. Pipeline Products By Therapy Area 80
16.2.4 OMRON HEALTHCARE Co., Ltd. Pipeline Products by News Summary 80
17 Draegerwerk Aktiengesellschaft Firms Profile 81
17.1 Corporate Presentation 81
17.2 Value Chain Analysis 81
17.2.1 Manufacturing 82
17.2.1.1 Outsourcing 82
17.2.1.2 In House Manufacturing 82
17.2.2 Product Development 82
17.2.2.1 Regulatory Approvals 82
17.2.2.2 Research and Development 82
17.2.3 Sales and March keting 82
17.2.3.1 Licensing Agreements 82
17.2.3.2 Partnerships and Alliances 82
17.3 Drager Medical AG & Co. KG Pipeline Products 83
17.3.1 Drager Medical AG & Co. KG Pipeline Products by Equipment Type 83
17.3.2 Drager Medical AG & Co. KG Pipeline Products by Development Stage 83
17.3.3 Drager Medical AG & Co. KG Pipeline Products by Therapy Area 83
18 Abbott Laboratories Firms Profile 84
18.1 Corporate Presentation 84
18.2 Value Chain Analysis 84
18.2.1 Manufacturing 85
18.2.1.1 In House Manufacturing 85
18.2.2 Product Development 85
18.2.2.1 Regulatory Approvals 85
18.2.2.2 Research and Development 85
18.2.2.3 Clinical Trials 85
18.2.3 Sales and March keting 86
18.2.3.1 Partnerships and Alliances 86
19 HARTMANN GROUP Firms Profile 87
19.1 Corporate Presentation 87
19.2 Value Chain Analysis 87
19.2.1 Manufacturing 88
19.2.1.1 Outsourcing 88
19.2.1.2 In House Manufacturing 88
19.2.2 Product Development 88
19.2.2.1 Regulatory Approvals 88
19.2.2.2 Research and Development 88
19.2.3 Sales and March keting 88
19.2.3.1 Partnerships and Alliances 88
20 Appendix 89
20.1 Global March kets Direct Research Methodology 89
20.2 Coverage 90
20.3 Secondary Research 90
20.4 Primary Research 91
20.5 Models 91
20.6 Projections 92
20.7 Expert Panels 92
20.8 Currency Conversion 93
20.9 Contact Us 94
20.10 Disclaimer 94
1.1 List of Tables
Table 1: Number of Doctors by Specialty in Spain, from 2003 to 2007 17
Table 2: Number of Hospital Wards by Specialty in Spain, from 2003 to 2007 18
Table 3: Healthcare Institutions in Spain, 2005 19
Table 4: Hospital Beds by Type in Spain, 2005 19
Table 5: Number of Healthcare Personnel in Spain, 2005 19
Table 6: Number of Medical Equipment in Spain, 2005 20
Table 7: Patient Monitoring Cross Country Comparison, Revenue ($ mn), from 2000 to 2015 36
Table 8: Patient Monitoring, Spain, Overall Revenue ($ mn), from 2000 to 2015 37
Table 9: Patient Monitoring, Spain, Portfolio Analysis, from 2000 to 2015 38
Table 10: Patient Monitoring, Spain, Overall Revenue ($ mn), Historic, from 2000 to 2008 39
Table 11: Patient Monitoring, Spain, Overall Revenue ($ mn), Projection , from 2008 to 2015 40
Table 12: Patient Monitoring, Spain, Overall Volume (Units), from 2000 to 2015 41
Table 13: Patient Monitoring, Spain, Overall Volume (Units), Historic, from 2000 to 2008 41
Table 14: Patient Monitoring, Spain, Overall Volume (Units), Projection , from 2008 to 2015 42
Table 15: Patient Monitoring, Spain, Firms Share by Revenue ($ mn), from 2006 to 2007 43
Table 16: Micro-Electromechanical Systems, Spain, Revenue ($ mn), Historic, from 2000 to 2008 44
Table 17: Micro-Electromechanical Systems, Spain, Revenue ($ mn), Projection , from 2008 to 2015 45
Table 18: Micro-Electromechanical Systems, Spain, Volume (Units), Historic, from 2000 to 2008 46
Table 19: Micro-Electromechanical Systems, Spain, Volume (Units), Projection , from 2008 to 2015 47
Table 20: Micro-Electromechanical Systems, Spain, Average Price ($), Historic, from 2000 to 2008 48
Table 21: Micro-Electromechanical Systems, Spain, Average Price ($), Projection , from 2008 to 2015 48
Table 22: Micro-Electromechanical Systems, Spain, Distribution Share by Revenue ($mn), from 2007 to 2008 48
Table 23: Micro-Electromechanical Systems, Spain, Firms Share by Revenue ($ mn), from 2006 to 2007 49
Table 24: Multiparameter Patient Monitoring, Spain, Overall Revenue ($ mn) by Segment, Historic, from 2000 to 2008 50
Table 25: Multiparameter Patient Monitoring, Spain, Overall Revenue ($ mn) by Segment, Projection , from 2008 to 2015 51
Table 26: Multiparameter Patient Monitoring, Spain, Overall Volume (Units) by Segment, Historic, from 2000 to 2008 52
Table 27: Multiparameter Patient Monitoring, Spain, Overall Volume (Units) by Segment, Projection , from 2008 to 2015 53
Table 28: Multiparameter Patient Monitoring, Spain, Average Price ($), Historic, from 2000 to 2008 54
Table 29: Multiparameter Patient Monitoring, Spain, Average Price ($), Projection , from 2008 to 2015 54
Table 30: Multiparameter Patient Monitoring, Spain, Distribution Share by Revenue ($mn), from 2007 to 2008 54
Table 31: Multiparameter Patient Monitoring, Spain, Firms Share by Revenue ($ mn), from 2006 to 2007 55
Table 32: Non-Invasive Blood Pressure Monitors, Spain, Overall Revenue ($ mn) by Segment, Historic, from 2000 to 2008 56
Table 33: Non-Invasive Blood Pressure Monitors, Spain, Overall Revenue ($ mn) by Segment, Projection , from 2008 to 2015 56
Table 34: Non-Invasive Blood Pressure Monitors, Spain, Overall Volume (Units), Historic by Segment, from 2000 to 2008 57
Table 35: Non-Invasive Blood Pressure Monitors, Spain, Overall Volume (Units) by Segment, Projection , from 2008 to 2015 58
Table 36: Non-Invasive Blood Pressure Monitors, Spain, Average Price ($), Historic, from 2000 to 2008 59
Table 37: Non-Invasive Blood Pressure Monitors, Spain, Average Price ($), Projection , from 2008 to 2015 59
Table 38: Non-Invasive Blood Pressure Monitors, Spain, Distribution Share by Revenue ($mn), from 2007 to 2008 60
Table 39: Non-Invasive Blood Pressure Monitors, Spain, Firms Share by Revenue ($ mn), from 2006 to 2007 61
Table 40: Remote Patient Monitoring, Spain, Revenue ($ mn), Historic, from 2000 to 2008 62
Table 41: Remote Patient Monitoring, Spain, Revenue ($ mn), Projection , from 2008 to 2015 63
Table 42: Remote Patient Monitoring, Spain, Volume (Units), Historic, from 2000 to 2008 64
Table 43: Remote Patient Monitoring, Spain, Volume (Units), Projection , from 2008 to 2015 65
Table 44: Remote Patient Monitoring, Spain, Average Price ($), Historic, from 2000 to 2008 66
Table 45: Remote Patient Monitoring, Spain, Average Price ($), Projection , from 2008 to 2015 66
Table 46: Remote Patient Monitoring, Spain, Distribution Share by Revenue ($mn), from 2007 to 2008 66
Table 47: Remote Patient Monitoring, Spain, Firms Share by Revenue ($ mn), from 2006 to 2007 67
Table 48: Wireless and Ambulatory Monitoring, Spain, Overall Revenue ($ mn) by Segment, Historic, from 2000 to 2008 68
Table 49: Wireless and Ambulatory Monitoring, Spain, Overall Revenue ($ mn) by Segment, Projection , from 2008 to 2015 69
Table 50: Wireless and Ambulatory Monitoring, Spain, Overall Volume (Units) by Segment, Historic, from 2000 to 2008 70
Table 51: Wireless and Ambulatory Monitoring, Spain, Overall Volume (Units) by Segment, Projection , from 2008 to 2015 71
Table 52: Wireless and Ambulatory Monitoring, Spain, Average Price ($), Historic, from 2000 to 2008 72
Table 53: Wireless and Ambulatory Monitoring, Spain, Average Price ($), Projection , from 2008 to 2015 72
Table 54: Wireless and Ambulatory Monitoring, Spain, Distribution Share by Revenue ($mn), from 2007 to 2008 72
Table 55: Wireless and Ambulatory Monitoring, Spain, Firms Share by Revenue ($ mn), from 2006 to 2007 73
Table 56: OMRON HEALTHCARE Co., Ltd. Pipeline Products by Equipment Type 79
Table 57: OMRON HEALTHCARE Co., Ltd. Pipeline Products By Development Stage 79
Table 58: OMRON HEALTHCARE Co., Ltd. Pipeline Products By Therapy Area 80
Table 59: OMRON HEALTHCARE Co., Ltd. Pipeline Products By News Summaries 80
Table 60: Drager Medical AG & Co. KG Pipeline Products by Equipment Type 83
Table 61: Drager Medical AG & Co. KG Pipeline Products by Development Type 83
Table 62: Drager Medical AG & Co. KG Pipeline Products By Therapy Area 83
Table 63: Currency Conversion from US Dollar to Local Currency at 2008 Constant Rate 93
1.2 List of Figures
Figure 1: Total Healthcare Expenditure in Spain, 2000 – 2006 16
Figure 2: Flowchart for Classification of Non-invasive Devices in Spain, 2007 22
Figure 3: Flowchart for Classification of Invasive Devices in Spain, 2007 23
Figure 4: Flowchart for Classification of Invasive Devices in Spain, 2007 24
Figure 5: Flowchart for Classification of Invasive Devices in Spain, 2007 25
Figure 6: Flowchart for Classification of Invasive Devices in Spain, 2007 26
Figure 7: Flowchart for Classification of Active Devices in Spain, 2007 27
Figure 8: Flowchart for Classification of Active Devices in Spain, 2007 28
Figure 9: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in Spain, 2007 29
Figure 10: Conformity Assessment of Class-I Medical Devices in Spain, 2007 30
Figure 11: Conformity Assessment of Class-IIa Medical Devices in Spain, 2007 31
Figure 12: Conformity Assessment of Class-IIb Medical Devices in Spain, 2007 32
Figure 13: Conformity Assessment of Class-III Medical Devices in Spain, 2007 33
Figure 14: Patient Monitoring Cross Country Comparison, Revenue ($ mn), from 2000 to 2015 36
Figure 15: Patient Monitoring, Spain, Overall Revenue ($ mn), from 2000 to 2015 37
Figure 16: Patient Monitoring, Spain, Portfolio Analysis, from 2000 to 2015 38
Figure 17: Patient Monitoring, Spain, Overall Revenue ($ mn), Historic, from 2000 to 2008 39
Figure 18: Patient Monitoring, Spain, Overall Revenue ($ mn), Projection , from 2008 to 2015 40
Figure 19: Patient Monitoring, Spain, Firms Share (%), 2007 43
Figure 20: Micro-Electromechanical Systems, Spain, Revenue ($ mn), Historic, from 2000 to 2008 44
Figure 21: Micro-Electromechanical Systems, Spain, Revenue ($ mn), Projection , from 2008 to 2015 45
Figure 22: Micro-Electromechanical Systems, Spain, Volume (Units), Historic, from 2000 to 2008 46
Figure 23: Micro-Electromechanical Systems, Spain, Volume (Units), Projection , from 2008 to 2015 47
Figure 24: Micro-Electromechanical Systems, Spain, Firms Share (%), 2007 49
Figure 25: Multiparameter Patient Monitoring, Spain, Overall Revenue ($ mn) by Segment, Historic, from 2000 to 2008 50
Figure 26: Multiparameter Patient Monitoring, Spain, Overall Revenue ($ mn) by Segment, Projection , from 2008 to 2015 51
Figure 27: Multiparameter Patient Monitoring, Spain, Overall Volume (Units) by Segment, Historic, from 2000 to 2008 52
Figure 28: Multiparameter Patient Monitoring, Spain, Overall Volume (Units) by Segment, Projection , from 2008 to 2015 53
Figure 29: Multiparameter Patient Monitoring, Spain, Firms Share (%), 2007 55
Figure 30: Non-Invasive Blood Pressure Monitors, Spain, Overall Volume (Units) by Segment, Historic, from 2000 to 2008 57
Figure 31: Non-Invasive Blood Pressure Monitors, Spain, Overall Volume (Units) by Segment, Projection , from 2008 to 2015 58
Figure 32: Non-Invasive Blood Pressure Monitors, Spain, Firms Share (%), 2007 61
Figure 33: Remote Patient Monitoring, Spain, Revenue ($ mn), Historic, from 2000 to 2008 62
Figure 34: Remote Patient Monitoring, Spain, Revenue ($ mn), Projection , from 2008 to 2015 63
Figure 35: Remote Patient Monitoring, Spain, Volume (Units), Historic, from 2000 to 2008 64
Figure 36: Remote Patient Monitoring, Spain, Volume (Units), Projection , from 2008 to 2015 65
Figure 37: Remote Patient Monitoring, Spain, Firms Share (%), 2007 67
Figure 38: Wireless and Ambulatory Monitoring, Spain, Overall Revenue ($ mn) by Segment, Historic, from 2000 to 2008 68
Figure 39: Wireless and Ambulatory Monitoring, Spain, Overall Revenue ($ mn) by Segment, Projection , from 2008 to 2015 69
Figure 40: Wireless and Ambulatory Monitoring, Spain, Overall Volume (Units) by Segment, Historic, from 2000 to 2008 70
Figure 41: Wireless and Ambulatory Monitoring, Spain, Overall Volume (Units) by Segment, Projection , from 2008 to 2015 71
Figure 42: Wireless and Ambulatory Monitoring, Spain, Firms Share (%), 2007 73
Figure 43: Philips Medical Systems Value Chain Analysis 76
Figure 44: Drager Medical AG & Co. KG Value Chain Analysis 81
Figure 45: Abbott Laboratories Value Chain Analysis 84
Figure 46: Hartmann Group Value Chain Analysis 87
Figure 47: Global March kets Direct Methodology 89