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Spain Medical Devices Report Q3 2015, Business Monitor International

  • June 2015
  • -
  • Business Monitor International
  • -
  • 200 pages

Includes 3 FREE quarterly updates

BMI Industry View: We forecast low medical device market growth over the 2013-2018 period, as precrisis
import growth levels are unlikely to return. The market size continues to be attractive to multinationals, while medium-sized national companies, focused on export markets to counterbalance contained sales in the internal market and still sizeable SNS debts, will be threatened by an ailing demand from core eurozone economies. Most of the market will remain accountable to the public sector, affected by cost-containment measures implemented in the National Health System.

Headline Industry Forecasts

- We forecast that the medical device market will register a 2013-2018 CAGR of 1.1% in US dollar terms, due to the depreciation of the euro against the US dollar. The market ranks fifth in Western Europe (WE) but is only half the size of the UK in comparison. In per capita terms, Spain ranks outside the top 20 and lags behind the major economies of Germany, France, the UK and Italy.
- Medical device imports, which represent over three-quarters of the market, will struggle to maintain high pre-crisis growth in US dollar terms in the long term. Imports rose by 7.2% USD4.4bn in the 12 months to January 2015, due to a strong performance in H114. Previously, imports recorded a 2008-2013 CAGR of -1.8% and double-digit rises between 2004 and 2008.

Table Of Contents

Spain Medical Devices Report Q3 2015, Business Monitor International
BMI Industry View 9
SWOT 12
Medical Device Market 12
Political 14
Economic 15
Operational Risk 16
Industry Forecast 17
Medical Device Market Forecast 17
2008-2013 Performance 17
2013-2018 Performance 18
Table: Projected Medical Device Market, 2013-2018 19
Table: Detailed Medical Device Market By Product Area, 2008-2018 (USDmn) 20
Consumables Market Forecast 23
Bandages and Dressings 24
Suturing Materials 24
Syringes, Needles and Catheters 24
Other Consumables 25
Table: Consumables Market, 2008-2018 (USDmn) 25
Table: Consumables Market, 2009-2018 (USDmn % Change) 27
Diagnostic Imaging Market Forecast 28
Electrodiagnostic Apparatus 29
Radiation Apparatus 29
Imaging Parts and Accessories 30
Table: Diagnostic Imaging Market, 2008-2018 (USDmn) 30
Table: Diagnostic Imaging Market, 2009-2018 (USDmn % Change) 31
Dental Products Market Forecast 32
Capital Equipment 33
Instruments and Supplies 33
Table: Dental Products Market, 2008-2018 (USDmn) 34
Table: Dental Products Market, 2009-2018 (USDmn % Change) 34
Orthopaedics and Prosthetics Market Forecast 36
Fixation Devices 36
Artificial Joints 36
Other Artificial Body Parts 36
Table: Orthopaedics and Prosthetics Market, 2008-2018 (USDmn) 37
Table: Orthopaedics and Prosthetics Market, 2009-2018 (USDmn % Change) 37
Patient Aids Market Forecast 38
Portable Aids 39
Therapeutic Appliances 39
Table: Patient Aids Market, 2008-2018 (USDmn) 39
Table: Patient Aids Market, 2009-2018 (USDmn % Change) 40
Other Medical Devices Market Forecast 41
Table: Other Medical Devices Market, 2008-2018 (USDmn) 43
Table: Other Medical Devices Market, 2009-2018 (USDmn % Change) 44
Annual Medical Device Imports 45
Table: Medical Device Imports By Product Area, 2009-2013 (USD000s) 48
Table: Medical Device Imports By Product Area, 2009-2013 (USD000s % Change) 49
Table: Medical Device Imports By Product Area, 2009-2013 (Local Currency 000s) 50
Table: Medical Device Imports By Product Area, 2009-2013 (Local Currency 000s % Change) 51
Table: Top 20 Medical Device Suppliers, 2013 (USD000s) 53
Table: Detailed Medical Device Imports By Product Area, 2009-2013 (USD000s) 54
Table: Detailed Medical Device Import Trends By Product Area, 2013 57
Table: Detailed Leading Medical Device Suppliers By Product Area, 2013 (USD000s) 61
Monthly Medical Device Imports 65
Table: Monthly Medical Device Imports By Product Area, December 2011 - January 2015 (USDmn) 65
Annual Medical Device Exports 67
Table: Medical Device Exports By Product Area, 2009-2013 (USD000s) 70
Table: Medical Device Exports By Product Area, 2009-2013 (USD000s % Change) 71
Table: Medical Device Exports By Product Area, 2009-2013 (Local Currency 000s) 72
Table: Medical Device Exports By Product Area, 2009-2013 (Local Currency 000s % Change) 73
Table: Top 20 Medical Device Destinations, 2013 (USD000s) 75
Table: Detailed Medical Device Exports By Product Area, 2009-2013 (USD000s) 76
Table: Detailed Medical Device Export Trends By Product Area, 2013 79
Table: Detailed Leading Medical Device Destinations By Product Area, 2013 (USD000s) 83
Table: Detailed Medical Device Trade Balance, 2009-2013 (USD000s) 86
Monthly Medical Device Exports 89
Table: Monthly Medical Device Exports By Product Area, September 2011 - September 2014 (USDmn) 90
Macroeconomic Forecasts 92
Economic Analysis 92
Table: Economic Activity (Spain 2010-2019) 100
Industry Risk/Reward Index 101
Table: WE Medical Devices Risk/Reward Index, Q315 102
Market Overview 103
Medical Device Market Overview 103
Table: Medical Device Market, Key Ratios, 2013 104
Table: Medical Device Market By Product Area, 2013 105
Healthcare Overview 105
Health Status 105
Healthcare System 106
Healthcare Funding 107
Table: Private Health Insurance Market, 2003-2011 107
Healthcare Resources 109
Table: Hospital And Ambulatory Diagnostic Imaging Units, 2007-2012 111
Table: Hospital Medical Equipment Units, 2008-2013 113
Table: Hospital Medical Equipment Units By Region, 2013 114
Healthcare Activity 114
Healthcare Personnel 115
Key Healthcare Data 115
Table: Key Healthcare Data, 2009-2014 115
Industry Trends And Developments 118
Industry Trends and Developments 118
Regulatory Development 126
Medical Device Regulations 126
Competent Authority 126
Regulations 126
Fees 129
Table: Fees Enforced Since January 1 2015 129
Regulatory Statistics 130
Table: Company Licences For Health Products, 2003-2013 130
Table: Registrations Of Class I Health Products And In Vitro Diagnostic Devices, Marketed By A Spanish Company, 2003-2013 131
Table: Marketing Authorisations Of Medium And High Risk Health Products, 2003-2013 131
Table: Other Evaluations and Authorisations Of Health Products, 2003-2013 132
Table: Vigilance System Of Health Products, 2003-2013 133
Table: Notified Adverse Incidents By Product Type, 2003-2013 134
Table: Market Control Of Health Products, 2003-2013 135
EU Medical Device Regulations 135
Designated Authorities 135
Existing Regulations 136
Proposed Regulatory Changes 137
Implications For The Industry 140
Medical Device Pricing and Reimbursement 142
Pricing 142
Reimbursement 144
Table: SNS Co-Payment Levels For Orthopaedics and Prosthetics Used In Ambulatory Care, 2012 145
Health Technology Assessment 145
Table: Members Of The Council Of The Spanish Network Of HTA Agencies And SNS Services, 2013 146
Procurement 146
Debt 147
Competitive Landscape 149
Domestic Medical Device Production 149
Production Reported By INE 149
Table: Medical and Dental Device Production Indicators, 2008-2013 (EURmn) 149
Production Reported By Eurostat 150
Table: Medical Device Production By Product Area, 2009-2013 (EURmn) 150
Table: Detailed Medical Device Production By Product Area, 2009-2013 (EURmn) 151
Table: Detailed Medical Device Production By Product Area, 2009-2013 (USDmn) 155
Table: Detailed Medical Device Production By Product Area, 2009-2013 (% Total) 158
Domestic Medical Device Manufacturing 162
Producers Reported By INE 162
Table: Medical and Dental Device Producers, 2000-2013 162
Personnel Reported By INE 162
Table: Medical and Dental Device Personnel, 2000-2013 163
National Medical Device Manufacturers 164
Table: Inibsa Group's Sales, 2007-2014 (EURmn) 165
Table: WerfenLife's Sales, 2005-2013 (EURmn) 167
Table: Prim Group's Net Sales, 2009-2014 (EURmn) 170
Multinational Medical Device Manufacturers 175
Table: B. Braun's Sales By Company, 2012-2014 (EURmn) 176
Multinational Market Activity 182
Table: Multinational Market Activity, 2015 182
Medical Device Market Access 186
Market Environment 186
Distribution 186
Trade Association 186
Table: FENIN's Sectors, 2013 188
Trade Fairs 189
Methodology 190
Forecast Methodology 190
Trade Code Classifications 191
Table: Used HS Trade Codes 191
Table: Rearranged HS Trade Codes 193
Risk/Reward Index Methodology 196
Table: Medical Devices Risk/Reward Index Indicators 197
Sources 199
Contact 200

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