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Italy Medical Devices Report Q3 2015, Business Monitor International

  • May 2015
  • -
  • Business Monitor International
  • -
  • 192 pages

Includes 3 FREE quarterly updates

BMI Industry View: The Italian medical device market ranks fourth in Western Europe (WE) but per capitaexpenditure is low by WE standards.
The public sector, which accounts for around 70% of the market, isnotorious for the amount of red tape and payment delays.
This has affected the sustainability of smallmedical device companies.
However, the adoption of the latest European Directive on delayed payments(Decree 192/2012) resulted in a reduction in the level of debt during 2013 and 2014.
As the public sector isstruggling to cope with rising costs, the government has implemented a number of laws in recent years thatwill continue to affect public health expenditure, including capping public medical device expenditure in2014.Headline Industry Forecasts

We value the medical device market at USD9.2bn in 2013, ranking seventh in the world and fourth inWE.
We forecast exhibit sluggish market growth with a projected 2013-2018 CAGR of 1.4% in USdollar terms, which should see the market grow to USD9.9bn in 2018.
Per capita expenditure is estimatedat USD151, ranking 18th in the world and 13th in WE, only ahead of Spain and Portugal.

Despite having a sizeable local manufacturing industry, the market remains dependent on importedproducts in many sectors.
A downturn in imports in Q414 in US dollar terms moderated growth for the 12months to December 2014 at 4.8%, with imports valued at USD6.6bn.
Nonetheless, all product areasrecorded increases in import value, with a double digit percentage rise in patient aids (10.1%).

Table Of Contents

Italy Medical Devices Report Q3 2015, Business Monitor International
BMI Industry View ....... 9
SWOT .. 12
Medical Device Market ..... 12
Political . 13
Economic ....... 14
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 (USD mn) . . . . . 20
Consumables Market Forecast ... 24
Bandages and Dressings .... 24
Suturing Materials . 24
Syringes, Needles and Catheters .. 24
Other Consumables 25
Table: Consumables Market, 2008-2018 (USD mn) . . . . 25
Table: Consumables Market, 2009-2018 (USD mn % Change) 26
Diagnostic Imaging Market Forecast .. 28
Electrodiagnostic Apparatus .... 28
Radiation Apparatus ....... 29
Imaging Parts and Accessories .... 29
Table: Diagnostic Imaging Market, 2008-2018 (USD mn) . . . . . 30
Table: Diagnostic Imaging Market, 2009-2018 (USD mn % Change) . 31
Dental Products Market Forecast ....... 33
Capital Equipment . 33
Instruments and Supplies ... 33
Table: Dental Products Market, 2008-2018 (USD mn) 34
Table: Dental Products Market, 2009-2018 (USD mn % Change) . . . . 34
Orthopaedics and Prosthetics Market Forecast 36
Fixation Devices .... 36
Artificial Joints ...... 36
Other Artificial Body Parts ...... 37
Table: Orthopaedics and Prosthetics Market, 2008-2018 (USD mn) . . . . 37
Table: Orthopaedics and Prosthetics Market, 2009-2018 (USD mn % Change) 37
Patient Aids Market Forecast ..... 38
Portable Aids 39
Therapeutic Appliances ... 39
Table: Patient Aids Market, 2008-2018 (USD mn) . . . . . 39
Table: Patient Aids Market, 2009-2018 (USD mn % Change) . 40
Other Medical Devices Market Forecast ...... 41
Table: Other Medical Devices Market, 2008-2018 (USD mn) . 42
Table: Other Medical Devices Market, 2009-2018 (USD mn % Change) . . . . . 43
Annual Medical Device Imports . 46
Table: Medical Device Imports By Product Area, 2009-2013 (USD 000s) . . . . 49
Table: Medical Device Imports By Product Area, 2009-2013 (USD 000s, % Change) 50
Table: Medical Device Imports By Product Area, 2009-2013 (Local Currency 000s) 51
Table: Medical Device Imports By Product Area, 2009-2013 (Local Currency 000s % Change) . . . . . 52
Table: Top 20 Medical Device Suppliers, 2013 (USD 000s) . . . 54
Table: Detailed Medical Device Imports By Product Area, 2009-2013 (USD 000s) . . 55
Table: Detailed Medical Device Import Trends By Product Area, 2013 . . . . . . . 58
Table: Detailed Leading Medical Device Suppliers By Product Area, 2013 (USD 000s) . . . . . 61
Monthly Medical Device Imports 65
Table: Monthly Medical Device Imports By Product Area, December 2011 - December 2014 (USDmn) . . . . 65
Annual Medical Device Exports . 68
Table: Medical Device Exports By Product Area, 2009-2013 (USD 000s) . . . . 71
Table: Medical Device Exports By Product Area, 2009-2013 (USD 000s % Change) 72
Table: Medical Device Exports By Product Area, 2009-2013 (Local Currency 000s) 73
Table: Medical Device Exports By Product Area, 2009-2013 (Local Currency 000s % Change) . . . . . 74
Table: Top 20 Medical Device Destinations, 2013 (USD 000s) 76
Table: Detailed Medical Device Exports By Product Area, 2009-2013 (USD 000s) . . 77
Table: Detailed Medical Device Export Trends By Product Area, 2013 . . . . . . . 80
Table: Detailed Leading Medical Device Destinations By Product Area, 2013 (USD 000s) . . 84
Table: Detailed Medical Device Trade Balance, 2009-2013 (USD 000s) . . . . . 87
Monthly Medical Device Exports 91
Table: Monthly Medical Device Exports By Product Area, December 2011 - December 2014 (USDmn) . . . . 91
Macroeconomic Forecasts ....... 93
Economic Analysis ... 93
Table: Economic Activity (Italy 2010-2019) . . . 102
Industry Risk/Reward Index ... 103
Table: WE Medical Device Risk/Reward Index, Q315 104
Market Overview ..... 105
Medical Device Market Overview ..... 105
Table: Medical Device Market, Key Ratios, 2013 . . . . . 106
Table: Medical Device Market By Product Area, 2013 . . . . . . . 107
Healthcare Overview ...... 107
Health Status ....... 107
Healthcare System 108
Healthcare Funding ...... 113
Table: Estimated Savings In Public Medical Device Expenditure, 2012-2014 (EURmn) . . . . . 114
Healthcare Resources ... 115
Table: Diagnostic Imaging Technology By Type And Sector, 2008-2012 (Units) . . . . 116
Healthcare Activity ....... 118
Healthcare Personnel ... 118
Key Healthcare Data .... 118
Table: Key Healthcare Data, 2009-2014 . . . . . . 118
Industry Trends And Developments ...... 121
Industry Trends and Developments ...... 121
Regulatory Development 128
Medical Device Regulations .... 128
Competent Authority ..... 128
Notified Bodies .... 128
Table: Notified Bodies In Italy By Product, 2015 . . . . . 129
Regulations . 129
EU Medical Device Regulations ....... 134
Designated Authorities .. 134
Existing Regulations ..... 134
Proposed Regulatory Changes 135
Implications For The Industry 138
Medical Device Pricing and Reimbursement . 140
Competent Authorities ... 140
Reimbursement .... 142
Health Technology Assessment ....... 143
Debt To Medical Technology Suppliers .... 144
Table: SSN Debt To Medical Device Suppliers By Region, February 2015 . . . 145
Competitive Landscape .. 146
Domestic Medical Device Production 146
Table: Medical Device Production By Product Area, 2009-2013 (EURmn) . . 146
Table: Detailed Medical Device Production By Product Area, 2009-2013 (EURmn) 147
Table: Detailed Medical Device Production By Product Area, 2009-2013 (USD mn) . . . . . . . 150
Table: Detailed Medical Device Production By Product Area, 2009-2013 (% Total) 153
Domestic Medical Device Manufacturing ... 157
National Medical Device Manufacturers .... 157
Artsana Group ..... 157
Table: Artsana Group's Financial Indicators, 2009-2013 (EURmn) . . 158
Bellco 159
Bracco Imaging ... 159
Castellini .... 160
Cardioline .. 160
Cosmed ...... 161
Esaote 161
Table: Esaote's Financial Indicators, 2010-2013 (EUR mn) . . 162
Euronda ..... 163
IGEA . 164
IMS ... 164
Lima Corporate ... 164
Major Dental ...... 165
Medel Group ....... 165
A. Menarini Diagnostics 165
Table: A. Menarini Diagnostics' Turnover, 2008-2012 (EURmn) . . . . 166
Sorin Group 166
Table: Sorin Group's Financial Indicators By Business Unit, 2010-2014 (EURmn) . 168
Multinational Medical Device Manufacturers ..... 170
Alvimedica .. 170
B. Braun ..... 170
Fresenius .... 172
Haemonetics ....... 172
Medtronic ... 172
Orthofix International ... 173
Table: Orthofix International's Net Sales, 2011-2013 (USDmn) . . . . . . 173
Ottobock .... 174
Philips ....... 175
Siemens ...... 175
Smiths Medical .... 176
Multinational Market Activity .. 177
Table: Multinational Market Activity, 2015 . . . 177
Medical Device Market Access . 179
Market Environment ..... 179
Distribution 179
Trade Associations ....... 179
Trade Fairs . 180
Methodology .... 182
Forecast Methodology .. 182
Trade Code Classifications .... 183
Table: Used HS Trade Codes . . 183
Table: Rearranged HS Trade Codes . . . 185
Risk/Reward Index Methodology ..... 188
Table: Medical Devices Risk/Reward Index Indicators . . . . . . . 189
Sources ...... 191
Contact ...... 192

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