GBIME0076MR-Peripheral Vascular Devices Market …devices devices

Peripheral Vascular Devices Market to 2018 Increasing Demand for Minimally Invasive Endovascular Procedures Presents Growth Opportunities for Manufacturers

GBI Research Report Guidance

GBIME0076MR / Published OCT 2012

© GBI Research. This is a licensed product and is not to be photocopied

GBI Research Report Guidance

Chapter three provides information on the market size for the historic period (2004-2011) and the forecast period (2011-2018). It also outlines market trends; dynamics, with comprehensive information on market drivers and restraints; and the competitive landscape.

Chapter four discusses stent grafts, peripheral vascular stents, PTA balloons, peripheral embolic protection devices, IVCFs, synthetic surgical grafts, peripheral guidewires and PTA peripheral DEBs. The market size for the historic period (2004-2011) and the forecast period (2011-2018) is also discussed for each segment.

Chapter five gives information on the market size for the historic period (2004-2011) and the forecast period (2011-2018) for the US, Canada, the UK, France, Germany, Italy, Spain, Japan, China, India, Australia and Brazil, with cross-country analysis. Market information for PTA peripheral DEBs has not been provided for the US, Canada and Japan, as they have not been approved in these countries.

Chapter six gives profiles of the leading peripheral vascular device companies, outlining their products, features and benefits.

Chapter seven focuses on the pipeline products for a range of segments. The key pipeline products are listed and discussed in detail alongside product approval and expected launch dates.

Chapter eight discusses the deals that took place in the peripheral vascular devices industry between 2008 and 2011.


© GBI Research. This is a licensed product and is not to be photocopied

Executive Summary

Executive Summary

The Peripheral Vascular Devices Market is Forecast to Exceed $XXbn by 2018

The following figure gives the forecast revenues for the global peripheral vascular devices market.

Peripheral Vascular Devices Market, Global, Revenues ($bn), 2011-2018

2011 2018

Rev

enue

($bn

)

CAGR (2011-2018): XX%

Source: GBI Research’s proprietary database, [accessed July 12, 2012]; interviews with marketing managers and other industry experts

The global market is forecast to exceed $XX billion by 2018 having grown at a Compound Annual Growth Rate (CAGR) of XX% from 2011, driven by a growing patient pool due to the aging population, and other risk factors such as diabetes, obesity and lack of physical activity. Rising demand for endovascular procedures and the launch of new innovative devices such as Drug-Eluting Balloons (DEBs) will also drive market growth.

Launch of Technologically Advanced Devices Such as Drug-eluting Balloons to Drive Future Adoption

The launch of advanced products such as DEBs has resulted in growing demand for non-stent treatments for Peripheral Arterial Disease (PAD) and below-the-knee disorders in which stents cannot be used.

Factors such as the shorter dual antiplatelet therapy regimen required by DEBs and the high risk of thrombosis associated with other treatment options are some of the favorable factors that will drive their adoption. DEBs are also able to overcome various issues associated with stents, such as high risk of restenosis, incomplete drug delivery and limited area coverage for drug delivery. These advantages are encouraging physicians to opt for DEBs for the treatment of Peripheral Vascular Diseases (PVDs), and the market is forecast to grow in the near future as a result.

Due to the high risk of stent thrombosis, patients are prescribed anti-platelet therapy to prevent clot formation, making it unsuitable for elderly patients, pregnant women and those at high risk of bleeding. DEBs are preferable in this case as they require approximately three months of therapy in contrast to the 12 months required for Drug-Eluting Stents (DESs). This has increased demand for DEBs around the world.

DEBs such as Paccocath from Bayer, SeQuent Please by B. Braun Melsungen, Advance PTX from Cook Medical, Dior from Eurocor and In.Pact Amphirion paclitaxel-eluting PTA balloon catheter from Medtronic have been launched and are available in Europe.

The global peripheral vascular devices market is forecast to exceed $XX billion by 2018 having grown at a Compound Annual Growth Rate (CAGR) of XX% from 2011


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Table of Contents

1 Table of Contents

1 Table of Contents................................................................................................................................. 6 1.1 List of Tables............................................................................................................................. 9 1.2 List of Figures...........................................................................................................................11

2 Introduction........................................................................................................................................12 3 Global Peripheral Vascular Devices Market - Market Characterization..................................................13

3.1 Peripheral Vascular Devices Market, Revenue ($m), 2004-2011 ................................................13 3.2 Peripheral Vascular Devices Market, Revenue ($m), 2011-2018 ................................................15 3.3 Peripheral Vascular Devices Market, Key Company Shares (%), 2011.........................................17 3.4 Peripheral Vascular Devices Market, Key Trends.......................................................................18

3.4.1 High Risk of Deep Vein Thrombosis Associated with Permanent Filters is Promoting the Use of Retrievable Inferior Vena Cava Filters ...........................................................................18

3.4.2 Preference of Minimally Invasive Endovascular Procedures to Treat Peripheral Vascular Disease is a Global Trend..................................................................................................20

3.5 Peripheral Vascular Devices: Market Dynamics.........................................................................21 3.5.1 Market Drivers.................................................................................................................21 3.5.2 Market Restraints ............................................................................................................25

4 Global Peripheral Vascular Devices Market - Segment Analysis and Forecasts.......................................26 4.1 Stent Grafts Market, Global, Revenue ($m), 2004-2011 ............................................................26 4.2 Stent Grafts Market, Global, Revenue ($m), 2011-2018 ............................................................27 4.3 Peripheral Vascular Stents Market, Global, Revenue ($m), 2004-2011.......................................28 4.4 Peripheral Vascular Stents Market, Global, Revenue ($m), 2011-2018.......................................29 4.5 PTA Balloons Market, Global, Revenue ($m), 2004-2011...........................................................30 4.6 PTA Balloons Market, Global, Revenue ($m), 2011-2018...........................................................31 4.7 Peripheral Embolic Protection Devices Market, Global, Revenue ($m), 2004-2011.....................32 4.8 Peripheral Embolic Protection Devices Market, Global, Revenue ($m), 2011-2018.....................33 4.9 Inferior Vena Cava Filters Market, Global, Revenue ($m), 2004-2011 ........................................34 4.10 Inferior Vena Cava Filters Market, Global, Revenue ($m), 2011-2018 ........................................35 4.11 Synthetic Surgical Grafts Market, Global, Revenue ($m), 2004-2011..........................................36 4.12 Synthetic Surgical Grafts Market, Global, Revenue ($m), 2011-2018..........................................37 4.13 Peripheral Guidewires Market, Global, Revenue ($m), 2004-2011.............................................38 4.14 Peripheral Guidewires Market, Global, Revenue ($m), 2011-2018.............................................39 4.15 PTA Peripheral Drug-eluting Balloons Market, Global, Revenue ($m), 2004-2011 ......................40 4.16 PTA Peripheral Drug-eluting Balloons Market, Global, Revenue ($m), 2011-2018 ......................41

5 Global Peripheral Vascular Devices Market - Country Analysis and Forecasts........................................42 5.1 Peripheral Vascular Devices Market: Cross-country Analysis .....................................................42 5.2 Historic and Forecast Revenue, by Country...............................................................................43

5.2.1 Peripheral Vascular Devices Market, the US, Revenue ($m), 2004-2011 .............................43 5.2.2 Peripheral Vascular Devices Market, the US, Revenue ($m), 2011-2018 .............................45 5.2.3 Peripheral Vascular Devices Market, Canada, Revenue ($m), 2004-2011............................46 5.2.4 Peripheral Vascular Devices Market, Canada, Revenue ($m), 2011-2018............................48 5.2.5 Peripheral Vascular Devices Market, Germany, Revenue ($m), 2004-2011 .........................49 5.2.6 Peripheral Vascular Devices Market, Germany, Revenue ($m), 2011-2018 .........................50 5.2.7 Peripheral Vascular Devices Market, the UK, Revenue ($m), 2004-2011 .............................51 5.2.8 Peripheral Vascular Devices Market, the UK, Revenue ($m), 2011-2018 .............................52 5.2.9 Peripheral Vascular Devices Market, France, Revenue ($m), 2004-2011.............................53 5.2.10 Peripheral Vascular Devices Market, France, Revenue ($m), 2011-2018.............................54 5.2.11 Peripheral Vascular Devices Market, Italy, Revenue ($m), 2004-2011.................................55 5.2.12 Peripheral Vascular Devices Market, Italy, Revenue ($m), 2011-2018.................................56 5.2.13 Peripheral Vascular Devices Market, Spain, Revenue ($m), 2004-2011...............................57 5.2.14 Peripheral Vascular Devices Market, Spain, Revenue ($m), 2011-2018...............................59



Table of Contents

5.2.15 Peripheral Vascular Devices Market, Brazil, Revenue ($m), 2004-2011...............................60 5.2.16 Peripheral Vascular Devices Market, Brazil, Revenue ($m), 2011-2018...............................61 5.2.17 Peripheral Vascular Devices Market, Japan, Revenue ($m), 2004-2011 ..............................62 5.2.18 Peripheral Vascular Devices Market, Japan, Revenue ($m), 2011-2018 ..............................63 5.2.19 Peripheral Vascular Devices Market, China, Revenue ($m), 2004-2011...............................64 5.2.20 Peripheral Vascular Devices Market, China, Revenue ($m), 2011-2018...............................65 5.2.21 Peripheral Vascular Devices Market, India, Revenue ($m), 2004-2011................................67 5.2.22 Peripheral Vascular Devices Market, India, Revenue ($m), 2011-2018................................68 5.2.23 Peripheral Vascular Devices Market, Australia, Revenue ($m), 2004-2011..........................69 5.2.24 Peripheral Vascular Devices Market, Australia, Revenue ($m), 2011-2018..........................70

6 Global Peripheral Vascular Devices Market - Profiles of Key Market Participants ..................................71 6.1 Cordis......................................................................................................................................71

6.1.1 Marketed Products...........................................................................................................71 6.2 Boston Scientific ......................................................................................................................71

6.2.1 Marketed Products...........................................................................................................71 6.3 Abbott Laboratories.................................................................................................................71

6.3.1 Marketed Products...........................................................................................................72 6.4 Medtronic ...............................................................................................................................72

6.4.1 Marketed Products...........................................................................................................72 6.5 C. R. Bard.................................................................................................................................72

6.5.1 Marketed Products...........................................................................................................72 6.6 Covidien ..................................................................................................................................73

6.6.1 Marketed Products...........................................................................................................73 6.7 Terumo....................................................................................................................................73

6.7.1 Marketed Products...........................................................................................................73 7 Global Peripheral Vascular Devices Market - Product Pipeline Analysis.................................................74

7.1 Stent Grafts Market: Product Pipeline ......................................................................................75 7.1.1 Stent Grafts Market: List of Pipeline Products....................................................................75 7.1.2 Stent Grafts Market: Profiles of Key Pipeline Products .......................................................76

7.2 Peripheral Vascular Stents Market: Product Pipeline.................................................................78 7.2.1 Peripheral Vascular Stents Market: List of Pipeline Products ..............................................78 7.2.2 Peripheral Vascular Stents Market: Profiles of Key Pipeline Products..................................79

7.3 PTA Balloons Market: Product Pipeline.....................................................................................81 7.3.1 PTA Balloons Market: List of Pipeline Products ..................................................................81 7.3.2 PTA Balloons Market: Profiles of Key Pipeline Products......................................................81

7.4 Peripheral Embolic Protection Devices Market: Product Pipeline...............................................82 7.4.1 Peripheral Embolic Protection Devices Market: List of Pipeline Products.............................82 7.4.2 Peripheral Embolic Protection Devices Market: Profiles of Key Pipeline Products ................82

7.5 Inferior Vena Cava Filters Market: Product Pipeline ..................................................................83 7.5.1 Inferior Vena Cava Filters Market: List of Pipeline Products................................................83 7.5.2 Inferior Vena Cava Filters Market: Profiles of Key Pipeline Products ...................................83

7.6 Synthetic Surgical Grafts Market: Product Pipeline ...................................................................84 7.6.1 Synthetic Surgical Grafts Market: List of Pipeline Products.................................................84 7.6.2 Synthetic Surgical Grafts Market: Profiles of Key Pipeline Products ....................................85

7.7 Peripheral Guidewires Market: Product Pipeline.......................................................................86 7.7.1 Peripheral Guidewires Market: List of Pipeline Products ....................................................86 7.7.2 Peripheral Guidewires Market: Profiles of Key Pipeline Products ........................................87

7.8 PTA Peripheral Drug-eluting Balloons Market: Product Pipeline ................................................88 7.8.1 PTA Peripheral Drug-eluting Balloons Market: List of Pipeline Products..............................88 7.8.2 PTA Peripheral Drug-eluting Balloons Market: Profiles of Key Pipeline Products .................88

8 Global Peripheral Vascular Devices Market - Consolidation Landscape .................................................91 8.1 Deals by Count.........................................................................................................................91



Table of Contents

8.2 Key Deals (2008-2011) .............................................................................................................93 8.2.1 C. R. Bard’s Acquisition of Lutonix .....................................................................................93 8.2.2 Medrad’s Acquisition of Pathway Medical Technologies ....................................................93 8.2.3 Boston Scientific’s Acquisition of S.I. Therapies..................................................................93 8.2.4 Endologix’s Acquisition of Nellix Endovascular...................................................................93 8.2.5 St. Jude Medical’s Acquisition of AGA Medical Holdings for $1.3 Billion..............................94 8.2.6 Covidien’s Acquisition of ev3 for $2.6 Billion......................................................................94 8.2.7 Degania Silicone’s Acquisition of Arthesys.........................................................................94 8.2.8 C. R. Bard’s Acquisition of FlowCardia For $80.1m.............................................................94 8.2.9 Avinger Merges with Sawtooth Labs.................................................................................95 8.2.10 Medtronic’s Acquisition of Invatec and Affiliated Companies .............................................95 8.2.11 Lake Region Medical’s Acquisition of Brivant Medical........................................................95 8.2.12 Covidien’s Acquisition of Bacchus Vascular........................................................................95 8.2.13 Medical Ventures’ Acquisition of B-Balloon .......................................................................96

9 Appendix ............................................................................................................................................97 9.1 Definitions...............................................................................................................................97

9.1.1 Peripheral Vascular Devices..............................................................................................97 9.2 Acronyms ................................................................................................................................98 9.3 Sources....................................................................................................................................99 9.4 Research Methodology ............................................................................................................99

9.4.1 Secondary Research .........................................................................................................99 9.4.2 Primary Research ...........................................................................................................100 9.4.3 Models ..........................................................................................................................100 9.4.4 Forecasts .......................................................................................................................100 9.4.5 Expert Panels .................................................................................................................101

9.5 Contact Us.............................................................................................................................101 9.6 Disclaimer..............................................................................................................................101



Table of Contents

1.1 List of Tables

Table 1: Peripheral Vascular Devices Market, Global, Revenue ($m), 2004-2011....................................14 Table 2: Peripheral Vascular Devices Market, Global, Revenue ($m), 2011-2018....................................16 Table 3: Peripheral Vascular Devices Market, Global, Key Company Revenue ($m), 2011.......................17 Table 4: Peripheral Vascular Devices Market, Germany, Number of Procedures (‘000), 2005-2008.........21 Table 5: Stent Grafts Market, Global, Revenue ($m), 2004-2011............................................................26 Table 6: Stent Grafts Market, Global, Revenue ($m), 2011-2018............................................................27 Table 7: Peripheral Vascular Stents Market, Global, Revenue ($m), 2004-2011......................................28 Table 8: Peripheral Vascular Stents Market, Global, Revenue ($m), 2011-2018......................................29 Table 9: PTA Balloons Market, Global, Revenue ($m), 2004-2011..........................................................30 Table 10: PTA Balloons Market, Global, Revenue ($m), 2011-2018..........................................................31 Table 11: Peripheral Embolic Protection Devices Market, Global, Revenue ($m), 2004-2011....................32 Table 12: Peripheral Embolic Protection Devices Market, Global, Revenue ($m), 2011-2018....................33 Table 13: Inferior Vena Cava Filters Market, Global, Revenue ($m), 2004-2011 .......................................34 Table 14: Inferior Vena Cava Filters Market, Global, Revenue ($m), 2011-2018 .......................................35 Table 15: Synthetic Surgical Grafts Market, Global, Revenue ($m), 2004-2011.........................................36 Table 16: Synthetic Surgical Grafts Market, Global, Revenue ($m), 2011-2018.........................................37 Table 17: Peripheral Guidewires Market, Global, Revenue ($m), 2004-2011............................................38 Table 18: Peripheral Guidewires Market, Global, Revenue ($m), 2011-2018............................................39 Table 19: PTA Peripheral Drug-eluting Balloons Market, Global, Revenue ($m), 2004-2011......................40 Table 20: PTA Peripheral Drug-eluting Balloons Market, Global, Revenue ($m), 2011-2018......................41 Table 21: Peripheral Vascular Devices Market, Global, Cross-country Analysis, CAGR (%), 2004-2018.......42 Table 22: Peripheral Vascular Devices Market, the US, Revenue ($m), 2004-2011....................................44 Table 23: Peripheral Vascular Devices Market, the US, Revenue ($m), 2011-2018....................................45 Table 24: Peripheral Vascular Devices Market, Canada, Revenue ($m), 2004-2011 ..................................47 Table 25: Peripheral Vascular Devices Market, Canada, Revenue ($m), 2011-2018 ..................................48 Table 26: Peripheral Vascular Devices Market, Germany, Revenue ($m), 2004-2011................................49 Table 27: Peripheral Vascular Devices Market, Germany, Revenue ($m), 2011-2018................................50 Table 28: Peripheral Vascular Devices Market, the UK, Revenue ($m), 2004-2011 ...................................51 Table 29: Peripheral Vascular Devices Market, the UK, Revenue ($m), 2011-2018 ...................................52 Table 30: Peripheral Vascular Devices Market, France, Revenue ($m), 2004-2011 ...................................53 Table 31: Peripheral Vascular Devices Market, France, Revenue ($m), 2011-2018 ...................................54 Table 32: Peripheral Vascular Devices Market, Italy, Revenue ($m), 2004-2011 .......................................55 Table 33: Peripheral Vascular Devices Market, Italy, Revenue ($m), 2011-2018 .......................................56 Table 34: Peripheral Vascular Devices Market, Spain, Revenue ($m), 2004-2011 .....................................58 Table 35: Peripheral Vascular Devices Market, Spain, Revenue ($m), 2011-2018 .....................................59 Table 36: Peripheral Vascular Devices Market, Brazil, Revenue ($m), 2004-2011 .....................................60 Table 37: Peripheral Vascular Devices Market, Brazil, Revenue ($m), 2011-2018 .....................................61 Table 38: Peripheral Vascular Devices Market, Japan, Revenue ($m), 2004-2011.....................................62 Table 39: Peripheral Vascular Devices Market, Japan, Revenue ($m), 2011-2018.....................................63 Table 40: Peripheral Vascular Devices Market, China, Revenue ($m), 2004-2011 .....................................64 Table 41: Peripheral Vascular Devices Market, China, Revenue ($m), 2011-2018 .....................................66 Table 42: Peripheral Vascular Devices Market, India, Revenue ($m), 2004-2011 ......................................67 Table 43: Peripheral Vascular Devices Market, India, Revenue ($m), 2011-2018 ......................................68 Table 44: Peripheral Vascular Devices Market, Australia, Revenue ($m), 2004-2011 ................................69 Table 45: Peripheral Vascular Devices Market, Australia, Revenue ($m), 2011-2018 ................................70 Table 46: Peripheral Vascular Devices Market, Global, Product Pipeline Analysis, 2012............................74 Table 47: Stent Grafts Market, Pipeline Product Summary, 2012, Table 1................................................75 Table 48: Stent Grafts Market, Pipeline Product Summary, 2012, Table 2................................................76 Table 49: Fluency Plus Endovascular Stent Graft, Product Status, 2012....................................................76 Table 50: Amplatzer TAA Vascular Graft, Product Status, 2012................................................................77 Table 51: Amplatzer AAA Vascular Graft, Product Status, 2012................................................................77 Table 52: Peripheral Vascular Stents Market, Global, Pipeline Product Summary, 2012 Table 1................78 Table 53: Peripheral Vascular Stents Market, Global, Pipeline Product Summary, 2012, Table 2...............79 Table 54: Absolute Pro LL Peripheral Self-Expanding Stent System, the US, Product Status, 2012.............79 Table 55: Complete SE SFA, the US, Product Status, 2012........................................................................80 Table 56: Astron Peripheral Vascular Stent, the US, Product Status, 2012................................................80 Table 57: PTA Balloons Market, Global, Pipeline Product Summary, 2012................................................81



Table of Contents

Table 58: Joker 014, the US, Product Status, 2012...................................................................................81 Table 59: Peripheral Embolic Protection Devices Market, Global, Pipeline Product Summary, 2012 .........82 Table 60: Montage System, the US, Product Status, 2012........................................................................82 Table 61: Inferior Vena Cava Filters Market, Global, Pipeline Product Summary, 2012 .............................83 Table 62: Bard Denali Retrievable Inferior Vena Cava Filter System, the US, Product Status, 2012............83 Table 63: Synthetic Surgical Grafts Market, Global, Pipeline Product Summary, 2012 ..............................84 Table 64: VasoGraft, the US, Product Status, 2012..................................................................................85 Table 65: Ariste Anti-Proliferative Vascular Graft, the US, Product Status, 2012.......................................85 Table 66: MultiGeneGraft, the US, Product Status, 2012 .........................................................................86 Table 67: Peripheral Guidewires Market, Global, Pipeline Product Summary, 2012..................................86 Table 68: Next Generation Fathom, Oncology, the US, Product Status, 2012 ...........................................87 Table 69: Endovascular Guidewire, Global, Product Status, 2012.............................................................87 Table 70: PTA Peripheral Drug-Eluting Balloons Market, Global, Pipeline Product Summary, 2012 ...........88 Table 71: Boston Drug-Eluting Balloon, Europe, Product Status, 2012 .....................................................88 Table 72: In.Pact Admiral Drug-Eluting Balloon, the US, Product Status, 2012..........................................89 Table 73: Lutonix, the US, Product Status, 2012......................................................................................89 Table 74: In.Pact Pacific Balloon Catheter, the US, Product Status, 2012..................................................90 Table 75: Peripheral Vascular Devices Market, M&A, Global, 2008-2011 .................................................92



Table of Contents

1.2 List of Figures

Figure 1: Peripheral Vascular Devices Market, Global, Revenue ($m), 2004-2011....................................13 Figure 2: Peripheral Vascular Devices Market, Global, Revenue ($m), 2011-2018....................................15 Figure 3: Peripheral Vascular Devices Market, Global, Key Company Shares (%), 2011 ............................17 Figure 4: Usage Trends for Inferior Vena Cava Filters, Global, Volume (Absolute Units), 2004-2011.........19 Figure 5: Peripheral Vascular Devices Market, Germany, Number of Procedures (‘000), 2005-2008.........20 Figure 6: Stent Grafts Market, Global, Volume (‘000), 2004-2011 ...........................................................23 Figure 7: Increase in the Percentage of Elderly People in the Population, Global (%), 2010-2050.............24 Figure 8: Stent Grafts Market, Global, Revenue ($m), 2004-2011............................................................26 Figure 9: Stent Grafts Market, Global, Revenue ($m), 2011-2018............................................................27 Figure 10: Peripheral Vascular Stents Market, Global, Revenue ($m), 2004-2011......................................28 Figure 11: Peripheral Vascular Stents Market, Global, Revenue ($m), 2011-2018......................................29 Figure 12: PTA Balloons Market, Global, Revenue ($m), 2004-2011..........................................................30 Figure 13: PTA Balloons Market, Global, Revenue ($m), 2011-2018..........................................................31 Figure 14: Peripheral Embolic Protection Devices Market, Global, Revenue ($m), 2004-2011....................32 Figure 15: Peripheral Embolic Protection Devices Market, Global, Revenue ($m), 2011-2018....................33 Figure 16: Inferior Vena Cava Filters Market, Global, Revenue ($m), 2004-2011 .......................................34 Figure 17: Inferior Vena Cava Filters Market, Global, Revenue ($m), 2011-2018 .......................................35 Figure 18: Synthetic Surgical Grafts Market, Global, Revenue ($m), 2004-2011.........................................36 Figure 19: Synthetic Surgical Grafts Market, Global, Revenue ($m), 2011-2018.........................................37 Figure 20: Peripheral Guidewires Market, Global, Revenue ($m), 2004-2011............................................38 Figure 21: Peripheral Guidewires Market, Global, Revenue ($m), 2011-2018............................................39 Figure 22: PTA Peripheral Drug-eluting Balloons Market, Global, Revenue ($m), 2004-2011......................40 Figure 23: PTA Peripheral Drug-eluting Balloons Market, Global, Revenue ($m), 2011-2018......................41 Figure 24: Peripheral Vascular Devices Market, Global, Cross-country Analysis, CAGR (%), 2004-2018.......42 Figure 25: Peripheral Vascular Devices Market, the US, Revenue ($m), 2004-2011....................................43 Figure 26: Peripheral Vascular Devices Market, the US, Revenue ($m), 2011-2018....................................45 Figure 27: Peripheral Vascular Devices Market, Canada, Revenue ($m), 2004-2011 ..................................46 Figure 28: Peripheral Vascular Devices Market, Canada, Revenue ($m), 2011-2018 ..................................48 Figure 29: Peripheral Vascular Devices Market, Germany, Revenue ($m), 2004-2011................................49 Figure 30: Peripheral Vascular Devices Market, Germany, Revenue ($m), 2011-2018................................50 Figure 31: Peripheral Vascular Devices Market, the UK, Revenue ($m), 2004-2011 ...................................51 Figure 32: Peripheral Vascular Devices Market, the UK, Revenue ($m), 2011-2018 ...................................52 Figure 33: Peripheral Vascular Devices Market, France, Revenue ($m), 2004-2011 ...................................53 Figure 34: Peripheral Vascular Devices Market, France, Revenue ($m), 2011-2018 ...................................54 Figure 35: Peripheral Vascular Devices Market, Italy, Revenue ($m), 2004-2011 .......................................55 Figure 36: Peripheral Vascular Devices Market, Italy, Revenue ($m), 2011-2018 .......................................56 Figure 37: Peripheral Vascular Devices Market, Spain, Revenue ($m), 2004-2011 .....................................57 Figure 38: Peripheral Vascular Devices Market, Spain, Revenue ($m), 2011-2018 .....................................59 Figure 39: Peripheral Vascular Devices Market, Brazil, Revenue ($m), 2004-2011 .....................................60 Figure 40: Peripheral Vascular Devices Market, Brazil, Revenue ($m), 2011-2018 .....................................61 Figure 41: Peripheral Vascular Devices Market, Japan, Revenue ($m), 2004-2011.....................................62 Figure 42: Peripheral Vascular Devices Market, Japan, Revenue ($m), 2011-2018.....................................63 Figure 43: Peripheral Vascular Devices Market, China, Revenue ($m), 2004-2011 .....................................64 Figure 44: Peripheral Vascular Devices Market, China, Revenue ($m), 2011-2018 .....................................65 Figure 45: Peripheral Vascular Devices Market, India, Revenue ($m), 2004-2011 ......................................67 Figure 46: Peripheral Vascular Devices Market, India, Revenue ($m), 2011-2018 ......................................68 Figure 47: Peripheral Vascular Devices Market, Australia, Revenue ($m), 2004-2011 ................................69 Figure 48: Peripheral Vascular Devices Market, Australia, Revenue ($m), 2011-2018 ................................70 Figure 49: Peripheral Vascular Devices Market, Global, Product Pipeline Analysis (%), 2012......................74 Figure 50: Peripheral Vascular Devices Market, M&A, Number of Deals, Global, 2008-2011......................91



Introduction

2 Introduction

Peripheral vascular devices are medical devices used in the treatment of Peripheral Vascular Disease (PVD). PVD involves the buildup of plaque, which leads to narrowing or blockage of the arteries and insufficient blood flow. The devices used to treat PVD include peripheral vascular stents, Percutaneous Transluminal Angioplasty (PTA) balloons, PTA Drug-Eluting Balloons (DEBs), embolic protection devices, Inferior Vena Cava Filters (IVCFs), aortic stent grafts, synthetic surgical grafts and peripheral guide wires.

PVD can be treated surgically or via minimally invasive catheter-based techniques. The growth of the peripheral vascular device market is being driven by rising incidence rates of PVD and other conditions such as diabetes, end-stage renal disease and obesity.

The global market for peripheral vascular devices is underpenetrated and is expected to be driven by market expansion into new untapped geographies. As a result, more companies are focusing on the peripheral vascular devices market for revenue generation.



Global Peripheral Vascular Devices Market: Market Characterization

3.3 Peripheral Vascular Devices Market, Key Company Shares (%), 2011

The following figure gives the percentage market shares in 2011 for key peripheral vascular device companies.

Figure 3: Peripheral Vascular Devices Market, Global, Key Company Shares (%), 2011

Cordis

Boston Scientific

Abbott Laboratories

Medtronic

C. R. Bard

Covidien

Terumo

Others


The following table gives the 2011 market shares for key peripheral vascular devices companies.

Table 3: Peripheral Vascular Devices Market, Global, Key Company Revenue ($m), 2011

Company Name Revenue ($m)

Cordis

Boston Scientific

Abbott Laboratories

Medtronic

C. R. Bard

Covidien

Terumo

Others

Total


The peripheral vascular devices market is dominated by seven major companies which account for a combined share of XX%. Cordis is the market leader with a share of XX%, closely followed by Boston Scientific with XX%. Abbott Laboratories and Medtronic each have a share of XX%, and are followed by Covidien with XX% and Terumo with XX%.



Global Peripheral Vascular Devices Market: Segment Analysis and Forecasts

4.2 Stent Grafts Market, Global, Revenue ($m), 2011-2018

The following figure gives the annualized global stent grafts market revenues from 2011 to 2018.

Figure 9: Stent Grafts Market, Global, Revenue ($m), 2011-2018

2011 2012 2013 2014 2015 2016 2017 2018

Rev

enue

($m

)

Abdominal Aortic Stent Grafts Thoracic Aortic Stent Grafts


The following table gives the annualized global stent grafts market revenues and CAGRs from 2011 to 2018.

Table 6: Stent Grafts Market, Global, Revenue ($m), 2011-2018

2011 2012 2013 2014 2015 2016 2017 2018 CAGR 2011-2018

Abdominal aortic stent grafts

Thoracic aortic stent grafts

Total


The global stent grafts market is forecast to reach $XX billion in 2018 at a CAGR of XX% from 2011. The market will be driven by an increase in the adoption of EVAR for the treatment of AAA and further new product launches such as Medtronic’s Endurant graft system.

The global stent grafts market is forecast to reach $XX billion in 2018 at a CAGR of XX% from 2011




4.7 Peripheral Embolic Protection Devices Market, Global, Revenue ($m), 2004-2011

The following figure gives the annualized global peripheral embolic protection devices market revenues from 2004 to 2011.

Figure 14: Peripheral Embolic Protection Devices Market, Global, Revenue ($m), 2004-2011

2004 2005 2006 2007 2008 2009 2010 2011

Rev

enue

($m

)

Lower Extremity Embolic Protection Devices Carotid Embolic Protection Devices Renal Embolic Protection Devices


The following table gives the annualized global peripheral embolic protection devices market revenues and CAGRs from 2004 to 2011.

Table 11: Peripheral Embolic Protection Devices Market, Global, Revenue ($m), 2004-2011

2004 2005 2006 2007 2008 2009 2010 2011 CAGR 2004-

2011 (%)

Lower extremity embolic protection devices

Carotid embolic protection devices

Renal embolic protection devices

Total


The global peripheral embolic protection devices market was valued at $XX billion in 2004 and grew at a CAGR of XX% to reach $XXm in 2011, driven by the need to reduce complications by clearing embolic matter released during interventional procedures.




4.12 Synthetic Surgical Grafts Market, Global, Revenue ($m), 2011-2018

The following figure gives the annualized global synthetic surgical grafts market revenues from 2011 to 2018.

Figure 19: Synthetic Surgical Grafts Market, Global, Revenue ($m), 2011-2018

2011 2012 2013 2014 2015 2016 2017 2018

Rev

enue

($m

)


The following table gives the annualized global synthetic surgical grafts market revenues and CAGRs from 2011 to 2018.

Table 16: Synthetic Surgical Grafts Market, Global, Revenue ($m), 2011-2018

2011 2012 2013 2014 2015 2016 2017 2018 CAGR 2011-2018

Synthetic surgical grafts


The global market for synthetic surgical grafts is forecast to decline at a negative CAGR of XX% to $XXm by 2018. Growth will be hindered by higher occlusion rates for smaller diameter grafts. Synthetic surgical grafts may also be replaced by autologous grafts, further negatively impacting growth.



Appendix

9 Appendix

9.1 Definitions

9.1.1 Peripheral Vascular Devices

Peripheral vascular devices are those used to treat PVD. They include peripheral vascular stents, PTA balloons, grafts (allograft and artificial) and embolic protection devices.

9.1.1.1 Peripheral Vascular Stents

A peripheral vascular stent is a tube which is inserted into a blood vessel or a passageway to keep it open. This segment includes stents used to treat PVD in the femoral, popliteal and renal arteries.

Carotid Artery Stent

A carotid artery stent is a tube that is inserted into the carotid artery to increase the flow of blood blocked by plaque. It is generally recommended for people who are unable to undergo an endarterectomy.

Fem-pop Stents

A fem-pop stent is a tiny, expandable metal coil that is inserted into the femoral and popliteal arteries located in the thigh and knee during femoropopliteal artery stenting procedures.

Iliac Artery Stents

An iliac artery stent is a tube that is inserted into a narrowed iliac artery to increase the flow of blood.

Infrapop Stents

An infrapop stent is a tiny, expandable metal coil that is inserted into the tibial, peroneal or pedal arteries to establish a blood flow.

Renal Stents

A renal stent is a tube that is inserted into the renal arteries to increase blood flow to kidneys.

9.1.1.2 Stent Grafts

Aortic stent grafts, either allograft or PTFE, are used to surgically reinforce part of the diseased aorta and are used in cases that cannot be treated with intervention. These include thoracic aortic stent grafts and abdominal aortic stent grafts.

Abdominal Aortic Stent Grafts

Abdominal aortic stent grafts are used to treat AAAs by reinforcing a part of the aorta using a minimally invasive procedure.

Thoracic Aortic Stent Grafts

Thoracic aortic stent grafts are used to treat TAAs by reinforcing a part of the aorta using a minimally invasive procedure.

9.1.1.3 Percutaneous Transluminal Angioplasty Balloons

PTA catheters are used to inflate and compress plaque and dilate the narrowed artery to restore the flow of blood in blocked peripheral arteries.

9.1.1.4 Synthetic Surgical Grafts

Synthetic surgical grafts are vascular grafts made of Dacron or PTFE to repair or replace blood vessels. These grafts are chemically inert and well tolerated by the body

9.1.1.5 Inferior Vena Cava Filters

An IVCF is used during peripheral interventional procedures to prevent debris (thrombus) from reaching the heart and causing an embolism. It includes retrievable IVCFs and permanent IVCFs.

Permanent Inferior Vena Cava Filter

Permanent IVCFs cannot be removed or repositioned.



Appendix

Retrievable Inferior Vena Cava Filters

Temporary or retrievable IVCFs can be retrieved or repositioned up to a certain point of time. This includes both temporary filters that must be retrieved and retrievable filters where retrieval is optional.

9.1.1.6 Peripheral Embolic Protection Devices

Peripheral embolic protection devices prevent the emboli or other debris from blocking and disrupting blood flow.

9.1.1.7 Peripheral Guidewires

Peripheral guidewires are used during PTA to guide the stent or catheter to the site of action in the peripheral vasculature.

9.1.1.8 PTA Peripheral Drug-eluting Balloons

A DEB is an anti-restenotic drug-coated percutaneous transluminal coronary angioplasty balloon intended to prevent re-narrowing of the coronary artery after stent placement. It is designed for the intra-luminal drug application in coronary arteries and peripheral vessels during the treatment of in-stent restenosis, bifurcations, small vessels and long lesions.

9.2 Acronyms

AAA: Abdominal Aortic Aneurysm

CAGR: Compound Annual Growth Rate

CMS: Centers for Medicare and Medicaid Services

DEB: Drug-Eluting Balloon

DES: Drug-Eluting Stent

EVAR: Endovascular Aortic Repair

FDA: Food and Drug Administration

IDE: Investigational Devices Exemption

IVCF: Inferior Vena Cava Filter

PAD: Peripheral Arterial Disease

PE: Pulmonary Embolism

PMA: Pre-Market Approval

PTA: Percutaneous Transluminal Angioplasty

PTFE: Polytetrafluoroethylene

PVD: Peripheral Vascular Disease

SAAAVE: Screen AAAs Very Effectively

SFA: Superficial Femoral Artery

TAA: Thoracic Aortic Aneurysm

TAAA: Thoraco-Abdominal Aortic Aneurysm

VCF: Venous Thromboembolic Event



Appendix

9.3 Sources

American Heart Association (2011). Awareness of peripheral artery disease low among those with highest risk. American Heart Association. Available from: http://newsroom.heart.org/pr/aha/awareness-of-peripheral-artery-214884.aspx. [Accessed on August 14, 2012].

B. Braun Melsungen AG, The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses, (P E P C A D II), NCT00393315. Available from: http://clinicaltrials.gov/ct2/show/NCT00393315. [Accessed on August 27, 2012].

Centers for Disease Control and Prevention (2012). Peripheral Arterial Disease in the Legs. Available from: http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/docs/fs_PAD.pdf. [Accessed on August 17, 2012].

Eickmeyer, F. et al. (2011) Trends in lower extremity surgical and endovascular revascularization in Germany. Vasa; 40(5): 398-403

Harris K (ed.) (2008). The Worldwide Burden of Peripheral Artery Disease. TASC II Intersociety Consensus for Management of PAD. Available from: www.tasc-2-pad.org/upload/SSRubriqueProduit/Fichier2/961.pdf.

Liang P. et al. (2012). The Rise and Fall of Renal Artery Angioplasty and Stenting in the United States, 1988-2009. Available from: http://symposium.scvs.org/abstracts/2012/EP12.cgi. [Accessed on August 28, 2012].

Medtronic Endovascular, IN.PACT Admiral Drug-Eluting Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA) (INPACT SFA II), NCT01566461. Available from: http://clinicaltrials.gov/ct2/show/NCT01566461?term=IN.PACT+SFA+II&rank=1. [Accessed on August 28, 2012].

United States Census Bureau (2012). World Population by Age and Sex [database]. Available from: http://www.census.gov/population/international/data/worldpop/tool_population.php. [Accessed on August 13, 2012].

Veith et al. (2009). Collected World and Single Center Experience with Endovascular Treatment of Ruptured Abdominal Aortic Aneurysms. Annals of Surgery. 2009 Nov;250(5):818-24.

9.4 Research Methodology

GBI Research’s dedicated research and analysis teams consist of experienced professionals in marketing and market research with consulting backgrounds in the medical devices industry and advanced statistical expertise.

GBI Research adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Strategic and Competitive Intelligence Professionals (www.scip.org).

All GBI Research databases are continuously updated and revised. The following research methodology is followed for all databases and reports.

9.4.1 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings.

Industry trade journals, scientific journals and other technical literature.

Internal and external proprietary databases.

Relevant patent and regulatory databases.



Appendix

National government documents, statistical databases and market reports.

Procedure registries.

News articles, press releases and web-casts specific to the companies operating in the market.

9.4.2 Primary Research

GBI Research conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on the market size, market trends, growth trends, competitive landscape and future outlook.

It helps in validating and strengthening the secondary research findings.

It further develops the analysis team’s expertise and market understanding.

Primary research involves email correspondence, telephone interviews and face-to-face interviews for each market, category, segment and sub-segment across geographies.

The participants who typically take part in such a process include, but are not limited to:

Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers.

Hospital stores, laboratories, pharmacies, distributors and paramedics.

Outside experts: investment bankers, valuation experts, research analysts specializing in specific medical equipment markets.

Key opinion leaders: physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment.

9.4.3 Models

Where no hard data is available GBI Research uses modeling and estimates in order to produce comprehensive data sets. The following rigorous methodology is adopted:

Available hard data is cross referenced with the following data types to produce estimates:

Demographic data: population, split by segment.

Macro-economic indicators: Gross Domestic Product, Inflation rate. .

Healthcare Indicators: health expenditure, physician’s base, healthcare infrastructure and facilities.

Selected epidemiological and procedure statistics.

Data is then cross-checked by the expert panel.

All data and assumptions relating to modeling are stored and are available to clients on request.

9.4.4 Forecasts

GBI Research uses proprietary forecast models. The following four factors are utilized in the forecast models:

Historic growth rates.

Macro indicators such as population trends and healthcare spending.

Forecast epidemiological data.

Qualitative trend information and assumptions.

Data is then cross-checked by the expert panel.

All data and assumptions relating to modeling are stored and are available to clients on request.



Appendix

9.4.5 Expert Panels

GBI Research uses a panel of experts to cross verify its databases and forecasts.

GBI Research’s expert panel comprises marketing managers, product specialists, international sales managers from medical device companies; academics from research universities, KOLs from hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment and supplies.

Historic data and forecasts are relayed to GBI Research’s expert panel for feedback and adjusted in accordance with this feedback.

9.6 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research.

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