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REFERENCE CODE GDME1117CFR | PUBLICAT ION DATE OCTOBER 2014
AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
Aortic Stent Grafts – EU Analysis and Market Forecasts 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
Executive Summary
Table below provides the key metrics for aortic
stent grafts in the 5EU (France, Germany, Italy,
Spain, and UK,).
Aortic Stent Grafts, Key Metrics in Major Markets (2013) Procedure Volume of Abdominal Aortic Aneurysms 24,773
(2013) Procedure Volume of Thoracic Aortic Aneurysms 5,981
5EU $288m
Key Events (2012–2019) Impact
(2014) Cordis Corporation of Johnson & Johnson; the INCRAFT endograft is currently undergoing clinical trials in Europe, Japan, and the US; it is expected to be approved in 2014, 2018, and 2017 in each of the territories, respectively.
↑↑↑
(2014) Strong expectation from Endologix to continue to acquire more market share, thereby slicing into the top three players’ shares.
↑↑↑
(2014) Medtronic to acquire Covidien for $42.9bn, which can result in cuts in their endovascular business.
↑↑
(2014) Strong pipeline of stent grafts with good pipeline products from Asian and Western players. ↑↑
Competitive Assessment
Number of Devices in Marketing Phase 56
5EU $445m
Source: GlobalData; primary research interviews with leading vascular surgeons in 5EU 5EU = France, Germany, Italy, Spain, and UK
Sales for Aortic Stent Grafts
The total aortic stent graft sales market in 2013
was estimated to be $288m across the 5EU.
By the end of the forecast, the stent graft sales
market will grow to over $445m, with a Compound
Annual Growth Rate (CAGR) of 6.4%.
The key drivers for the market in the forecast are:
The growing prevalence of aortic aneurysms
along with the aging population across the
globe with hypertension and obesity.
The growing technological advancement in
minimally invasive procedures and the desire
to eliminate the need for open surgical
procedures for aneurysms.
The major underserved population for
minimally invasive aneurysm treatment in the
emerging markets that is driving the procedural
numbers up.
The unmet need for better clinical outcomes
and long-term studies to reduce the risk of
endoleaks and other complications.
Aortic Stent Grafts – EU Analysis and Market Forecasts 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
Executive Summary
Figure below depicts the projected growth revenue
for aortic stent grafts in the 5EU from 2013 to
2020.
Aortic Stent Graft Revenue by Major Market (2013–2020)
18%
35%27%
8%
12%
France
Germany
Italy
Spain
UK
2013$288m
18%
35%28%
8%
11%
2020$445m
Source: GlobalData; primary research interviews and surveys with leading vascular surgeons in the 5EU
The European Union (EU) forms about 24% of the
global share in 2013. The EU is technologically the
most advanced market, with the best availability of
fenestrated and custom stent grafts on the market.
The emerging markets see the most open surgical
procedures, but stent use is restricted due to the
cost of the products and procedures. As training
programs for surgeons increase and product prices
decrease, the emerging markets will present a
strong opportunity for additional revenue for
manufacturers. The overall CAGR across all EU
markets is 6.4%, with XYZ representing the biggest
growth opportunities. The growing concerns for
multinational companies reside with the need to
better target the fast-growing markets and the
need to continue to be the leader in development
to combat the threat of rising local manufacturers.
Technological Trends
Within the last twenty years, endovascular
products have dramatically changed with
development relating to improved navigation,
trackability, and flexibility, as well as with the
stability of access, especially through tortuous
anatomy. Imaging technology has had an immense
impact on the treatment rates and detection of
aneurysms as well. The advances in ultrasound
technology have greatly reduced the incidence of
aneurysm rupture. As a result of better detection,
there can be earlier intervention and fewer open
surgeries, thereby resulting in more stent graft
placement.
Aortic Stent Grafts – EU Analysis and Market Forecasts 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
Executive Summary
The technological developments in endovascular
repair will essentially continue to result in positive
growth. The primary technological drivers include
the development of ultra-low profile systems to
access difficult anatomies and arteries that are
smaller in diameter. The customized fenestrated
products have provided a major opportunity for
physicians to treat a new patient pool that was only
subject to open repair. Thoracic endovascular
aneurysm repair (TEVAR) is also an area that is
still in its infancy, thus yielding low procedure
numbers. As there is more development in those
product lines and as the abdominal aortic stent
graft product matures, there can be a strong
platform for development in the abdominal market
as well. Generally, there is still much room for
development in endovascular aortic repair (EVAR)
and TEVAR, and as the products evolve, there will
be continued growth in this market.
Unmet Needs Remain a Challenge
The complications in endovascular repair usually
occur during or immediately after the procedure,
which must be treated immediately through either
interventional or open surgery methods. Endoleaks
are the most common complication and area of
focus; the remaining complications, such as
paraplegia, infection, and limb thrombosis,
amongst others, occur from time to time and
knowledge of them can help enhance future
product design.
Technological challenges also pose an opportunity
for the development of better products with better
clinical outcomes. The availability of lower profile
systems will continue to improve accessibility.
Customized fenestrated stent grafts will allow more
complicated aneurysms to be treated, thereby
enhancing the potential patient pool. Multi-
branched systems will also allow for more tortuous
anatomy to be treated. Finally, addressing the
need for more long-term clinical data will allow
more surgeons to be comfortable implanting stent
grafts, with the assurance of durability in younger
patients.
Key Players in the Aortic Stent Graft Market
At present, the aortic stent grafts market is still
dominated by the top three players: Cook Medical,
Gore Medical, and Medtronic. The products that
are currently approved and on the market are all of
high quality and each have their strengths with
fixation types. The products in development by
those outside of the top three players are all
innovative in their own way, but a product that will
show superior benefits with a lower or at least
equal cost will be the one to grow the most.
The most talked about emerging player in the
market, based on GlobalData’s key opinion leaders
(KOLs), is Endologix. Endologix has one of the
strongest product pipelines with significantly new
product features and a new approach to treatment
that has the potential to grab a piece of market
share. The next one to three years will determine
the quality of the potential products for Endologix,
Aortic Stent Grafts – EU Analysis and Market Forecasts 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
Executive Summary
based on approval and clinical trials. In the EU, the
top 82% of the EVAR market and top 92% in
TEVAR market belongs to the three companies
mentioned earlier. The ongoing trend in the aortic
stent grafts market is that the leading players will
continue to maintain market share, unless a
disruptive technology in this segment dramatically
changes clinical outcomes.
Aortic Stent Graft Market Future Outlook
The economic downturn has been a source of
continued concern for high priced medical devices
across the global market. The aortic stent grafts
market is not one that is excluded from this trend.
Despite the high product price, physicians still see
a significant benefit in providing endovascular
options versus performing open surgery. As
physician education improves and they have
access to more clinical trial data, the outlook for
the aortic stent grafts looks strong with there being
much room for product improvement.
The market outlook looks strong in the Western
markets, as there is still much room for product
adoption and growth. Regionally, one can expect
slightly different drivers for growth.. In some
countries, the EU market is still restricted by cost,
thereby making physicians choose their patients
carefully before implantation of the device.
The aortic stent grafts market is a moderately
growing market at a CAGR of 6.7% in EU, with
some individual markets boasting a stronger
CAGR over others. Within the 5EU, it is the
cardiovascular sector that is expected to continue
to grow the most in response to the continual
technological developments and physicians’
acceptance of the products’ successful clinical
performance. The EU market is based on, and will
be driven by, the rising prevalence of aortic
aneurysms and the aging population.
GlobalData expects continued growth in this niche
market with the major deterrent, globally, to be
product price once a product is accepted by a
surgeon.
What Do Physicians Think?
Physicians expect the cost of implants to be a
growing concern for practices and hospitals.
“Cost is a major issue all across the board,
specifically here. We try to do everything with the
least cost possible. So, if the grafts are exactly the
same and treat the same problem, then we try to
use the graft that's cheaper.”
Key Opinion Leader
“In an economic downturn, we need to be able to
show that what we do is cost-effective. Many
hospitals, for example, have capped down the
number of procedures that can be done in a year.”
Key Opinion Leader
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
Executive Summary
With regard to the technological trends and
product enhancement expectations, KOLs
speak on what is needed the most today.
“Smaller sheath size, introduction diameter. And
the reason being, is that a major limitation is the
size of the external iliac arteries, disease there, not
allowing you to pass the stent graft up. Lower-
profile delivery devices, which are also in trial.
Actually, they're not on trial. For many companies,
they're brand-new.”
Key Opinion Leader
Physicians discuss government regulations
where reimbursement plays a big part in
choosing to do endovascular repair
procedures.
“We use the product we think we need. The
expensive price is limiting our activity, of course.
So, we have to choose the product by indication.
So, we cannot use these products. More patients;
[we] have to select the best patients to use on this
because of the price, sure.”
Key Opinion Leader
Physicians are interested in solid clinical
studies to prove outcomes in products.
“In all honesty, the specific product features don't
matter as much as the trials that show whether a
device is durable or not. Everyone has their little,
‘We have a hook here,’ and other people have the
supra-aortic stents. ‘We have ones with hooks,
ones without hooks. We have screws that go into
the aortic wall.’ The reality is, unless there's some
sort of published data, everything else is just
theoretical. And to me, that doesn't matter.”
Key Opinion Leader
Physicians talk about the shift from open
surgery to endovascular repair.
“In the smaller hospitals where you have older
surgeons who didn't have endovascular training,
those are the ones who need more experience with
the devices than people like myself, who've been
out about four or five years.”
Key Opinion Leader
“[The] endovascular device, we would use that
almost exclusively, except in super young patients.
Patients less than 60, we offer an open operation
just because it's durable. Technically speaking,
you're fixing the problem both ways. It's just that
we know that open will last 30, 40 years. We still
don't know that about endovascular.”
Key Opinion Leader
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Table of Contents
AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
1 Table of Contents
1 Table of Contents ....................................................................................................................... 7
1.1 List of Tables .................................................................................................................... 15
1.2 List of Figures ................................................................................................................... 20
2 Introduction ............................................................................................................................... 21
2.1 Catalyst ............................................................................................................................. 22
2.2 Related Reports ................................................................................................................ 23
2.3 Upcoming Related Reports ............................................................................................... 23
3 Industry Overview ..................................................................................................................... 24
3.1 Overview ........................................................................................................................... 24
3.2 Indications ......................................................................................................................... 25
3.2.1 Aortic Abdominal Aneurysm .......................................................................................... 25
3.2.2 Thoracic Aortic Aneurysm ............................................................................................. 26
3.2.3 Aortic Dissection ........................................................................................................... 27
3.3 Clinical Outcomes ............................................................................................................. 28
3.3.1 Lifestyle Changes .......................................................................................................... 29
3.3.2 Medication ..................................................................................................................... 30
3.3.3 Open Surgery ................................................................................................................ 30
3.3.4 Endovascular Repair ..................................................................................................... 31
3.4 Procedure Trends ............................................................................................................. 33
3.4.1 EU ................................................................................................................................. 33
3.5 Market Access .................................................................................................................. 35
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
3.5.1 Adoption ........................................................................................................................ 36
3.5.2 Regulation ..................................................................................................................... 41
3.5.3 Reimbursement ............................................................................................................. 42
3.6 Regulatory Issues/Recalls ................................................................................................. 48
3.6.1 Anaconda Back on the Market in March 2014 after a Voluntary Recall of Anaconda by
Vascutek ...................................................................................................................... 48
3.6.2 Terminated FDA’s Class II Recall of TriVascular’s Ovation Prime in April 2014 ............. 48
3.7 Mergers, Deals, and Acquisitions ...................................................................................... 48
3.7.1 Medtronic Acquires Covidien ......................................................................................... 48
3.7.2 TriVascular Launches $100m Initial Public Offering....................................................... 49
3.7.3 Lombard Medical Pursues US Initial Public Offering ...................................................... 49
3.7.4 TriVascular Raises $40m in Series E Financing ............................................................ 49
3.7.5 LifeTech Scientific Creates Partnership with Medtronic ................................................. 49
3.7.6 LeMaitre Vascular Terminates Distribution Agreement with Endologix .......................... 49
3.7.7 Jotec Enters Licensing Agreement with Hydromer ........................................................ 50
3.7.8 Endologix Public Offering of Notes ................................................................................ 50
3.7.9 Aptus Endosystems Secures Financing ........................................................................ 50
3.7.10 Altura Medical Secures Financing ................................................................................. 50
3.7.11 Endologix Acquires Nellix Endovascular ........................................................................ 50
3.8 Economic Impact .............................................................................................................. 51
3.8.1 Economic Impact of Aneurysms .................................................................................... 51
3.8.2 Treatment Costs of Aortic Aneurysms ........................................................................... 52
4 Unmet Needs ............................................................................................................................ 54
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
4.1 Addressing the Complications ........................................................................................... 54
4.1.1 Endoleaks ..................................................................................................................... 54
4.1.2 Ischemic Complications ................................................................................................. 55
4.1.3 Limb Thrombosis ........................................................................................................... 56
4.1.4 Infection ........................................................................................................................ 56
4.1.5 Paraplegia in Thoracic Aortic Aneurysm ........................................................................ 56
4.2 The Seal and Landing Zone .............................................................................................. 57
4.3 Short Neck ........................................................................................................................ 58
4.4 Cost Containment ............................................................................................................. 59
4.5 More Low Profile Systems................................................................................................. 60
4.6 Customized Fenestrated Stent Grafts ............................................................................... 60
4.7 Multi-Branch Stent Grafts .................................................................................................. 61
4.8 Thoracic Endovascular Aneurysm Repair Unmet Needs ................................................... 62
4.9 Long-Term Clinical Data ................................................................................................... 63
5 Market Opportunity Analysis ..................................................................................................... 64
5.1 Emerging Markets ............................................................................................................. 64
5.2 Thoracic Aortic Disease Market ........................................................................................ 65
5.3 Addition of Physician Training Programs ........................................................................... 66
5.4 Disruptive Technologies .................................................................................................... 67
5.5 Minimally Invasive Trend ................................................................................................... 68
6 Market Drivers, Barriers, and Substitutes .................................................................................. 69
6.1 Driver: Rising Disease Prevalence .................................................................................... 69
6.1.1 Diabetes Mellitus ........................................................................................................... 69
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
6.1.2 Hypertension ................................................................................................................. 69
6.1.3 Obesity .......................................................................................................................... 69
6.1.4 Tobacco Use ................................................................................................................. 70
6.2 Driver: Aging ..................................................................................................................... 70
6.3 Driver: Imaging.................................................................................................................. 71
6.4 Driver: Improved Clinical Outcomes with Endovascular Therapy....................................... 72
6.5 Driver: Time Savings ......................................................................................................... 72
6.6 Driver: Patient Demand and Awareness............................................................................ 73
6.7 Driver: Technological Developments ................................................................................. 74
6.7.1 Custom Branched and Fenestrated Stent Grafts ........................................................... 74
6.7.2 Low Profile Delivery Systems ........................................................................................ 74
6.8 Driver: Rising Competition and Innovation ........................................................................ 76
6.9 Barrier: Availability of Venture Capital ............................................................................... 76
6.10 Barrier: Burden of Rising Regulation ................................................................................. 77
6.11 Barrier: High Treatment Cost ............................................................................................ 78
6.12 Barrier: Proving Long-Term Efficacy ................................................................................. 79
6.13 Barrier: High Radiation Dosages with Excessive Imaging ................................................. 80
6.14 Surgical Limitations ........................................................................................................... 80
6.15 Barrier: Medical Device Excise Tax ................................................................................... 81
6.16 Substitute: Open Surgery .................................................................................................. 81
6.17 Substitute: Chimney Technique versus Fenestrated Grafts ............................................... 82
7 Competitive Assessment .......................................................................................................... 84
7.1 Overview ........................................................................................................................... 84
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
7.2 Key Marketed Products ..................................................................................................... 84
7.2.1 Endovascular Aneurysm Repair and Thoracic Endovascular Aneurysm Repair Products
..................................................................................................................................... 84
8 Pipeline Assessment................................................................................................................. 95
8.1 Overview ........................................................................................................................... 95
8.2 Product Profiles ................................................................................................................. 95
8.2.1 Altura Medical Endograft ............................................................................................... 95
8.2.2 Cordis INCRAFT ........................................................................................................... 96
8.2.3 EndoSpan Horizon ........................................................................................................ 97
8.2.4 EndoSpan Nexus .......................................................................................................... 98
8.2.5 MicroPort Scientific Castor Branched Stent Graft System ............................................. 99
8.2.6 BiFlow Medical Novel Side-Branch Stent .................................................................... 100
8.2.7 Endoluminal Sciences Endograft Mechanism .............................................................. 101
8.2.8 Medtronic Valiant Mona LSA Stent Graft System ........................................................ 102
8.2.9 Endologix Ventana Fenestrated Stent Graft ................................................................ 102
9 Clinical Trials to Watch ........................................................................................................... 104
9.1 Overview ......................................................................................................................... 104
9.2 Altura Medical ................................................................................................................. 104
9.3 Cook Medical .................................................................................................................. 105
9.4 Gore Medical .................................................................................................................. 107
9.5 Terumo Corporation ........................................................................................................ 108
9.6 Endologix ........................................................................................................................ 109
9.7 TriVascular ...................................................................................................................... 110
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
9.8 Bolton Medical ................................................................................................................ 111
9.9 Medtronic ........................................................................................................................ 112
9.10 Cordis Corporation .......................................................................................................... 114
10 Current and Future Players ..................................................................................................... 115
10.1 Overview ......................................................................................................................... 115
10.2 Trends in Corporate Strategy .......................................................................................... 115
10.3 Company Profiles ............................................................................................................ 116
10.3.1 Cook Medical .............................................................................................................. 116
10.3.2 Endologix .................................................................................................................... 119
10.3.3 Gore Medical ............................................................................................................... 122
10.3.4 Medtronic .................................................................................................................... 124
10.3.5 Terumo Corporation .................................................................................................... 127
10.3.6 Altura Medical ............................................................................................................. 129
10.3.7 Aptus Endosystems..................................................................................................... 130
10.3.8 Bolton Medical............................................................................................................. 132
10.3.9 Braile Biomédica ......................................................................................................... 134
10.3.10 B. Braun ...................................................................................................................... 137
10.3.11 Cardiatis ...................................................................................................................... 138
10.3.12 LeMaitre Vascular ....................................................................................................... 140
10.3.13 Lifetech Scientific ........................................................................................................ 142
10.3.14 Getinge Group............................................................................................................. 144
10.3.15 Grikin Advanced Materials........................................................................................... 147
10.3.16 Johnson & Johnson’s Cordis Corporation .................................................................... 148
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
10.3.17 Jotec ........................................................................................................................... 150
10.3.18 Lombard Medical ......................................................................................................... 152
10.3.19 MicroPort Scientific Corporation .................................................................................. 153
10.3.20 Nano Endoluminal ....................................................................................................... 156
10.3.21 TriVascular .................................................................................................................. 158
10.3.22 Weike Medical Apparatus and Instrument ................................................................... 161
10.3.23 YTH Biological Material Scitech................................................................................... 161
11 Market Outlook ....................................................................................................................... 162
11.1 Company Market Share .................................................................................................. 162
11.2 By Market Segment......................................................................................................... 163
11.2.1 Overview ..................................................................................................................... 163
11.2.2 Endovascular Aneurysm Repair .................................................................................. 165
11.2.3 Thoracic Endovascular Aneurysm Repair .................................................................... 166
11.3 By Geography ................................................................................................................. 167
11.3.1 EU Overview ............................................................................................................... 167
11.3.2 EU ............................................................................................................................... 170
12 Appendix................................................................................................................................. 182
12.1 Bibliography .................................................................................................................... 182
12.2 Abbreviations .................................................................................................................. 196
12.3 Research Methodology ................................................................................................... 199
12.3.1 Overview ..................................................................................................................... 199
12.3.2 Coverage .................................................................................................................... 199
12.3.3 Secondary Research ................................................................................................... 199
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
12.4 Physicians and Specialists Included in this Study ........................................................... 201
12.4.1 Christopher Abularrage, MD, FACS ............................................................................ 201
12.4.2 Gaspar Mestres Alomar, MD ....................................................................................... 201
12.4.3 Enio Buffolo, MD, PhD ................................................................................................ 201
12.4.4 Ludovic Canaud, MD, PhD .......................................................................................... 201
12.4.5 Holger Eggebrecht, MD ............................................................................................... 201
12.4.6 Daisuke Fukui, MD, PhD ............................................................................................. 201
12.4.7 Germano Melissano, MD ............................................................................................. 201
12.4.8 Dr. Raghuram Sekhar MS, FRCS (Edinburgh), FRCS (Glasgow) ................................ 201
12.4.9 Ferdinand Serracino-Inglott, MD, MSc, FRCSI, FRCS (Gen Surg), DIC ...................... 202
12.4.10 Jiang Xiong, MD, PhD ................................................................................................. 202
12.5 Primary Research ........................................................................................................... 203
12.5.1 Primary Research – Key Opinion Leader Interviews.................................................... 203
12.5.2 Primary Research – Physician and Industry Interviews ............................................... 203
12.5.3 Expert Panel Validation ............................................................................................... 204
12.6 Forecasting Methodology ................................................................................................ 205
12.7 About the Authors ........................................................................................................... 206
12.7.1 Analysts ...................................................................................................................... 206
12.7.2 Global Head of Healthcare .......................................................................................... 207
12.8 About MediPoint .............................................................................................................. 208
12.9 About GlobalData ............................................................................................................ 208
12.10 Disclaimer ....................................................................................................................... 208
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Table of Contents
AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
1.1 List of Tables
Table 1: Summary of Indications, Symptoms, and Treatments ....................................................................... 25
Table 2: Thoracic Aortic Aneurysm Types ...................................................................................................... 27
Table 3: Medications for Reducing Risk of Aneurysm Growth and Rupture .................................................... 30
Table 4: Advantages and Disadvantages of Open Repair versus Endovascular Repair .................................. 32
Table 5: Group Purchasing Organizations in the EU ...................................................................................... 40
Table 6: Regulatory Differences between the US and EU............................................................................... 42
Table 7: Direct and Indirect Costs of Open Surgery and Endovascular Repair ................................................ 52
Table 8: Comparison Costs and Other Variables for Treating AAA By Open Repair and Stent Grafts in 2012
($US) .......................................................................................................................................... 53
Table 9: Endoleak Types ............................................................................................................................... 54
Table 10: Zenith Family Marketed Products ................................................................................................... 86
Table 11: Zenith AAA SWOT ......................................................................................................................... 86
Table 12: Zenith TAA SWOT ......................................................................................................................... 87
Table 13: Endologix’s Marketed Products ...................................................................................................... 88
Table 14: AFX Endovascular SWOT .............................................................................................................. 88
Table 15: IntuiTrak Powerlink System SWOT ................................................................................................. 88
Table 16: Gore Medical’s Marketed Products ................................................................................................. 90
Table 17: Gore AAA Product SWOT .............................................................................................................. 90
Table 18: Gore TAA Product SWOT .............................................................................................................. 91
Table 19: Medtronic’s Marketed Products ...................................................................................................... 92
Table 20: Medtronic AAA Product SWOT ....................................................................................................... 93
Table 21: Medtronic TAA Product SWOT ....................................................................................................... 93
Table 22: Terumo Corporation Marketed Products ......................................................................................... 94
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
able 23: Terumo Corporation AAA Product SWOT ......................................................................................... 94
Table 24: SWOT Analysis – Altura Medical Endograft .................................................................................... 96
Table 25: SWOT Analysis – Cordis INCRAFT ................................................................................................ 97
Table 26: SWOT Analysis – EndoSpan Horizon ............................................................................................. 98
Table 27: SWOT Analysis – EndoSpan Nexus ............................................................................................... 99
Table 28: SWOT Analysis – MicroPort Scientific Castor Branched Stent Graft System ................................. 100
Table 29: SWOT Analysis – BiFlow Medical Novel Side-Branch Stent .......................................................... 101
Table 30: SWOT Analysis – Endoluminal Sciences Endograft Mechanism ................................................... 101
Table 31: SWOT Analysis – Medtronic Valiant Mona LSA Stent Graft .......................................................... 102
Table 32: SWOT Analysis – Endologix Ventana Fenestrated Stent Graft...................................................... 103
Table 33: Major Clinical Trials of Altura Medical’s Aortic Stent Grafts ........................................................... 105
Table 34: Major Clinical Trials of Cook Medical’s Aortic Stent Grafts ............................................................ 106
Table 35: Major Clinical Trials of Gore Medical’s Aortic Stent Grafts............................................................. 107
Table 36: Major Clinical Trials of Terumo’s Aortic Stent Grafts ..................................................................... 108
Table 37: Major Clinical Trials of Endologix’s Aortic Stent Grafts .................................................................. 109
Table 38: Major Clinical Trials of TriVascular’s Aortic Stent Grafts ................................................................ 110
Table 39: Major Clinical Trials of Bolton Medical’s Aortic Stent Grafts .......................................................... 111
Table 40: Major Clinical Trials of Medtronic’s Aortic Stent Grafts .................................................................. 112
Table 41: Major Clinical Trials of Cordis’ Aortic Stent Grafts ......................................................................... 114
Table 42: Company Profile – Cook Medical.................................................................................................. 117
Table 43: Cook Medical Marketed Products ................................................................................................. 118
Table 44: SWOT Analysis – Cook Medical ................................................................................................... 119
Table 45: Company Profile – Endologix Inc. ................................................................................................. 120
Table 46: Endologix Marketed Products ....................................................................................................... 121
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Table 47: Endologix Pipeline Products ......................................................................................................... 121
Table 48: SWOT Analysis – Endologix Inc. .................................................................................................. 121
Table 49: Company Profile – Gore Medical .................................................................................................. 122
Table 50: Gore Medical Marketed Products ................................................................................................. 123
Table 51: SWOT Analysis – Gore Medical ................................................................................................... 124
Table 52: Company Profile – Medtronic ....................................................................................................... 125
Table 53: Medtronic Marketed Products ....................................................................................................... 126
Table 54: SWOT Analysis – Medtronic ......................................................................................................... 126
Table 55: Company Profile – Terumo Corporation........................................................................................ 127
Table 56:Terumo Corporation Marketed Products ........................................................................................ 128
Table 57: SWOT Analysis – Terumo Corporation ......................................................................................... 129
Table 58: Company Profile – Altura Medical Inc. .......................................................................................... 129
Table 59: Altura Medical Inc. Marketed Products ......................................................................................... 130
Table 60: SWOT Analysis – Altura Medical Inc. ........................................................................................... 130
Table 61: Company Profile – Aptus Endosystems, Inc. ................................................................................ 131
Table 62: Aptus Endosystems Inc. Marketed Products ................................................................................. 132
Table 63: SWOT Analysis – Aptus Endosystems Inc. ................................................................................... 132
Table 64: Company Profile – Bolton Medical ................................................................................................ 133
Table 65: Bolton Medical Marketed Products ............................................................................................... 134
Table 66: SWOT Analysis – Bolton Medical ................................................................................................. 134
Table 67: Company Profile – Braile Biomédica............................................................................................. 135
Table 68: Braile Biomédica Marketed Products ............................................................................................ 136
Table 69: SWOT Analysis – Braile Biomédica .............................................................................................. 136
Table 70: Company Profile – B. Braun ......................................................................................................... 137
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Table 71: B. Braun Marketed Products ........................................................................................................ 138
Table 72: SWOT Analysis – B. Braun .......................................................................................................... 138
Table 73: Company Profile – Cardiatis ......................................................................................................... 139
Table 74: Cardiatis Marketed Products ........................................................................................................ 139
Table 75: SWOT Analysis – Cardiatis .......................................................................................................... 140
Table 76: Company Profile – LeMaitre Vascular ........................................................................................... 141
Table 77: LeMaitre Vascular Medical Marketed Products ............................................................................. 141
Table 78: SWOT Analysis – LeMaitre Vascular ............................................................................................ 142
Table 79: Company Profile – Lifetech Scientific............................................................................................ 143
Table 80: Lifetech Scientific Marketed Products ........................................................................................... 143
Table 81: SWOT Analysis – Lifetech Scientific ............................................................................................. 144
Table 82: Company Profile – Getinge Group ................................................................................................ 145
Table 83: Getinge Group Marketed Products ............................................................................................... 146
Table 84: SWOT Analysis – Getinge Group ................................................................................................. 146
Table 85: Company Profile – Grikin Advanced Materials .............................................................................. 147
Table 86: Grikin Advanced Materials Marketed Products ............................................................................. 147
Table 87: SWOT Analysis – Grikin Advanced Materials ............................................................................... 148
Table 88: Company Profile – Johnson & Johnson Cordis Corporation .......................................................... 148
Table 89: Cordis Corporation’s Pipeline Product .......................................................................................... 149
Table 90: SWOT Analysis – Cordis Corporation ........................................................................................... 149
Table 91: Company Profile – Jotec .............................................................................................................. 150
Table 92: Jotec’s Marketed Products ........................................................................................................... 151
Table 93: SWOT Analysis – Jotec ................................................................................................................ 151
Table 94: Company Profile – Lombard Medical ............................................................................................ 152
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Table 95: Lombard Medical Marketed Products ........................................................................................... 153
Table 96: SWOT Analysis – Lombard Medical ............................................................................................. 153
Table 97: Company Profile – Microport Scientific Corporation ...................................................................... 154
Table 98: MicroPort Scientific Marketed Products ........................................................................................ 155
Table 99: SWOT Analysis – MicroPort Scientific .......................................................................................... 156
Table 100: Company Profile – Nano Endoluminal ........................................................................................ 157
Table 101: Nano Endoluminal Medical Marketed Products ........................................................................... 157
Table 102: SWOT Analysis – Nano Endoluminal .......................................................................................... 158
Table 103: Company Profile – TriVascular ................................................................................................... 159
Table 104: TriVascular Marketed Products................................................................................................... 160
Table 105: SWOT Analysis – TriVascular .................................................................................................... 160
Table 106: 5EU Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011–2020 ...................................... 164
Table 107: 5EU Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011–2020 ............................................... 165
Table 108: 5EU Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011–2020 ............................................. 166
Table 109: Aortic Stent Grafts Sales ($m) for the 5EU, 2011–2020 .............................................................. 167
Table 110: Aortic Stent Grafts Sales ($m) Forecast for the 5EU, 2011–2020 ................................................ 170
Table 111: Aortic Stent Grafts Sales ($m) Forecast for France, 2011–2020.................................................. 172
Table 112: Aortic Stent Grafts Sales ($m) Forecast for Germany, 2011–2020 .............................................. 174
Table 113: Aortic Stent Grafts Sales ($m) Forecast for Italy, 2011–2020 ...................................................... 177
Table 114: Aortic Stent Grafts ($m) Forecast for Spain, 2011–2020 ............................................................. 179
Table 115: Aortic Stent Grafts Sales ($m) Forecast for the UK, 2011–2020 .................................................. 181
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
1.2 List of Figures
Figure 1: Treatment Methodology Markov Model ........................................................................................... 29
Figure 2: Aortic Stent Graft Product Image ..................................................................................................... 32
Figure 3: EU Abdominal Aortic Stent Grafts Procedure Volume, 2011–2020 .................................................. 34
Figure 4: EU Thoracic Aortic Stent Grafts Procedure Volume, 2011–2020 ..................................................... 35
Figure 5: EU Market Share for EVAR, 2013 ................................................................................................. 162
Figure 6: EU Market Share for TEVAR, 2013 ............................................................................................... 163
Figure 7: 5EU Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011–2020 ......................................... 164
Figure 8: 5EU Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011–2020 .................................................. 165
Figure 9: 5EU Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011–2020 ................................................ 166
Figure 10: Aortic Stent Grafts Sales ($m) for 5EU, 2011–2020 ..................................................................... 168
Figure 11: Aortic Stent Grafts by Major Market, 2013 and 2020 .................................................................... 169
Figure 12: 5EU Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ...................................................... 171
Figure 13: France Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 .................................................. 173
Figure 14: Germany Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ............................................... 175
Figure 15: Italy Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ....................................................... 177
Figure 16: Spain Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 .................................................... 179
Figure 17: UK Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ........................................................ 181
Figure 18: Aortic Stent Graft Primary Research, Supply and Demand-Side Interviews.................................. 204
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
Introduction
2 Introduction
Aortic stent grafts are most commonly used to reinforce a weak spot in an artery, which is known
as an aneurysm. The stent grafts are designed to seal tightly with the patient’s native artery above
and below the aneurysm, and are used to treat abdominal aortic aneurysms (AAAs) as well as
thoracic aortic aneurysms (TAAs). Aortic aneurysms, as opposed to aneurysms found elsewhere in
the body, are potentially very serious, as a burst aorta results in massive internal bleeding that can
be fatal unless treated rapidly by an experienced emergency medical team. Since their introduction
in patients in 1991, aortic stent graft devices have gained wide acceptance and availability, with
their adoption fueled in great part by advances in stent-graft design and by a variety of devices for
various anatomic features. Over time, these devices have gained traction for use in patients with
ruptured aneurysms because they are minimally invasive and have shorter recovery times.
Based on GlobalData’s key opinion leader (KOL) research, in the more mature Western markets,
about 80% of surgical treatments for aneurysms are treated through endovascular therapy. The
remaining market is treated by open surgical options. This surgical rate is reduced further in the
emerging nations, due to the high product cost. While endovascular therapy has its clear benefits,
there are strong arguments still being made both clinically, and from a cost perspective, to continue
doing open surgery. Overall, this minimally invasive endovascular technique saves hospitalization
costs in the short run while it continues to bring in revenue for hospitals and practices, as several
more of these cases can be scheduled in a day, with shorter surgical times.
From a clinical standpoint, there are a multitude of clinical trials in progress as the stent grafts and
their delivery systems are trending towards lower and lower profile systems, thereby allowing the
products to be used on a wider patient population that previously, was treatable only through open
techniques. Overall, GlobalData expects the procedural data to continue to grow across the
European major markets (5EU) (France, Germany, Italy, Spain and UK,), with the greatest
opportunity being in the emerging nations.
This report focuses on the aortic stent graft implant market for abdominal and TAAs. The
abdominal aortic market comprises about 80–90% of the market, with the niche market being the
thoracic one. The thoracic aneurysm repair market is still a young market where there is a strong
pipeline of products from both the large manufacturers and small emerging players. For most
manufacturers, following the successful launch of an AAA product, the thoracic stent graft segment
presents the opportunity with the most unmet needs for pursuit.
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
Introduction
The 5EU are covered and forecast in this report, which provides the unmet needs, future adoption,
and Compound Annual Growth Rates (CAGRs) in both the abdominal stent graft and thoracic stent
graft markets. GlobalData’s analysis demonstrates this market to be a young and growing market,
subject to rapid technological development and with much room for product adoption.
2.1 Catalyst
Increasing the applicability of aortic stent grafts to patients with difficult anatomic features will
likewise require improvements as well as innovation in device design. Currently, the three most
common anatomic reasons for exclusion from the endovascular repair of AAAs are inappropriate
aortic (proximal) neck access, iliac artery aneurysms, and inadequate iliac access. Researchers
have noted that the next frontier for aortic stent grafts will be the continued adoption and
development of endografts that are capable of treating various types of aortic aneurysms for a
number of different patient anatomies. Further, in order to avoid follow-up on patients with
implanted devices, future aortic stent graft products will have increased durability, refined designs
to allow for treatment in the most difficult anatomies, and advanced abilities to treat aneurysms
involving the renal and visceral segments of the aorta.
There are significant opportunities remaining for companies that can develop slimmer devices with
reduced sheath diameter, improve the fixation of grafts, or add additional features including
branches or fenestrated necks. Currently, some of the most frequently encountered barriers for
aortic stent graft use consist of an inadequate or inappropriate proximal neck anatomy and an
inadequate caliber of iliofemoral access vessels. As such, the ability of devices to accommodate
patients with difficult necks or treacherous access vessels is important. That said, novel bifurcated
endografts along with the development of widely available branched and fenestrated grafts are
expected to address these barriers, thereby improving upon the already remarkable clinical
success of this procedure. This report looks at the current aortic stent grafts market for
cardiovascular disease and evaluates the adoption and opportunities for this technology in the
5EU. In the 5EU region, this market is expected to rise from $288 million in 2014 to $445 million in
2020, at a CAGR of 6.4%.
Currently, some of the most frequently encountered barriers for aortic stent graft use consist of an inadequate or inappropriate proximal neck anatomy and an inadequate caliber of iliofemoral access vessels.
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AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
Introduction
2.2 Related Reports
GlobalData (2012). Bioabsorbable Stents – Global Market Analysis and Forecasts, December
2012, GDME0164MAR
GlobalData (2012). Peripheral Vascular Stents – Global Market Analysis and Forecasts, April
2012, GDME0168MAR
GlobalData (2013). Drug Eluting Balloons – Global Market Analysis and Forecasts, September
2013, GDME0179MAR
GlobalData (2014). Neurovascular Interventions – Global Market Analysis and Forecasts April
2014, GDME0194MAR
2.3 Upcoming Related Reports
GlobalData (2014). Coronary Stents – Global Market Analysis and Forecast, to be published
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Appendix
AORTIC STENT GRAFTS – EU ANALYSIS AND MARKET FORECASTS
12.8 About MediPoint
MediPoint is the flagship product for GlobalData’s Medical team. Each MediPoint report is built
from the ground up by our team of healthcare analysts in the US and UK. Each report includes
input from experienced physicians and leading Key Opinion Leaders (KOLs). Running throughout
each report in the series are, “What Do Physicians Think” quotes, which provide a unique insight
into how healthcare professionals are reacting to events within the industry, and what their
responses could mean for industry strategists.
12.9 About GlobalData
GlobalData is a leading global provider of business intelligence in the healthcare industry.
GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical research and development. Our integrated business
intelligence solutions include a range of interactive online databases, analytical tools, reports, and
forecasts. Our analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, San Francisco, Boston, London, India, Korea, Japan,
Singapore, and Australia.
12.10 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, GlobalData.
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