aortic stent grafts – global analysis and ... trials in europe, japan, and the us; it is expected...

REFERENCE CODE GDME0186MAR | PUBLICATION DATE OCTOBER 2014

AORTIC STENT GRAFTS – GLOBAL ANALYSIS AND MARKET FORECASTS

Aortic Stent Grafts – Global 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.


Executive Summary

Table below provides the key metrics for aortic

stent grafts in the 10 major markets (10MM) (US,

France, Germany, Italy, Spain, UK, Japan, India,

China, and Brazil).

Aortic Stent Grafts, Key Metrics in Major Markets

(2013) Procedure Volume of Abdominal Aortic Aneurysms 82,041

(2013) Procedure Volume of Thoracic Aortic Aneurysms 22,075

2013 Global Market Sales for Aortic Stent Grafts ($m) $1,224m

US $543m

5EU $288m

Asia-Pacific $334m

Brazil $59m

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

2019 Global Market Sales for Aortic Stent Grafts ($m) $1,930m

US $811m

5EU $445m

Asia-Pacific $570m

Brazil $103m

Source: GlobalData; primary research interviews with leading vascular surgeons in 10 markets (US, France, Germany, Italy, Spain, UK, Japan, India, China, and Brazil) 5EU = France, Germany, Italy, Spain, and UK; Asia-Pacific = Japan, India, and China

Sales for Aortic Stent Grafts

The total aortic stent graft sales market in 2013

was estimated to be $1,224m across the 10MM.

By the end of the forecast, the stent graft sales

market will grow to over $1,930m, with a

Compound Annual Growth Rate (CAGR) of 6.7%.

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.



Executive Summary

Figure below depicts the projected growth revenue

for aortic stent grafts in the 10MM from 2013 to

2020.

Aortic Stent Graft Revenue by Major Market (2013–2020)

53.2%

3.1%7.5%

2.0%

2.8%

3.0%

13.0%

3.6%

3.7%5.3%

US

France

Germany

Italy

Spain

UK

Japan

Brazil

China

India

2013$1.2bn

59.8%2.8%

7.6%

1.8%2.2%2.8%

9.6%

3.0%3.1% 4.8%

2020$1.9bn

Source: GlobalData; primary research interviews and surveys with leading vascular surgeons in the 10MM.

The US market consists of the largest portion of

the aortic stent graft market. The US and European

Union (EU) combined formed close to 70% of the

global share in 2013. In the remaining markets,

Japan is the largest with China and Brazil to follow.

India is by far, the smallest market. 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 10 markets is 6.7%, with

Japan and China 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



Executive Summary

aneurysm rupture. Within the emerging markets,

these imaging techniques represent an opportunity

for stent graft manufacturers to continue training

programs for better detecting the aneurysms that

are asymptomatic. As a result of better detection,

there can be earlier intervention and fewer open

surgeries, thereby resulting in more stent graft

placement.

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, especially in the Asian

population. The customized fenestrated products

have provided a major opportunity for physicians to

treat a new patient pool that was only subject to

open repair. As more of these products are

approved in the US and other markets, there can

be a strong case for greater product adoption.

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



Executive Summary

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,

based on approval and clinical trials. Globally, the

top 88% of the EVAR market and top 91% in

TEVAR market belongs to the three companies

mentioned earlier. The emerging markets are still

dominated by the top three manufacturers as well,

although the emerging markets also have a

growing number of local players within Brazil,

China, and Japan. India represents the smallest of

the emerging markets, with the potential to grow

upon lower product prices and an increase of

product availability. 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. The US market

is expected to see a significant amount of growth

once there is more availability of the customized

grafts. In some countries, the EU market is still

restricted by cost, thereby making physicians

choose their patients carefully before implantation

of the device. Finally, the markets such as Japan,

China, and Brazil are seeing emerging competition

from smaller firms, which will provide a landscape

for pressuring large firms to reduce product prices.

The aortic stent grafts market is a moderately

growing market at a CAGR of 6.7% globally, with

some individual markets boasting a stronger

CAGR over others. Within the 10MM, 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 global market is based on, and

will be driven by, the rising prevalence of aortic

aneurysms and the aging population.



Executive Summary

Countries to watch are India and China, but these

markets depend heavily on physician comfort with

the procedure itself and the availability of new

products beyond the major cities and the

distribution networks. 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

“I can frankly tell you that if the cost doesn’t come

down, there’s going to be a stagnation. Because

cost is huge now and it’s only done in a few

corporate centers in India; big corporate centers in

India where they have access to everything…

Even the top guys doing the procedure – they also

think the same thing. Even at their level, cost is a

major issue.”

Key Opinion Leader

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.



Executive Summary

“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

“They are capitated. I know [in] Canada, they limit

the number of procedures they can do in a year.

I'm allowed to do 20 a year, and after that, they

[patients] all get open [surgery]. So, socialized

medicine does that a lot.”

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


Table of Contents


1 Table of Contents

1 Table of Contents ....................................................................................................................... 8

1.1 List of Tables .................................................................................................................... 16

1.2 List of Figures ................................................................................................................... 22

2 Introduction ............................................................................................................................... 24

2.1 Catalyst ............................................................................................................................. 25

2.2 Related Reports ................................................................................................................ 26

2.3 Upcoming Related Reports ............................................................................................... 26

3 Industry Overview ..................................................................................................................... 27

3.1 Overview ........................................................................................................................... 27

3.2 Indications ......................................................................................................................... 28

3.2.1 Aortic Abdominal Aneurysm .......................................................................................... 28

3.2.2 Thoracic Aortic Aneurysm ............................................................................................. 29

3.2.3 Aortic Dissection ........................................................................................................... 30

3.3 Clinical Outcomes ............................................................................................................. 31

3.3.1 Lifestyle Changes .......................................................................................................... 32

3.3.2 Medication ..................................................................................................................... 33

3.3.3 Open Surgery ................................................................................................................ 33

3.3.4 Endovascular Repair ..................................................................................................... 34

3.4 Procedure Trends ............................................................................................................. 36

3.4.1 Global............................................................................................................................ 36

3.4.2 US ................................................................................................................................. 39


Table of Contents


3.4.3 EU ................................................................................................................................. 41

3.4.4 Asia-Pacific ................................................................................................................... 43

3.4.5 South America............................................................................................................... 46

3.5 Market Access .................................................................................................................. 48

3.5.1 Adoption ........................................................................................................................ 50

3.5.2 Regulation ..................................................................................................................... 57

3.5.3 Reimbursement ............................................................................................................. 63

3.6 Regulatory Issues/Recalls ................................................................................................. 76

3.6.1 Anaconda Back on the Market in March 2014 after a Voluntary Recall of Anaconda by

Vascutek ...................................................................................................................... 76

3.6.2 Terminated FDA’s Class II Recall of TriVascular’s Ovation Prime in April 2014 ............. 76

3.7 Mergers, Deals, and Acquisitions ...................................................................................... 76

3.7.1 Medtronic Acquires Covidien ......................................................................................... 76

3.7.2 TriVascular Launches $100m Initial Public Offering....................................................... 77

3.7.3 Lombard Medical Pursues US Initial Public Offering ...................................................... 77

3.7.4 TriVascular Raises $40m in Series E Financing ............................................................ 77

3.7.5 LifeTech Scientific Creates Partnership with Medtronic ................................................. 77

3.7.6 LeMaitre Vascular Terminates Distribution Agreement with Endologix .......................... 78

3.7.7 Jotec Enters Licensing Agreement with Hydromer ........................................................ 78

3.7.8 Endologix Public Offering of Notes ................................................................................ 78

3.7.9 Aptus Endosystems Secures Financing ........................................................................ 78

3.7.10 Altura Medical Secures Financing ................................................................................. 78

3.7.11 Endologix Acquires Nellix Endovascular ........................................................................ 79


Table of Contents


3.8 Economic Impact .............................................................................................................. 79

3.8.1 Economic Impact of Aneurysms .................................................................................... 79

3.8.2 Treatment Costs of Aortic Aneurysms ........................................................................... 80

4 Unmet Needs ............................................................................................................................ 82

4.1 Addressing the Complications ........................................................................................... 82

4.1.1 Endoleaks ..................................................................................................................... 82

4.1.2 Ischemic Complications ................................................................................................. 83

4.1.3 Limb Thrombosis ........................................................................................................... 84

4.1.4 Infection ........................................................................................................................ 84

4.1.5 Paraplegia in Thoracic Aortic Aneurysm ........................................................................ 84

4.2 The Seal and Landing Zone .............................................................................................. 85

4.3 Short Neck ........................................................................................................................ 86

4.4 Cost Containment ............................................................................................................. 87

4.5 More Low Profile Systems................................................................................................. 88

4.6 Customized Fenestrated Stent Grafts ............................................................................... 89

4.7 Multi-Branch Stent Grafts .................................................................................................. 90

4.8 Thoracic Endovascular Aneurysm Repair Unmet Needs ................................................... 91

4.9 Long-Term Clinical Data ................................................................................................... 92

5 Market Opportunity Analysis ..................................................................................................... 93

5.1 Emerging Markets ............................................................................................................. 93

5.2 Thoracic Aortic Disease Market ........................................................................................ 94

5.3 Addition of Physician Training Programs ........................................................................... 95

5.4 Disruptive Technologies .................................................................................................... 96


Table of Contents


5.5 Minimally Invasive Trend ................................................................................................... 97

6 Market Drivers, Barriers, and Substitutes .................................................................................. 98

6.1 Driver: Rising Disease Prevalence .................................................................................... 98

6.1.1 Diabetes Mellitus ........................................................................................................... 98

6.1.2 Hypertension ................................................................................................................. 98

6.1.3 Obesity .......................................................................................................................... 99

6.1.4 Tobacco Use ................................................................................................................. 99

6.2 Driver: Aging ..................................................................................................................... 99

6.3 Driver: Imaging................................................................................................................ 100

6.4 Driver: Improved Clinical Outcomes with Endovascular Therapy..................................... 101

6.5 Driver: Time Savings ....................................................................................................... 102

6.6 Driver: Patient Demand and Awareness.......................................................................... 102

6.7 Driver: Technological Developments ............................................................................... 103

6.7.1 Custom Branched and Fenestrated Stent Grafts ......................................................... 103

6.7.2 Low Profile Delivery Systems ...................................................................................... 104

6.8 Driver: Rising Competition and Innovation ...................................................................... 105

6.9 Barrier: Availability of Venture Capital ............................................................................. 105

6.10 Barrier: Burden of Rising Regulation ............................................................................... 106

6.11 Barrier: High Treatment Cost .......................................................................................... 107

6.12 Barrier: Proving Long-Term Efficacy ............................................................................... 109

6.13 Barrier: High Radiation Dosages with Excessive Imaging ............................................... 109

6.14 Surgical Limitations ......................................................................................................... 110

6.15 Barrier: Medical Device Excise Tax ................................................................................. 110


Table of Contents


6.16 Substitute: Open Surgery ................................................................................................ 111

6.17 Substitute: Chimney Technique versus Fenestrated Grafts ............................................. 112

7 Competitive Assessment ........................................................................................................ 114

7.1 Overview ......................................................................................................................... 114

7.2 Key Marketed Products ................................................................................................... 114

7.2.1 Endovascular Aneurysm Repair and Thoracic Endovascular Aneurysm Repair Products

................................................................................................................................... 114

8 Pipeline Assessment............................................................................................................... 125

8.1 Overview ......................................................................................................................... 125

8.2 Product Profiles ............................................................................................................... 125

8.2.1 Altura Medical Endograft ............................................................................................. 125

8.2.2 Cordis INCRAFT ......................................................................................................... 126

8.2.3 EndoSpan Horizon ...................................................................................................... 127

8.2.4 EndoSpan Nexus ........................................................................................................ 128

8.2.5 MicroPort Scientific Castor Branched Stent Graft System ........................................... 129

8.2.6 BiFlow Medical Novel Side-Branch Stent .................................................................... 130

8.2.7 Endoluminal Sciences Endograft Mechanism .............................................................. 131

8.2.8 Medtronic Valiant Mona LSA Stent Graft System ........................................................ 132

8.2.9 Endologix Ventana Fenestrated Stent Graft ................................................................ 132

9 Clinical Trials to Watch ........................................................................................................... 134

9.1 Overview ......................................................................................................................... 134

9.2 Altura Medical ................................................................................................................. 134

9.3 Cook Medical .................................................................................................................. 135


Table of Contents


9.4 Gore Medical .................................................................................................................. 137

9.5 Terumo Corporation ........................................................................................................ 138

9.6 Endologix ........................................................................................................................ 138

9.7 TriVascular ...................................................................................................................... 139

9.8 Bolton Medical ................................................................................................................ 140

9.9 Medtronic ........................................................................................................................ 141

9.10 Cordis Corporation .......................................................................................................... 143

10 Current and Future Players ..................................................................................................... 144

10.1 Overview ......................................................................................................................... 144

10.2 Trends in Corporate Strategy .......................................................................................... 144

10.3 Company Profiles ............................................................................................................ 145

10.3.1 Cook Medical .............................................................................................................. 145

10.3.2 Endologix .................................................................................................................... 148

10.3.3 Gore Medical ............................................................................................................... 151

10.3.4 Medtronic .................................................................................................................... 153

10.3.5 Terumo Corporation .................................................................................................... 156

10.3.6 Altura Medical ............................................................................................................. 158

10.3.7 Aptus Endosystems..................................................................................................... 159

10.3.8 Bolton Medical............................................................................................................. 161

10.3.9 Braile Biomédica ......................................................................................................... 163

10.3.10 B. Braun ...................................................................................................................... 166

10.3.11 Cardiatis ...................................................................................................................... 167

10.3.12 LeMaitre Vascular ....................................................................................................... 169


Table of Contents


10.3.13 Lifetech Scientific ........................................................................................................ 171

10.3.14 Getinge Group............................................................................................................. 173

10.3.15 Grikin Advanced Materials........................................................................................... 176

10.3.16 Johnson & Johnson’s Cordis Corporation .................................................................... 177

10.3.17 Jotec ........................................................................................................................... 179

10.3.18 Lombard Medical ......................................................................................................... 181

10.3.19 MicroPort Scientific Corporation .................................................................................. 182

10.3.20 Nano Endoluminal ....................................................................................................... 185

10.3.21 TriVascular .................................................................................................................. 187

10.3.22 Weike Medical Apparatus and Instrument ................................................................... 190

10.3.23 YTH Biological Material Scitech................................................................................... 190

11 Market Outlook ....................................................................................................................... 191

11.1 Company Market Share .................................................................................................. 191

11.1.1 Global Market Share ................................................................................................... 191

11.1.2 US Market Share ......................................................................................................... 194

11.1.3 EU Market Share ......................................................................................................... 196

11.2 By Market Segment......................................................................................................... 198

11.2.1 Overview ..................................................................................................................... 198

11.2.2 Endovascular Aneurysm Repair .................................................................................. 199

11.2.3 Thoracic Endovascular Aneurysm Repair .................................................................... 200

11.3 By Geography ................................................................................................................. 201

11.3.1 Global Overview .......................................................................................................... 201

11.3.2 US ............................................................................................................................... 205


Table of Contents


11.3.3 EU ............................................................................................................................... 207

11.3.4 Asia-Pacific ................................................................................................................. 219

11.3.5 South America............................................................................................................. 228

12 Appendix................................................................................................................................. 231

12.1 Bibliography .................................................................................................................... 231

12.2 Abbreviations .................................................................................................................. 247

12.3 Research Methodology ................................................................................................... 251

12.3.1 Overview ..................................................................................................................... 251

12.3.2 Coverage .................................................................................................................... 251

12.3.3 Secondary Research ................................................................................................... 251

12.4 Physicians and Specialists Included in this Study ........................................................... 253

12.4.1 Christopher Abularrage, MD, FACS ............................................................................ 253

12.4.2 Gaspar Mestres Alomar, MD ....................................................................................... 253

12.4.3 Enio Buffolo, MD, PhD ................................................................................................ 253

12.4.4 Ludovic Canaud, MD, PhD .......................................................................................... 253

12.4.5 Holger Eggebrecht, MD ............................................................................................... 253

12.4.6 Daisuke Fukui, MD, PhD ............................................................................................. 253

12.4.7 Germano Melissano, MD ............................................................................................. 253

12.4.8 Dr. Raghuram Sekhar MS, FRCS (Edinburgh), FRCS (Glasgow) ................................ 253

12.4.9 Ferdinand Serracino-Inglott, MD, MSc, FRCSI, FRCS (Gen Surg), DIC ...................... 254

12.4.10 Jiang Xiong, MD, PhD ................................................................................................. 254

12.5 Primary Research ........................................................................................................... 255

12.5.1 Primary Research – Key Opinion Leader Interviews.................................................... 255


Table of Contents


12.5.2 Primary Research – Physician and Industry Interviews ............................................... 255

12.5.3 Expert Panel Validation ............................................................................................... 256

12.6 Forecasting Methodology ................................................................................................ 257

12.7 About the Authors ........................................................................................................... 258

12.7.1 Analysts ...................................................................................................................... 258

12.7.2 Global Head of Healthcare .......................................................................................... 259

12.8 About MediPoint .............................................................................................................. 260

12.9 About GlobalData ............................................................................................................ 260

12.10 Disclaimer ....................................................................................................................... 260

1.1 List of Tables

Table 1: Summary of Indications, Symptoms, and Treatments ....................................................................... 28

Table 2: Thoracic Aortic Aneurysm Types ...................................................................................................... 30

Table 3: Medications for Reducing Risk of Aneurysm Growth and Rupture .................................................... 33

Table 4: Advantages and Disadvantages of Open Repair versus Endovascular Repair .................................. 35

Table 5: Global Abdominal Aortic Stent Grafts Procedure Volume, 2011–2020 .............................................. 36

Table 6: Global Thoracic Aortic Stent Grafts Procedure Volume, 2011–2020 ................................................ 38

Table 7: Group Purchasing Organizations in the US and EU .......................................................................... 56

Table 8: Regulatory Differences between the US and EU............................................................................... 58

Table 9: Medicare National Average of Inpatient Hospital Payment for EVAR and TEVAR, 2013–2014 .......... 65

Table 10: Medicare Coding Guide for EVAR and TEVAR, 2014 ..................................................................... 65

Table 11: Direct and Indirect Costs of Open Surgery and Endovascular Repair .............................................. 81

Table 12: Comparison Costs and Other Variables for Treating AAA By Open Repair and Stent Grafts in 2012

($US) .......................................................................................................................................... 81


Table of Contents


Table 13: Endoleak Types ............................................................................................................................. 82

Table 14: Zenith Family Marketed Products ................................................................................................. 116

Table 15: Zenith AAA SWOT ....................................................................................................................... 116

Table 16: Zenith TAA SWOT ....................................................................................................................... 117

Table 17: Endologix’s Marketed Products .................................................................................................... 118

Table 18: AFX Endovascular SWOT ............................................................................................................ 118

Table 19: IntuiTrak Powerlink System SWOT ............................................................................................... 118

Table 20: Gore Medical’s Marketed Products ............................................................................................... 120

Table 21: Gore AAA Product SWOT ............................................................................................................ 120

Table 22: Gore TAA Product SWOT ............................................................................................................ 121

Table 23: Medtronic’s Marketed Products .................................................................................................... 122

Table 24: Medtronic AAA Product SWOT ..................................................................................................... 123

Table 25: Medtronic TAA Product SWOT ..................................................................................................... 123

Table 26: Terumo Corporation Marketed Products ....................................................................................... 124

able 27: Terumo Corporation AAA Product SWOT ....................................................................................... 124

Table 28: SWOT Analysis – Altura Medical Endograft .................................................................................. 126

Table 29: SWOT Analysis – Cordis INCRAFT .............................................................................................. 127

Table 30: SWOT Analysis – EndoSpan Horizon ........................................................................................... 128

Table 31: SWOT Analysis – EndoSpan Nexus ............................................................................................. 129

Table 32: SWOT Analysis – MicroPort Scientific Castor Branched Stent Graft System ................................. 130

Table 33: SWOT Analysis – BiFlow Medical Novel Side-Branch Stent .......................................................... 131

Table 34: SWOT Analysis – Endoluminal Sciences Endograft Mechanism ................................................... 131

Table 35: SWOT Analysis – Medtronic Valiant Mona LSA Stent Graft .......................................................... 132

Table 36: SWOT Analysis – Endologix Ventana Fenestrated Stent Graft...................................................... 133


Table of Contents


Table 37: Major Clinical Trials of Altura Medical’s Aortic Stent Grafts ........................................................... 135

Table 38: Major Clinical Trials of Cook Medical’s Aortic Stent Grafts ............................................................ 136

Table 39: Major Clinical Trials of Gore Medical’s Aortic Stent Grafts............................................................. 137

Table 40: Major Clinical Trials of Terumo’s Aortic Stent Grafts ..................................................................... 138

Table 41: Major Clinical Trials of Endologix’s Aortic Stent Grafts .................................................................. 139

Table 42: Major Clinical Trials of TriVascular’s Aortic Stent Grafts ................................................................ 140

Table 43: Major Clinical Trials of Bolton Medical’s Aortic Stent Grafts .......................................................... 141

Table 44: Major Clinical Trials of Medtronic’s Aortic Stent Grafts .................................................................. 142

Table 45: Major Clinical Trials of Cordis’ Aortic Stent Grafts ......................................................................... 143

Table 46: Company Profile – Cook Medical.................................................................................................. 146

Table 47: Cook Medical Marketed Products ................................................................................................. 147

Table 48: SWOT Analysis – Cook Medical ................................................................................................... 148

Table 49: Company Profile – Endologix Inc. ................................................................................................. 149

Table 50: Endologix Marketed Products ....................................................................................................... 150

Table 51: Endologix Pipeline Products ......................................................................................................... 150

Table 52: SWOT Analysis – Endologix Inc. .................................................................................................. 150

Table 53: Company Profile – Gore Medical .................................................................................................. 151

Table 54: Gore Medical Marketed Products ................................................................................................. 152

Table 55: SWOT Analysis – Gore Medical ................................................................................................... 153

Table 56: Company Profile – Medtronic ....................................................................................................... 154

Table 57: Medtronic Marketed Products ....................................................................................................... 155

Table 58: SWOT Analysis – Medtronic ......................................................................................................... 155

Table 59: Company Profile – Terumo Corporation........................................................................................ 156

Table 60:Terumo Corporation Marketed Products ........................................................................................ 157


Table of Contents


Table 61: SWOT Analysis – Terumo Corporation ......................................................................................... 158

Table 62: Company Profile – Altura Medical Inc. .......................................................................................... 158

Table 63: Altura Medical Inc. Marketed Products ......................................................................................... 159

Table 64: SWOT Analysis – Altura Medical Inc. ........................................................................................... 159

Table 65: Company Profile – Aptus Endosystems, Inc. ................................................................................ 160

Table 66: Aptus Endosystems Inc. Marketed Products ................................................................................. 161

Table 67: SWOT Analysis – Aptus Endosystems Inc. ................................................................................... 161

Table 68: Company Profile – Bolton Medical ................................................................................................ 162

Table 69: Bolton Medical Marketed Products ............................................................................................... 163

Table 70: SWOT Analysis – Bolton Medical ................................................................................................. 163

Table 71: Company Profile – Braile Biomédica............................................................................................. 164

Table 72: Braile Biomédica Marketed Products ............................................................................................ 165

Table 73: SWOT Analysis – Braile Biomédica .............................................................................................. 165

Table 74: Company Profile – B. Braun ......................................................................................................... 166

Table 75: B. Braun Marketed Products ........................................................................................................ 167

Table 76: SWOT Analysis – B. Braun .......................................................................................................... 167

Table 77: Company Profile – Cardiatis ......................................................................................................... 168

Table 78: Cardiatis Marketed Products ........................................................................................................ 168

Table 79: SWOT Analysis – Cardiatis .......................................................................................................... 169

Table 80: Company Profile – LeMaitre Vascular ........................................................................................... 170

Table 81: LeMaitre Vascular Medical Marketed Products ............................................................................. 170

Table 82: SWOT Analysis – LeMaitre Vascular ............................................................................................ 171

Table 83: Company Profile – Lifetech Scientific............................................................................................ 172

Table 84: Lifetech Scientific Marketed Products ........................................................................................... 172


Table of Contents


Table 85: SWOT Analysis – Lifetech Scientific ............................................................................................. 173

Table 86: Company Profile – Getinge Group ................................................................................................ 174

Table 87: Getinge Group Marketed Products ............................................................................................... 175

Table 88: SWOT Analysis – Getinge Group ................................................................................................. 175

Table 89: Company Profile – Grikin Advanced Materials .............................................................................. 176

Table 90: Grikin Advanced Materials Marketed Products ............................................................................. 176

Table 91: SWOT Analysis – Grikin Advanced Materials ............................................................................... 177

Table 92: Company Profile – Johnson & Johnson Cordis Corporation .......................................................... 177

Table 93: Cordis Corporation’s Pipeline Product .......................................................................................... 178

Table 94: SWOT Analysis – Cordis Corporation ........................................................................................... 178

Table 95: Company Profile – Jotec .............................................................................................................. 179

Table 96: Jotec’s Marketed Products ........................................................................................................... 180

Table 97: SWOT Analysis – Jotec ................................................................................................................ 180

Table 98: Company Profile – Lombard Medical ............................................................................................ 181

Table 99: Lombard Medical Marketed Products ........................................................................................... 182

Table 100: SWOT Analysis – Lombard Medical ........................................................................................... 182

Table 101: Company Profile – Microport Scientific Corporation .................................................................... 183

Table 102: MicroPort Scientific Marketed Products ...................................................................................... 184

Table 103: SWOT Analysis – MicroPort Scientific ........................................................................................ 185

Table 104: Company Profile – Nano Endoluminal ........................................................................................ 186

Table 105: Nano Endoluminal Medical Marketed Products ........................................................................... 186

Table 106: SWOT Analysis – Nano Endoluminal .......................................................................................... 187

Table 107: Company Profile – TriVascular ................................................................................................... 188

Table 108: TriVascular Marketed Products................................................................................................... 189


Table of Contents


Table 109: SWOT Analysis – TriVascular .................................................................................................... 189

Table 110: Global Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011–2020 ................................... 198

Table 111: Global Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011–2020 ............................................ 199

Table 112: Global Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011–2020 .......................................... 201

Table 113: Aortic Stent Grafts Sales ($m) for the Major Markets, 2011–2020 ............................................... 202

Table 114: Aortic Stent Grafts Sales ($m) for the US, 2011–2020 ................................................................ 205

Table 115: Aortic Stent Grafts Sales ($m) Forecast for the 5EU, 2011–2020 ................................................ 208

Table 116: Aortic Stent Grafts Sales ($m) Forecast for France, 2011–2020.................................................. 210

Table 117: Aortic Stent Grafts Sales ($m) Forecast for Germany, 2011–2020 .............................................. 212

Table 118: Aortic Stent Grafts Sales ($m) Forecast for Italy, 2011–2020 ...................................................... 215

Table 119: Aortic Stent Grafts ($m) Forecast for Spain, 2011–2020 ............................................................. 217

Table 120: Aortic Stent Grafts Sales ($m) Forecast for the UK, 2011–2020 .................................................. 219

Table 121: Aortic Stent Grafts Sales ($m) Forecast for the APAC Region, 2011–2020 ................................. 220

Table 122: Aortic Stent Grafts Sales ($m) Forecast for Japan, 2011–2020 ................................................... 223

Table 123: Aortic Stent Grafts Sales ($m) Forecast for China, 2011–2020 ................................................... 224

Table 124: Aortic Stent Grafts Sales ($m) Forecast for India, 2011–2020 ..................................................... 227

Table 125: Aortic Stent Grafts Sales ($m) Forecast for Brazil, 2011–2020 .................................................... 230


Table of Contents


1.2 List of Figures

Figure 1: Treatment Methodology Markov Model ........................................................................................... 32

Figure 2: Aortic Stent Graft Product Image ..................................................................................................... 35

Figure 3: Global Abdominal Aortic Stent Grafts Procedure Volume, 2011–2020 ............................................. 37

Figure 4: Global Thoracic Aortic Stent Grafts Procedure Volume, 2011–2020 ................................................ 38

Figure 5: US Abdominal Aortic Stent Grafts Procedure Volume, 2011–2020 .................................................. 40

Figure 6: US Thoracic Aortic Stent Grafts Procedure Volume, 2011–2020 ..................................................... 41

Figure 7: EU Abdominal Aortic Stent Grafts Procedure Volume, 2011–2020 .................................................. 42

Figure 8: EU Thoracic Aortic Stent Grafts Procedure Volume, 2011–2020 ..................................................... 43

Figure 9: APAC Abdominal Aortic Stent Grafts Procedure Volume, 2011–2020 .............................................. 45

Figure 10: APAC Thoracic Aortic Stent Grafts Procedure Volume, 2011–2020 ............................................... 46

Figure 11: South America Abdominal Aortic Stent Grafts Procedure Volume, 2011–2020 .............................. 47

Figure 12: South America Thoracic Aortic Stent Grafts Procedure Volume, 2011–2020.................................. 48

Figure 13: Global Market Share for EVAR, 2013 .......................................................................................... 193

Figure 14: Global Market Share for TEVAR, 2013 ........................................................................................ 194

Figure 15: US Market Share for EVAR, 2013 ............................................................................................... 195

Figure 16: US Market Share for TEVAR, 2013 ............................................................................................. 196

Figure 17: EU Market Share for EVAR, 2013 ............................................................................................... 197

Figure 18: EU Market Share for TEVAR, 2013 ............................................................................................. 197

Figure 19: Global Aortic Stent Grafts Sales ($m) Forecast, by Segment, 2011–2020.................................... 199

Figure 20: Global Aortic Stent Grafts Sales ($m) Forecast, EVAR, 2011–2020 ............................................. 200

Figure 21: Global Aortic Stent Grafts Sales ($m) Forecast, TEVAR, 2011–2020........................................... 201

Figure 22: Aortic Stent Grafts Sales ($m) for the Major Markets, 2011–2020 ................................................ 203

Figure 23: Aortic Stent Grafts by Major Market, 2013 and 2020 .................................................................... 204


Table of Contents


Figure 24: US Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ........................................................ 206

Figure 25: 5EU Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ...................................................... 209

Figure 26: France Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 .................................................. 211

Figure 27: Germany Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ............................................... 213

Figure 28: Italy Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ....................................................... 215

Figure 29: Spain Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 .................................................... 217

Figure 30: UK Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 ........................................................ 219

Figure 31: APAC Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 .................................................... 221

Figure 32: Japan Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 .................................................... 223

Figure 33: China Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 .................................................... 225

Figure 34: India Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020...................................................... 228

Figure 35: Brazil Sales ($m) Forecast for Aortic Stent Grafts, 2011–2020 .................................................... 230

Figure 36: Aortic Stent Graft Primary Research, Supply and Demand-Side Interviews.................................. 256



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 10

major markets (10MM) (US, France, Germany, Italy, Spain, UK, Japan, India, China, and Brazil),

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.



Introduction

The 10MM 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

10MM. Globally, this market is expected to rise from $1.3 billion in 2014 to $1.9 billion in 2020, at a

CAGR of 6.7%.

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.



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


Appendix


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. The MediPoint series also features Excel-based

forecast models that are robust, fully transparent, and easy to navigate. Moreover, our models

support the data that is presented in the reports, and the complete methodology is outlined in the

report and the model.

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.

aortic stent grafts – global analysis and ... trials in europe, japan, and the us; it is expected...

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