gdme1002fpr bioabsorbable stents - current and …bioabsorbable stents future outlook bioabsorbable...
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Bioabsorbable Stents Current and Future Players
GDME1002FPR / Published December 2012
Executive Summary
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Bioabsorbable Stents, Key Metrics in the Major Markets
Diagnosed Prevalence
Coronary Artery Disease 4.5 million
Peripheral Artery Disease 4.1 million
2011 Market Sales ($m)
Coronary Market $0.39m
Peripheral Market $0.24m
Total $0.63m
Pipeline Assessment
Number of stents at preclinical phase 9
Number of stents at early clinical phase 5
Number of stent at late clinical phase 4
Stents for coronary artery disease 67%
Stents for peripheral artery disease 33%
Key events (2011-2018) Level of Impact
Commercial launch of DREAMS stent for coronary artery disease in 2014 in the EU
↑↑
Commercial launch of ReZolve stent for coronary artery disease in 2014 in the EU
↑↑
Commercial launch of Absorb BVS and DREAMS stent in the US in 2015
↑↑↑
2018 Market Sales ($m)
US $319m
5 EU $383m
Total $702m
Source: GlobalData Note: 5 EU = France, Germany, Italy, Spain and UK.
Sales for Bioabsorbable Stents by Region
We estimate 2012 Bioabsorbable Stent sales to be
$4.2m across the six regions covered in this report, which
are the US, France, Germany, Italy, Spain and the UK.
The coronary bioabsorbable stent market is expected to
have a larger market share than the peripheral
bioabsorbable stent market, with the stent sales in the
coronary market expected to be 15 times that of the
peripheral market.
By the end of the forecast period, sales will grow to over
$702m with a CAGR of 172%.
The key drivers for the market in the forecast period are:
The rising prevalence of coronary and peripheral
artery disease in the major markets covered in this
report.
The need for effective therapies that reduce the risk
of complications such as restenosis and thrombosis
associated with current drug-eluting and bare metal
stents.
The cost-savings for healthcare payers resulting from
reducing the need for repeat revascularization
procedures.
FDA approval and launch of Absorb BVS and
Remedy in the US.
The launch of pipeline fully bioabsorbable stent
products such as the DREAMS stent developed by
Biotronik.
Executive Summary
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Companies Working to Get Their Stents Approved in the Bioabsorbable Stent Market
Bioabsorbable stent technology is in its infancy and has a
long road ahead before it is widely adopted into clinical
practice. This technology has the potential to
revolutionize the stent industry and improve treatment
outcomes for patients with coronary and peripheral artery
disease.
Germany is leading the way with bioabsorbable stenting
and has the largest market share in Europe; other
European countries such as France are not far behind.
The US will acquire market share steadily as
bioabsorbable stents receive approval.
Companies such as Biotronik and REVA Medical are also
developing fully bioabsorbable stents that will increase
the competition in the market. As these stents enter the
market, they will affect the current selling price and the
market share of Absorb BVS and Remedy.
Bioabsorbable Stents Total Revenue
19%
44%
18%
9%
10%
France
Germany
Italy
Spain
UK
2011 Total: $0.63m
45%
9%
27%
7%
4%
8%
USFranceGermanyItalySpainUK
2018 Total: $702m
Source: GlobalData
Executive Summary
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Unmet Needs Remain a Challenge
Stent technology has evolved over the years to address
the challenges of treating patients with coronary and
peripheral artery disease. Although stents such as drug-
eluting stents improve patient prognosis compared to
invasive cardiac surgeries, there still remain several
unmet needs and limitations with current therapies.
Complications such as restenosis and thrombosis remain
a concern. Effective therapies need to be developed to
reduce the number of stent-in-stent procedures that are
performed, where additional permanent stents are
implanted into patients. Additionally, physicians have
called for other treatment improvements such as
reducing or eliminating the need for dual anti-platelet
therapy that is administered when implanting bare metal
and drug-eluting stents.
A fully degradable and absorbable stent can lower the
risk of restenosis and thrombosis and ensure quality
long-term results for the patient.
Key Players in the Bioabsorbable Stent Market
Currently, the key players in the bioabsorbable stent
market are Abbott Vascular and Kyoto Medical Planning.
Abbott Vascular received CE approval for its Absorb BVS
for coronary artery disease, which is available for sale in
Europe, the Middle East, and parts of Asia-Pacific and
Latin America.
Kyoto Medical Planning received CE approval for its
Remedy stent, which is used to treat peripheral artery
disease and is available for sale in Europe and the
Middle East. These stents have yet to receive FDA
approval for use in the United States.
In the next few years as competitors such as Biotronik
enter the market, GlobalData believes that Abbott
Vascular and Kyoto Medical Planning will see a decrease
in market share of their bioabsorbable stent products.
Bioabsorbable Stents Future Outlook
Bioabsorbable stents provide temporary scaffolding to
the vessel and then disappear over time, leaving behind
a healed artery.
Although bioabsorbable stents offer several advantages,
adoption of this technology will be slow in the US and
Europe. The slow adoption can be attributed to the lack
of long-term clinical data and high selling prices. In the
European markets, the lack of integration of new stent
technologies into the existing reimbursement system will
slow the adoption of bioabsorbable stents.
Although the prevalence of peripheral artery disease is
high in the US and Europe, the market share of the
peripheral market is nine times lower than that of the
coronary market. The low market share can be attributed
to lack of data demonstrating clinical effectiveness of
stents such as drug-eluting stents for different peripheral
lesions.
GlobalData believes that the bioabsorbable stent market
will steadily grow in the future as long-term clinical data
becomes available, appropriate reimbursement
guidelines are implemented and the selling price
decreases.
Executive Summary
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What do Physicians Think?
Physicians are cautiously optimistic and acknowledge the benefits of bioabsorbable stents.
“I think bioabsorbable stents are a very exciting
technology. The benefit of having a biodegradable stent
is that if and when it fails, you can go back and do it
again.”
Key Opinion Leader, November 2012
Physicians want to see long-term clinical data to evaluate the clinical effectiveness of bioabsorbable stents.
“Adoption of bioabsorbable stents depends on the clinical
data. If it is shown to be cost-effective, then I would
probably use it in 100% of my patients.”
Key Opinion Leader, October 2012
“There will be some adoption…. We still need to wait for
strong clinical data. We cannot replace drug-eluting and
bare metal stents that have thousands and thousands of
patients followed over five or 10 years.”
Key Opinion Leader, October 2012
The high selling price of bioabsorbable stents currently in the market will hinder widespread adoption.
“If the costs continue to be four times the cost of drug-
eluting stents, I cannot think of a hospital that can afford
that.”
Key Opinion Leader, October 2012
Bioabsorbable stents can potentially change the treatment paradigm for coronary artery disease.
“It is very possible for bioabsorbable stents to change the
treatment paradigm. However, it is a long way to go for
bioabsorbable stents. They are at the very, very
beginning.”
Key Opinion Leader, October 2012
Table of Contents
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1 Table of Contents
1 Table of Contents ...............................................................................................................6
1.1 List of Tables...............................................................................................................9
1.2 List of Figures ...........................................................................................................11
2 Introduction.......................................................................................................................12
2.1 Catalyst.....................................................................................................................12
2.2 Related Reports ........................................................................................................13
3 Competitive Assessment...................................................................................................14
3.1 Overview...................................................................................................................14
3.2 Absorb BVS - Abbott Vascular...................................................................................15
3.2.1 Efficacy...............................................................................................................16
3.2.2 SWOT Analysis...................................................................................................17
3.3 Remedy - Kyoto Medical Planning.............................................................................18
3.3.1 Efficacy...............................................................................................................19
3.3.2 SWOT Analysis...................................................................................................19
4 Pipeline Products..............................................................................................................20
4.1 Overview...................................................................................................................20
4.2 Pipeline by Phases in Development - Coronary Artery Disease..................................20
4.3 Pipeline Product Profiles - Coronary Artery Disease ..................................................22
4.3.1 Igaki-Tamai Stent................................................................................................22
4.3.2 ReZolve Sirolimus Eluting Bioabsorbable Coronary Scaffold ...............................23
4.3.3 Drug-Eluting Absorbable Metal Scaffold ..............................................................25
4.3.4 Absorbable Metal Stents .....................................................................................26
4.3.5 DESolve Bioabsorbable Coronary Scaffold System .............................................28
4.3.6 ART Stent ...........................................................................................................28
4.3.7 The OrbusNeich Stent.........................................................................................28
4.3.8 TephaFLEX Absorbable Stent .............................................................................29
4.3.9 The Arterius Stent ...............................................................................................29
Table of Contents
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4.3.10 Zorion Medical Stent ...........................................................................................29
4.3.11 3V Avatar............................................................................................................29
4.3.12 Biosorb ...............................................................................................................30
4.3.13 Summary ............................................................................................................30
4.4 Pipeline by Phases in Development - Peripheral Artery Disease ................................31
4.5 Pipeline Product Profiles- Peripheral Artery Disease..................................................32
4.5.1 Magic Explorer Stent...........................................................................................32
4.5.2 Esprit Bioabsorbable Vascular Scaffold ...............................................................33
4.5.3 ART Stent ...........................................................................................................34
4.5.4 TephaFLEX Absorbable Peripheral Stent ............................................................34
4.5.5 Zorion Medical Stent ...........................................................................................34
4.5.6 Amaranth Medical Stent ......................................................................................35
4.5.7 Summary ............................................................................................................35
5 Current and Future Players...............................................................................................36
5.1 Overview...................................................................................................................36
5.2 Trends in Corporate Strategy.....................................................................................36
5.3 Company Profiles......................................................................................................37
5.3.1 Abbott Vascular...................................................................................................37
5.3.2 Kyoto Medical Planning Co., Ltd..........................................................................39
5.3.3 Biotronik SE & Co. KG ........................................................................................42
5.3.4 REVA Medical, Inc. .............................................................................................44
5.3.5 Elixir Medical Corporation ...................................................................................47
5.3.6 Arterial Remodeling Technologies.......................................................................48
5.3.7 Tepha, Inc...........................................................................................................50
5.3.8 OrbusNeich.........................................................................................................52
5.3.9 Arterius ...............................................................................................................54
5.3.10 Zorion Medical ....................................................................................................55
5.3.11 S3V Vascular Technologies ................................................................................56
Table of Contents
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5.3.12 ICON Interventional Systems ..............................................................................57
5.3.13 Amaranth Medical ...............................................................................................58
5.3.14 Medlogics Device Corporation.............................................................................59
6 Appendix ..........................................................................................................................60
6.1 Bibliography ..............................................................................................................60
6.2 Abbreviations ............................................................................................................70
6.3 Report Methodology..................................................................................................72
6.3.1 Overview.............................................................................................................72
6.3.2 Coverage............................................................................................................72
6.3.3 Secondary Research...........................................................................................72
6.3.4 Forecasting Methodology....................................................................................73
6.4 Physicians and Specialists Included in this Study ......................................................74
6.5 Physician Survey.......................................................................................................75
6.6 About the Authors .....................................................................................................76
6.6.1 Analysts..............................................................................................................76
6.6.2 Global Head of Healthcare ..................................................................................77
6.7 About MediPoint........................................................................................................77
6.8 About GlobalData......................................................................................................78
6.9 Contact Us ................................................................................................................78
6.10 Disclaimer .................................................................................................................78
Table of Contents
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1.1 List of Tables
Table 1: Marketed Bioabsorbable Stent Products .................................................................14
Table 2: Absorb BVS Product Portfolio .................................................................................15
Table 3: Absorb BVS SWOT Analysis, 2012.........................................................................17
Table 4: Remedy Stent Product Portfolio ..............................................................................18
Table 5: Remedy SWOT Analysis, 2012...............................................................................19
Table 6: BAS Global Product Pipeline (Coronary) .................................................................21
Table 7: Igaki-Tamai Stent SWOT Analysis, 2012.................................................................22
Table 8: ReZolve Stent SWOT Analysis, 2012......................................................................24
Table 9: DREAMS SWOT Analysis, 2012.............................................................................25
Table 10: AMS SWOT Analysis, 2012 ....................................................................................27
Table 11: BAS Global Product Pipeline (Peripheral) ...............................................................31
Table 12: Magic Explorer Stent SWOT Analysis, 2012............................................................32
Table 13: Esprit BVS SWOT Analysis, 2012 ...........................................................................34
Table 14: Company Profile - Abbott Vascular..........................................................................37
Table 15: Marketed Bioabsorbable Stent Products by Abbott Vascular ...................................37
Table 16: Pipeline Bioabsorbable Stent Products by Abbott Vascular .....................................38
Table 17: Abbott Vascular SWOT Analysis, 2012 ...................................................................38
Table 18: Company Profile - Kyoto Medical Planning..............................................................39
Table 19: Marketed Bioabsorbable Stent Products by Kyoto Medical Planning........................41
Table 20: Pipeline Bioabsorbable Stent Products by Kyoto Medical Planning..........................41
Table 21: Kyoto Medical Planning SWOT Analysis, 2012........................................................41
Table 22: Company Profile - Biotronik.....................................................................................42
Table 23: Pipeline Bioabsorbable Stent Products by Biotronik ................................................43
Table 24: Biotronik SWOT Analysis, 2012 ..............................................................................43
Table 25: Company Profile - REVA Medical............................................................................44
Table 26: Pipeline Bioabsorbable Stent Products by REVA Medical........................................45
Table 27: REVA Medical SWOT Analysis, 2012 .....................................................................46
Table of Contents
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Table 28: Company Profile - Elixir Medical Corporation ..........................................................47
Table 29: Pipeline Bioabsorbable Stent Products by Elixir Medical Corporation ......................47
Table 30: Elixir Medical Corporation SWOT Analysis, 2012 ....................................................48
Table 31: Company Profile - Arterial Remodeling Technologies..............................................48
Table 32: Pipeline Bioabsorbable Stent Products by Arterial Remodeling Technologies..........49
Table 33: Arterial Remodeling Technologies SWOT Analysis, 2012........................................49
Table 34: Company Profile - Tepha ........................................................................................50
Table 35: Pipeline Stent Products by Tepha ...........................................................................50
Table 36: Tepha SWOT Analysis, 2012 ..................................................................................51
Table 37: Company Profile - OrbusNeich................................................................................52
Table 38: Pipeline Bioabsorbable Stent Products by OrbusNeich............................................52
Table 39: OrbusNeich SWOT Analysis, 2012..........................................................................53
Table 40: Company Profile - Arterius ......................................................................................54
Table 41: Arterius SWOT Analysis, 2012................................................................................54
Table 42: Company Profile - Zorion Medical ...........................................................................55
Table 43: Zorion Medical SWOT Analysis, 2012 .....................................................................55
Table 44: Company Profile - S3V Vascular Technologies .......................................................56
Table 45: S3V Vascular Technologies SWOT Analysis, 2012 .................................................56
Table 46: Company Profile - ICON Interventional Systems .....................................................57
Table 47: ICON Interventional Systems SWOT Analysis, 2012 ...............................................57
Table 48: Company Profile - Amaranth Medical ......................................................................58
Table 49: Amaranth Medical SWOT Analysis, 2012................................................................58
Table 50: Company Profile - Medlogics Device Corporation....................................................59
Table 51: Medlogics Device Corporation SWOT Analysis, 2012..............................................59
Table 52: Physicians Surveyed, By Country ...........................................................................75
Table of Contents
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1.2 List of Figures
Figure 1: BAS Coronary Pipeline by Stage in Clinical Development, 2012..............................20
Figure 2: BAS Peripheral Pipeline by Stage in Clinical Development, 2012.............................31
Figure 3: Kyoto Medical Planning Co., Ltd. Sales Volume ($m), May 2002-May 2012 ............40
Introduction
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2 Introduction
Coronary artery disease and peripheral artery disease are global public health and socioeconomic
issues that affect millions of lives each year. Bioabsorbable stents, which provide transient support
to the vessel, are viable alternatives to permanent drug-eluting and bare metal stent implants. In
the report, bioabsorbable stents are defined as fully biodegradable stents that completely
disappear from the vessel overtime. Stents such as BioMatrix Flex by Biosensors International and
Synergy by Boston Scientific are not included in the report because they are drug-eluting stents
with bioabsorbable polymer coatings. Absorption of the bioabsorbable polymer coating still leaves
behind a permanent bare metal stent inside the vessel.
This report focuses on the bioabsorbable stent market in Europe and the future market in the US.
The global stent and bioabsorbable stent markets are determined for the six countries covered in
the report, including the US, France, Germany, Italy, Spain and the UK. This report identifies the
unmet needs in the market, provides an understanding of physician perception of bioabsorbable
stents, and evaluates its adoption in the future. Through GlobalData’s analysis, it is evident that
although there will be early adopters in Europe and eventually in the US, widespread adoption of
bioabsorbable stents will be slow. Large-scale, long-term studies need to be conducted to
demonstrate clinical efficacy, and new stent technologies need to be integrated appropriately into
the existing reimbursement systems throughout Europe and the US. To successfully market
bioabsorbable stents, companies need to design novel stent platforms that address the current
unmet needs of conventional drug-eluting and bare metal stents and show superior clinical
performance to the stents currently in the market.
2.1 Catalyst
Bioabsorbable stents offer a novel treatment solution for patients with coronary artery disease and
peripheral artery disease. They represent the future of stents, as they address the unmet needs of
the current stent market. As more long-term clinical data is available demonstrating its superior
therapeutic benefits, adoption of bioabsorbable stents by the medical community will increase in
the future. As coronary artery disease and peripheral artery disease present enormous global
public health and socioeconomic issues, it is pertinent to find effective treatment modalities that
ensure long-term quality results for patients. This report will look at the market breakdown by
company, new entrants to the Bioabsorbable Stent industry and drivers for future growth.
As coronary artery disease and peripheral artery disease present enormous global public health and socioeconomic issues, it is pertinent to find effective treatment modalities that ensure long-term quality results for patients.
Introduction
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2.2 Related Reports
Transcatheter Arotic Valve Replacement - Market Analysis and Forecasts
GDME0165MAR / Published November 2012
Appendix
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6.8 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, Boston, London, India and Singapore.
6.10 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.