GDME1002FPR Bioabsorbable Stents - Current and …Bioabsorbable Stents Future Outlook Bioabsorbable...

14
Bioabsorbable Stents Current and Future Players GDME1002FPR / Published December 2012

Transcript of GDME1002FPR Bioabsorbable Stents - Current and …Bioabsorbable Stents Future Outlook Bioabsorbable...

Page 1: GDME1002FPR Bioabsorbable Stents - Current and …Bioabsorbable Stents Future Outlook Bioabsorbable stents provide temporary scaffolding to the vessel and then disappear over time,

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XXX / Published XXX

Bioabsorbable Stents Current and Future Players

GDME1002FPR / Published December 2012

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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.

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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

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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.

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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

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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

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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

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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

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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

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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

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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

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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.

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Introduction

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2.2 Related Reports

Transcatheter Arotic Valve Replacement - Market Analysis and Forecasts

GDME0165MAR / Published November 2012

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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.