All Change in the Coronary Stent Market

  • May 2010
  • -
  • Espicom Business Intelligence

Use this report to…

Review the prospects for key stent sectors
Evaluate how the market is developing
Know the current size and split in major regions and technology sectors
Know the market shares and performance of leading players
Understand how new applications could affect the market
Contrast and compare the competitive landscape in terms of product offering by stent sector
Understand the growth drivers and dampeners that will affect the market's development
Compare and review the research in new areas such as bioabsorbable and polymer-free stents.
All major current and future stent technologies are covered

Bare metal
Drug-eluting
Polymer-free
Bioabsorbable polymer
Bioabsorbable
Bifurcation applications
Unique 5-year sales forecasts for major stent sectors
A comprehensive examination of all current technologies, products and companies
Detailed evaluation of new technologies and the companies developing them
The development of the coronary stent market is dependent on the number of people with Coronary Artery Disease (CAD) requiring treatment. The number of Percutaneous Coronary Interventions (PCI) procedures performed, the percentage of PCIs in which stents are used, the number of stents used in each procedure and average selling prices for stents, all influence market values. In addition, whether a Bare Metal Stent (BMS) or Drug-Eluting Stent (DES) is used in the procedure impacts the market, as DESs command a much higher selling price than BMSs, while increased competition in the DES market has a major impact on the price companies can command for their DES products.


A recovering sector...
The coronary stent sector was knocked back when, in 2006, there emerged safety fears regarding the use of DESs when some longer-term clinical data indicated there was a small risk of late stent thrombosis for DES patients. It is believed this risk of late stent thrombosis relates to the use of a polymer on the DES and potentially the doses of drug used, both of which impair re-endothelialisation. While endothelialisation can take place within two months for a BMS, it can take up to a year for this process to be completed when a DES is used.

...Looking to a new generation of technology
The industry has responded with a range of new approaches, and the next-generation technologies have received much interest from the medical community due to their potential to address the problems of current coronary stents. These products would also be able to command a higher selling price than current stents and competition for the products would initially be limited. However, as relatively new products with little clinical and longer-term safety data, their potential for success cannot be assured. It therefore remains to be seen if they can reinvigorate the market for coronary stents and provide an effective alternative to current products.

The coronary stent market is expected to exceed US$5.3 billion by 2015 but new technologies must surmount clinical and regulatory hurdles

A regional perspective
Unlike many medical technology sectors, the coronary stent market is not reliant on the USA – this is both a limitation and an opportunity. Since clinical and regulatory concerns over stent safety emerged in 2006, the number of procedures has fallen, although numbers are recovering now. Even so, in 2009 the leading region for the number of PCI procedures was Europe with 1,230,000, a 39% share of the global market. While around 30 companies now have DES products available, only four have a DES available in either Japan or the US, which represent the largest two markets for such products.

Advanced technology will drive the sector
Given the limitations of currently-available coronary stenting products, which include higher rates of restenosis for BMSs and the potential for thrombosis for DESs, there is currently a major drive by manufacturers to develop products that improve on these designs. There are three main approaches being undertaken by coronary stent manufacturers, which can be summarised as follows:-

Polymer-free DESs –
These entirely eliminate use of the polymer, which is believed to lead to increased rates of thrombosis. Instead, these products include coatings or surface modification technologies that control drug elution. Only four companies are developing or sell such a product, mainly due to the difficulties of developing a product that does not release the drug too quickly without the polymer in place to control drug elution.

Bioabsorbable polymer DESs –
These include a BMS, a drug and a polymer that biodegrades once it has eluted the drug. In the longer-term, only a BMS is left in place in the vessel. These products are currently the most widely-developed next-generation stenting technologies. They offer the benefit of continuing to have a polymer to control drug elution, but one that is not left in the body over the longer-term. The idea is that once the polymer has dissolved, the risk of thrombosis would be reduced and patients would not require long-term dual anti-platelet therapy.

Bioabsorbable BMSs and DES –
These are stents that totally dissolve after a certain period of time. The aim is to provide the initial scaffolding needed by the vessel and to reduce the risk of restenosis, but then the stent would dissolve, leaving a natural, healed vessel. The main challenge is the development of a suitable stent material that can provide the initial strength required, not dissolve too quickly and not fail on deployment or as its properties change.

Table Of Contents

EXECUTIVE SUMMARY
BACKGROUND
CURRENT MARKET TRENDS
Percutaneous Coronary Intervention and the COURAGE Trial

Fig.1: Number of PCI Procedures Undertaken by Region, 2009
Fig.2: Number of PTCA Procedures Undertaken in the US, 2000-2007

Number of PTCA and CABG Procedures Undertaken in US Hospitals, 2000-2007
United Kingdom

Fig.3: PCI Procedures Undertaken in the UK, 2005-2008
Fig.4: UK PCI Procedures, Per million of the Population, 2005-2008
Fig.5: UK PCI Rates Per million of the Population by Country, 2009

Bare Metal Versus Drug-Eluting Stents

Fig.6: Global Coronary Stent Market by Product Type, 2009

COMPETITIVE ENVIRONMENT
Major Manufacturers’ Coronary Stent Revenue, 2006-2009 (US$ million)

Fig.7: Coronary Stent Market Share by Company, 2009

Major Manufacturers’ US Coronary Stent Revenue, 2006-2009 (US$ million)
Major Manufacturers’ International Coronary Stent Revenue, 2006-2009 (US$ million)
Patent Litigation
Abbott v Medtronic and evYsio Medical Devices
Boston Scientific v Cordis
Boston Scientific v Medtronic
Cordis v Medtronic
Johnson and Johnson v Abbott
OrbusNeich v Boston Scientific
Medinol v Abbott
Industry Consolidation and Collaboration
FUTURE MARKET POTENTIAL
Diabetes Prevalence, 2000 and 2030

Fig.8: Coronary Stent Market, 2009-2015(E) (US$ million)

Coronary Stent Market Growth Rates, 2010-2015(E) (%)
BARE METAL STENTS
Leading Manufacturers’ BMS Sales, 2006-2009 (US$ million)

Fig.9: Global BMS Market Shares by Company, 2009
Fig.10: BMS Market, 2007-2015(E) (US$ million)
Fig.11: Global BMS Market by Region, 2009

CONTINUED PRODUCT INNOVATION
Competitive Landscape: Bare Metal Coronary Stents
New Products
Abbott’s Multi-Link 8
Atrium Medical’s Cinatra CoCr Stent
Biotronik’s PRO-Kinetic Coronary Stents
CID’s Avantgarde CoCr Carbostent
ClearStream Technologies’ SatinFlex
CorNova’s Valecor Platinum Coronary Stent System
DISA Vascular’s SolarFlex
euatech’s Camouflage Stent System
Hexacath’s Titan2 BAS
InspireMD’s MGuard Stent with Embolic Protection
ITGI Medical’s Over and Under Pericardium Covered Stent
Medinol’s Presillion and Presillion Plus CoCr Coronary Stents
Medlogics Device’s Cobra Coronary Stent System
Medtronic’s Driver Stents
Medtronic’s Integrity
OrbusNeich’s Genous Bio-engineered R stent
Prescient Medical’s vProtect Luminal Shield
Stentys’ Self-Expanding Stent
Translumina’s Yukon CC
Products in Development
Palmaz Scientific’s Nanotechnology-Based Stents
Svelte Medical Systems’ Stent-on-a-Wire Stent
Veryan Holdings’ BioMimics 3D Stent
DRUG-ELUTING STENTS
Fig.12: Global DES Market, 2006-2009 (US$ billion)
DESs and Late Stent Thrombosis
DAPT Study
CURRENT MARKET DYNAMICS
Major Manufacturers’ DES Revenue, 2005-2009 (US$ million)
Major Manufacturers’ Quarterly DES Revenue, 2008-Q1 2010 (US$ million)

Fig.13: Global DES Market Share Data, 2006-2009 (%)

Drug-Device Combinations
Competitive Landscape: Pharmaceuticals Used in Drug-Eluting Stents
REGIONAL PERSPECTIVE

Fig.14: DES Market by Region, 2009

United States

Fig.15: US Market: Quarterly DES Penetration Rates, 2008-2009 (%)
Fig.16: US DES Market Share Data, 2007-2009 (%)
Fig.17: US DES Market Share by Product, 2009
Fig.18: US DES Market Share by Company, 2009
Fig.19: US DES Market Share by Company, Q1 2010

Major Manufacturers’ US DES Revenue, 2006-2009 (US$ million)
Major Manufacturers’ Quarterly US DES Revenue, 2008-Q1 2010 (US$ million)
International Market
Selected Manufacturers’ OUS DES Revenue, 2006-2009 (US$ million)
Selected Manufacturers’ Quarterly OUS DES Revenue, 2008-Q1 2010 (US$ million)
Japan

Fig.20: Japan: DES Market Share by Company, 2009
Fig.21: Japan: DES Market Share by Product, Q1 2010
Fig.22: Japan: DES Market Share by Company, Q1 2010

United Kingdom

Fig.23: Percentage of PCI Cases Using DESs in the UK, 2003-2008

FUTURE TRENDS AND FORECAST

Fig.24: Global DES Market, 2007-2015(E) (US$ million)

DURABLE POLYMER DRUG-ELUTING STENTS
Currently-Available Durable Polymer DESs
Aachen Resonance’s Vita Tretinoin-eluting Coronary Stent
Abbott’s Xience Everolimus-Eluting Coronary Stent Systems
Abbott’s DES Sales, 2007-2009 (US$ million)

Fig.25: Abbott’s DES Quarterly Sales Data, 2008-Q1 2010 (US$ million)
Fig.26: Promus Quarterly Sales Data, 2008-Q1 2010 (US$ million)
Fig.27: Promus Sales by Region, Q4 2009

Xience V
Xience Clinical Trials
Xience Prime
amg International’s Pico Elite
B Braun’s Coroflex Please
Boston Scientific’s Drug-Eluting Coronary Stents
Boston Scientific DES Sales, 2004-2009 (US$ million)
Boston Scientific DES Sales by Product Line, 2007-2009 (US$ million

Fig.28: Boston Scientific DES Sales by Region, 2009
Fig.29: Boston Scientific DES Sales by Product, 2009
Fig.30: BSCI: Quarterly Sales Data, 2008-Q1 2010 (US$ million)
Fig.31: BSCI: Quarterly International Sales by Region, 2009 (US$ million)
Fig.32: Taxus Quarterly Sales Data, 2008-Q1 2010 (US$ million)
Fig.33: Taxus Sales by Region, Q4 2009

Taxus Express2 Paclitaxel-Eluting Stent System
TAXUS Clinical Trials
TAXUS ARRIVE Registry
HORIZONS AMI
SYNTAX
Taxus Liberte
TAXUS Liberte Post-Approval Registry
OLYMPIA Registry (Formerly OLYMPIC Registry)
TAXUS ATLAS
Taxus Express Atom and Taxus Liberte Atom
Promus Element Everolimus-Eluting Coronary Stent System

Fig.34: Promus Element Sales by Region, Q1 2010

Taxus Element Paclitaxel-Eluting Coronary Stent System
ClearStream Technologies’ Intrepide
Cordis’ Cypher Products
Cypher Sales Performance
Cypher Revenue by Region, 2006-2009 (US$ million)

Fig.35: Cypher Sales by Region, 2009
Fig.36: Cypher Quarterly Sales Data, 2008-Q1 2010 (US$ million)

Cypher Clinical Studies
CYPRESS
TYPHOON
SIRIUS
CARDia
ACROSS-CYPHER
Patients with Multi-Vessel Disease
Cypher Select
e-SELECT Registry
Cypher Select Plus
Iberhospitex’ Active and IRIST DESs
Lepu Medical’s Partner Sirolimus-Eluting Stent
Medtronic’s Endeavor DESs

Fig.37: Endeavor Quarterly Sales Data, Fiscal 2008-Q3 2010 (US$ million)

Endeavor Zotarolimus-Eluting Coronary Stent
Endeavor Clinical Trials
Endeavor Resolute Zotarolimus-Eluting Coronary Stent
MicroPort Medical’s Firebird Rapamycin-Eluting Coronary Stent Systems
Rontis’ PhoenixPico
DES Clinical Comparisons
COMPARE Trial
Swedish Coronary Angiography and Angioplasty Registry
ZEST Trial: Cypher, Endeavor and Taxus Liberte
SORT OUT III
Western Denmark Heart Registry
Small Coronary Vessel Meta-Analysis
Swiss National Science Foundation Meta-Analysis
Products in Development
Atrium Medical’s Cinatra Voclosporin Drug Eluting Coronary Stent System
Atrium Medical’s Cinatra Corolimus-Eluting Coronary Stent System
Elixir Medical’s Novolimus and Myolimus Eluting Stents
Novolimus-Eluting Stents
Myolimus-Eluting Stents
Svelte Medical Systems’ SOAW DES
NEXT-GENERATION TECHNOLOGIES
POLYMER-FREE DRUG-ELUTING STENTS
Aachen Resonance’s ARTAX Paclitaxel-eluting Coronary Stent
Biosensors International’s BioFreedom
CID’s Janus Flex
CID’s Optima Jet
Deutsches Herzzentrum Muenchen’s Polymer-Free Dual Drug-Eluting Stent
Minvasys’ Amazonia Pax Polymer-Free PES
Translumina’s Yukon Choice DES+
Translumina’s Yukon Choice 4
BIOABSORBABLE POLYMER DRUG-ELUTING STENTS
Competitive Landscape: Bioabsorbable Polymer DES Technologies
Marketed Products
Biosensors International’s BioMatrix and BioMatrix Flex
LEADERS Clinical Study
eucatech’s euca TAX
Eurocor’s Taxcor Paclitaxel-Eluting Coronary Stent Systems
JW Medical Systems’ Excel Sirolimus-Eluting Stent
Meril Life Sciences’ BioMime Sirolimus Eluting Coronary Stent System
Sahajanand Medical Technologies’ Supralimus and Infinnium Products
Terumo’s NOBORI Stent
Vascular Concepts’ ProTAXX
Products in Development
amg International’s ITRIX
Blue Medical Devices’ PEA Stent
Boston Scientific's Evolution Everolimus-Eluting Stent
Boston Scientific's Labcoat Element
Cordis’ Cypher NEVO
Cypher NEVO Clinical Studies
DISA Vascular’s Stellium
Elixir Medical’s Novolimus and Myolimus Eluting Stents
Kaneka’s MAHOROBA Tacrolimus-Eluting Stent
Medlogics Device’s Cobra-P
Micell Technologies’ MiStent
OrbusNeich’s Combo Bio-engineered Sirolimus Eluting Stent
Rontis’ Rapamycin-Eluting Stent
FULLY-BIOABSORBABLE STENTS
Bioabsorbable Bare Metal Stents
Arterial Remodeling Technologies’ PLA Stents
Bioring
Kyoto Medical Planning’s IGAKI-TAMAI Stent
Bioabsorbable Drug-Eluting Stents
Abbott’s Bioabsorbable DES
Bioabsorbable Therapeutics’ Salix Stents
Biotronik’s Absorbable Metal Stent
Elixir Medical’s Myolimus-Eluting Biodegradable Stent
Reva Medical’s ReZolve Bioresorbable Coronary Stent
BIFURCATION STENTING
Competitive Landscape - Bifurcation Stenting
Abbott’s Multi-Link Frontier Coronary Bifurcation Stent System
Cappella’s Sideguard Coronary Sidebranch Stent and Delivery System
Devax’ AXXESS Biolimus A9-Eluting Bifurcation Stent System
Invatec’s (Medtronic) Twin-Rail System
Medtronic’s Y-Stent Bifurcation Stent
Minvasys’ Nile Croco, Nile Delta and Nile Pax Bifurcation Stents
Rontis’ Bifurcation Stent System
Stentys’ Bifurcation Stent
TriReme Medical’s Antares Coronary Stent System
Tryton Medical’s Tryton Side Branch Stent System
COMPANY DIRECTORY
APPENDICES
APPENDIX 1 - LIST OF ABBREVIATIONS
APPENDIX 2 - GLOSSARY
APPENDIX 3 - REPORT METHODOLOGY

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