All Change in the Coronary Stent Market

Transcription

1 All Change in the Coronary Stent Market Phone: Fax:

2 All Change in the Coronary Stent Market Date: May 1, 2010 Pages: 120 Price: US$ 1, ID: A EN 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 All Change in the Coronary Stent Market 2

3 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 Content All Change in the Coronary Stent Market 3

4 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, Number of PTCA and CABG Procedures Undertaken in US Hospitals, United Kingdom Fig.3: PCI Procedures Undertaken in the UK, Fig.4: UK PCI Procedures, Per million of the Population, 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, (US$ million) Fig.7: Coronary Stent Market Share by Company, 2009 Major Manufacturers US Coronary Stent Revenue, (US$ million) Major Manufacturers International Coronary Stent Revenue, (US$ million) Patent Litigation Abbott v Medtronic and evysio Medical Devices Boston Scientific v Cordis Boston Scientific v Medtronic Cordis v Medtronic Johnson & 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, (E) (US$ million) Coronary Stent Market Growth Rates, (E) (%) BARE METAL STENTS Leading Manufacturers BMS Sales, (US$ million) Fig.9: Global BMS Market Shares by Company, 2009 Fig.10: BMS Market, (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 All Change in the Coronary Stent Market 4

5 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, (US$ billion) DESs and Late Stent Thrombosis DAPT Study CURRENT MARKET DYNAMICS Major Manufacturers DES Revenue, (US$ million) Major Manufacturers Quarterly DES Revenue, 2008-Q (US$ million) Fig.13: Global DES Market Share Data, (%) 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, (%) Fig.16: US DES Market Share Data, (%) 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, Q Major Manufacturers US DES Revenue, (US$ million) Major Manufacturers Quarterly US DES Revenue, 2008-Q (US$ million) International Market Selected Manufacturers OUS DES Revenue, (US$ million) Selected Manufacturers Quarterly OUS DES Revenue, 2008-Q (US$ million) Japan Fig.20: Japan: DES Market Share by Company, 2009 Fig.21: Japan: DES Market Share by Product, Q Fig.22: Japan: DES Market Share by Company, Q United Kingdom Fig.23: Percentage of PCI Cases Using DESs in the UK, FUTURE TRENDS AND FORECAST All Change in the Coronary Stent Market 5

6 Fig.24: Global DES Market, (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, (US$ million) Fig.25: Abbott s DES Quarterly Sales Data, 2008-Q (US$ million) Fig.26: Promus Quarterly Sales Data, 2008-Q (US$ million) Fig.27: Promus Sales by Region, Q 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, (US$ million) Boston Scientific DES Sales by Product Line, (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-Q (US$ million) Fig.31: BSCI: Quarterly International Sales by Region, 2009 (US$ million) Fig.32: Taxus Quarterly Sales Data, 2008-Q (US$ million) Fig.33: Taxus Sales by Region, Q 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, Q Taxus Element Paclitaxel-Eluting Coronary Stent System ClearStream Technologies Intrepide Cordis Cypher Products Cypher Sales Performance Cypher Revenue by Region, (US$ million) Fig.35: Cypher Sales by Region, 2009 Fig.36: Cypher Quarterly Sales Data, 2008-Q (US$ million) Cypher Clinical Studies CYPRESS TYPHOON All Change in the Coronary Stent Market 6

7 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-Q (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 BIOABSORBABLE POLYMER DRUG-ELUTING STENTS Competitive Landscape: Bioabsorbable Polymer DES Technologies Marketed Products All Change in the Coronary Stent Market 7

8 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 & 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 All Change in the Coronary Stent Market 8

9 APPENDIX 2 - GLOSSARY APPENDIX 3 - REPORT METHODOLOGY All Change in the Coronary Stent Market 9

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