DRUG-ELUTING STENTS

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

• Study Reliability and Reporting Limitations
• Disclaimers
• Data Interpretation & Reporting Level:
• Quantitative Techniques & Analytics
• Product Definitions and Scope of Study

II. EXECUTIVE SUMMARY

1. Market Overview

• Current and Future Analysis
• Regional Analysis
• Major Issues and Trends
• Drug-Eluting Stents Transforming the Scenario of Interventional Cardiology Market
• Table 1: World DES Market (2001, 2003 and 2005): Sales Comparison of CABG, Bare-Metal Stents and Drug-Eluting Stents (In ‘000 units) (includes corresponding Graph/Chart)
• Adverse Effects Restrict Market Growth
• Innovation and Development Drive Market Growth
• High Price of DES- A Major Impediment to Rapid Development
• Potential Decline in Hospital Revenues
• Glaring Lack of Health-Related Initiatives World Over
• Bioabsorbable Stents Closer to Reality Than Expected

2. Coronary Stenting - An Insight

• Cardiovascular Diseases -A Brief Description
• Table 2: World Market for Cardiovascular Therapies (2006): Percentage Share Breakdown of Value Sales by Product Category-Drug-Eluting Stents, Cardiac Resynchronization Therapy, Cardiac Markers, Portable Automated External Defibrillators, and Angiogenesis/Gene Therapy ($ Millions) (includes corresponding Graph/Chart)
• Coronary Heart Disease
• Traditional Methods of Treating Blockage of Coronary Arteries
• Percutaneous Transluminal Coronary Angioplasty (PTCA)
• Coronary Artery Bypass Graft (CABG)
• Restenosis
• Evolution of Coronary Stents as a Replacement for Traditional Methods
• What are Coronary Stents?
• How is Coronary Stenting Performed - Procedure
• Risks and Problems Associated with Placing a Stent
• Restenosis Still Pervasive Even after the Use of Stents
• Market Analysis for Coronary Stents
• By Types
• Table 3: World Coronary Stents Market (2005 & 2006 E): Percentage Share Breakdown of Value Sales by Type- Eluting and Bare
• By Region/Country
• Table 4: World Market for Coronary Stents (2006): Percentage Share Breakdown of Value Sales by Region/ Country -US, Japan, Europe, Japan, and Rest of World (includes corresponding Graph/Chart)
• By Major Players
• Table 5: World Market for Coronary Stents (All Stents) (2005- 2007): Percentage Share Breakdown of Value Sales by Major Players- Johnson & Johnson, Guidant, Boston Scientific, Medtronic, Abbott, and Others (includes corresponding Graph/Chart)
• In-Stent Restenosis - Outcome of Bare Metal Stents
• In-Stent Restenosis - Definition
• Causes of In-Stent Restenosis

3. Product Overview

• A Brief Introduction to DES
• Suitable Patient Types for Drug-Eluting Stents
• Major Drugs Used in DES
• Sirolimus
• Paclitaxel
• Other Treatments Available for Treating In-Stent Restenosis
• Major Drug-Eluting Stent Products in the Market
• World Market for Drug-Eluting Stents (2002 - 2007): DES Brands Launched by Major Manufacturers- Cordis, Boston Scientific, Cook Group, Guidant, and SMT
• Table 6: World Drug Eluting Stents Market (2006 ): Percentage Share Breakdown of Sales by Leading DES Brands - Cypher, Taxus, and Others (includes corresponding Graph/Chart)
• Cypher
• Taxus

4. Competitive Scenario

• Drug-Eluting Stents-Competitive Arena
• Table 7: World Drug Eluting Stents Market (2005-2008): Percentage Breakdown of Value Sales by Leading Players - Johnson & Johnson, Boston Scientific, Medtronic, Abbott, Conor, and Others (includes corresponding Graph/Chart)
• Market Dominated by Small Band of Players
• Cordis (A Johnson & Johnson Company)
• Cypher Leads the Drug-Eluting Stent Market
• Boston Scientific
• Taxus Beats Cypher in the US

5. Cost and Price Economics

• Cost Evaluation of DES
• Initial Procedural Costs Remain High
• Table 8: Average Price Per DES Unit for the Period 2004-2005
• Table 9: Worldwide Average Stent Prices (2002-2005): Breakdown of Regions by Drug Eluting Stents and Bare Metal Stents (includes corresponding Graph/Chart)
• Follow-Up Costs Provide Relief
• Table 10: A Comparative Presentation of Long-Term Costs of DES and CABG
• Conversion of CABG Procedures to DES
• Impact of DES on Indirect Costs

6. Research and Development Initiatives

• Boston Completes European and Intercontinental Enrollment Phases
• Medtronic To Start Clinical Study
• Guidant Accomplishes Patient Enrollment
• Abbott Receives FDA Approval for Initiation of ZoMaxx Clinical Trials
• Medtronic Commences Endeavor I Clinical Trial
• MIV Therapeutics Completes Drug-Eluting Stent Coating R&D Program
• Guidant Conducts First Implant as Part of Drug Eluting Stent Trial
• Medtronic’s Endeavor Drug Eluting Stent Shows Positive Results
• Cypher™ Coronary Stent Trial Show Restenosis Rates Decline by 5.1%
• Boston Scientific Demonstrates Positive Results for Taxus IV Clinical Trial
• Medtronic Initiates Endeavor Clinical Trials for Endeavor Drug Eluting Stent
• Guidant’s Clinical Trials for Coronary Stent Demonstrates Positive Results
• Clinical Trials Undertaken from 2002-2007
• MIV Commences Clinical Trials of HC Stent
• XTNT Voiced CUSTOM I Trial Program of NX™ DES System
• Dynatek Completes DES Coating Durability Trial
• STEALTH Trial
• SIROCCO Trial
• Cook Trial
• ZoMAXX Trial
• Ravel Trial
• Sirius Trial
• C - Sirius Trial
• E - Sirius Trial
• Taxus I through VI Clinical Trials
• Other Clinical Trials

7. Regulatory Environment

• FDA Framework
• FDA to Monitor Drug-Eluting Stents
• Issues Raised by FDA Regarding the Safety of Stent
• Major DES Products Approved by FDA
• FDA Approves Boston Scientifis’s Taxus Stent with Extended Shelf Life
• Conor COSTAR Receives US FDA Approval
• Boston Scientific’s Taxus Gets FDA Approval
• Cypher Stent Receives Approval from FDA
• Concerns Raised by FDA

8. Recent Industry Activity

• MIV Therapeutics Acquires Biosync Scientific
• J & J Acquires Conor Medsystems
• Lombard Collaborates With S&N
• India Establishes Asia’s first Catheter and Stent Unit.
• Abbott Requests FDA Approval for Xience
• Brookwood and TTV Start Joint Venture
• SurModics Acquires Brookwood Pharmaceuticals, Inc
• ARIAD Collaborates with ICON Medical
• Biosensors Acquires 50% Stake in JWMS
• Cordis’ Cypher Select™ Plus Receives Approval in Europe
• Boston Scientific Acquires Guidant for $27 Billion, Abbott Gets Guidant’s Vascular and Cardiac Therapies Businesses as Part of Deal
• Abbott Expands Vascular Sites in Ireland
• Medtronic’s Endeavor® Attains Reimbursement Approval in France
• SurModics Offers License for Hydrophilic Technology to Devax
• Conor obtains License for Novartis’ Pimecrolimus
• Medtronics Makes Final PMA Submission for Endeavor
• Volcano Collaborates with CRF, Cardialysis and Stanford University
• Boston’s PROMUS Receives CE Mark Approval
• SurModics and X-Cell Inks Licensing Agreement
• Medtronic Receives Regulatory Approval for Endeavor (R)
• Medtronics’ Endeavor Obtains Chinese Regulatory Approval
• Biosensors Collaborates with JW Medical
• Biosensors and Weigao To Consolidate Joint Venture
• Biotronik Enters Multi-Drug Deal with Novartis
• MIVT Enters Collaboration Deal with SMT
• SMT’s Infinnium Paclitaxel System Receives CE Mark
• Guidant’s Xience V Receives European Approval
• Medtronic Files Initial PMA Module TO US FDA
• Boston Scientific Receives European Approval for TAXUS(R)
• Biosensors Attains US Patent Covering DES Technology
• MediVas LLC and Estracure Inc Sign Agreement for Development of DES
• Relisys Medical of India Finalizes Deal with Germany Based Blue Membranes
• X-cell Medical Enrolls for Clinical Trial of ETHOS I Estradiol Eluting Stent.
• Biosensors International Group Receives CE Approval for First DES, Axxion
• Boston Scientific Corp Receives CE Mark Approval for Marketing Larger Stent Sizes
• Medtronic Receives CE Mark Approval for Commercial Sale of Endeavor DES in Europe
• Biosensors International Opens New Interventional Cardiology Unit in Singapore
• Johnson & Johnson Recalls Cypher Drug-Eluting Stents
• Boston Scientific Buys Out Precision Vascular Systems
• Implant Sciences and CardioTech International enter into Partnership with CorNova
• Avantec Vascular Corporation Signs Agreement with Novartis Pharma AG…
• Guidant and Cordis Enter into Promotion Agreement
• Genvec Collaborates with Cordis
• Cordis Receives Approval from Japanese Ministry of Health
• Boston Scientific Modifies Production of Taxus Drug-Eluting Stent
• Guidant Acquired CE Mark Approval for Multi-Link Bifurcation Stent System
• Boston Scientific Receives Reimbursement Approval from French Government
• Boston Scientific Withdraws Consortium of Drug-Coated Stents
• AVD Acquires the Assets of Jomed' s Coronary and Peripheral Business Line
• Guidant Acquires Biosensors' Everolimus Eluting Stent Assets
• Biosensors Signs Distribution Agreement with Terumo
• Guidant Obtains the Rights of Polymer Technologies Developed By MediVas
• Biosensors Pens a Deal with X-Cell to Start Drug-Eluting Stent Company
• Debiotech Receives Global License to Drug Eluting Stent Technology
• Boston Scientific Markets Drug-Eluting Stents to Indian Market
• Hoag Heart First to Receive New Drug-Eluting Stents
• Abbott Purchases Biocompatibles' Cardiovascular Stent Business
• Guidant Takes Over Cook Group
• Medtronic Enters into a Co-Exclusive Agreement with Abbott
• Angiotech Accords with NeoRx for Paclitaxel License
• Novartis Pharma AG Enters into a Licensing Agreement with Guidant
• Cordis Declares Positive Results in Bifurcation Feasibility Study
• PharmaSonics Initiates the Clinical Trials for Intravascular Sonotherapy
• Guidant Declares Deliver Clinical Trial Results
• Clinsights Opens a Drug-Eluting Stent Center
• Boston Scientific Acquires Global Co-Exclusive Rights from Angiotech
• Angiotech Pharmaceuticals Elucidates the Conclusions of Taxus I Clinical Trial
• Boston Scientific Proclaims Zero Restenosis for Taxus Drug-Eluting Stent Trial
• Boston Scientific Conducts Taxus I ISR Clinical Trial

9. Product Innovations/Introductions

• Abbott Launches Drug-Eluting Coronary Stent
• Boston Introduces Taxus(R) Express2(TM) in Japan
• Cordis Brings Advanced Drug-Eluting Stent
• Sorin Unveils Enhanced Janus Flex in Europe
• EUREKA Develops Latest Generation of Drug- Eluting Stent
• MIV Therapeutics Develops New Drug Eluting Coating Technology in Canada
• Medtronic to Launch Endeavor DES in Europe
• DISA Vascular (Pty) Ltd Introduces ChromoFlex in Europe
• Boston Scientific Introduces Taxus Liberté Drug Eluting Stent in Europe
• Boston Scientific Introduces Innovative Drug-Eluting Stent, Taxus in the US Market
• Johnson & Johnson Introduces Drug-Eluting Stent
• MIV Therapeutics to Introduce Advanced Biocompatible Coatings
• Guidant Develops Champion Drug-Eluting Stent System
• University of Virginia Launches Drug-Eluting Stent
• Implant Sciences and CardioTech Jointly Develop Drug Eluting Stent
• Boston Scientific Introduces Express™ Stent in the European Market

10. Focus on Select Global Players

• Abbott Vascular (USA)
• Angiotech Pharmaceuticals, Inc (Canada)
• AngioDynamics® Inc. (USA)
• Boston Scientific, Inc. (USA)
• Boston Scientific Cardiac Rhythm Management (USA)
• Biocompatibles International Plc (UK)
• Biosensors International Pte Ltd. (Singapore)
• Cordis Corporation (USA)
• Implant Sciences Corporation (USA)
• Medtronic, Inc.(USA)
• MIV Therapeutics Inc (Canada)
• SurModics, Inc. (USA)

11. Global Market Perspective

• Table 11: World Recent Past, Current and Future Analysis for Drug-Eluting Stents by Geographic Region - US, Japan, Europe and Rest of the World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding Graph/Chart)
• Table 12: World Long-term Projections for Drug-Eluting Stents by Geographic Region - US, Japan, Europe and Rest of the World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
• Table 13: World 7-Year Perspective for Drug-Eluting Stents by Geographic Region - Percentage Breakdown of Dollar Sales for US, Japan, Europe and Rest of the World Markets for Years 2003, 2007, & 2010 (includes corresponding Graph/Chart)

III. MARKET

1. The United States

• A. Market Analysis
  • Current and Future Analysis
  • Issues and Trends
  • US Healthcare Ideology
  • The Important Role of Medicaid in the US
  • Drug-Eluting Stents-Competitive Arena
  • Table 14: US Market for Coronary Stents (2005 - 2007): Percentage Share Breakdown of Value Sales by Leading Players- Abbott/Guidant, Medtronic, Johnson & Johnson, and Boston Scientific (includes corresponding Graph/Chart)
  • Table 15: US Market for Drug Eluting Stents (2005 - 2008): Percentage Share Breakdown of Sales Revenue by Major Players- Johnson & Johnson, Boston Scientific, Medtronic, Abbott, and Conor (includes corresponding Graph/Chart)
  • US Market for Drug-Eluting Stents (2003 - 2007):DES Products Launched by Major Manufacturers -Cordis (Johnson & Johnson), Boston Scientific,and Cook Group
  • Leading DES Products in the Market
  • Cypher - First to Market
  • Taxus Beats Cypher
  • Regulatory Environment
  • FDA Framework
  • Issues Raised by FDA Regardingthe Safety of Stent
  • Major Drug-Eluting Stents Approved by FDA
  • FDA Approvals in the Recent Past
  • Key Players
  • Product Innovations/ Introductions
  • Product Innovations/Introductions in the Recent Past
  • Recent Industry Activity
• B. Market Analytics
  • Table 16: US Recent Past, Current and Future Analysis for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding Graph/Chart)
  • Table 17: US Long-term Projections for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

2. Japan

• A. Market Analysis
  • Current and Future Analysis
  • Healthcare System in Japan
  • Table 18: Japanese Market for Drug Eluting Stents (2005-2008): Percentage Share Breakdown of Sales Revenue by Major Players- Johnson & Johnson Boston Scientific, and Medtronic (includes corresponding Graph/Chart)
  • Table 19: Japanese Market for Stents (2005-2007): Percentage Share Breakdown of Sales Revenues by Major Players- Abbott/Guidant, Medtronic, Johnson & Johnson, Boston Scientific, and Others (includes corresponding Graph/Chart)
  • Key Player
  • Product Innovations/ Introductions
  • Industry Activity in the Recent Past
• B. Market Analytics
  • Table 20: Japanese Recent Past, Current and Future Analysis for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding Graph/Chart)
  • Table 21: Japanese Long-term Projections for Drug- Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

3. Europe

• A. Market Analysis
  • Healthcare System in Europe
  • Current and Future Analysis
  • Regional Analysis
  • Issues and Trends
  • Reimbursement a Major Hurdle in European MarketPenetration of DES
  • Slow Market Penetration of New Medical Devicesin Europe
  • Taxus - Leading the European Stent Market
  • Leading DES Players in the Market
  • Table 22: European Market for Drug Eluting Stents (2005-2008): Percentage Share Breakdown of Sales Revenue by Major Players- Johnson &Johnson, Boston Scientific, Medtronic, Abbott, Conor, and Others (includes corresponding Graph/Chart)
  • Table 23: European Market for Stents (2005-2007): Percentage Share Breakdown of Sales Revenue by Major Players- Abbott/Guidant, Johnson & Johnson, Boston Scientific, Medtronic, and Others (includes corresponding Graph/Chart)
  • Key Players
  • Product Innovations/Introductions
  • Recent Industry Activity
  • Industry Activity in the Recent Past
• B. Market Analytics
  • Table 24: European Recent Past, Current and Future Analysis for Drug-Eluting Stents by Geographic Region - France, Germany, Italy, UK, Spain and Rest of the World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding Graph/Chart) (includes corresponding Graph/Chart)
  • Table 25: European Long-term Projections for Drug-Eluting Stents by Geographic Region - France, Germany, Italy, UK, Spain and Rest of the Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)
  • Table 26: European 7-Year Perspective for Drug-Eluting Stents by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, Spain and Rest of Europe Markets for Years 2003, 2007 and 2010 (includes corresponding Graph/Chart)

3a. France

• A. Market Analysis
  • Healthcare System in France
  • Current and Future Analysis
  • Recent Industry Activity
• B. Market Analytics
  • Table 27: French Recent Past, Current and Future Analysis for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding Graph/Chart)
  • Table 28: French Long-term Projections for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

3b. Germany

• A. Market Analysis
  • Health Care Policies in Germany
  • Lower Market Penetration of DES
• B. Market Analytics
  • Table 29: German Recent Past, Current and Future Analysis for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding Graph/Chart)
  • Table 30: German Long-term Projections for Drug- Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

3c. Italy

• A. Market Analysis
  • Current and Future Analysis
  • Italian Healthcare System
  • Local Healthcare Agencies
  • National Health System in Italy
• B. Market Analytics
  • Table 31: Italian Recent Past, Current and Future Analysis for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding Graph/Chart)
  • Table 32: Italian Long-term Projections for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

3d. The United Kingdom

• A. Market Analysis
  • Current and Future Analysis
  • National Health System in the UK
  • Key Player
  • Recent Industry Activity
• B. Market Analytics
  • Table 33: UK Recent Past, Current and Future Analysis for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding Graph/Chart)
  • Table 34: UK Long-term Projections for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

3e. Spain

• A. Market Analysis
  • Current and Future Analysis
  • Healthcare System in Spain
• B. Market Analytics
  • Table 35: Spanish Recent Past, Current and Future Analysis for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding Graph/Chart)
  • Table 36: Spanish Long-term Projections for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

3f. Rest of Europe

• A. Market Analysis
  • Crumbling Healthcare System in Rest of Europe
  • Current and Future Analysis
  • Recent Industry Activity
• B. Market Analytics
  • Table 37: Rest of Europe Recent Past, Current and Future Analysis for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding Graph/Chart)
  • Table 38: Rest of Europe Long-term Projections for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)

4. Rest of World

• A. Market Analysis
  • Current and Future Analysis
  • Asia-Pacific
  • Key Player
  • Recent Industry Activity
  • Canada
  • Key Players
  • Product Innovations/Introductions
  • Recent Industry Activity
• B. Market Analytics
  • Table 39: Rest of the World Recent Past, Current and Future Analysis for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2010 (includes corresponding Graph/Chart)
  • Table 40: Rest of World Long-term Projections for Drug-Eluting Stents Independently Analyzed with Annual Sales Figures in US$ Million for Years 2011 through 2015 (includes corresponding Graph/Chart)