Drug-Eluting Stents

Published by: Global Industry Analysts

Published: Mar. 1, 2008 - 264 Pages

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 Regarding the 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 Market Penetration of DES

Slow Market Penetration of New Medical Devices in 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)

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 39 (including Divisions/Subsidiaries - 46)

Canada 3

Japan 1

Europe 11

Germany 2

The United Kingdom 3

Italy 1

Rest of Europe 5

Asia-Pacific (Excluding Japan) 4

Africa

Abstract

This report analyzes the worldwide markets for Drug-Eluting Stents in Millions of US$. The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual forecasts are provided for each region for the period of 2003 through 2015. The report profiles 39 companies including many key and niche players worldwide such as Abbott Vascular, Angiotech Pharmaceuticals, Inc., AngioDynamics®, Inc., Boston Scientific, Inc., Boston Scientific Cardiac Rhythm Management, Biocompatibles International PLC, Biosensors International Pte Ltd., Cordis Corporation, Implant Sciences Corporation, Medtronic, Inc., MIV Therapeutics, Inc., and SurModics, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.


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