Drug-Eluting Stents: Can the Market Rebound from Recent Setbacks?

SUMMARY

Introduction

A few years after their introduction in 2002, drug-eluting stents had all but replaced bare-metal stents in the treatment of coronary heart disease, capturing up to 90% of the market. Physicians favored the new stents primarily because of their ability to minimize the risk of restenosis associated with bare-metal stents. Recently, however, new safety concerns have begun to erode the market share of drug-eluting stents. The promise of next-generation drug-eluting stents that are beginning to emerge-including Medtronic's Endeavor, expected to launch in the United States in late 2007, and Abbott's Xience, currently in clinical trials in the United States and Japan-is likely to help the drug-eluting stent market rebound from its current low. However, lingering safety concerns and the possibility of competitive pricing may keep the market from achieving its earlier high.

Get the Answers You Need to Shape Your Strategy

• The need to effectively compete with the next generation of drug-eluting stents has prompted the current market leaders-Johnson & Johnson and Boston Scientifi c-to acquire companies with next-generation stents in their pipelines. How do next-generation stents differ from currently available drug-eluting stents? Will the recent mergers of Boston Scientifi c and Guidant and Johnson & Johnson and Conor Medsystems help the market leaders to retain their market dominance?
• Recent concerns that drug-eluting stents are associated with increased risk of late stent thrombosis arise from data on just two products-Boston Scientifi c's Taxus stent and Cordis/Johnson & Johnson's Cypher stent. What competitive opportunities does the potential for late stent thrombosis offer to manufacturers of other drug-eluting stents? How do current concerns about the risk of late stent thrombosis affect the outlook for Medtronic's Endeavor stent, if it receives approval in the United States?
• To acquire Guidant, Boston Scientifi c not only took on a heavy debt load, it also struck a deal with Abbott Laboratories that gave Abbott rights to Guidant's Xience V DES platform. Was the decision to acquire Guidant a good strategic move for Boston Scientifi c? Will Boston Scientifi c's privatelabel Xience stent, Promus, affect the company's overall sales of drug-eluting stents?
• Recent safety concerns about drug-eluting stents have dampened the early enthusiasm for this technology. How is the FDA likely to respond to the recent safety concerns about drug-eluting stents? Is the drug-eluting stent market likely to rebound from its recent fall?
• In March 2007, Medtronic released two-year results from the largest and longest drug-eluting stent clinical trial program to date. What advantages does Medtronic's Endeavor stent offer over existing drug-eluting stents? How is the availability of the Endeavor stent likely to affect the market share of the Taxus and Cypher stents?

Scope

• Use of stents in coronary heart disease: the limitations of “balloon” angioplasty; introduction of bare-metal stents; the advantages and mechanisms of drug-eluting stents.
• Market leaders: Boston Scientifi c's Taxus versus Cordis/Johnson & Johnson's Cypher; the takeover battle for Guidant.
• Recent concerns: the risk of late stent thrombosis; discontinuation of antiplatelet therapies; the effects of drug-eluting stents on coronary collateral functions; FDA conclusions.
• Emerging innovations: new stents from Medtronic, Abbott/Boston Scientifi c, Conor Medsystems, and Biosensors.
• Outlook: upcoming diffi culties with regulatory approval; potential growth of antiplatelet medications; the emergence of competitive pricing; future competition from bioabsorbable stents.

TABLE OF CONTENTS

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Coronary Heart Disease and Stent Use
  • Coronary Heart Disease
  • Treatment for Coronary Heart Disease
  • The Use of Cardiac Stents
• The Drug-Eluting Stent Market
  • Market Leaders
  • The Battle for Guidant
• Concerns Arise over Drug-Eluting Stents
• Emerging Innovations in Drug-Eluting Stents
  • Medtronic's Endeavor Stent
  • Abbott's Xience/Boston Scientifi c's Promus
  • Conor Medsystems' Costar
  • Biosensors' BioMatrix
• The Outlook for the Drug-Eluting Stent Market
  • Safety Concerns Create Commercial Opportunities
  • The Emergence of Competitive Pricing
  • Bioabsorbable Stents
  • Market Rebound

Tables

• 1. Prevalence of Coronary Heart Disease and Acute Coronary Syndrome, 2006
• 2. Emerging Drug-Eluting Stents

Figures

• 1. Milestones in the Drug-Eluting Stent Market
• 2. Stent Implantation, Restenosis, and Thrombosis
• 3. Worldwide Sales of Taxus Versus Cypher