Medical Device Coatings

Report Highlights

• The value of worldwide sales for all categories of coatings and surface treatment processes used in manufacturing medical devices reached $2.96 billion in 2005.
• Fueled by an explosive growth in high-value combination products, such as arterial stents and antimicrobial-coated catheters, the global medical device coatings business will experience an average annual growth rate (AAGR) of 12.4%, reaching worldwide sales of $5.31 billion by 2010.
• The swift acceptance of drug-eluting stents as a "gold standard" treatment by surgeons around the globe suggests that the demand for other coated versions of existing medical devices will be equally swift. Our analysis further suggests that there will be a correspondingly swift acceptance of new coated devices as they are introduced.

INTRODUCTION

In this report, BCC Research examines medical device coatings, the most rapidly expanding sector of the $213-billion global medical device market. These coatings increase the functionality, longevity and cost-effectiveness of medical devices. They have been so effective that over the last decade the medical community rapidly accepted drug eluting coatings and streamlined the regulatory process with the creation of the FDA Office of Combination Products. As a result, pure-play medical device coating enterprises have grown swiftly. This comprehensive analysis examines the market for these heavily regulated products and forecasts the direction of the medical device coatings through 2010.

SCOPE OF STUDY

This report:

• Analyzes the markets for medical device coatings and surface treatment technologies worldwide, by medical specialty and material, with forecasts through 2010.
• Examines the seven basic types of materials currently used to create coatings for more than 92,000 unique medical devices.
• Explains how the successful commercialization of engineered alloys, ceramics and polymers has transformed coatings from passive to active components in medical devices.
• Discusses changing medical needs that are accelerating the future demand for coated medical products.
• Reviews more than 200 patents and profiles key coating and medical device suppliers.

METHODOLOGY

BCC presents an analysis of the demand for the most commonly used coated medical devices shipped to 16 FDA-identified categories of end-users. Our estimated value is what manufacturers have paid in 2005. Then, based on our surveys, we analyze the potential applications for each of the seven coating technologies, and forecast shipments in constant dollars for 2010.

To forecast emerging technologies and products we analyze medical devices currently undergoing FDA review, patents and coating-related activities at individual companies, corporate consortia and universities. Our forecast of emerging coating technologies includes the dollar value of shipments beginning the year shipments started to 2010.

INFORMATION SOURCES

BCC studied more than 200 companies to obtain data for this study. Included were coating manufacturers, medical device manufacturers and pharmaceutical companies. We also reviewed reports and studies prepared by the FDA; organizations representing physicians, surgeons, hospital administrators, trade and professional associations; foreign government trade associations; and insurers. In addition, we compiled data from the FDA medical device data registry, the U.S. Security and Exchange Commission corporate filings database, and the U.S. Patent and Trademark office.

ANALYST'S CREDENTIALS

James Wilson is the author of more than 300 articles and several books dealing with science, medicine, technology and business. Formerly the editor of the Princeton Business Journal and a senior science and technology editor for Hearst Magazines, he is member of the National Association of Science Writers and American Medical Writers Association. He has served on the adjunct faculty of Temple University and on the staffs of Drexel University and the Academy of Natural Sciences.