Drug-Device Combinations

Report Highlights

• The total market for drug-device combinations worldwide was valued at $5.4 billion in 2004 and is expected to rise at an average annual growth rate (AAGR) of 13.6% to $11.5 billion in 2010.
• The star category is drug-eluting stents that will continue to show average annual growth of 11.5%. This will result in the market doubling to $8 billion in 2010.
• With the exception of bone graft substitutes and antibiotic bone cements, all categories will show double-digit growth.
• The U.S. dominates the market for drug-device combination products, mainly because the largest-selling drug-eluting stents have been enthusiastically accepted in this market and consequently are penetrating the market more quickly than in Europe.

INTRODUCTION

Therapeutic drug-device combination products are an area of intense interest and unlimited potential from a clinical as well as an investment point of view. Devices, in general, are used to treat conditions rather than cure them. Drugs and biologics also generally treat disease, although some products provide cures. The combining of two treatment approaches, drugs/biologics and devices, should enhance the quality of treatment by increasing efficacy and reducing side effects. In some cases, the one-two treatment punch may, in fact, effect a cure.

The purpose of drug-device combination products either is to augment a device's efficacy and/or safety through the use of a drug coating, or to use a device to deliver a drug locally. This BCC report covers devices that serve a therapeutic function and have a drug component incorporated into them.

The study provides an overview of the current drug-device combination product market and an insight into the emerging market. The categories for this report were chosen because they represent areas for which therapeutic drug-device combination products recently have been introduced and/or are emerging.

SCOPE OF STUDY

The report contains:

• Analysis of the technologies for five areas of drug-device combination products, including antimicrobial catheters, biologic wound care products, bone graft substitutes and bone cements, drug-eluting stents and photodynamic therapy (PDT)
• Analysis of global markets for these products with forecasts to 2010
• Detailed discussion of the current regulatory environment for drug-device combination products and how this is affecting development and approval of such devices
• Further analysis of overall market trends and competitors and profiles of selected competitors in the category.

METHODOLOGY

The base year for this study is 2004. Market figures are based on revenues at the manufacturer's level and are projected at 2005-dollar value (i.e., inflation is not computed into the projection figures).

INFORMATION SOURCES

Data to prepare this study was derived from information obtained from interviews with management at companies competing in the various categories of drug-device combination products, or which have products in development that will compete in the categories covered in the report. In addition, interviews were conducted with physicians and other professionals to gain insight into clinical assessment and usage of, and preference for different therapeutics and technologies. In particular, input from regulatory experts was included, as regulations and guidelines for the development and approval of drug-device combination products are continually being challenged and refined. Key information from literature was used to obtain expert opinions on commercial potential and market sizes from industry professionals.

AUTHOR'S CREDENTIALS

Lynn Gray has been a research analyst in the biotechnology and life sciences since 1989. Her collaboration with Communications Co. (BCC) began in 1996, and during that time, she has authored over 20 BCC biomedical reports.