Catheter Industry to grow at 10.4% annually
from 1996-2003

In the catheter industry, acquisitions, mergers, and alliances occur frequently. This means that the corporate landscape is always shifting and changing the competitive positioning of manufacturers. Moreover, catheters are among the more technology-based medical instruments available today and are becoming more so with every new advancement in the industry. On the legal side, the Federal Drug Administration’s (FDA) Modernization Act of 1997, which took effect in February 1998, is the first major legislation that directly impacts medical device manufacturers since 1976. In addition, as of June 14, 1998, the European Union requires all exports to meet European standards for quality, as demonstrated by a CE Mark. This is the only study of the catheter industry following implementation of FDA’s Modernization Act and the tightening of regulations in Europe presently available.

According to a soon-to-be released BUSINESS COMMUNICATIONS, INC. study RB-129 The Catheter Business: How Much? Who? Where? American medical device manufacturers dominate the catheter industry, producing 70 to 80 percent of the catheters used around the world. In 1997, worldwide sales of catheter products totaled approximately $7.3 billion, and are growing at a healthy pace of 10.4% annually.

The fastest growing segment of the catheter industry, the coronary catheter market, is expected to reach $4 billion by 2003, growing at 11.2% annually. Cutting-edge catheter technology is used primarily in the U.S., although there is a growing demand in the European Union and Japan. Coronary catheters explored in this report are used for angiography, electro-physiology, angioplasty, atherectomy, and ultrasound procedures in the heart or in peripheral veins and arteries.

Interventional cardiologists and radiologists are typical end users for these precision devices. The coronary catheter segment of the market is undergoing tremendous change and evolution at this time as new, more effective, and less invasive products are introduced, each building on the previous generation of products.

The largest segment, however, is the renal market, which is comprised primarily of urinary catheters and dialysis catheters. Currently being a $4 billion segment, it is expected to reach $7.1 billion in 2003. The best-known urology catheters are Foley catheters, which have been commercially available since the 1930s. These catheters and others, both internal and external condom-type catheters, are used for incontinence, for dying patients, and often for bladder drainage following surgery or an incapacitating injury or illness. These relatively easy-to-use catheters are used throughout the world in hospitals, nursing homes, and home-care settings. There are two types of dialysis catheters: hemodialysis and peritoneal. End users for this catheter segment are vascular surgeons and interventional radiologists, although once long-term catheter ports are in place, nephrologists monitor access sites and catheter-based dialysis treatments.

Table I

Intravenous (IV) catheters are also widely used throughout the world. These catheters are used on a short-term, long-term, or an intermittent basis for infusion of blood, drugs, or other fluids, and to obtain blood samples. Depending on the purpose of the IV line, plus the length of indwelling time needed, various catheter products are used. Types include standard IV, peripherally inserted central catheter (PICC)/midline, central venous catheters (CVC), and needles.

Developing countries that lack a strong medical infrastructure utilize relatively few of the innovative life-saving devices available today for diagnosis, treatment, and monitoring of cardiovascular diseases. Basic catheters, however, such as intravenous and urinary drainage catheters, are universally used in hospitals around the world. The demand for simple, easy-to-use catheters is growing throughout Asia, Eastern Europe, and Latin America.

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