Drug Device Combination Products: A Blessing Or a Boon?


Published Date : Jan 11, 2016

Drug device combination products are the distinct products, which consists of an active pharmaceutical component, two regulated components, and a medical device that are physically or chemically brought together in order to create a single product. The drugs, which exist in the device are either surface coated or impregnated. In the recent years, combination products have developed as advanced and innovative medical products owing to their participation in advancing medical care and so they are anticipated to have an important impact on the global medical devices market. 

According to FDA, combination products refer to a product consisting of two or more regulated components, such as biologic/device, drug/device, drug/biologic, or drug/device/biologic, which are chemically, physically, or in any other way combined or mixed and produced as a single component. Some of the examples of combination products which fall under the category of drugs are implants whose primary purpose is to release a drug, contrast media, peritoneal dialysis solutions, prefilled syringes, alcohol swabs, dental products impregnated with a drug, wound dressings, patches for transdermal drug delivery, and red blood cell processing solutions. 

Some of the prominent factors that are projected to boost the demand of the drug device combination products are asthma, colorectal cancer, growing prevalence of cardiovascular diseases, diabetic retinopathy, anomalies caused by pain, prostate cancer, obesity, and growing geriatric population. The global market for drug device combination products is projected to witness a substantial growth in the coming years due to many factors such as NGO and government initiatives to encourage drug delivery implants, growing demand for minimally invasive surgeries, and rising number of interventional cardiologists. However, product recalls owing to the side effects caused by certain products is one of the important restraining factors, which is expected to curb the growth of this market in near future. 

The prominent players engaged in this business are Ethicon, Inc., Arrow International, Inc., W.L. Gore & Associates, Inc., Medline Industries, Inc., Allergan, Inc., Mylan, Inc., Abbott Laboratories, Stryker Corporation, Alcon, Inc., Boston Scientific Corporation, Pinnacle Biologics, Inc., C.R. Bard, Inc., CareFusion Corporation, Terumo Corporation, Medtronic, Inc., Covidien PLC. Analyzing the profit margins associated with this business, many players are trying to enter this market in the next few years.