According to the U.S. Food and Drug Administration, drug device combination products are defined as therapeutic products comprising an active pharmaceutical ingredient and a medical device that are physically and/or chemically, combined to be produced as a single product. The drug present in the device may be impregnated or surface coated. Such products can be designed for local as well as systemic administration of drug to the patient. Recently, combination products are emerging as innovative medical products due to their contribution in advancing medical care and are thus expected to have major impact in the coming years.
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Moreover, these products offer several advantages which include reduced adverse side effects, improved patient compliance, controlled release administration of drug, and also provide targeted drug delivery. The major product types in the market include drug eluting stents, infusion pumps, photosensitizers, orthopedic combination products, wound care combination products, inhalers, transdermal patches and others which include intraocular implants and drug eluting beads. Various emerging technologies such as implants with drugs to permit faster healing, relief from pain and decreased morbidity currently form the major driver for the growth of this market. The global drug device combination products market was valued at USD 66 billion in 2012 and is expected to grow at a CAGR of 7.9% from 2013 to 2019, to reach an estimated value of USD 115billion in 2019.
High incidence rates of chronic pain causing diseases, prostate cancer, diabetic retinopathy, cardiovascular diseases, colorectal cancer, asthma, obesity along with rapidly aging global population also form the key drivers for the global drug device combination products market. Government and NGO initiatives to promote drug delivery implants, rising number of interventional cardiologists and increase in the demand for minimally invasive surgeries are some of the other factors propelling the growth of the market. Introduction of biodegradable drug delivery technologies willserve as future growth opportunities for various drug device combination products. However, product recalls act as a major growth restraint for the market due to incidences such as adverse side effects to the patient. Also, these products form a challenge to FDA owing to their classification overlapping the regulated products and thus complicating their approval process.
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Geographically, North America dominated the global drug device combination products market and is expected to continue to lead in terms of revenue generation throughout the forecast period. The market in North American region was valued at USD 28.5 billion in the year 2012.Asia-Pacific is considered as the most lucrative market for drug device combination products owing to the increase in incidences of cardiovascular diseases, diabetes related disorders and obesity through 2019. The leading players in the market for drug device combination products are Abbott Laboratories, Inc., Medtronic, Inc., Boston Scientific Corporation, CareFusion Corporation, Allergen, Inc. and others.