Combination products are a fascinating area of the pharmaceutical industry and present great future promise. The segment is projected to reach $115 billion in global sales by the end of 2019. It has grown solidly at a rate of 7.9% CAGR since 2013 and is projected to continue at that rate through 2019.1
Some of the key factors driving this growth include higher levels of patient compliance, demand for minimally invasive surgeries, opportunities for precise pain relief, quicker healing, and governments and non-governmental organizations (NGO) embracing combination drugs for their ease of administration.
Combination products defined in 21 CFR 3.2(e)2 are therapeutic and diagnostic products that are composed of any combination of a drug, device, or biological products, with the intention of creating safer, more effective, precisely targeted, and easier to administrate therapies.
While the technologies and innovations driving the combination product market deliver a great deal of value to patients and to the medical community, the novelty of these products is often challenging for drug developers and regulatory agencies. The marriage of two different disciplines – drug and medical device – creates a complex regulatory process that must be well-managed. In addition, evolving regulations as the combination product segment matures can present challenges for older, legacy combination products.