Many advanced products in the area of medical/surgical wound closure have already been in use in the European Union for several years, stemming primarily from the EU’s straightforward, predictable and faster regulatory process compared to the FDA in the U.S. By comparison to Europe, the FDA requirements often include spending millions of dollars and years of clinical trials before a product will be considered and potentially cleared for launch in the U.S. Hence, EU surgeons tend to be out in front of their US counterparts in the use of products such as high-end hemostats, sealants, adhesives and adhesion prevention products. Once approved, though, for all its ills, the U.S. remains the more lucrative market.
The U.S. also represents a bigger upside opportunity in the area of surgical sealants, glues, hemostats, anti-adhesion and other advanced wound closure products, since adoption of these new technologies results in their higher growth in the U.S. compared to Europe as caseload trends, shift from traditional wound closure (e.g., sutures) and other trends are more favorable in the U.S.
Below is illustrated the 2012 markets for wound closure products in the U.S. and Europe.
Source: MedMarket Diligence, LLC; Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017”.
There is also a change taking place in the types of surgery performed, with endoscopic and laparoscopic surgery becoming more common. To some degree, these surgical formats favor “traditional” wound closure technologies like sutures and staples, especially as manufacturers have of sutures, staples and clips (e.g., Ethicon, Coviden) have had a head start in the development of laparoscopically- and other endoscopically-delivered versions of their sutures, staples and clips. Nonetheless, the concurrent drive for minimally invasive technologies also supports the expanded use of hemostats and sealants, which offer a smaller “footprint” in accomplishing wound closure than even absorbable sutures. These forces are impacting the U.S. and Europe differently. One should also consider that the premise of the European “Union” is an ideal that is not quite reflected yet in the patterns and practices that vary across its member countries.