Hemostats have been used for over a hundred years to stop bleeding in surgical and traumatic wounds. Primarily these products were first introduced to prevent hematomas during surgery with the aim of preventing resultant infections. During the 1980s and 1990s, the popularity of hemostats increased rapidly as surgeons tried to avoid excessive use of blood transfusions for reasons of economy and the threat of disease transmission. Products were launched during this period by many of the large medical device manufacturers.
The value of hemostasis lies in its ability to quickly improve patient clinical status and/or improve surgeons’ ability to do so by clearing the surgical field in order to assess traumatic wounds or facilitate surgical procedures. Hemostats also play a less technically challenging role than providing closure of wounds, which is offered instead by a variety of sealants and glues. Consequently, the barriers to entry for this market are relatively low — and getting lower, as many companies are developing formulations of collagen and gelatin for introduction in world markets. (Components of hemostats on the market and under development also include thrombin, fibrin, synthetics and others.) However, a number of proprietary products and formulations still face significant regulatory hurdles associated with their development and manufacture.
There are some well established companies controlling the current market, among King Pharmaceuticals, Ethicon, and Pfizer, with many competitors vying for increasingly larger shares of this market.
"Others" include CSL Behring, Hemcon Medical Technologies, BioCore Medical Technologies, BIOSTER, Ceremed, Collagen Matrix, C.R. Bard, CryoLife, Entegrion, FibroGen, Flamel Technologies, Gelita Medical, Harvest Technologies, Kensey Nash, Marine Polymer Technologies, MedTrade Products, Nycomed, Omrix (J&J), Pfizer, PlasmaSeal, Polyganics, PolyHeal, Resorba, Scion Cardio-Vascular, Starch Medical, Synovis Life Technologies, TissueMed, TramaCure, Vascular Solutions, Zymogenetics, and Z-Medica Corporation.
Source: MedMarket Diligence Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."