See the updated, published 2012 Report #S190, “Surgical Sealants, Glues, Sutures, Other Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017.”
Cyanoacrylate products are the main form of high-strength surgical glue that is approved for human clinical use in the worldwide market. A number of new materials are under development for internal use in particular, but these represent new chemical entities and their commercialization is likely to be delayed by regulatory requirements. While sutures will be replaced by cyanoacrylate glues in many procedures over the next 10 years, this will only occur after some technical challenges are overcome. For example, cyanoacrylate glues used for external skin closure are approximately five times less strong than sutures, and cyanoacrylates produce cytotoxic compounds as part of the curing process when used for securing torn or excised tissue. This has delayed the development and clinical evaluation of these potentially useful materials for internal surgical procedures. However, cyanoacrylate glues are marketed actively by a number of companies for topical wound closure in accident/emergency situations and in surgical closure.
Given the current size of the global market for high strength glues (at over $700 million) and the potential for this market to expand as products overcome the challenges of strength and toxicity, a respectable number of competitors compete in this space and many are working on further developing cyanoacrylate-based and other high strength adhesives (including fibrin-based and other “bio-glues”) to not only garner greater share of the existing market but to also erode the market for sutures and other mechanical wound closure products (e.g., clips and staples).
Source: MedMarket Diligence Report #S180, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2015.”
Ethicon (J&J), Covidien and B. Braun (Aesculap) hold the major positions in the market for high strength medical and surgical adhesives, but their positions are at risk, and will continue to be at risk, as long as the unmet need exists for stronger, more compatible glues. Some of the many products on the market and in development in the area of high strength glues include SurgiSeal, DermaSeal, FloraGuard, LiquiBand, SkinLink, Histoacryl, Gluetiss, Autologous biological glue, Chemence USP Class VI adhesives, TissueGlu, Indermil, Glubran2, Glubran Tiss, GluSeal, GluSite, PeriAcryl, GluShield, Dermabond, InteguSeal, Epiglu, Surgical Tissue Sealants (STS) and others.
Given their ability to effectively adhere minor to moderate lacerations quickly, preempting the need for sutures that may lead to permanent scarring, and given manufacturers’ ability to promote their use, topical applications of medical adhesives have established routine clinical use. Internal applications of high strength glues, particularly cyanoacrylates will be held back until toxicity issues are addressed or avoided in the development of new chemical or biological glue types. The market for hight strength glues will nonetheless demonstrate the aggressive growth exhibited for the last few years.
There were also a growing number of companies developing medical devices and equipment specifically designed to allow the preparation of autologous fibrin sealant for surgical applications. All this effort led to a number of products being approved for use in the major surgical indications (see exhibit). In 2006, sealant products were used in over three million surgical procedures. This represents up to 5 million units of commercially available fibrin sealant products, and approximately four million units of autologous fibrin prepared by hospitals. The autologous fibrin material, prepared using commercial medical devices, was used in approximately 70,000 surgical operations worldwide and represents a new market that has developed over the last five years. Similarly, the use of high-strength glues for wound closure evolved since 1992 in Europe and since 1998 in the United States and Japan. High-strength adhesives were used on approximately 6 million cuts, grazes and minor incisions in 2006. This usage is growing rapidly driven by greater awareness and cost-effectiveness. 