High Strength Medical and Surgical Glues

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.

Sealants, Glues and Advanced Securement in the Americas

Taken together, the Americas represent some 60% of the global market, led by the United States with more than 50%.  The main medical markets in Latin America are Brazil and Mexico, followed by Argentina.

non-usa-securement1Unlike the wealthier U.S. market where private insurance dominates the market, 75% of the population in Brazil is covered by the state-run Unified Health System (although only 42% of the country’s healthcare spending is in the public sector).  Accordingly, securement markets in Brazil are dominated by use of conventional, low-cost closures (sutures, staples, tapes) dominate the market, while more expensive novel closures (sealants and glues) have relatively modest market shares. The same is true of Argentina, which is still recovering from a severe economic depression in the 1990s. Mexico, the eighth biggest trading market in the world, operates a health care system under which 60%–70% of the population are covered by public insurance schemes. In terms of expenditure on medical products, Mexico occupies a position between that of developed and developing economies, and this is reflected in the shares of the wound closure market represented by premium-priced and commodity product groups.

Nonetheless, growth of conventional closures like sutures, staples and tapes is relatively stagnant in the non-USA Americas compared to growth of advanced securement market.

From "Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009-2013," published by MedMarket Diligence. See report #S175.

High strength medical glues and adhesives

Originally from MedMarket Diligence Report #S175. See the 2012 Report #S190, “Worldwide Surgical Sealants, Glues and Wound Closure, 2010-2017.” See also “High-Strength Adhesives versus Sutures/Staples in Wound Closure” from the 2012 Report #S190.

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.

Sutures will be replaced by cyanoacrylate glues in many procedures over the next 10 years but these adhesives do not represent the ideal alternative to suturing. 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.

 Companies Commercializing Cyanoacrylate-based High-Strength Medical Adhesives

cyanoacrylates

Source: MedMarket Diligence. See 2012 updated report #S190.

Active programs are under development in three categories of new high-strength adhesive closure and securement products. The first of these comprises the application of medical grade cyanoacrylates to internal procedures for many new surgical indications and the development of procedure-enabling devices for the delicate and precise application of these strong adhesives will lead to strong market segment growth. The second category of new products will arise from improvements and new indications for existing biomaterial adhesives. The third category of new products will arise over the next decade and will include new polymer adhesives based on new chemistries.

Growth in high strength medical adhesives is in excess of 20% annually due to recent regulatory approvals and will be sustained, though at more modest rates, over the next decade. It will be fueled by increased incidence of surgery, greater adoption of these cyanoacrylate and newer adhesive products for internal surgical applications, and the need for improved, fast-acting and easy-to-use products for use in minimally invasive procedures. In addition, it is becoming recognized that these products have a role to play in reducing infection and improving cosmesis of surgical wounds to the surface of the skin and this will also drive the value of this attractive market segment.


See the 2012 Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.”