Tag Archives: surgical adhesive

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.

Report: Surgical Sealants, Glues, Wound Closure and Anti-adhesion Worldwide

MedMarket Diligence (MMD) has published its 2010 report on the worldwide market for surgical sealants and related products in surgical and traumatic wound management.

The analysis by MMD reveals the size of the evolving opportunity for a diverse set of products in global markets. Based on extensive primary and secondary research, and leveraging MMD’s position as the leading source for the medtech industry on the subject, the report provides industry participants and hopefuls with invaluable data and insights.

The report is described below and at link

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, from tapes, sutures and staples to hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments in this huge and rapidly growing worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity.

This report is a market and technology assessment and forecast of surgical sealants, glues, hemostasis, other wound closure and anti-adhesion. The report details the current and emerging products, technologies and markets involved in wound closure and sealing using sutures and staples, tapes, hemostats, fibrin and sealant products, medical adhesives and products to prevent surgical adhesions. The report provides a worldwide historic (from 2008), current and annual forecast to 2015 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the coming decade.  The report provides specific forecasts and shares of the worldwide market by segment for the U.S., Europe (United Kingdom, German, France, Italy, BeNeLux), Latin America, Japan, Korea and Rest of World.

The report provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies.

The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a five-year forecast. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

See link for complete table of contents and list of exhibits.  The report may be ordered for immediate download from link.

Technology platforms and clinical applications overlap

Diverse technologies have a surprising number of common threads, whether in the technologies themselves or in the clinical applications.  For this reason, manufacturers need to consider that:

1. A technology platform can be the launchpad for products in clinically diverse areas. Case in point, cell therapy, which as a fundamental scientific discipline can have uses as far afield as wound management, bone repair, treatment of myocardial ischemia and others.

2. A disease state can sometimes be targeted by many very different technologies.  Examples include that wound management can be accomplished by tissue engineering, sutures, fibrin-based surgical glues, cyanoacrylate-based surgical glues, dressings and others.

The driver behind technologies having multiple clinical applications is, of course, that companies wish to maximize their ROI.  

The driver behind single disease states being the target of multiple alternative technologies is cost — healthcare systems (in principle, anyway) seek the most competitive options for treating specific patient populations, and this driver has been gaining momentum over the past ten years due to “managed care” efforts as well as aggressive, cost-focus innovators creating technologies that displace market share with convincingly better patient outcomes compared to alternative technologies.


MedMarket Diligence publishes medical technology market reports on a wide range of clinical and technology subjects (of course, sometimes overlapping). See list.

(This post was done via the Palm Pre WebOS app Po’ster by Gabriele Nizzoli.) 

High-strength surgical glues: From the outside looking in

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.  

high-strength-gluesGiven 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.

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.


"Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013." Published 2009, MedMarket Diligence, LLC.

Surgical closure, hemostsis and sealant market; approvals, market growth

During the 1990s, many technology-based companies began to target the huge unmet closure and sealant market and extensive literature appeared, advising practitioners on specific methodology to create the ideal autologous fibrin sealant product and on applying these products to surgical indications. In addition, a number of specialist societies were established to support and advise on the process of preparing and using hospital-derived fibrin sealants.

fda-approvedThere 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.  


Excerpt from "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013." Report #S175, published by MedMarket Diligence, LLC.

 

Adoption of surgical securement products by clinical category and key determinants

The potential for products in the surgical securement (sealants, glues, sutures/staples, hemostats, anti-adhesion) is driven by clinical category and the impact of the particular products, in each specialty, on a hierarchy of determinants, from the "important and enabling" to the "aesthetic and perceived benefits".  This results in a variable distribution by clinical category in the potential of each.

On a relative basis (absolute values provided in report S175), the distribution by clinical category for the adjunctive use of sealants, glues, hemostats and anti-adhesion products are illustrated below graphically, followed by the description of each category.

 

category-sealant-products

Category I: Important and Enabling
Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.

Category II: Improved Clinical Outcome
Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).

Category III: Cost-Effective and Time-Saving
Immediate reduction in surgical treatment time and follow-up treatments.

Category IV: Aesthetic and Perceived Benefits
Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.
 

See report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013."

Surgical closure and securement products defined

The market for securement pRoducts may be subdivided into the following product categories: sutures, staples and other mechanical closure devices; tapes; hemostats; fibrin and other sealants; high-strength medical adhesives; and post-surgical adhesion prevention. The total securement market is forecast to grow from almost $7.3 billion in 2007 to reach $11.8 billion in 2013 at a CAGR of 8.4%.

Definitions of Surgical Closure and Securement Products

Souce:  MedMarket Diligence, LLC; Report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013." Published December 2008.