Sealants/Glues, Hemostats, Other Wound Closure Markets, Size and Growth

Products in wound closure include sutures/staples, tapes, vascular closure devices, surgical hemostats, and surgical sealants/glues.

Wound types have not changed over history, with a slight exception being the emergence (several decades ago) of femoral punctures associated with catheterization procedures. But what has changed, and what continues to evolve, is the practice of closing those wounds. Sutures, staples and tapes are a mainstay of medical practice, representing uncomplicated methods to secure wounds. And while innovators continue to change the form and function of these products to improve performance, the more recently introduced surgical hemostats, vascular closure, and surgical sealants/glues have seized significant shares of wound closure caseload and are growing marginally faster than sutures/staples and tapes. The result is and will be an erosion of traditional wound closure technology shares.

Below is illustrated the size/growth of segments in the global wound closure market.

Screen Shot 2015-04-13 at 7.05.33 AM
Source: MedMarket Diligence, LLC; “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018″, Report #S192.

Sticky stuff: remora, mussels, geckos, crab shells, Australian burrowing frogs, spider webs, porcupine quills, sandcastle worms

It may not be obvious what links all of these creatures, but it is their all-natural adhesiveness. While we have covered these before, today Researchers at Purdue University report on the development of new glues with industrial applications (including medical) based on glues derived from, or inspired by, mussels and oysters.

The reality is that there is a very wide range of naturally occurring “bio-glues” or other adhesives (or adhesive mechanisms) that are being evaluated for their potential use as medical/surgical glues and adhesives.

(This technique of “biomimicry”, in which products are developed that exploit or replicate features in nature, is not new. Velcro, for instance, was invented in 1941 by Swiss engineer George de Mestral, who recognized a potential product in burrs, the plant seed pods covered with hooked spines that readily attach to fur, fabrics and almost any surface that has filamentous covering.)

Below is a list of organism-derived “bio-glues”, a wide range of naturally-occurring adhesives that are being investigated for their potential development as commercial adhesives, including for medical/surgical adhesion.

Most of these have at least been preliminarily investigated as to why they have such high strength, why they adhere under certain challenging conditions and other considerations. Further research and development, in some cases to an advanced degree, has been done on a number of these to actually either directly utilize these glues, modify them or develop new ones inspired by them.

MedMarket Diligence tracks the medical/surgical markets for fibrin and other sealants, glues, hemostats, tapes, vascular closure devices, and staples/sutures/clips in Report #S192. Products specifically related to closure of wounds (excluding hemostasis*) will exceed $11 billion in sales by 2018:

Screen Shot 2015-04-03 at 8.08.01 AM

*Hemostasis is covered in report #S192.

Source: MedMarket Diligence, LLC; Report #S192.

Surgical Sealants, Glues, and Hemostats with Bioactive Agents

Excerpt from Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure 2013-2018″.

Screen Shot 2015-03-30 at 10.14.59 AMBiologically active sealants typically contain various formulations of fibrin and/or thrombin, either of human or animal origin, which mimic or facilitate the final stages of the coagulation cascade. The most common consist of a liquid fibrin sealant product in which fibrinogen and thrombin are stored separately as a frozen liquid or lyophilized powder. Before use, both components need to be reconstituted or thawed and loaded into a two-compartment applicator device that allows mixing of the two components just prior to delivery to the wound. Because of the laborious preparation process, these products are not easy to use. However, manufacturers have been developing some new formulations designed to make the process more user friendly.

Selected Biologically Active Sealants, Glues, and Hemostats 

CompanyProduct NameDescription/
(Status*)
Asahi Kasei MedicalCryoSeal FS SystemFibrin sealant system comprising an automated device and sterile blood processing disposables that enable autologous fibrin sealant to be prepared from a patient's own blood plasma in about an hour.
BaxterArtissFibrin sealant spray
BaxterTisseelBiodegradable fibrin sealant made of human fibrinogen and human thrombin. For oozing and diffuse bleeding.
BaxterFloSealHemostatic bioresorbable sealant/glue containing human thrombin and bovine-derived, glutaraldehyde-crosslinked proprietary gelatin matrix. For moderate to severe bleeding.
BaxterGelFoam PlusHemostatic sponge comprising Pfizer's Gelfoam hemostatic sponge, made of porcine skin and gelatin, packaged with human plasma-derived thrombin powder.
Behring/NycomedTachoCombFleece-type collagen hemostat coated with fibrin glue components.
Bristol-Myers Squibb/ZymoGenetics (Sold by The Medicines Company in the US and Canada)RecothromFirst recombinant, plasma-free thrombin hemostat.
CSL BehringBeriplast P/Beriplast P Combi-SetFreeze dried fibrin sealant. Comprised of human fibrinogen-factor XIII and thrombin in aprotinin and calcium chloride solution.
CSL BehringHaemocomplettan P, RiaSTAPFreeze-dried human fibrinogen concentrate. Haemocomplettan (US) and RiaSTAP (Europe).
J&J/EthiconEvicelEvicel is a new formulation of the previously available fibrin sealant Quixil (EU)/Crosseal (US). Does not contain the antifibrinolytic agent tranexamic acid, which is potentially neurotoxic, nor does it contain synthetic or bovine aprotinin, which reduces potential for hypersensitivity reactions.
J&J/EthiconEvarrestAbsorbable fibrin sealant patch comprised of flexible matrix of oxidized, regenerated cellulose backing under a layer of polyglactin 910 non-woven fibers and coated on one side with human fibrinogen and thrombin.
J&J/EthiconBIOSEAL Fibrin SealantLow-cost porcine-derived surgical sealant manufactured in China by J&J company Bioseal Biotechnology and targeted to emerging markets.
J&J/EthiconEvithromHuman thrombin for topical use as hemostat. Made of pooled human blood.
Pfizer/King PharmaceuticalsThrombin JMIBovine-derived topical thrombin hemostat.
Stryker/OrthovitaVitagel SurgicalBovine collagen and thrombin hemostat.
Takeda/NycomedTachoSilAbsorbable surgical patch made of collagen sponge matrix combined with human fibrinogen and thrombin.
Teijin Pharma Ltd/Teijin Group (Tokyo, Japan)KTF-374Company is working with Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN) to develop a sheet-type surgical fibrin sealant. Product combines KAKETSUKEN's recombinant thrombin and fibrinogen technology with Teijin's high-performance fiber technology to create the world's first recombinant fibrin sealant on a bioabsorbable, flexible, nonwoven electrospun fiber sheet.
The Medicines Company (TMC)Raplixa (formerly Fibrocaps)Sprayable dry-powder formulation of fibrinogen and thrombin to aid in hemostasis during surgery to control mild or moderate bleeding.
The Medicines Company (TMC)In development: Fibropad patchFDA accepted company's BLA application for Fibrocaps in April 2014 and set an action date (PDUFA) in 2015. In November 2013, the European Medicines Agency agreed to review the firm's EU marketing authorization application. Status update in report #S192.
Vascular SolutionsD-Stat FlowableThick, but flowable, thrombin-based mixture to prevent bleeding in the subcutaneous pectoral pockets created during pacemaker and ICD implantations.

Note: Status of products detailed in Report #S192.

Source: MedMarket Diligence, LLC

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.

Secrets of Bio Glues

Researchers at the University of Akron have revealed the evolutionary strength of spider web glue. Published in the May 17, 2010, issue of Nature Communications, the research revealed that the effectiveness and strength of the spider web glue ensues from the highly entangled, cross-linked polymers in each droplet of the glue, which enables the adhesive force to be transmitted throughout the glue.

UA researcher Vasav Sahni notes:

[The] stickiness of the glue droplets depends on the speed at which they are stretched.

Subsequently, the glue droplets can hold on to fast-flying insects when they initially impact webs and retain trapped insects for a time period long enough for them to be subdued by the spider.

“This finding should significantly benefit the development of synthetic adhesives for biomedical, orthopedics and wound-healing applications. The understanding of how spiders use this unique glue will allow scientists to develop reversible adhesives that work in the presence of water,” says Dhinojwala.

As we have often highlighted in the past ("Sea life and other sources of glue to mend people" link or "Bio Glues" link), a wide range of biological sources have been identified and are under evaluation (or adaptation) as medical and surgical glues due to their evolutionarily-designed strength, biocompatibility and other inherent advantages.

See also the MedMarket Diligence, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013." Report #S175

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.)