Add to the list of naturally occurring glue sources — mussels, the C. crescentus bacteria, Australian burrowing frogs and the gecko ("geckel" glue) — the sandcastle worm. University of Utah bioengineers have made a synthetic version of a superglue based on a naturally occurring glue produced by sandcastle worms, which use this glue to build tube shaped homes out of bits of sand and shell fragments.
The synthetic version of the sandcastle worm glue is being explored for its application in orthopedic applications — glueing together small bone fragments in fractured knees, wrists, elbows, and ankles, as well as the face and skull. The applications will at least initially not be for gluing load-bearing sites like large bone fractures, since these can be addressed with screws and pins, while small fractures are more problematic for existing methods.
The researchers will be publishing their findings in the journal Macromolecular Biosciences.
Naturally occurring glues, especially those such as the above, which have demonstrated high strength, are particularly of interest for medical/surgical applications, since existing "biocompatible" glues such as autologous fibrin sealants provide reasonably effective sealing, and even hemostasis, but do not withstand the more challenging stresses of orthopedics and other applications like sealing leaks in lung resections. The higher-strength alternative to fibrin sealants is cyanoacrylate-based glues, but for all their "superglue" strength, their toxicity is a limiting factor. It is for this reason that naturally occurring "bioglues" like those from mussels, geckos and sandcastle worms hold such promise.
MedMarket Diligence published its report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009-2013" for publication in January 2009.
The market for surgical closure and securement — sealants, glues, sutures, tapes, and anti-adhesion — has entered a phase in which major driving forces are the introduction of new procedures and techniques by the surgical profession, the development by the medical device industry of new wound closure devices and biomaterials, and the growing willingness of surgical specialists to use these devices in appropriate circumstances.
There is now a continuum between simple closure using sutures and the use of specially designed devices and delivery systems with new bioresorbable securement materials either as supplements to conventional closure methodology or as stand-alone replacements.
Worldwide expenditures on all medical devices is estimated to have surpassed $173 billion in 2006. In the field of tissue repair and surgical securement, the total market reached almost $7 billion, underpinned by product advances reflecting improved understanding of the underlying mechanisms of tissue repair, patient demographic pressures creating an increasing caseload of procedures, and a rapidly expanding number of new products (see below).
Introduction (through early 2007) of New Securement Technologies to the U.S. Market
Johnson & Johnson
Fabric adhesion prevention
Hyaluronic acid adhesion prevention
Fibrin based sealant/hemostats
Hyaluronic acid adhesion prevention
Autologous blood sealant
Bovine serum albumin-based surgical adhesive
Syneture (US Surgical)
Cyanoacrylate tissue adhesive
Source: Report #S145, to be updated in Report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013". December 2008.
The tissue closure and securement market can be regarded as a benchmark indicator for overall expansion of medical device usage. This is because surgical closure and securement products are becoming components of all surgical procedures. These products are used for rapid and efficient closure of surgical wounds, and internal securement of tissues to reduce pain and accelerate rehabilitation. Appropriate use of these products can reduce risk of infection, and can optimize the repair process to enhance the speed and strength of tissue repair, as well as reducing complications such as those resulting from post-surgical adhesions.
Overall industry spending in the health care system has a major impact on this segment. Consolidation in health care purchasing organizations (particularly in the United States) creates a pressure for cost-effectiveness arguments and supporting clinical efficacy data, and may also limit pricing potential, often when the overall cost in a category appears to be growing uncontrollably. The shift to outpatient and community-based treatment sites and practices affects the way that products are designed, marketed and distributed. In the securement segment, hospital administrators are involved in purchasing more routine and generic surgical securement and closure products, with surgeons selecting newer, more advanced technologies. In addition, the case for cost-effectiveness involves professional preferences and adoption of new procedures, as well as the potential to reduce surgical theater time and costs.
Many new surgical procedures have been established over the last 10 years as products and procedures have been modified to accommodate increased patient awareness and to support practitioner-based competencies. These procedures are often linked to new technologies. For example, minimally invasive procedures that were comparatively rare 10 years ago are now routine; more than 70% of gall bladder surgeries are performed laparoscopically and more than 60% of patients with angina pectoris receive image-guided PTCA (percutaneous transluminal coronary angioplasty) instead of open heart surgery. These procedures depend on new devices and instruments, including improved means of internal and external closures and securement. In addition, aging of the population adds progressively to the surgical caseload. For example, in the United States, Medicare beneficiaries are forecast to increase from 34 million to 70 million between 2000 and 2030. Products targeted at this primarily elderly population would be expected to reflect this trend by compound annual sales growth of 2%–3%. In other regions of the world, this trend is also seen as a major market growth rate determinant.
The market potential for surgical securement products is driven by a combination of new technologies coming to market and expanding caseload for which these technologies are applicable. The potential for these products continues to grow as surgical practices improve and the benefits of new products address the requirement for fast and effective closure.
Source: Report #S145, to be updated in Report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, 2009-2013". December 2008.
We forecast that approximately 70 million procedures worldwide might benefit from products in this category and, due to demographic trends and evolving surgical capabilities, this number is forecast to increase at an annualized rate of 3%–5% (see chart, “Potential Procedure Volume for Surgical Sealants, Glues and Wound Closure”).
Of the 70 million surgical and procedure-based wounds created each year in surgeries worldwide, 23 million are created during surgical procedures in the United States. Although it is possible that healing all these wounds could be improved through use of adjunctive products for surgical closure and securement, use of the most advanced of these products has been limited to a fraction of these procedures. For example, there are approximately 3 million procedures worldwide that receive sealant products, generating $1 billion in sales. We forecast much greater usage of sealants once clinical efficacy is proven in a broad range of procedures and as new sealant products are launched. In addition to improvements in adjunctive treatment of bleeding, new procedure-enabling devices for soft tissue repair and securement have been introduced. These products have expanded the total market for securement and closure of soft tissues with bioresorbable materials.
This field is expanding rapidly as new devices allow the surgeon to perform closure more quickly and with improved outcomes for patients. A significant premium is possible when new products and devices enable complex securement procedures to be performed under minimally invasive protocols with significant time savings in the operating room. New technologies and new biomaterials allow improved tissue repair, and it is possible to revalue segments of this market based on significant improvements in clinical practice. We expect this market segment to triple in value over the next decade.
Driven by procedure volumes, the total market potential for currently available products is in excess of $3 billion for hemostats and sealants, and over $1 billion for skin wound closure using high-strength glues. The introduction of a high-strength, nontoxic elastic glue would revolutionize the market further and lead to even higher sales potential.
In the field of postoperative adhesion control, newly developed products improve on early prototypes and have substantial clinical efficacy data to allow for a significant premium cost. Over $500 million in revenues were generated in 2006 in this market segment, and we expect that this market will grow to over $1 billion within the next five years.
Market Consolidation, Competition on the Rise
A number of market leaders have consolidated their positions within the surgical closure and securement markets through successful internal development programs and through technology partnerships with innovative vendors of next-generation technologies. For example, U.S. Surgical (a Tyco company) and Ethicon (Johnson & Johnson) are major suppliers of cyanoacrylate products in the United States; with dominant sales resources to sell these products, these companies lead the market, even though they face competition from the Canadian company Glustitch, the U.K.-based MedLogic and others. Synovis (formally Biovascular Inc.) has targeted cardiovascular and other procedures, and has a range of closure products; it has recently partnered with GEM to develop and exploit GEM’s internal high-strength glue product (Glubran) in the United States.
Companies in the sealant market are highly competitive, and acquisitions and mergers have also played a significant role in shaping both this market and the individual companies with their products and underlying strategic focus. For example, Baxter launched fibrin sealant technology (acquired when it bought Immuno) in the United States. In addition, its purchase of Immuno in 1998 forced Baxter to relinquish a monopoly position by forming a partnership with Haemacure, thus allowing it to market fibrin products in the United States. Baxter has also acquired rights to Fusion Inc. technology, giving Baxter a portfolio of sealant products. Separately, CryoLife has demonstrated the potential to compete within the rapidly evolving sealants market in the United States by developing superior products.
MedMarket Diligence is completing the 2008 report, publishing December 2008, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-adhesion, 2009-2013." See Report #S175.
The companies involved in the marketing and development of surgical sealants, glues, and other wound closure and anti-adhesion products are a robust group. The number of competitors and the breadth and depth of their offerings are testimony to the size of the active market as well as its considerable potential. Below is the list of companies preliminarily profiled in the pending, December 2008, report #S175, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-adhesion, 2009-2013." The report is described here.
[Publisher’s note: The report #S175 described below is the most recent in a highly regarding industry series tracking this huge med/surg market, with its implication for devices, biologics, biomaterials and other products across a wide range of clinical application sectors. The report is pending publication in early December 2008.]
Report #S175, entitled, "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013," (see link) 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.
The report is a market and technology assessment and forecast of products in wound closure. 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 and medical adhesives. The report provides a worldwide current and annual forecast to 2013 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 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 ten-year forecast. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.
Below is a a report to be published (December 2008) from MedMarket Diligence on the worldwide surgical sealants, glues, wound closure and anti-adhesion market. The report is described at this link.
Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013
· 225 pages · 60 Exhibits · 79 Company Profiles · Report #S175 · Publishing December 2008
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 products in wound closure. 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 and medical adhesives. The report provides a worldwide current and annual forecast to 2013 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 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 ten-year forecast. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.
(For more information, see link or contact Patrick Driscoll, patrick at mediligence dot com, or tel: 949-859-3401.)
Below is a preliminary list of the companies being profiled in the report #S175 on “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2009-2013”.
Note, please, that we have revised the report’s title to reflect that the report covers the “flip-side” of sealing and adhesion — anti-adhesion. Given the developing use of fibin sealants, ironically, in the prevention of post-surgical adhesions, it is a natural extension of the analysis to address anti-adhesion as well.
The readers should also note that the list of companies profiled in the forthcoming report #S175 is preliminary, subject to change as we complete research and determine relevant companies for coverage.
Section 4: Company Profiles (preliminary)
4.1Â Â 3DM, Inc. (3D-Matrix, Ltd.) 4.2Â Â AccessClosure, Inc. 4.3Â Â Adhezion Biomedical, LLC 4.4Â Â Advanced Medical Solutions 4.5Â Â Angiotech Pharmaceuticals, Inc. 4.6Â Â Anika Therapeutics, Inc. 4.7Â Â ARC Pharmaceuticals Inc. 4.8Â Â Arch Therapeutics (formerly Clear Nano Solutions) 4.9Â Â ArthroCare Corporation 4.10Â Â B. Braun Melsungen AG 4.11Â Â Bard Medical Division, CR Bard 4.12Â Â Baxter International Inc. 4.13Â Â BD (Becton Dickinson and Company) 4.14Â Â Biogentis, Inc. 4.15Â Â Biiosyntech Inc. 4.16Â Â Biocoral Inc 4.17Â Â BIOSTER a.s. 4.18Â Â Cardiovascular Sciences, Inc. 4.19Â Â Ceremed, Inc. 4.20Â Â Chemence Ltd. 4.21Â Â Cohera Medical, Inc. 4.22Â Â Collagen Matrix, Inc. 4.23Â Â Covidien 4.24Â Â CryoLife, Inc. 4.25Â Â CSL Behring 4.26Â Â CSMG, Inc. 4.27Â Â CuraMedical BV 4.28Â Â DePuy, Inc. 4.29Â Â Ethicon, Inc., Johnson & Johnson 4.30Â Â FibroGen, Inc. 4.31Â Â Fidia Advanced Biopolymers SpA 4.32Â Â Flamel Technologies SA 4.33Â Â Focal, Inc. 4.34Â Â Forticell Bioscience 4.35Â Â FzioMed, Inc. 4.36Â Â GEM s.r.l. 4.37Â Â Genzyme Biosurgery 4.38Â Â GluStitch, Inc. 4.39Â Â Haemacure Corporation 4.40Â Â Harvest Technologies Corporation 4.41Â Â HemCon, Inc. 4.42Â Â Henkel Loctite Corp. 4.43Â Â HyperBranch Medical Technology, Inc. 4.44Â Â Innovasa Corporation 4.45Â Â Integra Lifesciences Corporation 4.46Â Â Interpore Cross International 4.47Â Â Isto Technologies, Inc. 4.48Â Â I-Therapeutix, Inc. 4.49Â Â Kaketsuken (Chemo-Sero-Therapeutic Research Institute) 4.50Â Â Kensey Nash Corporation 4.51Â Â Kimberly-Clark Health Care 4.52Â Â King Pharmaceuticals, Inc. 4.53Â Â LifeBond, Ltd. 4.54Â Â Lifecore Biomedical Inc. 4.55Â Â Marine Polymer Technologies 4.56Â Â Medafor, Inc. 4.57Â Â Meyer-Haake GmbH Medical Innovations 4.58Â Â Nycomed Pharma AS 4.59Â Â Omrix Biopharmaceuticals Inc. 4.60Â Â Organogenesis, Inc. 4.61Â Â Pharming Group NV 4.62Â Â PlasmaSeal LLC 4.63Â Â Pluromed, Inc. 4.64Â Â Polyganics, BV 4.65Â Â Protein Polymer Technologies, Inc. 4.66Â Â Radi Medical Systems AB 4.67Â Â Scion Cardio-Vascular, Inc. 4.68Â Â Sea Run Holdings 4.69Â Â Smith & Nephew Plc 4.70Â Â Synovis Life Technologies, Inc. 4.71Â Â Teleflex Medical 4.72Â Â ThermoGenesis Corp. 4.73Â Â Therus Corporation 4.74Â Â Thrombotargets Corp. 4.75Â Â Tissuemed Ltd. 4.76Â Â TraumaCure, Inc. 4.77Â Â TyRx Pharma, Inc. 4.78Â Â Vectura Group plc 4.79Â Â Vivostat A/S
From MedMarket Diligence report #S145, “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011.” See link.
The use of products such as tapes and sutures for wound closure and securement leads to faster wound healing with less risk of contamination by debris and infectious agents, and with improved cosmetic outcomes. Failure to use these products can lead to significant complications, infections, significant delays to healing, and potentially loss of life through infection of the tissue leading to septicemia.
Hemostats, sealants and glues have been shown to aid recovery and rehabilitation after invasive surgical procedures, to reduce morbidity associated with infection rates and post-surgical adhesions, and to reduce morbidity associated with specific procedures. For example these products may be used to reduce the risk of deep vein thromboses resulting from tourniquet application to reduce bleeding during total knee replacements.
Hemostats and sealants have been demonstrated to have substantial cost-effective benefits during many surgical operations and the cost of these products are increasingly seen as minor in comparison with the time saved during the surgical procedure alone, even without taking into account rehabilitation. These products have been shown to be highly cost effective for topical wound closure and there are also many potential internal applications for these products.
Use of cyanoacrylate glues for closure has established a considerable following in all regions of the world. Conservative accident and emergency costs for closure of a small bleeding trauma laceration with sutures, local anaesthetic, antibiotic cream and suture removal kit are approximately $75 (before labor and time are included). Cyanoacrylate products can be used without anaesthetic, without sutures, and since cyanoacrylate sloughs off the skin surface, without a removal kit. The FDA has approved cyanoacrylate products as having an anti-microbial outcome, which further reduces the cost of using them to approximately 30% of using sutures. Once labor and time are added this falls to 5%.
Effective haemostasis also demonstrates attractive cost attributes; hemostats can be used for rapid and effective control of bleeding during surgery, thus avoiding an element of the hourly cost of an operating room ($2000 to $10000 per hour). For example, a $115 haemostat needs to shave 4 minutes off the operating time to â€˜pay its wayâ€™. Often, these materials can save from five minutes to two hours depending on procedure.
Sealants also have attractive health economic attributes. The most obvious cases come from specific procedures which have become the lead indications and focus for development programs in many companies. For example, air leaks during lung surgery lead to the need for extended hospitalization (up to 28 days) and more intensive care, as well as additional surgical procedures. Sealants are also commonly applied to avoid cerebrospinal fluid leakage during neurological and spine surgery; leakage of cerebrospinal fluid would otherwise result in infection (including meningitis), debilitating headaches and other problems. In addition, the surgeon uses significant direct time to achieve meticulously leak-proof closure of the dura. This can be avoided by expert and experienced application of appropriate sealant products.
Significant cost-effectiveness arguments can be made for products that avoid blood transfusions or reduce the quantities of blood transfusion products required. Approximately 8 million patients worldwide would benefit directly from increased usage of hemostats, sealants and glue products to reduce bleeding during cardiovascular, orthopaedic, urologic, and other general surgical procedures. Units of blood cost approximately $180 each; however the benefit of reducing transfusion requirement goes beyond this simple saving. Often, the real benefit is that appropriate haemostasis reduces the risk of mortality. For example, reducing blood loss during cardiovascular procedures in particular not only prevents the use of large volumes of donated blood (e.g. 5-10 units for dissection of aortic aneurysms) but significantly reduces mortality rates (which can be as high as 30% for aortic aneurysm procedures).
Adhesion-prevention products have been shown to significantly reduce post-surgical adhesions associated with gynaecological, spinal, cardiovascular and orthopedic procedures. Post-operative adhesions can severely complicate subsequent interventions by making re-entry hazardous, and impeding orientation and visibility, which can lead to damaging the surrounding tissues or vessels. There may also be increased blood loss, and significantly longer operating time required to cut through the adhesions.
The sealants and securement market may be subdivided into Sutures and Staples, Tapes, Haemostats, Sealants, High Strength Glues, and Adhesion Prevention Products.This total market is forecast to grow from almost $7 billion in 2006 to reach $10 billion in 2011 at a CAGR of 7.5%.
The complete report on “Worldwide Surgical Sealants, Glues and Wound Closure Market, 2007-2011” is described with complete table of contents and list of exhibits here. Â This report is available for purchase online or via Google Checkout (below).