The list of companies profiled in the forthcoming MedMarket Diligence report #S175 on Surgical Sealants, Glues, Wound Closure and Anti-Adhesion has been expanded based on the additional company data gathered from the worldwide analysis. The list now stands at 136 companies. See below:
4.1 3DM, Inc. (3D-Matrix, Ltd.)
4.3 Abbott Vascular
4.4 AccessClosure, Inc.
4.5 Adhezion Biomedical, LLC
4.6 Advanced Medical Solutions
4.8 Angiotech Pharmaceuticals, Inc.
4.9 Anika Therapeutics, Inc.
4.10 ARC Pharmaceuticals Inc.
4.11 Arch Therapeutics (formerly Clear Nano Solutions)
4.12 ArthroCare Corporation
4.13 ASO LLC
4.14 Aspen Surgical Products
4.15 Atrax Medical Group
4.16 Avery Dennison
4.17 B. Braun Melsungen AG
4.18 Bard Medical Division, CR Bard
4.19 Bastos Viegas, s.a.
4.20 Baxter International Inc.
4.21 Bayer HealthCare
4.22 BD (Becton Dickinson and Company)
4.23 Berlin Heart GmbH
4.24 Bernsco Surgical Supply
4.25 Biocoral Inc
4.26 BioCore Medical Technologies, Inc.
4.27 Biogentis, Inc.
4.28 Biomet, Inc.
4.29 BIOSTER a.s.
4.30 BSN Medical
4.31 Cardiovascular Sciences, Inc.
4.32 Cardiva Medical, Inc.
4.33 Carl Auffarth GmbH & Co. KG
4.34 Ceremed, Inc.
4.35 Chemence Ltd.
4.36 Chemopharma, s.a.
4.37 Cohera Medical, Inc.
4.38 Collagen Matrix, Inc.
4.39 Coloplast A/S
4.42 CryoLife, Inc.
4.43 CSIRO PhotoMedical Technologies
4.44 CSL Behring
4.45 CSMG Technologies, Inc.
4.46 CuraMedical BV
4.47 Cypress Medical Products
4.48 DePuy, Inc.
4.49 Derma Sciences
4.50 Distrex Ibérica S.A.
4.52 Ethicon, Inc., Johnson & Johnson
4.53 FibroGen, Inc.
4.54 Fidia Advanced Biopolymers SpA
4.55 Flamel Technologies SA
4.56 Focal, Inc.
4.57 Forticell Bioscience
4.58 FzioMed, Inc.
4.59 Gelita Medical BV
4.60 GEM s.r.l.
4.61 Genzyme Biosurgery
4.62 GluStitch, Inc.
4.63 Graceduty Company Limited
4.64 GramsMed, LLC
4.65 Haemacure Corporation
4.66 HAPTO Biotech Israel Ltd.
4.67 Hartmann Group
4.68 Harvest Technologies Corporation
4.69 HemCon Medical Technologies, Inc.
4.70 Hemostasis LLC
4.71 HyperBranch Medical Technology, Inc.
4.72 Incisive Surgical, Inc.
4.73 Innovasa Corporation
4.74 Integra Lifesciences Corporation
4.75 I-Therapeutix, Inc.
4.76 Kaketsuken (Chemo-Sero-Therapeutic Research Institute)
4.77 Kensey Nash Corporation
4.78 Kimberly-Clark Health Care
4.79 Kinetic Concepts, Inc.
4.80 King Pharmaceuticals, Inc.
4.81 Kookbo Chemicals Co., Ltd. (KB Chem.)
4.82 Laboratoires Urgo (Urgo Medical)
4.83 Lewis Medical Supplies
4.84 LifeBond, Ltd.
4.85 Lifecore Biomedical Inc.
4.86 Lohmann & Rauscher
4.87 Marine Polymer Technologies
4.88 Medafor, Inc.
4.89 Medi Surgichem Pvt. Ltd.
4.90 MedTrade Products
4.91 Meyer-Haake GmbH Medical Innovations
4.92 Mölnlycke Health Care AB
4.93 Morris Innovative
4.94 Motex Healthcare Corp.
4.95 Myco Medical
4.96 NeatStitch Ltd.
4.97 Neose Technologies Inc.
4.99 Nycomed Pharma AS
4.100 Omrix Biopharmaceuticals Inc. (J&J)
4.101 Pac-Kit Safety Equipment
4.102 Pfizer Inc.
4.103 Pharming Group NV
4.104 Plasma Technologies, Inc.
4.105 PlasmaSeal LLC
4.106 Pluromed, Inc.
4.107 Polyganics, BV
4.108 Polyheal Ltd.
4.109 ProFibrix BV
4.110 Progressive Surgical, Ltd.
4.111 Protein Polymer Technologies, Inc.
4.112 Radi Medical Systems AB
4.113 Resorba Wundversorgung GmbH & Co. KG
4.114 Scapa Group plc
4.115 Scion Cardio-Vascular, Inc.
4.116 Sea Run Holdings
4.118 Smith & Nephew Plc
4.119 Starch Medical, Inc.
4.120 Stereoplast Ltd.
4.121 Sutura Inc.
4.122 Synovis Life Technologies, Inc.
4.123 SyntheMed, Inc.
4.124 Teleflex Medical
4.125 ThermoGenesis Corp.
4.126 Therus Corporation
4.127 Thrombotargets Corp.
4.128 Tissuemed Ltd.
4.129 TraumaCure, Inc.
4.130 TyRx Pharma, Inc.
4.131 Vascular Solutions, Inc.
4.132 Vectura Group plc
4.133 Vivostat A/S
4.135 Z-Medica Corp.
4.136 ZymoGenetics, Inc.
The post below is, in part, a re-post from earlier in 2008. It is being revisited to illustrate that the most prevalent wound type, generally chronic wounds like ulcers, are among the highest growth wound types. This illustrates that, while more acute wound types are readily treated with traditional wound closure and even a growing array of surgical sealants, glues and adhesives, there remains an enormous opportunity for would closure and wound management of these chornic types. These opportunities are discussed in the MedMarket Diligence "Worldwide Wound Management report #S245 and the forthcoming Worldwide Surgical Sealants, Glues, Wound Closure and Anti-adhesion 2009 report #S175.
Wound types fall into four general categories — surgical, traumatic, burns, and chronic — yet there is a wide variety of specific types, with different prevalence and growing at different rates. The exhibit below illustrates the current patient population (prevalence) and the compound annual growth rate for each wound type over the 2005-2014 period.
Wound Management Trends
Surgical wounds account for the vast majority of skin injuries. We estimate that there are over 100 million surgical incisions a year, which require some wound management treatment. Approximately 80% of these wounds use some form of closure product (sutures, staples, and tapes). Many employ hemostasis products, and use fabric bandages and surgical dressings.
Surgical wounds are projected to increase in number at an annual rate of 3.1%, but overall the severity and size of surgical wounds will continue to decrease over the next ten years as a result of the continuing trend toward minimally invasive surgery.
Surgical procedures generate a preponderance of acute wounds with uneventful healing and a lower number of chronic wounds, such as those generated by wound dehiscence or post-operative infection. Surgical wounds are most often closed by primary intention, using products such as sutures, staples, or glues, where the two sides across the incision line are brought close and mechanically held together. Surgical wounds that involve substantial tissue loss or may be infected are allowed to heal by secondary intention where the wound is left open under dressings and allowed to fill by granulation and close by epithelialization. Some surgical wounds may be closed through delayed primary intention where they are left open until such time as it is felt it is safe to suture or glue the wound closed.
A significant feature of all wounds is the likelihood of pathological infection occurring. Surgical wounds are no exception, and average levels of infection of surgical wounds are 7 to 10 percent dependent on the procedure. These infections can be prevented by appropriate cleanliness, surgical discipline and skill, wound care therapy, and antibiotic prophylaxis. Infections usually lead to more extensive wound care time, the use of more expensive products and drugs, significantly increased therapist time, and increased morbidity and rehabilitation time. A large number of wounds will also be sutured to accelerate closure, and a proportion of these will undergo dehiscence and require aftercare for healing to occur.
There are estimated to be 1.5 million cases of traumatic wounding every year. These wounds required cleansing and treatment with low adherent dressings to cover them, prevent infection, and allow healing by primary intention. Lacerations are a specific type of trauma wound that are generally more minor in nature and require cleansing and dressing for a shorter period of healing. Lacerations occur frequently (approximately 19 million cases a year) as a result of cuts and grazes and can usually be treated within the doctor’s surgery and outpatient medical center and hospital accident and emergency department.
Burn wounds can be divided into minor burns, medically treated, and hospitalized cases. Out-patient burn wounds are often treated at home, at the doctor’s surgery, or at outpatient clinics. As a result a large number of these wounds never enter the formal health service system. We estimate that approximately 3.3 million burns in this category do enter the outpatient health service system and receive some level of medical attention. These burns use hydrogels and advanced wound care products, and may even be treated with consumer based products for wound healing. Medically treated burn wounds usually get more informed care to remove heat from the tissue, maintain hydration, and prevent infection. Advanced wound care products are used on these wounds. Approximately 6.3 million burns like this are treated medically every year. Hospitalized burn wounds are rarer and require more advanced and expensive care. These victims require significant care, nutrition, debridement, tissue grafting and often tissue engineering where available. They also require significant aftercare and rehabilitation to mobilize new tissue, and physiotherapy to address changes in physiology.
Chronic wounds generally take longer to heal and care is enormously variable, as is the time to healing. There are approximately 7.4 million pressure ulcers in the world that require treatment every year. Many chronic wounds around the world are treated sub-optimally with general wound care products designed to cover and absorb some exudate. The optimal treatment for these wounds is to receive advanced wound management products and appropriate care to address the underlying defect that has caused the chronic wound; in the case of pressure ulcers the causal effect is pressure and a number of advanced devices exist to reduce pressure for patients. There are approximately 11 million venous ulcers, and 11.3 million diabetic ulcers in the world requiring treatment. Chronic wounds are growing in incidence due to the growing age of the population, and due mostly to awareness and improved diagnosis. At present these factors are contributing to growth of this pool of patients faster than the new technologies are reducing the incidence of wounds by healing them.
Wound management products are also used for a number of other conditions including amputations, carcinomas, melanomas, and other complicated skin cancers, which are all on the increase.
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.)