Sealants, Glues, Wound Closure, Anti-Adhesion

[Below is an excerpt from Report #S145, “Worldwide Surgical Sealants, Glues & Wound Closure”, published Feb. 2007.  This report is the subject of a new analysis, Report #S175, to be published December 2008.]

Introduction

The market for surgical closure and securement 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 expenditure on all medical devices surpassed $173 billion in 2006, and in the field of tissue repair and surgical securement, the total market reached almost $7 billion, underpinned by product advances reflecting our 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 available.

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 growing to be 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 healthcare system has a major impact on this segment. Consolidation in healthcare buying organizations (particularly in the USA) 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 out-patient 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 more advanced and new technologies. In addition, the case for cost-effectiveness involves professional preferences and adoption of new procedures, as well as the potential to reduce surgical theatre time and costs.

Demographic trends

Many new surgical procedures have been established over the last ten years as products and procedures are modified to accommodate increased consumer (i.e. 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, ageing of the population adds progressively to the surgical caseload. For example in the USA, Medicare beneficiaries (disabled and elderly patients) are forecast to increase from 34 million to 70 million between 2000 and 2030. Products that are targeted at this elderly population – and reimbursed – 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.

Consumer Driven Product Selection

Other important driving factors are accelerating public healthcare awareness and education, improved communication techniques and media, rises in gross domestic product in many countries around the world, and awareness of patient rights (including litigation potential). All lead to increased uptake for the best new products, technologies, and techniques, once these have been proven safe and effective. For example, it might now be viewed as negligent for a gynaecological surgeon to not use an adhesion prevention product on a female patient of child-bearing age. Patient access to clinical trial records and regulatory approval information is now becoming more universal, and this contributes powerfully to consumer-driven product selection.

Mechanisms of Tissue Repair

As recently as ten years ago, the biochemical mechanisms underlying tissue repair were still incompletely understood. For example, during the early 1990s as many as a hundred companies were actively engaged in clinical trials evaluating efforts to accelerate repair based on applying higher than physiological levels of growth factor to non-healing tissue. By 2003, many companies had abandoned this approach due to disappointing results. A better understanding of the underlying mechanisms of tissue repair has led to the evaluation of more complex approaches, combining structural repair materials with active pharmacological agents, biologically-derived and cellular components. This improved knowledge of physiological healing processes has led to formulation and adoption of new securement and adjunctive surgical devices, resulting in improved hemostasis, reduction in post-surgical adhesion (PSA) formation, and stronger and quicker biological repair.

Commercial Imperatives

MedMarket Diligence carried out a survey of the companies exploiting medical devices targeted at the surgical securement market, to examine the products they market and the timelines associated with their approvals. A greater awareness of regulatory approval mechanisms and requirements around the world has become apparent in this market sector, and we believe this indicates a growing trend in the medical device industry overall. In the USA, a new medical device is usually marketed after the FDA approves a pre-market application, or clears a 510K pre-market notification submission. The time required for the FDA to carry out this approval has been steadily reducing (around 3 months now for a 510k and 13 months for a PMA). The FDA has improved to accelerate this process and make the approval process less arbitrary.

Regulatory bodies in Europe and Japan have also made marked advances in the last ten years to streamline their approval processes, so that clear guidelines are given for approval and for reimbursement categories. In addition, companies making submissions have become more aware of the need to identify the key factors for approval (KFA), and to engage with the regulatory bodies early in the process to clarify the routes forward for any exceptional aspects of product development.
We also found that all medical devices businesses (from small biotechnology companies to large capital conglomerates) are becoming more efficient at managing their new product pipelines, and focusing on a mixture of short-term product concepts and longer term, more risky breakthrough opportunities.

Industry Consolidation

In the last few years there has been a significant consolidation of the securement industry, as venture-based companies are incorporated into larger market-based corporations with critical mass in their sales effort. This represents a welcome development for investors in leading-edge technologies, which are now being developed into marketable ventures. Examples exist covering the full range of deal structures from exclusive distribution deals and joint development agreements with exclusive marketing licenses through to full acquisitions of companies.

In addition, regulatory progress in the securement field has led to a continued stream of new approvals around the world offering real value to the patient, and demonstrating improved awareness of regulatory needs, understanding of the biochemical mechanisms of repair, and offering real potential to build market value.

Clinical Caseload

The market potential for products in the surgical securement field 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.
We forecast that approximately 70 million procedures around the world might benefit from products in this category in the future, and due to demographic trends and evolving surgical capabilities, this number is forecast to increase at an annualized rate of 3-5%.
In the forthcoming decade we will see strong penetration of new therapies into new procedure areas, and some new introductory techniques for treatment of orthopedic, cardiovascular and neurological procedures.

Market Segmentation and Dynamics

This market may be subdivided into Sutures and Staples, Tapes, Haemostats, Sealants, High Strength Glues, and Adhesion Prevention Products. The total securement market is forecast to grow from almost $7 billion in 2004 to reach $10 billion in 2011 at a CAGR of 7.5%.

Aggregate growth rates worldwide per segment are shown for illustrative purposes below:

 

 


The 2007 report #S145 on worldwide sealants, glues and wound closure is available for purchase and immediate download. The December 2008 report may also be purchased with pre-paid advance discount (price noted below is $1,500 off the publication price).

 

Report #S175, “Worldwide Surgical Sealants, Glues and Wound Closure 2009-2013.” Purchase in advance at this link or purchase via Google Checkout, below.

























Report #S145, “Worldwide Surgical Sealants, Glues and Wound Closure 2009-2013.” Purchase for immediate download at this link or purchase via Google Checkout, below.

























Wound Management Product Growth, Up and Down, to 2016

Excerpt from MedMarket Diligence report #S245, “Worldwide Wound Management, 2007-2016.” See link for more information. Available for purchase online.

Wound Management Market Growth by Segments, 2007-2016Technologies developed and in use for the management of acute and chronic wounds have diversified from traditional dressings, bandages and wound closure techniques to include an increasing number of diverse technologies ranging from tissue engineering, growth factors, physical therapies (e.g., negative pressure) and others. Traditional dressings and bandages have evolved to contain more active elements contributing to wound healing, with products including films, hydrocolloids, foams, alginates, hydrogels, non-adherents and antimicrobials. Wound closure is a specific area of intense development and market growth beyond traditional suturing and more recent stapling technologies and has seen proliferation and high market growth for surgical sealants, glues and hemostasis products.

The size of the worldwide wound management market is ultimately driven by the clinical need for advanced wound management products. That need is most clearly reflected in the prevalence of chronic wounds and burns. Current estimates put the total annual incidence of chronic wounds at almost 9 million worldwide, and there are 177 million cases of diabetes worldwide; 10-15% of diabetic patients will develop ulcers at some point. The market for products used in the management of venous stasis (as in chronic venous ulcers) is put at over $3 billion, while the decubitus ulcer (e.g., bedsores) market is in excess of $2 billion. Sales of products used to treat diabetic foot ulcers are estimated around $1.5 billion, and the market for burns dressings is approximately $60 million.

It should be noted that a large proportion of worldwide wound product sales are accounted for by traditional types of wound management products. An estimated two-thirds of the world’s physicians are not making routine use of advanced wound management products, with availability playing only a minor role in limiting their use. Conversely, while the U.S. healthcare market is characterized by an almost overindulgent attitude toward new technologies, U.S. physicians are much more conservative in their approach to advanced wound healing technologies than their European counterparts. For this reason, the European share of the advanced wound care market is significantly higher than the U.S. share.

Market Growth in Wound Management Product Segments
Until recently, the product categories with most growth potential were alginates and foams; both have substantial shares of the total market and both are set to increase their shares substantially between 2007 and 2016. Hydrocolloids had a considerable market share in 2007 but their star is in decline; it is anticipated that they will lose several percentage points in the market share table by 2016. (Segment growth in chart from MedMarket Diligence report #S245, “Worldwide Wound Management, 2007-2016,” publishing November 2007. See link for description, table of contents.)

The most significant market entrants are growth factors and, even more dramatically, physical therapies – specifically, negative pressure (also known as VAC therapy) devices. This market sector grew from a small base to gain $1.2 billion by 2007 and is set to capture an estimated 20% of the advanced woundcare market by 2016.

Films, antimicrobials and non-adherent dressings will maintain steady growth although their shares of a vigorously expanding market will decline.


Report #S245, “Worldwide Wound Management” is available for purchase online or via Google Checkout, below.

 

 

 

The Uses of Adjunctive Surgical Closure and Sealant Products

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 ‘pay its way’. 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.  This report is available for purchase online or via Google Checkout (below).

Wound Management Market Segment Growth, 2008-2017

Excerpt from MedMarket Diligence report #S245, “Worldwide Wound Management, 2007-2016.”  See link for more information. Available for purchase online.

Wound Management Market Growth by Segments, 2007-2016Technologies developed and in use for the management of acute and chronic wounds have diversified from traditional dressings, bandages and wound closure techniques to include an increasing number of diverse technologies ranging from tissue engineering, growth factors, physical therapies (e.g., negative pressure) and others.Traditional dressings and bandages have evolved to contain more active elements contributing to wound healing, with products including films, hydrocolloids, foams, alginates, hydrogels, non-adherents and antimicrobials.  Wound closure is a specific area of intense development and market growth beyond traditional suturing and more recent stapling technologies and has seen proliferation and high market growth for surgical sealants, glues and hemostasis products.

The size of the worldwide wound management market is ultimately driven by the clinical need for advanced wound management products. That need is most clearly reflected in the prevalence of chronic wounds and burns. Current estimates put the total annual incidence of chronic wounds at almost 9 million worldwide, and there are 177 million cases of diabetes worldwide; 10-15% of diabetic patients will develop ulcers at some point. The market for products used in the management of venous stasis (as in chronic venous ulcers) is put at over $3 billion, while the decubitus ulcer (e.g., bedsores) market is in excess of $2 billion. Sales of products used to treat diabetic foot ulcers are estimated around $1.5 billion, and the market for burns dressings is approximately $60 million.

It should be noted that a large proportion of worldwide wound product sales are accounted for by traditional types of wound management products. An estimated two-thirds of the world’s physicians are not making routine use of advanced wound management products, with availability playing only a minor role in limiting their use. Conversely, while the U.S. healthcare market is characterized by an almost overindulgent attitude toward new technologies, U.S. physicians are much more conservative in their approach to advanced wound healing technologies than their European counterparts. For this reason, the European share of the advanced wound care market is significantly higher than the U.S. share.

Market Growth in Wound Management Product Segments
Until recently, the product categories with most growth potential were alginates and foams; both have substantial shares of the total market and both are set to increase their shares substantially between 2007 and 2016. Hydrocolloids had a considerable market share in 2007 but their star is in decline; it is anticipated that they will lose several percentage points in the market share table by 2016. (Segment growth in chart from MedMarket Diligence report #S245, “Worldwide Wound Management, 2007-2016,” publishing November 2007. See link for description, table of contents.)

The most significant market entrants are growth factors and, even more dramatically, physical therapies — specifically, negative pressure (also known as VAC therapy) devices. This market sector grew from a small base to gain $1.2 billion by 2007 and is set to capture an estimated 20% of the advanced woundcare market by 2016.

Films, antimicrobials and non-adherent dressings will maintain steady growth although their shares of a vigorously expanding market will decline.

(Report #S245, “Worldwide Wound Management” is available for purchase online.)

New Wound Closures Get Seal of Approval

From January 2008 issue of MedMarkets, with excerpts from Report #S145, "Worldwide Surgical Sealants, Glues & Wound Closure, 2007-2011."  This report has beeen updated by Report #S175, with forecasts for 2009-1013.

The market for surgical sealants is expected to grow in double digits over the next five years as aging populations drive increases in caseloads (see chart below). In addition, less morbidity and better outcomes are seen with the latest fibrin sealants, high-strength glues and adhesion prevention products, thus spurring increased adoption of these technologies over traditional wound closure methods.

There are several main categories of closure and securement devices in use in the OR: sutures and staples, tapes, hemostats, fibrin glues and sealants, adhesion prevention products, and soft tissue attachment products. Some leading companies in the modern wound closure market established their leadership positions when the market consisted exclusively of sutures, staples and tapes; others are new entrants based on expertise in areas such as adhesives. While the fibrin sealant market segment is dominated by Baxter Healthcare and CSL Behring, the high-strength glue segment is led by U.S. Surgical (now part of Covidien), Ethicon, and Aesculap (a B. Braun company). Key players in the market for adhesion prevention products are Ethicon, U.S. Surgical and Genzyme. Market shares for these companies are shown in the charts, “Leading Companies in the Sealants Market by Market Share.”

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Fibrin—The Body’s Sealant

Fibrin sealants are the most useful surgical hemostats because they can be used to clot blood but are also valuable for sealing around suture lines for organ transplants, mastectomies, and various resection procedures, as well as to prevent leakage of fluids and gases. A number of companies, including Harvest Technologies, Plasmaseal, ThermoGenesis, and Interpore Cross Medical, have developed active mixes of growth factors to aid repair and devices capable of preparing autologous fibrin and platelet formulations that can be used as sealants. In July 2007, ThermoGenesis announced that the FDA had approved the CryoSeal FS system, the company’s autologous fibrin sealant, as an adjunct to hemostasis in liver resection surgery. The product was already cleared for sale throughout the European Community (CE Mark) for any type of surgery. The CryoSeal FS system, an automated device with a companion sterile blood processing disposable, is used to prepare fibrin sealants from plasma in about an hour. The system produces a surgical sealant by harvesting, from a patient’s plasma, wound healing proteins including fibrinogen and Factor VIII, and the activating enzyme thrombin. When combined at the bleeding wound site, the two components form an adhesive gel that helps stop bleeding and bonds tissue. Thrombin is a predecessor of fibrin in the clotting cascade and is involved in converting (soluble) fibrinogen to (insoluble) fibrin. It is used in combination with fibrin for accelerated hemostasis. On January 10, 2008, Omrix Biopharmaceuticals announced that the FDA had granted an expanded indication for general hemostasis in surgery for Evicel liquid fibrin sealant (human). Evicel is the first liquid fibrin sealant to be indicated as an adjunct to hemostasis for use in patients undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical. Ethicon is Omrix’s marketing partner and will actively promote Evicel for a wide range of surgeries.

High-Strength Medical Adhesives

Fibrin-based wound closure products achieve hemostasis and have moderate adhesive properties that can help sutures to keep wound edges in apposition. Where greater adhesive strength is required, cyanoacrylate products are the main form of high-strength surgical glue approved for human clinical use. They are replacing sutures in many procedures but do not represent the ideal alternative to suturing, an ideal technology that is still sought by researchers. 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 potentially useful materials for internal surgical procedures. Nonetheless, cyanoacrylate glues are marketed actively by a number of companies for topical wound closure in accident/emergency situations and in surgical closure. Leading products in this category include Dermabond, which is developed by Closure Medical and marketed by Ethicon. Dermabond is marketed in about 40 countries under EU- and FDA-approval for topical wound closure. For Ethicon, Dermabond represents the culmination of a five-year joint development program with Closure Medical that started in 1996. Closure Medical, which is now incorporated into Ethicon, also developed Omnex vascular sealant, a high-strength adhesive that received the CE mark in 2005.

Post-Surgical Adhesion Prevention

Post-operative adhesions tend to arise when internal connective tissues are exposed to air and instrumentation during the surgical procedure and any irritation caused to internal organs. Abdominal surgery often leads to some form of adhesion formation, as does cardiovascular surgery. There are roughly 8 million–9 million abdominal surgeries, more than 2 million gynecologic surgeries, and 9 million cardiovascular surgeries every year, with about 1.7 million procedures associated with some risk of critical adhesion formation. Thus there is enough risk for adhesions from these procedures to encourage the use of adhesion prevention products in approximately 10% of the cases over the next decade. Among companies that have led the growth in adhesion prevention products are Johnson & Johnson/Ethicon with its Interceed brand, and Genzyme Biosurgery, which launched Seprafilm approximately five years after the J&J product. Interceed (made out of neutralized oxidized regenerated cellulose by the company’s Noramco chemical synthesis business) and Seprafilm both provide a bioresorbable protective layer between tissues susceptible to adhesion formation. Other contenders in this field include Omrix Biopharmaceuticals, which has developed an anti-adhesion product named Adhexil; an IND for Adhexil was filed in December 2006. Meanwhile, SyntheMed has developed the Repel-CV bioresorbable adhesion barrier; the company announced favorable results from a pivotal trial in neonatal patients in September 2006. When Angiotech acquired Cohesion Technologies, it inherited the Adhibit sprayable adhesion prevention product. In April 2006, the company announced data from a 71-patient human clinical study (conducted in the EU) designed to assess the safety and efficacy of Adhibit for preventing adhesions in patients undergoing a myomectomy procedure. The trial data indicated that the use of Adhibit reduced post-operative adhesion. Baxter Healthcare has been granted exclusive worldwide (excluding the United States) marketing and distribution rights to Adhibit. In July 2007, Protein Polymer Technologies (PPTI) announced it had entered into an agreement with an unnamed multinational biotechnology device company in which PPTI will provide genetically engineered protein polymer biomaterials for use in the prevention of post-surgical adhesions. PPTI believes its protein polymer materials can improve the outcome of abdominal and gynecological surgery by substantially reducing adhesions. PPTI is also in discussions with several U.S. and international biotechnology and medical device companies, which are evaluating PPTI’s surgical sealant and drug delivery product applications. These products are intended to aid in the closure of surgical incisions and tissue trauma reducing, for example, the incidence of post-operative bleeding and the local delivery of therapeutic agents.

Market Potential

The commercial importance of wound closure and adhesion prevention products is directly linked to clinical need, which is reflected in the numbers of procedures that can benefit from improved closure and adhesion-prevention technology. Approximately 10 million cardiovascular procedures in the United States have the potential to benefit from improved hemostasis, sealants and glue products. In an estimated 1.5 million procedures, these products can make a major contribution to the work of the surgeon in carrying out a safe procedure with minimal risk from blood transfusion and complications associated with loss of blood. Procedures that fall into this category include open heart bypass procedures with vein harvesting and many heart revascularization procedures, aortic valve replacements, mitral valve replacements, carotid endarterectomy, femoral distal bypass, and femoral popliteal bypass. Of more than 9 million musculoskeletal surgical operations worldwide, a large number (approximately 4 million) involve minimally invasive arthroscopy or are closed fractures in which hemostats, sealants and glues cannot be used. However, open trauma cases, knee reconstruction, total knee replacement, some hip reconstruction procedures, and all spine fusion procedures have the potential to benefit from improved appropriate use of hemostat, sealants and glues. Some of these procedures cause the patient to lose substantial quantities of blood. Effective use of sealants/hemostats can prevent loss of time during surgery, reduce the requirement for replacement blood products, and significantly improve rehabilitation due to reduced morbidity. Also there are 450,000 fusions and 432,000 discectomies performed in the United States each year. Particularly in the case of fusion, patients may require replacement of up to half the blood in their bodies. These procedures can take up to six hours to perform, and effective hemostasis can significantly improve cost effectiveness by saving surgical theater time and related costs, improving recovery and outcomes for the patient (e.g., reduced risk of infection) and reducing morbidity. There are approximately 2.5 million joint reconstruction procedures worldwide. Although minimally invasive procedures have reduced the burden of these procedures, reconstructive surgery is likely to increase with the growth of the aging population and with increased recreational activity. These procedures can benefit from improved use of closure and hemostatic products. Typically, tourniquets are used to prevent excessive bleeding during many of these procedures; it is assumed that lack of blood flow results in morbidity of tissue and delayed recovery as well as leading to increased complications, although the reduced need for blood transfusion is thought to outweigh these disadvantages. The introduction of effective sealants and hemostats offers the possibility of selectively reducing bleeding at sites of reconstruction without the concomitant effect of increased morbidity. It seems realistic to expect that a new category of procedure-enabling high-strength glue products will evolve and enable gluing of ligaments, tendon and bone in the orthopedic arena. Although there are a number of cement and bone graft substitute materials that have glue-like characteristics, none yet have the weight-loading potential or the torque-strength characteristics to meet the demand to fix bone fragments together without hardware support. Gynecological and urological procedures include transurethal prostate resections, bladder surgery, prostatectomy, hysterectomy and surgical resection of adhesions, as well as cesarean sections. Hemostasis and sealing in these procedures is critical to prevent complications that can result from excessive bleeding. Neurosurgery (4 million procedures annually in the United States) is highly vulnerable to the effects associated with healing: inflammation, angiogenesis, and generation of fibrous tissue—all attributes of normal tissue repair—cause problems for neural tissue. Effective hemostasis and sealing of blood can avoid these traumatic effects and are vital to reduce morbidity. Most traumatic wounds offer potential to be appropriately treated with hemostats, sealants and glues. Many lacerations can be adequately treated with high-strength glue products; this would avoid a secondary visit to a medical center for removal of sutures with associated costs. For example, conservative estimates of ER costs for closure of a small bleeding trauma laceration with sutures, (including local anesthetic, antibiotic cream and suture removal kit) are approximately $75 before labor and time are included. Further, in U.S. acute care hospitals, 5%–10% of patients develop hospital-acquired (nosocomial) infections, many of them in wounds. The cost per wound ranges from $3,000 to $27,000.

Revenue Implications

Fibrin-Based Sealants: The world market for fibrin-based sealants and similar products is estimated to be worth roughly $1.5 billion per annum, with annual growth rates in low double figures. Most fibrin and similar sealant products were first used for internal surgical hemostasis and sealant effects. This is now changing with the realization that appropriate hemostasis and gluing of surgical wounds results in reduced infection rates and better cosmesis. Growth rates in the synthetic and biological adhesives segment of the market will be relatively modest because these technologies have the most potential in niche opportunities, competing with established use of autologous and allogeneic fibrin products from major established players and a number of new device suppliers, as well as future recombinant human fibrin producers such as PPTI. Fibrin sealant usage worldwide is forecast to increase steadily during the coming years, driven by such factors as the requirement to use these materials in new procedures and an increasing caseload. One market in which these products are of special interest is Japan, where the loss of blood and avoidance of transfusion are extremely emotive issues. Growth rates here for autologous products and sealants not derived from blood may be delayed by long approval mechanisms, but will be rapid once these products appear on the Japanese market. In addition, this growth rate will be supported by the sales of new devices for the preparation of autologous fibrin sealants. High-Strength Glues: Cyanoacrylate products are the primary form of high-strength surgical glues 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. Even though cyanoacrylate glues are not the ideal replacement for sutures, such a perfect replacement has yet to be fully developed, leaving room for cyanoacrylate glues to replace conventional sutures in many procedures over the next 10 years. To that end, cyanoacrylate glues are marketed actively by a number of companies for topical wound closure in accident/emergency situations and in surgical closure. The $500 million world market for high-strength surgical glues is growing vigorously and expected to more than double in value over the next five years, driven by increased incidence of surgery, greater adoption of 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. Also, it is increasingly recognized that these products have a role to play in reducing infection and improving cosmesis of superficial surgical wounds, which will also drive the value of this market segment.

Adhesion Prevention

The market for products to prevent post-surgical adhesions is driven by the introduction of new technologies, by impressive data on product effectiveness, by increasing caseload and by growing acceptance of this type of product. World sales of products in this category are forecast to increase by solid double-digit annual growth rates from a value around $700 million to something approaching $1.5 billion in five years’ time.


Links: Advanced Medical Solutions (Winsford, U.K.; http://www.admedsol.com) Aesculap (Center Valley, PA; http://www.aesculap.com) Angiotech (Vancouver, Canada; http://www.angiotech.com) B. Braun (Melsungen, Germany; http://www.bbraun.com) Baxter Healthcare (Deerfield, IL; http://www.baxter.com) Chemence (Corby, U.K.; http://www.chemence.com) Closure Medical (Raleigh, NC; http://www.closuremed.com) Covidien (Norwalk CT; http://www.covidien.com) CSL Behring (King of Prussia, PA; http://www.cslbehring.com) Daiichi Sankyo (Montvale, NJ; http://www.daiichius.com) Ethicon (Somerville, NJ; http://www.ethicon.com) GEM (See Synovis Life Technologies) Genzyme Biosurgery (Cambridge, MA; http://www.genzyme.com) GluStitch (Delta, Canada; http://glustitch.com) Harvest Technologies (Plymouth, MA; http://www.harvestech.com) Interpore Cross Medical (Irvine, CA; http://www.interpore.com) Johnson and Johnson (Somerville, NJ; http://www.ethus.jnj.com) Kaketsuken (Kumamoto, Japan; http://www.kaketsuken.or.jp) MedLogic Global (See Advanced Medical Solutions) Nissui Pharmaceutical (Tokyo, Japan; http://www.nissui-pharm.co.jp) Omrix Biopharmaceuticals (Kiryat Ono, Israel; http://www.omrix.com) Pharming Group (Leiden, The Netherlands; http://www.pharming.com) Plasmaseal (San Francisco, CA; http://www.plasmaseal.com) Protein Polymer Technologies (San Diego, CA; http://www.ppti.com) Synovis Life Technologies (St. Paul, MN; http://synovislife.com) SyntheMed (Iselin, NJ; http://www.synthemed.com) SysCore (E-mail: Helmut.Kranzmaier@cnc-communications.com) ThermoGenesis (Rancho Cordova, CA; http://www.thermogenesis.com) U.S. Surgical (Norwalk, CT; http://ussurg.com)  


The complete report on Surgical Sealants, Glues & Wound Closure is described in detail here.   This report may be purchased in its entirety online or via Google Checkout, below.