Prevalence of surgical, traumatic, burn and chronic wounds

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

 

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.

Traumatic Wounds

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.

Burns

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

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.

 

Wound care technology balance is shifting

The global market for wound management includes many products that fall into more than one category. For simplicity sake, however, product-based revenues can be assembled into categories including fabric dressings, first aid dressings, dressings and internal wound management products for surgery, advanced wound management products, active pharmaceutical wound care products, tissue engineering, physical therapies for wound care, and pressure relief products and skin treatments, for preventative wound management.

The total wound management market worldwide yields revenues in the range $13-14 billion. The aggregate market is forecast to grow at a modest annual rate through 2016. While some well established wound care product segments will grow at barely more than inflationary rates, the aggregate market growth will be driven predominantly through exceptional growth in advanced wound management (roughly $5 billion in 2005) and in active therapy areas (roughly only $900 million in 2005).

The charts below illustrate the size and evolution of the Advanced Wound Care market from 2007 to 2016.

Advanced Wound Care Market, by Segment, 2007 & 2016

 Source:  See Report #S245, "Worldwide Wound Management, 2007-2016."

Wound management: established and emerging products, technologies and markets worldwide

Below is a report from MedMarket Diligence on the worldwide wound management market.  The report is described in detail here.

Worldwide Wound Management, 2007-2016: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World 

· 256 pages · 64 Exhibits · 69 Company Profiles · Report #S245 · Published Nov. 2007

This report details the complete range of products and technologies used in wound management and wound care, from dressings, bandages, hydrogels, tissue engineered products, physical treatments and others. The report details current clinical and technology developments in this huge worldwide market with high growth sectors, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity.

This report details the current and projected market for wound management products, including dressings, closure devices, debridement, pharmacological products, tissue engineered products and others. Particular emphasis is placed on advanced and leading edge developments (i.e., those approaching wound management from novel perspective) such as growth factors, stem cells, gene therapy and other approaches, while baseline data (current and forecast market size and current competitor market shares) is provided for established segments — multiple dressings types (film, foam, alginate, antibacterial, non-adherent), hydrogels, hydrocolloids, pharmaceuticals, and physical treatments. The report details the clinical and technology developments underlying the huge and evolving worldwide wound care market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. Separate size, growth and competitor data are presented for the U.S., leading western European countries, Japan and the Rest of World category. The report profiles leading and emerging companies, with profiles providing detailed profile information on major competitors, brief profiles of companies with less sizeable current or potential positions in the market, and additional profiles of companies with novel or advanced wound care research activities in the market.

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 and 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.)

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.

 

 

 

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.)

Energy-Based Technologies (Ablation, Other), 2007-2017, Worldwide

Ablation Worldwide Market, 2007 to 2017
Ablation Worldwide Market, 2007 to 2017

Technologies for ablation and other energy-based treatments in medical/surgical markets are currently dominated by electrosurgical-type therapies, but a growing array of other modalities are creating new applications or penetrating existing ones.

At right is shown the forecast, by modality type, of ablation and other energy-based therapies through 2017. The most significant growth is expected to come from microwave, thermal, hydromechanical and cryotherapy, each of which will demonstrate compound growth rates in excess of 15% annually.


Excerpt from report #A125, “Ablation Technologies Worldwide Market,” (August 2008).  See link.  Report #A125, “Ablation Technologies Worldwide”, may be purchased online.

The Uses of Adjunctive Surgical Closure and Securement 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 securement 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 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.

Medical Technology Market Analysis, MedMarkets (April 2008)

Below is the coverage in the April 2008 issue of MedMarkets.

Ablation:  An Energized Market

Demand for Hip and Knee Implants Expected to Increase

MedMarket Outlook: Beyond Technology Innovation: Current and Future Market Forces and Trends

Early Stage Companies: Evalve, ES Vascular, Cardiorobotics, TriVascular

Early Stage Company Financings: Alure Medical, Arbel Medical, Breathe Technologies, CoAxia, IDev Technologies, IlluminOss Medical, Lanx, Pathway Medical Technologies, Tryton Medical

Recent Medtech Startups

Biotechnology Update: Self-Assembling Nanofibers Show Promise for Spinal Cord Injury

Drivers: Sluggish Economy Slows Venture Capital Market

Leading Clinical Edge
Nanovalve Useful for Drug Delivery
Molecular Machine Serves as Remote Control
Progress Made on Biosensing Nanodevice
Mutant Proteins Stimulate Heart Cell Growth
Specialized MRI Identifies Brain Cancer Early
New Therapy for Pediatric Retinoblastoma
Eye Drops Monitor Brain Tissue Repair
Nanoengineered Gel for Spinal Cord Injury
Cell-Sorting System May Detect Cancer

Developments
FDA Approves OrNim’s Monitoring Device
Study Challenges Aspect Medical’s Device
Kinetic Concepts to Acquire LifeCell
Promising Results for Evalve’s MitraClip
U.S. Patient Receives CardioKinetix Heart Implant
Medtronic Improves Talent Stent Graft
FDA Reports Medtronic AneuRx Deaths
Medtronic CRT Clinical Trial Fails
Positive Results for Echo Therapeutics’ Symphony
Abbott’s Glucose Monitor Approved
Datascope to Sell Business to Mindray
Philips Completes Respironics Acquisition
ArthroCare’s Ablation Device Successful
Benefits from Genzyme’s Carticel Sustained
J&J Considers Design Changes for Charité
LifeNet Health Launches Cervical Implant
BioMimetic Refutes FDA Comments
AngioDynamics to Buy Diomed

Complete content available to subscribers only.  For coverage in all past issue of MedMarkets, see link.

See Reports from MedMarket Diligence.

Wound Prevalence Growth: Surgical, Traumatic, Burns, Chronic

This is an excerpt from Report #S245, “Wound Management, 2007-2016: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World,” published by MedMarket Diligence, LLC (November 2007).

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 Prevalence by Etiology Worldwide

Wound Management Trends

Surgical Wounds

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.

Traumatic Wounds

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.

Burns

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

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.


See wound report #S245 description, table of contents here. This report may be ordered online or via downloadable order form.


Commercial Evolution of Med/Surg Sealants and Adhesives

Product Development History

During the 19th century, surgeons began to experiment with materials designed to achieve hemostasis: gelatin, collagen, natural fabrics, and thrombin and fibrin materials. In the early 1980s today’s commercial products began to appear. They were rapidly adopted in Japan where bleeding is an extremely emotive issue, and also in Europe where local regulatory requirements allowed a sequential roll-out of product introductions. In the USA, early FDA concerns associated with disease transmission led to delayed launch of products derived from human sources. These regulatory delays, plus the perceived high cost of products and surgeons’ concerns regarding disease transmission risk, drove surgeons and hospitals to continue to look for alternative hemostats, sealants and glues. As a result, to this day, there is a tendency for hospitals to continue to prepare autologous fibrin (from the patient’s own blood taken before surgery) and to use a number of inferior haemostasis products.

Topical high strength glues were first used by the military, and to achieve immediate repair of sports injuries during professional sports like ice hockey, boxing and American football. These products became the subject of collaborative efforts between innovative suppliers and major suture manufacturing and marketing companies, keen to evolve their product portfolios to include next-generation closure materials.

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

There were also a growing number of companies developing medical devices and equipment specifically designed to allow the preparation of autologous fibrin sealant for surgical applications. All this effort led to a number of products being approved for use in the major surgical indications (see Exhibit). In 2006, sealant products were used in over three million surgical procedures. This represents up to 5 million units of commercially available fibrin sealant products, and approximately four million units of autologous fibrin prepared by hospitals. The autologous fibrin material, prepared using commercial medical devices, was used in approximately 70,000 surgical operations worldwide and represents a new market which has developed over the last five years. Similarly, the use of high strength glues for wound closure evolved since 1992 in Europe and since 1998 in the USA and Japan. High strength adhesives were used on approximately six million cuts, grazes and minor incisions in 2006. This usage is growing rapidly driven by greater awareness and cost effectiveness.

    Exhibit: U.S. FDA Approved Uses of Sealants, Glues, and Hemostats

      Hemostats Sealants Adhesive
    Cardiovascular

    Yes

    Yes

    No

    Orthopaedic

    Yes

    Yes

    No

    Neurological

    Yes

    Yes

    Yes

    Gastrointestinal

    Yes

    Yes

    No

    Pediatric

    Yes

    Yes

    No

    Thoracic

    Yes

    Yes

    No

    Pulmonary

    Yes

    Yes

    No

    Skin

    Yes

    No

    Yes

    Source:  MedMarket Diligence, LLC , Report #S145, “Worldwide Surgical Sealants, Glues & Wound Closure, 2007-1011.”

    Evolution of Commercial Markets for Sealants and Adhesives

    The use of fibrin and other hemostats expanded rapidly in the 1980s in Japan driven by the strong cultural desire to avoid the need for blood transfusions in that market. In addition, regulatory barriers to launching homologous pooled plasma-derived products in Europe were not as stringent as those imposed by the US FDA in the late 1980s and 1990s. As a result the scientific literature from Asia and Europe records many novel and experimental uses for sealant and haemostasis products across all surgical disciplines from ENT to major open heart surgery.

    In addition to commercial sources of sealant products, surgical centers in all regions of the world also prepare autologous fibrin for surgical procedures in efforts to save on commercial product costs, and to avoid potential for product-borne infection. Delays to the introduction of fibrin-based products in the USA led to a pent-up unmet need, which was addressed in the 1990s by the preparation of autologous fibrin in medical centers prior to surgical operations.

    Historically, closure of surgical incisions has been achieved through an ever-evolving portfolio of suture, staple and tape products. In the early 1990s physicians involved in sports medicine were the first non-military practitioners to adopt cyanoacrylate glues to achieve immediate closure of small cuts and lacerations, and an awareness of this opportunity developed in large multinational manufacturers of sutures and staples. Joint development efforts were commenced at Davis and Geck (now U.S. Surgical), and Ethicon (subsidiary of Johnson and Johnson), and in a number of companies manufacturing cyanoacrylates which ultimately resulted in topical cyanoacrylate closure products being launched around the world during the 1990s.

    Postoperative adhesion prevention evolved as a market in the early 1990s, and expanded with the addition of new entrant products from Genzyme, Focal, and others. Lifecore and Ethicon have developed a surgical adhesion prevention product based on hyaluronic acid. Angiotech, Fidia, Fziomed and Tissuemed all have adhesion-prevention products that are CE approved in the European Union.


    Report #S145, “Surgical Sealants, Glues & Wound Closure Worldwide, 2007-2011.” For details, see link.