Tag Archives: wound care

Growth in Sealants, Glues, Hemostats, and Wound Closure is Absolute, Relative

Of late, I have needed to re-emphasize the difference between absolute and relative growth in medtech markets (and its importance). So, here it is again, this time regarding surgical sealants and other wound closure products.

The lowest relative rate of growth in this industry is the well-established sutures and staples segment. Sales of these products globally, even supported by innovations in bioresorbables and laparoscopic delivery technologies, are only growing at a 5.6% compound annual growth rate from 2013 to 2018. By comparison, growth of sales of surgical glues and sealants is at 9.4% for 2013-2018.

But from an absolute sales growth point of view, sales of sutures and staples will go from $5.2 billion to $6.9 billion, or absolute growth of $1.7 billion. Simultaneously, the relatively high growth in surgical glues and sealants translates to the absolute growth from 2013 to 2018 of only $0.9 billion.

Obviously, both absolute and relative growth are of interest.

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Source: MedMarket Diligence, LLC; Report #S192.

Bioactive Agents in Wound Sealing and Closure

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

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

Selected Biologically Active Sealants, Glues, and Hemostats 

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

Note: Status of products detailed in Report #S192.

Source: MedMarket Diligence, LLC

Wound Sealant and Securement Procedure Volumes by Clinical Area and End-Point

Sealants, glues, hemostats, and other products in wound closure and securement offer benefits that vary by clinical area, but the nature of that benefit also varies by the type of end-point (benefit) the product achieves — does it provide a life-saving benefit? A time-saving? Cost-savings? A cosmetic or aesthetic benefit?

Accordingly, by examining the volume of procedures for which closure and securement products provide which kind of benefit is crucial to understanding demand, especially between competitive products.

Below is a categorization of benefits ranging from the critical (I) to the aesthetic (IV).

Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery

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Source: MedMarket Diligence, LLC (Report #S192)

Considering these different categories, below are the volumes of procedures distributed by category across each of the major clinical disciplines.

Surgical Procedures with Potential for the Use of Hemostats, Sealants, Glues and Wound Closure Products, Worldwide (Millions), 2014





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Source: MedMarket Diligence, LLC (Report #S192)

Classification of Wounds by Morphology

Wounds may be classified according to their depth and whether underlying tissues are damaged. Partial-thickness wounds do not intrude through the dermis and can heal by regeneration; full-thickness wounds involve both the epidermis and dermis, and sometimes underlying tissues as well. They generally heal by scar formation. Wound classification by morphology is shown below:

TypeTissue CharacteristicsEtiologyPrognosis for Healing
Partial thicknessInvolves entire epidermis and portions of dermis.Friction, pressure, small cuts, minor burns.Heal within 10-18 days, epidermal element germinates and migrates up to the epithelial layer. Heals without significant scarring or functional impairment.
Deep partial thicknessInvolves entire epidermis and almost entire dermis.Friction, cuts, significant burns.Healing within 20-35 days.
Full thicknessInvolves epidermis and dermis; may extend into subcutaneous tissue. Sweat glands and hair follicles are destroyed.Severe deep cuts, surgical incisions, most chronic wounds, and third-degree burns.Heals by granulation, formation of new blood vessels, new biomaterial deposition, and new cells over many weeks. Scarring usually results.
Underlying tissue damageConsidered more extensive than full- thickness wounds. Involves subcutaneous tissue, muscle, fascia, bone, and other organs.Surgery of organs, electrical burns and certain thermal burns, such as molten metal or severe scalding, massive traumatic injury, and untreated chronic damage.May require debridement or removal of all necrotic tissue to expose viable bleeding tissue. Systemic antibiotic therapy and grafts/flap skin replacement.

Source: MedMarket Diligence, LLC

The global wound management market is the subject of Report #S249.

The global market for surgical sealants, glues, hemostats, vascular closure devices, sutures/staples, and tapes is the subject of Report #S192.

See also the October 2015 report, “Worldwide Wound Management, Forecast to 2024:
Established and Emerging Products, Technologies and Markets
in the Americas, Europe, Asia/Pacific and Rest of World”, Report #S251.

Absolute and Relative Growth in Wound Closure Product Sales Worldwide

Medtech manufacturers interested in “growth” markets need to consider the relative versus absolute. Nascent markets can growth from $1 million sales in year 1 to $2 million in year 2, obviously a 100% increase. But in multi-billion markets, a $1 million increase will elicit a yawn from all but the smallest manufacturers.

Just as an exercise, I ranked the growth rates for sales of wound closure products detailed in our Report #S192 by both the absolute sales growth from 2014 to 2018 and the compound annual growth rate over this period. To reveal the differences even further, I did this ranking by the all combinations of geographic area and wound closure product type. Partial results — just the top growth rankings, since the list is too long to show all — are shown side by side below (click on the chart to see a more legible version).

Wound Closure Sales Growth, Absolute and Relative, 2014-2018

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Source: “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, Report #S192.

Even though tapes, sutures and staples have very modest growth rates in many geographic markets, their current dollar volume sales make such growth much more significant in absolute terms.

Sealants, Glues, Hemostasis and Wound Closure Market, Size and Growth

The simple practice of closing wounds is not so simple, driven as it is by the fact that wounds can be the conduit for blood, infectious agents and every other liquid, gas or solid that should not enter or exit the wound.  The closure has to be readily accomplished, regardless of where the wound exists. The closure should not only prevent blood from being lost but ideally should actively stop the bleeding. The wound must stay closed despite the pressures exerted upon it. The closure should also have a minimal “footprint”, with the closure components being easily removed, absorbed or otherwise leaving the least possible trace of the closure, including scar tissue.

Hence, tapes, staples, sutures, clips, hemostatic agents, sealants, glues and other devices have been developed to get the job done.  The market for this range of closure options now reflects biologics, absorbable materials, devices and other products. Fundamentally, the market remains largely dominated by sutures and staples/clips, which have satisfied the demands of internal/external closure, easy of use, low cost, strength of closure and other considerations, not least of which is the evolving nature of surgical practice from the “open” to endo/laparoscopic. Nonetheless, tighter wound sealing, less bleeding and better outcomes in general have driven manufacturers to develop improvements.

Below is illustrated the 2014 market for the range of wound closure products along with their associated growth rates. The prospects for medical/surgical tapes are the exception to the rule, demonstrating a steady decline while better alternatives demonstrate steady growth.

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Source: MedMarket Diligence, LLC; Report #S192

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

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

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

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

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Source: MedMarket Diligence, LLC; “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, Report #S192.

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

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

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

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

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

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

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

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*Hemostasis is covered in report #S192.

Source: MedMarket Diligence, LLC; Report #S192.

Factors Affecting Wound Market Growth Rates

See also the October 2015 report, “Worldwide Wound Management, Forecast to 2024:
Established and Emerging Products, Technologies and Markets
in the Americas, Europe, Asia/Pacific and Rest of World”, Report #S251.

 Gauze dressings, bioengineered skin, alginates, negative pressure devices, cellular growth factors, hydrogels, antimicrobial dressings — all of these products (and more) represent the practice of wound management for the entire spectrum of wound types and severities.

Practice patterns, regulatory requirements, price pressures, healthcare delivery system gatekeepers, demographics, cultural sensitivities — all of these represent a sampling of the different forces that dictate the size and outlook of the markets for different wound management products in global markets.

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It’s no surprise, then, that product sales are growing (or declining) at different rates in different regions of the world, but the data is clear on this. MedMarket Diligence researched and published this data in its global wound management market Report #S249, which details the clinical practice of wound management, the products on the market and in development, the current and forecast markets for each worldwide and regionally and the competitors vying for market presence now and in the future.  Research from primary and secondary sources, the global wound market data illustrated above (which is also detailed by country) and presented in Report #S249 is a compelling read for market participants.

Hemostat products and companies

[exp date=”28/02/13″]Until February, 28, 2013, save 50% on Report #S190 “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion” online and, at checkout, enter the coupon code 1361569280 to apply the discount.[/exp]

Hemostats have been used for over a hundred years to prevent bleeding in the surgical situation. Primarily these products were first introduced to prevent hematomas during surgery with the aim of preventing resultant infections. During the 1980s and 1990s, the popularity of hemostats increased rapidly as surgeons tried to avoid excessive use of blood transfusions for reasons of economy and the threat of disease transmission. Products were launched during this period by many of the large medical device manufacturers, such as Johnson & Johnson, which now sells Surgicel (an oxidized regenerated cellulose hemostat), Instat (a freeze-dried collagen product), and Spongostan/Surgifoam (a freeze-dried gelatin hemostat). For stopping bleeding, modern hemostats go far beyond simple gauze.

Almost all hemostatic agents work in conjunction with or in addition to the body’s own blood clotting activity. These agents generally work by physically obstructing the outflow of blood in the wound, accelerating clotting reactions, and providing a matrix for increased platelet interactions, resulting in faster and stronger fibrin clot formation that can bind to and seal vascular injuries. However, the effective hemostatic action of these products depends heavily on the patient having a capable and intact coagulation function. This may not be the case if the patient has received, for example, a synthetic colloid fluid in the field to prevent shock, which results in hemodilution, or if the patient is hypothermic or in hypovolemic shock. If there is pre-existing coagulation deficiency, then many of these hemostats will not work. There is a need for a hemostatic agent that can function effectively in the absence of the patient’s coagulation function. One of the products that function well in these situations is the fibrinogen-based dressing.

Fibrin sealants can also act as hemostatic agents, so there is in effect some overlap between the ‘Fibrin and Other Sealants’ and the ‘Hemostats’ categories. However, at upwards of $600 per use, fibrin sealants are rather too expensive to use as hemostats. There are over 40 active companies market and/or developing hemostat products and many of them have multiple types of hemostats based on the constituent active ingredients.  Below is illustrated the number of active hemostat companies based on the product types they are pursuing or selling.

Source: MedMarket Diligence, LLC, Report #S190.

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