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.

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

Screen Shot 2015-05-25 at 9.40.11 AM

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.

Screen Shot 2015-05-20 at 10.08.13 AM

Source: MedMarket Diligence, LLC; Report #S192

Surgical Glues, Sealants, Hemostats and Wound Closure Worldwide Markets

Acute wounds have long represented a core focus of healthcare, one that manufacturers have been steadily changing through innovative new technologies. MedMarket Diligence’s global report on wound closure markets reveals the dynamics of this change, detailing the clinical practices, products, technologies, companies and the resulting current and forecast markets.

PRLogApril 7, 2015MISSION VIEJO, Calif.The products and technologies focused on the management of acute wounds, encompassing hemostasis, closure and sealing represent a significant, growing segment of the total medical device market. The global market for surgical sealants, glues, and wound closure devices reached over $10.8 billion in 2014 and is forecast to increase to about $14 billion in 2018, exhibiting an overall compound annual growth rate (2014-2018) of 7.0%, according to the latest global report on wound closure and related products, published by MedMarket Diligence.

“We have tracked this market as manufacturers introduced novel wound sealing and closure technologies intended to integrate with one of the highest volume areas of healthcare,” says Patrick Driscoll, President of MedMarket Diligence. According to Driscoll, the level of innovation has been remarkable — from the advent of fibrin glues, to the continued evolution of sutures and staples, to the emergence of products working alone or in tandem to achieve better outcomes in a cost sensitive climate.This market is comprised of sutures/staples, vascular closure devices, surgical tapes, surgical hemostats, and surgical sealants and glues. There are well over 100 companies active in the marketing and development of these products, with the associated technologies running the gamut from devices to biologics to synthetics.

Wound closure has become a clinical practice that is rapidly evolving from what was once simple suturing or taping wounds to more sophisticated procedures that ensure rapid cessation of blood loss, prompt closure, strong adhesion of wound edges, tight sealing, reduced scarring, reduced risk of infection and more rapid healing — all accomplished largely with existing surgeon skills and with reasonable costs for healthcare payers and margins for manufacturers.

Surgical sealants and glues are expected to demonstrate the highest growth rate over the forecast period, but the largest segment in terms of revenues is the sutures and staples market, which comprise about half of the worldwide total. Hemostats represent the next largest segment, followed by surgical sealants and glues, tapes, and vascular closure devices.

The market leaders in this area are Johnson & Johnson, Covidien, B. Braun, and 3M, but market shares have proven to be fluid as innovations from hundreds of competitors are gaining and expanding footholds in the big companies’ territories.

The MedMarket Diligence report, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018“, provides specific forecasts and shares of the worldwide market by segment for Americas (detail for U.S., Rest of North America and Latin America), Europe (detail for United Kingdom, German, France, Italy, Spain, Rest of Europe), Asia/Pacific (detail for Japan, Korea, Rest of Asia/Pacific) and Rest of World.

The report also provides background data on the surgical, disease and traumatic wound patient populations targeted by current technologies and those under development, and the current clinical practices in the management of these patients, including the dynamics among the various clinical specialties or subspecialties vying for patient population and facilitating or limiting the growth of technologies.

The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market through 2018. The report also assesses and projects the composition of the market as technologies gain or lose relative market performance over this period.

The report profiles the top companies by revenue and a reasonable selection of the most promising or otherwise noteworthy companies in the markets covered in this report, providing data on their current products, current market position and products under development.

The report is described in detail at http://www.mediligence.com/rpt/rpt-s192.htm and may be ordered for immediate download from http://www.mediligence.com/store/page50.html.

Surgical Sealants, Glues, and Hemostats with Bioactive Agents

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/
(Status*)
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

Fibrin and other med/surg sealants have broad, expanding use

Fibrin and other medical/surgical sealants have developed a broad repertoire of applications supported by their utility addressing different wound and tissue types.

Below is a sampling of applications of fibrin and other sealants:

  • Local hemostatic measures for both surgical and trauma cases
  • Surgery in patients with bleeding disorders (e.g., hemophilia, severe thrombocytopenia) and non-bleeding cases with suspected fluid oozing
  • Surgery in nonsuturable organs (e.g., brain, liver, lung, pancreas, thymus) or to repair unhealthy tissue (e.g., irradiated bowel or tissue of elderly patients)
  • Cardiovascular, microvascular surgery and vascular grafts (e.g., aneurysm repair, coronary bypass, etc.)
  • Nerve grafts
  • Skin grafts, particularly plastic surgery
  • Surgery of small or difficult to reach organs (e.g., tympanoplasty, ENT, eye)
  • Sealing of body cavities, fistulae, pneumothorax, cranium, etc.
  • Anastomosis of gastrointestinal, tract and other ductal organs

Source: MedMarket Diligence, LLC; Report #S175

Fibrin sealants represent a revolution in local hemostatic measures for both bleeding and nonbleeding disorders. Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for hundreds of years. Fibrin sealant has the potential to provide life-saving control of excessive bleeding in many critical surgical operations and during a number of elective procedures. It is used for local hemostasis and as an augmenting material during arterial bleeding. It has been applied to every organ except eyeballs. It has been shown to be very useful for local hemostasis, a valuable tool for adhesion, sealing, anastomosis, vascular and nerve grafts, and many other procedures.

The challenges to even more widespread adoption of fibrin and other sealants are fading as formulations and delivery methods have been aggressively developed by manufacturers to meet the demand, but opportunities remain, including providing better tensile strength, ease of delivery, better cost and others.

The worldwide market for fibrin and other sealants stands at $2 billion (see link).


Purchase for download:  Report #S175, "Sealants, Glues, Wound Closure (2009) PDF" — $3,250.00
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CryoLife Announces First Clinical Use of BioFoam(R)

CryoLife Announces First Clinical Use of BioFoam(R)
(Reuters )

BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed. BioFoam received CE mark approval for …  | See original press release

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The use of BioFoam for liver resection represents a strong trend toward the expanded use of sealants and glues for internal applications, even if only used adjunctively with other closure. 

See the MedMarket Diligence report #S175 on "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013".

Posted via email from medmarket’s posterous

DuraSeal(TM) Spine Sealant Receives FDA Approval

Covidien gained FDA approval this week for its DuraSeal for the sealing of sutured dural tears, which occur in 10% of all spinal fusion procedures.  (See DuraSeal(TM) Spine Sealant Receives FDA Approval.) 

DuraSeal

DuraSeal, originally developed by Confluent Surgical, is a PEG (polyethylene glycol) solution and a trilysine amine solution, that has been shown effective in preventing intra-operative and post-operative surgical complications as a result of fluid, air and blood leaks.  In 2005, the FDA gave approval for DuraSeal in cranial procedures.  

The development of surgical sealants is moving increasingly toward internal use. Currently, most sealants are fibrin- or thrombin-derived and are effective at hemostasis, with sealing being a less significant function served due their need for greater strength in in adhesion.  Cyanacrylate-based sealants might otherwise represent a viable alternative for internal sealing, but their toxicity has kept their use to predominantly topical applications.  

Sealants like DuraSeal (HyperBranch Medical also makes a dural sealant, which has received CE Mark for Europe but is awaiting U.S. FDA approval) are making progress in demonstrating internal applications, albeit via adjunctive use (e.g., creating a seal along suture lines) rather than as stand-alone sealants.


Below is an overview of fibrin sealant and glue use and development (from MMD report #S175).

The terms “sealant” and “glue” tend to be used interchangeably in the surgical context, but in fact there is a difference in adhesive strength between sealants, pioneered by fibrin products (sometimes homemade) and the later, stronger glues of which cyanoacrylate-based products were the leaders.

Fibrin sealants represented a revolution in local hemostatic measures for both bleeding and nonbleeding disorders. Tourniquet, pressure and sutures have been used for controlling excessive bleeding during surgical procedures for hundreds of years. Fibrin sealant has the potential to provide life-saving control of excessive bleeding in many critical surgical operations and during a number of elective procedures. It is used for local hemostasis and as an augmenting material during arterial bleeding. It has been applied to every organ except eyeballs. It has been shown to be very useful for local hemostasis, a valuable tool for adhesion, sealing, anastomosis, vascular and nerve grafts, and many other procedures.

Fibrin and other sealant products have been approved and used outside the United States for many years and their use has created strong awareness of their surgical and economic benefits in Europe, Latin America and Asia. As a result, many such products have been marketed in these regions for up to 20 years and have been developed for a variety of surgical uses. While in the United States these products were approved initially as hemostatic adjuncts to suturing, they are increasingly being used for sealing of tissues, yet their use beyond hemostasis (i.e., as sealants and low-strength glues) lags that of markets outside the United States.
For the vast majority of surgical procedures, sutures and staples remain the most common methods of closure, but often they are sub-optimal. They do not have inherent sealing capabilities, and therefore cannot stop air and fluid leakage (for example in lung resection) and fluid leakage at the wound site. Furthermore, friable tissues such as the liver, brain or spleen, are fragile and often cannot support sutures or staples. Therefore, other means of wound closure are required for repair of these tissues.

However, the steady pace of FDA approvals and market introductions for products with sealing capabilities illustrates the success manufacturers have had in surmounting many of the technical hurdles to these products providing strong roles in tissue sealing. These include approvals by Baxter (Tisseel), Genzyme (FocalSeal), GluStitch (GluShield), Angiotech (CoSeal, Vitagel), CryoLife (BioGlue), and Syneture/Covidien (Indermil).

See MedMarket Diligence report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."