Absolute and Relative Growth in Wound Closure Product Sales Worldwide

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

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 ranked 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

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.

 

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

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

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

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

 

(See the 2016 published report #S290, “Sealants, Glues, Hemostats, 2016-2022”.)

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.

Screen Shot 2015-04-13 at 7.05.33 AM
Source: MedMarket Diligence, LLC; “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, 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://mediligence.com/rpt/rpt-s192.htm and may be ordered for immediate download from http://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

Report: Surgical Sealants, Glues, Wound Closure and Anti-adhesion Worldwide

MedMarket Diligence (MMD) has published its 2010 report on the worldwide market for surgical sealants and related products in surgical and traumatic wound management.

The analysis by MMD reveals the size of the evolving opportunity for a diverse set of products in global markets. Based on extensive primary and secondary research, and leveraging MMD’s position as the leading source for the medtech industry on the subject, the report provides industry participants and hopefuls with invaluable data and insights.

The report is described below and at link

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, from tapes, sutures and staples to hemostats, fibrin sealants/glues and medical adhesives. The report details current clinical and technology developments in this huge and rapidly growing worldwide market, with data on products in development and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity.

This report is a market and technology assessment and forecast of surgical sealants, glues, hemostasis, other wound closure and anti-adhesion. The report details the current and emerging products, technologies and markets involved in wound closure and sealing using sutures and staples, tapes, hemostats, fibrin and sealant products, medical adhesives and products to prevent surgical adhesions. The report provides a worldwide historic (from 2008), current and annual forecast to 2015 of the markets for these technologies, with particular emphasis on the market impact of new technologies through the coming decade.  The report provides specific forecasts and shares of the worldwide market by segment for the U.S., Europe (United Kingdom, German, France, Italy, BeNeLux), Latin America, Japan, Korea and Rest of World.

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

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

See link for complete table of contents and list of exhibits.  The report may be ordered for immediate download from link.

Secrets of Bio Glues

Researchers at the University of Akron have revealed the evolutionary strength of spider web glue. Published in the May 17, 2010, issue of Nature Communications, the research revealed that the effectiveness and strength of the spider web glue ensues from the highly entangled, cross-linked polymers in each droplet of the glue, which enables the adhesive force to be transmitted throughout the glue.

UA researcher Vasav Sahni notes:

[The] stickiness of the glue droplets depends on the speed at which they are stretched.

Subsequently, the glue droplets can hold on to fast-flying insects when they initially impact webs and retain trapped insects for a time period long enough for them to be subdued by the spider.

“This finding should significantly benefit the development of synthetic adhesives for biomedical, orthopedics and wound-healing applications. The understanding of how spiders use this unique glue will allow scientists to develop reversible adhesives that work in the presence of water,” says Dhinojwala.

As we have often highlighted in the past ("Sea life and other sources of glue to mend people" link or "Bio Glues" link), a wide range of biological sources have been identified and are under evaluation (or adaptation) as medical and surgical glues due to their evolutionarily-designed strength, biocompatibility and other inherent advantages.

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

Technology platforms and clinical applications overlap

Diverse technologies have a surprising number of common threads, whether in the technologies themselves or in the clinical applications.  For this reason, manufacturers need to consider that:

1. A technology platform can be the launchpad for products in clinically diverse areas. Case in point, cell therapy, which as a fundamental scientific discipline can have uses as far afield as wound management, bone repair, treatment of myocardial ischemia and others.

2. A disease state can sometimes be targeted by many very different technologies.  Examples include that wound management can be accomplished by tissue engineering, sutures, fibrin-based surgical glues, cyanoacrylate-based surgical glues, dressings and others.

The driver behind technologies having multiple clinical applications is, of course, that companies wish to maximize their ROI.  

The driver behind single disease states being the target of multiple alternative technologies is cost — healthcare systems (in principle, anyway) seek the most competitive options for treating specific patient populations, and this driver has been gaining momentum over the past ten years due to “managed care” efforts as well as aggressive, cost-focus innovators creating technologies that displace market share with convincingly better patient outcomes compared to alternative technologies.


MedMarket Diligence publishes medical technology market reports on a wide range of clinical and technology subjects (of course, sometimes overlapping). See list.


(This post was done via the Palm Pre WebOS app Po’ster by Gabriele Nizzoli.) 

Surgical, chronic and other wound prevalence, growth

A useful starting point for determining which adjunctive surgical closure and securement products are appropriate for different wound healing treatments is to recognize the major distinction between different wound types. Surgical wounds are usually appropriate for treatment with adjunctive surgical closure and securement products because they are created under clean conditions, the usual acute healing cascade of events begins immediately and control of the bleeding and closure process can lead to accelerated healing, improved prognosis, and enhanced aesthetic effects such as reduced scarring.

Surgical wounds offer the potential for devices to ensure hemostasis, prevent internal adhesions and anastomoses, soft tissue securement, and closure of the skin. Traumatic wounds also offer potential for skin closure products and for hemostats, and adhesion prevention during post-trauma surgery. New wound-covering sealant products may also offer potential for treatment of cuts, grazes, and burns.

Chronic wounds are generally not amenable for treatment by adhesives, sealants and hemostats unless the wound has been debrided to a sterile bleeding surface (in which case it becomes like a surgical wound), or the product offers some stimulant activity; many hemostats exhibit some inflammatory and cytokinetic activity, which has been associated with accelerated healing.

To help determine how these applications for closure and securement products may translate into market potential, it is relevant to note the prevalence and rates of growth of the different types of wounds; see below.  

Source: MedMarket Diligence, LLC; Report #S175

The potential contribution of newly developed products to the management of these different wounds is discussed later in this section.


Purchase for download:  Report #S175, "Sealants, Glues, Wound Closure (2009) PDF" — $3,250.00

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MedMarket Diligence has also recently published its "Worldwide Wound Management Market, 2008-2017."  Report #S247.

CryoLife Gets IDE Approval BioFoam Use in Hemostasis of Liver

CryoLife's BioFoam, a protein hydrogel, received FDA approval today to begin an IDE for sealing of liver parenchymal tissue when conventional methods (e.g., ligature) prove ineffective.

The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group. CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial.

"Following our July 2009 CE Mark approval to distribute BioFoam in the EU, we now have approval to begin a clinical trial, a critical step forward in the process to gain FDA approval of BioFoam in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. He added, "We believe that BioFoam may hold tremendous promise for surgeons around the world and are excited by the early data published thus far."

See link .

The use of hemostatic and sealing agents in liver surgery represents a significant opportunity for developers of biologically based sealants and glues. CryoLife has a good start, having received approval earlier this year to market BioFoam in the EU.

See report #S715 for the worldwide analysis of surgical sealants, glues and wound closure products.

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