Six Key Trends in Sealants, Glues, Hemostats Markets to 2022

From July 2016 published Report #S290.

Here are six key trends we see in the global market for surgical sealants, glues, and hemostats:

  1. Aggressive development of products (including by universities, startups, established competitors), regulatory approvals, and new product introductions continues in the U.S., Europe, and Asia/Pacific (mostly Japan, Korea) to satisfy the growing volume of surgical procedures globally.
  2. Rapid adoption of sealants, glues, hemostats in China will drive much of the global market for these products, but other nations in the region are also big consumers, with more of the potential caseload already tapped than the rising economic China giant. Japan is a big developer and user of wound product consumer. Per capital demand is also higher in some countries like Japan.
  3. Flattening markets in the U.S. and Europe (where home-based manufacturers are looking more at emerging markets), with Europe in particular focused intently on lowering healthcare costs.
  4. The M&A, and deal-making that has taken place over the past few years (Bristol-Myers Squibb, The Medicines Company, Cohera Medical, Medafor, CR Bard, Tenaxis, Mallinckrodt, Xcede Technologies, etc.) will continue as market penetration turns to consolidation.
  5. Growing development on two fronts: (1) clinical specialty and/or application specific product formulation, and (2) all purpose products that provide faster sealing, hemostasis, or closure for general wound applications for internal and external use.
  6. Bioglues already hold the lead in global medical glue sales, and more are being developed, but there are also numerous biologically-inspired, though not -derived, glues in the starting blocks that will displace bioglue shares. Nanotech also has its tiny fingers in this pie, as well.

See Report #S290, “Worldwide Sealants, Glues, and Hemostats Markets, 2015-2022”.

The Demand for Sealants, Glues, and Hemostats in 2016

The following is drawn from “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.” Report #S290.

The need for surgical sealants, glues and hemostats is directly related to the clinical caseload and procedure volumes, as well as to the adoption of these products for multiple uses, such as the use of one product for sealing, hemostasis and anti-adhesion. It is fair to say that use of these products has become routine in the surgical suite and in other clinical locations. Procedure volumes are in turn driven by demographic forces, including global aging populations, while regulatory changes will continue to influence uptake of these products.

wound-prevalance

Source: MedMarket Diligence, LLC; Report #S290.

Medical Sealants

Fibrin sealants are made of a combination of thrombin and fibrinogen. These sealants may be sprayed on the bleeding surface, or applied using a patch. Surgical sealants might be made of glutaraldehyde and bovine serum albumin, polyethylene glycol polymers, and cyanoacrylates.

Sealants are most often used to stop bleeding over a large area. If the surgeon wishes to fasten down a flap without using sutures, or in addition to using sutures, then the product used is usually a medical glue.

Hemostatic Products

The surgeon and the perioperative nurse have a variety of hemostats from which to choose, as they are not all alike in their applications and efficacy. Selection of the most appropriate hemostat requires training and experience, and can affect the clinical outcome, as well as decrease treatment costs. Some of the factors that enter into the decision-making process include the size of the wound, the amount of hemorrhaging, potential adverse effects, whether the procedure is MIS or open surgery, and others.

Active hemostats contain thrombin products which may be derived from several sources, such as bovine pooled plasma purification, human pooled plasma purification, or through human recombinant manufacturing processes. Flowable-type hemostats are made of a granular bovine or porcine gelatin that is combined with saline or reconstituted thrombin, forming a flowable putty that may be applied to the bleeding area.

Medical Glues

Sealants and glues are terms which are often used interchangeably, which can be confusing. In this report, a medical glue is defined as a product used to bond two surfaces together securely. Surgeons are increasingly reaching for medical glues to either help secure a suture line, or to replace sutures entirely in the repair of soft tissues. Medical glues are also utilized in repairing bone fractures, especially for highly comminuted fractures that often involve many small fragments. This helps to spread out the force-bearing surface, rather than focusing weight-bearing on spots where a pin has been inserted.

Thus, the surgeon has a fairly wide array of products from which to choose. The choice of which surgical hemostat or sealant to use depends on several factors, including the procedure being conducted, the type of bleeding, severity of the hemorrhage, the surgeon’s experience with the products, the surgeon’s preference, the price of the product and availability at the time of surgery. For example, a product which has a long shelf life and does not require refrigeration or other special storage, and which requires no special preparation, usually holds advantages over a product which must be mixed before use, or held in a refrigerator during storage, then allowed to warm up to room temperature before use.

 

USA and Asia/Pacific Size Versus Growth in Sealants, Glues, Hemostats

The market dynamics in Asia/Pacific stand apart from those in the U.S. In the case of surgical sealants, glues, and hemostats, what stands out is the Size versus Growth metric.

Much of the potential in China, in particular, remains untapped (low volume, high growth), while in the U.S., these markets are more well established and, therefore, more penetrated.

Below are the size/growth “bubbles” for, alternating, the U.S. and Asia/Pacific.

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Source: MedMarket Diligence, LLC; Report #S290.

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

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

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.

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

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

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)

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

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.

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.

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Source: MedMarket Diligence, LLC; Report #S192

 

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

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.

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.

Surgical Sealants and Glues in the Balance of Wound Closure

Sealants and glues are emerging as important adjunctive tools for sealing staple and suture lines, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.Suture-line-pixelated

Surgical sealants are made of synthetic or naturally occurring materials and are commonly used with staples or sutures to help completely seal internal and external incisions after surgery. In this capacity, they are particularly important for lung, spinal, and gastrointestinal operations, in which leaks of air, cerebrospinal fluid, or blood through the anastomosis can cause numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.

Although some form of suturing wounds has been used for thousands of years, sutures and staples can be troublesome. There are procedures in which sutures are too large or clumsy to place effectively, and locations in which it is difficult for the surgeon to suture. Moreover, sutures can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot forming and obstructing blood flow. In addition, sutures and staples may trigger an immune response, leading to inflamed tissue, which also increases the risk of a blockage. Finally, as mentioned above, sutured and stapled internal incisions may leak, leading to dangerous post-surgical complications.

These are some of the reasons why surgical adhesives are becoming increasingly popular, both for use in conjunction with suture and staples and on a stand-alone basis. As a logical derivative, surgeons want a sealant product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. In reality, it is difficult for manufacturers to meet all of these requirements, particularly with biologically active sealants, which tend to be pricey. Thus, for physicians, there is usually a trade-off to consider when deciding whether or not to employ these products.

Screen Shot 2014-12-29 at 9.28.14 AMClosure of general surgical wounds (internal or external) is largely accomplished by a combination of surgical tapes, sutures & staples and, increasingly, surgical sealants and glues. For the reasons discussed, the rates of technology development and adoption among these causing a relative but not absolute decline of sutures and staples revenues worldwide.

Surgical sealants, glues, and hemostats can be divided into several different categories based on their primary components and/or their intended use. From a practical standpoint, they may be subdivided by composition into products containing biologically active agents, products made from natural and synthetic (nonactive) components, and nonactive scaffolds, patches, sponges, putties, powders, and matrices used as surgical hemostats.


Data drawn from MedMarket Diligence, LLC, Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018.” See link.