Definitions of surgical securement products

The market for "surgical securement" products is subdivided into the following product categories:

  • sutures, staples and other mechanical closure devices
  • tapes
  • hemostats
  • fibrin and other sealants
  • high-strength medical adhesives
  • post-surgical adhesion prevention.

The total securement market is forecast over the next four years at a compound annual growth rate of 8.4%.

Definition of Surgical Closure and Securement Products

Source:  MedMarket Diligence, LLC, Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

Surgical wound closure and securement, market size versus growth

The worldwide market for products used in securement (sutures, staple, hemostasis, tapes, surgical sealants, high-strength glues) is characterized by both well established markets (sutures, staples and tapes) and novel products (surgical sealants, hemostasis and high-strength glues).

The attractiveness of the surgical securement market is that there are some sizable segments that continue to demonstrate high annual market growth, and these are the surgical sealant segment (fibrin and other biological sealants), in particular, and the high-strength glue segment.

Illustrating this is the bubble chart, below, with bubble sizes (and horizontal axis) representing market size and with position along the horizontal axis representing annual market growth for 2010.

securement-bubbles

Source: MedMarket Diligence, LLC, Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

While there is growth coming from the expanding market of new clinical applications for advanced surgical selants, glues, hemostats (and anti-adhesion, not shown in above graph), the established market and caseload for sutures and staples (represented by the big blue, low growth bubble in the upper left of the graph) is also a ripe target for the new products, which can improve outcomes and facilitate wound closure compared to traditional products.

 

Wound types driving relative use of surgical closure and securement

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 incidence of the different types of wounds; the exhibit below summarizes this data. (The potential contribution of newly developed products to the management of these different wounds, as well as market size, forecast, competitors shares and other data, is discussed in the body of Surgical Sealants report #S175.)

 

Worldwide Prevalence of Different Wound Types, 2008

 

Wound Type
Worldwide Prevalence
(Thousands)
Healing Time
(Days)
CAGR
Surgical wounds

100,000

14

3.1%
Traumatic wounds

1,600

28

1.4%
Lacerations

19,600

14

1.0%
Burn wounds

9,800

21

1.0%
Chronic wounds

28,200

7.4%
Carcinomas

600

14

3.0%
Melanoma

200

14

3.0%
Complicated skin cancer

200

28

3.0%

 

Source: MedMarket Diligence, LLC; Report #S175, "Worldwide Market for Surgical Sealants, Glues & Wound Closure, 2009-2013."
 

Wound closure: suture, staple, tape, hemostat, sealant, glue/adhesive

sutures-handThe tissue closure and securement market can be regarded as a benchmark indicator for overall expansion of medical device usage. This is because surgical closure and securement products are growing to be components of all surgical procedures. These products are used for rapid and efficient closure of surgical wounds, and internal securement of tissues to reduce pain and accelerate rehabilitation. Appropriate use of these products can reduce risk of infection, and can optimize the repair process to enhance the speed and strength of tissue repair, as well as reducing complications such as those resulting from post-surgical adhesions. Below are definitions for the products in the field of surgical closure and securement.

Definition of Surgical Closure and Securement Products

Suture
Sutures are medical devices made out of woven or single filament fibers of steel, synthetic polymer or natural biomaterials that are used to secure cuts, lacerations, and incisions in the surface or internal tissues.
Staple
Staples are rigid or semi-rigid suture-like materials delivered through a closure device and consisting of single- or multi-filament fibers of steel, synthetic polymer or natural biomaterials that are used to secure cuts, lacerations, and incisions in the surface or internal tissues.
Tape
Tapes are fabric and polymer-based medical devices that are used to secure cuts, lacerations, and incisions in the surface of the skin as an adjunct to wound closure.
Hemostat
A hemostat reacts in the presence of blood to establish the normal cascade of factors that arrest bleeding. These products can be added to a bleeding field during surgery to prevent further bleeding, and are mostly dependent on a full complement of normal factors in the patient’s blood.
Sealant
A sealant will prevent leakage of fluid and/or gas from a surgical incision (such as pulmonary gases or spinal fluids). These products will often hold back pressurized fluids from normal vascular activity. Although their efficiency does not normally require the full complement of active clotting factors in blood to be within normal levels, these products (e.g., fibrin sealants) normally also have some hemostatic activity.
Glue/adhesive
Glues and adhesives (e.g., cyanoacrylate glues) are used to attach organs, structures, or tissues to each other or to effect repair. These materials can be enhanced by incorporating additional hemostatic or sealant properties, such as Angiotech’s Vitagel (a combination of collagen and thrombin) and Nycomed’s Tachocomb (a combination of thrombin, collagen and fibrin).
Adhesion
Abnormal joining of two organs or tissues occurring after inflammation, especially post-surgery. Adhesion-prevention products are medical devices or substances made from synthetic polymer or natural biomaterials that are manufactured into gels, fabrics, films, and dried solids that are used to avoid the formation of post-surgical adhesions (PSA).

Source: MedMarket Diligence, LLC;  Report #S190, "Worldwide Surgical Sealants, Glues and Wound Closure 2010-2017." Published February 2012.

Product development trend in surgical sealants, glues, hemostats

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 United States, 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 hemostasis products.

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

 

Hemostats

Sealants

Adhesives

Cardiovascular

X

Orthopaedic

X

Neurological

√*

Gastrointestinal

X

Paediatric

X

Thoracic

X

Pulmonary

X

Skin

x

 

*Specific indication (few procedures per year) approved 

Source: MedMarket Diligence, LLC; Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

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 and basketball. 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 and 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 (Exhibit 1-7). 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 that 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 United States and Japan. High-strength adhesives were used on approximately 6 million cuts, grazes and minor incisions in 2006. This usage is growing rapidly driven by greater awareness and cost-effectiveness.
 

Hemostasis in wound management

operating-room

Hemostatic agents 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.  

Hemostat products can be classified in six subsegments depending on their active principle: thrombin, gelatin, collagen, fibrin, synthetic materials, and other miscellaneous products that exhibit additional attributes.

The barriers for entry to the hemostasis market are reducing as many companies develop formulations of collagen and gelatin formulations for world markets. Currently, over 50 companies worldwide have products on the market for hemostatic applications.  However, a number of proprietary products and formulations still face significant regulatory hurdles associated with their development and manufacture. Most of the companies currently offering hemostat products are also actively pursuing new technologies and regulatory submissions for new products. In addition, a number of new companies are progressing additional and new technologies to market.

Sales in topical absorbable hemostats are forecast to increase at a roughly 7.5% compound annual growth rate through 2013. This growth will be fuelled by increased incidence of surgery, greater adoption of these products within the European surgical environment, and the need for improved hemostasis products during minimally invasive surgical procedures.


Excerpted from Report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure Market, 2009."