Use of Surgical Sealants for Cranial and Spinal Dura

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

Surgical sealants have an enormous range of applications in the treatment of acute and chronic wounds, but while the majority of sealant revenues derives from their use in the hemostasis, closure and sealant of tissues to prevent blood loss…

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Source: MedMarket Diligence, LLC; Report #S190

… a different niche use of sealants is stopping cerebrospinal fluid leaks and other dural wound treatments associated with cranial and spinal procedures. These include their use in:

  • Cranial and spinal dural plastic surgery to prevent CSF fistulas.
  • Dural plastic surgery in residual cavities following tumor removal.
  • Dural lacerations in hemilaminectomy operations

Of this, most of the use is currently in cranial applications, but use in spinal applications is growing considerably faster:

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Source: MedMarket Diligence, LLC; Report #S190

 

 

 

The increasing problem of chronic wounds, and their medtech solutions

See the 2016 published report #S290, “Worldwide Surgical Sealants, Glues, Hemostats, 2016-2022” and 2018 published report #S254,”Wound Management to 2026.”

Wounds have many different sources, etiologies and forms and, therefore, demand a range of approaches. By virtue of these differences, they have considerably different costs. At the top of the list of wound culprits driving up cost is the category of chronic wounds. Simply put, these wounds are very slow to heal due to poor circulation at the site (e.g., decubitus stasis, or pressure, ulcers), concomitant health issues (diabetes) and the difficulty in changing the local environment toward one with conditions more conducive to the healing process.

Chronic wounds are not the most common — that is a category represented by surgical wounds, in which the wound has been created medically or surgically in order to excise or otherwise manage diseased tissue. But surgical wounds, traumatic wounds and lacerations are by their nature acute and, especially for surgical wounds, can be surgically managed to create clean wound edges, good vascularization and other conditions that accelerate healing. Therefore, while the volume of surgical and traumatic wounds and lacerations is significant, their costs are manageable and their growth is unremarkable.

But the costs of chronic wounds are higher due to both the types of different products required and the length of time required for those products to be used. Moreover, given the association of chronic wounds with conditions that are growing in prevalence due to increasing incidence of obesity, diabetes and other conditions, combined with an aging population that is increasingly sedentary, the prevalence of chronic wounds is shifting the balance among wound types. Below is the balance of wound types by prevalence worldwide in 2011, followed by the projected balance of wound types in 2025.

Worldwide Share of Wound Prevalence By Type, 2011

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Source: MedMarket Diligence, LLC; Report #S190 and Report #S249.

 

Worldwide Share of Wound Prevalence By Type, 2025

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Source: MedMarket Diligence, LLC; Report #S190 and Report #S249.

Surgical wounds offer the potential for use of devices which can ensure hemostasis, prevent internal adhesions and anastomoses, secure soft tissue, and close 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 to treatment by adhesives, sealants and hemostats unless the wound has either 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. However, this inflammatory activity has also been known to burn the patient’s skin. Chronic wounds are instead dealt with often by a combination of debridement, frequent dressing changes, products to address local vascular circulation and pressure (negative and positive) and others. Progress is being made in reducing the associated healing times, but a large opportunity remains.

Wound management: A $21.8 billion+ worldwide market in 2021

UAdvanced wound products, sales to 2026pdate — The global wound market is now projected to reach almost $38 billion by 2026, with almost $25 billion in advanced products. See the March 2018 Report #S254.

 


The worldwide market for products in wound management, as reflected in the MedMarket Diligence report #S249, encompasses twelve discrete product segments:

  • Traditional Adhesive Dressings
  • Traditional Gauze Dressings
  • Non-Adherent Dressings
  • Film Dressings
  • Foam Dressings
  • Hydrogel Dressings
  • Hydrocolloid Dressings
  • Alginate Dressings
  • Antimicrobial Dressings
  • Negative Pressure Wound Therapy Devices
  • Bioengineered Skin and Skin Substitutes
  • Wound Care Growth Factors

These segments include traditional wound care products, like dressings and bandages, but also include their more evolved forms with embedded components or constructions to enhance wound healing by shortening healing times or improving outcomes. But, wound care has also evolved to included equipment/device-mediated care as in NPWT as well as biologically-derived or engineered products in regenerative medicine.

The MedMarket Diligence report details the current and forecast wound market by product type in North and South America, the European Union, Asia/Pacific and Rest of World, and looks at markets and growth rates by product and country for the years 2012-2021.

The world market in 2012 stood at approximately $12.45 billion. By 2021, the total wound management market represented by the segments listed above is projected to be worth over $21.85 billion million, reflecting a 2013-2021 CAGR over 7%.

wound-pie-2013

Source: Report #S249.

There are some market restraints at work, primarily the high cost of the new technologies. Not all country healthcare budgets can afford advanced wound care products, even if they are proven to decrease healing times and hospital costs over the longer run. The development of substitute products threatens existing product categories, while a lack of sufficient clinical and economic evidence backing new technology hinders growth and acceptance of some of the more advanced wound management technologies. In addition, improved wound prevention and a lack of regulation on tissue engineering in the EU are also expected to hold back the development of new technologies.

In addition to market restraints, there are a number of drivers that are expected to shape this market in the years to come. One of the primary drivers is the aging of the global population. Chronic diseases, such as circulatory conditions, anemias and autoimmune diseases influence the healing process as a result of their influence on a number of bodily functions. Illnesses that cause the most significant problems include diabetes, chronic obstructive pulmonary disease (COPD), arteriosclerosis, peripheral vascular disease (PVD), heart disease, and any conditions leading to hypotension, hypovolemia, edema, and anemia. While chronic diseases are more frequent in the elderly, wound healing will be delayed in any patient with underlying illness. Happily, most wounds heal without any problems. However, chronic wounds may take months or years to fully close, or may never close. Chronic wounds adversely affect the individual’s quality of life, and are a leading cause of burgeoning healthcare costs.

Type 2 diabetes represents 85-95% of all diabetes in developed countries, and accounts for an even higher percentage in developing countries. There were 26 million diabetic patients in the US in 2012 and 285 million patients globally.   Of these patients, approximately 15% will develop a diabetic foot ulcer and 50% of these will become infected, representing an estimated 2 million patients. Diabetic foot infections are currently treated with systemic antibiotics, but the estimated failure rate of antibiotics for diabetic foot ulcers is in excess of 22%.

A patient with diabetes is at significant risk of damage to tissues caused by impaired homeostasis due to the disease process. For example there is a tendency for such tissues to develop blockages in smaller blood vessels, which reduces the ability of these vessels to provide sufficient oxygen to tissues already under stress due to compromised nutrient supply and the diabetic condition. These patients then develop arterial ulcers. They may also have a tendency to suffer from venous ulcers, due to the underlying poor condition of cells as a result of the diabetes.

The diabetic foot is the most common cause of non-traumatic lower extremity amputations in the US and Europe: there is an average of 82,000 amputations per year in the U.S., costing an estimated $1.6 billion annually. The estimated cost of foot ulcer care in the U.S. ranges from $4,595 per ulcer episode to more than $28,000 and the total annual cost of foot ulcer care in the US has been estimated to be as high as $5 billion.

Pressure, or decubitus, ulcers are another of the most common types of chronic wounds. The treatment of pressure ulcers places a major burden on healthcare systems worldwide, with an emerging additional cost of litigation increasing in importance over recent years. Healthcare practitioners need to be aware of both the direct and indirect costs and consider how the implementation of prevention protocols may offer cost savings in the longer term. The cost of a dressing for example as a prevention tool is minimal in comparison to the costs of treating an established pressure ulcer.

Following are a few hard numbers on the true financial cost of pressure ulceration:

  • The estimated cost to the US hospital sector is $11 billion per annum
  • The estimated cost to the UK national health service is estimated at £1.4-£2.1 billion annually (4% of total NHS expenditure)
  • Lawsuits remain common in both acute and long term care — with high payments in certain cases
  • The average cost to treat an individual with an unstageable ulcer or a deep tissue injury is estimated to be $43,180
  • The average length of stay in hospital is almost three times longer for chronic wounds
  • The mean hospital cost for management of pressure ulcers in the U.S. is $14,426. In comparison, the same cost in Korea is identified as $3,000-$7,000.

The cost of treating chronic wounds is one element driving the development and utilization of advanced wound care technologies. Other drivers are the aging of the population, and the obesity epidemic, which is expected to produce a wave of diabetics in the years to come.

Worldwide Wound Management Market, Segment Size & Growth, 2013-2021

wound-bubbles-2013-2021

Source: Report #S249.

In 2009, four companies (Johnson and Johnson, Kinetic Concepts Inc., Hill-Rom and Smith & Nephew) were responsible for about 60 percent of total market revenue. However, mergers, acquisitions and sales of intellectual property have rapidly changed the market share picture. By the end of 2012, more than half of the global wound care market was held by Johnson and Johnson, 3M, Smith & Nephew, and Systagenix. In addition, competition on price has driven down prices in the well established (i.e., traditional wound care) markets, while novel technologies are taking hold with introductory revenues and generating high, early stage growth rates.


Update: See the March 2018 Report #S254. “Wound Management Forecast to 2026.”

Global market for surgical sealants, glues, hemostats and anti-adhesion

See the 2016 published report #S290, “Worldwide Surgical Sealants, Glues, Hemostats, 2016-2022” and 2018 published report #S254,”Wound Management to 2026.”

Potential for the Use of Hemostats, Sealants, Glues and Adhesion Prevention Products, Worldwide

This report details the complete range of sealants & glues technologies used in traumatic, surgical and other wound closure, including tapes, sutures/staples/mechanical closure, hemostats, fibrin sealants/glues and medical adhesives and anti-adhesion products. The report details current clinical and technology developments, with data on products in development (detailing market status) and on the market; market size and forecast; competitor market shares; competitor profiles; and market opportunity. The report provides full year actual data from 2011. The report provides a worldwide forecast to 2017 of the markets for these technologies, with emphasis on the market impact of new technologies through the forecast period. The report 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 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 establish the current worldwide market size for major technology segments as a baseline for and projecting growth in the market through 2017. The report assesses and projects the composition of the market as technologies gain or lose relative market performance over this period. The report profiles 122 active companies in this industry, providing data on their current products, current market position and products under development.

See description, table of contents and list of exhibits at http://mediligence.com/rpt/rpt-s190.htm Published February 2012..

Growth of High Strength Medical Adhesives

See the 2016 published report #S290, “Worldwide Surgical Sealants, Glues, Hemostats, 2016-2022” and 2018 published report #S254,”Wound Management to 2026.”

The market for high strength medical adhesives is growing, and is expected to continue to grow due to regulatory approvals and steady ongoing research and development. Active programs are currently under development in three areas for high strength surgical adhesives:

  • The use of cyanoacrylate adhesives and new application devices for new internal surgical procedures
  • New adhesive products based on existing biomaterial adhesives such as fibrin and albumin compounds
  • New polymer adhesives based on entirely new chemistries (e.g., polyurethanes, proteins from living organisms).

The global market for high-strength medical adhesives is forecast to show strong double-digit growth during the forecast period, growing from roughly $713 million in 2011 to $1.72 billion by 2017. The USA represents, by far, the largest share of the global high strength medical adhesives market, and this is not expected to change during the forecast period.

Worldwide Market for High Strength Medical Adhesives, 2010-2017

Source: MedMarket Diligence Report #S190, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2017.”

Although some form of suturing wounds has been used for probably thousands of years due to their ease of use and strength of closure, but sutures’ simplicity can also be limiting. There are procedures in which sutures are too large or clumsy, and locations in which it is difficult for the surgeon to suture. They 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 getting stuck and obstructing blood flow. In addition, sutures may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage. These are some of the reasons why surgical adhesives are becoming increasingly popular.

As a logical derivative, surgeons want a product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. TissuGlu (Cohera Medical), a urethane adhesive suited for plastic surgery procedures, is both biocompatible and resorbable, making it ideal for internal applications. It is also strong, user-friendly, and does not contain human/animal product derivatives. TissuGlu is currently only available for sale in Germany, but the company is rapidly preparing to sell in the other major markets of the EU.

One of the top five plastic surgery procedures performed in the United States is abdominoplasty, which has a reported post-operative complication rate of 15-52%. The most common complication is the formation of seroma. Usual methods to combat seroma formation include the placement of closed suction drains, use of compression garments around the tissue, use of progressive tension sutures, and use of fibrin sealants to reduce fluid accumulation. However, most of these methods can still lead to further complications such as leakage from drain sites, skin necrosis and inconsistent adhesion. High strength glues like TissuGlu and other products can solve this problem and garner significant caseload.

Demand drivers for products in wound sealing, closure, hemostasis and anti-adhesion

See the 2016 published report #S290, “Worldwide Surgical Sealants, Glues, Hemostats, 2016-2022” and 2018 published report #S254,”Wound Management to 2026.”

MedMarket Diligence’s global market Report #S190 on the range of products involved in wound securement encompasses surgical sealants, high-strength medical adhesives, sutures/staples/clips, hemostatic agents and products to prevent post-surgical adhesion.

The potential impact of emerging products in this area is driven by not only caseload but by the nature of the clinical “need”, ranging from a product being critical to provide treatment for a particular indication to a need that may only be represented in perceived benefits.

We have quantified the current and future market for products in surgical wound closure, hemostasis, anti-adhesion and related applications by detailing the products on the market and under development and assessed their current and forecast utilization based on the net result of clinical need drivers and the competitive landscape into which these products may find adoption.

For the sake of characterizing the nature of the need behind possible future product adoption, we have quantified the caseload, by clinical area, relative to a spectrum of needs levels from “important and enabling” to “aesthetic and perceived benefits”.

Category I:  Important and Enabling

Important to prevent excessive bleeding and transfusion, to ensure safe procedure, and to avoid mortality and to avoid complications associated with excessive bleeding and loss of blood.

Category II: Improved Clinical Outcome

Reduces morbidity due to improved procedure, reduced surgery time, and prevention of complications such as fibrosis, post-surgical adhesion formation, and infection (includes adjunct to minimally invasive surgery).

Category III: Cost-Effective and Time-Saving

Immediate reduction in surgical treatment time and follow-up treatments.

Category IV: Aesthetic and Perceived Benefits

Selection is driven by aesthetic and perceived benefits, resulting in one product being favored over a number of medically equivalent treatments.

On this basis, see the graphic representation below, which illustrates that the majority of demand for these products arises from the fact that they improve the clinical outcome for patients. Another key element of this is that the primary clinical areas of application contributing to demand for these products is in cardiovascular, general surgery, neurology and digestive specialties.  Note, please the categories of I-IV refer to the categories described above.

sealant-product-caseload

Source: MedMarket Diligence, LLC; Report #S190.

As further indication of the value of these products is the fact that the category exhibiting the lowest level of demand is for products that offer only aesthetic or perceived benefits.