Traditional and Advanced Wound Product Types

Wound management technologies have been under development for hundreds of years. The current state of product and technology development is now largely represented by thirteen different product categories described with their specific typical applications (1)Specific companies and products are detailed in “Wound Management to 2026”, report S254.

Wound Management Technologies By Type

Wound product categoryDescriptionPotential applicationsProduct and Manufacturer Examples
Traditional GauzeInexpensive, common, breathable, usually dries out the wound, may stick to wound causing damage when removedMay be used to secure a dressing in place, or directly over any wound type to keep it clean while allowing aeration.See link
Traditional AdherentDry, inexpensive, common, non-absorbent, will not stick to wound. Usually uses a wide mesh material with a finer mesh or foam, nonstick material.Applied directly to wound; used for large surface wounds such as abrasions or burns. Indicated when a good granulation bed has developed.

"

Traditional Non-AdherentConforms to wound, keeps wound bed moist, will not stick to the surface of wound.Light to moderately exudative wounds, burns.

"

FilmAvailable as adhesive, thin transparent polyurethane film, and as a dressing with a low adherent pad attached to the film.Clean, dry wounds, minimal exudate; also used to cover and secure underlying absorptive dressing, and on hard-to-bandage locations, such as heel.

"

FoamPolyurethane foam dressing available in sheets or in cavity filling shapes. Some foam dressings have a semipermeable, waterproof layer as the outer layer of the dressingEnables a moist wound environment for healing. Used to clean granulating wounds with moderate to severe exudation.

"

HydrogelColloids that consist of polymers that expand in water. Available in gels, sheets, hydrogel impregnated dressings.Provides moist wound environment to add moisture to dry wound, aids in cell migration, reduces pain, helps to rehydrate eschar. Used on dry, sloughy or necrotic wounds.

"

HydrocolloidMade of hydroactive or hydrophilic particles attached to a hydrophobic polymer. The hydrophilic particles absorb moisture from the wound, convert it to a gel at the interface with the wound. Conforms to wound surface; waterproof and bacteria proof.Gel formation at wound interface provides moist wound environment. Dry necrotic wounds, or for wounds with minimal exudate. Also used for granulating wounds.

"

AlginateA natural polysaccharide derived from seaweed; available in a range of sizes, as well as in ribbons and ropes.Because highly absorbent, used for wounds with copious exudate. Can be used in rope form for packing exudative wound cavities or sinus tracts.

"

AntimicrobialBoth silver and honey are used as antimicrobial elements in dressings.Silver: Requires wound to be moderately exudative to activate the silver, in order to be effective

"

CollagenAvailable in several forms, including gels, pads, pastes, particles, sheets, solutions, and are derived from bovine, porcine or avian sources. Collagen dressings are often used for PUs, VLUs, skin donor sites and surgical wounds, arterial ulcers, DFUs, second-degree burns and trauma wounds.

"

NPWTComputerized vacuum device applies continuous or intermittent negative or sub-atmospheric pressure to the wound surface. NPWT accelerates wound healing, reduces time to wound closure. Comes in both stationary and portable versions.May be used for traumatic acute wound, open amputations, open abdomen, etc. Seems to increase burn wound perfusion. Also used in management of DFUs. Contraindicated for arterial insufficiency ulcers. Contraindicated if necrotic tissue is present in over 30% of the wound.

"

Bioengineered Skin & Skin SubstitutesBio-engineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), xenographic, synthetic materials, or a composite of these materials.Burns, trauma wounds, DFUs, VLUs, pressure ulcers, postsurgical breast reconstruction, bullous diseases

"

Growth FactorsOften derived from human placenta from a healthy delivery (i.e. amniotic tissue allografts) and amniotic fluid components.May be used for any type of wound, but most often used for chronic, non-healing wounds such as DFUs and VLUs, and potentially with second-degree burns.

"

Source: MedMarket Diligence, LLC; Report S254.

References   [ + ]

1. Specific companies and products are detailed in “Wound Management to 2026”, report S254

Billions in global wound care sales, yet chronic wounds still a chronic problem

Healthcare systems move billions in global wound care sales, yet chronic wounds still are a chronic problem. Despite the legion of products developed for wound care, from dressings to bioengineered skin, the obesity- and age-driven increase in chronic slow-healing and non-healing wounds plague healthcare systems globally. Results according to MedMarket Diligence’s biennial, 2018 Wound Management report (#S254).


Trends in wound prevalence by type
Trends in wound prevalence by type including chronic wounds

BIDDEFORD, Maine – April 1, 2018 – PRLog — Research and routine clinical practice in wound management have advanced the science to better understand and address chronic wounds, but much work remains for research and manufacturing to impact the growing caseload.

Chronic wounds represent a large but still underestimated problem for health systems globally and industry needs to step up in response, according to MedMarket Diligence, LLC.

“Our recent research shows that chronic wounds, which have long been no secret to clinicians, epidemiologists, and product manufacturers as a growing health problem, are actually even more prevalent and costly than has been previously reported,” says Patrick Driscoll of MedMarket Diligence, who has tracked wounds in clinical practice and industry for 25 years.

Care of chronic wounds is a significant, global burden on healthcare systems. In the USA alone, it is estimated that at least 6.7 million people suffer with chronic wounds, requiring treatment in excess of $20-50 billion per year (estimates vary according to the definitions). A report from the UK suggests, based on National Health System (NHS) data, that chronic wound prevalence in developed countries is about 6% and that care of chronic wounds accounts for around 3-5.5% of total healthcare spending in those countries. (Phillips CJ, et al. Estimating the costs associated with the management of patients with chronic wounds using linked routine data. Int Wound J. 2015. doi: 10.1111/iwj.12443.)

Definitions help clinicians determine whether a wound is healing or not. For example, for venous leg ulcers (VLUs), if the wound has not shown at least a 40% reduction in wound size in about four weeks, then additional therapies are called for. A non-healing foot ulcer is generally defined to be any ulcer that is unresponsive to standard therapies and persists after four weeks of standard care. Once a foot ulcer occurs, unfortunately some 60% of patients end up moving into the chronic non-healing category. Many diabetics develop foot ulcers.

Chronic wounds and burns continue to present challenging clinical problems. For example, chronic wounds may present with persistent infections, inflammation, hypoxia, non-responsive cells at the wound edge, the need for regular debridement, etc. For DFUs, it is important for the patient to continuously wear an offloading device such as a special boot. Additionally, the practitioner must carefully debride not only the necrotic tissue in the wound bed, but the wound edges. Cells at the wound edge seem to be unresponsive to typical healing signals, and therefore must be removed to promote and support proper healing.

Wound management is the subject ongoing research and publications (https://mediligence.com/s254/) by MedMarket Diligence, LLC. https://mediligence.com.

Contact
Patrick Driscoll

The Human Burden of Wound Care

To the person with a chronic wound, the condition represents pain, social and psychological debilitation and usually a financial load. To society, wound care—and especially the treatment of difficult-to-heal wounds—may represent great human suffering, social discomfort, days lost from work, mental health problems, recurrent infections and great economic burden and the human burden of wound care. Having a chronic wound not only necessitates physical care of the wound, including cleaning, disinfecting, irrigating, and changing dressings; it also impacts the emotional and psychological health of the patient. Depression can set in due to a lower quality of life and dependence on others for care of the wound, as well as for overall assistance, both physical and financial. Wounds may cause odors or may have visible drainage, staining clothing and triggering feelings of embarrassment and shame. These in turn may lead to isolation due to decreased mobility and the fear of being a burden on family and friends. To make things worse, increased stress can slow the progress of wound healing.

In caring for a chronic wound, the dressing costs are only part of the picture; the less visible costs include such items as nursing care, medications for pain and infections, and hospitalization. Hospitalization is a leading cost driver for wound care, accounting for at least 50% of the global economic burden. Nursing time to properly care for the patient with a chronic wound can be lengthy, and this is time that could be spent with other patients. In a new report published in the December 2017 online version of the International Society for Pharmacoeconomics and Outcomes Research’s (ISPOR) Value in Health journal (An Economic Evaluation of the Impact, Cost, and Medicare Policy Implications of Chronic Nonhealing Wounds. Nussbaum, Samuel R. et al. Value in Health, Volume 21 , Issue 1 , 27 – 32) (see the study), the researchers found that the costs related to wound care in the Medicare population (USA) were much higher than originally estimated, and that care took place primarily in outpatient settings. For the calendar year 2014, there is considerable variation in the estimates originating from different sources:

“Total Medicare spending estimates for all wound types ranged from $28.1 to $96.8 billion. Including infection costs, the most expensive estimates were for surgical wounds ($11.7, $13.1, and $38.3 billion), followed by diabetic foot ulcers ($6.2, $6.9, and $18.7 billion,). The highest cost estimates in regard to site of service were for hospital outpatients ($9.9–$35.8 billion), followed by hospital inpatients ($5.0–$24.3 billion).”

The development of advanced wound care dressings, devices and biologics is helping to change this situation. Although these advanced products may seem (or may be) expensive, they end up saving money for health care systems by healing wounds more rapidly.

Industry Structure

The wound care industry remains quite fragmented, with about eight companies holding leading market shares, but with possibly thousands of small cap companies around the world that are also manufacturing and marketing various wound care products. The Traditional Wound Care space remains attractive, in part since gauze dressings are relatively easy to manufacture and are also still the most commonly-used wound dressing. Even a small company can invent a novel twist to a dressing and experience a rise in profits and inroads into the market.

Low to medium industry concentration. As the traditional and advanced market shares diagrams below demonstrate, there are five to eight major players in Traditional and Advanced Wound Care Markets.

Traditional Wound Care Market Shares, 2017

Source: Report S254, “Wound Management to 2026”.

While these firms account for about 79% and 73% of the total markets, respectively, a significant portion of these markets are covered by hundreds or thousands of Other companies. This low to medium level of concentration means that smaller companies, or large companies looking to break into Wound Care, are able to do so more easily than if, say, three companies controlled 95% of the market.

Johnson & Johnson is estimated to be the Traditional Wound Care market leader with about 26% share, followed by Smith & Nephew, 3M Health Care and Hartmann. Medline Industries is estimated to account for about 8%, while Others account for about 21% of this market.

Breaking into the Advanced Wound Care markets presents a somewhat greater challenge. Here, the leading companies have invested heavily in R&D to gain strategic competitive advantage, as well as to create improved products for patients. Smith & Nephew is holds an estimated 21% of this market, followed by Acelity and Johnson & Johnson with 11% each, and Mölnlycke, 3M Health Care, Hartmann, Cardinal Health and ConvaTec accounting for smaller shares. Here again, Others accounts for at least 27% of this market.

Advanced Wound Care Market Shares, 2017

Source: Report S254. 

Opportunities exist in both Traditional and Advanced Wound Care, especially if a company is in the position of acquiring part or all of an existing wound care company, and if the company can then invest in the development of its new products. If points of distribution overlap, then so much the better.

Relatively low barriers to entry. Good news for companies wishing to break into wound care: barriers to entry into the traditional wound dressing segments (Adherents, Gauze and Non-Adherent Dressings) are relatively low, while demand remains strong. Typically, once a company is established in a traditional segment, it may either plow revenues into research and development, or it may acquire companies to more easily break into new product segments and markets. Many companies in wound care have followed just this path to gain market share and make an impact in the industry.


From, “Wound Management to 2026”; Report S254. Excerpts available on request.

Global wound care market segmentation best done one country at a time

In March 2018, MedMarket Diligence published its biennial report on the global wound care market, “Worldwide Wound Management, Forecast to 2026: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.Details.


Markets for medical technologies work according to the forces in play where products sell. There is no “global market”, per se, but an amalgamation of far-flung markets where, in one country, a new technology is embraced, and in another it’s passe or taboo or too expensive or de rigueur.

Cultural differences regarding medicine can be significant. How the sick are treated socially, how wounds are considered, the value of an innovation — may all be viewed differently through local lenses.

Differences in effective sales and distribution can exist, particularly for new technologies, in technology-importing countries.

Regulatory differences can be HUGE.  Besides the timing of FDA PMA or 510(K) versus the CE mark for the same technology, the regulatory entities are not entirely in sync regarding approval for new technologies.

On the global playing field, all active players know that some countries sre better than others at allowing foreign conpetition.

Even well established products, like traditional wound products (gauze, adherent, non-adherent), remain less well established in emerging markets.

below are the shares of each country’s total wound market represented by each technology, for non-adherent dressings, adherent dressings, gauze dressings, NPWT, and antimicrobial wound products.

The  net effect on local markets? — Each country has greater/lesser relative demand for different technologies, without respect to overall market size.


Technology/Treatment Share of Country Total Wound Market

The balance of sales across different wound technologies varies by country, with different products accounting for greater or lesser shares of the total wound sales per country. Below are illustrated, for example, that non-adherent dressings account for a higher share of wound product sales in China than in all other countries.

Source: MedMarket Diligence, LLC; Report S254.

Other traditional products like adherent dressings and gauze show a pattern of lesser use in the U.S., western European countries, and Japan.

Traditional gauze is a less significant component of the U.S. or Japan, both of which have rapidly adopted and instead use more advanced technologies.

Negative Pressure Wound Therapy, a more involved wound care technology, shows different patterns in demand across countries than other wound products.

The actual level of risk of infection, the perceived risk of infection, and the resulting differences in adoption of antimicrobials give rise to some different adoption than one might expect.

Markets for advanced wound care technologies, such bioengineered skin or growth factors (not shown), illustrates a common dynamic, with the highest country use being the U.S. and whose manufacturers have often pursued the U.S. market for new technology introduction, to be followed by Europe, Asia, South America, etc. as technology migrates to less well developed markets.

Other products in wound with their own country-to-country dynamics include film dressings, foam, hydrogel, hydrocolloid, alginate, collagen, and growth factors.


See Report #S254, published March 2018.

 

Global Wound Prevalence Forecast by Type, 2016-2026

The clinical driver of sales in wound care is the prevalence of different wound types and the associated cost to manage them. While surgical wounds made by primary intent as part of surgical procedures (e.g., excision of skin lesion, appendectomy, coronary artery bypass graft, etc.) represent the biggest source of wounds, the biggest focus on reining in costs in medtech is slow-healing, chronic wounds, such as ulcers.

We have projected the global prevalence for the most common wound types through 2026, shown below.

Source: MedMarket Diligence, LLC; Report #S254(Request excerpts.)

 

Bioengineered Skin and Skin Substitutes, Sales and Growth, 2017 to 2026

The use of bioengineered skin and skin substitutes in the treatment of wounds is on a strong, but variable growth curve. Currently, the highest sales of these products in wound management occurs in the United States, where sales are in excess of $700 million annually already and growth in sales of these products is projected at or near 10% annually through 2026.

While China “only” has sales of just over $200 million in bioengineered skin and skin substitutes, the projected >20% CAGR to 2026 will result in China’s sales approximating U.S. sales in a decade.

Source: MedMarket Diligence, LLC; Report #S254.

Wound Care Market Shares Worldwide

Analyzing data from Report #S254 ,”Wound Management to 2026″, we present the distribution of top competitors’ sales in each segment in 2017. Smith & Nephew, Johnson & Johnson, and 3M dominate the global wound management, with varying dominance between them — or by other companies — in each segment.

Source: MedMarket Diligence, LLC; Report #s254. (Publishing March 2018)

S&N leads the global market, following closely by JNJ. Both companies are active in multiple segments of wound management. S&N has lower traditional wound management product sales (simple dressings and bandages) and higher sales of “advanced” wound management products. J&J does $800 million more sales in traditional dressings, gauze and bandages than S&N, but lesser involvement in newer wound technologies such as NPWT, bioengineered skin, and growth factors.

Source: MedMarket Diligence, LLC; Report #s254. (Publishing March 2018)

 

Wound Care Shares: Traditional/Advanced Products, Fragmented/Dominated

Traditional wound care products (gauze, non-adherents, and adhesive dressings) encompass low innovation, commodity-like pricing and ultimately different sets of competitors than advanced wound care products.

Below illustrates the global market shares of wound care sales in traditional versus advanced  products. JNJ and S&N have swapped positions in the traditional versus advanced wound markets.

Source: Report #S254; MedMarket Diligence.

 

Among wound care’s most fragmented markets in terms of competitive activity are hydrocolloids and foam dressings, with no one competitor dominating the market. While 3M and S&N control significant shares of the hydrocolloid and foam dressings market, their aggregate share is still well under 50%.

Global Wound Management Market Shares in
Hydrocolloids and Foam Dressings, 2017

Source: Report #S254; MedMarket Diligence.

By comparison, other markets have clearly dominant players, such as in negative pressure wound therapy (NPWT) and growth factors used in wound care. In each, there is clearly one dominant player and the top two players control a large majority of each market.

Global Wound Management Market Shares in
NPWT and Growth Factors, 2017

Source: Report #S254; MedMarket Diligence.

 

 

Untapped potential for sealants, glues, hemostats in wound caseloads and procedures

Today’s surgeon has a broad range of products from which to choose for closing and sealing wounds. These include sutures, stapling devices, vascular clips, ligatures, and thermal devices, as well as a wide range of topical hemostats, surgical sealants and glues.

However, surgeons still primarily use sutures for wound closure and securement—sutures are cheap, familiar and work most of the time. Now, in addition to reaching for a stapling device, the surgeon must frequently decide at what point to augment or replace the commonly used items in favor of other products, which product is best for what procedure or condition, how much to use, and ease of use in order to achieve optimal patient outcomes. Because of budget pressures, the surgeon must also consider price when selecting a product. Of course in the USA, the product must also be FDA-approved, although the surgeon still has the choice of using a product off-label.

In the areas of sealants, hemostats and glues, there is room for both improvement and additional products.  There are a number of products already on the market, but the fact is that there is no one product that meets all needs in all situations and procedures. There are few products that stand out from the rest, apart, perhaps, from DermaBond® and BioGlue®. There are unmet needs, and companies having the necessary technology, or which may acquire and further develop the technology, can enter this market and launch novel items. These products have yet to significantly tap the potential for wound management and medical/surgical procedures.

Note: Log10 scale; Chronic wounds includes pressure, venous/arterial and diabetic ulcers.

Source: MedMarket Diligence, LLC; Report #S290.

Sealants, Fibrin and Others

Numerous variants of fibrin sealant exist, including autologous products. “Other” sealants refers to thrombin, collagen & gelatin-based sealants.

Fibrin sealants are used in the US in a wide array of applications; they are used the most in orthopedic surgeries, where the penetration rate is thought to be 25-30%. Fibrin sealants can, however, be ineffective under wet surgical conditions. The penetration rate in other surgeries is estimated to be about 10-15%.

Fibrin-based sealants were originally made with bovine components. These components were judged to increase the risk of developing bovine spongiform encephalopathy (BSE), so second-generation commercial fibrin sealants (CSF) avoided bovine-derived materials. The antifibrinolytic tranexamic acid (TXA) was used instead of bovine aprotinin. Later, the TXA was removed, again due to safety issues. Today, Ethicon’s (JNJ) Evicel is an example of this product, which Ethicon says is the only all human, aprotinin free, fibrin sealant indicated for general hemostasis. Market growth in the Sealants sector is driven by the need for improved biocompatibility and stronger sealing ability—in other words, meeting the still-unsatisfied needs of physician end-users.

High Strength Medical Glues

Similar to that of sealants, the current market penetration of glues in the US is about 25% of eligible surgeries. There are several strong points in favor of the use of medical glues: their use can significantly reduce healthcare costs, for example by reducing time in the surgical suite, reducing the risk of a bleed, which may mean a return trip to the OR, and general ease of use. Patients seem to prefer the glues over receiving sutures for external wound closure, as glues can provide a suture-free method of closing wounds. In addition, if glues are selected over sutures, the physician can avoid the need (and cost) of administering local anesthesia to the wound site.

Hemostats

Hemostats are normally used in surgical procedures only when conventional methics to stop bleeding are ineffective or impractical. The hemostat market offers opportunities as customers seek products that better meet their needs. Above and beyond having hemostatic agents that are effective and reliable, additional improvements that they wish to see in hemostat products include: laparoscopy-friendly; work regardless of whether the patient is on anticoagulants or not; easy to prepare and store, with a long shelf life; antimicrobial; transparent so that the surgeon continues to have a clear field of view; and non-toxic; i.e. preferably not made from human or animal materials.


Drawn from, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022:  Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.” Report #S290.

Add tick cement to the list of natural adhesives pursued for medical applications

In past posts, we have reported on multiple naturally-occurring substances or methods for strong adhesion that are being investigated for their potential to be exploited for medical or surgical adhesion. These include adhesives from remora, mussels, geckos, crab shells, barnacles, Australian burrowing frogs, spider webs, porcupine quills, sandcastle worms, etc.

Researchers from MedUni Vienna and Vienna University of Technology are now investigating 300 different ticks for the “cement” used by the parasites to attach to hosts. The goal is to study the composition of the natural tick “dowel” used by the mouthparts of ticks and determine how it might serve as a template for new tissue adhesives.

The Vienna research also notes other natural adhesives are similarly being investigated for medical and surgical use:

Other potential “adhesive donors” are sea cucumbers, which shoot sticky threads out of their sac; species of salamander, which secrete extremely fast-drying adhesive out of skin glands, if attacked; or insect larvae, which produce tentacles or crabs, which can remain firmly “stuck,” even under water.

The incentive for studying natural adhesives is that they have been driven by evolution to provide strong adhesion without toxicity in various wet or dry conditions that are challenging for existing synthetic or existing natural glues (e.g., fibrin glues, cyanoacrylates, etc.). Surgical glues currently in use have some limitation arising from lesser strength, ease of use, toxicity, and other shortcomings. New glues will gain wider adoption, capturing procedure volume used with sutures, clips and other closure methods, particularly in internal use, if they are stronger and/or provide tighter seals (without needing to be combined with sutures on the same incision/wound) and do not cause the toxicity that some high strength medical glues do (e.g., synthetics like cyanoacrylates; “super glues”). The biologically-derived glues (or the surfaces structures of gecko feet) avoid the toxicities of synthetics and have often proven to have very high tensile strength. (The fast-curing cement used by barnacles has been shown to have a remarkable tensile strength of 5,000 pounds per square inch.)

Edit: See also, Biomimetic Glue, based on shellfish natural adhesive.


MedMarket Diligence tracks the technologies, clinical practices, companies, and markets associated with medical and surgical sealants and glues, with the most recent coverage in, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022,” (report #S290).