(This is drawn in part from the Executive Summary of MedMarket Diligence's "Worldwide Wound Management Market, 2008-2017", Report #S247.)
The skin is our protection from the environment. Far from being just a physical barrier, the skin is a complex organ, protecting our bodies from chemical, biological and physical insult, keeping organs and tissues in their place, and regulating various secretions including sweat (to control temperature), and pheromones (to act as sexual attractants). It is constantly renewed and maintained. Injuries to the skin cause the potential for infection and significant disruption to the healthy functioning of the tissues beneath. Healing of the skin has been an essential pre-requisite for evolutionary and individual survival, and complex biochemical systems have evolved for repair of the skin.
Acute Wounds
Surgical wounds account for the vast majority of skin injuries. There are more than 110 million surgical incisions every year, which require some wound management treatment. In approximately 80% of these cases, some form of closure product is used, such as sutures, staples, and tapes. Many require hemostasis (blood clotting) promoters, and of course the use of fabric bandages and surgical dressings is almost universal.
Traumatic wounds occur at a rate of about 1.6 million cases every year. Lacerations are a specific type of trauma wound that are generally minor in nature and require only cleansing and dressing for a shorter period. Lacerations occur frequently (approximately 20 million cases a year), as a result of cuts and grazes. They can usually be treated in the doctor’s surgery, outpatient medical center, or hospital accident and emergency department.
Burns
Burn wounds can be divided into minor burns, medically treated, and hospitalized cases. Outpatient burn wounds are often treated at home, at the physician’s office, or at outpatient clinics. As a result, a large number of these wounds never enter the formal health care system. We estimate that approximately 3.4 million patients in this category do seek outpatient care and receive some level of medical attention. These burns are mostly treated using hydrogels and advanced wound care products or, alternately, with consumer-based products for wound healing.
Medically treated burn wounds get more specialist levels of care to remove heat from the tissue, maintain hydration, and prevent infection. Advanced wound care products are used on these wounds. There are approximately 6.5 million burns like this treated medically every year.
Hospitalized burn wounds are more rare and require more advanced and expensive care. These victims require significant care, nutrition, debridement, tissue grafting and often tissue engineering where available. They also require significant nursing care and rehabilitation to mobilize new tissue, and physiotherapy to address changes in physiology.
Chronic Wounds
Chronic wounds generally take longer to heal, and care required is enormously variable, as is the healing time. There is an incidence of approximately 8.5 million pressure ulcers in the world that require treatment every year. Optimally, these wounds receive advanced wound management products and appropriate care to address the underlying defect that has caused the chronic wound. Pressure ulcers are caused by compression of the skin and underlying tissues, as when a patient is bedridden and the buttocks are pressed onto the mattress; a number of advanced devices exist to reduce pressure for patients. Other skin ulcers are caused by poor circulation, even without the added complication of pressure. There are approximately 12.5 million venous ulcers, and approximately 13.5 million diabetic ulcers in the world requiring treatment.
Chronic wounds are growing in incidence due to the growing numbers of elderly individuals in the population, and the caseload is also increasing due to improved diagnosis and education. At present these factors are contributing to growth of this pool of patients faster than new technologies are reducing the incidence of wounds by healing them.
Wound management techniques are also used for a number of other conditions including amputations, carcinomas, melanomas, and other complicated skin cancers, which are all on the increase.
Products Used in Advanced Wound Management
Dressings can be divided into categories using a number of different classification systems. In this report we focus our product, marketing, and technology review on the category known as Advanced Wound Management. This includes film dressings, hydrocolloids, foam dressings, alginate dressings, hydrogels, non-adherent dressings, antimicrobial dressings, cleansing and debridement products, tissue engineered products, pharmacological products, (including pain control, antibiotics, growth factors, non-growth factor modulators, gene therapy, and scarring modulators), physical treatments (like pressure devices, hydrotherapy, electrical stimulation, electromagnetic stimulation, ultraviolet therapy, hyperbaric oxygen therapy, mechanically assisted wound closure devices, ultrasound, laser and information systems. Some of these product categories are well established; others are in development.
Film Dressings
Film dressings are a vital segment of the advanced wound management market. The potential for film dressings in moist wound healing is a concept that is now over 20 years old. Due to the age of many of the strong brands in this segment, key patents on technologies and the delivery/application systems are expiring. This will erode premium prices, which have been maintained by creating new and differentiating application systems and the strong branding that is associated with them. Companies with strong know-how coupled with highly integrated low-cost manufacturing, and strong brand awareness will retain share in the marketplace.
Overall, despite increased competition and price pressure, this market segment will continue to demonstrate positive growth resulting from continued adoption of moist wound healing principles and switching from general non-occlusive dressings to advanced products such as films. The market for transparent film dressings is mature, and although individual products may provide a number of separate features, such as different moisture vapor transmission rates (MVTRs), they are purchased as commodities by buying groups. Given acceptable delivery systems, films compete on price.
Hydrocolloid Dressings
The market for hydrocolloids grew rapidly in the 1980s and 1990s due to the products’ convenience and the fact that they can be left on some wounds for up to five days, together with widespread experience in their use, significant clinical support, and intensive marketing, that have helped grow sales volume over the years. Clinician customers developed a high awareness of these hydrocolloid brands and effectively substituted them for traditional fabric dressings once they had adopted the rationale for advanced wound care using moist wound healing. Major players in this segment of the market encouraged the use of hydrocolloids for all moist wound healing applications.
Hydrocolloids are used extensively in long-term care sites where wear time and ease of use are determining factors in dressing selection and in hospitals where they are popular with opinion leaders. However, hydrocolloids are now starting to lose ground in the face of competition from newer types of dressings with superior benefits. Sales of hydrocolloids are projected to grow modestly through 2017. ConvaTec, Coloplast, and other strong players will find it increasingly difficult to defend these brands from advancing generic hydrocolloid equivalents produced by lower cost manufacturers with generic cost bases. In addition, there is a growing customer recognition that hydrocolloids have been superseded by other technologies (for example, foam dressings) for some wounds.
Foam Dressings
The ability to outperform hydrocolloids in highly exuding wounds, lack of dressing debris, and moderate cost have made foam dressings one of the fastest growing segments in the advanced wound care market. Foams are expected to maintain an average growth rate in excess of 10% into the immediate future as these products take share from hydrocolloids due to their superior handling characteristics, and as they erode traditional gauze dressing usage.
Alginate Dressings
Alginate dressings are popular in the home care and extended care markets where high absorption capacity is used to reduce the number and expense of skilled visits. In deeper wounds, alginates conform to the wound bed and contain exudates better than foam dressings. As with other advanced wound dressings, the alginate market is experiencing pricing pressure due to the continued cost consciousness of many individual country’s health care systems, and the generic nature of these materials and lack of proprietary intellectual property. Use of alginate dressings is especially common on moderate-to-highly exuding wounds. Alginates were quickly categorized as devices and reimbursed in the USA, UK, France and Germany, leading to strong growth in these countries. The relatively strong support for these products by expert wound care clinicians and the need for management of highly exudative wounds led to high sales growth in the mid 1990s. The alginate dressings market segment will grow at around in excess of 10% annually from 2008 to 2017; in 2008.
Hydrogels
Hydrogels are often promoted by referring to their aesthetic cooling effects, which help to reduce wound pain. Hydrogels are now perceived by clinicians as effective in encouraging autolytic debridement, and encouraging the healing of dry or minimally exuding wounds. Amorphous hydrogels and gauze-stabilized formats provide a real advantage in wound packing, and these products have been readily adopted by clinicians. In addition, hydrogels have good potential to serve as delivery systems for active agents. Competitors are actively introducing new hydrogel products to the market, and targeting alternate and home care markets. Thus, hydrogel sales are projected to grow only modestly through 2017.
Approximately 50% of amorphous hydrogel products are used by clinicians to re-hydrate black necrosis or yellow slough for purposes of debridement. The other 50% of amorphous hydrogels are sold for use as a general hydration material for controlling moisture to aid moist wound healing.
Non-Adherent Dressings
Non-adherents are a vital part of the advanced wound management market. Products are used to permit less frequent changes of dressings and to allow the use of dressings that manage higher quantities of exudates but reduce the potential for these dressings to stick to the wound. They are also used in combination with traditional dressings as an alternative to more expensive advanced wound dressings. These dressings are also used as the primary contact layer for compression bandaging systems (although we have excluded sales due to this usage from our market estimates). Thus, non-adherent sales are projected to continue to grow anemically through 2017.
Anti-Microbial Dressings
Anti-microbial dressings are used to manage the effects of microbial colonization and growth. Bacterial infection of wounds is a significant complication of wound repair. There is a growing concern regarding the use of antibiotic products in the wound care environment, and there are few “non-resistant-microbe-forming” antibiotic technologies on the horizon that offer potential to be launched within the next five years. In contrast to this, antimicrobial technologies are being pursued by all wound management companies, to enhance existing brands, and to address the recognized need in this area. Topical antiseptics are one option to treat patients with infected wounds; they act rapidly and locally to destroy microbes. Products fall into a number of categories, which tend to overlap with other categories of wound care products due to the product base technology used for the dressing category that inspired them. For example Tulle Gras delivery systems have been used for some antibacterial products such as Inadine, Bactigras, and generic antibiotic impregnated products. Sales are projected to continue to grow at only a nominal rate through 2017.
Wound Cleansers and Debriding Agents
The wound cleanser and debridement market is expected to grow to an estimated sales value of $375 million in 2008 to more than $695 million in 2017. The enzymatic debridement subsegment of this market is driven by the increase in the elderly population with the corresponding increase in nursing home populations and in-home health care environments where chronic wounds are prevalent. The increasing prevalence of diabetic ulcers contributes to the market potential for these agents.
Skin Replacements and Substitutes
Skin replacements and substitutes compete in the severe burn market, venous leg ulcers market, and the diabetic foot ulcer markets where their high cost is offset by their ability to save lives and/or save limbs from amputation. These products have taken some time to demonstrate clinical effectiveness and to be approved for use to heal wounds faster than alternative treatments. In addition, these products are currently significantly more expensive than alternative therapies, and publicly funded health care schemes around the world have found it difficult to accept these costs despite strong cost-effectiveness claims. It is highly likely that these products will take some time to be widely adopted. The move towards cost- effectiveness procurement practice is likely to increase uptake of these products as purchasers advance from decisions based on unit product cost towards outcomes assessments and data. In addition, manufacturers are developing alternative manufacturing and lower cost product designs that should enhance the cost effectiveness of these products over the next few years.
Pharmacological Products
In the field of wound management there are a large number of companies commercializing technologies in the pharmacological field. These technologies include recombinant growth factors and growth factor mixtures, gene therapy, chemical cell stimulants, natural plant extracts and other pharmaceuticals including analgesics, antibiotics, scar reduction products etc. Advanced wound care practices and dressings have focused on removal of the underlying cause of the wound, altering the physical environment, and provision of a moist wound healing environment. These efforts have greatly improved wound care by facilitating wound repair by supporting the body’s own repair and regenerative processes. Recent interest and efforts have been directed to evolving products and procedures designed to actively manipulate the wound healing process. In addition, antibiotics and analgesics have direct and beneficial application in the treatment of wounds in specific cases.
Physical Therapies
Physical modalities have been used in the attempt to encourage wound healing for centuries. Passive compression is a popular approach for the treatment of venous stasis ulcers and many of the current passive compression products have their roots in traditional practices (e.g., paste bandages). Passive compression addresses the underlying etiology of chronic venous insufficiency.
Alternatively there is a market for devices designed to remove pressure from wounds that have been caused by extended pressure on the skin surface, and this market segment has shown astronomical growth within the past 3-4 years, driven by the demonstrated ability of application of negative (i.e., sub-atmospheric) pressure to speed up and improve the healing of chronic wounds.
There are also a great number of devices that are designed to immobilize limbs to avoid weight-bearing behavior, and sophisticated footwear and devices for diagnosing neuropathy. In addition, devices exist to manipulate pressure around limbs to maintain and improve venous blood flow. There are devices designed to accelerate healing through the use of physical treatments including ultrasound, electrical, magnetic, hyperbaric, and pressure relief.
Taken together, these physicial treatment modalities commanded sales of more than $1.4 billion
Skin replacements and substitutes (see image at right: Apligraf by Organogenesis, Inc.) compete in the severe burn, venous leg ulcer, and the diabetic foot ulcer markets where their high cost is offset by their ability to save lives and/or preserve limbs from amputation. These products have taken some time to demonstrate clinical effectiveness and to be approved for use to heal wounds more quickly than alternative treatments. In addition, these products are still significantly more expensive than alternative therapies, and publicly funded health care organizations around the world have sometimes found it difficult to absorb these costs despite strong cost-effectiveness claims. It is highly likely that products will take some time to reach high acceptance levels. The move towards cost effectiveness procurement practice is likely to increase uptake of these products as they move purchasers away from decisions based on unit product cost towards outcomes assessments and data. In addition, manufacturers are developing alternative manufacturing and lower-cost product designs that should enhance the cost-effectiveness of these products over the next few years.
