February 1, 2008 (Vol. 28, No. 3)
Bruce Carlson Publisher Kalorama Information
Recombinant Growth Factor Therapies Are Predicted to Be Up-and-Coming Players
Burn injuries, which have reached epidemic proportions in recent years, are considered a healthcare problem more serious than the polio epidemic was at its peak. According to the CDC, on average in the U.S. in 2005, someone died in a fire about every two hours (143 minutes), and someone was injured every 25 minutes.
Burn victims, more so than many other accident victims, face a multitude of roadblocks on the road to recovery. Beyond the shock and trauma of the initial incident, they must endure agonizing pain, the ever-present risk of infections, and the excruciating treatment of their wounds, which often entails scraping the burn site to promote new skin growth.
Burn pain is an extremely unpleasant form of suffering, and can be difficult to treat. An estimated 2.1 million Americans seek medical care each year for burns. Approximately 100,000 are hospitalized, and 72,000 require intensive care services. An estimated 11,000 of these people die annually as a direct result of their burns. Children and elderly adults account for more than two-thirds of all burn fatalities.
Fortunately, a new array of treatment methods have arrived in the clinical setting in time to meet the growing need. Developments in treatments of burns have made tremendous strides in the last decade. Recently, however, these advances are taking place on a daily basis with the most significant changes seen in the past 30 years.
In addition to the always-improving synthetic dressing materials, newer technologies in wound treatment include the xenogeneic tissue scaffold, bilayered human dermal substitutes, recombinant growth factors, endoscopic subfascial ligation of venous perforators, endovascular arterial repair techniques, and hyperbaric oxygen therapy.
The growing incidence of burn wounds and these new methods to approach the problem point to a robust market for those companies that make products to treat burns. Kalorama Information estimates in “Wound Care Markets, Vol. II, Burn Treatments” that the worldwide burn-treatment market reached revenues of nearly $1.9 billion in 2006.
The burn treatment market will continue to grow in revenues reaching $2.6 billion revenues in 2011, with a compound annual growth rate of 6.9% during that timeframe. The bulk of revenue in the burn-treatment market originates from conventional therapies such as anti-infectives, burn management, and pressure-relief devices. Here the market has for the most part reached maturity. But the lion’s share of the growth is coming from the novel therapies that result in decreasing healing times and subsequent cost savings.
High-Growth Burn Treatment Areas
An example of one such area is in biologic dressings. Obtained from humans (homografts), from other animals (xenographs or heterographs), or amnion from human placentas, these treatments are being used on large burns. These coverings provide a temporary wound closure until autographing is complete and are also used to debride dirty wounds after eschar separation. They decrease evaporative fluid and protein loss, protect new nerve endings, and provide a bacterial barrier enhancing reepitheliazation.
When the biologic dressing appears to be taking, or adheres to the granulating wound surface with a minimum of underlying exudates, the patient is ready for permanent placement of an autograft. Because of the cost of biologic dressings, synthetic substitutes have also become available, such as Biobrane and artificial skin.
While still in the beginning stages of development, they demonstrate a large opportunity for continued growth. These dressings earned $85.8 million in 2006 and are expected to grow at a 23.6% compound annual rate to an estimated $109 million by 2011. Johnson and Johnson, with its Promogram and NUGEL brands, dominates this area with 26% of the market share.
Silver wound dressings, containing stabilized antimicrobial silver, have also proven their effectiveness. Products such as AcryMed’s SilverSorb single-use sheet, Argentum’s Silverlon multilayer fabric pad, and Johnson and Johnson’s Actisorb Silver 220 will lead this category of burn care to 12 times its current market size by 2011, or nearly $175 million.
Vacuum-assisted or sub-atmospheric pressure have established a key role in speeding up the wound-healing process. Numerous clinical studies show that vacuum-assisted therapy can promote wound healing significantly better than conventional methods. Vaccum-assisted products make up $108 million of the burn-care market and show promise in the future.
Miscellaneous treatments will be an important part of a comprehensive strategy to treat burn wounds. Electrostimulation transfers energy in the form of electric current through an applied surface electrode pad that is in wet contact with the external skin surface and/or wound bed. Hyperbaric oxygen, 100% oxygen delivered at two to three times ambient pressure, is also a powerful treatment to speed up wound healing. These miscellaneous treatments make up $117 million of the market and in tandem with vacuum-assisted therapies will grow to $335 million by 2011.
Development has certainly not stopped with these therapies, and there are many others in development.
Recombinant Growth Factors
Another wound treatment that is not visible yet in terms of revenues but is expected to provide real results in coming years is recombinant growth factors. Recombinant growth factors are laboratory-cloned replicas of peptides that have small biochemical differences. Recombinant growth factor manufacturers strive to make the laboratory-generated growth factors similar to the original human growth factor, with equal or greater bioactivity. This has been the major problem for manufacturers of growth factors to overcome.
Medical studies have shown that growth factors stimulate normal growth, as well as help regenerate and accelerate the repair of aged or injured muscle, skin collagen, bone, cartilage, and nerve tissues.
In addition, growth factors can be used as an effective topical application for burns, injuries, and skin rejuvenation. For some time researchers have known that endogenous growth factors released at the location of wounds are conducive to wound healing. The identification of these growth factors and the roles they serve in wound healing has changed the outlook of wound care in general.
Growth factors are a large and diverse group of peptides that coordinate all aspects of interactions between cells. They are signal proteins released from local tissues or blood products that activate target cells to replicate or migrate. They can be produced outside the body by two methods.
The first entails centrifuging blood to isolate platelets and then adding thrombin (e.g., platelet-derived wound-healing formula). This produces a crude preparation with uncertain concentrations of different growth factors. The second method uses recombinant techniques to isolate the gene that produces a specific growth factor protein. The gene is used to create a purified quantity of a single type of growth factor, for example, basic fibroblast growth factor, epidermal growth factor, and platelet-derived growth factor.
Another example of a growth factor used in wound healing is placental angiogenic growth factors. Growth factor preparation is applied as a topical salve, and reportedly stimulates the regrowth of soft tissue, capillaries, and skin.
There is only one growth factor product on the market, RegranX, which is not indicated for burns at this time. But the theoretical case can be made and the use of this biological solution for burn treatment is anticipated. It is these unutilized approaches as well as the many creative products in use and in development that will be of most importance in understanding the long-term future of the burn market.
Bruce Carlson is associate publisher
at Kalorama Information ([email protected]).
To order “Wound Care Markets, Vol. II, Burn Treatments” or find out more
about the report go to: www.kaloramainformation.com.