Permanent artificial skin is generally used in case of burn victims with superficial, deep, or partial wounds and chronic and acute wounds. Permanent artificial skin is a skin substitute employed for wound closure in order to replace the layer of the skin, especially at the burn site, permanently. Major advantages of artificial skin substitutes are increased wound healing, flexibility, and prevention of infection at the site of wound. Different types of permanent artificial skin are: epicel, alloderm, and integra.
Epicel is also known as cultured epithelial auto graft. It is made from the patient’s own skin and cultured for 2–3 weeks before being used as a graft. Alloderm is employed to replace damaged soft tissue in case of deep wounds. It cannot be used for large surface areas. Integra is a permanent synthetic artificial skin substitute, which promotes growth of the cells and helps in formation of the red blood cells.
The global Permanent Artificial Skin Market is anticipated to be driven by increasing rate of incidence of burn injuries, growing rate of prevalence of chronic and acute wounds such as diabetic foot ulcers, rising R&D efforts for the development of new products, technological advancements such as sprays for treating burn injuries by using the patient’s own cells for rapid recovery, and increasing healthcare expenditure in developed as well as developing economies. On the other hand, high costs associated with artificial skin implant, stringent regulations regarding launch of new products, and low awareness in low-income economies are likely to be major restraints of the global permanent artificial skin market during the forecast period.
Increasing incidence of burn injuries has led to increase in the demand for permanent artificial skin for efficient treatment of severe burns. Thus, manufacturers are constantly looking for opportunities for the development of new products through regular investments in research and development. According to the American Burn Association reports, approximately 40,000 patients were hospitalized for burn injuries in the U.S from 2017 to 2018 Similar studies have been reported by other major national organizations for burn injuries. For example, the CDC (Center for Diseases Control) has reported that approximately 10,000 individuals in the U.S. die every year due to infections caused after burn injuries.
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Increasing demand for artificial skin substitutes has led to increase in adoption of expansion strategies by foreign manufactures to expand their geographical presence by introducing innovative products in newer geographies through strategic collaborations. For instance, on March 04, 2019, AVITA Medical collaborated with COSMOTEC, a subsidiary of M3 Group Company, for marketing and distribution of RECELL in Japan, which is used for the treatment of wounds caused by burns and other injuries. The launch of the product in Japan is anticipated to provide a lucrative opportunity for AVITA Medical, as there has been increase in the patient population suffering from chronic wounds and decubitus ulcers in Japan in recent times.
According to the FDA guidelines, skin substitute products are categorized as Class-III medical devices. They should protect and provide a stable biodegradable scaffold to promote healing of wounds. Therefore, failure in complying with the regulations set by different regulatory bodies, such as the FDA, can lead to failure to obtain a premarket approval for a new product. For instance, according to the FDA, use of biosynthetic products and animal-derived products is regulated under the 510K. Failure to adhere with this regulation can lead to delay in PMA (Pre-market Approval) and cause loss in revenues to manufacturers and restrict the market entry of new players. Thus, a stringent regulatory framework is anticipated to act as a restraint of the global permanent artificial skin market during the forecast period.
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