A Top-Down Analysis on Skin Substitutes

Apligraf Skin Substitute
Apligraf® , a bi-layered bioengineered skin substitute

What Are Skin Substitutes?

Skin substitutes are a group of biologic, synthetic, or biosynthetic materials designed to provide temporary or permanent coverage of skin wounds. The aim of skin substitutes is to replicate the properties of organic, cellular skin. They’re an important addition in the management of acute or chronic wounds and are often utilized to cover defects that occur following burns and injuries or for reconstruction.

Each version of a skin substitute has its own set of advantages and pitfalls. As wound healing is unique to the individual, the use of skin substitutes must be highly personalized, with the choice depending on the type of wound (chronic, acute), its etiology (trauma, inflammation), and the skin component (epidermis, dermis, both) that requires replacement. 

What Do Skin Substitutes Assist With?

Skin substitutes, as they are a heterogeneous group of materials, ideally have the function of the skin or the potential for autologous regenerative healing when applied to a wound. The most common chronic wounds (where skin substitutes are deemed necessary) are venous leg ulcers (VLU) and diabetic foot ulcers (DFU) along with pressure ulcers, which compromise a majority of nonhealing wounds amongst the U.S. aging population. While the pathophysiology of ulcer development varies between the chronic wound types, the commonality is noted once the ulcers develop. Once the ulcer develops and does not heal, the chronic wound takes on its own characteristics and growth factors are often deficient and unavailable. However, alternatives such as skin substitutes are designed as tissue-engineered biological dressings designed to mitigate the look and feel of chronic wounds, Apligraf® being a strong competitor within this market. 

Analysis of Apligraf:

Apligraf® (Organogenesis), is an advanced, tissue-engineered composite skin equivalent consisting of bovine type collagen matrix culture with allogeneic male neonatal fibroblasts and keratinocytes that resemble the structure of human skin. Apligraf®, the bi-layered bioengineered skin substitute, was the first FDA-approved engineered skin designed to promote the healing of ulcers that failed standard wound care. Although its exact mechanism of action is not known, it is understood to produce cytokines and growth factors similarly to healthy adult human skin. Apligraf® provides both the cells and matrix for non-healing wounds. 

Timeline of FDA Approval:

The U.S. Food and Drug Administration (FDA) initially approved Apligraf® in 1998 to treat venous ulcers that have not responded to conventional therapy. In 2000, Apligraf® received approval for the treatment of diabetic foot ulcers, and the skin substitute is now considered the top-tier treatment of chronic venous leg ulcers and diabetic foot ulcers. 

Further Market Analysis:

Overall, the total U.S. market for wound care is growing at a rate of 4.6% and is projected to reach $15 billion by 2025. With an increase in product innovation throughout the wound and tissue management market, companies are working to create products that are easier for physicians to use, fight infection, and take less time for wound closure. Apligraf® has proven itself to be a valuable treatment of chronic nonhealing venous leg ulcers and diabetic foot ulcers, as both conditions affect a large part of the U.S. aging population and has established its product as an asset to physician treatment of wounds. 

For more information on the U.S. Wound Care Market, including unit sales, average selling prices, market drivers and limiters, competitive market share analysis, and more, follow the link below to receive a free research summary of this report. In addition, we offer our complete Global Wound Care Market report series which includes the analysis of the wound care market in 70 countries and 7 regions.


FREE Sample Report


Via: U.S. National Library of Medicine

Leave a Reply