Artificial Skin Therapies; Strategy for Product Development.

Significance: Tissue-engineered artificial skin for clinical reconstruction can be regarded as an established practice. Bi-layered skin equivalents are available as established allogenic or autologous therapy, and various acellular skin replacements can support tissue repair. Moreover, there is considerable commonality between the skin and other soft tissue reconstruction products. This article presents an attempt to create a comprehensive global landscape review of advanced replacement materials and associated strategies for skin and soft tissue reconstruction. Recent Advances: There has been rapid growth in the number of commercial and pre-commercial products over the past decade. In this survey, 263 base products for advanced skin therapy have been identified, across 8 therapeutic categories, giving over 350 products in total. The largest market is in the United States, followed by the E.U. zone. However, despite these advances, and the investment of resources in each product development, there are key issues concerning the clinical efficacy, cost-benefit of products, and clinical impact. Each therapeutic strategy has relative merits and limitations. Critical Issues: A critical consideration in developing and evaluating products is the therapeutic modality, associated regulatory processes, and the potential for clinical adoption geographically, determined by regulatory territory, intellectual property, and commercial distribution factors. The survey identifies an opportunity for developments that improve basic efficacy or cost-benefit. Future Directions: The economic pressures on health care systems, compounded by the demands of our increasingly ageing population, and the imperative to distribute effective health care, create an urgent global need for effective and affordable products.