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Chapter category: BioMaterials

Tissue Engineering Constructs and Commercialization

This chapter appears in the following book:

Biomaterials in the Design and Reliability of Medical Devices

Edited by: Michael N. Helmus
ISBN: 0-306-47690-8
» Get more information about this book at landesbioscience.com «

Chapter authors:
Kelvin G.M. Brockbank

Tissue engineering is an interdisciplinary field that applies the principles of engineering (materials science and biomedical engineering) and the life sciences (biochemistry, genetics, cell and molecular biology) to the development of biological substitutes that can restore, maintain, or improve tissue functions. In its broader definition, tissue engineering includes isolated cells, tissue-inducing substances, and cells placed on or within matrices. However, in this instance the discussion of tissue engineering is limited to the development, design and implantation of devices consisting of matrices in association with cells, which can migrate, differenciate and perform normal cell/tissue functions. The matrices can be fashioned from natural materials such as collagen or from synthetic polymers. The cellular components may be of human or animal origin, with or without genetic modification. The purpose of this chapter is to present some of the key commercialization issues which exist in the new field of tissue engineering and consider how to utilize these as potential business opportunities. The largest market for tissue engineered products is replacement of structurally or physiologically deficient or diseased tissues and organs in humans. The potential markets for tissue engineered products vary extremely both in size and degree of market development. For example, a recent report1 indicated that the heart valve replacement and skin repair product markets have maximum potential market sizes of $225 and $5,945 million, respectively. Because the heart valve market is well developed, new products must compete with existing products for market share. In contrast, the skin market is virtually untapped, with room for many new products for a variety of clinical indications. Revenues in the total market are anticipated to grow at double-digit rates for the next five years,1 making this a potentially rewarding field for investment. Tissue engineering may eventually address diseases and disorders which account for approximately half of current annual U.S. health care costs, which are estimated to be approximately one trillion dollars at this time.2-5

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