Recent business and scientific trends

摘要

Over the last 10 years or so, the level of scientific, medical, and commercial interest in the field of tissue engineering has grown dramatically. While the potential replacement of complex organs through this route maintains a high level of publicity, in the short to medium term, the most credible area of application lies in tissue repair. The repair of damaged tissue, whether the damage is as a result of disease, traumatic injury, surgery, or simply ageing, still presents major challenges to the medical professions. Wounds such as pressure sores, diabetic foot ulcers, and venous leg ulcers may be extremely slow and difficult to heal with severe implications for the individual, and costly to the health system. However, unlike skin, which has some potential for self-repair, other tissues, such as the cartilage of the joints and the cornea of the eye, once damaged have little or no such potential and new approaches are required. The emergence of the multidisciplinary field of tissue engineering has provided some new ways in order to treat such disorders. The 'first phase' of the commercialisation of tissue engineering has generated some exciting new products, principally in the treatment of recalcitrant skin ulcers. However, whereas skin is essentially a two-dimensional tissue, the delivery of truly three-dimensional bio-engineered tissues will require the solution of an additional series of scientific research challenges. It is interesting to reflect on the early emergence of tissue-engineering-based companies and product developments, which, in some cases, almost preceded the necessary research base. A retrospective view indicates what have been the most significant research inadequacies, and also, in this most multi-disciplinary of fields, what skills have yet to be applied to the level necessary. Examples are given from current work, of progress towards filling some of the gaps in our knowledge base. From a business perspective, the worldwide investment in tissue-engineering research and development continues to rise, and new companies continue to emerge, striving to gain a share of what is potentially a large market. However, the experiences of the pioneering companies are not universally encouraging. The paper provides some perspectives on the business challenges in tissue engineering, relating, for example, to the level of investment of time and money needed to bring a tissue-engineered product to market, and the current level of uncertainty in respect of international regulatory approvals.