Biomaterials: your life may depend on them
During the 20th century, diagnosis and treatment of injury and illness improved significantly. This was partly made possible through the development of biomaterials, which save lives, relieve suffering and help maintain quality-of-life for a European population enjoying ever-increasing longevity. At first limited to materials originally developed for aeronautics, electronics and mechanical engineering, a new generation of cost-effective materials that positively encourage the repair or restoration of natural tissue (`tissue-engineered' materials) is now being developed. In addition, continuing advances in medical software design now allow surgeons to use accurate models to assist them in preparing for increasingly complex surgery. With strong support from the European Commission's Fifth Framework Programme for Research and Development, Europe is a strong competitor in this rapidly growing sector, whose world market is worth over 25 billion euros annually. Background Our knowledge and understanding of the human body has grown enormously over recent years, leading to treatments which were previously unimaginable. Whilst it is hard to single out one particular aspect of this technological advance, the use of medical devices and implants, usually based on biomaterials, is certainly amongst the most significant. Most of us are aware of the improved mobility that can be achieved from an operation to replace a hip joint, for example, or the life-saving effect of dialysis which maintains the function of diseased or traumatised organs until replacements are available. With 750 000 hip operations carried out world-wide every year and 100 000 revision operations - nearly half of these in the EU - plus 500 000 primary knee operations and 70 000 revisions, the importance of biomaterials for this application alone is clear. Similarly, with serious burns running at 50 000 cases per year world-wide, 10% of which result in death, and fully 1% of the world's population affected by leg ulcers, there is a great need for biomaterials as skin replacement. The `first-generation' biomaterials have traditionally been developed by technology transfer from other market sectors such as aeronautical and mechanical engineering, and electronics. As a result, and despite the progress that has been made to date, the complexity of replacing the nature and function of natural tissue has placed limitations on a number of prostheses. The invention of new biomaterials therefore relies on multi-disciplinary innovation and imagination. Such developments offer greater hope for patients and may have far-reaching implications for European healthcare. With an ageing population - the number of adults in retirement is forecast to increase almost 50% by 2025 and to approach 100 million over the next 50 years, with one in three European citizens over 60 - and greater life expectancy, the likely benefits of biomaterials in helping reduce the increasing burden of healthcare costs on society are clear. Biomaterials - a growing market Apart from the potential benefits for society as a whole, the sector represents a growing market world-wide. While Europe is competing primarily with the United States and Japan, where advanced materials technology is already a national priority, emerging economies such as South Korea and Taiwan are also moving rapidly into the market place. The overall medical-device market (including diagnostic and therapeutic) was estimated at approximately 150 billion euros in 1996 - up some 50% over the previous four years - with Europe's share put at 30%, behind that of the US (44%). By 1998, the orthopaedic market for biomaterials was estimated to be about 8 billion euros with a growth rate of 5-7% and hip implants accounting for 30%. The wound-care market was worth over 10 billion euros each year, of which acute treatments represented almost 40%, and the cardiovascular applications market some 3 billion euros. Finally, the tissue repair market, excluding orthopaedic and cardiovascular applications, was estimated at some 4 billion euros. This made the estimated world-wide value of the biomaterials market some 25 billion euros, with a predicted growth rate of 12% per year. Almost one third of this world market, about 7 billion euros, is in Europe, with the US biomaterials market somewhat larger at around 10 billion euros. It is worth noting that the 20% annual growth rate in US biomaterials outstrips all other sectors of the medical device industry. What does the future hold? A recent survey into future trends for biomaterials suggests developments over the next decade based on scientific advances, a growing number of delivery methods, and specific product types. Devices and systems will begin to reflect a more sophisticated capability for intelligent behaviour. The movement towards more mature information databases, and products which are both smarter and simpler, will lead to a greater decentralisation and monitoring of treatment with associated convenience and cheaper self-care healthcare procedures. At the same time, new diagnostic and therapeutic genetic-based, tissue-engineered or organ assist/replacement innovations will increasingly blur the distinction between biological processes on the one hand, and engineered devices on the other, with integrated and hybrid systems playing an expanded role. Technological advances could offer greater precision in clinical interventions, with advances in miniaturisation and progress towards earlier diagnosis contributing to the development of less-invasive forms of treatment. The European Research Area: a big role for small businesses Despite US dominance, Europe has a strong biomaterials sector (especially in tissue engineering) and is well placed to benefit from continuing market expansion. Crucial to European growth will be the participation of small and medium-sized high-tech enterprises (SMEs), which already play an active part in most of the Commission's ongoing projects. By bringing academic and medical experts into contact with highly skilled and specialised industries at a European level, and overcoming the various constraints faced at a national level, the Framework Programme can play a significant catalytic role in establishing a European Research Area for biomaterials while boosting industry and job creation. Biomaterials in the Framework Programme Competitive and Sustainable Growth is one of the four thematic programmes within the EU's Fifth Framework Programme. Under this heading lie four `key actions' and several generic research areas. The aim is to put science and technology in a position to tackle the major economic and social challenges facing European society, departing from the purely knowledge- and technology-driven approach of previous Framework Programmes. One of the important aspects of biomaterials is that the associated research is generic, and often not related to a specific application. Biomaterials research thus fits best under the Growth programme's generic materials research. Growth and wealth creation in European manufacturing depends on access to such advanced functional (bio)materials, and their use in the creation of high value-added components, products and systems. In addition to the projects described in the next few pages, the Growth programme funds biomaterials research in such areas as dental materials, joint replacements, tendon and ligament replacements, soft tissue replacement, new bio-active coatings for biomaterials, ocular materials, osteo-integrative materials, biomaterials with improved resistance to infection, drug delivery systems, tissue-engineered cartilage, materials for modulation of hair follicle growth and materials for vascular grafts.