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 100 000 hip operations carried out world-wide every
year – over half of these in the EU – the importance of biomaterials
for this application alone is clear. Similarly, with serious burns running
at 50 000 cases per year, 10% of which result in death, and fully 1%
of the world’s population affected by non-healing 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%).
Looking more specifically at some of
the medical areas where biomaterials are used, the orthopaedic market now
amounts to some 8 billion euros with a growth rate of 5-7% and hip
implants accounting for 30%. The wound-care market is worth over 10
billion euros each year, of which acute treatments represent almost 40%,
and the cardiovascular applications market some 3 billion euros. The
tissue repair market, excluding orthopaedic and cardiovascular
applications, is estimated at some 4 billion euros.
By 1998, the world-wide value of the
specific biomaterials market was estimated to be 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,
boosting European research, industry and job creation in the process.
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.
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