The worldwide medical device market in 2003 is valued at over €184 billion, with an estimated nominal increase of about 16% as compared to 2002. The largest market is the US with 38-45% of the world share, followed by the European market (30-34%). Of the European countries, Germany is the largest, with 6.8% of the world market, followed by France with 3%. Together, these two countries account for half of the European market.
In Europe, 6.2% of total health expenditure goes on medical devices: 7.6% in the new and 5.4% in the 15 old Member States. The share of medical devices over total health expenditure is lower in both the US and in Japan (about 5.1%).
The medical devices sector has been affected by pressures from national cost-containment policies that have curbed the positive trend of growth in the sector. Nevertheless, growing income, aging populations and a general commitment of societies to improving the quality of life has benefited the sector.
Medical device production grew in the EU-25 by 12.5% in 2001 and 7.8% in 2002, well above the average of the manufacturing sector (1.8% and 0.3 % for each year respectively).
Medical device manufacturers are usually large companies, of which the majority are located in the United States. The world market leader in the medical device industry is Johnson & Johnson. However, SMEs also play an important role in the sector, especially in Europe, where they benefit from the proximity to their clients.
EAMDR has not yet collected detailed data on the market for sterilization and disinfection from its members and partners. The overview is therefore limited to the following information.
With a market for reprocessing services being created in Europe, professional third party reprocessors have entered the market. While reprocessing of medical devices has been done for many years within hospitals, the reprocessing market, i.e. the market of third-party reprocessing service providers startet just a few years ago. Given that reprocessing is only allowed in some Member States, the industry is not as developed as the manufacturers’ market. The development of the past years does show the raising acceptance of reprocessing and the market by manufacturers. So some of the leading US-manufacturers did expant their business to the reprocessing market by taking over some reprocessing companies themself.
Latest analyses of German reprocessing companies have demonstrated that 15-20% of all single-use labelled medical devices (about 30,000 devices have been tested) are reprocessable according to the Robert-Koch-Institute’s (RKI) guidelines. Looking at this market potential, it is expected that the industry will grow rapidly once the legal situation in the EU has been clarified and a quality system supervised by the public authorities has been established.
To date, up to 10 million of these medical devices have been reprocessed safely through members of the EAMDR, applying strict quality standards for reprocessing approved by national hygiene boards (such as the Robert-Koch-Institute in Germany) – without a single claim.
The market for medical device reprocessing currently expands into exporting reprocessing technology to countries located outside the EU.
Medical device reprocessing is one of the most dynamic and fastest-growing industries in Europe. The European Union has the chance to strengthen its technology leadership in this sector.
High-quality reprocessing is part of the Lisbon Agenda aimed at strengthening the EU’s competitiveness in the world.
Taking into account that approximately 80% of “single-use” devices are imported from outside the EU, while medical device reprocessing is bound to the region where the hospitals are located, this industry has a positive impact on income and employment.
With a European legal framework allowing reprocessing in all EU-Member States, the EAMDR expects the formation of new companies and, hence, the creation of further jobs. Finally, a common legal framework for medical device reprocessing would provide a framework for research on state-of-the-art reprocessing technology within the European Research Area.
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