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Production
Within the EU, the medical devices and medical disposables industry is characterised by high market concentration, i.e. a few large enterprises control the market. At the same time the EU is facing greater competition from non-EU countries. The size of the medical devices and medical disposables production industry reflects the size of individual country markets. Hence, the main producing countries are Germany, Italy, the United Kingdom, France and Sweden.
Imports
In 2002, the EU-15 imported 1,551,555 tonnes of the selected medical devices and disposables, which represented a value of Euro 30,920 million. Germany is the largest EU importer of the selected products, followed by the Netherlands and France. Together, these three countries account for almost half of total EU imports. For the products analysed in this survey, the value of imports from developing countries is growing much faster than overall imports. While total imports grew by 16 percent in the two years to 2002, imports from developing countries expanded by almost 30 percent during this period. Nevertheless, developing countries account for a relatively small share of 5 percent of overall EU-15 imports. An exception is the import of ‘Latex medical disposables’ of which 64 percent originates from developing countries. The largest developing suppliers from developing countries of medical devices and medical disposables in 2002 were Malaysia, China, and Thailand. The new member states of the EU exported ? 622 million of the selected medical devices and disposables to the EU-15 countries in 2002, which is equal to 2 percent of the total. Although the share of the new member states is smaller than the share of the developing countries, it grows much faster at a growth rate of above 60 percent in the two years to 2002. Especially Poland is becoming an important supplier to the EU-15.
Exports
Together the 15 EU Member States exported Euro 34,891 million worth of the selected medical devices and medical disposables in 2002. Half of the EU exports did not leave the EU, but was traded between the 15 Member States themselves. The developing countries received 10 percent of EU-exports. Of the developing countries, China received the most EU exports of the selected medical devices and disposables, worth Euro 371 million, followed by Turkey with Euro 296 million. The new member states received 4 percent of total EU-15 exports of medical devices and medical disposables in 2002. Poland and the Czech Republic were the largest recipients within this category with Euro 342 million and Euro 322 million respectively.
Trade Structure
In most cases importers or agents with a lot of knowledge of the specific market are the link between the producers and the local dealer/wholesalers or the market. Within the EU, agents and importers are the most commonly used distribution channel for medical devices and medical disposables.
Opportunities for exporters
High labour costs force manufacturers in the EU to increasingly shift production to developing countries, which is also reflected in the import figures. This shift partly takes the form of outsourcing. The process of outsourcing in conjunction with the stringent market access requirements imply that the best opportunities for developing countries are in the following areas: contract manufacturing, sub contracting, private label manufacturing, assembling and sterilising. Particularly for higher value products, cooperation with a European partner is essential.
Requirements for Access
Three European Directives regulate the marketing and putting into service of medical devices: (1) the Active Implantable Medical Devices Directive, (2) the Medical Devices Directive (MDD), and (3) the In Vitro Diagnostic Directive. The intention of the Directives is to provide a harmonised regulatory environment to allow medical devices to be sold throughout the EU without further national regulation. Although these regulations are non-discriminatory, they may nevertheless put a heavy administrative burden on developing country exporters.
Based on market developments and access requirements discussed in part A, part B develops a set of export marketing guidelines. It is demonstrated how information is to be used to identify opportunities in the market, and how these have to be evaluated against the capabilities of the company. The information collected should then be combined into a SWOT (Strengths, Weaknesses, Opportunities, and Threats) - analysis on the basis of which a decision to export can then be taken. The last chapter discusses relevant marketing tools that can be used to increase the chances of success. Finally, the appendices contain a number of addresses that may be useful for companies developing their export strategy and researching their target market.
This report should be read in conjunction with other CBI-publications. Additional information can be found on the CBI-website :
www.cbi.nl .
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