Disposable Devices-An outperforming Medical Device Segment Report.pdf
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1、 DISPOSABLE DEVICES-AN OUTPERFORMING MEDICAL DEVICE SEGMENT Edition-Dec, 09 Disclaimer The research reports provided by A Volume in 000 tonnes Source: Eurostat and Industry estimates 4.1.1 Medical devices Out of the total imports by EU the share of imported medical devices has declined slightly from
2、 75% to 74%. The structure of EU imports in 2007consisted of the following: Medical, Surgical Instruments Wound care Latex medical disposables 1% The intra EU imports have increased by 25% every year. The imports of all product group has increased but especially of syringes, needles Germany (9%); Be
3、lgium (7%); France (6%); UK (5%) 10481 13769.95 17671.92 18969.02 Extra-EU excl. DC: USA (21%); Switzerland (7%); Japan (3%); Singapore (1%); Iserael (0.8%) 1188.81 2065.866 3595.928 30421.37 DC: Mexico (2%); China (2%); Malaysia (0.8%); Thailand (0.4%); South Korea (0.2%); Dominican Rep. (0.2%); In
4、dia (0.2%); Turkey (0.2%); Pakistan (0.2%); Indonesia (0.2%) Medical and surgical instruments France (7%); Germany (7%); Ireland (6%); Belgium (5%) 2788.695 4134.218 5267.664 5617 Extra-EU excl. DC: USA (16%); Switzerland (15%); Japan (3%); Singapore (2%); Australia (1%) 200.34 391.545 527.52 513*1.
5、37 DC: Mexico (0.5%); China (2%); Malaysia (0.1%); Thailand (0.1%); South Korea (0.2%); Dominican Rep. (0.3%); Turkey (0.2%); Pakistan (0.2%); Indonesia (0.1%); Brazil (0.2%); Tunisia (0.2%); Belarus (0.1%) Medical and diagnostic equipment 3300.885 5031.664 6339.032 7015.77 Intra-EU: The Netherlands
6、 (12%); Germany (8%); Belgium (7%); France (7%); UK (5%) 3192.21 4156.592 5010.184 5448.49 Extra-EU excl. DC: USA (31%); Switzerland (4%); Japan (3%); Singapore (0.5%); Israel (2%) 215.46 385.33 666.936 871.32 DC: Mexico (2%); China (1%); Pakistan (0.5%); Malaysia (0.4%); South Korea (0.4%); Dominic
7、an Rep. (0.3%); Tunisia (0.3%); Costa Rica (0.3%); Thailand (0.1%); India (0.2%) Syringes, needles, The Netherlands (8%); Germany (11%); Belgium (9%); France (5%) 1388.205 1957.725 2783.296 2629.03 Extra-EU excl. DC: USA (21%); Switzerland (3%); Japan (2%); Singapore (0.5%); Taiwan (0.3%) 167.265 51
8、0.873 1276.096 1242.59 DC: Mexico (9%); China (0.7%); Malaysia (1%); Thailand (0.4%); Turkey (0.2%); Brazil (0.2%); Turkey (0.2%); South Korea (0.1%); India (0.1%); Dominican Rep. (0.1%); Belarus (0.1%) X-Ray equipment 1963.71 2778.105 3839.592 3907.24 Intra-EU: The Netherlands (21%); Germany (12%);
9、 France (10%); Ireland (5%); Italy (4%) 1169.91 1346.169 1723.232 1938.55 Extra-EU excl. DC: USA (20%); Japan (6%); Israel (2%); Canada (2%); Switzerland (2%) Figures in US$ millions Source: Eurostat Exports 27 EU member states combined, in 2007 exported more than 67 billion of medical devices a gre
10、ater awareness of the need for hygiene; new applications for gloves; and a world population growth rate of 1.0-1.2% p.a. in the next ten years. Figure 6.4: Worldwide Gloves Purchase by Industry in 2007 050100150200250300350400450 Aerospace Bloclean CR Suppliers Disk Drive Flat Panels Food Hospital M
11、edical Devices Pharmaceutical Semiconductor Other Electronics Other Industry US$ Millions Source: Company profiles 7. Growth Drivers 7.1 Intensifying Hospital Supplies with Growing Elderly World Population The worlds population aged above 80 has been increasing at a rapid rate of 3% over the past 20
12、 years. Going forward, the UN predicts growth rate to plateau over the next 25 years, but the worlds population will continue to age as the 21st century will witness more rapid ageing than in the past century. An increasing ageing population is strongly correlated to the rise in healthcare expenditu
13、re, but the UN expects that while more than half of the worlds population above 80 years now live in developed regions, by 2025, the statistics will be reversed, with 57% living in less developed countries. The surge in healthcare expenditure for developing nations as opposed to developed countries
14、again reinforces our positive view on demand for Top Glove products in the long-term. Like many other developed countries, the elderly population in China is rapidly increasing. According to the China Statistical Yearbooks, the absolute number of individuals 60 years and older, as well as their perc
15、entage within the total population, are in an upswing. According to an estimate, by 2011, this age group will increase to 217 million, accounting for 16% of the projected population in China. With the implementation of “one-child policy” in 1979, the natural population growth rate in China experienc
16、ed significant decline to around 0.53% in 2006 while average life expectancy improved continuously to more than 71.4 years due to higher living standard and advanced medical technologies (China Statistical Yearbook 2007). Percentage of Chinese population above 60 years old has been increasing steadi
17、ly. We expect around 16% of Chinese population above 60 years old in 2020 versus 10% in 2000. In EU, the first and most important factor that influences the consumption of medical devices and disposables is the ageing population, which places pressure on the need for healthcare services. The Organiz
18、ation for Cooperation and Economic Development (OECD) reported in OECD Health Data 2006 that healthcare expenditures rose faster than GDP in all OECD member countries, except Finland, between 1990 and 2004. Life expectancy in the new EU member states is lower when compared to Western Europe, but lif
19、e expectancy of the total population in new EU member states has improved even when accounting for migration from Eastern European countries to Western Europe. In 2006, production consisted of medical devices (84%) and disposables (16%). The biggest producers of medical devices and disposables are G
20、ermany (48%), the UK (13%), Italy (11%) and France (8%). Those top 5 countries represent 87% of total EU production. Frances key production is in medical and surgical instruments Medical Device Reporting; Medical Device Tracking; Medical Device Corrections and Removals; Quality System Regulation; La
21、beling; and Premarket Requirements. “Premarket Requirements” refers to a submission that must be made to FDA before the device may be used. The type and complexity of the premarket submission (e.g. whether clinical data is needed) depends on the type of device. In general, the submission must demons
22、trate that the reprocessed device is safe and effective. Hospitals would be required to comply with all of the requirements listed above other than the Premarket Requirements beginning six months after FDA publishes a final guidance document. The Agency has proposed a phased-in enforcement scheme fo
23、r the Premarket Requirements based on the risks posed by the particular device. For high risk devices (such as biopsy needles and keratome blades), FDA would require a premarket submission within six months of the issuance of a final guidance. For moderate risk devices (such as urethral catheters),
24、a submission would be required within twelve months of the final guidance. For low risk devices (such as endoscopic guidewires), a submission would be required within eighteen months. Another item to note is that a bill has been introduced in Congress to require that patients be notified before cert
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