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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
25、ain reprocessed single-use devices are used. FDA, for its part, has thus far taken the position that it does not have the authority to require such notification. The US Food and Drug Administration (FDA)s promotion of international cooperation and free trade will keep imports rising at a respectable
26、 pace. Due to the large, advanced nature of the domestic health care sector and greater pricing flexibility for products, the US market will remain a major target of disposable medical supply exporters throughout the world. In addition, labor and other cost saving advantages will prompt domestic pro
27、ducers to continue manufacturing a number of commodity products offshore, such as medical gloves and garments. Global markets for US-produced medical disposables will become increasingly competitive due to the expansion of local production and constraints on overall health care spending. 8.1.2 India
28、n Ministry of Health Set Deadline to Switch to Disposable Syringes In February 2009, Indian health ministry had issued guidelines asking state governments to put an end to the practice of reusing the syringes by April 30, 2009. Around 1500 million syringes are used in the country for over 5000 milli
29、on injections administered every year which means that a syringe is used at least thrice. Till now only 5% of the injections administered in the country are auto disposables and with five states agreeing to completely switching over to disposable syringes, the number is expected to go up to 10%. 8.1
30、.3 Ukraine Imposes Anti-Dumping Tariff on Chinese-Made Syringes The Ukraine Inter-Departmental Committee of International Trade decided on October 9 to impose a five-year anti-dumping tariff on Chinese-made syringes. The anti-dumping tariff on 2ml syringes imported from China is 24.36%, and 54.1% on
31、 5ml and 347.14% on 10ml China-made syringes. The decision also involves syringes from Spain, the UK and German. Spain-made 5ml and 10ml syringes will have anti-dumping tariffs of 10.54% and 196.38% respectively. UK-made 10ml syringes will have a 23 per cent tariff, and 10ml syringes from Germany wi
32、ll have a 37% tariff. On July 23, 2008, the Ukraine Inter-Departmental Committee of International Trade began its anti-dumping investigation on syringes imported from China, Spain, German and the UK according to the appeal of two domestic companies. China is the worlds largest manufacturer and expor
33、ter of disposable syringes. Because of the fierce competition in the domestic disposable syringe market and there is no key technology involved, the profit margins of Chinas disposable syringe exporters is very low. 8.2 Future Outlook of Disposable Medical Device Industry 8.2.1 Global Outlook Dispos
34、able medical device is continuously showing an upward trend despite the worldwide market affected by the economic slowdown, due to rising hospital admissions and growing home healthcare market. Contract manufacturers specialized in medical products are the major factor behind the growth in demand fo
35、r medical disposables such as syringes and intravenous devices. Hospitals remain the largest source of demand for these products, but home healthcare needs are on the rise for products such as pre-filled inhalers, pre-filled syringes, and dialysis delivery devices. United States and Europe represent
36、 the leading markets in the global special purpose needles but China is the most prospective market in near future. Table 8.1: Global Disposable Medical Plastic market Demand by Application Application 2005 2006 2011 Medical bags 505.96 535.44 671.6 Syringes 356.72 379.04 478.4 Labware 323.96 345.92
37、 441.6 Kits 307.58 329.36 419.52 Catheters/IV units 316.68 329.36 401.12 Tubing 283.92 301.76 388.24 Gloves 214.76 228.16 285.2 Utensils 203.84 215.28 259.44 Trays 161.98 172.96 222.64 Other 191.1 200.56 241.04 Total 2866.5 3037.84 3808.8 Note: Figures are in US$ millions; data is only for disposabl
38、e medical plastic, excluding other medical disposable devices Source: Medical plastics, November 2006, BCC research Worldwide, the medical disposable markets demand for plastic is expected to reach more than US$3.8 billion by 2011, with a combined annual growth rate for injection moulded products ra
39、nging from 4.0-5.5% between 2006 and 2011. Pre-filled syringes accounts for a small portion of the industry which is growing steadily over a period of 5 years from 2003-2007, in 2007 1.2 billion units of pre-filled syringes sold worldwide with a CAGR of 8.7%. This growth was led by increased use of
40、heparin, insulin, vaccines, and biodrugs. In 2008 this growth slowed down with an unnoticeable margin but the future prospect of this market is positive and expected to reach 5 billion units by 2013. The increased use of pre-filled syringes is not only following the general consumer trend of a growi
41、ng demand for convenient and easy-to-use products, it is also driven by the pharmaceutical producers as a consequence of improved safety and the reduction in drug overfills. Medical bags have a strong hold in the market and despite the economic downfall growing with continuous rise in hospital admis
42、sions. By 2013 this market is expected to cross sales of 800 billion units Worldwide. 8.2.2 Outlook in United States Demand for medical disposables in the US is forecast to increase 4.6% annually to US$61 billion in 2013. The best growth opportunities are anticipated for intermittent catheters for u
43、rinary drainage; dry powder inhalers, prefilled syringes and transdermal patches for drug delivery; blood glucose test strips for diabetes monitoring; polymer and biological tissue sealants for wound closure; and daily contact lenses. All of these products offer significant therapeutic, infection pr
44、evention and/or convenience advantages over competitive supplies. Figure 8.1: US. Medical Disposable Forecasted Demand 47.17 48.59 51.75 54 58 61 0 10 20 30 40 50 60 70 20082009F2010F2011F2012F2013F US$ Billions Source: A in addition, several of its currently marketed and well-performing products re
45、ceived regulatory approval for new indications. Also the company has received approvals in additional markets in 2008: The European Commission approved once-daily dosing of 800 mg PREZISTA (darunavir) with low-dose ritonavir as part of combination therapy in treatment-nave adults (those who have nev
46、er taken HIV medication). Acquisitions Strengthening Operations Acquisitions help the company to develop its capability and offerings. Sometimes it helps in entering into a new market or geography. J activities of medical laboratories; activities of blood banks, sperm banks, transplant organ banks;
47、and ambulance transport of patients by any mode of transport including airplanes. 9.2.2 Recent Financials With fiscal 2009 net sales of the company reached to US$10,677.0 million. Companys Medical Devices businesses comprise 57% of its net sales. In fiscal 2008 and 2007, net sales totalled US$5,900
48、million or 57% and US$5,200 million, respectively. Medical Supplies businesses comprise 16% of the net sales and reached to US$1,800 million. Figure 9.2: Covidien Revenue (2005-2009) 9.53 8.31 9.32 10.3610.68 0 2 4 6 8 10 12 20052006200720082009 US$ Billions Note: Year ends on September Source: Comp
49、any Reports 9.2.3 Business Strategies Leveraging Global Structure The company has ample of opportunities to further expand its position outside of the United States. Companys organization and management structure integrate its U.S. and non-U.S. operations and provide its management team with a global perspective. This infrastructure provides opportunities to develop and commercialize new products that meet global needs and can be rapidly launched in multiple markets. Its global organizational focus will allow the company to grow operational sales outsid