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1、THE GLOBAL ANTI-INFECTIVES MARKET OUTLOOK TO 2011 By Fox Analytics ii Fox Analytics Fox Analytics brings together experienced private consultants working in the field of market research, analysis, modeling and forecasting in order to deliver custom solutions, insights and analysis in pharmceuticals
2、and healthcare markets. Copyright 2006 Business Insights Ltd This Management Report is published by Business Insights Ltd. All rights reserved. Reproduction or redistribution of this Management Report in any form for any purpose is expressly prohibited without the prior consent of Business Insights
3、Ltd. The views expressed in this Management Report are those of the publisher, not of Business Insights. Business Insights Ltd accepts no liability for the accuracy or completeness of the information, advice or comment contained in this Management Report nor for any actions taken in reliance thereon
4、. While information, advice or comment is believed to be correct at the time of publication, no responsibility can be accepted by Business Insights Ltd for its completeness or accuracy. iii Table of Contents Anti-infectives Market Outlook to 2011 Executive Summary 14 Patient potential 14 Global mark
5、et analysis 15 Pipeline analysis 16 Competitive landscape 17 Chapter 1 Epidemiology of Anti-infectives market 20 Summary 20 Introduction 21 Bacterial infections 22 Overview 22 Respiratory tract infections 22 Urinary tract infections 23 Skin and skin structure infections 23 Diagnosis, treatment and m
6、anagement 25 Respiratory tract infections 25 Urinary tract infections 26 Skin and skin structure infections 26 Epidemiology 27 Respiratory tract infections 27 Urinary tract infections 28 Skin and skin structure infections 30 Forecast epidemiology 30 Respiratory tract infections 31 Urinary tract infe
7、ctions 33 Skin and skin structure infections 35 Viral infections 36 Hepatitis 36 Overview 36 Diagnosis, treatment and management 37 Epidemiology 39 iv Forecast epidemiology 40 Influenza 43 Overview 43 Diagnosis, treatment and management 44 Epidemiology 46 Forecast epidemiology 46 Herpes 47 Overview
8、47 Diagnosis, treatment and management 49 Epidemiology 51 Forecast epidemiology 53 Vaccines 55 Tetanus, diphtheria, pertussis 55 Overview 55 Diagnosis, treatment and management 56 Epidemiology 57 Mumps, measles and rubella 58 Overview 58 Diagnosis, treatment and management 59 Epidemiology 60 Polio 6
9、1 Overview 61 Diagnosis, treatment and management 62 Epidemiology 63 Fungal infections 63 Overview 63 Diagnosis, treatment and management 64 Epidemiology 65 Forecast epidemiology 66 Chapter 2 Global market analysis 70 Summary 70 Introduction 71 Market analysis by country 72 Licensing trends 73 Marke
10、t analysis by drug class 74 Leading brands dynamics 77 Key events in the anti-infectives market 81 Safety warning issued for Sanofi-Aventis Ketek (telithromycin) 81 Serious adverse effects reported with the use of penicillins 81 Launch of new innovative class of drugs 81 Wyeths Prevnar gains from be
11、ing the first vaccine to reach blockbuster status in 2005 82 Increased competition within the hepatitis B market 82 v Arrival of generic competition to market leading products in the anti- infectives market 83 Anti-virals 84 Leading brands of anti-viral treatments 85 Key brands analysis 87 Anti-Vira
12、ls sales forecasts to 2011 95 Vaccines 96 Key brands analysis 98 Vaccines sales forecasts to 2011 106 Anti-bacterials 107 Market analysis by drug class 107 Leading brands of anti-bacterial treatments 109 Macrolides 112 Key brands analysis 113 Beta-lactams 119 Key brands analysis 120 Other anti-bioti
13、cs 125 Key brand analysis 126 Penicillins 134 Market dynamics 134 Key brands analysis 136 Cephalosporins market analysis 143 Market dynamics 143 Key brands analysis 144 Tetracyclines market analysis 149 Market dynamics 149 Key brands analysis 150 Fluroquinolones 152 Market dynamics 152 Key brands an
14、alysis 153 Anti-bacterials sales forecasts to 2011 160 Anti-fungals 163 Market analysis by drug class 163 Leading brands of the anti-fungal market 164 Market dynamics 164 Key brands analysis 167 Anti-fungals sales forecasts to 2011 176 Total anti-infective market sales forecasts to 2011 177 Chapter
15、3 Pipeline analysis 180 Summary 180 Introduction 181 Key trends in R ERS 2002; Hak et al., 2005; UK HPA, 2007; CDC 2007; WHO 2007; Eurosurveillance 2007; Viegi et al., 2006; various other sources Business Insights Ltd There is limited comparable data across bacterial species causing respiratory trac
16、t infections, although data points to wide variation across countries, even in the context of Western Europe. The incidence of some forms of pneumonia, is variable among the population at large over longitudinal studies according to disease surveillance measures, but higher risk populations are cons
17、idered to be the elderly, children, immunocompromized, and individuals in the institutional setting. 28 For infections of the upper respiratory tract, an estimated 95-100% of individuals acquire at least one upper respiratory tract infection each year, although the vast majority of these infections
18、are viral in nature. The estimated incidence of upper respiratory bacterial infections, using the most common pathogen, streptococcus, is summarized in the table below. Table 1.3: Estimated incidence of uRTIs caused by streptococcus infection across seven major markets, 2005 Country Incidence (000s)
19、 Incidence (%) Share in 2005 (%) France 9,455 15.6% 8.4% Germany 12,386 15.0% 11.0% Italy 8,623 14.8% 7.7% Spain 6,030 14.9% 5.4% UK 9,390 15.5% 8.4% EU5 45,884 15.2% 40.9% US 47,215 16.0% 42.1% Japan 19,020 14.9% 17.0% Total 112,118 15.6% 100.0% Source: Principi et al., 1990; UK HPA, 2007; CDC 2007
20、; WHO 2007; Hak et al., 2005; Eurosurveillance 2007; various other sources Business Insights Ltd Due to a lack of comprehensive studies, and the low rates reporting, diagnosis and treatment which are associated with pharyngitis, it is difficult to estimate the incidence of the disease. Therefore est
21、imates are based on US studies, adjusted for demographics in order to reflect the increased incidence of pharyngitis among children as opposed to adults. Age and annual climatic conditions represent the most significant risk factors for an increased annual incidence of pharyngitis, of which only a s
22、mall proportion (approximately 15-20%), are caused by streptococcus species. Urinary tract infections Estimates of the incidence of urinary tract infections across the seven major markets are summarized in Table 1.4 below. 29 Table 1.4: Estimated incidence of community acquired urinary tract infecti
23、ons across seven major markets, 2005 Country Incidence (000s) Incidence (%) Share in 2005 (%) France 6,771 11.2% 9.9% Germany 10,022 12.2% 14.7% Italy 6,793 11.7% 9.9% Spain 4,817 11.9% 7.1% UK 6,687 11.1% 9.8% EU5 35,090 11.6% 51.4% US 21,455 7.3% 31.4% Japan 11,770 9.2% 17.2% Total 68,315 9.4% 100
24、.0% Source: Stamm et al., 2001; Kunin et al., 1997; Bouza et al., 2001; UK HPA, 2007; CDC 2007; WHO 2007; Eurosurveillance 2001; Foxman et al., 2002; various other sources Business Insights Ltd The prevalence of urinary tract infections is estimated to be similar among the seven major markets, altho
25、ugh due to a greater incidence of the condition in the elderly, the institutionalized, patients using a catheter, and women, incidence rates vary from country to country. In community acquired urinary tract infections, age and gender are the most important determinants of the incidence of the condit
26、ion, which favors countries with the highest number of elderly, such as Germany Spain and Italy. 30 Skin and skin structure infections Estimates of the incidence of skin and skin structure infections across the seven major markets are summarized in Table 1.5 below. Table 1.5: Estimated incidence of
27、bacterial skin and skin structure infections across seven major markets, 2005 Country Incidence (000s) Incidence (%) Share in 2005 (%) France 2,548 4.2% 8.4 Germany 3,462 4.2% 11.4 Italy 2,440 4.2% 8.0 Spain 1,994 4.2% 5.6 UK 2,539 4.2% 8.3 EU 5 12,683 4.2% 41.6 US 12,421 4.2% 40.8 Japan 5,352 4.2%
28、17.6 Total 29,005 4.2% 100.0 Figures not inclusive of acne Source: UK HPA, 2007; CDC 2007; WHO 2007; Eurosurveillance 2007 Business Insights Ltd There is limited epidemiological data available on skin and skin structure infections due to the wide range of conditions, and difficulties in detection an
29、d surveillance except in the hospital setting and in patients which have been afflicted by rare conditions such as necrotizing infections. However, the incidence of skin and skin structure infections is more believed to be more common in children, the elderly and institutionalized patients, particul
30、arly those that feature limited levels of mobility, although there are no studies available to assess the incidence of the sub-indications within this category by country and by demographic. Forecast epidemiology This section provides forecasts on the incidence of the three major bacterial infection
31、s that are analyzed in this report. 31 Respiratory tract infections Table 1.6 summarizes the forecast incidence of CAP over the period 2005-11. Table 1.6: Forecast epidemiology of CAP across the seven major markets, 2005-11 Country 2005 2006(f) 2007(f) 2008(f) 2009(f) 2010(f) 2011(f) France Incidenc
32、e (000s) 567 570 572 574 577 579 582 Incidence rate (%) 0.94% 0.94% 0.94% 0.94% 0.94% 0.94% 0.94% Germany Incidence (000s) 1,022 1,023 1,025 1,026 1,027 1,028 1,030 Incidence rate (%) 1.24% 1.24% 1.24% 1.24% 1.25% 1.25% 1.25% Italy Incidence (000s) 543 544 546 547 548 549 550 Incidence rate (%) 0.94
33、% 0.94% 0.94% 0.94% 0.94% 0.94% 0.94% Spain Incidence (000s) 355 356 357 358 359 360 361 Incidence rate (%) 0.88% 0.88% 0.88% 0.88% 0.89% 0.89% 0.89% UK Incidence (000s) 465 467 469 471 473 474 476 Incidence rate (%) 0.77% 0.77% 0.77% 0.77% 0.77% 0.77% 0.77% EU Incidence (000s) 2,953 2,961 2,968 2,9
34、76 2,984 2,992 2,999 Incidence rate (%) 0.98% 0.98% 0.98% 0.98% 0.98% 0.98% 0.98% US Incidence (000s) 3,253 3,287 3,321 3,355 3,389 3,424 3,459 Incidence rate (%) 1.10% 1.10% 1.10% 1.10% 1.10% 1.11% 1.11% Japan Incidence (000s) 841 842 844 845 847 848 850 Incidence rate (%) 0.66% 0.66% 0.66% 0.66% 0
35、.66% 0.66% 0.66% Total Incidence (000s) 7,047 7,090 7,133 7,176 7,220 7,264 7,308 Incidence rate (%) 0.97% 0.97% 0.97% 0.98% 0.98% 0.98% 0.98% Source: Arch. Intern. Med., 1997; ERS 2002; Hak et al., 2005; UK HPA, 2007; CDC 2007; WHO 2007; Eurosurveillance 2007; Viegi et al., 2006; Principi et al., 1
36、990; UK HPA, 2007; CDC 2007; WHO 2007; Hak et al., 2005; various other sources Business Insights Ltd There is an absence of factors exerting an influence on any one national market among the seven major pharmaceutical markets and as such, forecasts of the incidence of 32 upper and lower respiratory
37、tract infections are forecast to remain in line with demographic changes over the forecast period, with the largest populations present in the US, Germany and Japan, and with Germany and Italy forecast to maintain the highest incidence rates of the major markets. Table 1.7 summarizes the forecast in
38、cidence of upper respiratory tract infections over the period 2005-11. Table 1.7: Forecast epidemiology of uRTIs caused by streptococcus infection across the seven major markets, 2005-11 Country 2005 2006(f) 2007(f) 2008(f) 2009(f) 2010(f) 2011(f) France Incidence (000s) 9,455 9,505 9,548 9,591 9,63
39、4 9,677 9,721 Incidence rate (%) 15.6% 15.6% 15.6% 15.6% 15.6% 15.7% 15.7% Germany Incidence (000s) 12,386 12,384 12,404 12,424 12,444 12,464 12,484 Incidence rate (%) 15.0% 15.0% 15.0% 15.1% 15.1% 15.1% 15.1% Italy Incidence (000s) 8,623 8,614 8,629 8,643 8,658 8,673 8,687 Incidence rate (%) 14.8%
40、14.8% 14.8% 14.8% 14.9% 14.9% 14.9% Spain Incidence (000s) 6,030 6,026 6,041 6,056 6,071 6,086 6,102 Incidence rate (%) 14.9% 14.9% 14.9% 14.9% 15.0% 15.0% 15.0% UK Incidence (000s) 9,390 9,406 9,444 9,481 9,519 9,557 9,596 Incidence rate (%) 15.5% 15.5% 15.5% 15.6% 15.6% 15.6% 15.6% EU Incidence (0
41、00s) 45,884 45,935 46,065 46,196 46,326 46,458 46,589 Incidence rate (%) 15.2% 15.2% 15.2% 15.2% 15.2% 15.3% 15.3% US Incidence (000s) 47,215 47,815 48,317 48,825 49,339 49,857 50,374 Incidence rate (%) 16.0% 16.0% 16.0% 16.1% 16.1% 16.1% 16.1% Japan Incidence (000s) 19,020 19,004 19,023 19,042 19,0
42、61 19,080 19,099 Incidence rate (%) 14.9% 14.9% 14.9% 14.9% 14.9% 14.9% 14.9% Total Incidence (000s) 112,118 112,754 113,406 114,063 114,726 115,395 116,063 Incidence rate (%) 15.5% 15.5% 15.5% 15.5% 15.5% 15.6% 15.6% Source: Arch. Intern. Med., 1997; ERS 2002; Hak et al., 2005; UK HPA, 2007; CDC 20
43、07; WHO 2007; Eurosurveillance 2007; Viegi et al., 2006; Principi et al., 1990; UK HPA, 2007; CDC 2007; WHO 2007; Hak et al., 2005; various other sources Business Insights Ltd 33 The US, Japan and Germany are forecast to feature the largest patient populations for uRTIs over the forecast period, wit
44、h the highest incidence rates forecast to continue to be in the US, France and the UK. The total incidence in 2011 of uRTIs is forecast at $116m. Urinary tract infections Table 1.8: Forecast epidemiology of urinary tract infections across the seven major markets, 2005-11 Country 2005 2006(f) 2007(f)
45、 2008(f) 2009(f) 2010(f) 2011(f) France Incidence (000s) 6,771 6,810 6,849 6,888 6,927 6,967 7,006 Incidence rate (%) 11.2% 11.2% 11.2% 11.2% 11.3% 11.3% 11.3% Germany Incidence (000s) 10,022 10,053 10,084 10,116 10,147 10,178 10,210 Incidence rate (%) 12.2% 12.2% 12.2% 12.3% 12.3% 12.3% 12.4% Italy
46、 Incidence (000s) 6,793 6,819 6,844 6,869 6,895 6,920 6,946 Incidence rate (%) 11.7% 11.7% 11.8% 11.8% 11.8% 11.9% 11.9% Spain Incidence (000s) 4,817 4,838 4,860 4,882 4,904 4,926 4,948 Incidence rate (%) 11.9% 12.0% 12.0% 12.0% 12.1% 12.1% 12.2% UK Incidence (000s) 6,687 6,719 6,751 6,784 6,816 6,8
47、49 6,882 Incidence rate (%) 11.1% 11.1% 11.1% 11.1% 11.2% 11.2% 11.2% EU Incidence (000s) 35,090 35,239 35,388 35,538 35,689 35,840 35,992 Incidence rate (%) 11.6% 11.7% 11.7% 11.7% 11.7% 11.8% 11.8% US Incidence (000s) 21,455 21,674 21,895 22,119 22,344 22,572 22,800 Incidence rate (%) 7.3% 7.3% 7.
48、3% 7.3% 7.3% 7.3% 7.3% Japan Incidence (000s) 11,770 11,811 11,853 11,894 11,936 11,977 12,019 Incidence rate (%) 9.2% 9.3% 9.3% 9.3% 9.3% 9.4% 9.4% Total Incidence (000s) 68,315 68,724 69,136 69,551 69,969 70,390 70,811 Incidence rate (%) 9.4% 9.4% 9.4% 9.5% 9.5% 9.5% 9.5% Source: Stamm et al., 200
49、1; Kunin et al., 1997; Bouza et al., 2001; UK HPA, 2007; CDC 2007; WHO 2007; Eurosurveillance 2001; Foxman et al., 2002; various other sources Business Insights Ltd 34 Table 1.8 summarizes the forecast incidence of urinary tract infections over the period 2005-11. There is an absence of factors exerting an influence on any one national market among the seven major pharmaceutical markets and as such, forecasts of the i