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1、THE ASTHMA, COPD 20 ? Through controlling the chronic inflammatory process drugs are taken daily on a long-term basis and include anti-inflammatory agents and long-acting bronchodilators. SABA therapy may be taken as needed to relieve asthma symptoms, whilst daily anti- inflammatory therapy is only
2、necessary for patients with persistent asthma. In mild persistent asthmatics, an inhaled steroid such as fluticasone or budesonide is recommended, or a leukotriene antagonist (LTA), such as montelukast. For patients with moderate or severe asthma, higher doses of inhaled steroid are recommended in c
3、ombination with a long-acting beta2 agonist (LABA), such as salmeterol or formoterol. These therapies, commonly delivered as fixed combinations, have transformed the asthma market since their launch, displacing inhaled corticosteroid (ICS) monotherapies, which were the principal class of anti-inflam
4、matory products. The addition of a leukotriene antagonist, such as montelukast, may improve asthma control in patients remaining symptomatic with inhaled corticosteroid therapy (with or without a LABA). The use of leukotriene antagonists is estimated to be higher in patients with mild intermittent a
5、sthma and patients that have severe persistent asthma than in other disease categories, but with limited use in other disease segments. The prominent use of leukotriene antagonists as first-line treatments is largely due to the requirements of pediatric patients, as steroid use in children is often
6、viewed unfavorably by physicians due to its potential to interfere with ocular function and normal bone growth. An incremental stepwise approach to controlling asthma is recommended by current treatment guidelines, with emphasis on physicians taking opportunities to reduce the number of asthma medic
7、ations that a patient requires to control the disease. A reduction in medication can only be achieved through the long-term control of a patients asthma, but such opportunities are rare unless environmental triggers can be eliminated. Therefore patients tend to be prescribed medications on a continu
8、ous basis, or in the case of an exacerbation, are prescribed an additional medication. This treatment pattern therefore creates a distinct pattern of prescriptions. 21 Figure 1.2 below illustrates typical treatment patterns for the most prescribed drug classes associated with asthma in the seven maj
9、or pharmaceutical markets. Figure 1.2: Typical treatment patterns in the treatment of asthma Short-acting beta-2 agonist Low-dose ICS or LTA Short-acting beta-2 agonist Low-dose ICS Short-acting beta-2 agonist Long-acting beta-2 agonist or LTA Short-acting beta-2 agonist High-dose ICS Long-acting be
10、ta-2 agonist Theophylline, LTA or anticholinergic Short-acting beta-2 agonist High-dose ICS Long-acting beta-2 agonist Theophylline, LTA or anticholinergic Oral prednisolone Disease Progression Mild episodicMild persistent Mild/Moderate persistent Moderate persistent Severe persistent Short-acting b
11、eta-2 agonist Low-dose ICS or LTA Short-acting beta-2 agonist Low-dose ICS Short-acting beta-2 agonist Long-acting beta-2 agonist or LTA Short-acting beta-2 agonist High-dose ICS Long-acting beta-2 agonist Theophylline, LTA or anticholinergic Short-acting beta-2 agonist High-dose ICS Long-acting bet
12、a-2 agonist Theophylline, LTA or anticholinergic Oral prednisolone Disease Progression Mild episodicMild persistent Mild/Moderate persistent Moderate persistent Severe persistent ICS = inhaled corticosteroids; LTA = leukotriene antagonists Source: Authors research and analysis Business Insights Ltd
13、The mainstays of asthma treatment regardless of disease severity are inhaled corticosteroids and short-acting beta-2 agonists, with a trend towards increasing use of other drugs as disease severity increases. Although the most common first-line therapies are SABAs and ICS treatments, in patients tha
14、t have failed to respond to therapy, SABAs are sometimes dropped from a patients treatment regimen in order to promote patient compliance. According to the British asthma treatment guideline, it is estimated that the use of SABAs is at the highest in mild intermittent asthma patients, where an estim
15、ated 68% of patients are treated with SABAs, whilst in severe persistent asthma patients, the proportion of patients treated with SABAs drops to 57%. 22 Epidemiology Across the seven major pharmaceutical markets, it is observed that there is moderate variation in prevalence, although these levels of
16、 variation do not appear to be positively correlated with levels of industrialization/urbanization or lifestyle factors in the countries analyzed. Estimates on the prevalence of asthma are detailed in Table 1.1. Table 1.1: Estimated prevalence of asthma in across seven major markets, 2005 Country Pr
17、evalence (000s) Prevalence (%) Share in 2005 (%) France 5,156 8.5 9.7 Germany 5,226 6.3 9.8 Italy 3,777 6.5 7.1 Spain 2,663 6.6 5.0 UK 7,253 12.0 13.6 EU5 24,074 8.0 45.3 US 19,814 6.7 37.3 Japan 9,301 7.3 17.5 Total 53,190 7.7 100.0 Source: NHIS 2003, LAIA 2003 Business Insights Ltd Within the seve
18、n major markets, it is estimated that some 53.2m individuals suffer from asthma, with the US carrying the highest disease burden due its large population, accounting for a 37.3% share of the entire patient population in 2005. While considering the prevalence rates of asthma across the seven countrie
19、s, it is observed that the UK has the highest prevalence rate of asthma, estimated at 12.0% in 2005. The causes of the UKs high estimated prevalence of asthma are not known, with limited differentiation between urban and rural areas. Instead it is suggested that the increased prevalence of asthma ma
20、y be due to more accurate recognition of symptoms of asthma that has corresponded to an increase in diagnosed prevalence over the past two decades. Environmental change may also be a risk factor promoting an increase in the prevalence of asthma, as may be obesity, physical inactivity and the decreas
21、es in the level of breast-feeding of infants, although none of these factors are backed by conclusive proof. High estimated prevalence rates in Japan and France are also not easy 23 to explain except through levels of urbanization and environmental change. Table 1.2 forecasts the prevalence of asthm
22、a to 2011 across the seven markets. Table 1.2: Forecast epidemiology of asthma across the seven major markets, 2005-11 Country 2005 2006(f) 2007(f) 2008(f) 2009(f) 2010(f) 2011(f) France Prevalence (000s) 5,156 5,219 5,283 5,347 5,413 5,479 5,546 Prevalence rate (%) 8.5 8.5 8.6 8.6 8.6 8.6 8.7 Germa
23、ny Prevalence (000s) 5,226 5,348 5,473 5,601 5,731 5,865 6,002 Prevalence rate (%) 6.3 6.4 6.5 6.6 6.7 6.8 6.9 Italy Prevalence (000s) 3,777 3,815 3,854 3,894 3,933 3,973 4,014 Prevalence rate (%) 6.5 6.5 6.5 6.5 6.5 6.5 6.5 Spain Prevalence (000s) 2,663 2,690 2,717 2,745 2,773 2,801 2,830 Prevalenc
24、e rate (%) 6.6 6.6 6.6 6.6 6.6 6.6 6.6 UK Prevalence (000s) 7,253 7,393 7,536 7,681 7,829 7,980 8,134 Prevalence rate (%) 12.0 12.1 12.2 12.4 12.5 12.6 12.7 EU Prevalence (000s) 24,074 24,465 24,862 25,267 25,679 26,098 26,525 Prevalence rate (%) 8.0 8.0 8.1 8.1 8.2 8.2 8.3 US Prevalence (000s) 19,8
25、14 20,116 20,423 20,735 21,051 21,372 21,698 Prevalence rate (%) 6.7 6.7 6.8 6.8 6.9 6.9 6.9 Japan Prevalence (000s) 9,301 9,500 9,702 9,909 10,120 10,336 10,556 Prevalence rate (%) 7.3 7.4 7.5 7.6 7.7 7.7 7.8 Total Prevalence (000s) 53,190 54,081 54,988 55,911 56,850 57,807 58,780 Prevalence rate (
26、%) 7.7 7.8 7.8 7.9 7.9 8.0 8.0 Source: NHIS 2003, LAIA 2003 Business Insights Ltd The estimated prevalence of asthma is forecast to modestly increase at a CAGR of 1.7% over the 2006-11 period, increasing from 53.1m individuals in 2005 to 58.8m individuals in 2011. The prevalence of asthma is forecas
27、t to continue to be driven by 24 increasing patient populations in Germany, Japan and the UK, countries which are all forecast to feature the highest rates of increase in the prevalence rate of asthma. Net growth in prevalence to 2011 is forecast to be 10.2% across the EU5, 13.5% in Japan, and 9.5%
28、in the US, resulting in an overall growth in the net prevalence of 10.5% Chronic Obstructive Pulmonary Disease (COPD) Overview Chronic Obstructive Pulmonary Disease (COPD) is a chronic, slowly progressive disorder resulting from decreased respiratory function mainly caused by airway obstruction (FEV
29、1 4 days/week 4 weeks at a time Severity of symptoms Frequency of symptoms Mild Moderate to severe Mild Moderate to severe Severity of symptoms INTERMITTENT Symptoms present for 4 days/week 4 weeks at a time Severity of symptoms Frequency of symptoms Mild Moderate to severe Mild Moderate to severe S
30、everity of symptoms Source: ARIA Guidelines Business Insights Ltd Further clarification of the cause of the allergy can be achieved through use of a skin test that subjects the patient to common allergens in order to identify which triggers are responsible for the symptoms of the disease. Testing fo
31、r AR is undertaken to determine the presence of allergen-specific IgE and also to confirm which allergens are relevant to the symptoms and which therapeutics should be included in immunotherapy 32 regimens. If a skin test cannot be performed, a radioallergosorbent blood test (RAST) may be taken, alt
32、hough its results are often not as accurate as a skin test. First-line treatment for AR remains the identification and avoidance of provoking allergens, together with the use of decongestants and second-generation antihistamines, while second-line therapy includes corticosteroids (intranasal/oral/in
33、jected), LTAs and anticholinergics. Immunotherapy constitutes the third line treatment for AR but is seldom prescribed due to cost. The treatment paradigm for AR is summarized in Figure 1.5. Figure 1.5: Treatment of allergic rhinitis across different stages of disease progression Disease Progression
34、 Mild IntermittentModerate/Severe Intermittent Mild Persistent Moderate/Severe Persistent Allergen and irritant avoidance Second generation Antihistamines Intranasal decongestant Intranasal Corticosteroid Leukotriene-receptor antagonist/Anticholinergic agent/Oral and injected depot Corticosteroid Al
35、lergen Immunotherapy Disease Progression Mild IntermittentModerate/Severe Intermittent Mild Persistent Moderate/Severe Persistent Allergen and irritant avoidance Second generation Antihistamines Intranasal decongestant Intranasal Corticosteroid Leukotriene-receptor antagonist/Anticholinergic agent/O
36、ral and injected depot Corticosteroid Allergen Immunotherapy Source: ARIA Guidelines, N ENGL J MED 353; 18, 2005 Business Insights Ltd Either an oral antihistamine or a nasal corticosteroid alone is typically sufficient to improve mild symptoms of AR. For patients with moderate-to-severe symptoms of
37、 AR, the therapy should generally be started with the daily use of a nasal corticosteroid, which would typically be combined with a second-generation oral antihistamine. To achieve results, this therapy should be started before the anticipated appearance of allergens and continue during the time of
38、likely exposure. 33 The management of allergic rhinitis includes allergen avoidance, medication (pharmacological treatment), immunotherapy and awareness. Although allergen avoidance is included in the treatment plan for allergic rhinitis, the major challenge is to create a low allergen environment i
39、n patients homes. However, the majority of single interventions have failed to achieve a sufficient reduction in allergen load to lead to a clinical improvement. A wide range of allergens have been associated with allergic rhinitis, of which house dust mites are the most important and most investiga
40、ted. Otherwise, any airborne biological particles, such as dander from animals, material from excreta, bacteria and viruses, fungal spores and pollen, can be the trigger in both indoor and outdoor locations. Outdoor allergens, such as pollens and fungal spores, are more difficult to avoid and as suc
41、h represent a major contributor to the disease burden. Moreover, the magnitude of the reduction of allergen load needed to reduce symptoms is still unclear. Hence, though allergen avoidance measures are still recommended, more research is strongly needed in this area. Medications used for AR have no
42、 long-lasting effect when stopped, especially in persistent stages of the disease. Most commonly medications are administered intranasally or orally, although in exceptional circumstances, they may be administered intramuscularly. Antihistamines, the mainstay treatment of allergic rhinitis, substant
43、ially reduce symptoms of nasal itching and watery eyes and have moderate but clinically and statistically significant effects in reducing rhinorrhea and sneezing. However, although first-generation antihistamines are clinically effective, their use is limited by their anticholinergic and sedative ef
44、fects. More recently, second-generation antihistamines lacking substantial sedative properties have largely supplanted the earlier drugs. For moderate-to-severe AR, nasal corticosteroids are mostly considered safe as first line therapy while for mild, intermittent symptoms lasting a few hours to a f
45、ew days, an oral second generation antihistamine, such a cetirizine, loratadine or fexofenadine, are prescribed on an as-needed basis owing to their safety and ease of use. Combination therapy with antihistamines and nasal corticosteroids is viewed as being superior to nasal corticosteroids alone in
46、 treating patients with moderate or severe symptoms 34 because antihistamines and nasal corticosteroids influence different pathogenetic mechanisms of action. The leukotriene-receptor antagonist, montelukast, is used as an adjunct in the treatment of patients who do not adequately respond to an anti
47、histamine, a nasal corticosteroid, or both. A mast-cell stabilizer or cromolyn may be more effective when administered just before exposure to an allergen and is available over the counter for intranasal use. However, patients with severe symptoms not responding to or intolerant of other medications
48、 may be treated with either oral or injected corticosteroids. Immunotherapy, viewed as a third-line treatment, is recommended for patients with moderate-to-severe symptoms following a lack of efficacy with prior systemic corticosteroid therapy or in patients exhibiting an inadequate response to the
49、recommended doses of nasal corticosteroids, or who have comorbid conditions such as sinusitis, asthma, or both. Epidemiology The prevalence of AR is highest among the three major respiratory indications, and is estimated to affect some 150m individuals in the seven major markets. This prevalence may even be underestimated, as many patients do not recognize AR as a disease, particularly in its seasonal form, and therefore do not consult a physician. In the past few years, an increasing prevalence of AR has been recognized an