《Lifestyle Drugs Market Outlook.pdf》由会员分享，可在线阅读，更多相关《Lifestyle Drugs Market Outlook.pdf（195页珍藏版）》请在三一文库上搜索。
1、HEALTHCARE Lifestyle Drugs Market Outlook Key Indications, Epidemiology, and Emergent Drugs By Isabel Fraser-Moodie ii Isabel Fraser-Moodie Isabel Fraser-Moodie is an analyst within the healthcare practice of Business Insights. She previously worked in competitive intelligence, where she undertook s
2、everal multinational pharmaceutical projects. Her areas of interest are drug discovery, R EU5, Japan, USA 105 Figure 5.10: Geographic market sizes for prescription oral contraceptives by sales revenue, 2006 ($m) 106 Figure 5.11: Promotional spend on top oral contraceptive brands in major markets (EU
3、5, USA), 2006 ($m) 113 ix Figure 5.12: Pipeline for oral contraceptives, 2007 115 Figure 6.13: Geographic market size for erectile dysfunction products by sales revenue, 2006, $m 133 Figure 6.14: Pipeline for erectile dysfunction therapies, 2007 136 Figure 6.15: Possible caused of female sexual dysf
4、unction 142 Figure 6.16: Pipeline for female sexual dysfunction therapies, 2007 145 Figure 7.17: Factors influencing cosmeceutical consumption across the major markets 156 Figure 7.18: Demographics of skin aging concerns 157 Figure 7.19: Pipeline for skin aging therapies, 2007 166 Figure 8.20: Globa
5、l sales of smoking cessation drugs, 2006 ($m) 182 Figure 8.21: Pipeline for smoking cessation products, 2007 186 List of Tables Table 1.1: Distribution channels covered in IMS MIDAS database 39 Table 2.2: Top 10 Alcohol dependency therapies 2007, Growth Metrics 55 Table 2.3: Pipeline analysis; alcoh
6、ol dependence therapies 57 Table 3.4: Drug therapy for common types of alopecia 69 Table 3.5: Top 10 alopecia brands 2007, growth metrics 70 Table 4.6: Classification of overweight, obesity by BMI, waist circumference and associated disease risk 79 Table 4.7: Obesity-linked Genotypes 81 Table 4.8: P
7、rojected prevalence of obesity, 2006-2012 (000s) 83 Table 4.9: Top 10 anti-obesity brands 2007, growth metrics 88 Table 4.10: Obesity pipeline products 95 Table 5.11: Forecast growth of the childbearing population; EU5, US and Japan, 2007-10 (000s) 101 Table 5.12: Top 10 oral contraceptive brands, 2
8、007 ($m) 107 Table 6.13: Common physiological causes of erectile dysfunction 128 Table 6.14: Prevalence of moderate and severe ED in the seven major markets 129 Table 6.15: Top 5 erectile dysfunction brands 2007; growth metrics 134 Table 6.16: Pipeline analysis; female sexual dysfunction (FSD) 147 T
9、able 7.17: Symptoms of skin aging 152 Table 8.18: Factors influencing smoking cessation success 176 Table 8.19: Smoking prevalence; EU5, US, Japan; 2002 177 Table 8.20: Top 10 smoking cessation brands 2007, growth metrics 182 10 Executive Summary 11 Executive Summary Introduction ? Lifestyle drugs e
10、nhance or improve human function in individuals who believe that their problems negatively impact what they would otherwise regard as being normal aspects of everyday living. ? The prescription lifestyle drug market was worth $7846.1m in 2006, growth of 3.44% on 2005 revenues, with the increasing nu
11、mber of Rx to OTC switches underestimating total sales revenues and growth respectively. ? The ability to create new diseases and hence therapy markets, as is currently happening in the area of female sexual dysfunction, will cause the overall lifestyle market to continue expanding in a step-wise fa
12、shion. ? When developing and defining a new lifestyle condition: (a) the disorder must be capable of being clearly defined and diagnosed with reference to measurable characteristics (b) the epidemiology of the condition must be known (c) prospective patients must be capable of being targeted and con
13、vinced of the value of pharmacotherapy. ? Future lifestyle market opportunities lie in ever-narrowing classifications of perceived normality. Thus, predicting future lifestyle conditions requires an understanding of how society will change. ? Three potential strategies are available to pharmaceutica
14、l companies whose lifestyle drugs have failed to achieve the desired reimbursement status. They may work closely with decision-makers to clarify the clinical and cost advantages of a new drug, broker deals with payors to manage the financial risks of reimbursement, or lobby payors to reimburse at th
15、e desired level. 12 Alcohol Dependence ? Drugs which treat Alcohol dependence can be split into therapies targeting alcohol withdrawal syndrome and therapies which promote abstinence. ? Pharmacotherapy is usually administered in combination with behavioral therapy. ? While patient populations are es
16、timated to be high many do not seek treatment or receive behavioral therapy alone. ? Individual drug approval (efficacy trials) and reimbursement have been limiting factors for entry into potential new markets. ? Sales in the US accounted for 40.7% of those across all of the major markets in 2006, w
17、ith the French market responsible for a further 31.4% of sales. ? In addition to being the largest, the US market is also growing at the fastest rate. ? Globally, the best-selling brand is Mercks Campral (Acomprosate) which generated $56.71m in revenue in 2006 and $30.8m over Q1 and Q2 of 2007. ? Ca
18、mpral now controls 53% of market revenues, attributable to its novel (patented) molecular structure, high success and tolerance rates, and successful chronic long- term prescription use. ? The primary limit for sales of alcohol dependency sales across the markets has been regulatory approval. ? Prod
19、uct pipeline is suffering from a lack of novel compounds, with new delivery mechanisms being the primary method pursued in developing new formulations Alopecia ? Alopecia is a condition with complex etiology and several subtypes, each with their own treatment implications, have been identified. 13 ?
20、 Approximately 25% of men will begin to lose their hair by the time they reach 30 years of age, while approximately 66% will have balding hair loss pattern or be bald by the time they reach 60 years of age. ? While many alopecia therapies are sold OTC, across the seven major markets prescription sal
21、es of minoxidil alopecia products generated $423.53m in 2006. ? Finasteride products are available on private prescription. In spite of the market entry of generic substitutes, Merck in the US, the largest market, prior to gaining accreditation the NCQA does not examine services for obesity on any h
22、ealthcare plan. ? Within the EU obesity accounts for up to 6% of total health costs, with indirect costs to the individual (loss of income and productivity etc) being at least twice this. ? The US currently accounts for 53% of the global market for anti-obesity drugs this represents a significant de
23、cline from the share of 65% in 2002. This is mainly due to the lack of reimbursement for anti-obesity drugs in the US with patients not willing to pay out of their own pockets, as well as the shrinking faith in the anti- obesity medication. 14 ? The UK has the second-largest market share at 17% and
24、has experienced growth since 2002. The growth can be explained by the growing potential and actual patient population together with more favorable circumstances in the UK market, namely partial reimbursement of weight-loss drugs. ? Xenical controls 38% of the global market in terms of sales. In spit
25、e of its patent expiration and the decline of 1.2% in revenues of obesity therapies prescribed for that specific indication, 05-06 saw sales revenues for xenical increase by 10%. ? Xenicals success has been attributed to its positive side-effect profile and novel mode of action which guaranteed fast
26、 patient uptake upon launch. Meridia and xenical are both indicated for long-term success. ? Geographical expansions of sales, particularly into the growing Latin American markets, and indication expansion, are the two primary methods being pursued in order to differentiate the product, expand the m
27、arket and promote reimbursement in light of the new indication approval. Oral Contraception ? Only 13.5% of the contraceptive market is derived from non-oral contraceptives, including hormonal implants, injections and intra-uterine systems. ? The oral contraceptive market was worth $4,378.7m in 2006
28、 with the US contributing to 74.4% of sales. ? Within the EU, the German market produced the highest revenues, more than three times that of UK sales. ? The oral contraceptives (OC) market is highly fragmented with a large number of both branded and generic products available. 15 ? The lead product,
29、 Yasmin, controlled 17% of the revenues generated by the sales of contraceptive products in 2006; this has been attributed to its innovative, patented formulation, positive side effect profile and extended indication approval. ? One of the factors limiting market penetration of the newer generation
30、contraceptives has been reimbursement, where older cheaper generics remain favorable with payors. ? Approval of new dosage regimens, delivery mechanisms, and indication expansion have been successful in targeting new patient populations and extending patent protection of innovative formulations, eg.
31、 Yaz, Estrostep Fe. ? In the longer term formulations of progesterone antagonists, presently in the clinical and preclinical phase, have the potential to significantly impact the oral contraceptives market.with improved side effect profiles and patient compliance resulting from the absence of estrog
32、en. ? Recognition of the compliance benefits of continuous use of OCs is growing. It is thought that recentry approved Lybrel (Anya), will be promoted as a as more of a “lifestyle drug”, with a focus on the absence of menstruation and PMT. Sexual Dysfunction ? With the erosion of social stigmas, pre
33、senting cases of both male and female sexual dysfunction are increasing. ? In the UK, the average incidence of erectile dysfunction increased gradually over the mid-1990s before rising two-fold to three-fold in the 1998-2000 period across all age groups. This followed the introduction sildenafil ont
34、o the market. ? The ability to self-diagnose creates further patient-defined unmet needs; recent studies have indicated that across the major markets between 10-25% of males aged 25-75 report erection difficulties. 16 ? Prevalence of diseases recognized as co-factors in the development of sexual dys
35、function disorders; obesity, hypertension, diabetes, depression and cardiovascular disease, have all been rising. ? Sales of prescription formulations generated $2,140m in 2006, with the US accounting for 66.8% of these revenues. ? Year on year revenue growth was most significant across the EU5 mark
36、ets, at 13% (05-06) compared with US market growth of 7.7%. ? In spite of declining sales in the run up to patent expiration, Pfizers Viagra still controls 50.9% of the market. This is largely due to strong brand recognition which is expected to inhibit market growth of newer PDE inhibitor therapies
37、, at least in the short term. ? In June 2007 Eli Lilly announced that it had gained EMEA approval for a once daily version of its successful PDE-5 inhibitor treatment Cialis (tadalafil). ? Whilst a number of different drug compounds are under investigation, current treatment approaches for female se
38、xual dysfunction (FSD) include patient education on healthy female sexual function, counselling on the psychosocial aspects of the disorder, non-prescription remedies and off-label prescribing of medications. Skin Aging ? For the past decade anti-aging products have comprised the fastest growing sec
39、tor of the worldwide cosmeceutical market, with skincare cosmeceuticals now accounting for 80% of the total US and European cosmeceutical sales by revenue; ? The EU5 and US markets for skincare were estimated to be worth $6,590m in 2006, with a projected value of $8,486m by 2011; 17 ? Across all of
40、the markets, the two key groups which stood out as having spent more time on their appearance in 2006 were females and young adults/ early mid-lifers; ? As societies age, the fear of visible signs of aging will have the greatest influence on cosmeceutical products; ? Neither Renova nor Retin-A nor B
41、otox were originally developed for the treatment of skin ageing per se. However, these products have been found to be effective for some of the symptoms of skin aging, and are increasingly being used off-label; ? The FDA tightly controls the way in which Renova is marketed, since there have been pri
42、or disputes concerning the promotion of Retin-A by J ? Sales of Retin-A products for J ? In spite of EMEA warnings, global sales are set to rise and are forecast by Allergan to amass $1.1bn globally by 2007 year end for Botox and Vistabel collectively. ? Lack of consumer trust remains a market barri
43、er, particularly with respect to the potential untargeted patient populations; Smoking Cessation ? According to the World Health organization there were 1.3 billion smokers worldwide, the majority of whom (80%) reside in developing countries. ? The US is the largest market in terms of potential and
44、actual patients, with 22.3% of the population qualifying as smokers. ? The US market for smoking cessation therapies generated sales of $320.8m in 2006; this amounts to 44.9% of combined sales in the top seven markets. 18 ? Despite only having been launched in 2006, Champix generates the highest Rx
45、product sales revenues, accounting for 50% of total revenues across the market. ? Pfizer, during the launch of Champix, launched an extensive marketing campaign directly targeting GPs, smoking cessation therapists, cardiologists and lung specialists. ? Since the imposition of smoking bans across Eur
46、ope, sales of nicotine replacement therapies have been rising. ? Unmet needs in the nicotine abuse market revolve around the deficiency of neurological treatments for the condition, a direct effect of the lack of knowledge about the physiological basis of addiction. ? Future drug therapies need to i
47、mitate the effects of smoking more accurately. Increasing the speed at which drug therapy replicates the effects of smoking will reduce the risk of relapse due to withdrawal symptoms. Increasing the ease with which nicotine can be titrated will allow self-medicating patients to increase the effectiv
48、eness of tapering strategies. ? Vaccines that prevent nicotine entering the brain have the greatest potential to revolutionize the nicotine addiction market but are only in early-stage trials. Celtic Pharmas TA-NIC requires a short course of injections to induce antibody responses, before being effe
49、ctive for up to nine months. 19 CHAPTER 1 Introduction 20 Chapter 1 Introduction Summary ? Lifestyle drugs enhance or improve human function in individuals who believe that their problems negatively impact what they would otherwise regard as being normal aspects of everyday living. ? The prescription lifestyle drug market was worth $7846.1m in 2006, growth of 3.44% on 2005 revenues, with the increasing number of Rx to OTC switches underestimating total sales revenues and growth respectively. ? The ability to create new diseases and hence therapy markets, as is currently hap