Lifestyle Drugs Market Outlook Key Indications, Epidemiology, and Emergent Drugs

Executive Summary 11

Introduction 11
Alcohol Dependence 12
Alopecia 12
Obesity 13
Oral Contraception 14
Sexual Dysfunction 15
Skin Aging 16
Smoking Cessation 17

Summary 20
Introduction 21
Defining the Market 21

Defining Lifestyle Conditions 22
Social Characteristics 24
Disease characteristics 25
Product Characteristics 25

High demand upon launch 27
Ability to create new markets 28

An aging population 30
Growth in disposable income 30
Increasing consumer awareness 30
Rise in branding activities 31

Demonstrating favorable health economics to payors – the road to rationing 33
Drug abuse and misuse 34
Loss of corporate control over brand 35

Recommendations for securing reimbursement of lifestyle drugs 37

Gender Influence 48
Genetic Influence 49

Disulfiram (Aldehyde Dehydrogenase Inhibitor) 52
Naltrexone 53
Benzodiazepines 53
Sodium Oxybate 53
Acamprosate 53
Metadoxine 54

Campral (Acamprosate) 55
Antabuse 56
Naltrexone Therapies 56

Alopecia areata 62
Androgenetic alopecia 63
Anagen effluvium 64
Telogen effluvium 64
Scarring alopecia 65
Self-induced alopecia 65
Other causes 65

Propecia 70
Rogaine (minoxidil) 72

Age and Gender Influence 80
Genetic Influence 81
Nutritional Influence 82

Xenical 89
Reductil/Meridia/Ectiva (sibutramine) 90
Acomplia (Rimobant) 92

Novel Mechanisms 95

Side Effect Profile 102

The Yasmin Franchise 107
Ortho Tri-cyclen Lo 109
Estrostep Fe 110

Ortho Evra 110
Mirena 111
Seasonale 111

Pathophysiology & diagnostic indicators 123
Erectile dysfunction (ED) 123
Loss of libido 124
Priapism 125
Peyronie’s disease 125
Premature and delayed ejaculation 126

PDE-5 Inhibitors 132
Alprostadil 132

Viagra 134
Cialis 134
Levitra 135

Delivery Mechanism 136
Niche Markets 137
OTC Retail 137
Phosphodiesterase Inhibitors 137

Sexual desire disorders 139
Female sexual arousal disorder 139
Sexual orgasmic disorder 140
Sexual pain disorders 140

Genetic Influence 143

Demographic Influence 155
Personal Appearance Gain 157
Acceptance of Cosmetic Procedures 158

Renova (tretinoin) 161
Retin-A/Retin-A Micro (tretinoin) 162
Botox (botulinum toxin type A) 163
Tazarotene 164

Nicotine replacement therapy 179
Antidepressants 180

Nicotine partial receptor agonists 180

Champix/Chantix (US) 183
Nicotine Replacement Therapies 183
Zyban 184

Opioid Receptor Agonists 187
Cannabinoid Receptor Antagonists 187
Clonidine 188
Nicotine Conjugate Vaccine 189
Glycine Receptor Antagonist 190

Alcohol Dependence 192
Alopecia 192
Obesity 192
Oral Contraception 192
Sexual Dysfunction 192
Smoking Cessation 192

List of Figures

Figure 1.1: Defining Lifestyle Drugs 23
Figure 1.2: The reimbursement decision process 36
Figure 1.3: Improving reimbursement status of lifestyle drugs: a three-pronged approach 37
Figure 2.4: Geographic market shares for Alcohol Dependence Drugs by sales revenue, 2006 ($m)
54
Figure 2.5: Pipeline for alcohol dependence therapies, 2007 58
Figure 3.6: Pipeline for alopecia therapies, 2007 74
Figure 4.7: Geographic market shares for anti-obesity products by sales revenue, 2006 ($m) 87
Figure 4.8: Pipeline for obesity therapies, 2007 94
Figure 5.9: Revenues by drug class for prescription oral contraceptives ($m), 2006; EU5, Japan,
USA 105
Figure 5.10: Geographic market sizes for prescription oral contraceptives by sales revenue, 2006
($m) 106
Figure 5.11: Promotional spend on top oral contraceptive brands in major markets (EU5, USA),
2006 ($m) 113

Figure 5.12: Pipeline for oral contraceptives, 2007 115
Figure 6.13: Geographic market size for erectile dysfunction products by sales revenue, 2006, $m
133
Figure 6.14: Pipeline for erectile dysfunction therapies, 2007 136
Figure 6.15: Possible caused of female sexual dysfunction 142
Figure 6.16: Pipeline for female sexual dysfunction therapies, 2007 145
Figure 7.17: Factors influencing cosmeceutical consumption across the major markets 156
Figure 7.18: Demographics of skin aging concerns 157
Figure 7.19: Pipeline for skin aging therapies, 2007 166
Figure 8.20: Global sales of smoking cessation drugs, 2006 ($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; alcohol 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: Projected 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, 2007 ($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
Table 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