Pipeline and Commercial Perspectives: Insomnia
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the Insomnia market - page 4
- Key metrics - page 7
- CHAPTER 2 PATIENT POTENTIAL - page 20
- Definition of insomnia - page 20
- Segmentation of insomnia - page 21
- Types of insomnia - page 21
- Transient insomnia - page 21
- Intermittent or short-term insomnia - page 22
- Chronic insomnia - page 22
- Other types of insomnia - page 22
- Types of insomnia - page 21
- Epidemiology of insomnia - page 24
- Prevalence of insomnia - page 24
- Gender - page 24
- Age - page 26
- Prevalence of insomnia - page 24
- Diagnosis of insomnia - page 28
- Diagnosis rates of insomnia - page 28
- Impacts of insomnia and working life - page 31
- Economic consequences - page 32
- Unmet needs in insomnia - page 33
- CHAPTER 3 MARKET OVERVIEW - page 38
- The current insomnia market - page 38
- The insomnia market players and franchises - page 42
- Sanofi-Aventis's insomnia franchise - page 42
- King/Wyeth's Sonata - page 46
- The insomnia market players and franchises - page 42
- Benzodiazepines - page 49
- Herbal hypnotics and sedatives - page 50
- Antihistamines - page 51
- Antidepressants - page 51
- Other drugs - page 52
- Non-pharmacological therapy - page 52
- Consumer trends in sleep aids - page 54
- Summary of major players and their vital statistics - page 57
- Consumer trends in sleep aids - page 54
- The current insomnia market - page 38
- CHAPTER 4 COUNTRY MARKET ASSESSMENT - page 59
- Global opportunities and threats - page 59
- Opportunities - page 59
- Global aging population - page 59
- New EU legislation will increase data exclusivity period, providing increased return on investment for new products - page 60
- Threats - page 60
- Parallel imports; EU expansion is likely to drive down price - page 60
- Drive towards generic prescribing - page 61
- Opportunities - page 59
- US - page 61
- Opportunities - page 64
- High public awareness driven by advocacy and DTC campaigns - page 64
- Direct access to specialist physicians helps patients receive optimal treatment quicker - page 65
- High price of branded drugs - page 65
- Threats - page 65
- Clamp down on DTC advertising - page 65
- Generic substitution - page 66
- Widespread parallel importing is driving down drug prices - page 67
- Opportunities - page 64
- Japan - page 69
- Opportunities - page 72
- Rising population over the age of 65 - page 72
- Pricing process slows generic incursion - page 73
- Separation of manufacturing and marketing entities opens market to overseas companies - page 73
- Faster product approval accelerates the time to market - page 74
- Threats - page 74
- Biennial price cuts restrict profit - page 74
- Restriction of physician incentives decreases pharmaceutical influence on prescribers - page 75
- Genericization is slowly taking off - page 75
- Opportunities - page 72
- European market - page 76
- EU cost differential - page 79
- Opportunities - page 80
- Revisions to EU pharmaceutical laws - page 80
- Threats - page 80
- NICE fails to distinguish second-generation hypnotics from benzodiazepines - page 80
- Single European pricing - page 81
- Facilitated entry of generics - page 82
- Generic substitution - page 82
- France - page 83
- Market overview - page 83
- Germany - page 86
- Market overview - page 86
- Italy - page 89
- Market overview - page 89
- Spain - page 92
- Market overview - page 92
- UK - page 95
- Market overview - page 95
- Global opportunities and threats - page 59
- CHAPTER 5 R&D APPROACH - page 98
- Clinical trials and drug development - page 98
- Measurement scales in insomnia - page 98
- Sleep questionnaires - page 98
- Alertness tests - page 99
- Quality of life measures - page 100
- Sleep monitoring - page 101
- Novel approaches to enhance traditional clinical trials - page 102
- Manufacturers need to demonstrate drug cost-effectiveness - page 102
- More diverse clinical trial endpoints need to be investigated - page 105
- Patient reported outcomes and endpoints are key - page 107
- NIH recommendations - page 108
- Measurement scales in insomnia - page 98
- Clinical trials and drug development - page 98
- CHAPTER 6 RECENTLY LAUNCHED HYPNOTIC ANALYSIS & FORECASTS - page 110
- Recently launched drugs - page 110
- Comparative positioning of novel hypnotics - page 111
- Methodology of competitive positioning analysis - page 112
- Ambien - the gold-standard insomnia drug therapy - page 116
- Competitive positioning analysis of Ambien - page 117
- Recently launched hypnotic drug analysis - page 118
- Lunesta - page 118
- Lunest demonstrates long-term efficacy - page 118
- Competitive positioning analysis of Lunesta - page 122
- The first hypnotic approved for sleep onset and maintenance - page 123
- Lunesta grows hypnotics market? - page 126
- Cost-effective Lunesta? - page 128
- Lunesta will reach peak revenues in 2008 - page 130
- Rozerem - page 133
- Rozerem demonstrates a strong safety profile - page 133
- Competitive positioning analysis of Rozerem - page 135
- Lack of scheduling and no next day residual effects key features of Rozerem - page 137
- Young professionals and the elderly are likely to be key markets - page 139
- Takeda should primarily target PCPs - page 140
- Rozerem forecast to be next drug launched in Japan - page 142
- Forecast revenues - page 143
- Ambien CR - page 145
- Improving the Ambien brand - page 145
- Competitive positioning analysis of Ambien CR - page 148
- Building upon the safety, efficacy and commercial strength of the Ambien - page 149
- Ambien CR grows Sanofi-Aventis's insomnia franchise in the short-term - page 150
- The threat of generic incursion - page 151
- Ambien CR will fail to sustain the Ambien franchise - page 158
- Lunesta - page 118
- Recently launched drugs - page 110
- CHAPTER 7 LATE-STAGE PIPELINE HYPNOTIC ANALYSIS & FORECASTS - page 161
- Pipeline summary - page 161
- Registered and Phase III overview - page 161
- Phase II overview - page 162
- Phase I and preclinical overview - page 163
- Recently discontinued pipeline drugs - page 165
- Physician awareness of pipeline drugs - page 166
- Pipeline drug analysis - page 168
- Indiplon - page 168
- Clinical data - Indiplon IR - page 168
- Clinical data - Indiplon MR - page 172
- Competitive positioning analysis of indiplon - page 175
- Two formulations will give indiplon a key profile - page 176
- Pfizer's marketing prowess will win through for indiplon - page 179
- Indiplon set to become the US market leader from 2008 - page 180
- Gaboxadol - page 184
- Limited clinical trial data published for gaboxadol - page 184
- Competitive positioning analysis of gaboxadol - page 186
- More efficacy data required - page 187
- Focus on lack of next day residual effects - page 190
- Gaboxadol expected to grow throughout the forecast period - page 191
- Silenor - page 193
- Targeting sleep maintenance - page 193
- Competitive positioning analysis of Silenor - page 195
- Concerns over the 17 hour half life - page 196
- Limited commercial potential in re-marketing an existing generic - page 197
- Limited uptake due to availability of superior hypnotics - page 199
- Phase II 5-HT 2a receptor antagonists - page 201
- Eplivanserin - page 201
- M-100907 - page 201
- Org-50081 - page 202
- Differentiating factors of the 5-HT 2a antagonists - page 204
- Competition in the insomnia market from 2009 onwards limits revenue potential of 5-HT 21 antagonists - page 207
- PD-6735 - page 209
- Limited clinical trial data published for PD-6735 - page 209
- Competitive positioning analysis of PD-6735 - page 209
- Another Rozerem? - page 211
- Potential marketing partners - page 211
- PD-6735 will face strong competition form Rozerem and the GABA A hypnotics, limiting uptake - page 213
- Indiplon - page 168
- Pipeline summary - page 161
- CHAPTER 8 FORECAST ANALYSIS - page 215
- Assumptions and events - page 215
- 2005 - page 215
- US launch of Lunesta - page 215
- US launch of Rozerem - page 215
- US launch of Ambien CR - page 216
- 2006 - page 217
- US launch of indiplon - page 217
- Ambien US patent expiry - page 217
- 2008 - page 218
- Sonata US patent expiry - page 218
- US and EU launch of gaboxadol - page 218
- US launch of Silenor - page 219
- 2009 - page 219
- US launch of PD-6735 - page 219
- EU launch of Org-50081 - page 220
- 2010 - page 220
- US launch of eplivanserin or M-100907 - page 220
- 2011 - page 220
- Sonata EU patent expiry - page 220
- 2012 - page 221
- Ambien Japanese patent expiry - page 221
- Lunesta patent expiry - page 221
- 2013 - page 222
- Silenor patent expiry - page 222
- Ongoing events - page 222
- 2005 - page 215
- Assumptions and events - page 215
- CHAPTER 9 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 224
- Comparative drug launches and DTC marketing - page 224
- Lunesta - page 224
- Rozerem - page 228
- Ambien CR - page 230
- Innovation is key - manufacturers need to differentiate their drugs from the influx of generic GABA A agonists - page 231
- Novel non-stimulant, non-scheduled drugs - page 232
- Extended-release formulations and treatment of sleep maintenance - page 234
- Long-term treatment of chronic insomnia - page 237
- Lack of next day residual effects - page 240
- Targeting comorbid disorders - page 243
- Changing physicians' prescribing strategies - page 247
- Targeting additional sleep disorders - page 248
- No-go comorbid niches for hypnotics - page 252
- Future directions - page 253
- Pediatric and adolescent insomnia still a no go area - page 253
- Targeting transient insomnia - page 255
- Transient insomnia market is severely under treated - page 255
- Erosion of the OTC market may prove difficult - page 257
- Targeting transient insomnia - page 258
- Reformulation of hypnotics - page 263
- Comparative drug launches and DTC marketing - page 224
- APPENDIX A - page 265
- Insomnia market data - page 265
- Market Forecast Data - page 272
- US forecasts - page 272
- Japan forecasts - page 273
- MEU5 forecasts - page 274
- Global forecasts - page 275
- Contributing experts - page 276
- Anonymous US Sleep Disorders Expert - Requested total anonymity. - page 276
- Bibliography - page 277
- Websites - page 283
- APPENDIX B - page 287
- Syndicated Forecasting Methodology - page 287
- Regional launch dates for new products - page 289
- About Datamonitor - page 290
- Syndicated Forecasting Methodology - page 287
- List of Tables
- Table 1: Global revenues ($m) in the hypnotics market from 2005-14 - page 7
- Table 2: ICSD-R Criteria for severity of insomnia - page 22
- Table 3: Insomnia revenues across the seven major markets in 2004 - page 38
- Table 4: Sanofi-Aventis's marketed and pipeline insomnia drugs, 2005 - page 44
- Table 5: Sanofi-Aventis's marketed CNS portfolio, 2004 - page 46
- Table 6: Benzodiazepines approved for the treatment of insomnia in the US and UK - page 50
- Table 7: Non-pharmacological insomnia therapy - page 52
- Table 8: Advantages and disadvantages of non-pharmacological therapy, alone and combined with drug treatment - page 53
- Table 9: Insomnia patient populations (000s) across the seven major markets, 2004 - page 55
- Table 10: Number of patients taking second-generation insomnia drugs in the US in 2004 - page 56
- Table 11: Revenues of insomnia drugs in the US, 2004 - page 61
- Table 12: Revenues of insomnia drugs in Japan, 2004 - page 69
- Table 13: Revenues of insomnia drugs in Europe, 2004 - page 76
- Table 14: Cost differential of second-generation hypnotics between the EU, US and Japan, 2004 - page 79
- Table 15: Revenues of insomnia drugs in France, 2004 - page 83
- Table 16: Revenues of insomnia drugs in Germany, 2004 - page 86
- Table 17: Revenues of insomnia drugs in Italy, 2004 - page 89
- Table 18: Revenues of insomnia drugs in Spain, 2004 - page 92
- Table 19: Revenues of insomnia drugs in the UK, 2002-04 - page 95
- Table 20: Important directions for insomnia-related research - page 109
- Table 21: Insomnia drugs approved or launched in 2005 to date - page 110
- Table 22: Commercial strength / weakness factors - weightings and scoring definitions - page 113
- Table 23: Product specific strength / weakness factors - weightings and scoring definitions - page 114
- Table 24: Forecast revenues of Lunesta in the US, EU and Japan to 2014 - page 132
- Table 25: Forecast revenues of Rozerem in the US, EU and Japan, 2005-14 - page 144
- Table 26: Comparison of Paxil CR, Adderall XR and Ambien CR's profiles and competitive environment - page 155
- Table 27: Forecast revenues of Ambien CR in the US, EU and Japan, 2005-14 - page 160
- Table 28: Insomnia drugs in pre-registration, 2005 - page 161
- Table 29: insomnia drugs in Phase III clinical development, 2005 - page 161
- Table 30: Insomnia drugs in Phase II clinical development, 2005 - page 162
- Table 31: Insomnia drugs in Phase I development, 2005 - page 163
- Table 32: Insomnia drugs in preclinical development, 2005 - page 165
- Table 33: Insomnia drugs recently discontinued from development - page 165
- Table 34: Forecast revenues of indiplon in the US, EU and Japan, 2005 - page 183
- Table 35: Forecast revenues of gaboxadol in the US, EU and Japan to 2014 - page 192
- Table 36: Forecast revenues of Silenor in the US, EU and Japan, 2005-14 - page 200
- Table 37: Forecast revenues of eplivanserin, M-100907 and Org-50081 across the seven major markets, 2005-14 - page 208
- Table 38: Forecast revenues of PD-6735 in the US, EU and Japan, 2005-14 - page 214
- Table 39: Disorders and conditions associated with insomnia - page 243
- Table 40: Ambien and Ambien CR key facts - page 265
- Table 41: Key Ambien and Ambien CR events, 2004-2005 - page 266
- Table 42: Sonata key facts - page 267
- Table 43: Key Sonata events, 2004-2005 - page 267
- Table 44: Rozerem key facts - page 268
- Table 45: Key Rozerem events, 2004-2005 - page 268
- Table 46: Lunesta key facts - page 269
- Table 47: Key Lunesta events, 2004-2005 - page 270
- Table 48: Datamonitor's competitive positioning analysis of insomnia drugs compared to existing market players - page 271
- Table 49: US revenues ($m) in the hypnotics market from 2005-14 - page 272
- Table 50: Japanese revenues ($m) in the hypnotics market from 2005-14 - page 273
- Table 51: MEU5 revenues ($m) in the hypnotics market from 2005-14 - page 274
- Table 52: Global revenues ($m) in the hypnotics market from 2005-14 - page 275
- List of Figures
- Figure 1: Competitive positioning analysis of insomnia drugs - page 8
- Figure 2: Symptoms of insomnia in the US population at least a few times a week - page 20
- Figure 3: Symptoms of insomnia in the US population at least a few times a week (male vs. female) - page 25
- Figure 4: Prevalence of sleep disorders in peri- and post-menopausal women - page 26
- Figure 5: Symptoms of insomnia in the US population at least a few times a week (age) - page 27
- Figure 6: Proportion of insomnia patients who actively seek medical treatment in the US - page 30
- Figure 7: Characteristics of the ideal hypnotic drug - page 34
- Figure 8: Physicians' views on the main barriers to the optimal and timely management of sleep disturbance - page 37
- Figure 9: Weekly physician prescribing intent of total prescriptions by PCPs and psychiatrists - page 40
- Figure 10: Quarterly insomnia drug revenues across the seven major markets, 1999-2005 - page 41
- Figure 11: Revenues launched, pipeline and generic hypnotics in the US, EU and Japan, 2001-14 - page 41
- Figure 12: US revenue forecast of Sanofi-Aventis's insomnia franchise, 2001-14 - page 43
- Figure 13: Impact of generic of zopiclone on Imovane revenues in the EU, 1999-2005 - page 44
- Figure 14: Competitive positioning analysis of Sanofi-Aventis's marketed and pipeline insomnia drugs. - page 45
- Figure 15: Global Sonata franchise, 2001-14 - page 48
- Figure 16: Competitive positioning analysis of Sonata - page 48
- Figure 17: Revenue growth, market share and revenues of existing insomnia drugs across the seven major markets, 2003-04 - page 57
- Figure 18: Key players in the insomnia market - page 58
- Figure 19: Quarterly insomnia drug revenues in the US, 1999-2005 - page 62
- Figure 20: Cash market share of the US insomnia market, 1999-2004 - page 62
- Figure 21: Quarterly insomnia drug revenues in Japan, 1999-2005 - page 71
- Figure 22: Insomnia drug cash market in Japan, 1999-2004 - page 71
- Figure 23: Japan over 65 population (m), 1950-2050 - page 72
- Figure 24: Quarterly insomnia drug revenues in the EU, 1999-2005 - page 77
- Figure 25: Insomnia drug cash market in Japan, 1999-2004 - page 77
- Figure 26: Quarterly insomnia drug revenues in France, 1999-2005 - page 84
- Figure 27: Insomnia drug cash market in France, 1999-2004 - page 85
- Figure 28: Quarterly insomnia drug revenues in Germany, 1999-2005 - page 88
- Figure 29: Insomnia drug cash market in Germany, 1999-2004 - page 88
- Figure 30: Quarterly insomnia drug revenues in Italy, 1999-2005 - page 91
- Figure 31: Insomnia drug cash market in Italy, 1999-2004 - page 91
- Figure 32: Quarterly insomnia drug revenues 1999-2005 in Spain - page 94
- Figure 33: Insomnia drug cash market in Spain, 1999-2004 - page 94
- Figure 34: Quarterly insomnia drug revenues in the UK, 1999-2005 - page 96
- Figure 35: Insomnia drug cash market in the UK, 1999-2004 - page 97
- Figure 36: NICE measurement cost-effectiveness of drug treatment - page 103
- Figure 37: Impairment in quality of life associated with insomnia - page 106
- Figure 38: Competitive positioning analysis of recently launched hypnotics - page 111
- Figure 39: Competitive positioning analysis of insomnia drugs - page 115
- Figure 40: The competitive positioning analysis of Sanofi-Aventis's Ambien - page 117
- Figure 41: The competitive positioning analysis of Sepracor's Lunesta. - page 122
- Figure 42: The pharmacologic profile of Lunesta compared to Ambien - page 123
- Figure 43: Growth of Lunesta new prescription share from launch. - page 126
- Figure 44: Total weekly prescription growth in sedative hypnotics in 2005 - page 127
- Figure 45: Total prescription growth in sedative hypnotics, 2002-05 - page 128
- Figure 46: The competitive positioning analysis of Takeda's Rozerem - page 136
- Figure 47: The pharmacologic profile of Rozerem compared to Ambien - page 137
- Figure 48: The competitive positioning analysis of Sanofi-Aventis's Ambien CR - page 148
- Figure 49: The pharmacologic profile of Ambien CR compared to Ambien. - page 149
- Figure 50: Weekly total US prescriptions of Ambien and Ambien CR since Ambien CR launch - page 151
- Figure 51: Revenues of the Paxil and Adderall franchises after generic incursion - page 154
- Figure 52: Comparison of Paxil and Adderall franchise promotional spend - page 157
- Figure 53: Physicians' confidence that they are up-to-date on the most recent pharmacologic treatments for sleep disturbance - page 166
- Figure 54: The competitive positioning analysis of Neurocrine/Pfizer's indiplon. - page 175
- Figure 55: The pharmacologic profile of indiplon compared to Ambien. - page 176
- Figure 56: The competitive positioning analysis of Lundbeck/Merck's gaboxadol - page 186
- Figure 57: The pharmacologic profile of gaboxadol compared to Ambien. - page 187
- Figure 58: The competitive positioning analysis of Somaxon's Silenor - page 195
- Figure 59: The pharmacologic profile of Silenor compared to Ambien. - page 196
- Figure 60: The competitive positioning analysis of the 5-HT 2a antagonists - page 203
- Figure 61: The pharmacologic profile of eplivanserin, M-100907 and Org-50081 compared to Ambien - page 204
- Figure 62: The competitive positioning analysis of Phase 2 Discovery's PD-6735 - page 210
- Figure 63: The pharmacologic profile of PD-6735 compared to Ambien. - page 210
- Figure 64: Lunesta drug homepage - page 226
- Figure 65: Lunesta versus other prescription sleep aids - page 227
- Figure 66: Sleep science - page 229
- Figure 67: The Ambien CR homepage - page 231
- Figure 68: Total revenues of non-scheduled drugs to 2014 - page 234
- Figure 69: Total revenues of extended release insomnia drugs to 2014 - page 236
- Figure 70: Duration of symptoms of insomnia in the US - page 237
- Figure 71: Duration of symptoms of insomnia in the EU - page 237
- Figure 72: Medical conditions associated with insomnia - page 244
- Figure 73: Prevalence of comorbid insomnia in diagnosed MDD patients - page 244
- Figure 74: Prevalence of insomnia, RLS and sleep apnea in the US population - page 249
- Figure 75: Proportion of US children receiving sleep aids, 2004 - page 254
- Figure 76: Frequency of sleep aid usage by US population, 2005 - page 256
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