Commercial and Pipeline Insight: ADHD
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Central Nervous System pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Contributing experts - page 4
- Datamonitor insight into the ADHD market - page 4
- CHAPTER 2 MARKET OVERVIEW AND POTENTIAL - page 10
- Disease definition - page 11
- Etiology of ADHD - page 11
- Genetic predisposition - page 11
- Neurotransmitter dysfunction - page 12
- Acquired brain lesions and structural abnormalities - page 13
- Environmental influence - page 13
- Diagnostic criteria of ADHD - page 14
- Etiology of ADHD - page 11
- Epidemiology of ADHD - page 16
- ADHD is estimated to affect over 37 million people in the seven major markets - page 16
- The adult ADHD population is twice the size of the current pediatric population - page 20
- Key patient segments - page 21
- ADHD is more prevalent in boys than girls - page 21
- ADHD carries a high risk of co-morbidity - page 22
- ADHD negatively impacts on quality of life - page 25
- ADHD is estimated to affect over 37 million people in the seven major markets - page 16
- Clinical unmet needs of ADHD - page 25
- More effective medications for patients who do not respond to stimulants - page 27
- Efficacy in the absence of insomnia - page 28
- Improved compliance - page 29
- Diagnostic unmet needs of ADHD - page 30
- Developmentally appropriate diagnostic criteria at older ages - page 30
- Current treatment classes and mechanisms - page 31
- Treatment algorithm - page 31
- Pharmacological treatment - page 32
- Psychosocial therapy - page 34
- Treatment algorithm - page 31
- Current market value and future market forecasts - page 35
- The ADHD market has grown consistently over the last 4 years - page 35
- The US dominates the ADHD market with a 94% market share - page 36
- Shire's Adderall XR continues to reign as market leader - page 38
- There exists seasonal variation in uptake of ADHD drugs - page 40
- The ADHD market is set to grow throughout the forecast period - page 42
- Near-term growth (2008-2010) - continued strong growth followed by decline in sales - page 43
- Medium-term growth (2010-2015) - continued growth driven by ongoing uptake of marketed drugs - page 43
- Long-term outlook (2015-2017) - patent expiries take their toll - page 43
- The ADHD market has grown consistently over the last 4 years - page 35
- Disease definition - page 11
- CHAPTER 3 GLOBAL OPPORTUNITIES AND THREATS - page 44
- Key opportunities - page 45
- Opportunities for growth remain in the adult ADHD market - page 45
- There remains room in the market for further patch formulations - page 48
- Substantial commercial potential exists for efficacious non-stimulant - page 48
- Garner competitive edge by targeting cognition - page 48
- Key threats - page 49
- Less acceptance of pharmaceutical intervention in non-US markets - page 49
- Increasing presence of leading players is a barrier to market entry - page 51
- Key opportunities - page 45
- CHAPTER 4 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES - page 53
- Marketed brands overview - page 54
- Adderall and Adderall XR (amphetamine) - page 55
- Drug overview - page 56
- Forecasts to 2017 - page 57
- SWOT analysis - page 59
- Clinical trial data - page 59
- Adderall XR's clinical trial program and study designs - page 60
- Efficacy of Adderall XR - page 60
- Adderall side effects - page 62
- Mechanism of action - page 63
- Concerta (methylphenidate) - page 63
- Concerta drug overview - page 63
- Forecasts to 2017 - page 65
- SWOT analysis - page 66
- Clinical trial data - page 67
- Concerta's clinical program and study designs - page 67
- Efficacy of Concerta - page 67
- Concerta demonstrates efficacy in treating adult ADHD - page 68
- Concerta side effects - page 68
- Mechanism of action - page 69
- Strattera (atomoxetine) - page 69
- Drug overview - page 70
- Forecasts to 2017 - page 72
- SWOT analysis - page 73
- Clinical trial data - page 73
- Strattera clinical program and study designs - page 74
- Efficacy of Strattera - page 74
- Strattera efficacious in improving ADHD symptoms in patients with co-morbid alcohol abuse - page 74
- Side effects of Strattera - page 74
- Mechanism of action - page 75
- Focalin and Focalin XR (dexmethylphenidate) - page 75
- Drug overview - page 75
- Forecasts to 2017 - page 77
- SWOT analysis - page 78
- Clinical trial data - page 78
- Focalin XR clinical program and study designs - page 78
- Efficacy of Focalin XR - page 79
- Side effects of Focalin XR - page 79
- Mechanism of action - page 80
- Metadate (methylphenidate hydrochloride) - page 80
- Drug overview - page 80
- Forecasts to 2017 - page 82
- SWOT analysis - page 83
- Clinical trial data - page 84
- Metadate CD's clinical trial program and study designs - page 84
- Efficacy of Metadate CD - page 84
- Side effects of Metadate CD - page 85
- Daytrana (methylphenidate) - page 85
- Drug overview - page 85
- Forecasts to 2017 - page 88
- SWOT analysis - page 89
- Clinical trial data - page 89
- Daytrana's clinical trial program and study designs - page 89
- Efficacy of Daytrana - page 90
- Side effects of Daytrana - page 90
- Vyvanse (lisdexamfetamine dimesylate) - page 90
- Drug overview - page 90
- Forecasts to 2017 - page 93
- SWOT analysis - page 94
- Clinical trial data - page 94
- Vyvanse clinical program and study designs - page 95
- Efficacy of Vyvanse - page 95
- Vyvanse demonstrates equivalent efficacy and duration of action to Adderall XR - page 95
- Phase III trial demonstrates Vyvanse's efficacy in adult patients - page 95
- Side effects of Vyvanse - page 96
- Ritalin (methylphenidate hydrochloride) - page 96
- Drug overview - page 96
- Forecasts to 2017 - page 99
- SWOT analysis - page 100
- Clinical trial data - page 100
- Ritalin LA clinical program and study designs - page 101
- Efficacy of Ritalin - page 101
- Side effects of Ritalin LA - page 101
- CHAPTER 5 FORECAST ANALYSIS - page 102
- Key events - page 103
- Product launches in the US and 5EU - page 104
- Key drug launch assumptions - page 104
- Product launches in Japan - page 107
- Strattera - page 107
- Patent expiries - page 107
- Adderall XR - page 108
- Focalin XR - page 109
- Ritalin LA - page 109
- Concerta - page 110
- Strattera - page 110
- Product launches in the US and 5EU - page 104
- Data definitions, limitations and assumptions - page 111
- Standard units - page 111
- Japanese market data - page 111
- Derivation of sales forecasts and pricing trends - page 111
- Forecast methodology - page 111
- Key events - page 103
- CHAPTER 6 PIPELINE OVERVIEW - R&D DYNAMICS AND APPROACH - page 112
- Pipeline overview - page 113
- Classification of pipeline products - page 114
- Alpha-adrenergic agonists - page 114
- Amphetamines - page 114
- Nicotinic agonists - page 115
- Other drug classes - page 115
- Clinical trial design - page 115
- Primary clinical trial endpoints in ADHD - page 116
- ADHD Rating Scale - page 116
- Conners Global Index - Parent and Teacher Forms (CGI-P & CGI-T) - page 116
- SKAMP behavioral rating scale - page 116
- The IOWA Conners Rating Scale - page 116
- Adult ADHD Investigator Symptom Rating Scale (AISRS) - page 117
- Conners Adult ADHD Rating Scale - Self-report (CAARS-S:S) - page 117
- Secondary clinical trial endpoints in ADHD - page 118
- Clinical Global Impression Improvement Scale - page 118
- Child Health Questionnaire - page 118
- Key considerations in clinical trial design - page 119
- Participant sample - page 119
- Objective clinical trial endpoints - page 120
- Regulatory barriers to the development of pediatric medications - page 120
- Non-regulatory barriers to the development of pediatric medications - page 121
- Primary clinical trial endpoints in ADHD - page 116
- CHAPTER 7 LATE-STAGE DRUG ANALYSIS & FORECASTS - page 123
- Late-stage pipeline overview - page 124
- Alpha adrenergic agonist pipeline drugs - page 127
- Pipeline summary - page 127
- Intuniv (guanfacine hydrochloride) - page 127
- Drug overview - page 128
- Forecasts to 2017 - page 129
- Marketing factors - page 130
- Patient potential - page 134
- Clinical trial data - page 135
- Clonicel (clonidine hydrochloride) - page 139
- Drug overview - page 139
- Forecasts to 2017 - page 139
- Marketing factors - page 141
- Patient potential - page 142
- Clinical trial data - page 143
- Amphetamine pipeline drugs - page 144
- Liquadd - page 144
- Drug overview - page 144
- Forecasts to 2017 - page 145
- Marketing factors - page 146
- Patient potential - page 147
- Satisfaction of unmet needs - page 147
- Clinical trial data - page 147
- SPD-465 - page 148
- Drug overview - page 148
- Forecasts to 2017 - page 148
- Marketing factors - page 150
- Patient potential - page 151
- Clinical trial data - page 152
- Liquadd - page 144
- Nicotinic acetylcholine receptor agonists - page 154
- Pipeline summary - page 154
- GTS-21 - page 155
- ABT-089 - page 156
- ABT-894 - page 156
- Other pipeline drugs - page 157
- Pipeline summary - page 157
- MK-0249 - page 158
- NRC 071A - page 158
- Abilify (aripiprazole) - page 158
- NS2359/GSK372475 - page 159
- Recently suspended/discontinued drugs - page 159
- CX717 - page 159
- Sparlon (modafinil) - page 160
- CHAPTER 8 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 161
- Introduction - page 162
- Focus on ADHD provides long-term growth - page 162
- Timely launch of Adderall XR was a winning strategy for Shire - page 163
- The future of Shire's ADHD franchise depends on a successful switch to Vyvanse - page 164
- Daytrana's novel delivery formulation has diversified Shire's ADHD franchise - page 166
- As the first patch formulation approved for ADHD, Daytrana offers convenient and flexible dosing - page 166
- Daytrana serves to reduce Shire's reliance on Vyvanse as a follow-on product to Adderall XR - page 167
- There is room in the market for further patch formulations - page 168
- Continued development of new treatments demonstrates long-term commitment - page 169
- Timely launch of Adderall XR was a winning strategy for Shire - page 163
- Concerta - a successful launch strategy - page 170
- First-to-market status of the once-daily treatments provided firm grounding for growth - page 170
- EU launch maximized the commercial potential of Concerta - page 171
- Focus promotional spend on maintaining relationships with prescribers - page 171
- J&J should look to in-licensing if it is to maintain long term market share - page 172
- First-to-market status of the once-daily treatments provided firm grounding for growth - page 170
- Seasonal factors should be considered at drug launch - page 173
- BIBLIOGRAPHY - page 175
- Journal papers, books, and conference abstracts - page 175
- Websites - page 186
- Datamonitor reports - page 195
- APPENDIX - page 196
- Report methodology - page 196
- Contributing experts - page 198
- About Datamonitor - page 198
- About Datamonitor Healthcare - page 198
- About the Disease analysis team - page 199
- Disclaimer - page 201
- Report methodology - page 196
- List of Tables
- Table 1: Symptoms for ADHD/HKD in the DSM-IV and ICD-10 - page 14
- Table 2: Definition of ADHD in the DSM-IV - page 15
- Table 3: Results of epidemiology studies of ADHD across the seven major markets - page 16
- Table 4: Prevalence of ADHD in the seven major markets, 2008 - page 19
- Table 5: Performance of the US, 5EU and Japan ADHD markets, 2006-7 - page 37
- Table 6: Adderall/Adderall XR: key facts, 2008 - page 57
- Table 7: Concerta: key facts, 2008 - page 64
- Table 8: Strattera: key facts, 2008 - page 71
- Table 9: Focalin/Focalin XR: key facts, 2008 - page 76
- Table 10: Metadate CD: key facts, 2008 - page 81
- Table 11: Daytrana: key facts, 2008 - page 87
- Table 12: Vyvanse: key facts - page 92
- Table 13: Ritalin franchise: key facts - page 98
- Table 14: Forecast launch dates in the US and 5EU - page 104
- Table 15: Forecast launch dates in Japan - page 107
- Table 16: Key patent expiries for key marketed drugs in the US and 5EU - page 107
- Table 17: Drugs in early stage development for ADHD, 2008 - page 113
- Table 18: Key pipeline drugs in late-stage development for ADHD, 2008 - page 126
- Table 19: Key late-stage development pipeline, alpha receptor agonist, 2008 - page 127
- Table 20: Factors impacting on the revenues of Intuniv, 2008-2017 - page 129
- Table 21: Factors impacting on the revenues of Clonicel, 2008-2017 - page 140
- Table 22: Factors impacting on the revenues of Liquadd, 2008-2017 - page 145
- Table 23: Factors impacting on the revenues of SPD-465, 2008-2017 - page 149
- Table 24: Key late-stage development pipeline for ADHD, nicotinic agonists, 2008 - page 154
- Table 25: Key late-stage development pipeline, other classes, 2008 - page 157
- Table 26: Shire's ADHD pipeline, 2008 - page 169
- Table 27: Datamonitor drug assessment parameters - page 197
- List of Figures
- Figure 1: Drug assessment summary overview of key marketed and pipeline ADHD drugs, 2008 - page 7
- Figure 2: Historical (2004-07) and forecast (2008-17) ADHD sales revenue for key marketed and pipeline drugs across the 7MM - page 8
- Figure 3: Prevalence of ADHD co-morbidities in the MTA study - page 24
- Figure 4: Key unmet clinical need in the treatment of ADHD - page 27
- Figure 5: Revenues of ADHD drugs, 7MM, 2004-07 - page 36
- Figure 6: Revenue market share of the leading branded ADHD drugs, 2004-07 - page 39
- Figure 7: US sales revenues for ADHD drugs, 2004-07 - page 41
- Figure 8: ADHD market value in the US, Japan and 5EU, 2004-17 - page 42
- Figure 9: Sales revenue ($m) of ADHD drugs prescribed for pediatric, adolescent and adult patients, 2004-07 - page 45
- Figure 10: Growth of sales revenue ($m) of drugs prescribed for pediatric, adolescent and adult ADHD in the US, 2004-07 - page 47
- Figure 11: Sales revenue garnered by key players in the ADHD market (2006-2007 estimates), 2008-17 forecasts - page 52
- Figure 12: Current key marketed drugs - clinical and commercial attractiveness, 2008 - page 54
- Figure 13: Historical (2004-07) and forecast (2008-2017) ADHD sales revenue for key marketed and pipeline drugs across the 7MM - page 55
- Figure 14: Adderall and Adderall XR ADHD-specific sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-2017 forecasts - page 58
- Figure 15: Adderall XR: SWOT analysis, 2008 - page 59
- Figure 16: Concerta sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-2017 forecasts - page 65
- Figure 17: Concerta: SWOT analysis - page 66
- Figure 18: Strattera sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-2017 forecasts - page 72
- Figure 19: Strattera: SWOT analysis - page 73
- Figure 20: Focalin XR revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 77
- Figure 21: Focalin XR: SWOT analysis - page 78
- Figure 22: Metadate CD sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 82
- Figure 23: Metadate CD: SWOT analysis - page 83
- Figure 24: Daytrana sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 88
- Figure 25: Daytrana: SWOT analysis - page 89
- Figure 26: Vyvanse sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 93
- Figure 27: Vyvanse: SWOT analysis - page 94
- Figure 28: Ritalin LA sales ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts - page 99
- Figure 29: Ritalin LA: SWOT analysis - page 100
- Figure 30: Impact of each key event on the ADHD market across the seven major markets, 2008-2017 - page 103
- Figure 31: Drugs in late-stage development for ADHD by class, 2008 - page 113
- Figure 32: Comparative late-stage pipeline ADHD drug sales revenue forecast, 2008-2017 - page 125
- Figure 33: Sales forecast of Intuniv in the 7MM, 2007-2017 - page 129
- Figure 34: Intuniv drug assessment summary, 2008 - page 130
- Figure 35: Sales forecast of Clonicel in the 7MMs, 2007-2017 - page 140
- Figure 36: Clonicel drug assessment summary, 2008 - page 141
- Figure 37: Sales forecast of Liquadd in the 7MMs, 2007-2017 - page 145
- Figure 38: Liquadd drug assessment summary - page 146
- Figure 39: Sales forecast for SPD-465 in the 7MMs - page 148
- Figure 40: SPD-465 drug assessment summary, 2008 - page 150
- Figure 41: Shire ADHD franchise forecast ($m), 2008-17 - page 162
- Figure 42: Vyvanse's drug homepage - page 165
- Figure 43: Promotional spend on physician detailing for key ADHD products in the US and 5EU, 2004-06 - page 172
- Figure 44: Seasonal revenue growth and decline of ADHD drug - page 173
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