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Published by: Datamonitor
Published: Apr. 10, 2008 - 211 Pages
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Central Nervous System pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Contributing experts
- Datamonitor insight into the ADHD market
- CHAPTER 2 MARKET OVERVIEW AND POTENTIAL
- Disease definition
- Etiology of ADHD
- Genetic predisposition
- Neurotransmitter dysfunction
- Acquired brain lesions and structural abnormalities
- Environmental influence
- Diagnostic criteria of ADHD
- Epidemiology of ADHD
- ADHD is estimated to affect over 37 million people in the seven major markets
- The adult ADHD population is twice the size of the current pediatric population
- Key patient segments
- ADHD is more prevalent in boys than girls
- ADHD carries a high risk of co-morbidity
- ADHD negatively impacts on quality of life
- Clinical unmet needs of ADHD
- More effective medications for patients who do not respond to stimulants
- Efficacy in the absence of insomnia
- Improved compliance
- Diagnostic unmet needs of ADHD
- Developmentally appropriate diagnostic criteria at older ages
- Current treatment classes and mechanisms
- Treatment algorithm
- Pharmacological treatment
- Psychosocial therapy
- Current market value and future market forecasts
- The ADHD market has grown consistently over the last 4 years
- The US dominates the ADHD market with a 94% market share
- Shire's Adderall XR continues to reign as market leader
- There exists seasonal variation in uptake of ADHD drugs
- The ADHD market is set to grow throughout the forecast period
- Near-term growth (2008-2010) - continued strong growth followed by decline in sales
- Medium-term growth (2010-2015) - continued growth driven by ongoing uptake of marketed drugs
- Long-term outlook (2015-2017) - patent expiries take their toll
- CHAPTER 3 GLOBAL OPPORTUNITIES AND THREATS
- Key opportunities
- Opportunities for growth remain in the adult ADHD market
- There remains room in the market for further patch formulations
- Substantial commercial potential exists for efficacious non-stimulant
- Garner competitive edge by targeting cognition
- Key threats
- Less acceptance of pharmaceutical intervention in non-US markets
- Increasing presence of leading players is a barrier to market entry
- CHAPTER 4 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES
- Marketed brands overview
- Adderall and Adderall XR (amphetamine)
- Drug overview
- Forecasts to 2017
- SWOT analysis
- Clinical trial data
- Adderall XR's clinical trial program and study designs
- Efficacy of Adderall XR
- Adderall side effects
- Mechanism of action
- Concerta (methylphenidate)
- Concerta drug overview
- Forecasts to 2017
- SWOT analysis
- Clinical trial data
- Concerta's clinical program and study designs
- Efficacy of Concerta
- Concerta demonstrates efficacy in treating adult ADHD
- Concerta side effects
- Mechanism of action
- Strattera (atomoxetine)
- Drug overview
- Forecasts to 2017
- SWOT analysis
- Clinical trial data
- Strattera clinical program and study designs
- Efficacy of Strattera
- Strattera efficacious in improving ADHD symptoms in patients with co-morbid alcohol abuse
- Side effects of Strattera
- Mechanism of action
- Focalin and Focalin XR (dexmethylphenidate)
- Drug overview
- Forecasts to 2017
- SWOT analysis
- Clinical trial data
- Focalin XR clinical program and study designs
- Efficacy of Focalin XR
- Side effects of Focalin XR
- Mechanism of action
- Metadate (methylphenidate hydrochloride)
- Drug overview
- Forecasts to 2017
- SWOT analysis
- Clinical trial data
- Metadate CD's clinical trial program and study designs
- Efficacy of Metadate CD
- Side effects of Metadate CD
- Daytrana (methylphenidate)
- Drug overview
- Forecasts to 2017
- SWOT analysis
- Clinical trial data
- Daytrana's clinical trial program and study designs
- Efficacy of Daytrana
- Side effects of Daytrana
- Vyvanse (lisdexamfetamine dimesylate)
- Drug overview
- Forecasts to 2017
- SWOT analysis
- Clinical trial data
- Vyvanse clinical program and study designs
- Efficacy of Vyvanse
- Vyvanse demonstrates equivalent efficacy and duration of action to Adderall XR
- Phase III trial demonstrates Vyvanse's efficacy in adult patients
- Side effects of Vyvanse
- Ritalin (methylphenidate hydrochloride)
- Drug overview
- Forecasts to 2017
- SWOT analysis
- Clinical trial data
- Ritalin LA clinical program and study designs
- Efficacy of Ritalin
- Side effects of Ritalin LA
- CHAPTER 5 FORECAST ANALYSIS
- Key events
- Product launches in the US and 5EU
- Key drug launch assumptions
- Product launches in Japan
- Strattera
- Patent expiries
- Adderall XR
- Focalin XR
- Ritalin LA
- Concerta
- Strattera
- Data definitions, limitations and assumptions
- Standard units
- Japanese market data
- Derivation of sales forecasts and pricing trends
- Forecast methodology
- CHAPTER 6 PIPELINE OVERVIEW - R&D DYNAMICS AND APPROACH
- Pipeline overview
- Classification of pipeline products
- Alpha-adrenergic agonists
- Amphetamines
- Nicotinic agonists
- Other drug classes
- Clinical trial design
- Primary clinical trial endpoints in ADHD
- ADHD Rating Scale
- Conners Global Index - Parent and Teacher Forms (CGI-P & CGI-T)
- SKAMP behavioral rating scale
- The IOWA Conners Rating Scale
- Adult ADHD Investigator Symptom Rating Scale (AISRS)
- Conners Adult ADHD Rating Scale - Self-report (CAARS-S:S)
- Secondary clinical trial endpoints in ADHD
- Clinical Global Impression Improvement Scale
- Child Health Questionnaire
- Key considerations in clinical trial design
- Participant sample
- Objective clinical trial endpoints
- Regulatory barriers to the development of pediatric medications
- Non-regulatory barriers to the development of pediatric medications
- CHAPTER 7 LATE-STAGE DRUG ANALYSIS & FORECASTS
- Late-stage pipeline overview
- Alpha adrenergic agonist pipeline drugs
- Pipeline summary
- Intuniv (guanfacine hydrochloride)
- Drug overview
- Forecasts to 2017
- Marketing factors
- Patient potential
- Clinical trial data
- Clonicel (clonidine hydrochloride)
- Drug overview
- Forecasts to 2017
- Marketing factors
- Patient potential
- Clinical trial data
- Amphetamine pipeline drugs
- Liquadd
- Drug overview
- Forecasts to 2017
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- SPD-465
- Drug overview
- Forecasts to 2017
- Marketing factors
- Patient potential
- Clinical trial data
- Nicotinic acetylcholine receptor agonists
- Pipeline summary
- GTS-21
- ABT-089
- ABT-894
- Other pipeline drugs
- Pipeline summary
- MK-0249
- NRC 071A
- Abilify (aripiprazole)
- NS2359/GSK372475
- Recently suspended/discontinued drugs
- CX717
- Sparlon (modafinil)
- CHAPTER 8 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
- Introduction
- Focus on ADHD provides long-term growth
- Timely launch of Adderall XR was a winning strategy for Shire
- The future of Shire's ADHD franchise depends on a successful switch to Vyvanse
- Daytrana's novel delivery formulation has diversified Shire's ADHD franchise
- As the first patch formulation approved for ADHD, Daytrana offers convenient and flexible dosing
- Daytrana serves to reduce Shire's reliance on Vyvanse as a follow-on product to Adderall XR
- There is room in the market for further patch formulations
- Continued development of new treatments demonstrates long-term commitment
- Concerta - a successful launch strategy
- First-to-market status of the once-daily treatments provided firm grounding for growth
- EU launch maximized the commercial potential of Concerta
- Focus promotional spend on maintaining relationships with prescribers
- J&J should look to in-licensing if it is to maintain long term market share
- Seasonal factors should be considered at drug launch
- BIBLIOGRAPHY
- Journal papers, books, and conference abstracts
- Websites
- Datamonitor reports
- APPENDIX
- Report methodology
- Contributing experts
- About Datamonitor
- About Datamonitor Healthcare
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: Symptoms for ADHD/HKD in the DSM-IV and ICD-10
- Table 2: Definition of ADHD in the DSM-IV
- Table 3: Results of epidemiology studies of ADHD across the seven major markets
- Table 4: Prevalence of ADHD in the seven major markets, 2008
- Table 5: Performance of the US, 5EU and Japan ADHD markets, 2006-7
- Table 6: Adderall/Adderall XR: key facts, 2008
- Table 7: Concerta: key facts, 2008
- Table 8: Strattera: key facts, 2008
- Table 9: Focalin/Focalin XR: key facts, 2008
- Table 10: Metadate CD: key facts, 2008
- Table 11: Daytrana: key facts, 2008
- Table 12: Vyvanse: key facts
- Table 13: Ritalin franchise: key facts
- Table 14: Forecast launch dates in the US and 5EU
- Table 15: Forecast launch dates in Japan
- Table 16: Key patent expiries for key marketed drugs in the US and 5EU
- Table 17: Drugs in early stage development for ADHD, 2008
- Table 18: Key pipeline drugs in late-stage development for ADHD, 2008
- Table 19: Key late-stage development pipeline, alpha receptor agonist, 2008
- Table 20: Factors impacting on the revenues of Intuniv, 2008-2017
- Table 21: Factors impacting on the revenues of Clonicel, 2008-2017
- Table 22: Factors impacting on the revenues of Liquadd, 2008-2017
- Table 23: Factors impacting on the revenues of SPD-465, 2008-2017
- Table 24: Key late-stage development pipeline for ADHD, nicotinic agonists, 2008
- Table 25: Key late-stage development pipeline, other classes, 2008
- Table 26: Shire's ADHD pipeline, 2008
- Table 27: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Drug assessment summary overview of key marketed and pipeline ADHD drugs, 2008
- Figure 2: Historical (2004-07) and forecast (2008-17) ADHD sales revenue for key marketed and pipeline drugs across the 7MM
- Figure 3: Prevalence of ADHD co-morbidities in the MTA study
- Figure 4: Key unmet clinical need in the treatment of ADHD
- Figure 5: Revenues of ADHD drugs, 7MM, 2004-07
- Figure 6: Revenue market share of the leading branded ADHD drugs, 2004-07
- Figure 7: US sales revenues for ADHD drugs, 2004-07
- Figure 8: ADHD market value in the US, Japan and 5EU, 2004-17
- Figure 9: Sales revenue ($m) of ADHD drugs prescribed for pediatric, adolescent and adult patients, 2004-07
- Figure 10: Growth of sales revenue ($m) of drugs prescribed for pediatric, adolescent and adult ADHD in the US, 2004-07
- Figure 11: Sales revenue garnered by key players in the ADHD market (2006-2007 estimates), 2008-17 forecasts
- Figure 12: Current key marketed drugs - clinical and commercial attractiveness, 2008
- Figure 13: Historical (2004-07) and forecast (2008-2017) ADHD sales revenue for key marketed and pipeline drugs across the 7MM
- Figure 14: Adderall and Adderall XR ADHD-specific sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-2017 forecasts
- Figure 15: Adderall XR: SWOT analysis, 2008
- Figure 16: Concerta sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-2017 forecasts
- Figure 17: Concerta: SWOT analysis
- Figure 18: Strattera sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-2017 forecasts
- Figure 19: Strattera: SWOT analysis
- Figure 20: Focalin XR revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
- Figure 21: Focalin XR: SWOT analysis
- Figure 22: Metadate CD sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
- Figure 23: Metadate CD: SWOT analysis
- Figure 24: Daytrana sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
- Figure 25: Daytrana: SWOT analysis
- Figure 26: Vyvanse sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
- Figure 27: Vyvanse: SWOT analysis
- Figure 28: Ritalin LA sales ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
- Figure 29: Ritalin LA: SWOT analysis
- Figure 30: Impact of each key event on the ADHD market across the seven major markets, 2008-2017
- Figure 31: Drugs in late-stage development for ADHD by class, 2008
- Figure 32: Comparative late-stage pipeline ADHD drug sales revenue forecast, 2008-2017
- Figure 33: Sales forecast of Intuniv in the 7MM, 2007-2017
- Figure 34: Intuniv drug assessment summary, 2008
- Figure 35: Sales forecast of Clonicel in the 7MMs, 2007-2017
- Figure 36: Clonicel drug assessment summary, 2008
- Figure 37: Sales forecast of Liquadd in the 7MMs, 2007-2017
- Figure 38: Liquadd drug assessment summary
- Figure 39: Sales forecast for SPD-465 in the 7MMs
- Figure 40: SPD-465 drug assessment summary, 2008
- Figure 41: Shire ADHD franchise forecast ($m), 2008-17
- Figure 42: Vyvanse's drug homepage
- Figure 43: Promotional spend on physician detailing for key ADHD products in the US and 5EU, 2004-06
- Figure 44: Seasonal revenue growth and decline of ADHD drug
AbstractIntroduction
The ADHD market is currently valued at $3.85 billion and is set to increase over the next 10 years at a CAGR of 1.2%. Despite the continuing dominance of stimulant drugs, the 2002 launch of Strattera, the first non-stimulant treatment for ADHD, and the 2006 launch of Daytrana have served to open up the market, giving patients and physicians a greater choice of treatment options.
Scope
- Sales volume and value forecasts to 2017 of marketed brands, generics, and key late-stage pipeline drugs.
- Analysis of patient potential, unmet needs and clinical trial design in the ADHD market.
- Overview of key marketed brands and late stage pipeline drugs.
- Identification of future market events that are expected to affect ADHD revenues.
Highlights
- Estimated to be twice the size of the pediatric ADHD population, the highly prevalent, yet largely untapped, adult ADHD population continues to represent an attractive niche to target. The rising awareness of ADHD brought about by marketing campaigns for Adderall XR and Strattera has paved the way for the entry of additional adult ADHD drugs.
- Due to a lack of innovation, none of the forecast drugs have the potential to match the commercial success experienced by currently marketed brands. Shire's Intuniv (guanfacine) is expected to be positioned as a second-line treatment and will benefit from the company's established reputation in the market.
- J&J's Concerta's strong uptake is due to its first-to-market status as a once-daily ADHD treatment. Anticipated approval for use in adult patients, combined with Adderall XR's patent expiry will see Concerta becoming the market leader by 2017. However, owing to patent litigations, the timing of Concerta's genericization remains uncertain.
Reasons to Purchase
- Benchmark key late-stage pipeline ADHD drugs against current market leading brands.
- Assess region-specific (US, Japan, 5EU) sales forecasts of key late-stage pipeline drugs and marketed brands.
- Understand unmet needs and opportunities in the ADHD market based on key opinion leader comments.
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