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Published by: Datamonitor
Published: Jul. 3, 2009 - 136 Pages
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Central Nervous System pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Strategic scoping and focus
- Datamonitor insight into the disease market
- Related reports
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Market definition for this report
- Countries and regions included in this report
- Seven major market assessment
- Current and future market overview
- The seven major ADHD market grew to almost $4.4 billion in 2008
- The seven major ADHD market is forecast to decline to $3.3 billion by 2018
- Regional market dynamics
- The US remained the largest ADHD market in 2008, occupying a 94% market share
- The dominance of the US ADHD market is set to continue
- Class market dynamics
- Market share of non-stimulant drugs is expected to double over the forecast period
- Comparison with previous market forecast
- Total ADHD market downgraded since 2008 forecast
- Launch of neuronal nicotinic receptor agonists represents the most fundamental change to pipeline ADHD drug forecast
- Rest of the world snapshot
- Rest of the world sales accounted for just 2.4% of the ADHD market in 2008
- Concerta is the market leading ADHD product in the Rest of the world market
- The Rest of the world offers limited sales potential to future market entrants
- CHAPTER 3 BRAND DYNAMICS
- Major market events
- US study links ADHD stimulant treatments and pediatric sudden death
- FDA identifies limitations of study and urges parents not to discontinue children's ADHD treatment
- Study has the potential to reignite the debate over the safety of ADHD drugs in children
- Datamonitor expects parents of children with ADHD to be most influenced by study results
- New NICE guidelines published in September 2008
- Emphasis on behavioral treatments represents a threat to the uptake of ADHD drugs among UK children
- Overview of competitive landscape
- Brand dynamics
- Shire's Adderall XR remained the market leading ADHD product in 2008
- Vyvanse is to become the leading brand in the ADHD market by 2012
- Shire's dominance of the ADHD market is set to continue
- Abbott/NeuroSearch's neuronal nicotinic agonists are expected to achieve the greatest sales of all current late-stage pipeline products
- Update of key marketed ADHD drugs
- Adderall XR (amphetamine extended release, Shire)
- The April 2009 launch of generic competition in the US will cause sales of Adderall XR to decline sharply
- Shire has endeavored to switch patients from Adderall XR to Vyvanse
- FDA Warning Letter addressing Adderall XR's webpage and video will exert a minimal impact on sales
- Vyvanse (lisdexamfetamine dimesylate, Shire)
- The April 2009 launch of generic Adderall XR will impact upon future sales of Vyvanse in the US
- Actavis' challenge to Vyvanse's US exclusivity represents a further threat to sales
- Approval for adult ADHD substantially broadens the patient potential of Vyvanse
- Slowed development pushes back Datamonitor's expected launch of Vyvanse in the EU to Q2 2011
- Shire and GlaxoSmithKline's March 2009 co-promotion deal is too late for Vyvanse
- June 2009 label change to include 13-hour post-dose efficacy in pediatrics is unlikely to influence physicians' prescribing behavior
- Non-ADHD indication expansions for Vyvanse are on the horizon
- Concerta (methylphenidate, Johnson & Johnson)
- The spectre of generic competition continues to loom following March 2009 ruling from US District Court
- Concerta faces strong competition for a share of the adult ADHD population
- Launch of Concerta in Japan has doubled the choice of treatments in this market
- Daytrana (methylphenidate transdermal system, Shire)
- Downgrade to Daytrana forecast following March 2009 withdrawal of European Marketing Authorization Application (MAA)
- Voluntary market recall of a limited portion of Daytrana patches in March 2009 does not pose a threat to long-term sales
- Despite demonstration of Daytrana's efficacy in adolescent ADHD, future approval is unlikely to strengthen uptake
- Strattera (atomoxetine, Eli Lilly)
- Despite challenges to Strattera's US patent, Datamonitor does not forecast generic competition until 2017
- Approval of Strattera in Japan correctly predicted by Datamonitor
- Approval for maintenance treatment of ADHD unlikely to substantially bolster sales
- In common with Adderall XR, Strattera was subject to an FDA Warning Letter in September 2008
- Metadate franchise (methylphenidate hydrochloride, Shire)
- Shire's February 2009 acquisition of non-US rights to Equasym from UCB paves the way for the European launch of Vyvanse
- Liquadd (dextroamphetamine sulfate, Auriga Laboratories Inc)
- Launch of Liquadd took place in the US in Q3 2008
- Forecast downgraded due to low initial uptake
- Forecasted pipeline products
- Intuniv (guanfacine hydrochloride, Shire)
- US launch of Intuniv is expected to take place in Q4 2009 following resubmission of New Drug Application to FDA in January 2009
- Pooled Phase III data announced in May 2008: Intuniv improves ADHD symptoms up to 24 hours post dose
- Phase III secondary endpoints demonstrate Intuniv's efficacy in patients with ADHD and oppositional defiant disorder (ODD)
- Datamonitor maintains the view that positioning as a second-line treatment option will limit uptake of Intuniv
- Seeking regulatory approval of Intuniv for the treatment of adult ADHD remains an option
- Clonicel (clonidine hydrochloride, Addrenex/Sciele)
- Positive Phase III data announced in 2008-09: Clonicel has a complementary effect when used with stimulants
- Clonicel is expected to receive approval as both a monotherapy and an add-on therapy to stimulant medication
- ABT-894 (sofinicline, Abbott/NeuroSearch)
- Positive Phase II results announced in June 2008: ABT-894 demonstrates efficacy in adult ADHD
- ABT-894 appears to have a good cardiovascular safety profile
- Can Abbott bring both neuronal nicotinic agonists to market at the same time?
- ABT-089 (pozanicline, Abbott)
- Positive Phase II data in adults with ADHD presented at the 161st Annual Meeting of the American Psychiatric Association in May 2008
- Update of unforecasted pipeline products
- AZD3480 (Ispronicline, AstraZeneca/Targacept)
- Preliminary results from Phase II trial in adult ADHD announced in May 2009
- Future development of AZD3480 remains uncertain
- Eltoprazine (PsychoGenics Inc)
- Promising Phase IIa data announced in June 2008: Eltoprazine leads to a 42% reduction in ADHD symptoms in adults
- SPN-810 (Supernus Pharmaceuticals)
- Phase IIa trial of SPN-810 in children with ADHD and persistent conduct problems initiated in September 2008
- Supernus would benefit from developing a once-daily formulation of SPN-810
- Supernus lacks the sales and marketing capability to commercialize SPN-810 independently
- MK-0249 (Merck)
- Phase IIa clinical trial completed in April 2008, although results are yet to be published
- Discontinued projects
- SPD-465 (mixed amphetamine salt, Shire)
- BIBLIOGRAPHY
- Journal papers/Books
- Websites
- Datamonitor reports
- APPENDIX A - MARKET ASSUMPTIONS
- New product launches
- Patent expiries
- Data definitions, limitations and assumptions
- Standard units
- Derivation of sales forecasts and pricing trends
- Forecast methodology
- APPENDIX B
- Contributing experts
- Conferences attended
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the central nervous system analysis team
- Disclaimer
- List of Tables
- Table 1: Performance of the attention-deficit hyperactivity disorder (ADHD) markets in the US, 5EU and Japan, 2004-08
- Table 2: Sales forecasts of drugs currently marketed for attention-deficit hyperactivity disorder (ADHD) in the seven major markets ($m), 2008-2018
- Table 3: Comparison of leading branded drug sales ($m) for attention-deficit hyperactivity disorder (ADHD) in the seven major markets and the rest of the world (ROW), 2008
- Table 4: Limitations of Gould et al.'s (2009) study into sudden death in children and use of stimulant medication
- Table 5: Top 6 branded drug sales ($m) for attention-deficit hyperactivity disorder (ADHD) in the seven major markets, 2008-2018
- Table 6: Key products in late-stage R&D pipeline for attention-deficit hyperactivity disorder (ADHD), 2009
- Table 7: Off-label prescribing of Vyvanse, 2008
- Table 8: Summary of Phase III results for Intuniv in attention-deficit hyperactivity disorder (ADHD), announced May 2008-May 2009
- Table 9: Summary of Phase III results for Clonicel (clonidine hydrochloride) for attention-deficit hyperactivity disorder (ADHD), announced in 2008-09
- Table 10: Clinical trial summary for ABT-894 (sofinicline) in attention-deficit hyperactivity disorder (ADHD)
- Table 11: Clinical trial summary for ABT-089 (pozanicline) in attention-deficit hyperactivity disorder (ADHD)
- Table 12: Top-line results from Phase II study of AZD3480 in adult attention-deficit hyperactivity disorder (ADHD)
- Table 13: Key facts: Phase IIa trial of SPN-810 in children with attention-deficit hyperactivity disorder (ADHD) and persistent serious conduct problems
- Table 14: Datamonitor's estimated launch dates for in attention-deficit hyperactivity disorder (ADHD) products in the seven major markets, 2009-2018
- Table 15: Patent expiry dates for the approved in attention-deficit hyperactivity disorder (ADHD) products in the seven major markets, 2009-2018
- List of Figures
- Figure 1: Sales of attention-deficit hyperactivity disorder (ADHD) drugs, ($m) in the US, 5EU and Japan, 2004-08
- Figure 2: Key events impacting the attention-deficit hyperactivity disorder (ADHD) market, April 2008-April 2009
- Figure 3: Attention-deficit hyperactivity disorder (ADHD) market value in the seven major markets, 2005-2018
- Figure 4: Impact of key events on the attention-deficit hyperactivity disorder (ADHD) market, 2009-2018
- Figure 5: Attention-deficit hyperactivity disorder (ADHD) market value ($m) in the seven major markets, 2008-2018
- Figure 6: Revenues of stimulant and non-stimulant attention-deficit hyperactivity disorder (ADHD) drugs across the seven major markets, 2005-2018
- Figure 7: Comparison of Datamonitor's updated seven major market attention-deficit hyperactivity disorder (ADHD) market forecast to 2018 with previous 2008 market forecast to 2017
- Figure 8: Datamonitor's previous and updated sales ($m) forecast for total pipeline attention-deficit hyperactivity disorder (ADHD) drugs in the seven major markets, 2008-2018
- Figure 9: The global attention deficit hyperactivity disorder (ADHD) market split by region, 2008
- Figure 10: Rest of the world sales in the attention-deficit hyperactivity disorder (ADHD), major depressive disorder and insomnia markets in 2007 and 2008
- Figure 11: Revenue market share of the leading branded attention-deficit hyperactivity disorder (ADHD) drugs, 2004-08
- Figure 12: Shire's attention-deficit hyperactivity disorder (ADHD) franchise forecast ($m), across the seven major markets 2008-2018
- Figure 13: Shire's promotional spend for Adderall XR and Vyvanse in the US, 2006-08
- Figure 14: Datamonitor's 2008 and updated sales ($m) forecast for Shire's Adderall XR in the seven major markets, 2008-2018
- Figure 15: Approval of key brands for the treatment of adult attention-deficit hyperactivity disorder (ADHD)
- Figure 16: Datamonitor's updated sales ($m) forecast for Shire's Vyvanse (lisdexamfetamine) in the seven major markets, 2008-2018
- Figure 17: Concerta sales revenue ($m) across the seven major markets, markets, 2008-2018
- Figure 18: Datamonitor's updated sales ($m) forecast for Daytrana in the seven major markets, 2008-2018
- Figure 19: Datamonitor's 2008 and updated sales ($m) forecast for Strattera in attention-deficit hyperactivity disorder (ADHD) in the seven major markets, 2008-2018
- Figure 20: Datamonitor's updated sales ($m) forecast for the Metadate franchise in the seven major markets, 2008-2018
- Figure 21: Datamonitor's 2008 and updated sales ($m) forecast for Liquadd in the seven major markets, 2008-2018
- Figure 22: Attention-deficit hyperactivity disorder (ADHD) sales ($m) for Intuniv in the seven major markets, 2008-2018
- Figure 23: Attention-deficit hyperactivity disorder (ADHD) sales ($m) for Clonicel in the seven major markets, 2009-2018
- Figure 24: Attention-deficit hyperactivity disorder (ADHD) sales ($m) for ABT-894/ABT-089 in the seven major markets, 2009-2018
AbstractIntroduction
Driven primarily by continued uptake of Shire's market leading ADHD drug, Adderall XR (amphetamine extended release), seven major market ADHD revenues grew strongly at a compound annual growth rate (200408) of 13.5% to reach almost $4.4 billion in 2008. Ongoing uptake of Shire's Vyvanse (lisdexamfetamine), was also a key contributor to market growth between 2007 and 2008.
Scope- This report gives a strategic analysis of the likely impact that recent events will have on the future ADHD market.
- Includes sales forecasts for the key ADHD brands and generics as well as pipeline agents in the seven major markets to 2018.
- Provides a global market snapshot by including sales analysis for leading ADHD brands outside the seven major markets.
- Key conclusions are supported by key opinion leader comment.
Highlights
The April 2009 launch of generic competition in the US will cause sales of Shire's leading ADHD product, Adderall XR, to decline sharply. However, Datamonitor maintains the expectation that Shire will remain the dominant player in the ADHD market over the forecast period due to the company's broad portfolio of products.
Intuniv (guanfacine hydrochloride) represents Shire's first venture into the non-stimulant segment of the ADHD market. Datamonitor believes Shire will market Intuniv as a second-line treatment option, due to clinical data demonstrating inferior efficacy to stimulant treatments, putting it in direct competition with Strattera.
The publication of a US government-sponsored study reporting an association between ADHD treatments and sudden unexplained death among pediatrics will reignite the debate over the safety of ADHD drugs in children. The media coverage will cause some parents in the US to choose to discontinue or not begin stimulant therapy for their children.
Reasons to Purchase- Understand when late-stage pipeline products will launch and what impact these will have on the market during the forecast period 2009 to 2018.
- Quantify the current size of the seven major markets and the trends in the rest of the world.
- Assess the impact of events, such as patent expiries and new product launches, on the future sales of key brand name ADHD products.
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