Commercial and Pipeline Insight: ADHD

Immature adult market continues to offer greatest commercial potential

Publication Date	April 2008
Publisher	Datamonitor
Product Type	Report
Pages	211
ISBN Number	not applicable
Product Code	DAT11464

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Summary

Introduction

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.

Content

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