ADHD（注意欠陥多動性障害）用薬剤の市場分析と動向

Introduction

The current ADHD market has long been saturated with traditional methylphenidate and amphetamine based drugs, with the only innovations being the development of extended release versions. However, the recent launch of Strattera (atomoxetine) has already shattered the traditional approach to drug therapy, opening the door for the uptake of new novel drug therapies.

Scope of this report

• Overview of the epidemiology, diagnosis and management of ADHD across the seven major pharmaceutical markets
• Examination of the ADHD pipeline with in-depth clinical and commercial profiles of late-stage candidates, incorporating Datamonitor opinion
• Seven market sales forecasts, commercial potential and research/clinical/commercial assessment of late-stage products to 2015
• Insight and commentary from qualitative interviews with ADHD opinion leaders in the US and Europe

Research and analysis highlights

The current global ADHD market is worth $2.7m and is expected to reach $3.4m by 2015, driven primarily by the launch of pipeline drugs and the continued growth of Strattera.

Innovation is key - manufacturers can no longer expect significant returns on standard extended release formulations. The current pipeline offers drugs with novel delivery mechanisms; improved durations of action and anti-abuse profiles, which will help differentiate these pipeline drugs from the current established ADHD therapies.

Although ADHD drugs have demonstrated significant efficacy in improving the three main symptoms of ADHD - inattention, hyperactivity and impulsivity - none have shown efficacy in treating the cognitive deficits of ADHD.

Key reasons to read this report

• Understand unmet needs in the ADHD market based on opinion leader comments regarding both currently marketed and pipeline products
• Benchmark key late-stage ADHD compounds against current market leaders
• Assess the global sales forecasts of late-stage pipeline drugs for ADHD and examine their clinical and commercial potential

ABOUT DATAMONITOR HEALTHCARE

About the CNS pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the ADHD market

ADHD market - key metrics

Datamonitor pipeline assessment summary

CHAPTER 2 PATIENT POTENTIAL

Disease definition and classification

Etiology of ADHD

Structural abnormalities

Genetic predisposition

Neurotransmitter dysfunction

Diagnostic criteria of ADHD

Epidemiology of ADHD

Key patient segments

Gender

Comorbidities

Clinical unmet needs of ADHD

Diagnostic complications

Hyperkinesis versus attention deficit hyperactivity disorder

Gender

Age

Duration of symptoms

Diagnostic tools

ADHD Rating Scale

Conners Rating Scale-Revised (CRS-R)

Copeland symptom checklist

Barkleys Current Symptoms Scale-Self Report Form (home and school)

Brown ADD Scale (diagnostic form)

Parent-completed Child Behavior Checklist

Teacher Report Form (TRF) of Child Behavior Checklist

ADD-H: Comprehensive Teacher Rating Scale (ACTeRS)

The IOWA Conners Rating scale

Diagnostic unmet needs

CHAPTER 3 R&D APPROACH

Classification of marketed and pipeline products

Marketed products

Stimulants - methylphenidate and amphetamines

Non-stimulants - Strattera

Pipeline compounds

Clinical trials and drug development

Regulatory barriers to the development of pediatric medications

Non-regulatory barriers to the development of pediatric medications

Novel approaches to enhance traditional pediatric clinical trials

Drug models in clinical trial development

CHAPTER 4 ADHD PIPELINE ANALYSIS

Pipeline overview

Drugs launched in 2005

Registered and Phase III overview

Phase II overview

Phase I overview

Preclinical overview

Key companies involved in the ADHD pipeline

Shire

Despite an initial decline in ADHD revenues, Shires pipeline ADHD drugs will save the day

Novartis

Focalin XR will rejuvenate Novartiss ADHD franchise, nearly doubling current revenues

Strategies for success

Innovation is key - manufacturers can no longer expect significant returns on standard extended-release formulations

Comparative positioning of pipeline drugs

Methodology of SWOT analysis

CHAPTER 5 LATE-STAGE METHYLPHENIDATE DRUG ANALYSIS & FORECASTS

Methylphenidate drugs

Recently launched drugs

Pipeline summary

Concerta - the gold-standard methylphenidate drug therapy

SWOT analysis of Concerta

Equasym XL

Equasym XL is more effective than Concerta during the morning hours

Equasym XL effective and safe in treating ADHD symptoms throughout the school day

SWOT analysis of Equasym XL

The proven safety and pharmacologic profile of Equasym XL will aid uptake in Europe

UCBs delayed launch strategy in Europe will impact long-term revenues

Equasym XL will reach peak share after the first two years of launch

Focalin XR

Focalin XR is generally perceived to act in less than one hour and remain effective for over eight hours

Focalin XR is effective in treating children and adolescents with ADHD with few adverse effects

SWOT analysis of Focalin XR

Despite the strong therapeutic profile of Focalin XR, it will face competition from numerous branded and generic extended-release stimulants in the near future

Approval for adult ADHD will significantly boost revenues

Despite the strength of Focalin XRs therapeutic profile and marketing potential, it will be hindered by generic stimulants and novel ADHD drugs

MTS

MTS

MTS failed to demonstrate clinical significance on the primary endpoint in its first Phase III clinical trial

MTS is significantly superior to placebo, with significantly improved scores in teacher, parent and clinician ratings of patient behavior and attention

MTS demonstrates significant efficacy compared to placebo in Phase II classroom study

MTS demonstrates significant efficacy compared to placebo in Phase II classroom study

SWOT analysis of MTS

Kids will love MTS

Patch technology improves safety, compliance and duration of action

MTS will become the market-leading stimulant by 2010

CHAPTER 6 LATE-STAGE AMPHETAMINE DRUG ANALYSIS & FORECASTS

Amphetamine drugs

Pipeline summary

Adderall XR - the gold-standard amphetamine drug therapy

SWOT analysis of Adderall XR

NRP-104

NRP-104 achieves similar blood amphetamine levels to current extended-release amphetamine products

NRP-104 demonstrates comparable efficacy to Adderall XR

SWOT analysis of NRP-104

NRP-104 - the first non-scheduled stimulant

Equivalent efficacy to Adderall XR in treating children and adults

NRP-104 will become the market-leading amphetamine by 2010

SPD-465

SWOT analysis of SPD-465

SPD-465 may sustain effect for too long in pediatric patients, limiting uptake

With Shires already strong ADHD pipeline, what will be the fate of SPD-465?

SPD-465 will be overshadowed by NRP-104

CHAPTER 7 LATE-STAGE OTHER ADHD DRUG ANALYSIS & FORECASTS

Other ADHD drugs

Pipeline summary

Strattera - the gold-standard non-stimulant drug therapy

SWOT analysis of Strattera

Attenace (modafinil)

Attenace consistently exhibits a robust efficacy on both the inattentive and hyperactive symptoms of ADHD

Attenace significantly improves ADHD symptoms and is well tolerated in children with ADHD

Attenace improves ADHD symptoms in children

Attenace improves cognition and response inhibition in adult ADHD

SWOT analysis of Attenace

Attenace (modafinil) will be well received as it is an established schedule IV drug with a proven safety record, approved across the seven major markets

Attenace to target comorbid cognitive deficits in ADHD

Attenace will climb to fourth position in the ADHD market by 2012

SPD-503

Guanfacine in the treatment of adult ADHD

Guanfacine treatment of hyperactivity and inattention in pervasive developmental disorders

Increased prescribing of guanfacine, in the absence of severe side effects

Guanfacine is a safe and effective treatment for children with tic disorders and ADHD

Ongoing Phase III pivitol studies

SWOT analysis of SPD-503

SPD-503 will have little time to maximize revenues before genericization

CX-516 & CX-717 (AMPAKINE)

SWOT analysis of AMPAKINES

AMPAKINES - a additive cognitive enhancer to traditional ADHD therapy

SGS-742

SWOT analysis of SGS-742

The first drug to solely target adult ADHD

Late-stage development compounds recently discontinued

TC-5231 (mecamylamine oral gel capsules)

SPD473

NS-2359

ABT-089

CHAPTER 8 INNOVATIVE EARLY-STAGE PROJECTS

Innovative early-stage projects

SON-216 (bifemelane)

DOV-102677

Dextroamphetamine (transdermal patch)

Lobeline

DAR-0300

PGI-256 and PGI-415

SPD-483

APPENDIX A

ADHD market data

KOL interviews

Contributing experts

Bibliography

APPENDIX B

Report methodology

About Datamonitor

List of Tables

Table 1: Forecast revenues of pipeline ADHD drugs to 2015 across the seven major markets

Table 2: Summary of ADHD pipeline drug SWOT analysis and peak US market share

Table 3: Symptoms for ADHD/HKD in the DSM-IV and ICD-10

Table 4: Definition of ADHD in the DSM-IV

Table 5: Prevalence of ADHD

Table 6: Prevalence, diagnosis and drug treatment rates of patients with ADHD across the seven major markets

Table 7: Forecast prevalence (000s) of ADHD across the seven major markets to 2010

Table 8: ADHD drugs in launched in 2005

Table 9: ADHD drugs in pre-registration, 2005

Table 10: ADHD drugs in Phase III clinical development, 2005

Table 11: ADHD drugs in Phase II clinical development, 2005

Table 12: ADHD drugs in preclinical development, 2005

Table 13: Revenues ($m) from Shires marketed CNS drugs across the seven major markets, (2001-04)

Table 14: Shires marketed and pipeline ADHD drugs, 2005

Table 15: Revenues ($m) from Novartiss marketed CNS drugs across the seven major markets, 2001-04

Table 16: Novartiss marketed and pipeline ADHD drugs, 2005

Table 17: Opportunity/threat factors and weightings

Table 18: Opportunity/threat factors - scoring definitions

Table 19: Strength/weakness factors and weightings

Table 20: Strength/weakness factors - scoring definitions

Table 21: Methylphenidate drugs in launched in 2005 to date

Table 22: Methylphenidate drugs in late stage development, 2005

Table 23: SWOT analysis of Concerta

Table 24: SWOT analysis of Equasym XL

Table 25: Forecast revenues of Metadate CD/Equasym XL across the seven major markets to 2015

Table 26: SWOT analysis of Focalin XR

Table 27: Promotional spend vs. drug revenues in the first year after launch

Table 28: Forecast revenues of Focalin XR across the seven major markets

Table 29: SWOT analysis of MTS

Table 30: Forecast revenues of MTS across the seven major markets

Table 31: Amphetamine drugs in late stage development, 2005

Table 32: SWOT analysis of Adderall XR

Table 33: SWOT analysis of NRP-104

Table 34: Forecast revenues of NRP-104 across the seven major markets

Table 35: SWOT analysis of SPD-465

Table 36: Forecast revenues of SPD-465 across the seven major markets

Table 37: Other ADHD drugs in late stage development, 2005

Table 38: SWOT analysis of Strattera

Table 39: SWOT analysis of Attenace

Table 40: Forecast revenues of Attenace across the seven major markets

Table 41: SWOT analysis of SPD-503

Table 42: Forecast revenues of SPD-503 across the seven major markets

Table 43: SWOT analysis of AMPAKINES

Table 44: SWOT analysis of SGS-742

Table 45: ADHD drugs recently suspended or discontinued, 2005

Table 46: ADHD drugs in preclinical development, 2005

Table 47: Strattera key facts

Table 48: Key Strattera events, 2003-2005

Table 49: Adderall and Adderall XR key facts

Table 50: Key Adderall and Adderall XR events, 2003-2005

Table 51: Concerta key facts

Table 52: Key Concerta events, 2003-2005

Table 53: Metadate franchise key facts

Table 54: Key Metadate franchise events, 2003-2005

Table 55: ADHD drugs in pre-clinical development, 2005

List of Figures

Figure 1: SWOT analysis of ADHD pipeline drugs compared to the gold standards marketed comparator products

Figure 2: Key findings from the UK ADDIS ADHD study

Figure 3: NICE method for measuring cost-effectiveness of drug treatment for ADHD

Figure 4: US sales of Shires Adderall ADHD franchise and its generic competitors

Figure 5: US revenue forecast of Shires ADHD franchise to 2015

Figure 6: SWOT analysis of Shires ADHD franchise

Figure 7: US revenues of Novartiss ADHD franchise

Figure 8: US revenue forecast of Novartis ADHD franchise to 2015.

Figure 9: SWOT of Novartiss ADHD pipeline

Figure 10: US revenues of stimulants (schedule II, and schedule II or non-classified) and non-stimulants to 2015

Figure 11: SWOT analysis of ADHD pipeline drugs compared to the gold-standard marketed comparator products

Figure 12: SWOT analysis of methylphenidate ADHD pipeline drugs compared to the gold standard-Concerta

Figure 13: Pharmacologic profile of Equasym XL compared to Concerta

Figure 14: Pharmacologic profile of Focalin XR compared to Concerta

Figure 15: Pharmacologic profile of MTS compared to Concerta

Figure 16: SWOT analysis of amphetamine ADHD pipeline drugs compared to the gold standard-Adderall XR

Figure 17: Pharmacokinetic profile of NRP-104 compared to marketed extended-release amphetamines

Figure 18: NRP-104 efficacy and duration of action - time course of SKAMP (least mean squares S.E.)

Figure 19: Pharmacologic profile of NRP-104 compared to Adderall XR

Figure 20: Pharmacologic profile of SPD-465 compared to Adderall XR

Figure 21: SWOT analysis of other ADHD pipeline drugs compared to the gold standard-Strattera

Figure 22: Pharmacologic profile of Attenace compared to Strattera

Figure 23: Change from baseline in ADHD-RS

Figure 24: Pharmacologic profile of SPD-503 compared to Strattera

Figure 25: Pharmacologic profile of AMPAKINES compared to Strattera

Figure 26: Pharmacologic profile of SGS-742 compared to Strattera