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Commercial Insight: ADHD - Strattera Reigns Supreme as Branded Stimulants Slump

Published by: Datamonitor

Published: Jul. 22, 2005 - 145 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE

About the CNS pharmaceutical analysis team



CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the ADHD market

Key metrics



CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

The current ADHD market

The major ADHD market players and franchises

J&J's Concerta
Shire's Adderall franchise
Novartis's methylphenidate franchises
UCB's Metadate franchise
Lilly's Strattera
Summary of major players and their vital statistics
Strategic scoping and focus



CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Current and future opportunities and threats in the ADHD market

Global opportunities and threats

Opportunities
Threats
US

Market overview
Opportunities
Threats
Japan

Market overview
Opportunities
Threats
France

Market overview
Opportunities
Threats
Germany

Market overview
Opportunities
Threats
Italy

Market overview
Opportunities
Threats
Spain

Market overview
Opportunities
Threats
UK

Market overview
Opportunities
Threats


CHAPTER 4 FORECAST ANALYSIS

Assumptions and events

2004-05

Revised AACAP guidelines recommend Strattera for first-line ADHD
US approval of new 72mg Concerta dosage regimen
FDA approval of Adderall XR for the treatment of adult ADHD
Adderall XR sNDA submitted for adolescent ADHD
Ongoing patent challenge to Adderall XR
Launch of Concerta in France and Spain
UK launch of Strattera
Strattera labeled with bold product warning
Adderall XR withdrawn from Canadian market
Concerta become the US market leader
Lilly predicts decline in Strattera revenues
Launch of Strattera across the remaining EU countries
Launch of Metadate CD across the remaining EU countries under the brand name Equasym XL
Label changes for methylphenidate drugs
US launch of Focalin XR
Genericization of Concerta
2006

US launch of SPD-503
US launch of MTS
US launch of Attenace
Launch of generic Adderall XR
2007

Launch of NRP-104
Launch of SPD-465: Adderall XR2
2010

Strattera launch in Japan
SPD-503 will have little time to maximize revenues before genericization
2015

Strattera patent expiry
Focalin and Ritalin LA US patent expiries


CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
Adderall XR - damage limitation

The future of J&J's ADHD franchise?

J&J's CNS franchise on top, but set for decline
J&J's ADHD franchise - where to next?
A future without ADHD?
Focus on cognition

Strattera will become market leader in 2007 despite recent setbacks

Strattera's product warning, significantly impacts revenues
All-day reduction in symptomology, may help Strattera to bounce back
Lilly - pushing the boundaries
Strattera's revenues bounce back with the drug becoming market leader in 2007
Licensed indications have driven growth in the adult ADHD market

Promotion of adult ADHD by drug websites
Ideal time to gain approval of adult ADHD in the US
Adult ADHD - a no go in Europe at present time
Seasonal factors should be considered at drug launch

Implications for drug launch


APPENDIX A

Bibliography

Websites
Journals and abstracts


APPENDIX B

Report methodology

Datamonitor forecast methodology
Sales calculations
About Datamonitor

Market Forecast Data

Global forecasts

US forecasts

Japan forecasts

MEU5 forecasts

France forecasts

Germany forecasts

Italy forecasts

Spain forecasts

UK forecasts

List of Tables

Table 1: Revenue forecast of ADHD drugs across the seven major markets, 2005-15
Table 2: Revenues of ADHD drugs across the seven major markets, 2004
Table 3: Revenues of ADHD drugs in the US, 2004
Table 4: Revenues of ADHD drugs in Japan, 2004
Table 5: Revenues of ADHD drugs in France, 2004
Table 6: Revenues of ADHD drugs in Germany, 2004
Table 7: Revenues of ADHD drugs in Spain, 2004
Table 8: Revenues of ADHD drugs in the UK, 2004
Table 9: J&J's US marketed CNS portfolio
Table 10: J&J's CNS R&D pipeline, 2005
Table 11: Child and adult revenues ($m) of ADHD drugs in the US market, 2001-04
Table 12: Child and adult revenues ($m) of ADHD drugs in the EU and Japan, 2001-04
Table 13: Strattera key facts
Table 14: Key Strattera events, 2004-2005
Table 15: Adderall and Adderall XR key facts
Table 16: Key Adderall and Adderall XR events, 2004-2005
Table 17: Concerta key facts
Table 18: Key Concerta events, 2004-2005
Table 19: Ritalin franchise key facts
Table 20: Dexedrine and Dexedrine SR key facts
Table 21: Dextrostat key facts
Table 22: Focalin key facts
Table 23: Key Focalin franchise events, 2004-2005
Table 24: Metadate franchise key facts
Table 25: Key Metadate franchise events, 2003-2005
Table 26: Global ADHD market forecasts (2005-2015) ($m)
Table 27: US ADHD market forecasts (2005-2015) ($m)
Table 28: Japan ADHD market forecasts (2005-2015) ($m)
Table 29: MEU5 ADHD forecasts (2005-2015) ($m)
Table 30: France ADHD market forecasts (2005-2015) ($m)
Table 31: Germany ADHD market forecasts (2005-2015) ($m)
Table 32: Italy ADHD market forecasts (2005-2015) ($m)
Table 33: Spain ADHD market forecasts (2005-2015) ($m)
Table 34: UK ADHD market forecasts (2005-2015) ($m)
List of Figures

Figure 1: Revenues of currently branded stimulants, atomoxetine, generics and pipeline ADHD drugs, 2001-15
Figure 2: Revenue market share of the leading branded ADHD drugs, 1999-2004
Figure 3: Seven major market revenue forecast of J&J's ADHD franchise to 2015
Figure 4: Seven major market revenue forecast of Shire's ADHD franchise to 2015
Figure 5: Seven major market revenue forecast of Novartis' ADHD franchise to 2015
Figure 6: Seven major market revenue forecast of UCB's ADHD franchise to 2015
Figure 7: Seven major market revenue forecast of Lilly's ADHD franchise to 2015.
Figure 8: Revenue growth, market share and revenues of leading ADHD drugs across the seven major markets, 2003-04
Figure 9: ADHD drug revenue market share of leading manufacturers, 2001-15
Figure 10: ADHD drug revenues of leading manufacturers, 2001-15
Figure 11: Key players in the ADHD market
Figure 12: NICE method for measuring cost-effectiveness of drug treatment for ADHD
Figure 13: Most cost-effective treatment of ADHD in the UK
Figure 14: Shire's damage limitation strategy for Adderall XR
Figure 15: Shire's on-line Adderall XR patient questionnaire
Figure 16: Global quarterly revenues of Strattera since launch and key lifecycle events
Figure 17: US revenues of the market-leading ADHD drugs, 2002-05
Figure 18: Adult revenues ($m) of ADHD drugs in the US market, 2001-04
Figure 19: Comparison of ADHD promotion of Strattera and Adderall XR home pages
Figure 20: US drug revenues, 2001-04
Figure 21: Monthly growth and decline of US drug revenues over time, 2001-04
Figure 22: Revenue growth of ADHD drug form launch

Abstract

Introduction
With annual revenues of over $2.6 billion in 2004, and a compound annual growth rate of 36.7% since 2002, the ADHD market is one of the most rapidly growing CNS markets. This growth is primarily attributed to the launches of several novel, once-daily ADHD therapies initially in the US and then periodically across the remaining major markets since 2000.

Scope
Overview of current market including profiles of key brands and key events impacting each brand during 2004-2005
Assessment of current and future opportunities and threats in the ADHD market across the seven major pharmaceutical markets
Global sales for leading ADHD products from 2002-2004 are presented, with projections for future performance up to 2015
In-depth discussion of assumptions and events used in forecast analysis

Highlights
US revenue growth within the ADHD market follows a distinct annual cycle, with the highest revenue growth occurring in August and September, coinciding with the end of the school summer vacation. Manufacturers wishing to maximize revenue potential on drug launch should therefore take advantage of this period of high drug revenue growth.

Drugs licensed for the treatment of adult ADHD are driving growth in this sector of the market, and derive significantly greater revenue shares as compared to drugs that are used off-label. Datamonitor believes that now is an ideal time for manufacturers to gain approval for adult ADHD in the US, and enter this expanding market.

Strattera was the most rapidly growing drug in the US ADHD market with 2004 revenues of $632m, However, Q1 2005 revenues of the drug fell by 25.1% over Q4 2004, as a result of a product warning and other adverse market events. Nevertheless, Datamonitor forecasts that Strattera will bounce back and become market leader form 2007 onwards.

Reasons to Purchase
Assess leading ADHD drugs and identify key success factors within this sector
Understand key market drivers and predict the future performance of key compounds
Benchmark pipeline ADHD drugs against currently marketed products and assess their future market potential


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