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Commercial Insight: Antipsychotics - From Blockbuster Brands to Billion Dollar Generics

Published by: Datamonitor

Published: Dec. 22, 2004 - 173 Pages


Table of Contents


TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY 3

Objective of the analysis 3

Datamonitor insight into the antipsychotics market 3

CHAPTER 2 MARKET DEFINITION AND OVERVIEW 10

Market definition for this report 10

Current market situation 10

Zyprexa - the gold-standard antipsychotic 13

Strategic scoping and focus 18

CHAPTER 3 COUNTRY MARKET ASSESSMENTS 20

Current and future opportunities and threats in the antipsychotic market 20

Global opportunities and threats 20

Opportunities 20

Threats 35

US 41

Market overview 41

Opportunity 42

Threats 45

Japan 50

Opportunities 51

Threats 55

France 57

Market overview 57

Opportunity 58

Threats 59

Germany 62

Market overview 62

Opportunities 63

Threats 67

Italy 71

Market overview 71

Opportunities 72

Threats 74

Spain 76

Market overview 76

Opportunities 77

Threats 78

UK 81

Market overview 81

Opportunities 82

Threats 86

CHAPTER 4 FORECAST ANALYSIS 92

Assumptions and events 92

2004 92

Genericization of Solian 92

Launch of IM Zyprexa 93

Zyprexa approval for bipolar disorders 93

Risperdal receives approvable letter for autism 94

Risperdal approval for bipolar disorders 95

Risperdal Consta launch 95

Seroquel approval for bipolar mania 95

Geodon approved for bipolar mania 96

Abilify launch in the EU and FDA approval for bipolar mania in the US 96

Poor 2004 performance for Zyprexa 97

2005 98

Re-launch of Serdolect 98

Launch of Seroquel in France 99

Abilify lifecycle management 99

2006 100

Launch of Asenapine 100

Launch of paliperidone ER 100

Serdolect patent expiry 101

2007 102

Zomaril launch 102

Geodon US patent expiry 102

Seroquel patent expiry 103

Launch of Bifeprunox 103

2008 104

Seroquel line extension 104

Risperdal patent expiry 105

Launch of ORG-24448 106

Launch of PNU170413 107

2009 107

Launch of blonanserin 107

Abilify global patent expiry 108

Zomaril patent expiry 108

2011 109

Seroquel US patent expiry 109

Zyprexa patent expiry 110

Limitations of data 110

Forecasts 110

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 111

Achieving and maintaining market leadership 111

Different strategies leading to differing definitions of market leader 111

Indication expansion 111

Reformulations 112

Specialization or generalization - Zyprexa versus Risperdal 113

Risperdal lifecycle strategies 114

Zyprexa lifecycle strategies 128

Strategies employed by Zyprexa and Risperdal 132

Lifecycle strategies - the pros, the cons and the implications 133

Choice, implementation and outcome of lifecycle strategies 135

BMS outlines future lifecycle strategies for Abilify 135

Generic threat to Zyprexa 138

Zyprexa patent challenge 138

Anticipation 139

Obviousness 139

Inequitable conduct 139

Double-patenting 140

Public use 140

Trial outcome 140

The worst case scenario - approval of generic olanzapine 141

The impact of generic olanzapine 141

APPENDIX A 145

APPENDIX B 161





Abstract

Introduction
Second Generation Antipsychotics (SGAs) continue to drive the antipsychotic market with a growth rate of 27.2% between 2002-2003, yielding revenues of over $9.5 billion in 2003 responsible for a 93.3% share of the market. However, several patent expiries and product launches are set to send the market through a period of change.

Scope
Overview of current market including profiles of key brands and key events impacting each brand during 2003-2004
Assessment of current and future opportunities and threats in the antipsychotics market across the seven major pharmaceutical markets
Global sales for leading antipsychotic products from 1999-2003 are presented, with projections for future performance up to 2014
In-depth discussion of assumptions and events used in forecast analysis
Highlights
With an increasingly crowded schizophrenia market, SGA manufacturers are seeking to add new indications to their products labeling, capitalizing on the existing high off-label. Already, the majority of SGAs are approved for bipolar mania, and many have or are in the process of gaining approval for bipolar maintenance, as well as other niche areas.

Zyprexa, the market leading SGA, is currently experiencing patent challenges from numerous generics manufacturers. Datamonitor believes it is likely that Lilly will prevail in the courts, although, if generic incursion occurs in 2005, the SGA market could look very different.

The extreme interest in this market place by generics manufacturers is unsurprising. The SGA market currently includes three blockbuster brands with Abilify joining this select club in 2005. Datamonitor forecasts that three of the generic molecules will see blockbuster revenues by 2013.

Reasons to Purchase
Quantify future size and scope of antipsychotics market and potential for new products
Understand key drivers to this market and predict future performance of these compounds
Identify hot areas of the market not targeted by competitors



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