市場調査報告書：抗精神病薬の市場分析

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 of this report

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

Research and 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.

Key reasons to read this report

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

ABOUT DATAMONITOR HEALTHCARE

About the CNS pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis
Datamonitor insight into the antipsychotics market

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report
Current market situation
Zyprexa - the gold-standard antipsychotic
Strategic scoping and focus

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Current and future opportunities and threats in the antipsychotic market
- Global opportunities and threats
  - Opportunities
  - Threats
- US
  - Market overview
  - Opportunity
  - Threats
- Japan
  - Opportunities
  - Threats
- France
  - Market overview
  - Opportunity
  - 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
  - Genericization of Solian
  - Launch of IM Zyprexa
  - Zyprexa approval for bipolar disorders
  - Risperdal receives approvable letter for autism
  - Risperdal approval for bipolar disorders
  - Risperdal Consta launch
  - Seroquel approval for bipolar mania
  - Geodon approved for bipolar mania
  - Abilify launch in the EU and FDA approval for bipolar mania in the US
  - Poor 2004 performance for Zyprexa
- 2005
  - Re-launch of Serdolect
  - Launch of Seroquel in France
  - Abilify lifecycle management
- 2006
  - Launch of Asenapine
  - Launch of paliperidone ER
  - Serdolect patent expiry
- 2007
  - Zomaril launch
  - Geodon US patent expiry
  - Seroquel patent expiry
  - Launch of Bifeprunox
- 2008
  - Seroquel line extension
  - Risperdal patent expiry
  - Launch of ORG-24448
  - Launch of PNU170413
- 2009
  - Launch of blonanserin
  - Abilify global patent expiry
  - Zomaril patent expiry
- 2011
  - Seroquel US patent expiry
  - Zyprexa patent expiry
Limitations of data
Forecasts

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Achieving and maintaining market leadership
- Different strategies leading to differing definitions of market leader
  - Indication expansion
  - Reformulations
  - Specialization or generalization - Zyprexa versus Risperdal
  - Risperdal lifecycle strategies
  - Zyprexa lifecycle strategies
  - Strategies employed by Zyprexa and Risperdal
  - Lifecycle strategies - the pros, the cons and the implications
  - Choice, implementation and outcome of lifecycle strategies
  - BMS outlines future lifecycle strategies for Abilify
Generic threat to Zyprexa
- Zyprexa patent challenge
  - Anticipation
  - Obviousness
  - Inequitable conduct
  - Double-patenting
  - Public use
  - Trial outcome
- The worst case scenario - approval of generic olanzapine
  - The impact of generic olanzapine

APPENDIX A

APPENDIX B

List of Tables
- Table 1: key players in the SGA market
- Table 2: Prescriptions (m) of antipsychotics in the US, 2000-03
- Table 3: Prescriptions (m) of antipsychotics in the EU, 2000-03
- Table 4: Prescriptions (m) of antipsychotics in Japan, 2000-03
- Table 5: On and off-label prescription breakdown of the key SGAs in the US market (000s), 2003
- Table 6: US antipsychotic market revenues ($m), 2002-03
- Table 7: Japanese antipsychotic market revenues ($m), 2002-03
- Table 8: French antipsychotic market revenues ($m), 2002-03
- Table 9: German antipsychotic market revenues ($m), 2002-03
- Table 10: Italian antipsychotic market revenues ($m), 2002-03
- Table 11: Spanish antipsychotic market revenues ($m), 2002-03
- Table 12: UK antipsychotic market revenues ($m), 2002-03
- Table 13: Forecast for Zyprexa revenues ($m) if the patent challenge is up held and alternatively if generic incursion occurs in 2005
- Table 14: Historical sales in the antipsychotics market, 2000-2003 (m)
- Table 15: Zyprexa key facts
- Table 16: Key Zyprexa events, 2003-2004
- Table 17: Risperdal key facts
- Table 18: Key Risperdal events, 2003-2004
- Table 19: Seroquel key facts
- Table 20: Key Seroquel events, 2003-2004
- Table 21: Geodon key facts
- Table 22: Key Geodon events, 2003-2004
- Table 23: Abilify key facts
- Table 24: Key Abilify, 2003-2004
- Table 25: Solian key facts
- Table 26: Key Solian, 2003-2004
- Table 27: Leponex key facts
- Table 28: Zoleptil key facts
- Table 29: Serdolect key facts
- Table 30: The late stage R&D pipeline for new antipsychotic agents, 2004
List of Figures
- Figure 1: Revenue growth, market share and revenues of leading antipsychotics, 2002-03
- Figure 2: Market share of the modern SGAs, 1999-2004
- Figure 3: Global sales of Zyprexa and key lifecycle events, 1996-2003
- Figure 4: Prescriptions rate of antipsychotics in the US, EU and Japan, 2000-03
- Figure 5: On and off-label prescription breakdown of the US SGA market by indication, 2000-2003
- Figure 6: On and off-label prescription breakdown of the key SGAs in the US market (000s), 2003
- Figure 7: Summary of opportunities for the global antipsychotic market and examples of strengths and weaknesses
- Figure 8: Non-compliance due to fear of antipsychotic side effects, 2004
- Figure 9: Summary of threats for the global antipsychotic market and examples of strengths and weaknesses
- Figure 10: Summary of opportunities for the US antipsychotic market and examples of strengths and weaknesses
- Figure 11: Summary of threats for the US antipsychotic market and examples of strengths and weaknesses
- Figure 12: Summary of opportunities for the Japanese antipsychotic market and examples of strengths and weaknesses
- Figure 13: Summary of threats for the Japanese antipsychotic market and examples of strengths and weaknesses
- Figure 14: Summary of opportunities for the French antipsychotic market and examples of strengths and weaknesses
- Figure 15: Summary of threats for the French antipsychotic market and examples of strengths and weaknesses
- Figure 16: Summary of opportunities for the German antipsychotic market and examples of strengths and weaknesses
- Figure 17: Summary of threats for the German antipsychotic market and examples of strengths and weaknesses
- Figure 18: Summary of opportunities for the Italian antipsychotic market and examples of strengths and weaknesses
- Figure 19: Summary of threats for the Italian antipsychotic market and examples of strengths and weaknesses
- Figure 20: Summary of opportunities for the Spanish antipsychotic market and examples of strengths and weaknesses
- Figure 21: Summary of threats for the Spanish antipsychotic market and examples of strengths and weaknesses
- Figure 22: Summary of opportunities for the UK antipsychotic market and examples of strengths and weaknesses
- Figure 23: Summary of threats for the UK antipsychotic market and examples of strengths and weaknesses
- Figure 24: Revenues of Risperdal formulations (US), 1999-2003
- Figure 25: Revenues of oral antipsychotic solutions (US), 1999-2003
- Figure 26: JNJs new Risperdal Consta website
- Figure 27: How well drug formulations could improve patient compliance in schizophrenia, 2004
- Figure 28: Revenues of Risperdal Consta since launch (US, EU and Japan)
- Figure 29: Promotional spend versus revenues for Risperdal, 1999-2004
- Figure 30: Global sales of Risperdal and key lifecycle events, 1993-2003
- Figure 31: US revenues of rapid-acting IM injectables, 2000-04
- Figure 32: Revenues of Zyprexa formulations (US), 1999-2003
- Figure 33: Revenues of dissolvable SGA tablets, 2000-2004
- Figure 34: Alternate SGA forecast, 2004-2014

抗精神病薬の市場分析：超ヒット・ブランドから販売好調のジェネリック医薬まで

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