Market Report Source

Overview

Introduction
Ambien has remained the clear leader in the insomnia market for over a decade, with 2006 sales of over $2.3 billion across the seven major markets. The success of Ambien is attributable to a favorable side-effect profile and half-life. However, due to recent patent expiries in the US and Japan, Ambien’s leadership status is finally under threat and the market is undergoing some dramatic changes

Scope

• This report focuses on the leading prescription therapies used in insomnia, with sales and volume country- and indication- specific forecasts to 2016
• Assessment of current and future opportunities and threats in the insomnia market across the seven major pharmaceutical markets
• Future market events that are expected to affect drug revenues are discussed and quantified for each of the seven major markets
• Discussion of lifecycle management and branding strategies, focusing on Sanofi-Aventis, Sepracor and Takeda with insight from opinion leaders

Highlights
Sanofi-Aventis’s continuing market leader status is attributable to astute portfolio management, beginning with the launch of a controlled release formulation of Ambien, Ambien CR, which Datamonitor forecasts to attain seven major market sales of $1.98 billion by 2016.

Strong branding supported by direct-to-consumer (DTC) advertising is an essential element to successful penetration of the insomnia market. Of the three insomnia products launched in 2005, Sepracor’s DTC advertising campaign for Lunesta has been the most successful owing to the pervasive use of a strong marketing symbol.

Although Takeda’s DTC advertising of Rozerem is distinctive, the strategy has been criticized by interviewed opinion leaders for being unnecessarily complex, a factor which hinders the target audience’s understanding of the drug’s indication.

Reasons to Purchase

• Assess the impact of events such as patent expiries and new product launches on the sales of key marketed insomnia products
• Quantify the future size of the insomnia market, in terms of volume and value, in each of the seven major markets
• Identify lifecycle management and branding strategies that ensure long term growth for key players and strong uptake for market entrants respectively

Table of Contents

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY

Scope and objective of the analysis

Datamonitor insight into the insomnia market

Contributing experts

Related reports

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

Current market situation

Insomnia market grows strongly to reach $4.6 billion in 2006

US market continues to grow while France shows the greatest decline

Plain non-barbiturate drugs dominate the market, with the top six brands contributing to 81% of the total market

Sanofi-Aventis’s Ambien remains the clear market leader

Strategic scoping and focus

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Summary of environmental issues affecting insomnia market size

Opportunities

Global ageing population will increase the sleep maintenance insomnia population

The emerging markets of India and China cannot be ignored

Reduction in residual sedation and the provision of effective treatments for elderly patients remain significant unmet needs

Targeting co-morbid disorders can expand a product’s customer base and provide differentiation

Threats

Perception of insomnia as a disorder of minor importance hinders patient presentation

Increased generic competition

Parallel trade; currently minimal but EU expansion is likely to drive down price

Revision to labeling of hypnotics will deter use although impact will be minimal

US: opportunities and threats

Opportunities

Advocacy and DTC campaigns drive public awareness of insomnia

Target the self-medicating population and unlock the massive insomnia patient potential

High price of branded drugs in the US compared to the other major markets

Threats

Curbing of DTC advertising will lead to greater emphasis on risk of products

Influx of generic zolpidem represents a barrier to market entry and introduces cost competition

Proposed cut to Medicare will reduce availability of insomnia products to elderly patients

Japan: opportunities and threats

Opportunities

Rapidly rising population over the age of 65 will boost prevalence of sleep maintenance insomnia

An underdeveloped generics market slows brand erosion

Japan regulators aim to speed up drug approval

Threats

Despite being underdeveloped, generics prescribing in Japan is set to increase in the future

France: opportunities and threats

Opportunities

The Internet is recognized as a source of high quality medical information by consumers in France

Threats

Generic incursion on the insomnia market is most rapid in France

Germany: opportunities and threats

Opportunities

Heavy use of herbal hypnotics means high potential for switching

High level of activity in sleep disorders research is conducive to acceptance of new drugs

Threats

German doctors set to receive bonuses for prescribing generics

Italy: opportunities and threats

Opportunities

Negligible impact of generics

PCP involvement in development of insomnia consensus report should lead to high rates of guideline implementation

Threats

Extensive cost containment measures are in place

Conservative treatment approach among primary care physicians will hinder uptake of new entrants

Trend towards prescribing older hypnotics means a challenging market for novel drugs

Spain: opportunities and threats

Opportunities

Reduced pharmaceutical tax set to save companies selling insomnia treatments over $188,000 per annum

Threats

Government awareness campaign promotes generic use in Spain

UK: opportunities and threats

Opportunities

Reduced clinical trial times will hasten pipeline insomnia products to the market

Threats

Failure of NICE to distinguish second-generation hypnotics from benzodiazepines

CHAPTER 4 FORECAST ANALYSIS

Key events

New product launches in the US and EU

Ambien CR launched in EU

Rozerem launched in EU

Indiplon IR

Org-50081

Zolpidem sublingual spray

Sublinox

Indiplon MR

Eplivanserin

VEC-162

PD-6735

ACT-078573

New product launches in Japan

Rozerem

Indiplon IR

Indiplon MR

Eplivanserin

Org-50081

VEC-162

ACT-078573

Additional Indications

Rozerem: label expansion to include circadian rhythm sleep disorders

Patent expiries

Ambien (zolpidem)

Lunesta (eszopiclone)

Sonata (zaleplon)

Rozerem (ramelteon)

Data definitions, limitations and assumptions

Standard units

Japanese market data

Derivation of sales forecasts and pricing trends

Generic erosion and pricing assumptions

Forecasts

Forecast methodology

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Introduction

Careful portfolio management will provide long-term growth

Case study 1: Sanofi-Aventis leads the way in successful franchise management

Ambien brand now faces strong generic competition

Launch of controlled release formulation is a key strategy for Sanofi-Aventis

New drug class holds the key to continuing Sanofi-Aventis’s successful insomnia portfolio

Strong branding supported by DTC advertising is an essential element to successful market penetration

Case study 2: Ambien DTC advertising campaign

Focus placed on differentiating Ambien CR from Ambien

Ambien CR’s DTC campaign provides holistic approach to insomnia management

Case study 3: Lunesta’s DTC advertising campaign

Sepracor’s ‘Luna Moth’ campaign has successfully created a strong brand identity

Case study 4: Rozerem’s DTC advertising campaign

Lag-time between launch and DTC campaign has hindered uptake

Uniqueness of DTC advertising not necessarily equated with success

BIBLIOGRAPHY

Journal papers

Websites

Datamonitor reports

APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS

Summary of insomnia market data

Key marketed brands

APPENDIX B – MARKET FORECAST DATA

Seven major market total

M5EU

US

Japan

France

Germany

Italy

Spain

UK

APPENDIX C

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the Disease analysis team

Disclaimer