Commercial Insight: Insomnia Strong brand identity critical to differentiation in an increasingly crowded market

Commercial Insight: Insomnia Strong brand identity critical to differentiation in an increasingly crowded market

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
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope and objective of the analysis 3
Datamonitor insight into the insomnia market 3
Contributing experts 5
Related reports 6
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 15
Market definition for this report 15
Current market situation 15
Insomnia market grows strongly to reach $4.6 billion in 2006 15
US market continues to grow while France shows the greatest decline 16
Plain non-barbiturate drugs dominate the market, with the top six brands contributing to 81% of the total market 17
Sanofi-Aventis’s Ambien remains the clear market leader 20
Strategic scoping and focus 21
CHAPTER 3 COUNTRY MARKET ASSESSMENTS 23
Summary of environmental issues affecting insomnia market size 23
Opportunities 26
Global ageing population will increase the sleep maintenance insomnia population 26
The emerging markets of India and China cannot be ignored 28
Reduction in residual sedation and the provision of effective treatments for elderly patients remain significant unmet needs 29
Targeting co-morbid disorders can expand a product’s customer base and provide differentiation 30
Threats 31
Perception of insomnia as a disorder of minor importance hinders patient presentation 31
Increased generic competition 32
Parallel trade; currently minimal but EU expansion is likely to drive down price 33
Revision to labeling of hypnotics will deter use although impact will be minimal 34
US: opportunities and threats 35
Opportunities 35
Advocacy and DTC campaigns drive public awareness of insomnia 35
Target the self-medicating population and unlock the massive insomnia patient potential 37
High price of branded drugs in the US compared to the other major markets 37
Threats 37
Curbing of DTC advertising will lead to greater emphasis on risk of products 37
Influx of generic zolpidem represents a barrier to market entry and introduces cost competition 39
Proposed cut to Medicare will reduce availability of insomnia products to elderly patients 40
Japan: opportunities and threats 41
Opportunities 41
Rapidly rising population over the age of 65 will boost prevalence of sleep maintenance insomnia 41
An underdeveloped generics market slows brand erosion 42
Japan regulators aim to speed up drug approval 42
Threats 43
Despite being underdeveloped, generics prescribing in Japan is set to increase in the future 43
France: opportunities and threats 44
Opportunities 44
The Internet is recognized as a source of high quality medical information by consumers in France 44
Threats 44
Generic incursion on the insomnia market is most rapid in France 44
Germany: opportunities and threats 46
Opportunities 46
Heavy use of herbal hypnotics means high potential for switching 46
High level of activity in sleep disorders research is conducive to acceptance of new drugs 47
Threats 48
German doctors set to receive bonuses for prescribing generics 48
Italy: opportunities and threats 49
Opportunities 49
Negligible impact of generics 49
PCP involvement in development of insomnia consensus report should lead to high rates of guideline implementation 50
Threats 52
Extensive cost containment measures are in place 52
Conservative treatment approach among primary care physicians will hinder uptake of new entrants 53
Trend towards prescribing older hypnotics means a challenging market for novel drugs 53
Spain: opportunities and threats 54
Opportunities 54
Reduced pharmaceutical tax set to save companies selling insomnia treatments over $188,000 per annum 54
Threats 55
Government awareness campaign promotes generic use in Spain 55
UK: opportunities and threats 55
Opportunities 55
Reduced clinical trial times will hasten pipeline insomnia products to the market 55
Threats 56
Failure of NICE to distinguish second-generation hypnotics from benzodiazepines 56
CHAPTER 4 FORECAST ANALYSIS 58
Key events 58
New product launches in the US and EU 59
Ambien CR launched in EU 59
Rozerem launched in EU 61
Indiplon IR 62
Org-50081 63
Zolpidem sublingual spray 64
Sublinox 65
Indiplon MR 65
Eplivanserin 66
VEC-162 67
PD-6735 68
ACT-078573 68
New product launches in Japan 69
Rozerem 70
Indiplon IR 70
Indiplon MR 70
Eplivanserin 71
Org-50081 71
VEC-162 72
ACT-078573 72
Additional Indications 72
Rozerem: label expansion to include circadian rhythm sleep disorders 72
Patent expiries 73
Ambien (zolpidem) 73
Lunesta (eszopiclone) 74
Sonata (zaleplon) 75
Rozerem (ramelteon) 75
Data definitions, limitations and assumptions 75
Standard units 75
Japanese market data 75
Derivation of sales forecasts and pricing trends 76
Generic erosion and pricing assumptions 76
Forecasts 76
Forecast methodology 77
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 78
Introduction 78
Careful portfolio management will provide long-term growth 78
Case study 1: Sanofi-Aventis leads the way in successful franchise management 78
Ambien brand now faces strong generic competition 80
Launch of controlled release formulation is a key strategy for Sanofi-Aventis 81
New drug class holds the key to continuing Sanofi-Aventis’s successful insomnia portfolio 84
Strong branding supported by DTC advertising is an essential element to successful market penetration 85
Case study 2: Ambien DTC advertising campaign 86
Focus placed on differentiating Ambien CR from Ambien 87
Ambien CR’s DTC campaign provides holistic approach to insomnia management 87
Case study 3: Lunesta’s DTC advertising campaign 88
Sepracor’s ‘Luna Moth’ campaign has successfully created a strong brand identity 89
Case study 4: Rozerem’s DTC advertising campaign 90
Lag-time between launch and DTC campaign has hindered uptake 90
Uniqueness of DTC advertising not necessarily equated with success 91
BIBLIOGRAPHY 94
Journal papers 94
Websites 95
Datamonitor reports 99
APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS 100
Summary of insomnia market data 100
Key marketed brands 101
APPENDIX B – MARKET FORECAST DATA 104
Seven major market total 104
M5EU 105
US 106
Japan 107
France 108
Germany 109
Italy 110
Spain 111
UK 112
APPENDIX C 113
Contributing experts 113
Report methodology 114
About Datamonitor 114
About Datamonitor Healthcare 114
About the Disease analysis team 115
Disclaimer 116