Abstract
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
- ABOUT DATAMONITOR HEALTHCARE
- About the Disease pharmaceutical analysis team
- 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
- Opportunities
- 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
- Opportunities
- 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
- Opportunities
- 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
- Opportunities
- 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
- Opportunities
- 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
- Opportunities
- 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
- Opportunities
- 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
- Opportunities
- Summary of environmental issues affecting insomnia market size
- 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)
- New product launches in the US and EU
- 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
- Key events
- 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
- Case study 1: Sanofi-Aventis leads the way in successful franchise
management
- 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
- Case study 2: Ambien DTC advertising campaign
- 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
- List of Tables
- Table 1: Performance of the US, 5EU and Japan insomnia markets, 2005-06
- Table 2: Key players in the insomnia market, 2007
- Table 3: Summary of environmental issues in the seven major insomnia markets, 2007
- Table 4: Summary of environmental issues in the US and Japanese insomnia markets, 2007
- Table 5: Summary of environmental issues in the French, German, Italian, Spanish and UK insomnia markets, 2007
- Table 6: Datamonitor' s estimated launch dates for products in the 5EU and US, 2007-2016
- Table 7: Datamonitor' s estimated launch dates for Japanese insomnia products, 2007-2016
- Table 8: Dates of key patent expiries in the insomnia market across the seven major markets, 2007-2016
- Table 9: Sanofi-Aventis' s marketed insomnia drug franchise, 2007
- Table 10: Sanofi-Aventis' s pipeline insomnia drugs, 2007
- Table 11: Insomnia summary market data, 2006
- Table 12: Ambien and Ambien CR key facts
- Table 13: Rozerem key facts
- Table 14: Lunesta key facts
- Table 15: Sonata key facts
- Table 16: Seven major market insomnia drug sales ($m) forecasts, 2006-2016
- Table 17: 5EU market total insomnia drug sales ($m) forecasts, 2006-2016
- Table 18: US insomnia drug sales ($m) forecasts, 2006-2016
- Table 19: Japan insomnia drug sales ($m) forecasts, 2006-2016
- Table 20: France insomnia drug sales ($m) forecasts, 2006-2016
- Table 21: Germany insomnia drug sales ($m) forecasts, 2006-2016
- Table 22: Italy insomnia drug sales ($m) forecasts, 2006-2016
- Table 23: Spain insomnia drug sales ($m) forecasts, 2006-2016
- Table 24: UK insomnia drug sales ($m) forecasts, 2006-2016
- List of Figures
- Figure 1: Performance of the US, 5EU and Japan insomnia markets ($m), 2005-06
- Figure 2: Key drug launches and patent expiries in the insomnia market 1992-2006
- Figure 3: Performance of the key insomnia therapies 2005-06
- Figure 4: Population aged over 65 years in the seven major markets from 2007-2017
- Figure 5: Population of Japan over the age of 65 (m), 1950-2050
- Figure 6: Generic incursion on the non-barbiturate plain class of hypnotics in France and 5EU, 2003-06
- Figure 7: Proportion of insomnia market accounted for by herbal hypnotics and sedatives, 2006
- Figure 8: Distribution of accredited sleep laboratories in Germany
- Figure 9: Generic incursion of key insomnia brands in Italy, 2003-2006
- Figure 10: Key events impacting the insomnia market 2007-2017
- Figure 11: Global sales forecast of Sanofi-Aventis' s insomnia franchise 2006-2017
- Figure 12: SWOT analysis of Ambien CR, 2007
- Figure 13: Forecast sales of Ambien and Ambien CR in the US market to 2017
- Figure 14: Ambien CR homepage
- Figure 15: Lunesta homepage featuring the brand' s ' Luna Moth' symbol
- Figure 16: Rozerem' s drug homepage
