Abstract
Overview
Introduction
Novel pipeline drugs, lifecycle management of the current branded antidepressants, and development of atypical antipsychotics for depression are set to grow the depression market through to 2010 when it will peak at $14.6 billion. Thereafter, however, generic incursion of the atypical antipsychotics and the remaining branded antidepressants will see the depression market value drop to 2016.
Scope
- This report focuses on the leading pharmacotherapies used to treat depression with sales and volume country- and indication-specific forecasts to 2016
- Assessment of current and future opportunities and threats in the depression 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
- Lifecycle management case studies show how previously successful strategies should be applied in today' s market
Highlights
Sales of atypical antipsychotics in depression are set to be stimulated by anticipated positive clinical trial data investigating the use of Seroquel (quetiapine) in this indication. Datamonitor forecasts peak class level seven major market sales of $1.43 billion in 2008, followed by a decline due to competition from pipeline drugs and generics.
Timing of launch of Wyeth' s reformulation Pristiq (desvenlafaxine) would appear to be optimal. However, no evidence exists to indicate that it is an improvement over the parent compound Effexor (venlafaxine). By focusing Pristiq on a niche cohort of depressed patients, Wyeth has done enough to diversify Pristiq to ensure moderate success.
The introduction of newer generation antidepressants such as the SNRIs Effexor and Cymbalta (duloxetine) and the SSRI Lexapro (escitalopram) into the Japanese depression market will drive its value considerably, resulting in a 52% increase by 2012.
Reasons to Purchase
- Assess the impact of events such as patent expiries and new product launches on the depression-specific sales of key marketed brands
- Quantify the future size of the depression market, in terms of volume and value, in each of the seven major markets
- Identify key lifecycle management strategies that can ensure growth in the competitive depression market
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the CNS pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Objective of the analysis
- Datamonitor insight into the depression market
- Contributing experts
- Related reports
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Market definition for this report
- Current market situation
- Key events and gold-standard
- Sales in the US dominate the total seven major MDD market
- Sales revenue generated in the US dominates the MDD market
- France is the largest MDD market in the 5EU
- Varying uptake of modern antidepressant drug classes across the seven major markets
- Prescribing trends for MDD by drug class in the US
- Strategic scoping and focus
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS
- Summary of environmental issues affecting the MDD market size
- Seven major market opportunities and threats
- Opportunities
- Large volume of sales for older antidepressants leaves room for expansion
- Differentiation of pipeline products possible by targeting the lag-time to efficacy observed with all current treatments
- Ageing population - expansion into the growing elderly and co-morbid depression patient groups
- Secondary indications
- Use of different delivery methods
- Threats
- Generics
- Lack of scope for further reformulations
- Increasing number and diversity of safety warnings on antidepressants labels
- Increasing placebo effect observed in clinical trials hinders drug development
- Opportunities
- US: opportunities and threats
- Opportunities
- Ethnic minorities
- Threats
- FDA extends black-box warnings on antidepressants
- Wal-Mart $4 a day generic program introduces further cost competition
- Opportunities
- Japan: opportunities and threats
- Opportunities
- Destigmatization of depression boosts Japan market and attracts Western investors
- Unsaturated antidepressant market encourages new market entry
- Drug approval lag-time being targeted by the Japanese Ministry of Health, Labor and Welfare
- Threats
- Generic substitution likely to increase over the medium term in Japan
- Opportunities
- France: opportunities and threats
- Opportunities
- Changes in psychiatrist demographics stimulates prescribing of mainstream antidepressants
- Threats
- Generic incursion on the antidepressant market is high in France, and is likely to increase in the future
- Opportunities
- Germany: opportunities and threats
- Opportunities
- Market share still to be gained by current market players, with a large volume of sales coming from older drugs
- Threats
- AKDA guidelines recommend psychotherapy as an alternative to pharmacotherapy
- Pharmaceutical-Prescribing-Efficiency-Act - bonus-malus encourages generic prescribing
- Opportunities
- Italy: opportunities and threats
- Opportunities
- Revenues can be maintained despite patent expiries
- Threats
- Established reference pricing system makes it difficult to set premiums on second generation drugs in a class
- Opportunities
- Spain: opportunities and threats
- Opportunities
- Reduced pharmaceutical tax could save companies selling depression treatments $6m per annum
- Threats
- The introduction of reference pricing will force antidepressant prices down
- Opportunities
- UK: opportunities and threats
- Opportunities
- NICE recommends antidepressants for co-morbid depression in Alzheimer' s
- PCPs freed to prescribe Effexor following recommendation in NICE update
- Threats
- Move towards psychotherapy at the expense of pharmacotherapy
- Opportunities
- CHAPTER 4 FORECAST ANALYSIS
- Key events
- New product launches in the US and EU
- Wellbutrin XL for MDD in the EU
- Pristiq
- Luvox CR
- Gepirone ER
- Agomelatine
- Saredutant
- Nemifitide
- Seroquel SR - indication expansion
- New project launches in Japan
- Remeron (mirtazapine)
- Effexor
- Cymbalta
- Lexapro
- Gepirone ER
- Patent expiries and generic launch dates
- Bupropion extended release (Wellbutrin XL)
- Duloxetine (Cymbalta)
- Venlafaxine XR (Effexor XR)
- Escitalopram (Lexapro)
- Gepirone ER
- Patent expiry of other drugs used to treat MDD
- New product launches in the US and EU
- Data definitions, limitations and assumptions
- Standard units
- Derivation of sales forecasts and pricing trends
- Generic erosion and pricing assumptions
- MDD-specific sales calculations
- ICD-10 codes used to define current MDD market
- Japanese market data
- Forecasts
- Forecast methodology
- Key events
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES
- Introduction
- Case studies
- Indication expansion of atypical antipsychotics into depression
- Significant off-label prescribing already exists
- Licensed indication expansion is likely to be the next step for atypical antipsychotics
- Indication expansion of atypical antipsychotics follows a similar lifecycle management strategy to the antidepressant class
- AstraZeneca has led the way into depression disorders with Seroquel
- Significant off-label prescribing already occurring
- Additional uptake likely to occur in the primary care setting and as a combination therapy with a current antidepressant
- Competition from pipeline MDD drugs in the medium-term
- Scenario forecast
- Reformulation strategies of the antidepressant drug class
- What makes a successful reformulation?
- Successful reformulation strategies in the depression market
- Unsuccessful reformulation strategies in the depression market
- Success or failure for forthcoming reformulations?
- Improving compliance via sexual dysfunction management strategies
would create patient and prescriber loyalty
- Switching antidepressants is the present solution to non-compliance
- Sexual dysfunction is the leading side effect associated with non-compliance
- Pharmaceutical companies would benefit from encouraging management strategies in primary care
- Patient education over sexual dysfunction management must be handle carefully
- Switching due to lack of efficacy after six weeks is appropriate and not an compliance issue
- Indication expansion of atypical antipsychotics into depression
- BIBLIOGRAPHY
- Journal papers
- Websites
- Other sources
- Datamonitor reports
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS
- Summary MDD market data
- SSRI market data
- SNRI market data
- APPENDIX B - MARKET FORECAST DATA
- Seven major markets
- M5EU
- US
- Japan
- France
- Germany
- Italy
- Spain
- UK
- APPENDIX C
- Contributing experts
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the CNS analysis team
- Disclaimer
- List of Tables
- Table 1: Summary of environmental issues in the seven major MDD markets, 2007
- Table 2: Reformulations of SSRIs/SNRIs, 2007
- Table 3: Wal-Mart is selling many generic antidepressants for less than the mean price per standard unit in the US in 2006
- Table 4: Datamonitor' s forecast launch dates for key pipeline products in the US and 5EU, 2007-16.
- Table 5: Datamonitor' s forecast launch dates in Japan, 2007-16.
- Table 6: Key drugs forecast to face generic competition during the forecast period, 2007-16.
- Table 7: Key off-label drugs used for MDD treatment facing patent expiry within the forecast period, 2007-2016
- Table 8: ICD-10 and DSM-IV codes for MDD
- Table 9: Summary MDD-specific market data, 2006
- Table 10: Prozac: key facts
- Table 11: Paxil: key facts
- Table 12: Zoloft: key facts
- Table 13: Luvox: key facts
- Table 14: Celexa: key facts
- Table 15: Lexapro: key facts
- Table 16: Effexor: key facts
- Table 17: Cymbalta: key facts
- Table 18: Seven major market MDD drug sales ($m) forecasts, 2007-16
- Table 19: 5EU MDD drug sales ($m) forecasts, 2007-16
- Table 20: US MDD drug sales ($m) forecasts, 2007-16
- Table 21: Japan MDD drug sales ($m) forecasts, 2007-16
- Table 22: France MDD drug sales ($m) forecasts, 2007-16
- Table 23: Germany MDD drug sales ($m) forecasts, 2007-16
- Table 24: Italy MDD drug sales ($m) forecasts, 2007-16
- Table 25: Spain MDD drug sales ($m) forecasts, 2007-16
- Table 26: UK MDD drug sales ($m) forecasts, 2007-16
- List of Figures
- Figure 1: Key events impacting the MDD market, 1950-2007
- Figure 2: MDD-specific sales revenue across the seven major markets, 2003-06
- Figure 3: MDD-specific sales across the seven major markets by standard units, 2003-06
- Figure 4: MDD-specific sales revenue in the 5EU, 2003-06
- Figure 5: MDD-specific sales revenues across the seven major markets by drug class, 2006
- Figure 6: MDD-specific sales revenue in the US by drug class, 2002-06
- Figure 7: Sales revenue for MDD by drug class across the seven major markets, 2006
- Figure 8: Ageing population across the seven major markets (%), 2000-2050
- Figure 9: Age-specific incidence of depression in Germany (cases per 100,000 population), 2004
- Figure 10: Generic incursion on branded MDD-specific antidepressant sales in the US (SUs), 2003-2016
- Figure 11: Wal-Mart' s $4 generic drug program web-page
- Figure 12: Generic incursion on the SSRI class of antidepressant in France and 5EU (%), 2003-06
- Figure 13: Percentage of total standard units for MDD attributed to the SSRI and SNRI drug classes in each of the seven major markets, 2006
- Figure 14: Generic incursion on the SSRI drug class across the seven major markets (%), 2006
- Figure 15: Generic incursion of the SSRI class in France, Italy and the UK (%), 2003-06
- Figure 16: Promotional spend for marketed SSRIs under generic competition in Italy ($m), 2003-06
- Figure 17: Price of branded SSRIs per standard unit in the seven major markets ($), 2006
- Figure 18: Price of SSRIs per standard unit in Italy ($), 2003-06
- Figure 19: Comparison of the standard unit price of branded SSRIs in Spain and Italy, 2003-06
- Figure 20: Impact of each key event on the MDD market across the seven major markets, 2007-2016
- Figure 21: Seroquel scenario forecast for MDD-specific US sales revenue, 2003-2010
- Figure 22: Wellbutrin franchise - all-indication global sales, 2002-06
- Figure 23: Paxil franchise all-indication company reported sales revenue, 2002-06
- Figure 24: Prozac franchise all-indication company reported sales revenue, 2000-05
