Commercial Insight: Depression - Atypical lifecycle management strategy rejuvenates 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
• 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
  • 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
• 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
• 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