Commercial Insight: Depression -Atypical lifecycle management strategy rejuvenates depression market
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the depression market - page 4
- Contributing experts - page 6
- Related reports - page 6
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 8
- Market definition for this report - page 8
- Current market situation - page 9
- Key events and gold-standard - page 9
- Sales in the US dominate the total seven major MDD market - page 9
- Sales revenue generated in the US dominates the MDD market - page 10
- France is the largest MDD market in the 5EU - page 11
- Varying uptake of modern antidepressant drug classes across the seven major markets - page 12
- Prescribing trends for MDD by drug class in the US - page 14
- Strategic scoping and focus - page 15
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 17
- Summary of environmental issues affecting the MDD market size - page 17
- Seven major market opportunities and threats - page 18
- Opportunities - page 18
- Large volume of sales for older antidepressants leaves room for expansion - page 18
- Differentiation of pipeline products possible by targeting the lag-time to efficacy observed with all current treatments - page 19
- Ageing population - expansion into the growing elderly and co-morbid depression patient groups - page 21
- Secondary indications - page 24
- Use of different delivery methods - page 26
- Threats - page 28
- Generics - page 28
- Lack of scope for further reformulations - page 31
- Increasing number and diversity of safety warnings on antidepressants labels - page 32
- Increasing placebo effect observed in clinical trials hinders drug development - page 35
- Opportunities - page 18
- US: opportunities and threats - page 35
- Opportunities - page 35
- Ethnic minorities - page 35
- Threats - page 37
- FDA extends black-box warnings on antidepressants - page 37
- Wal-Mart $4 a day generic program introduces further cost competition - page 38
- Opportunities - page 35
- Japan: opportunities and threats - page 41
- Opportunities - page 41
- Destigmatization of depression boosts Japan market and attracts Western investors - page 41
- Unsaturated antidepressant market encourages new market entry - page 42
- Drug approval lag-time being targeted by the Japanese Ministry of Health, Labor and Welfare - page 42
- Threats - page 43
- Generic substitution likely to increase over the medium term in Japan - page 43
- Opportunities - page 41
- France: opportunities and threats - page 44
- Opportunities - page 44
- Changes in psychiatrist demographics stimulates prescribing of mainstream antidepressants - page 44
- Threats - page 46
- Generic incursion on the antidepressant market is high in France, and is likely to increase in the future - page 46
- Opportunities - page 44
- Germany: opportunities and threats - page 48
- Opportunities - page 48
- Market share still to be gained by current market players, with a large volume of sales coming from older drugs - page 48
- Threats - page 50
- AKDA guidelines recommend psychotherapy as an alternative to pharmacotherapy - page 50
- Pharmaceutical-Prescribing-Efficiency-Act - bonus-malus encourages generic prescribing - page 51
- Opportunities - page 48
- Italy: opportunities and threats - page 51
- Opportunities - page 51
- Revenues can be maintained despite patent expiries - page 51
- Threats - page 55
- Established reference pricing system makes it difficult to set premiums on second generation drugs in a class - page 55
- Opportunities - page 51
- Spain: opportunities and threats - page 58
- Opportunities - page 58
- Reduced pharmaceutical tax could save companies selling depression treatments $6m per annum - page 58
- Threats - page 59
- The introduction of reference pricing will force antidepressant prices down - page 59
- Opportunities - page 58
- UK: opportunities and threats - page 61
- Opportunities - page 61
- NICE recommends antidepressants for co-morbid depression in Alzheimer's - page 61
- PCPs freed to prescribe Effexor following recommendation in NICE update - page 62
- Threats - page 64
- Move towards psychotherapy at the expense of pharmacotherapy - page 64
- Opportunities - page 61
- CHAPTER 4 FORECAST ANALYSIS - page 66
- Key events - page 66
- New product launches in the US and EU - page 68
- Wellbutrin XL for MDD in the EU - page 68
- Pristiq - page 70
- Luvox CR - page 71
- Gepirone ER - page 71
- Agomelatine - page 73
- Saredutant - page 75
- Nemifitide - page 75
- Seroquel SR - indication expansion - page 76
- New project launches in Japan - page 77
- Remeron (mirtazapine) - page 78
- Effexor - page 78
- Cymbalta - page 78
- Lexapro - page 78
- Gepirone ER - page 79
- Patent expiries and generic launch dates - page 79
- Bupropion extended release (Wellbutrin XL) - page 80
- Duloxetine (Cymbalta) - page 80
- Venlafaxine XR (Effexor XR) - page 81
- Escitalopram (Lexapro) - page 81
- Gepirone ER - page 81
- Patent expiry of other drugs used to treat MDD - page 82
- New product launches in the US and EU - page 68
- Data definitions, limitations and assumptions - page 84
- Standard units - page 84
- Derivation of sales forecasts and pricing trends - page 84
- Generic erosion and pricing assumptions - page 84
- MDD-specific sales calculations - page 85
- ICD-10 codes used to define current MDD market - page 86
- Japanese market data - page 86
- Forecasts - page 87
- Forecast methodology - page 87
- Key events - page 66
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 88
- Introduction - page 88
- Case studies - page 89
- Indication expansion of atypical antipsychotics into depression - page 89
- Significant off-label prescribing already exists - page 89
- Licensed indication expansion is likely to be the next step for atypical antipsychotics - page 89
- Indication expansion of atypical antipsychotics follows a similar lifecycle management strategy to the antidepressant class - page 89
- AstraZeneca has led the way into depression disorders with Seroquel - page 89
- Significant off-label prescribing already occurring - page 90
- Additional uptake likely to occur in the primary care setting and as a combination therapy with a current antidepressant - page 91
- Competition from pipeline MDD drugs in the medium-term - page 93
- Scenario forecast - page 93
- Reformulation strategies of the antidepressant drug class - page 94
- What makes a successful reformulation? - page 95
- Successful reformulation strategies in the depression market - page 96
- Unsuccessful reformulation strategies in the depression market - page 99
- Success or failure for forthcoming reformulations? - page 101
- Improving compliance via sexual dysfunction management strategies would create patient and prescriber loyalty - page 103
- Switching antidepressants is the present solution to non-compliance - page 103
- Sexual dysfunction is the leading side effect associated with non-compliance - page 103
- Pharmaceutical companies would benefit from encouraging management strategies in primary care - page 104
- Patient education over sexual dysfunction management must be handle carefully - page 105
- Switching due to lack of efficacy after six weeks is appropriate and not an compliance issue - page 106
- Indication expansion of atypical antipsychotics into depression - page 89
- BIBLIOGRAPHY - page 107
- Journal papers - page 107
- Websites - page 110
- Other sources - page 112
- Datamonitor reports - page 113
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 114
- Summary MDD market data - page 114
- SSRI market data - page 115
- SNRI market data - page 121
- APPENDIX B - MARKET FORECAST DATA - page 123
- Seven major markets - page 123
- M5EU - page 124
- US - page 125
- Japan - page 126
- France - page 127
- Germany - page 128
- Italy - page 129
- Spain - page 130
- UK - page 131
- APPENDIX C - page 132
- Contributing experts - page 132
- Report methodology - page 132
- About Datamonitor - page 132
- About Datamonitor Healthcare - page 133
- About the CNS analysis team - page 133
- Disclaimer - page 135
- List of Tables
- Table 1: Summary of environmental issues in the seven major MDD markets, 2007 - page 17
- Table 2: Reformulations of SSRIs/SNRIs, 2007 - page 31
- Table 3: Wal-Mart is selling many generic antidepressants for less than the mean price per standard unit in the US in 2006 - page 39
- Table 4: Datamonitor's forecast launch dates for key pipeline products in the US and 5EU, 2007-16. - page 68
- Table 5: Datamonitor's forecast launch dates in Japan, 2007-16. - page 77
- Table 6: Key drugs forecast to face generic competition during the forecast period, 2007-16. - page 79
- Table 7: Key off-label drugs used for MDD treatment facing patent expiry within the forecast period, 2007-2016 - page 83
- Table 8: ICD-10 and DSM-IV codes for MDD - page 86
- Table 9: Summary MDD-specific market data, 2006 - page 114
- Table 10: Prozac: key facts - page 115
- Table 11: Paxil: key facts - page 116
- Table 12: Zoloft: key facts - page 117
- Table 13: Luvox: key facts - page 118
- Table 14: Celexa: key facts - page 119
- Table 15: Lexapro: key facts - page 120
- Table 16: Effexor: key facts - page 121
- Table 17: Cymbalta: key facts - page 122
- Table 18: Seven major market MDD drug sales ($m) forecasts, 2007-16 - page 123
- Table 19: 5EU MDD drug sales ($m) forecasts, 2007-16 - page 124
- Table 20: US MDD drug sales ($m) forecasts, 2007-16 - page 125
- Table 21: Japan MDD drug sales ($m) forecasts, 2007-16 - page 126
- Table 22: France MDD drug sales ($m) forecasts, 2007-16 - page 127
- Table 23: Germany MDD drug sales ($m) forecasts, 2007-16 - page 128
- Table 24: Italy MDD drug sales ($m) forecasts, 2007-16 - page 129
- Table 25: Spain MDD drug sales ($m) forecasts, 2007-16 - page 130
- Table 26: UK MDD drug sales ($m) forecasts, 2007-16 - page 131
- List of Figures
- Figure 1: Key events impacting the MDD market, 1950-2007 - page 9
- Figure 2: MDD-specific sales revenue across the seven major markets, 2003-06 - page 10
- Figure 3: MDD-specific sales across the seven major markets by standard units, 2003-06 - page 11
- Figure 4: MDD-specific sales revenue in the 5EU, 2003-06 - page 12
- Figure 5: MDD-specific sales revenues across the seven major markets by drug class, 2006 - page 13
- Figure 6: MDD-specific sales revenue in the US by drug class, 2002-06 - page 15
- Figure 7: Sales revenue for MDD by drug class across the seven major markets, 2006 - page 19
- Figure 8: Ageing population across the seven major markets (%), 2000-2050 - page 22
- Figure 9: Age-specific incidence of depression in Germany (cases per 100,000 population), 2004 - page 23
- Figure 10: Generic incursion on branded MDD-specific antidepressant sales in the US (SUs), 2003-2016 - page 29
- Figure 11: Wal-Mart's $4 generic drug program web-page - page 40
- Figure 12: Generic incursion on the SSRI class of antidepressant in France and 5EU (%), 2003-06 - page 47
- Figure 13: Percentage of total standard units for MDD attributed to the SSRI and SNRI drug classes in each of the seven major markets, 2006 - page 49
- Figure 14: Generic incursion on the SSRI drug class across the seven major markets (%), 2006 - page 53
- Figure 15: Generic incursion of the SSRI class in France, Italy and the UK (%), 2003-06 - page 54
- Figure 16: Promotional spend for marketed SSRIs under generic competition in Italy ($m), 2003-06 - page 55
- Figure 17: Price of branded SSRIs per standard unit in the seven major markets ($), 2006 - page 57
- Figure 18: Price of SSRIs per standard unit in Italy ($), 2003-06 - page 58
- Figure 19: Comparison of the standard unit price of branded SSRIs in Spain and Italy, 2003-06 - page 60
- Figure 20: Impact of each key event on the MDD market across the seven major markets, 2007-2016 - page 66
- Figure 21: Seroquel scenario forecast for MDD-specific US sales revenue, 2003-2010 - page 94
- Figure 22: Wellbutrin franchise - all-indication global sales, 2002-06 - page 96
- Figure 23: Paxil franchise all-indication company reported sales revenue, 2002-06 - page 100
- Figure 24: Prozac franchise all-indication company reported sales revenue, 2000-05 - page 101
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