Forecast Insight: Depression - Generic induced brand erosion leads to market decline

Forecast Insight: Depression - Generic induced brand erosion leads to market decline

CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the depression market 3
Related reports 6
 

CHAPTER 2 MARKET DEFINITION AND OVERVIEW 8
Market definition for this report 8
Countries and regions included in this report 8
Seven major market assessment 10
Seven major market dynamics 10
Generic incursion erodes total market value 10
Generics - underlying inhibitor to growth across the US and 5EU 11
Regional contribution to seven major market forecasts 13
US contribution to total revenue declines over forecast period 2008-2017 13
US market dynamics 14
US market projected to decline as generics increasingly play a role 14
2004-07: historical major depressive disorder market 15
2007-2011: near-term US market growth forecast 15
2011-2017: long-term US market decline 16
5EU (France, Germany, Italy, Spain and the UK) market dynamics 16
5EU market anticipated to grow over the forecast period 2008-2017 16
Historical 5EU market showed growth in 2007 17
Future 5EU depression market set for moderate growth 17
Japanese market dynamics 18
Japan remains the key growth region 18
Drug class dynamics 20
Selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) 20
Use of the atypical antipsychotic drug class for treating depression has grown significantly 21
Comparison with previous forecast 27
Downgrade since 2007 forecast 27
Global sales and rest of the world snapshot 28
Rest of the world is a multi-billion dollar market 28
Rest of the world depression sales have grown rapidly over the last 4 years 29
Dynamics in the rest of the world 31
Canada and ex-5EU European markets are significant major depressive disorder markets 31
Major depressive disorder market growing sharply in Latin America 32
 

CHAPTER 3 BRAND DYNAMICS 33
Overview of competitive landscape 33
Leading brands across the seven major pharmaceutical markets 33
Effexor (venlafaxine, Wyeth) is the current depression market leading brand 33
Fragmentation and generic incursion erodes branded market 33
Pipeline drugs rank among the leading depression brands by 2017 34
Key pipeline drugs 36
Updated key marketed brand dynamics 37
Zoloft (sertraline, Pfizer) 38
Forecast downgrade following quicker than anticipated generic incursion 38
Abilify (aripiprazole, Bristol-Myers Squibb and Otsuka Pharmaceutical) 41
Forecast upgrade following approval for adjunctive depression therapy 41
Depression-specific forecast 42
Off-label prescribing high pre-approval 43
Boost in sales observed post-approval 44
Clinical trial data supporting approval 45
Lower dose of Abilify recommended for treating depression than for bipolar mania and schizophrenia 46
Pediatric extension to patent prolongs protection in the US 47
Pristiq (desvenlafaxine succinate extended release, Wyeth) 47
Delay in European launch impedes growth 47
Regulatory progress and launch in the US as anticipated 48
Development in the 5EU stalls following regulatory review delay 48
Switching from Effexor XR to Pristiq will be difficult 49
Wellbutrin XL (bupropion extended-release; GlaxoSmithKline) 50
Wellbutrin XL depression-specific sales forecast 51
Launch of Wellbutrin XL in the 5EU 51
End of Wellbutrin XL's lifecyle in the US 52
Further insight and case study 52
Cymbalta (duloxetine, Eli Lilly) 52
Forecast upgrade following launch in France 52
Depression-specific forecast 53
Effexor XR 53
Depression-specific forecast remains unchanged 53
Launch of AB-rated generic still anticipated for 2010 55
Non-AB-rated Effexor XR versions 56
Updated key pipeline drug assumptions 57
Valdoxan (agomelatine, Servier and Novartis) 57
Positive CHMP opinion and reduced pipeline competition 57
Favorable clinical profile 58
Large US clinical program ongoing 59
Seroquel XR (quetiapine extended-release, AstraZeneca) 59
Strong clinical trial data leads to forecast upgrade 59
Depression-specific forecasts 61
Regulatory submissions for depression on track 63
High level of current off-label prescribing inhibits strong growth post-approval 63
Proportional increase in depression-specific Seroquel sales 64
Switching to Seroquel XR has been slow in the US 66
Prescriber switching to generic twice-daily formulations post-patent expiry possible 67
Competition from other atypical antipsychotics 68
Clinical trial data in depression now available 68
Vilazodone (Clinical Data Inc) 69
Long-acting 5-HT1A partial agonist and serotonin uptake inhibitor 69
Progress initiates forecast coverage 70
New Phase III results are promising 70
Genetically guided antidepressant 71
Restricted patient population but strong differentiation 71
Saredutant (Sanofi-Aventis) 72
Regulatory approval uncertain 72
Cautious forecast maintained 72
Three out of five Phase III trials have failed 73
Datamonitor's assumptions regarding saredutant 74
DDS-04A (once-daily formulation of trazodone, Labopharm) 74
Coverage initiated following NDA filing 74
Modest forecast 75
FDA accepted filing in November 2008 75
Clinical trial data 76
Commercial viability 76
Lu AA21004 (Lundbeck) 77
Lack of published clinical trial data precludes commercial assessment 77
No detail regarding clinical trial data 77
Datamonitor comments 78
Corlux (mifepristone, C-1073, Corcept) 78
Enhanced risk of clinical trial and regulatory failure 78
Key project discontinuations 79
Amibegron - project terminated 79
Gepirone ER - project terminated 79
 

BIBLIOGRAPHY 80
Journal papers 80
Websites 80
Datamonitor reports 84
 

APPENDIX A - MARKET ASSUMPTIONS 85
New product launches 85
Patent expiry dates 85
Data definitions, limitations and assumptions 86
Standard units 86
Japanese market data 86
Derivation of sales forecasts and pricing trends 86
Forecast methodology 86
 

APPENDIX B 87
Contributing experts 87
Report methodology 87
About Datamonitor 87
About Datamonitor Healthcare 87
About the Central Nervous System analysis team 88
Disclaimer 90
 

List of Tables
Table 1: Depression-specific sales forecasts in the seven major markets ($m), 2007-2017 26
Table 2: Depression-specific sales revenue for the top eight ranked brands across the seven major markets, 2004-2017 35
Table 3: Key products in late-stage of development for depression, 2008 36
Table 4: Key products in Phase II development for depression, 2008 37
Table 5: Abilify (aripiprazole) recommended doses across indications, 2008 47
Table 6: Datamonitor's estimated launch dates for key depression products in the seven major markets, 2008-2017 85
Table 7: Patent expiry dates for the key depression brands in the seven major markets, 2007-2018 85
 

List of Figures
Figure 1: Depression-specific sales ($ billion) by country, 2004-2017 11
Figure 2: Regional share of the total major depressive disorder market, 2007-2017 14
Figure 3: Depression-specific sales revenue ($ billion) in US, 2004-2017 15
Figure 4: 5EU major depressive disorder market value and forecast ($ billion), 2004-2017 17
Figure 5: Japanese major depressive disorder market value and forecast ($ billion), 2004-2017 19
Figure 6: Percentage of major drug class sales revenue in major depressive disorder, 2004-2017 20
Figure 7: Atypical antipsychotic sales revenue from major depressive disorder across the seven major markets, 2004-2017 25
Figure 8: Comparison of depression-specific forecasts in the seven major markets, 2006-2017 27
Figure 9: The global major depressive disorder market split by region, 2007 29
Figure 10: The global major depressive disorder market growth trends ($ billion) split by region, 2004-08 30
Figure 11: Regional major depressive disorder market value ($m), 2004-07 31
Figure 12: Latin American major depressive disorder market ($m), 2004-07 32
Figure 13: Top eight depression-specific brands on value ($m) across the seven major markets, 2004-2017 34
Figure 14: Generic incursion on Zoloft (sertraline) depression-specific sales in the US ($m) 39
Figure 15: Switch in sertraline IMS Standard Units sold in the US, Q1 2006 to Q2 2008 39
Figure 16: Zoloft (sertraline) branded depression-specific sales revenue ($m) in the US, 2005-07 40
Figure 17: Depression-specific Zoloft (sertraline) historical and forecast sales revenue ($m), seven major markets, 2004-2017 41
Figure 18: Depression-specific Abilify (aripiprazole) sales revenue across the seven major markets, 2006-2017 42
Figure 19: Depression-specific sales of key atypical antipsychotic brands across the seven major markets, 2006-07 44
Figure 20: Change in quarterly total brand IMS Standard Units (SU) sold for Abilify (aripiprazole) in the US, Q3 2006 to Q2 2008 45
Figure 21: Depression-specific Pristiq forecast sales revenue ($m), seven major markets, 2008-2017 48
Figure 22: Depression-specific Wellbutrin XL (bupropion extended-release) historical and forecast sales revenue ($m), seven major markets, 2004-2017 51
Figure 23: Depression-specific Cymbalta historical and forecast sales revenue ($m), seven major markets, 2004-2017 53
Figure 24: Depression-specific Effexor XR historical and forecast sales revenue ($m), seven major markets, 2004-2017 55
Figure 25: Depression-specific Valdoxan (agomelatine) forecast sales revenue ($m), seven major markets, 2008-2017 58
Figure 26: Depression-specific Seroquel IR and Seroquel XR historical (2004-07) and forecast (2008-2017) sales revenue ($m), seven major markets 61
Figure 27: Depression-specific Seroquel franchise (IR + XR) historical (2004-07) and forecast (2008-2017) sales revenue ($m), seven major markets 62
Figure 28: Off-label depression-specific sales of Seroquel (quetiapine) IR+XR, 2004-07 65
Figure 29: Percentage of total Seroquel brand sales attributed to depression, 2005-07 66
Figure 30: Quarterly US total brand sales ($m) for Seroquel IR and Seroquel XR, Q3 2007 to Q2 2008 67
Figure 31: Depression-specific vilazodone forecast sales revenue ($m), seven major markets, 2010-2017 70
Figure 32: Depression-specific saredutant forecast sales revenue ($m), seven major markets, 2008-2017 73
Figure 33: Depression-specific DDS-04A (trazodone once daily) forecast sales revenue ($m), seven major markets, 2008-2017 75