Table of Contents

Forecast Insight: Depression - Generic induced brand erosion leads to market decline - Provides analysis of key events and their impact on the major depressive disorder market since over the last 2 years (200708). Includes an event-based, indication- and country-specific 10-year forecast of key marketed and pipeline products to 2017.

Product Code: dmhc2459

Publication Date: 19-Dec-2008

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Overview

Introduction

The depression market was valued at around $11.04 billion in 2007 across the seven major markets. Following marginal growth to 2011 ($12.01 billion), the market is forecast to decline in value through to 2017 ($9.81 billion) when brand erosion due to generic incursion affecting all major drug classes used to treat depression finally outweighs the success of reformulations and follow-on products.

Scope

· This report gives a strategic analysis of the likely impact that recent events will have on the future depression market

· Includes depression-specific sales forecasts for the key brands, generics, and pipeline agents in the seven major markets to 2017

· Provides a global depression-market snapshot, and analysis of growth trends in key markets outside of the seven major pharmaceutical markets

· Conclusions are supported by key opinion leader comment

Highlights

Datamonitor has upgraded its depression-specific Abilify and Seroquel forecasts following positive clinical trial data in depression for both atypical antipsychotics, and the observation that regulatory approval of Abilify as an adjunct to antidepressants in depression resulted in an increase in the brand's quarterly sales growth rate.

Servier and Novartis's Valdoxan has emerged as the most promising pipeline depression drug following failure of several late-stage candidates. Prescribing for depression patients suffering from comorbid sleep disorders will drive sales over the forecast period.

Datamonitor forecasts moderate uptake of saredutant in refractory depression patients as an add-on therapy. While the drug failed to show efficacy as a monotherapy in clinical trials published over the last year, Sanofi-aventis is continuing to develop saredutant with two add-on therapy trials ongoing.

Reasons to Purchase

· Quantify the current size of the global major depressive disorder market

· Assess the impact of recent and anticipated events (patent expiries, new product launches, regulatory approval) on depression-specific brand sales

· Understand the country-specific impact of key events in the major depressive disorder market during the forecast period 2008 to 2017

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ABOUT DATAMONITOR HEALTHCARE	2
About the depression pharmaceutical analysis team	2
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	91
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

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