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Published by: Datamonitor
Published: Dec. 19, 2008 - 90 Pages
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the depression pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Strategic scoping and focus
- Datamonitor insight into the depression market
- Related reports
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW
- Market definition for this report
- Countries and regions included in this report
- Seven major market assessment
- Seven major market dynamics
- Generic incursion erodes total market value
- Generics - underlying inhibitor to growth across the US and 5EU
- Regional contribution to seven major market forecasts
- US contribution to total revenue declines over forecast period 2008-2017
- US market dynamics
- US market projected to decline as generics increasingly play a role
- 2004-07: historical major depressive disorder market
- 2007-2011: near-term US market growth forecast
- 2011-2017: long-term US market decline
- 5EU (France, Germany, Italy, Spain and the UK) market dynamics
- 5EU market anticipated to grow over the forecast period 2008-2017
- Historical 5EU market showed growth in 2007
- Future 5EU depression market set for moderate growth
- Japanese market dynamics
- Japan remains the key growth region
- Drug class dynamics
- Selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)
- Use of the atypical antipsychotic drug class for treating depression has grown significantly
- Comparison with previous forecast
- Downgrade since 2007 forecast
- Global sales and rest of the world snapshot
- Rest of the world is a multi-billion dollar market
- Rest of the world depression sales have grown rapidly over the last 4 years
- Dynamics in the rest of the world
- Canada and ex-5EU European markets are significant major depressive disorder markets
- Major depressive disorder market growing sharply in Latin America
- CHAPTER 3 BRAND DYNAMICS
- Overview of competitive landscape
- Leading brands across the seven major pharmaceutical markets
- Effexor (venlafaxine, Wyeth) is the current depression market leading brand
- Fragmentation and generic incursion erodes branded market
- Pipeline drugs rank among the leading depression brands by 2017
- Key pipeline drugs
- Updated key marketed brand dynamics
- Zoloft (sertraline, Pfizer)
- Forecast downgrade following quicker than anticipated generic incursion
- Abilify (aripiprazole, Bristol-Myers Squibb and Otsuka Pharmaceutical)
- Forecast upgrade following approval for adjunctive depression therapy
- Depression-specific forecast
- Off-label prescribing high pre-approval
- Boost in sales observed post-approval
- Clinical trial data supporting approval
- Lower dose of Abilify recommended for treating depression than for bipolar mania and schizophrenia
- Pediatric extension to patent prolongs protection in the US
- Pristiq (desvenlafaxine succinate extended release, Wyeth)
- Delay in European launch impedes growth
- Regulatory progress and launch in the US as anticipated
- Development in the 5EU stalls following regulatory review delay
- Switching from Effexor XR to Pristiq will be difficult
- Wellbutrin XL (bupropion extended-release; GlaxoSmithKline)
- Wellbutrin XL depression-specific sales forecast
- Launch of Wellbutrin XL in the 5EU
- End of Wellbutrin XL's lifecyle in the US
- Further insight and case study
- Cymbalta (duloxetine, Eli Lilly)
- Forecast upgrade following launch in France
- Depression-specific forecast
- Effexor XR
- Depression-specific forecast remains unchanged
- Launch of AB-rated generic still anticipated for 2010
- Non-AB-rated Effexor XR versions
- Updated key pipeline drug assumptions
- Valdoxan (agomelatine, Servier and Novartis)
- Positive CHMP opinion and reduced pipeline competition
- Favorable clinical profile
- Large US clinical program ongoing
- Seroquel XR (quetiapine extended-release, AstraZeneca)
- Strong clinical trial data leads to forecast upgrade
- Depression-specific forecasts
- Regulatory submissions for depression on track
- High level of current off-label prescribing inhibits strong growth post-approval
- Proportional increase in depression-specific Seroquel sales
- Switching to Seroquel XR has been slow in the US
- Prescriber switching to generic twice-daily formulations post-patent expiry possible
- Competition from other atypical antipsychotics
- Clinical trial data in depression now available
- Vilazodone (Clinical Data Inc)
- Long-acting 5-HT1A partial agonist and serotonin uptake inhibitor
- Progress initiates forecast coverage
- New Phase III results are promising
- Genetically guided antidepressant
- Restricted patient population but strong differentiation
- Saredutant (Sanofi-Aventis)
- Regulatory approval uncertain
- Cautious forecast maintained
- Three out of five Phase III trials have failed
- Datamonitor's assumptions regarding saredutant
- DDS-04A (once-daily formulation of trazodone, Labopharm)
- Coverage initiated following NDA filing
- Modest forecast
- FDA accepted filing in November 2008
- Clinical trial data
- Commercial viability
- Lu AA21004 (Lundbeck)
- Lack of published clinical trial data precludes commercial assessment
- No detail regarding clinical trial data
- Datamonitor comments
- Corlux (mifepristone, C-1073, Corcept)
- Enhanced risk of clinical trial and regulatory failure
- Key project discontinuations
- Amibegron - project terminated
- Gepirone ER - project terminated
- BIBLIOGRAPHY
- Journal papers
- Websites
- Datamonitor reports
- APPENDIX A - MARKET ASSUMPTIONS
- New product launches
- Patent expiry dates
- Data definitions, limitations and assumptions
- Standard units
- Japanese market data
- Derivation of sales forecasts and pricing trends
- Forecast methodology
- APPENDIX B
- Contributing experts
- Report methodology
- About Datamonitor
- About Datamonitor Healthcare
- About the Central Nervous System analysis team
- Disclaimer
- List of Tables
- Table 1: Depression-specific sales forecasts in the seven major markets ($m), 2007-2017
- Table 2: Depression-specific sales revenue for the top eight ranked brands across the seven major markets, 2004-2017
- Table 3: Key products in late-stage of development for depression, 2008
- Table 4: Key products in Phase II development for depression, 2008
- Table 5: Abilify (aripiprazole) recommended doses across indications, 2008
- Table 6: Datamonitor's estimated launch dates for key depression products in the seven major markets, 2008-2017
- Table 7: Patent expiry dates for the key depression brands in the seven major markets, 2007-2018
- List of Figures
- Figure 1: Depression-specific sales ($ billion) by country, 2004-2017
- Figure 2: Regional share of the total major depressive disorder market, 2007-2017
- Figure 3: Depression-specific sales revenue ($ billion) in US, 2004-2017
- Figure 4: 5EU major depressive disorder market value and forecast ($ billion), 2004-2017
- Figure 5: Japanese major depressive disorder market value and forecast ($ billion), 2004-2017
- Figure 6: Percentage of major drug class sales revenue in major depressive disorder, 2004-2017
- Figure 7: Atypical antipsychotic sales revenue from major depressive disorder across the seven major markets, 2004-2017
- Figure 8: Comparison of depression-specific forecasts in the seven major markets, 2006-2017
- Figure 9: The global major depressive disorder market split by region, 2007
- Figure 10: The global major depressive disorder market growth trends ($ billion) split by region, 2004-08
- Figure 11: Regional major depressive disorder market value ($m), 2004-07
- Figure 12: Latin American major depressive disorder market ($m), 2004-07
- Figure 13: Top eight depression-specific brands on value ($m) across the seven major markets, 2004-2017
- Figure 14: Generic incursion on Zoloft (sertraline) depression-specific sales in the US ($m)
- Figure 15: Switch in sertraline IMS Standard Units sold in the US, Q1 2006 to Q2 2008
- Figure 16: Zoloft (sertraline) branded depression-specific sales revenue ($m) in the US, 2005-07
- Figure 17: Depression-specific Zoloft (sertraline) historical and forecast sales revenue ($m), seven major markets, 2004-2017
- Figure 18: Depression-specific Abilify (aripiprazole) sales revenue across the seven major markets, 2006-2017
- Figure 19: Depression-specific sales of key atypical antipsychotic brands across the seven major markets, 2006-07
- Figure 20: Change in quarterly total brand IMS Standard Units (SU) sold for Abilify (aripiprazole) in the US, Q3 2006 to Q2 2008
- Figure 21: Depression-specific Pristiq forecast sales revenue ($m), seven major markets, 2008-2017
- Figure 22: Depression-specific Wellbutrin XL (bupropion extended-release) historical and forecast sales revenue ($m), seven major markets, 2004-2017
- Figure 23: Depression-specific Cymbalta historical and forecast sales revenue ($m), seven major markets, 2004-2017
- Figure 24: Depression-specific Effexor XR historical and forecast sales revenue ($m), seven major markets, 2004-2017
- Figure 25: Depression-specific Valdoxan (agomelatine) forecast sales revenue ($m), seven major markets, 2008-2017
- Figure 26: Depression-specific Seroquel IR and Seroquel XR historical (2004-07) and forecast (2008-2017) sales revenue ($m), seven major markets
- Figure 27: Depression-specific Seroquel franchise (IR + XR) historical (2004-07) and forecast (2008-2017) sales revenue ($m), seven major markets
- Figure 28: Off-label depression-specific sales of Seroquel (quetiapine) IR+XR, 2004-07
- Figure 29: Percentage of total Seroquel brand sales attributed to depression, 2005-07
- Figure 30: Quarterly US total brand sales ($m) for Seroquel IR and Seroquel XR, Q3 2007 to Q2 2008
- Figure 31: Depression-specific vilazodone forecast sales revenue ($m), seven major markets, 2010-2017
- Figure 32: Depression-specific saredutant forecast sales revenue ($m), seven major markets, 2008-2017
- Figure 33: Depression-specific DDS-04A (trazodone once daily) forecast sales revenue ($m), seven major markets, 2008-2017
AbstractIntroduction
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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