Commercial Insight: Depression - Atypical lifecycle management strategy rejuvenates depression market

Commercial Insight: Depression - Atypical lifecycle management strategy rejuvenates depression market

Introduction
Novel pipeline drugs, lifecycle management of the current branded antidepressants, and development of atypical antipsychotics for depression are set to grow the depression market through to 2010 when it will peak at $14.6 billion. Thereafter, however, generic incursion of the atypical antipsychotics and the remaining branded antidepressants will see the depression market value drop to 2016.

Scope
This report focuses on the leading pharmacotherapies used to treat depression with sales and volume country- and indication-specific forecasts to 2016
Assessment of current and future opportunities and threats in the depression market across the seven major pharmaceutical markets
Future market events that are expected to affect drug revenues are discussed and quantified for each of the seven major markets
Lifecycle management case studies show how previously successful strategies should be applied in today's market
Highlights
Sales of atypical antipsychotics in depression are set to be stimulated by anticipated positive clinical trial data investigating the use of Seroquel (quetiapine) in this indication. Datamonitor forecasts peak class level seven major market sales of $1.43 billion in 2008, followed by a decline due to competition from pipeline drugs and generics.

Timing of launch of Wyeth's reformulation Pristiq (desvenlafaxine) would appear to be optimal. However, no evidence exists to indicate that it is an improvement over the parent compound Effexor (venlafaxine). By focusing Pristiq on a niche cohort of depressed patients, Wyeth has done enough to diversify Pristiq to ensure moderate success.

The introduction of newer generation antidepressants such as the SNRIs Effexor and Cymbalta (duloxetine) and the SSRI Lexapro (escitalopram) into the Japanese depression market will drive its value considerably, resulting in a 52% increase by 2012.

Reasons to Purchase
Assess the impact of events such as patent expiries and new product launches on the depression-specific sales of key marketed brands
Quantify the future size of the depression market, in terms of volume and value, in each of the seven major markets
Identify key lifecycle management strategies that can ensure growth in the competitive depression market

TABLE OF CONTENTS
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor insight into the depression market 4
Contributing experts 6
Related reports 6
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 15
Market definition for this report 15
Current market situation 16
Key events and gold-standard 16
Sales in the US dominate the total seven major MDD market 16
Sales revenue generated in the US dominates the MDD market 17
France is the largest MDD market in the 5EU 18
Varying uptake of modern antidepressant drug classes across the seven major markets 19
Prescribing trends for MDD by drug class in the US 21
Strategic scoping and focus 22
CHAPTER 3 COUNTRY MARKET ASSESSMENTS 24
Summary of environmental issues affecting the MDD market size 24
Seven major market opportunities and threats 25
Opportunities 25
Large volume of sales for older antidepressants leaves room for expansion 25
Differentiation of pipeline products possible by targeting the lag-time to efficacy observed with all current treatments 26
Ageing population – expansion into the growing elderly and co-morbid depression patient groups 28
Secondary indications 31
Use of different delivery methods 33
Threats 35
Generics 35
Lack of scope for further reformulations 38
Increasing number and diversity of safety warnings on antidepressants labels 39
Increasing placebo effect observed in clinical trials hinders drug development 42
US: opportunities and threats 42
Opportunities 42
Ethnic minorities 42
Threats 44
FDA extends black-box warnings on antidepressants 44
Wal-Mart $4 a day generic program introduces further cost competition 45
Japan: opportunities and threats 48
Opportunities 48
Destigmatization of depression boosts Japan market and attracts Western investors 48
Unsaturated antidepressant market encourages new market entry 49
Drug approval lag-time being targeted by the Japanese Ministry of Health, Labor and Welfare 49
Threats 50
Generic substitution likely to increase over the medium term in Japan 50
France: opportunities and threats 51
Opportunities 51
Changes in psychiatrist demographics stimulates prescribing of mainstream antidepressants 51
Threats 53
Generic incursion on the antidepressant market is high in France, and is likely to increase in the future 53
Germany: opportunities and threats 55
Opportunities 55
Market share still to be gained by current market players, with a large volume of sales coming from older drugs 55
Threats 57
AKDA guidelines recommend psychotherapy as an alternative to pharmacotherapy 57
Pharmaceutical-Prescribing-Efficiency-Act – bonus-malus encourages generic prescribing 58
Italy: opportunities and threats 58
Opportunities 58
Revenues can be maintained despite patent expiries 58
Threats 62
Established reference pricing system makes it difficult to set premiums on second generation drugs in a class 62
Spain: opportunities and threats 65
Opportunities 65
Reduced pharmaceutical tax could save companies selling depression treatments $6m per annum 65
Threats 66
The introduction of reference pricing will force antidepressant prices down 66
UK: opportunities and threats 68
Opportunities 68
NICE recommends antidepressants for co-morbid depression in Alzheimer’s 68
PCPs freed to prescribe Effexor following recommendation in NICE update 69
Threats 71
Move towards psychotherapy at the expense of pharmacotherapy 71
CHAPTER 4 FORECAST ANALYSIS 73
Key events 73
New product launches in the US and EU 75
Wellbutrin XL for MDD in the EU 75
Pristiq 77
Luvox CR 78
Gepirone ER 78
Agomelatine 80
Saredutant 82
Nemifitide 82
Seroquel SR – indication expansion 83
New project launches in Japan 84
Remeron (mirtazapine) 85
Effexor 85
Cymbalta 85
Lexapro 85
Gepirone ER 86
Patent expiries and generic launch dates 86
Bupropion extended release (Wellbutrin XL) 87
Duloxetine (Cymbalta) 87
Venlafaxine XR (Effexor XR) 88
Escitalopram (Lexapro) 88
Gepirone ER 88
Patent expiry of other drugs used to treat MDD 89
Data definitions, limitations and assumptions 91
Standard units 91
Derivation of sales forecasts and pricing trends 91
Generic erosion and pricing assumptions 91
MDD-specific sales calculations 92
ICD-10 codes used to define current MDD market 93
Japanese market data 93
Forecasts 94
Forecast methodology 94
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 95
Introduction 95
Case studies 96
Indication expansion of atypical antipsychotics into depression 96
Significant off-label prescribing already exists 96
Licensed indication expansion is likely to be the next step for atypical antipsychotics 96
Indication expansion of atypical antipsychotics follows a similar lifecycle management strategy to the antidepressant class 96
AstraZeneca has led the way into depression disorders with Seroquel 96
Significant off-label prescribing already occurring 97
Additional uptake likely to occur in the primary care setting and as a combination therapy with a current antidepressant 98
Competition from pipeline MDD drugs in the medium-term 100
Scenario forecast 100
Reformulation strategies of the antidepressant drug class 101
What makes a successful reformulation? 102
Successful reformulation strategies in the depression market 103
Unsuccessful reformulation strategies in the depression market 106
Success or failure for forthcoming reformulations? 108
Improving compliance via sexual dysfunction management strategies would create patient and prescriber loyalty 110
Switching antidepressants is the present solution to non-compliance 110
Sexual dysfunction is the leading side effect associated with non-compliance 110
Pharmaceutical companies would benefit from encouraging management strategies in primary care 111
Patient education over sexual dysfunction management must be handle carefully 112
Switching due to lack of efficacy after six weeks is appropriate and not an compliance issue 113
BIBLIOGRAPHY 114
Journal papers 114
Websites 117
Other sources 119
Datamonitor reports 120
APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS 121
Summary MDD market data 121
SSRI market data 122
SNRI market data 128
APPENDIX B – MARKET FORECAST DATA 130
Seven major markets 130
M5EU 131
US 132
Japan 133
France 134
Germany 135
Italy 136
Spain 137
UK 138
APPENDIX C 139
Contributing experts 139
Report methodology 139
About Datamonitor 139
About Datamonitor Healthcare 140
About the CNS analysis team 140
Disclaimer 142