Market Report Source

Overview

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

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the depression market

Contributing experts

Related reports

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

Current market situation

Key events and gold-standard

Sales in the US dominate the total seven major MDD market

Sales revenue generated in the US dominates the MDD market

France is the largest MDD market in the 5EU

Varying uptake of modern antidepressant drug classes across the seven major markets

Prescribing trends for MDD by drug class in the US

Strategic scoping and focus

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Summary of environmental issues affecting the MDD market size

Seven major market opportunities and threats

Opportunities

Large volume of sales for older antidepressants leaves room for expansion

Differentiation of pipeline products possible by targeting the lag-time to efficacy observed with all current treatments

Ageing population – expansion into the growing elderly and co-morbid depression patient groups

Secondary indications

Use of different delivery methods

Threats

Generics

Lack of scope for further reformulations

Increasing number and diversity of safety warnings on antidepressants labels

Increasing placebo effect observed in clinical trials hinders drug development

US: opportunities and threats

Opportunities

Ethnic minorities

Threats

FDA extends black-box warnings on antidepressants

Wal-Mart $4 a day generic program introduces further cost competition

Japan: opportunities and threats

Opportunities

Destigmatization of depression boosts Japan market and attracts Western investors

Unsaturated antidepressant market encourages new market entry

Drug approval lag-time being targeted by the Japanese Ministry of Health, Labor and Welfare

Threats

Generic substitution likely to increase over the medium term in Japan

France: opportunities and threats

Opportunities

Changes in psychiatrist demographics stimulates prescribing of mainstream antidepressants

Threats

Generic incursion on the antidepressant market is high in France, and is likely to increase in the future

Germany: opportunities and threats

Opportunities

Market share still to be gained by current market players, with a large volume of sales coming from older drugs

Threats

AKDA guidelines recommend psychotherapy as an alternative to pharmacotherapy

Pharmaceutical-Prescribing-Efficiency-Act – bonus-malus encourages generic prescribing

Italy: opportunities and threats

Opportunities

Revenues can be maintained despite patent expiries

Threats

Established reference pricing system makes it difficult to set premiums on second generation drugs in a class

Spain: opportunities and threats

Opportunities

Reduced pharmaceutical tax could save companies selling depression treatments $6m per annum

Threats

The introduction of reference pricing will force antidepressant prices down

UK: opportunities and threats

Opportunities

NICE recommends antidepressants for co-morbid depression in Alzheimer’s

PCPs freed to prescribe Effexor following recommendation in NICE update

Threats

Move towards psychotherapy at the expense of pharmacotherapy

CHAPTER 4 FORECAST ANALYSIS

Key events

New product launches in the US and EU

Wellbutrin XL for MDD in the EU

Pristiq

Luvox CR

Gepirone ER

Agomelatine

Saredutant

Nemifitide

Seroquel SR – indication expansion

New project launches in Japan

Remeron (mirtazapine)

Effexor

Cymbalta

Lexapro

Gepirone ER

Patent expiries and generic launch dates

Bupropion extended release (Wellbutrin XL)

Duloxetine (Cymbalta)

Venlafaxine XR (Effexor XR)

Escitalopram (Lexapro)

Gepirone ER

Patent expiry of other drugs used to treat MDD

Data definitions, limitations and assumptions

Standard units

Derivation of sales forecasts and pricing trends

Generic erosion and pricing assumptions

MDD-specific sales calculations

ICD-10 codes used to define current MDD market

Japanese market data

Forecasts

Forecast methodology

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

Introduction

Case studies

Indication expansion of atypical antipsychotics into depression

Significant off-label prescribing already exists

Licensed indication expansion is likely to be the next step for atypical antipsychotics

Indication expansion of atypical antipsychotics follows a similar lifecycle management strategy to the antidepressant class

AstraZeneca has led the way into depression disorders with Seroquel

Significant off-label prescribing already occurring

Additional uptake likely to occur in the primary care setting and as a combination therapy with a current antidepressant

Competition from pipeline MDD drugs in the medium-term

Scenario forecast

Reformulation strategies of the antidepressant drug class

What makes a successful reformulation?

Successful reformulation strategies in the depression market

Unsuccessful reformulation strategies in the depression market

Success or failure for forthcoming reformulations?

Improving compliance via sexual dysfunction management strategies would create patient and prescriber loyalty

Switching antidepressants is the present solution to non-compliance

Sexual dysfunction is the leading side effect associated with non-compliance

Pharmaceutical companies would benefit from encouraging management strategies in primary care

Patient education over sexual dysfunction management must be handle carefully

Switching due to lack of efficacy after six weeks is appropriate and not an compliance issue

BIBLIOGRAPHY

Journal papers

Websites

Other sources

Datamonitor reports

APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS

Summary MDD market data

SSRI market data

SNRI market data

APPENDIX B – MARKET FORECAST DATA

Seven major markets

M5EU

US

Japan

France

Germany

Italy

Spain

UK

APPENDIX C

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the CNS analysis team

Disclaimer