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Commercial Insight: Asthma & Copd - Combination Products Still Have Blockbuster Potential

Published by: Datamonitor

Published: Jul. 11, 2007 - 269 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE

About the respiratory pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the asthma/COPD market

Contributing experts

Related reports

CHAPTER 2 MARKET DEFINITION AND OVERVIEW

Market definition for this report

Indication sales split

Current market situation

Strategic scoping and focus

CHAPTER 3 COUNTRY MARKET ASSESSMENTS

Summary of environmental issues affecting the asthma/COPD market

Opportunities and threats in the seven major markets

Opportunities

Off-label prescribing is popular in the pediatric asthma market

EMEA harmonizes drug approval process

Smaller companies helped by European regulators

Threats

Governments try to stop increasing healthcare expenditure by controlling pricing and reimbursement

Parallel trading threatens return on investment

Asthma and COPD prevalence will remain stable

Non-compliance is particularly common in asthma

Difficulty in conducting clinical trials in COPD

US: opportunities and threats

Asthma/COPD market overview

Opportunities

New asthma clinical trial endpoints open doors

The CFC-HFA switch will lead to a branded salbutamol market

FDA initiatives to decrease product development times

US is the only country to allow direct-to-consumer (DTC) advertising of prescription medicines

Threats

Reimbursement controls are important in decreasing healthcare expenditure in the US

Implementation of Medicare Part D influences US healthcare market

Parallel trading could increase due to Medicare D's 'donut hole'

Prescription Drug User Fee Act (PDUFA) likely to increase fees

Reimbursement of nebulized beta2-agonists in COPD are under pressure

Japan: opportunities and threats

Asthma/COPD market overview

Opportunities

Characteristics of Japanese society impact the COPD market in particular

Separation of manufacturing and marketing entities benefits both Japanese and foreign companies

Japan shows initiatives to open their market

Threats

Price cuts still dominate pricing and reimbursement in Japan

Increasing uptake of generics

Lengthy approval process slows down access to the Japanese market

COPD remains underdiagnosed and undertreated

France: opportunities and threats

Asthma/COPD market overview

Opportunities

Generics use is still relatively low in France

Pricing and reimbursement negotiations to be shortened by new agency

Threats

France increases its pricing and reimbursement efforts

Varying formularies influence hospital prescribing

Germany: opportunities and threats

Asthma/COPD market overview

Opportunities

Encouraging environment for novel drug development

ePharmacy and mail-order drugs legalized

Disease management programs encourage patients to be more involved

Threats

Reimbursement controls are important in decreasing healthcare expenditure in Germany

Generic penetration in Germany is relatively high

Germany focuses attention on high doses of medicines for elderly patients

ICS/LABA combinations under scrutiny

Italy: opportunities and threats

Asthma/COPD market overview

Opportunities

Generic drugs play a small role in Italy

Reimbursement negotiations are less restrictive

Threats

Italy increases its pricing and reimbursement efforts

Spain: opportunities and threats

Asthma/COPD market overview

Opportunities

The pharmaceutical industry implements strategies to reduce parallel exportation

Health ministry introduces 'Spanish national formulary'

Threats

The introduction of a new medicines bill increases the focus on cost containment in Spain

The profile of generics is being raised in Spain

UK: opportunities and threats

Asthma/COPD market overview

Opportunities

The UK offers an attractive market

The pricing and reimbursement environment in the UK is relatively non-restrictive

Threats

The UK enjoys a strong generics market

The post-guidance and pre-guidance effects of NICE are a significant concern

CHAPTER 4 FORECAST ANALYSIS

Key events

Inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combinations

Advair/Seretide will lose first position in ICS/LABA class

Symbicort US approval and SMART approach will boost sales

Foster competes on price

New product launches

Major clinical trials

Additional indications

Patent expiries

Oral anti-inflammatories

Singulair will remain highest selling NSAID but will suffer from generic entry and new competitors

New product launches

Additional indications

Patent expiries

Long-acting anticholinergics (LAMAs)

BI tries to differentiate Spiriva before the entry of new competitors

New product launches

Major clinical trials

Additional indications

Patent expiries

Inhaled corticosteroids (ICS)

Pulmicort and Flixotide remain the highest-selling ICS products

New product launches

Additional indications

Patent expiries

Long-acting beta2-agonists (LABAs)

Serevent and Foradil lead the LABA class

New product launches

Major clinical trials

Patent expiries

Biologicals

Xolair to become blockbuster by 2014

New product launches

Additional indications

Patent expiries

Short-acting beta2-agonists (SABAs)

Sepracor's Xopenex franchise to reach revenues of over $1 billion

IVAX/Teva's ProAir set to make most out of CFC-HFA switch in the US

Combivent sales to decline slightly

Short-acting anticholinergics (SAMAs)

Other asthma and COPD therapies

Bronchial thermoplasty

Antibiotics

Immunotherapy

Data definitions, limitations and assumptions

Standard Units

Japanese Market Data

Derivation of Sales Forecasts and Pricing Trends

Regional launch dates for new products

Generic Erosion and Pricing Assumptions

The 'Others' class

Forecasts

Forecast methodology

CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES

The strategies behind combination products

Pricing

First-to-market advantage

Patent protection

Combinations are here to stay

The impact of the CFC-HFA switch in the US

HFA as alternative to CFC

3M's patents will prevent entry of other HFA SABAs

ProAir will be highest-selling SABA after 2009 with peak sales of $650m

The increasing importance of inhaler devices in the asthma/COPD market

Lack of detailed guidelines and physician skills

pMDIs versus DPIs

The ideal inhaler

The Novolizer and the Respimat SMI

The Novolizer - optimal patient feedback and fine particles

The Respimat SMI - slow moving mist with deep lung penetration

BIBLIOGRAPHY

Bibliography

APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS

Summary asthma/COPD market data

ICS/LABA combinations market data

ICS/LABA combinations market data

Anticholinergics market data

Biologicals market data

Oral anti-inflammatories market data

Beta2-agonists market data

Inhaled corticosteroids (ICS) market data

APPENDIX B - MARKET FORECAST DATA

Market forecast data

APPENDIX C

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

About the respiratory and infectious disease analysis team

Disclaimer

List of Tables

Table 1: Prescription of off-label and unlicensed drugs in pediatrics

Table 2: Sales of ICS/LABA combination products in the seven major markets ($m), 2006-2016

Table 3: Price difference between launched ICS/LABA combination products in Germany, 2007

Table 4: Sales of oral anti-inflammatory products in the seven major markets ($m), 2006-2016

Table 5: Sales of long-acting anticholinergic products in the seven major markets ($m), 2006-2016

Table 6: Sales of inhaled corticosteroid products in the seven major markets ($m), 2006-2016

Table 7: Sales of long-acting beta2-agonist products in the seven major markets ($m), 2006-2016

Table 8: GSK pool of LABA candidates in Phase II trials, 2006

Table 9: Sales of monoclonal antibody products in the seven major markets ($m), 2006-2016

Table 10: Sales of short-acting betas2-agonist products in the seven major markets ($m), 2006-2016

Table 11: Sales of short-acting anticholinergic products in the seven major markets ($m), 2006-2016

Table 12: Costs per bronchoscopy

Table 13: Launch forecast assumptions used in the asthma/COPD market, 2007

Table 14: Generic erosion in the seven major markets over 3 years (%)

Table 15: Generic price discounts in the seven major markets (%)

Table 16: Classes rolled up into the 'Others' category by country

Table 17: Prices of HFA (levo)salbutamol products in 2006

Table 18: US - Summary market data, 2006 and 2016

Table 19: Japan - Summary market data, 2006 and 2016

Table 20: France - Summary market data, 2006 and 2016

Table 21: Germany - Summary market data, 2006 and 2016

Table 22: Italy - Summary market data, 2006 and 2016

Table 23: Spain - Summary market data, 2006 and 2016

Table 24: UK - Summary market data, 2006 and 2016

Table 25: Advair/Seretide: key facts

Table 26: Symbicort: key facts

Table 27: Foster: key facts

Table 28: Spiriva: key facts

Table 29: Atrovent: key facts

Table 30: Combivent: key facts

Table 31: Duoneb: key facts

Table 32: Berodual: key facts

Table 33: Xolair: key facts

Table 34: Singulair: key facts

Table 35: Accolate: key facts

Abstract

Introduction

Detailed analysis of the Asthma and COPD market. 10 year sales forecast for all major drugs brands in these indications, taking into account new treatment trends, clinical trial data, patent expirations and key new product launches in the 7 major markets.

Scope

Indication based forecasts for asthma/COPD products and significant pipeline drugs Assessment of country-specific drivers and resistors likely to impact the market Future market outlook for individual products taking into account key market events, in particular patent expiry and competitor launch dates Market overview by geographical area, with value analysis of clinical and commercial factors underlying product performance

Highlights

Asthma/COPD sales in the seven major markets are expected to grow to over $24 billion annually by 2010 and drop slightly thereafter due to patent expiries of key products. The ICS/LABA class is set to remain the leading class by value throughout, while the LAMA market will experience the strongest growth, particularly in COPD. A once-daily LABA/LAMA product should become the top-selling single brand in the seven major markets in 2016, depending on which company launches such a combination product first. However, combined sales of the Advair franchise (Advair/Seretide and once-daily Beyond Advair) will dominate the asthma/COPD market over the next ten years. The phase-out of CFC-containing inhalers in the US after 2008 will have a big impact on the market for short-acting beta2-agonists (SABAs), increasing this class' size significantly. The main beneficiary is expected to be IVAX's (now Teva) ProAir due to its favourable price compared with other marketed HFA SABAs.

Reasons to Purchase

Identify key opportunities and threats that will impact the use and uptake of new and existing products Quantify the future size and

Scope

of the asthma/COPD market and predict the future performance of key compounds Understand and capitalize on clinical unmet needs in the market, either through lifecycle management of marketed drugs or new product development

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