Commercial Insight: Asthma and COPD - Get SMART : Market Research Report

Commercial Insight: Asthma and COPD - Get SMART

Published by: Datamonitor

Published: Nov. 21, 2005 - 136 Pages

About Datamonitor healthcare

About the Respiratory & Infectious Disease (RID) analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope
Datamonitor insight into the disease market

CHAPTER 2 MARKET OVERVIEW

Asthma/COPD market third fastest growing therapeutic category
Global forecast in 2014 is $23 billion
Performance by class: ICS/LABA combinations leading class by value
Products: Symbicort to become the top-selling brand
Form of drug: majority of therapies delivered by inhaled route, except in Japan
Geographical sales split: US continues to bear majority of drug costs
Top performance by indication: COPD to account for 34% of global sales
Company position: GSK has hit its maximal market share

CHAPTER 3 MARKET ENVIRONMENT

Global opportunities and threats: HFA reformulations protect against generic entry; Monoclonal antibody market is one of the fastest growing classes; The cost of non-compliance; Generic competition less intense in EU versus US; Asthma/COPD prevalence rates stabilizing; Safety and dosing are key clinical attributes
US: opportunities and threats: FDA sanctions LABA use with ICS - but does not go far enough; Medicare reforms boosts sales; FDA accepts new endpoints for novel asthma drugs; Medicare Modernization Act has implications for brand defense
Japan: opportunities and threats: Acceleration of drug approval process; Flat-sum reimbursement; Greater pricing restrictions; Under diagnosis and under treatmment of COPD
Europe: opportunities and threats: Impact of pricing controls reduced due to lack of generics; Poor representation of pulmonologists in Europe

CHAPTER 4 FORECAST ANALYSIS

ICS/LABA combinations: Symbicort SMART indication shifts initiative to AstraZeneca; Symbicort has billion-dollar potential in US; Super-Advair: generic defense; Seretide launch in Japan will boost sales; Novel ICS/LABA combinations need a strong differentiation profile based on improved safety and/or dosing; Altana’s ciclesonide/formoterol should have the strongest clinical profile; Novartis and SkyePharma combinations compete on price; Chiesi combination undercuts Symbicort
Biologicals: Xolair to achieve peak sales of $1 billion

Oral anti-inflammatories

Singulair to remain dominant in the oral US asthma market until patent expiry

Daxas results disappoint

Anticholinergics

Spiriva opens up the COPD market

B2-agonists

Long-acting beta-2 agonists sales remain flat

Short-acting beta-2 agonists class: Xopenex fuels growth

Inhaled corticosteroids

Pulmicort Respules challenged by IVAX

Asmanex - late-comer to a crowded market

Alvesco success hangs on FDA approval of highest dose

CHAPTER 5 CASE STUDY

Symbicort: pricing for success: Symbicort discount to components the major influence on launch performance; Strong exisiting R3 presence not vital to success; Total molecule sales, rather than brand sales, important in LABA class; Positive correlation between high Pulmicort Turbuhaler market share and success; Promotional spend in launch period should aim to achieve 50% market share

CHAPTER 6 SALES FORECASTS

Global forecasts
US forecasts
Japan forecasts
France forecasts
Germany forecasts
Italy forecasts
Spain forecasts
UK forecasts

CHAPTER 7 APPENDIX

Market definition
Indication sales split
Forecasting assumptions and estimates: Standard units; Japanese market data; Derivation of sales forecasts and pricing trends; General event information; Generic erosion and pricing assumptions; Predicted market share for new products
References
About Datamonitor
About Datamonitor Healthcare
About the Respiratory team
Disclaimer

List of Tables

Table 1: Global sales split by indication by class, 2004

Table 2: Global performance by class, 2004 and 2014

Table 3: Top 15 brands in the global markets, 2004

Table 4: Sales of major brands, 2004-14

Table 5: Global sales by delivery route, 2004

Table 6: Geographical sales split, 2004-14

Table 7: Global sales by split indication by class, 2004-2014

Table 8: Sales of Seretide/Advair by indication in 5EU and US, 2004-08

Table 9: Global company sales and market share, 2004-14

Table 10: Sales of inhaled products by delivery device, US, 2004

Table 11: US approved HFA-MDIs

Table 12: Monoclonal antibodies in clinical development for asthma

Table 13: Sales growth due to 2003 Medicare Act reforms

Table 14: Number of chest physicians per 100,000 population in 5EU

Table 15: Symbicort and Seretide sales, 5EU, 2004-14

Table 16: Launch price of Symbicort in the US

Table 17: Sales and market share of inhaled corticosteroids, US, 2004

Table 18: Symbicort and Seretide/Super-Advair sales, US, 2004-14

Table 19: Seretide and Super-Advair sales, 5EU, 2004-14

Table 20: Fluticasone/salmeterol generic entry, price differential and erosion rate, 5EU and US

Table 21: Seretide and Super-Advair sales, US, 2004-14

Table 22: Ratio of Flixotide sales in 2000 to Seretide sales in 2004

Table 23: Global ICS/LABA combination sales, 2004-14

Table 24: Market share of ICS/LABA class of Chiesi's beclomethasone/formoterol in 5EU

Table 25: Xolair sales, US, 2003-05

Table 26: Xolair patient model, US and 5EU, 2004-14

Table 27: Global antileukotriene sales, 2004

Table 28: Global Singulair sales by indication, 2004-14

Table 29: Global sales of anticholinergics, 2004

Table 30: Global sales of short-acting and long-acting beta-2 agonists, 2004

Table 31: Global sales of inhaled corticosteroids, 2004

Table 32: Symbicort launch phase market share of ICS/LABA combination class, 5EU

Table 33: Symbicort launch phase price discount to Seretide, Pulmicort/Oxis and generic ICS/Oxis

Table 34: Market share, sales and average cost per day of generic ICS in 5EU, 2001

Table 35: Market share, sales and average cost per day of Pulmicort Turbuhaler in 5EU, 2001

Table 36: Forecast sales, Global, 2004-14

Table 37: Forecast sales, US, 2004-14

Table 38: Forecast sales, Japan, 2004-14

Table 39: Forecast sales, France, 2004-14

Table 40: Forecast sales, Germany, 2004-14

Table 41: Forecast sales, Italy, 2004-14

Table 42: Forecast sales, Spain, 2004-14

Table 43: Forecast sales, UK, 2004-14

Table 44: Generic erosion and pricing assumptions

Table 45: First-year market share for second to market and "me-too" products

List of Figures

Figure 1: Global asthma/COPD sales growth, 2001-04

Figure 2: Global market share by ATC class by value, 2001-04

Figure 3: Global sales split by indication by class, 2004

Figure 4: Global sales split by indication for key brands, 2004

Figure 5: Positive outlook for respiratory market

Figure 6: Global sales forecast, 2004-14

Figure 7: Global performance of respiratory R3 classes, 2004-14

Figure 8: Top five brands by sales in global market, 2004

Figure 9: Global sales by delivery route, 2004-14

Figure 10: Asthma/COPD value market share by country, 2004

Figure 11: Percentage of global sales by indication, 2004-14

Figure 12: Pricing controls in Europe

Figure 13: Global ICS/LABA combination sales, 2004

Figure 14: Adjustable maintenance dosing versus stable dosing regimes

Figure 15: Symbicort adjustable maintenance dosing (AMD) regime

Figure 16: Symbicort SMART dosing regime

Figure 17: Symbicort, Seretide and Super-Advair sales, 5EU, 2004-14

Figure 18: Symbicort and Seretide/Super-Advair sales, US, 2004-14

Figure 19: Potential "dream ticket": ciclesonide/QAB-149 combination

Figure 20: Global ICS/LABA combination sales, 2004-14

Figure 21: Global Singulair sales by indication, 2004-14

Figure 23: Results from roflumilast RECORD and RATIO studies

Figure 23: Global sales of Spiriva, Atrovent and Combivent franchise, 2004-14

Figure 24: Xopenex sales, US, 2004-14

Figure 25: Global sales of inhaled corticosteroids products, 2004-14

Figure 26: Advantages and disadvantages of Altana's Alvesco

Figure 27: Sales of Symbicort, 5EU, 2001-04

Abstract

Introduction
There is a positive outlook for the respiratory market over the next five years, which will experience a sustained period of growth driven by the expansion of sales in existing classes, the launch of major new products, and the results from several landmark studies. However, the patent expiries of two leading products, Singulair and Seretide, will see growth flatten from the turn of the decade.

Scope
Indication based forecasts for asthma/COPD products, with additional coverage of antileukotrienes sales in allergic rhinitis
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 expiries, and competitor launches
Market overview by geographical area, with value analysis of clinical and commercial factors underlying product performance
Highlights
Global asthma/COPD sales should grow to $23 billion by 2014, with inhaled corticosteroid/long-acting bronchodilator combinations set to be the leading class by value in 2014, followed by leukotriene antagonists, and anticholinergics.

AstraZeneca's Symbicort should become the top-selling brand in the global market, driven by the approval of Symbicort Maintenance and Reliever therapy (SMART) in the EU, the launch of Symbicort in the US market, and the impact of generic competition on Advair/Seretide sales.

Four new launches are expected within the next five years, the most significant being Symbicort in the US and the launch of novel ICS/LABA combination products which will need a strong differentiation profile, based on improved safety, flexible dosing, or once-daily dosing to compete with Advair/Seretide and Symbicort.

Reasons to Purchase
Identify key environmental 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
Capitalize on clinical unmet needs in the market, either through the lifecycle management of marketed drugs or new product development

Get Full Details About This Report >>

US: 800.298.5699

Int'l: +1.240.747.3093

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 250,000 market research reports, company profiles and country profiles from over 650 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.

Commercial Insight: Asthma and COPD - Get SMART

Table of Contents

Abstract