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SPECIAL REPORT: How Will the Withdrawal of Generic Albuterol Change the U.S. Respiratory Disease Market?

Published By: Decision Resources
June 2007
R55-364
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Description

The price of this report has been reduced due to its age.
Introduction:

The albuterol inhaler market in the United States will soon change from low-value to signifi cant. The only MDIs sold will be branded HFA formulations; CFC propellants will be eliminated. Because the new HFA formulations are not bioequivalent, companies will compete for market leadership by convincing physicians and patients of their product’s superiority and by making strategic pricing decisions.

Questions Answered in This Spectrum Report:
  • The imminent discontinuation of many generic formulations of albuterol in the United States will be the most
  • signifi cant change in the respiratory disease market in some time. Will today’s sales leaders weather the change and continue to enjoy market dominance? How will the change affect generics manufacturers? What marketing strategies will be key elements in development of the market between 2006 and 2011? What are the market leaders doing now?
  • As production of albuterol CFC ends, patients will have to switch from familiar generics to more-expensive,
  • branded HFA formulations that are not interchangeable despite having the same active ingredient. How can companies differentiate their products to win patient and physician allegiance? How will higher costs affect patients and reimbursement providers? How will they react?
  • By the beginning of 2009, the U.S. market for inhaled albuterol MDIs will comprise branded products
  • exclusively. Which products will drive the market at least until 2011? Which company is likely to own the biggest market share in 2011? Which companies will lose market share? Are new companies with new formulations likely to impact the market by 2011?
Scope
  • Respiratory disease market:
  • asthma and chronic obstructive pulmonary disease prevalence and treatment; albuterol agents and manufacturers.
  • Montreal Protocol:
  • ban on CFC propellants; impact on the albuterol market and on brand and generic manufacturers, consumers, and payers.
  • From CFC to HFA:
  • supply and demand challenges; manufacturer compliance; non-bioequivalence of HFAs; reimbursement issues.
  • Market outlook:
  • continuing demand for albuterol products; DPI formulations; pricing and product differentiation; U.S. market forecast; winners and losers.
Table of Contents
Executive Summary
Strategic Considerations
Stakeholder Implications
Introduction
The Montreal Protocol
Respiratory Diseases
An Overview of Asthma
Disease Defi nition, Etiology, and Prevalence
Treatment of Asthma
An Overview of Chronic Obstructive Pulmonary Disease
Disease Defi nition, Etiology, and Prevalence
Treatment of COPD
Use of Symptomatic Bronchodilators in the Treatment of Asthma and COPD
The Respiratory Disease Market
Controller Agents
Reliever Agents
The Albuterol Market in the United States
Challenges of the Switch to HFA Formulations
Demand and Manufacturing Concerns
Manufacturer Compliance
Lack of Equivalence
Reimbursement Issues
Market Outlook
Demand for Albuterol
Competitive Threats
U.S. Market Forecast
Winners and Losers
Appendix A. Market Forecast Scenarios for Branded HFA Products in the United States, 2006-2011
Methodology and Assumptions
Drug-Treated Population
Treated Days and Compliance
Price per Patient per Year
Scenario 1: Proventil HFA Takes Early Market Leadership
Scenario 2: Competitive Pricing
Scenario 3: Physicians Choose to Switch Patients to Xopenex


Tables


1. Prevalent Cases of Asthma and COPD, 2006
2. Sales of Leading Agents to Treat Asthma and COPD, 2006
3. Forecasted Sales of Reliever Agents in the United States, 2008 and 2011
A. Combined Asthma and COPD Drug-Treated Populations in the United States, 2006-2011
B. Annual Cost of HFA Agents for a Single Patient


Figures


1. Sales of Albuterol, 1986 - 2006
2. Sales of Albuterol in the United States, 2000-2006
A. Sales of Short-Acting Beta2 Agonists (Scenario 1: Proventil Takes Early Market Leadership), 2006-2011
B. U.S. Market Shares, 2011 (Scenario 1: Proventil Takes Early Market Leadership)
C. Sales of Short-Acting Beta2 Agonists (Scenario 2: Competitive Pricing), 2006-2011
D. U.S. Market Shares, 2011 (Scenario 2: Competitive Pricing)
E. Sales of Short-Acting Beta2 Agonists (Scenario 3: Physicians Switch Patients to Xopenex), 2006-2011
F. U.S. Market Shares, 2011 (Scenario 3: Physicians Switch Patients to Xopenex)


Sidebars


Barriers to Entry:What Is Discouraging Companies from Developing Albuterol?
How Will Albuterol Manufacturers Differentiate Their Products?
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PUBLICATION:   SPECIAL REPORT: How Will the Withdrawal of Generic Albuterol Change the U.S. Respiratory Disease Market?
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