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

Published by	Decision Resources, Inc.
Published	June, 2007	Product code	53017
Content info	29 pages
Price	Not Available

Introduction
Related Reports

This publication has been discontinued on December 21, 2011.

Introduction

Abstract

Introduction:

The albuterol inhaler market in the United States will soon change from low-value to significant. 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.

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)