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

Published by: Decision Resources

Published: Jun. 8, 2007 - 29 Pages

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?

Abstract

• 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?

• 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.

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