How Have Safety Concerns and New Warnings Affected the Anemia Market?

Published by: Decision Resources

Published: Jun. 26, 2008 - 19 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

The Use of Recombinant ESAs in Anemia Patients

Causes and Types of Anemia

Prevalence

Anemia Associated with Chronic Kidney Disease

Anemia Related to Cancer

Recombinant ESA Treatment

Concerns Arise About ESA Use

Risk of ESAs in Cancer Patients

Risks of ESAs in Chronic Kidney Disease Patients

Effect of New Safety Warnings on ESA Sales

Outlook for the Anemia Market

Other Factors Infl uencing the Anemia Market

Biosimilars

Emerging Agents to Treat Anemia

Outlook for Geographic Markets

United States

Europe

Japan

Tables

1. Approved Erythropoietin-Stimulating Agents (ESAs), 2008

2. Sales of Erythropoietin-Stimulating Agents (ESAs), 2007

3. Emerging Agents to Treat Anemia, 2008

Figures

1. Erythropoiesis

2. Market Share of Manufacturers of Erythropoietin-Stimulating Agents (ESAs), 2007

3. Sales Growth of Erythropoietin-Stimulating Agents (ESAs), 2001-2007

4. Number of U.S. Prescriptions for Erythropoietin-Stimulating Agents (ESAs), by Quarter, 2000-2008

Abstract

• Concerns about the safety of ESAs have increased steadily since 2004, when the first of several studies suggesting that ESAs have negative effects on patient survival were published. What specific safety concerns are associated with ESA treatment? How has the FDA responded to these safety concerns? How has Medicare responded? What are market-leading companies doing to address safety concerns? Do the pipelines contain possible successors to the ESAs? Which emerging agents look most promising?
• In 2007, worldwide sales of ESAs totaled $11.6 billion, a significant, 10% decline from sales in 2006. Which of the three major markets accounts for most ESA sales? Which three companies claim the biggest shares of the anemia market worldwide? What are the sales-leading ESAs today? In light of the serious safety concerns and regulatory reactions, what are the likely prospects for current and emerging ESAs? What are the market leaders doing to defend their positions in the anemia market?
• Other factors, specifically the entrance of biosimilars and new agents, will affect the anemia market in the next five to ten years. How will the anemia market evolve in the three different regions: the United States, Europe, and Japan? How will the availability of biosimilars (already approved) in Europe affect the sales of branded agents in that market? What factors are delaying the approval of biosimilars in the United States? Which third-generation agent, legally trammeled in the United States, may capture a significant share of the European market by 2010?

• Overview of anemia: types of anemia and causes, prevalence, chronic kidney disease-associated anemia, chemotherapy-induced anemia.
• Anemia treatment: erythropoietin-stimulating agents (ESAs), emerging agents, biosimilars.
• ESA safety issues: risk in cancer patients, risk in chronic kidney disease patients, effects on ESA sales, restrictions on use and reimbursement.
• Outlook for the anemia market: Other factors affecting the market, outlook by geographic region.

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