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The Anemia Market: Biogenerics and Second-Generation Products Drive Change

Published by: Decision Resources

Published: Mar. 7, 2007 - 16 Pages

The price of this report has been reduced due to its age. The original price was $2,025 for PDF.

Table of Contents


Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

Causes of Anemia

Treatment Options

Current Market

United States

Europe

Japan

Emerging Therapies

New Biologics

Roche/Chugai's Mircera

Affymax/Takeda's Hematide

Neose's NE-180

Small-Molecule Therapeutics

Fibrogen/Astellas's FG-2216

ProMetic's PBI-1402

Biogenerics

Regulatory Hurdles to Biogenerics

Pricing

Biogeneric EPO Products

Market Outlook

United States

Europe

Japan

Emergence of New Market Leaders

Tables:

1. Sales of Erythropoietin Products, 2005

2. Products in Clinical Development for the Treatment of Anemia

3. Biogeneric Erythropoietin Products in Development for the Treatment of Anemia-Europe

Figures:

1. Erythropoiesis

2. Market Share of Key Players in the Anemia Market, 2005

3. U.S. Sales of Recombinant Erythropoietin Products, 2000-2005

Abstract

The availability of recombinant biologic agents has revolutionized the treatment of anemia and has created a market with a small number of players. However, the inconvenient administration and high prices of these biologic agents represent an opportunity for companies to enter this market with improved alternatives.

Get the Answers You Need to Shape Your Strategy

Worldwide sales of erythropoiesis-stimulating proteins reached $11.2 billion in 2005, and the market has grown annually at a rate of 13.5% since 2000. Which agents are driving the growth of the anemia market in the United States, Europe, and Japan, and what recent changes have established new market leaders?

Several therapies are in development for the treatment of anemia. Which emerging agents are likely to enjoy strong uptake, and which companies are likely to become key players in the anemia market?

Although many older protein therapeutics have lost patent protection, the road to the launch of biogeneric products (also referred to as biosimilars) has been long and complex. What are the regulatory and manufacturing obstacles to the launch of biogenerics? Which companies are currently developing biogeneric products?

The potential launch of Roche's Mircera, in development for the treatment of anemia, has sparked a legal battle with Amgen. What strategy is Amgen pursuing to block Roche's launch of Mircera in the United States, and how has Roche responded?

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