貧血症市場：バイオジェネリックと第2世代製品の変化

Abstract

Introduction:

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?

Scope:

• Causes of anemia: erythrocyte production, hemoglobin and oxygen transport, and the six common forms of anemia.
• Treatment options: treatments for the most common forms of anemia.
• Current market: sales of agents to treat anemia in the United States, Europe, and Japan.
• Emerging therapies: new biologics and small-molecule therapeutics.
• Biogenerics: regulatory hurdles, pricing, and biogeneric EPO products.
• Market outlook: market outlook and the emergence of new market leaders in the United States, Europe, and Japan.

Companies Mentioned in This Spectrum Report

• Affymax
• Amgen
• Astellas
• Barr
• Bioceuticals
• BioGenerix
• BioPartners
• Centocor
• Chugai
• Neose
• Fibrogen
• Fresenius Medical Care
• GeneMedix
• Hospira
• JCR
• Johnson & Johnson
• Kirin
• Kissei
• LG Life Sciences
• Mayne
• Pliva
• ProMetic
• Roche
• Sandoz
• Sanofi-Aventis
• Shire
• Stada
• Syntonix
• Takeda

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