世界のバイオジェネリック薬市場

Abstract

Worldwide interest in biogenerics or biosimilars is gaining momentum. Since Kalorama Information last visited the market for synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies four years ago, there has been much more worldwide involvement in the development of the biogeneric arena.

The biological drug market is at a crossroads. Some of the biggest-selling biological drugs developed during the first phase of the biotechnology revolution in the 1980s, including human growth hormone (hGH) and insulin, have lost patent protection or are set to lose patent protection in the US in 2007 and beyond. This opens up the market currently worth $40 billion and growing at over 20% per year if the regulatory hurdles can be overcome.

Kalorama Information' s survey includes as part of its market analysis a breakdown of generic replacements for:

• Drugs with Active patents
• Drugs with Expired patents

with this geographic breakdown:

• World
• US
• non-US

In addition to market information, this report includes:

• Complete Overview
• Patent dates for Major Biopharmaceuticals
• Issues and Trends in the Industry
• Scientific Differences Between Biopharmaceuticals and Biogenerics
• Key Regulations Affecting this Market
• Company Profiles

As part of Kalorama Information' s trusted information gathering process, this report is the result of both primary and secondary research. In addition to exhaustive research, Key executives at biogeneric companies were consulted to uncover key trends and develop models.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

• Introduction
• Scope and Methodology
• Size and Growth of the Market
• Trends Affecting the Market
• Market Outlook

CHAPTER TWO: INTRODUCTION AND OVERVIEW

• Biogenerics Overview
• Biopharmaceutical Industry and Approval Process
  • Genetic Engineering Patent Approval
• Regulations for Biopharmaceuticals
• History of the Prescription Generic Pharmaceuticals Industry
• History of the Generic Approval Process
• Regulation of Prescription Generic Pharmaceuticals
• Biopharmaceuticals
• Areas of Treatment for Biopharmaceuticals

CHAPTER THREE: BIOGENERIC PHARMACEUTICALS FOR EXPIRED BIOLOGIC PATENTS

• Market Size and Growth
  • Non-U.S. Market

CHAPTER FOUR: BIOGENERIC PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS

• Market Size and Growth
  • World Market
  • Non-U.S. Market

CHAPTER FIVE: ISSUES AND TRENDS

• Overview
• Worldwide Regulatory and Legislative Issues
  • Europe
  • United States
  • Rest of World
• Asia and Biogenerics
• Scientific Issues
• Patent Issues
• Pricing Issues
• Barriers to Entry
• Innovator Strategies and Challenges
• Bulk Suppliers and Contract Manufacturing
• Bioequivalence Issues
• International Issues
• Low Cost Branded HGH
• Biogenerics and Health-Care Spending
• Intellectual Property

CHAPTER SIX: MARKET SUMMARY

• Total Market Size and Forecast
• Competitor Analysis

CHAPTER SEVEN: CORPORATE PROFILES

• Analiza, Inc
• Apotex, Inc.
• Barr Laboratories, Inc.
• Biogenerix Ag
• Biocon Ltd .
• BioPartners GmbH
• Cangene Corporation
• Dr. Reddy' s Laboratories Limited
• Dragon Pharmaceuticals, Inc.
• GeneMedix PLC
• Hospira, Inc.
• Microbix Biosystems, Inc.
• Momenta Pharmaceuticals Inc
• Phage Biotechnology Corp
• Sandoz
• Sicor, Inc.
• STADA Arzneimittel AG
• TEVA Pharmaceutical Industries, Ltd.
• Watson Pharmaceuticals, Inc.

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-1: Total World Biogenerics Market Potential 2006-2012
• Figure 1-1: The World Market Potential for BioGeneric Drugs by Revenues 2006-2012

INTRODUCTION AND OVERVIEW

• Table 2-1: Scientific Differences of Pharmaceuticals and Biopharmaceuticals

CHAPTER THREE: BIOGENERIC PHARMACEUTICALS FOR EXPIRED BIOLOGIC PATENTS

• Table 3-2: Marketed Biopharmaceuticals with Expired Patents
• Table 3-3: Total World Biogenerics Market Potential 2006-2012, Products with Expired Patents
• Table 3-4: Total U.S. Biogenerics Market Potential 2006-2012, Products with Expired Patents Table 3-5: Total Non-U.S. Biogenerics Market Potential 2006-2012, Products with Expired Patents

CHAPTER FOUR: BIOGENERIC PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS

• Table 4-1: Marketed Biopharmaceuticals with Active Patents
• Table 4-2: Total World Biogenerics Market Potential 2006-2012, Products with Active Patents
• Table 4-3: Total U.S. Biogenerics Market Potential 2006-2012, Products withActive Patents
• Table 4-4: Total Non-U.S. Biogenerics Market Potential 2006-2012, Products with Active Patents

CHAPTER FIVE: ISSUES AND TRENDS

• Table 5-1: Estimates of Treatment Cost Per Patient of Selected Biopharmaceuticals

CHAPTER SIX: MARKET ANALYSIS

• Table 6-1: Total World Biogenerics Market Potential 2006-2012
• Table 6-2: The World Market Potential for BioGeneric Drugs by Patent Segment 2006-2012
• Figure 6-1 Total World Biogenerics Market Potential 2006-2012 (Active, Expired)
• Figure 6-2 The World Market Potential for BioGeneric Drugs by Patent Segment (Active, Expired) 2006-2012