Description
The World Market for Biosimlars (EPO, G-CSF, HGH, Insulin, Interferon Alpha, Monoclonal Antibodies, Other), 4th Edition
This study, The World Market for Biosimilars, 4th Edition (EPO, G-CSF, HGH, Insulin, Interferon alpha, mAbs, Others), is designed to provide a comprehensive look at the various strategies being used by select worldwide generic companies in exploring the emerging area of biosimilars, the issues and trends that are shaping the marketplace, and the potential feasibility of providing biosimilars within the United States regulatory environment.
Generic drugs continue to represent one of the greatest values in healthcare and are of great importance in the area of biopharmaceuticals as well because these products are among the most expensive treatments currently on the market. Generic drug manufacturers are poised for strong growth in the future because the patent protection for a host of major biopharmaceuticals will expire and new legislative reforms in the generic drug approval process may facilitate bringing products to market. While there are many issues to address, the outlook for biosimilar promotion is favorable in the next five years. As part of its coverage, the report provides the following:
- Scientific Differences of Pharmaceuticals and Biopharmaceuticals
- Market Share of Biosimilar Sales in Comparison to Brand Sales
- Marketed Biologics with Expired Patents
- Marketed Biologics with Active Patents
- Cost Savings From Biosimilar Use
- World Biosimilar Market Potential by Region 2010-2017
- World Biosimilar Market Potential by Biological Class 2010-2017 ( EPO, G-CSF, HGH, Insulin, Interferon Alpha, Monoclonal Antibodies, Other)
- Biosimilars Pipeline by Company and Product Type
For the purposes of this study, Kalorama has focused on the market for products which have lost patent in key markets. Projections were made based on the progress that is occurring within the generic arena in terms of capabilities, capital, interest, and development of biopharmaceuticals. Kalorama has identified the biopharmaceuticals that have lost patent protection and are the first products produced by generic companies. As part of its coverage, the following companies were profiled:
- 3SBio, Inc
- Actavis, Inc.
- Apotex, Inc.
- Beijing Four Rings Biopharmaceutical Co Ltd
- Biocad
- Biocon Ltd .
- Bio Sidus S.A.
- BioXpress Therapeutics S.A.
- Boehringer Ingelheim Gmbh
- Celltrion, Inc.
- Dong-A Pharmaceutical
- Dr. Reddy’s Laboratories Limited
- Epirus Biopharmaceuticals
- Gedeon Richter
- Harvest Moon Pharmaceuticals USA,
- Hospira, Inc.
- Kyowa Hakko Kirin Co., Ltd.
- Merck & Company
- Momenta Pharmaceuticals Inc
- Phage Pharmaceuticals, Inc.
- Ranbaxy Laboratories Limited
- Reliance GeneMedix PLC
- Reliance Life Sciences
- Samsung Bioepis Co Ltd
- Sandoz International GmbH
- STADA Arzneimittel AG
- TEVA Pharmaceutical Industries, Ltd.
- Wockhardt Ltd.
- Xiamen Amoytop Biotech Co Ltd.
Table of Contents
EXECUTIVE SUMMARY
Introduction
Scope and Methodology
Size and Growth of the Market
The World Market for Biosimilars
Trends Affecting the Market
Market Outlook
INTRODUCTION AND OVERVIEW
Biosimilars 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
BIOSIMILAR PHARMACEUTICALS FOR EXPIRED BIOLOGIC PATENTS
BIOSIMILAR PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS
ISSUES AND TRENDS
Overview
Worldwide Regulatory and Legislative Issues
Europe
United States
Japan
Rest of World
Asia and Biosimilars
India
China
South Korea
Scientific Issues
Patent Issues
Pricing Issues
Barriers to Entry
Biosimilar Development Paradigm Shift
Innovator Strategies and Challenges
Bulk Suppliers and Contract Manufacturing
Bioequivalence Issues
International Issues
Low-Cost Branded HGH
Biosimilars and Health-Care Spending
Patent Challenges
Intellectual Property
MARKET SUMMARY
Total Market Size and Forecast
Market Size and Growth
Regional Market Analysis
Biologic Class Market Analysis
Market Potential
Competitor Analysis
CORPORATE PROFILES
3SBio, Inc
Actavis, Inc.
Apotex, Inc.
Beijing Four Rings Biopharmaceutical Co Ltd
Biocad
Biocon Ltd .
BioPartners GmbH
Bio Sidus S.A.
BioXpress Therapeutics S.A
BOEHRINGER INGELHEIM GMBH
Celltrion, Inc.
Dong-A Pharmaceutical
Dr. Reddy’s Laboratories Limited
Epirus Biopharmaceuticals
Gedeon Richter
Harvest Moon Pharmaceuticals USA, Inc
Hospira, Inc.
Kyowa Hakko Kirin Co., Ltd.
Merck & Company
Momenta Pharmaceuticals Inc
Phage Pharmaceuticals, Inc.
Ranbaxy Laboratories Limited
Reliance GeneMedix PLC
Reliance Life Sciences
Samsung Bioepis Co Ltd
Sandoz International GmbH
Sandoz International GmbH
STADA Arzneimittel AG
TEVA Pharmaceutical Industries, Ltd.
Wockhardt Ltd.
Xiamen Amoytop Biotech Co Ltd.
COMPANY DIRECTORY
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1: Total World Biosimilar Market Potential 2010-2017
Figure 1-1: World Biosimilar Market Potential 2010-2017
CHAPTER TWO: INTRODUCTION AND OVERVIEW
Table 2-1: Scientific Differences of Pharmaceuticals and Biopharmaceuticals
CHAPTER THREE: BIOSIMILAR PHARMACEUTICALS FOR EXPIRED BIOLOGIC PATENTS
Table 3-1: Select Marketed Biologics with Expired Patents
CHAPTER FOUR: BIOSIMILAR PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS
Table 4-1: Select Marketed Biologics with Active Patents
Table 4-2: Number of Select Biosimilar Products in Development 2012
CHAPTER FIVE: ISSUES AND TRENDS
Table 5-1: Biosimilars Approved in EU
Figure 5-2: Cost of Selected Biopharmaceuticals
Table 5-2: Estimates of Treatment Cost Per Patient of Selected Biopharmaceuticals
Table 5-3: Patent Challenges by Company 2012
CHAPTER SIX: MARKET SUMMARY
Table 6-1: Total World Biosimilar Market Potential 2010-2017
Figure 6-1: World Biosimilar Market Potential 2010-2017
Table 6-2: World Biosimilar Market Potential by Region 2010-2017
Figure 6-2: World Biosimilar Market Potential by Region 2010-2017
Table 6-3: The World Market Potential for Biosimilars by Biological Class 2010-2017*
Figure 6-3: The World Market Potential for Biosimilars by Biological Class 2010-2017 (millions)
Figure 6-4: The World Market Potential for Biosimilars by Biological Class Market Share 2012
Figure 6-5: The World Market Potential for Biosimilars by Biological Class Market Share Forecast to 2012
Figure 6-6: The World Market Potential for Biosimilars by Biological Class, Market Share 2017
Table 6-4: Market Share of Biosimilar Sales in Comparison to Brand Sales, 2012 Estimates
Table 6-5: Biosimilars Pipeline by Product Type
Table 6-6: Market Share of Early Leaders in the World Biosimilar Market, 2012
