World Market for Biosimilars and the Potential for US Follow-on Biologics, The

World Market for Biosimilars and the Potential for US Follow-on Biologics, The

Biosimilars, or generic biologic drugs, are marketed around the world but still restricted in the U.S. This may soon change, and Kalorama Information has released this timely study of the market in Europe and other areas in the world and the possibility of a U.S. Market in the near future. As part of its research, this Kalormaa Information report provides the following

• Current market size and forecasts for biogenerics in Europe and Rest of World Markets


• Review of Marketed Biological Drugs with Expired Patents


• Review of Marketed Biological Drugs with Active Patents


• Profiles of the Major Competitors in biogenerics


• Discussion of FDA and EMEA regulatory activity


• Pending U.S. Legislation and Projections for US Markets


• Coverage of Patent Trends, Pricing Trends, Healthcare Spending, IP and ohter Relevant Issues and Trends

For purposes of 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 likely to be the first products that will be attempted by generic companies. Some of these products are relatively simple in structure (by biotech complexity) such as the insulins and human growth hormones, while others are extremely difficult to process.


There are a number of biopharmaceuticals that are identified as potential targets for generic development. Many of these biopharmaceutical patents have expired. Many of these products sport manufacturer sales of over $10 billion, presenting a ripe opportunity for generic manufacturers. However, because many of these products demonstrate sales of over $1 billion per year, it is anticipated that there will considerable resistance from the biotech innovator companies in allowing generic capitalization and consequently approvals.


The information and analysis presented in this report are based on an extensive survey of senior management in the biogeneric drug industry. Background information was obtained from a comprehensive search of published literature and reports obtained from various government, business, medical trade, and international journals.



Key information from published literature was used to conduct interviews with over 42 industry executives and product managers to validate and obtain expert opinion on current and future trends in the psychotherapeutic industry. Interviews were also used to confirm and/or adjust market size, as well as in formulating market projections.



All market data pertains to the world market at the manufacturers’ level. Data are expressed in current U.S. dollars. The geographic scope of the study is worldwide with particular emphasis on the United States and Europe.

CHAPTER ONE: EXECUTIVE SUMMARY

Introduction

Scope and Methodology

Size and Growth of the Market

Table 1-1: Total World Biosimilar Market Potential 2006-2013, Products with Currently Expired Patents

Figure 1-1: Total World Biosimilar Market Potential 2006-2013, Products with Currently Expired Patents

Trends Affecting the Market

Market Outlook

CHAPTER TWO: INTRODUCTION AND OVERVIEW

Biogenerics Overview

Table 2-1: Scientific Differences of Pharmaceuticals and Biopharmaceuticals

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

Table 3-1: Select Marketed Biopharmaceuticals with Expired Patents

Select Marketed Biopharmaceuticals with Expired Patents

CHAPTER FOUR: BIOGENERIC PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS

Table 4-: Select Marketed Biopharmaceuticals with Active Patents

CHAPTER FIVE: ISSUES AND TRENDS

Overview

Worldwide Regulatory and Legislative Issues

Europe

Table 5-1: Biosimilars Approved in EU

Biosimilars Approved in EU

United States

Pathway for Biosimilars Act

Promoting Innovation and Access to Life-Saving Medicine Act

Japan

Rest of World

Asia and Biogenerics

Scientific Issues

Immunogenicity

Patent Issues

Pricing Issues

Table 5-2: Estimates of Treatment Cost Per Patient of Selected Biopharmaceuticals

Barriers to Entry

Innovator Companies and Follow-on Biologics

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

Market Size and Growth

Table 6-: Total World Biosimilar Market Potential 2006-2013, Products with Currently Expired Patents

Figure 6-: World Biosimilar Market Potential by Region 2006-2013, Products with Currently Expired Patents

Regional Market Analysis

Table 6-2: World Biosimilar Market Potential by Region 2006-2013, Products with Currently Expired Patents

Figure 6-2: World Biosimilar Market Potential by Region 2006-2013, Products with Currently Expired Patents

Biologic Class Market Analysis

Table 6-3: The World Market Potential for Biosimilars by Biological Class (EPO, G-CSF, HGH, Insulin, Interfereon alpha, Others) 2006-2013*

Figure 6-3: The World Market Potential for Biosimilars by Biological Class 2006-2013

Figure 6-4: The World Market Potential for Biosimilars by Biological Class Market Share 2009

Figure 6-5: The World Market Potential for Biosimilars by Biological Class Market Share 2013

Key Biosimilar Markets and Comparison to Brand Market

Table 6-4: Market Share of Biosimilar Sales in Comparison to Brand Sales, 2009 Estimates

Market Potential

U.S. Market

Non-U.S. Market

Competitor Analysis

Potential ‘War’ between Brand and Generic

Table 6-5: Market Share of Early Leaders in the World Biosimilar Market, 2009

CHAPTER SEVEN: CORPORATE PROFILES

Apotex, Inc.

Biocon Ltd .

Biogenerix Ag

BioPartners GmbH

Cangene Corporation

Dr. Reddy’s Laboratories Limited

Dragon Pharmaceuticals, Inc.

GeneMedix PLC

Hospira, Inc.

Merck Bioventures

Microbix Biosystems, Inc.

Momenta Pharmaceuticals Inc

Phage Biotechnology Corp

Ranbaxy Laboratories Limited

Sandoz

STADA Arzneimittel AG

TEVA Pharmaceutical Industries, Ltd.

Watson Pharmaceuticals, Inc.

COMPANY DIRECTORY