全球生物學名藥市場及美國後發生物製劑的發展潛力 是由出版商Kalorama Information在2009年08月所出版的。
這份英文市場調查報告書包含150 pages 價格從美金3700起跳。
生物學名藥雖然在全球流通，但至今仍被美國限制流通。但不久的將來可望有所變化。
本報告書內容包括：全球各國生物非專利藥品市場現在的規模及預測、專利到期的生物製劑及專利有效期間中的藥劑、生物非專利藥品的主要競爭介紹、FDA及EMEA的法規動向、美國市場的未來預測等。內容綱要摘記如下：
第1章 實施概要
第2章 介紹及概要
- 生物非專利藥品概要
- 生物藥品產業及許可流程
- 基因工程
- 專利許可
- 法規
- 非專利藥品產業的發展歷史
- 非專利藥品許可流程的發展歷史
- 針對非專利藥品的法規限制
- 生物藥品
- 生物藥品的治療範圍
第3章 伴隨專利到期的生物非專利藥品
第4章 針對未來專利到期藥物的生物非專利藥品藥
第5章 課題及動向
- 概要
- 全球法規限制及法律問題
- 歐洲
- EU許可的生物學名藥
- 美國
- 在Biosimilars Act之前的發展經過
- 技術創新及Life-Saving Medicine Act分析
- 日本
- 其他各國
- 亞洲及生物非專利藥品
- 科學問題
- 免疫原性
- 專利問題
- 價格問題
- 進入障礙
- 創新企業及後發生物製劑
- 策略及課題 其他
第6章 市場摘要
- 市場規模及成長
- 地區別市場分析
- 分析別市場分析
- 主要生物學名藥市場及與品牌市場的比較
- 市場發展潛力
- 美國市場
- 美國以外的市場
- 競爭分析
- 品牌藥及與非專利藥品的"戰爭"
第7章 企業介紹
企業名錄
Abstract
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 Kalorma 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.
Table of Contents
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
