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市場調查報告書
新一代生物學：單株抗體改良
Next-Generation Biologics: Improving on Monoclonal Antibodies
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本報告已在2011年12月21日停止出版。
本報告書內容包括：生物科技概要、單株抗體產業概要、替代性單株抗體的製造動向等。內容綱要摘記如下：
實施概要
介紹
抗體結構
單株抗體改良
- 開發
- 製造
- 成本
- 競爭及授權權利金
- 傳輸
- 免疫原性
產業的關心重點及臨床發展
替代性單株抗體尚有的課題
附錄A：治療用單株抗體的生物學替代品種類
表
- 臨床發展上的替代性單株抗體
- 替代性單株抗體相關授權行為及共同行銷：2000年至2007年
- 代替單株抗體相關收購案：1999年至2007年
圖
- 生物療法的市場成長及小分子藥物：2002年至2006年
- 生物製劑市場中單株抗體的市場佔有率：2002年至2008年
- 抗體結構
- 開發階段別替代性單株抗體：2007年
- 替代性單株抗體相關交易：2000年至2007年
- 治療領域別開發中的替代性單株抗體：2007年
Abstract
Introduction
Monoclonal antibodies (MAbs) have become the most successful platform for
targeted biotherapeutics, demonstrating high affi nity and specifi city for
their target and considerably lower toxicity than small-molecule drugs.
Technological advances in the development and production of MAbs have revealed
that antibody fragments and other smaller, less complex proteins have the
potential to overcome many disadvantages of MAbs, and researchers have begun
to explore the therapeutic potential of peptides and nucleic acids as
alternatives to MAbs. The small biotechnology companies that sprang up to
commercialize these emerging technologies have benefi ted from a fl urry of
recent licensing and development deals and acquisitions as Big Pharma begins
to see the potential of MAb alternatives and hurries to get in on the action.
Get the Answers You Need to Shape Your Strategy
- The biotechnology and pharmaceutical industries are turning to MAb
alternatives as the next generation of targeted biotherapeutics. What
advantages do small MAb alternatives offer over large MAbs? What disadvantages
do these novel agents have? What choices are possible in the manufacture and
formulation of MAb alternatives?
- Because of the high price of biotherapeutic agents, health care payers,
government, and patients are exerting pressure on companies to lower the
prices of their drugs. How could MAb alternatives help companies respond to
this pressure and remain profi table? How fast and cost-effectively can these
agents be brought to market?
- Although some MAb alternatives are already on the market, and despite
growing industry confi dence in these novel technologies, the road ahead will
not be easy. Why is small size not always better? What clinical
disadvantages may be inherent in MAb alternatives? How will the anticipated
regulatory guidance on approval of biogenerics in the United States affect the
market for MAb alternatives?
Scope
- Biotechnology overview: Biotherapeutics; monoclonal antibodies
(MAbs); emerging MAb alternatives.
- Industry overview: Biotech and Big Pharma companies; marketed MAb
alternatives; molecules in development, by therapeutic area; industry deals
and acquisitions, 2000-2007.
- Production of MAb alternatives: Biological processes versus
cell-free or chemical synthesis; formulation; reducing immunogenicity; cost;
developmental timelines.
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- The Structure of an Antibody
- Improving on Monoclonal Antibodies
- Development
- Manufacturing
- Cost
- Competition and Royalty Stacking
- Delivery
- Immunogenicity
- Industry Interest and Clinical Development
- Remaining Challenges for MAb Alternatives
- Appendix A. Types of Biologic Alternatives to Therapeutic Monoclonal
Antibodies
Tables
- 1. MAb Alternatives in Clinical Development
- 2. Licensing and Comarketing Deals Involving MAb Alternatives, 2000-2007
- 3. Acquisitions Involving MAb Alternatives, 1999-2007
Figures
- 1. Market Growth of Biotherapeutics and Small-Molecule Drugs, 2002-2006
- 2. Share of Monoclonal Antibodies in the Biologics Market, 2002-2008
- 3. Structure of an Antibody
- 4. MAb Alternatives by Development Stage, 2007
- 5. Deals Involving MAb Alternatives, 2000-2007
- 6. MAb Alternatives in Development, by Therapeutic Area, 2007
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