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市場調查報告書
單株抗體的新方向
New Directions in Monoclonal Antibodies: Technologies, Markets, Competition
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本報告已在2011年07月19日停止出版。
自從導入製程生產後，單株抗體市場過去30年來呈現爆炸性成長。超過15種抗體被認可為治療用，有些則居於領導地位。目前市場仍舊火熱，各種治療、診斷用的單株抗體都在設計與生產中。
專精全球生活科學領域（基因、新藥物等）之最新技術與事業拓展調查，素有高度評價的 Insight Pharma Reports（總公司：美國麻州），調查分析了單株抗體市場後，出版了一本綜合報告書 "New Directions in Monoclonal Antibodies: Technologies, Markets, Competition" 。
報告書內容包括：單株抗體產品投入市場的廣範圍（製藥目的研究、生物體內診斷、治療）活動調查、各主要課題、研發中產品的市場性與競爭力等。全書附16幅圖表，內容綱要摘記如下：
摘要
1. 抗體與單株抗體的背景與科學概要
2. 單株抗體設計製造技術的現在與未來
- 30年研發過程的主要進展
- Library / Display 技術
- 其他設計技術
- 抗體的取代物
- 物性改良技術
- 生產技術改良
3. 治療用與生物體內診斷用單株抗體的現在與未來
- 已核准治療用單株抗體
- 癌症用研發中單株抗體
- 免疫性疾病用研發中單株抗體
- 傳染病用研發中單株抗體
- 心血管用研發中單株抗體
- 其他治療用研發中單株抗體
- 已核准與研發中的診斷用單株抗體
4. 單株抗體的動向與市場性
- 整體動向
- 治療用單株抗體市場
- 診斷用單株抗體市場業者資訊（主要17家）
- 專家意見（9人）
Abstract
New Directions in Monoclonal Antibodies: Technologies, Markets, Competition
reviews the broad drug development effort that is focused on bringing improved
mAb-based products to the market, including those used for drug discovery
research, in vivo diagnostics, and therapeutic applications.
The monoclonal antibody market has experienced explosive growth in the nearly
30 years since the process for creating mAbs was introduced. More than fifteen
therapeutic mAbs have been approved, several of which have reached blockbuster
status. Numerous diagnostic mAbs have also been approved, making this one of the
fastest growing fields in biotechnology. Today, the industry is working as
furiously as ever to perfect the design and production of mAbs for therapeutic,
diagnostic, and other purposes. This report evaluates the salient issues in
these endeavors.
New Directions in Monoclonal Antibodies examines the more than 110 mAb
products currently in clinical trials, as well as the products that are already
available and those still at the preclinical stage that are likely to play an
important role in the advancement of the field.
The report presents further analysis to evaluate the market potential for
monoclonal antibodies in development for a variety of diseases. It reviews some
general observations concerning commercialization of mAbs, then addresses the
major disease categories, including patient numbers for diseases of interest;
competing therapeutics already on the market, particularly those that have
recently gained regulatory approval; and, where available, estimates of market
sizes in dollars. Only those conditions for which drug candidates have been
identified or which have been prominently mentioned as potential markets by
pharmaceutical companies in the field are covered. Table of Contents
- Chapter 1. Background and Scientific Overview: Antibodies and Monoclonal
Antibodies
- 1.1. What Is an Antibody?
- 1.2. What is a Monoclonal Antibody?
- Chapter 2. Current and Emerging Technologies: Improving Monoclonal
Antibody Design and Production
- 2.1. Key Breakthroughs in the First 30 Years of Monoclonal Antibody
Development
- -Murine-Derived Monoclonal Antibodies
- -Chimeric Monoclonal Antibodies
- -Humanized Monoclonal Antibodies
- -Fully Human Monoclonal Antibodies
- --A Dissenting View on Humanization
- -Antibody Fragments
- -Antibody Conjugates
- 2.2. Monoclonal Antibody Libraries and Display Technologies
- -Phage Display
- -Ribosome Display
- -Other Library-Based Technologies
- 2.3. Other Technologies for Designing Monoclonal Antibodies
- -New Techniques for Generating Animal-Derived Monoclonal
Antibodies
- -Humanization Technology
- -Transgenic Mice
- 2.4. Alternative Antibody Formats
- -Antibody Fragments
- -Synthetic Antibodies
- -Bispecific Antibodies
- -Other Antibodies That Enhance Effector Function
- -Antibody Conjugates
- 2.5. Technologies for Improving Monoclonal Antibody Characteristics
- -Protein Engineering
- -Pegylation
- -Glycosylation
- -Reducing Immunogenicity
- -Alternative Modes of Administration
- 2.6. Technologies for Improving Monoclonal Antibody Production
- -Increasing Yields in Mammalian Cultures
- -Transgenic Animals
- -Transgenic Plants
- Chapter 3. Marketed and Emerging Monoclonal Antibodies: Present and Future
Therapeutics and In Vivo Diagnostics
- 3.1. Approved Therapeutic Monoclonal Antibodies
- -Profiles of Therapeutic Monoclonal Antibodies Approved for
Marketing
- 3.2. Monoclonal Antibodies in Development for Cancer
- -Unconjugated Monoclonal Antibodies for Cancer
- -Anti-Idiotype Monoclonal Antibodies for Cancer
- -Conjugated Monoclonal Antibodies for Cancer
- 3.3. Monoclonal Antibodies in Development for Immunologic Diseases
- 3.4. Monoclonal Antibodies in Development for Infectious Diseases
- 3.5. Antibodies in Development for Cardiovascular Diseases
- 3.6. Other Therapeutic Antibodies in Development
- 3.7. Approved and Developmental Diagnostic Antibodies
- -Profiles of Diagnostic Monoclonal Antibodies Approved for
Marketing
- -Companies Developing Diagnostic Monoclonal Antibodies
- Chapter 4. Business and Strategic Outlook: Market Potential for Monoclonal
Antibodies and Trends in the Field
- 4.1. General Trends
- -Addressing the Manufacturing Shortfall
- 4.2. The Market for Therapeutic Monoclonal Antibodies
- -Cancer--Solid Tumors
- -Cancer--Non-Hodgkins Lymphoma
- -Immune and Inflammatory Diseases
- -Other Emerging Markets
- 4.3. The Market for Diagnostic Monoclonal Antibodies
- 4.4. Company Profiles
- -AERES Biomedical Ltd.
- -Affibody
- -ARIUS Research Inc.
- -Biogen Idec
- -BioInvent
- -Biovation Limited
- -Centocor, Inc.
- -Crucell
- -Discerna UK
- -Domantis
- -Epitomics, Inc.
- -Genentech, Inc.
- -Genmab A/S
- -GTC Biotherapeutics
- -Human Genome Sciences, Inc.
- -ImmunoGen, Inc.
- -Raven Biotechnologies, Inc.
- 4.5. Expert Commentaries
- -Walter Blattler, Ph.D., ImmunoGen, Inc.
- -Carl Borrebaeck, BioInvent
- -Rathin Das, Affitech A/S
- -Robert Ladner, Dyax Corp.
- -Nils Lonberg, Medarex
- -Simon Moroney, MorphoSys
- -Clay B. Siegall, Seattle Genetics, Inc.
- -Stephen Worsley, Raven Biotechnologies, Inc.
- -Geoff Yarranton, KaloBios Pharmaceuticals Inc.
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