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全球雙特異性抗體市場 & 臨床實驗平台考察

Global Bispecific Antibody Market & Clinical Pipeline Insight 2020

出版商 KuicK Research 商品編碼 363080
出版日期 內容資訊 英文 213 Pages
商品交期: 最快1-2個工作天內
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全球雙特異性抗體市場 & 臨床實驗平台考察 Global Bispecific Antibody Market & Clinical Pipeline Insight 2020
出版日期: 2016年07月12日 內容資訊: 英文 213 Pages


第1章 單株抗體的歷史

第2章 雙特異性單株抗體概要

第3章 雙特異性抗體的作用機制

  • 三官能性抗體:Catumaxomab (Removab®)
  • Blinatumomab

第4章 雙特異性抗體的設計、工程

  • IgG (免疫球蛋白) 樣雙特異性抗體的設計、工程
  • 小型雙特異性抗體

第5章 勝過單一特異性單株抗體的雙特異性抗體的優點

第6章 雙特異性抗體的應用

  • 感染疾病診斷用BsMAb (雙特異性單株抗體)
  • 癌症診斷用BsMAb
  • 阻擋信號傳達途徑的BsMAb
  • 以腫瘤血管新生為目標的BsMAb
  • 對標的的效應器化合物的特異性遞送
  • 雙特異性抗體、基因治療

第7章 全球雙特異性抗體市場概要

  • 目前市場情況
  • 全球雙特異性抗體的臨床開發平台概要

第8章 全球雙特異性抗體市場動態

  • 可喜的市場參數
  • 商業化的課題

第9章 全球雙特異性抗體市場未來展望

第10章 全球雙特異性抗體的臨床實驗平台:各企業、症狀、階段

  • 研究階段
  • 前臨床
  • 階段I
  • 階段I/II
  • 階段II
  • 階段III

第11章 上司完畢雙特異性抗體臨床考察

  • Blinatumomab (Blincyto)
  • Catumaxomab (Removab)

第12章 臨床實驗平台的中止、停止中的雙特異性抗體:各企業、症狀、階段

  • 中止
  • 沒有開發報告

第13章 競爭情形

  • Ablynx
  • Adimab
  • Affimed Therapeutics
  • Amgen
  • AstraZeneca (MedImmune)
  • 中外製藥
  • Eli Lilly
  • EMD Serono
  • Emergent BioSolutions
  • Genentech
  • Genmab
  • Immunomedics
  • Jounce Therapeutics
  • MacroGenics
  • Merus
  • Neovii Biotech
  • NovImmune SA
  • OncoMed Pharmaceuticals
  • Pieris
  • Regeneron Pharmaceuticals
  • Roche
  • Sanofi



With revolutionization in the medicinal sector and more of inclination towards personalized therapy, the medical world is also witnessing the emergence of advanced analogues of monoclonal antibodies called as Bispecific monoclonal antibodies. As the name signifies the molecules possess "dual specificity". The licensing of the first monoclonal antibody for clinical use dates back to 1986, since then almost 70 therapeutic monoclonal antibodies (MAbs) have been approved throughout the world along with several antibody-related products (e.g., Fc-fusion proteins) making MAbs and related products a dominant component of the biopharmaceutical market, generating revenues of several billion dollars. The approach and specificity of these molecules is no doubt gaining the interest of numerous scientists, pharma, biotechnological companies, research laboratories as well as academic institutions adding to everyday improvement in the biological, physical, chemical and bio-chemical aspects of its action and functioning making the segment more interesting.

With coming of the new technology and more of research in this segment around 50 different formats of bispecific antibody production have been discovered and patented by big pharma ventures. Production of CrossMabs, Diabodies, Nano bodies, Bispecific T-cell engager antibodies (BiTEs), dual-variable-domain immunoglobulin (DVD-Ig™) are some of the most employed and significant techniques. These molecules two distinct binding specificities also have shown great potential for a wide range of clinical applications which includes targeting agents for in vitro and in vivo immunodiagnosis, therapy and for improving immunoassays. They have proven themselves as promising molecules for targeting cytotoxic effector cells, delivering radionuclides, toxins or cytotoxic drugs to specific targets, particularly tumor cells. Much more stills needs to be unravelled making this sector a huge matter of interest.

The applications of these molecules are as wide as the approaches of their development. They are being developed to tackle the plethora of diseases ranging from different cancers (Prostate, Breast, Colon, Squamous cell carcinomas) to non-oncological segment including various chronic inflammatory diseases such as Rheumatoid arthritis etc. Their multifactorial approach to deal with a disease is making them for acceptable as a player of future health market as most of the disease are multifactorial and require treatment with a combination of drugs. Development of single molecule with all the desirable approaches is no doubt a great driving factor when seen from patient compliance view. Moreover, it has been observed that a single molecule can heal more than one disease and nothing more can than this factor make a pharmaceutical venture to invest in Research and Development of this wonder molecule. As developing and patenting a single agent for multiple diseases is for sure a matter of huge profit for them. Following years of research and development (R&D), the first trifunctional antibody Catumaxomab (Removab®) was approved in 2009. Another BsAb Blinatumomab (Blincyto) marketed by Amgen entered the market in December 2014 and several more AMG-110, ABT-122, SAR156597 etc. are in clinical trials.

The pipeline of bispecific antibodies seems to be extremely rich with more than 100 proposed drugs in trials with most of them being in their Preclinical trials. Most of these drugs are propagated to enter the market in the coming 5 to 6 years, occupying a huge segment of health market. The phase is stipulated to swirl the medical world as this will for sure lead to more investments in this direction. The major challenges associated are the monetary restrictions for both the manufacturers as well as the consumers. Everything novel in medical sector comes with a huge price tag and this was proved by extensively costly therapy of Blinatumomab, which costed $178,000 per two-cycles making it unachievable for the common patients. Other associated challenges include stringent regulatory guidelines, conduction of clinical trials and long duration of research associated.

This report extensively covers the major events from the infancy to the present status of the Bispecific antibodies. It gives a purposeful outlook of the bright future of this wonder molecule which is sure to establish its niche in the coming years; as the abnormalities it is proposed to deal with along with the ways to mitigate them is proportionately too high to be ignored.

Report Highlights:

  • Overview of Bispecific Antibody
  • Mechanism of Action of Bispecific Antibody
  • Design & Engineering of Bispecific Antibodies
  • Applications of Bispecific Antibodies
  • Global Bispecific Antibodies Clinical Pipeline by Company, Indication & Phase
  • Global Bispecific Antibodies Clinical Pipeline: 123 Bispecific Antibodies
  • Marketed Bispecific Antibodies: Blinatumomab (Blincyto) & Catumaxomab (Removab)

Table of Contents

1. History of Monoclonal Antibodies

2. Overview of Bispecific Monoclonal Antibody

3. Mechanism of Action of Bispecific Antibody

  • 3.1 Trifunctional Antibody: Catumaxomab (Removab®)
  • 3.2 Blinatumomab

4. The Design & Engineering of Bispecific Antibodies

  • 4.1 The Design & Engineering of IgG like Bispecific Antibodies
    • 4.1.1 Quadroma (Hybrid Hydromas) Approach
    • 4.1.2 "Knobs Into Holes" Approach
    • 4.1.3 CrossMab Approach
    • 4.1.4 Dual-Variable-Domain Immunoglobulin Approach
  • 4.2 Small Bispecific Antibodies
    • 4.2.1 Bispecific Diabodies
    • 4.2.2 Bispecific T-Cell Engager Antibodies (BiTEs)

5. Advantage of Bispecific Antibodies upon Monospecific Monoclonal Antibodies

6. Applications of Bispecific Antibodies

  • 6.1 BsMAb for Diagnosis of Infectious Diseases
    • 6.1.1 Diagnosis of Bacterial Infections
    • 6.1.2 Diagnosis of Viral Infections
  • 6.2 BsMAb for Cancer Diagnostic
  • 6.3 BsAbs Blocking Signaling Pathways
  • 6.4 BsAbs Targeting Tumor Angiogenesis
  • 6.5 Specific Delivery of Effector Compounds to Targets
  • 6.6 Bispecific Antibodies & Gene Therapy

7. Global Bispecific Antibody Market Overview

  • 7.1 Current Market Scenario
    • 7.1.1 Catumaxomab (Removab)
    • 7.1.2 Blinatumomab
    • 7.1.3 Duligotumab
    • 7.1.4 SAR 156597
  • 7.2 Global Bispecific Antibodies Clinical Pipeline Overview

8. Global Bispecific Antibody Market Dynamics

  • 8.1 Favorable Market Parameters
    • 8.1.1 Target Patient Base
    • 8.1.2 Severity Of The Disease
    • 8.1.3 Unavailability Of Completely Curing Drugs
    • 8.1.4 Side Effects of the Existing Drugs
    • 8.1.5 Specificity of Monoclonal Antibodies in Targeting Cancer Cells
  • 8.2 Commercialization Challenges
    • 8.2.1 Stringent Regulatory Guidelines
    • 8.2.2 Long Duration of Research & Development
    • 8.2.3 Clinical Trial Timeline
    • 8.2.4 High Cost for Research & Development

9. Global Bispecific Antibody Market Future Prospects

10. Global Bispecific Antibodies Clinical Pipeline by Company, Indication & Phase

  • 10.1 Research
  • 10.2 Preclinical
  • 10.3 Phase-I
  • 10.4 Phase-I/II
  • 10.5 Phase-II
  • 10.6 Phase-III

11. Marketed Bispecific Antibodies Clinical Insight

  • 11.1 Blinatumomab (Blincyto)
  • 11.2 Catumaxomab (Removab)

12. Discontinued & Suspended Bispecific Antibodies in Clinical Pipeline by Company, Indication & Phase

  • 12.1 Discontinued
  • 12.2 No Development Reported

13. Competitive Landscape

  • 13.1 Ablynx
  • 13.2 Adimab
  • 13.3 Affimed Therapeutics
  • 13.4 Amgen
  • 13.5 AstraZeneca (MedImmune)
  • 13.6 Chugai Pharmaceutical
  • 13.7 Eli Lilly
  • 13.8 EMD Serono
  • 13.9 Emergent BioSolutions
  • 13.10 Genentech
  • 13.11 Genmab
  • 13.12 Immunomedics
  • 13.13 Jounce Therapeutics
  • 13.14 MacroGenics
  • 13.15 Merus
  • 13.16 Neovii Biotech
  • 13.17 NovImmune SA
  • 13.18 OncoMed Pharmaceuticals
  • 13.19 Pieris
  • 13.20 Regeneron Pharmaceuticals
  • 13.21 Roche
  • 13.22 Sanofi

List of Figures

  • Figure 3-1: Mechanism of Action of Bispecific Monoclonal Antibody
  • Figure 3-2: Mechanism of Action of Catumaxomab
  • Figure 3-3: Mechanism of Action of Blinatumomab
  • Figure 4-1: Types of Approaches to Form IgG like Bispecific Antibodies
  • Figure 4-2: Method of Formation of Hybrid Hybridoma
  • Figure 4-3: Limitations of Hybrid Hybridoma
  • Figure 4-4: Steps involved in "Knobs into Holes" Approach
  • Figure 4-5: Three different CrossMabs are Obtained by Three Different Modifications
  • Figure 4-6: Method for formation of Dual-Variable-Domain Immunoglobulin
  • Figure 4-7: Advantages of Dual Variable Domain Immunoglobulin approach
  • Figure 4-8: Types of Bispecific Antibodies
  • Figure 5 1: Advantages of Bispecific Antibodies
  • Figure 6-1: Applications of Bispecific Antibodies
  • Figure 7-1: Global Bispecific Antibodies Pipeline by Phase (%), 2016
  • Figure 7-2: Global Bispecific Antibodies Pipeline by Phase (Numbers), 2016
  • Figure 7-3: Global Bispecific Antibodies Pipeline by Phase (%), 2016
  • Figure 7-4: Global Bispecific Antibodies Pipeline by Phase (Numbers), 2016
  • Figure 8-1: Favorable Market Parameters Global Bispecific Antibody Market
  • Figure 8-2: Commercialization Challenges for Bispecific Antibody
  • Figure 13-1: Ablynx - Clinical Pipeline
  • Figure 13-2: Affimed Therapeutics - Clinical Pipeline
  • Figure 13-3: Amgen - Clinical Pipeline
  • Figure 13-4: EMD Serono - Clinical Pipeline
  • Figure 13-5: Emergent Bioscience - Clinical Pipeline
  • Figure 13-6: Genmab - Clinical Pipeline
  • Figure 13-7: Jounce Therapeutics - Clinical Pipeline
  • Figure 13-8: MacroGenics - Clinical Pipeline
  • Figure 13-9: Merus - Clinical Pipeline
  • Figure 13-10: Novimmune - Clinical Pipeline
  • Figure 13-11: OncoMed - Clinical Pipeline
  • Figure 13-12: Pieris Pharmaceuticals - Clinical Pipeline
  • Figure 13-13: Roche - Clinical Pipeline

List of Tables

  • Table 4-1: List of Bispecific Antibodies Formed by Hybrid Hybridoma Method
  • Table 4-2: List of Bispecific Antibodies Formed by DART
  • Table 4-3: List of Bispecific Antibodies Formed by BiTE Method
  • Table 4-4: List of Other BiTEs
  • Table 6-1: Bispecific Antibodies Targeting Cancer
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