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세계의 이중특이성항체 시장 및 임상 파이프라인 인사이트

Global Bispecific Antibody Market, Drug Sales & Clinical Pipeline Insight 2025

리서치사 KuicK Research
발행일 2019년 01월 상품 코드 363080
페이지 정보 영문 450 Pages
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세계의 이중특이성항체 시장 및 임상 파이프라인 인사이트 Global Bispecific Antibody Market, Drug Sales & Clinical Pipeline Insight 2025
발행일 : 2019년 01월 페이지 정보 : 영문 450 Pages

세계의 이중특이성항체(Bispecific Antibody) 시장에 대해 조사 분석했으며, 이중특이성항체 개요, 작용기서, 설계 및 엔지니어링, 용도, 임상 파이프라인, 출시 제품 등에 대해 전해드립니다.

제1장 단일클론항체의 역사

제2장 이중특이성 단일클론항체의 개요

제3장 이중특이성항체의 작용기서

  • 3중 기능 항체(Trifunctional Antibody) : Catumaxomab(Removab®)
  • Blinatumomab

제4장 IgG(면역글로블린) 유사 이중특이성항체의 설계 및 엔지니어링

제5장 소형 이중특이성항체

제6장 단일특이성 단일클론항체보다 우수한 이중특이성항체의 이점

제7장 이중특이성항체의 용도

  • 감염증 진단용 BsMAb(이중특이성 단일클론항체)
  • 암진단용 BsMAb
  • 신호전달 경로를 차단하는 BsMAb
  • 종양혈관 신생을 표적으로 하는 BsMAb
  • 표적으로의 이펙터 화합물(Effector Compounds)의 특이적 전달
  • 이중특이성항체와 유전자 치료

제8장 세계의 이중특이성항체 시장 개요

  • 시장 현황
  • 세계의 이중특이성항체 임상 파이프라인 개요

제9장 세계의 이중특이성항체 시장 역학

  • 바람직한 시장 파라미터
  • 상업화 과제

제10장 세계의 이중특이성항체 시장 전망

제11장 세계의 이중특이성항체 임상 파이프라인 : 기업별, 증상별, 단계별

  • 연구 단계
  • 전임상
  • 단계 I
  • 단계 I/II
  • 단계 II
  • 단계 III

제12장 출시된 이중특이성항체의 임상 인사이트

제13장 임상 파이프라인에서 중지·정지중인 이중특이성항체 : 기업별, 증상별, 단계별

  • 중지
  • 개발 보고 없음

제14장 경쟁 상황

  • Ablynx
  • Adimab
  • Affimed Therapeutics
  • Amgen
  • AstraZeneca(MedImmune)
  • Chugai Pharmaceutical
  • Eli Lilly
  • EMD Serono
  • Emergent BioSolutions
  • Genentech
  • Genmab
  • Immunomedics
  • Jounce Therapeutics
  • MacroGenics
  • Merus
  • Neovii Biotech
  • NovImmune SA
  • OncoMed Pharmaceuticals
  • Pieris
  • Regeneron Pharmaceuticals
  • Roche
  • Sanofi
KSM 19.01.21

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“Global Bispecific Antibody Market, Drug Sales & Clinical Pipeline Insight 2025” Report Highlights:

  • Applications of Bispecific Antibodies
  • Global Bispecific Antibody Market Overview: Drug & Market Sales
  • Global Bispecific Antibody Market Opportunity: US$ 8 Billion by 2025
  • US & Japan Market Share Opportunity: >40% by 2025
  • Bispecific Antibody Clinical Pipeline: 224 Drugs
  • Commercially Available Bispecific Antibody: 2 (HEMLIBRA & Blincyto)

The research and development of bispecific antibodies has emerged as a new unexplored growth frontier for pharmaceutical industry as per recent research study "Global Bispecific Antibody Market, Drug Sales and Clinical Pipeline Insight 2025" published by Kuick Research. As per report findings, the market opportunity of bispecific antibodies is estimated to surpass US$ 8 Billion by 2025 driven by application of existing commercially available bispecific antibodies to other multiple indications and increasing regulatory approvals from developing and developed markets. Currently, there are 2 bispecific antibodies (HEMLIBRA and Blincyto) commercially available in the market with combined sales of less than US$ 1 Billion in 2018.

The market for bispecific antibodies is quiet bright as they are the new emerging trends in the market. BsAbs due their specificity are gaining a lot of interest from multiple stake holders from the pharmaceutical industry. Now with the improved technology, monoclonal antibody therapy witnessed a drastic transition and is becoming more acceptable due to its site specific approach. They have become a critical component of clinical treatment procedure for a variety of indications.

Therapeutic antibodies in various segments have made the transition from human conception to clinical reality over the past two decades and reached from labs to bedside of the patients. Now, many of mAbs are being tested as adjuvant or first-line therapies to determine their efficacy in improving survival. The market is no doubt flourishing and is sure to increase many folds as with due acceptance of clinicians and patients due to their targeted effect.

Currently, there are more than 200 bispecific antibodies in the clinical trials and this number is further expected to increase in coming years driven by research and development and the favorable commercial success to 2 bispecific antibodies available in the market. Most of bispecific antibodies are being developed for the treatment of multiple cancers followed by infectious disease, CNS disorders, inflammatory and autoimmune disorders. The future for the research and development of bispecific antibodies remains highly progressive and profitable option driven by the fact that increasing number of big and small pharmaceutical companies are allocating their resources and are collaborating with other stake holders of the industry.

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 IgG like Bispecific Antibodies

  • 4.1. Quadroma (Hybrid Hydromas) Approach
  • 4.2. “Knobs Into Holes” Approach
  • 4.3. CrossMab Approach
  • 4.4. Dual-Variable-Domain Immunoglobulin Approach

5. The Design & Engineering of Small Bispecific Antibodies

  • 5.1. Bispecific Diabodies
  • 5.2. Bispecific T-Cell Engager Antibodies (BiTEs)

6. Advantage of Bispecific Antibodies upon Monospecific Monoclonal Antibodies

7. Applications of Bispecific Antibodies

  • 7.1. BsMAb for Diagnosis of Infectious Diseases
    • 7.1.1. Diagnosis of Bacterial Infections
    • 7.1.2. Diagnosis of Viral Infections
  • 7.2. BsMAb for Cancer Diagnostic
  • 7.3. BsAbs Blocking Signaling Pathways
  • 7.4. BsAbs Targeting Tumor Angiogenesis
  • 7.5. Specific Delivery of Effector Compounds to Targets
  • 7.6. Bispecific Antibodies & Gene Therapy

8. Global Bispecific Antibody Market Overview

  • 8.1. Current Market Scenario
    • 8.1.1. Catumaxomab (Removab)
    • 8.1.2. Blinatumomab
    • 8.1.3. Duligotumab
    • 8.1.4. SAR 156597
  • 8.2. Global Bispecific Antibodies Clinical Pipeline Overview

9. Global Bispecific Antibody Market Dynamics

  • 9.1. Favorable Market Parameters
    • 9.1.1. Target Patient Base
    • 9.1.2. Severity Of The Disease
    • 9.1.3. Unavailability Of Completely Curing Drugs
    • 9.1.4. Side Effects of the Existing Drugs
    • 9.1.5. Specificity of Monoclonal Antibodies in Targeting Cancer Cells
  • 9.2. Commercialization Challenges
    • 9.2.1. Stringent Regulatory Guidelines
    • 9.2.2. Long Duration of Research & Development
    • 9.2.3. Clinical Trial Timeline
    • 9.2.4. High Cost for Research & Development

10. Global Bispecific Antibody Market Future Prospects

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

  • 11.1. Research
  • 11.2. Preclinical
  • 11.3. Phase-I
  • 11.4. Phase-I/II
  • 11.5. Phase-II
  • 11.6. Phase-III

12. Marketed Global Bispecific Antibodies Clinical Insight by Company & Indication

  • 12.1. Emicizumab (HEMLIBRA)
  • 12.2. Blinatumomab (Blincyto)

13. No Development Reported & Discontinued Global Bispecific Antibodies Clinical Pipeline by Company, Indication & Phase

  • 13.1. No Development Reported
  • 13.2. Discontinued
  • 13.3. Market Withdrawal

14. Competitive Landscape

  • 14.1. Ablynx
  • 14.2. Adimab
  • 14.3. Affimed Therapeutics
  • 14.4. Amgen
  • 14.5. AstraZeneca (MedImmune)
  • 14.6. Chugai Pharmaceutical
  • 14.7. Eli Lilly
  • 14.8. EMD Serono
  • 14.9. Emergent BioSolutions
  • 14.10. Genentech
  • 14.11. Genmab
  • 14.12. Immunomedics
  • 14.13. Jounce Therapeutics
  • 14.14. MacroGenics
  • 14.15. Merus
  • 14.16. Neovii Biotech
  • 14.17. NovImmune SA
  • 14.18. OncoMed Pharmaceuticals
  • 14.19. Pieris
  • 14.20. Regeneron Pharmaceuticals
  • 14.21. Roche
  • 14.22. 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 5-1: Types of Bispecific Antibodies
  • Figure 6-1: Advantages of Bispecific Antibodies
  • Figure 7-1: Applications of Bispecific Antibodies
  • Figure 8-1: BLINCYTO - US v/s Rest of World Sales Share (%), 2017
  • Figure 8-2: BLINCYTO - US v/s Rest of World Sales Share (%), Q3'2018
  • Figure 8-3: BLINCYTO - US v/s Rest of World Sales (US$ Million), Q3'2018
  • Figure 8-4: BLINCYTO - Global Sales (US$ Million), Q1'2018 to Q3'2018
  • Figure 8-5: BLINCYTO - US & Rest of World Sales (US$ Million), Q1'2018 to Q3'2018
  • Figure 8-6: Global - Bispecific Antibodies Clinical Pipeline by Phase (%), 2019 till 2025
  • Figure 8-7: Global - Bispecific Antibodies Clinical Pipeline by Phase (Numbers), 2019 till 2025
  • Figure 8-8: Global - Inactive Bispecific Antibodies in Clinical Pipeline by Phase (%),2019 till 2025
  • Figure 8-9: Global - Inactive Bispecific Antibodies in Clinical Pipeline by Phase (Numbers), 2019 till 2025
  • Figure 9-1: Favorable Market Parameters Global Bispecific Antibody Market
  • Figure 9-2: Commercialization Challenges for Bispecific Antibody
  • Figure 10-1: Japan - HEMLIBRA Market Opportunity For Treatment of Hemophilia A ( US$ Million), 2019 - 2025
  • Figure 10-2: Global - HEMLIBRA Market Opportunity For Treatment of Hemophilia A- Inhibitors ( US$ Million), 2019 - 2025
  • Figure 10-3: USA - HEMLIBRA Market Opportunity For Treatment of Hemophilia A- Inhibitors ( US$ Million), 2019 - 2025
  • Figure 10-4: Global - HEMLIBRA Market Opportunity For Treatment of Hemophilia A - Non Inhibitors ( US$ Million), 2019 - 2025
  • Figure 10-5: USA - HEMLIBRA Market Opportunity For Treatment of Hemophilia A - Non Inhibitors ( US$ Million), 2019 - 2025
  • Figure 10-6: Global - Bispecific Antibody Market Opportunity ( US$ Billion), 2019 - 2025
  • Figure 14-1: Ablynx - Clinical Pipeline
  • Figure 14-2: Affimed Therapeutics - Clinical Pipeline
  • Figure 14-3: Amgen - Clinical Pipeline
  • Figure 14-4: EMD Serono - Clinical Pipeline
  • Figure 14-5: Emergent Bioscience - Clinical Pipeline
  • Figure 14-6: Genmab - Clinical Pipeline
  • Figure 14-7: Jounce Therapeutics - Clinical Pipeline
  • Figure 14-8: MacroGenics - Clinical Pipeline
  • Figure 14-9: Merus - Clinical Pipeline
  • Figure 14-10: Novimmune - Clinical Pipeline
  • Figure 14-11: OncoMed - Clinical Pipeline
  • Figure 14-12: Pieris Pharmaceuticals - Clinical Pipeline
  • Figure 14-13: Roche - Clinical Pipeline

List of Tables

  • Table 4-1: List of Bispecific Antibodies Formed by Hybrid Hybridoma Method
  • Table 5-1: List of Bispecific Antibodies Formed by DART
  • Table 5-2: List of Bispecific Antibodies Formed by BiTE Method
  • Table 5-3: List of Other BiTEs
  • Table 7-1: Bispecific Antibodies Targeting Cancer
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