Roots Analysis has done a detailed study on Bispecific Antibody Market (4^th Edition), 2020-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

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Key Market Insights            

• With two approved drugs and close to 300 clinical / preclinical product candidates, the bispecific antibody therapeutics pipeline has evolved significantly over the past few years
• The pipeline features drug candidates that target a wide range of biological antigens based on different antibody formats through novel mechanisms of action; more than 50% of these act by retargeting or activation of T-Cells
• To gain a competitive edge in the market, developers are actively exploring novel biological targets and mechanisms of action to treat diverse disease indications
• Although start-ups and mid-sized firms are spearheading the innovation, several big pharmaceutical companies are also actively engaged
• In order to cater to the evolving needs of developers, technology providers have established presence across different regions; the US and EU have emerged as the key hubs
• Close to 50,000 patients were estimated to have been enrolled in clinical trials evaluating bispecific antibody therapeutics, across various geographical locations and phases of development
• The increasing interest of stakeholders in this domain can also be gauged by the rising product development / commercialization, RD and technology licensing deals being signed across various regions
• Given the complexities associated with the development of bispecific antibodies, contract organizations have become an indispensable part of the development and manufacturing process of antibody therapeutics
• In order to keep patients and healthcare professionals informed and aware of the developments, companies are deploying diverse promotional strategies for their respective products

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Table of Contents

1. PREFACE
   1.1.                  Chapter Outlines
   1.2.                  Research Methodology
   1.3.                  Chapter Outlines
   
   
2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1.                  Chapter Overview

3.2.                  Concept of an Antibody

3.3.                  Structure of an Antibody

3.4.                  Functions of an Antibody

3.5.                  Mechanism of Action of an Antibody

3.6.                  Concept of Monoclonal Antibodies

3.7.                  Antibody Therapeutics

3.8.                  Historical Evolution of Antibody Therapeutics

3.9.                  Types of Advanced Antibody Therapeutics  

3.9.1.               Fc Engineered and Glycoengineered Antibodies

3.9.2.               Antibody Fragments

3.9.3.               Fusion Proteins

3.9.4.               Intrabodies

3.9.5.               Bispecific Antibodies

3.10.                Bispecific Antibody Formats

3.10.1.             Single-Chain-based Formats (Fc Independent Antibody Formats)

3.10.1.1.          Tandem scFvs (single-chain variable fragments) and Triple bodies  

3.10.1.2.          Bispecific Single-Domain Antibody Fusion Proteins

3.10.1.3.          Diabodies / Diabody Derivatives      

3.10.1.4.          Fusion Proteins          

3.10.1.5.          Fusion Proteins Devoid of Fc Regions          

3.10.2.             Immunoglobulin G (IgG)-based Formats (Fc Dependent Antibody Formats)          

3.10.2.1.          Quadromas     

3.10.2.2.          Knobs-Into-Holes      

3.10.2.3.          Dual Variable Domain Ig      

3.10.2.4.          IgG-scFv        

3.10.2.5.          Two-in-one or Dual Action Fab (DAF) Antibodies  

3.10.2.6.          Half Molecule Exchange       

3.10.2.7.          κλ- Bodies      

3.11.                Mechanisms of Action of Bispecific Antibodies      

3.11.1.             Retargeting Immune Effectors (NK Cells and T Cells) to Tumor Cells           

3.11.2.             Directly Targeting Malignant / Tumor Cells

3.11.3.             Retargeting of Toxins

3.11.5.             Targeting Tumor Angiogenesis

3.11.6.             Other Mechanisms

3.12.                Applications of Bispecific Antibodies

4                      MARKET OVERVIEW

4.1.                  Chapter Overview

4.2.                  Bispecific Antibody Therapeutics: Developer Landscape

4.2.1.               Analysis by Year of Establishment

4.2.2.               Analysis by Company Size

4.2.3.               Analysis by Geographical Location

4.3.                  Bispecific Antibody Therapeutics: Clinical Pipeline

4.3.1.               Analysis by Phase of Development

4.3.2.               Analysis by Target Antigen

4.3.3.               Analysis by Type of Antibody Format

4.3.4.               Analysis by Mechanism of Action

4.3.5.               Analysis by Disease Indication

4.3.6.               Analysis by Therapeutic Area

4.3.7.               Analysis by Broader Disease Segment

4.3.8.               Analysis by Route of Administration

4.3.9.               Analysis by Mode of Administration

4.3.10.             Analysis by Patient Segment

4.4.                  Bispecific Antibody Therapeutics: Early Stage Pipeline

4.4.1.               Analysis by Phase of Development

4.4.2.               Analysis by Target Antigen

4.4.4.               Analysis by Mechanism of Action

4.4.5.               Analysis by Therapeutic Area

4.4.6.               Analysis by Broader Disease Segment

4.6.                  Bispecific Antibody Therapeutics: Combination Therapy Candidates

4.7.                  Bispecific Antibody Therapeutics: Non-Industry Players

4.8.                  Emerging Novel Antibody Therapeutic Modalities

5                      Bispecific Antibody Therapeutics: Technology Platforms       

5.1.                  Chapter Overview

5.2.                  Bispecific Antibody Therapeutics: List of Technology Platforms

5.3.                  Bispecific Antibody Therapeutics: Technology Platform Profiles

5.3.1.               Bispecific T-cell Engager (BiTE®) (Amgen)

5.3.1.1.                        Overview       

5.3.1.2.                        Technology Details   

5.3.1.3.                        Structure of BiTE® Bispecific Antibodies   

5.3.1.4.                        Pipeline of BiTE® Bispecific Antibodies     

5.3.1.5.                        Advantages of BiTE® Bispecific Antibodies

5.3.1.6.                        Partnerships and Collaborations        

5.3.2.               DuoBody® (Genmab)

5.3.2.1.                        Overview       

5.3.2.2.                        Technology Details   

5.3.2.3.                        Structure of DuoBody® Bispecific Antibodies           

5.3.2.4.                        Pipeline of DuoBody® Bispecific Antibodies           

5.3.2.5.                        Advantages of DuoBody® Bispecific Antibodies     

5.3.2.6.                        Partnerships and Collaborations        

5.3.3.               Xmab™ Antibody Engineering Platform (Xencor)

5.3.3.1.                        Overview       

5.3.3.2.                        Technology Details   

5.3.3.3.                        Pipeline of Xmab™ Bispecific Antibodies   

5.3.3.4.                        Advantages of Xmab™ Bispecific Antibodies           

5.3.3.5.                        Partnerships and Collaborations        

5.3.4.               WuXibodyTM Bispecific Engineering Platform (WuXi Biologics)

5.3.4.1.                        Overview       

5.3.4.2.                        Pipeline of WuXibodyTM Bispecific Antibodies     

5.3.4.3.                        Advantages of WuXibodyTM Bispecific Antibodies     

5.3.4.4.                        Partnerships and Collaborations        

5.3.5.               Anticalin® (Pieris Pharmaceuticals)

5.3.5.1.                        Overview       

5.3.5.2.                        Structure of Anticalin® Bispecific Fusion Proteins          

5.3.5.3.                        Pipeline of Anticalin® Bispecific Fusion Proteins          

5.3.5.4.                        Advantages of Anticalin® Bispecific antibody Platform         

5.3.5.5.                        Partnerships and Collaborations        

5.3.6.               Azymetric™ (Zymeworks)

5.3.6.1.                        Overview       

5.3.6.2.                        Technology Details   

5.3.6.3.                        Structure of Azymetric™ Bispecific Antibodies           

5.3.6.4.                        Pipeline of Azymetric™ Bispecific Antibodies           

5.3.6.5.                        Advantages of the AzymetricTM Bispecific Antibodies     

5.3.6.6.                        Partnerships and Collaborations        

5.4.                  Geographical Distribution of Technology Providers

5.5.                  Bispecific Antibody Technology Platforms: Comparative Analysis

6                      DRUG PROFILES 

6.1.                  Chapter Overview

6.2.                  Marketed Drug Profiles

6.2.1.               Blincyto™ / Blinatumomab / AMG103 / MT103 (Amgen)

6.2.1.1.                        Company Overview   

6.2.1.1.1.         Financial Performance          

6.2.1.2.                        Drug Overview          

6.2.1.2.1.         Mechanism of Action and Targets    

6.2.1.2.2.         Dosage           

6.2.1.2.3.         Current Development Status 

6.2.1.2.4.         Development Process

6.2.1.2.5.         Annual Sales  

6.2.2.               Hemlibra® / Emicizumab / RG6013 / ACE910 / RO5534262 (Chugai Pharmaceutical / Roche)         

6.2.2.1.                        Company Overview   

6.2.2.1.1.         Financial Performance          

6.2.2.2.                        Drug Overview          

6.2.2.2.1.         Mechanism of Action and Targets    

6.2.2.2.2.         Dosage           

6.2.2.2.4.         Development Process

6.2.2.2.5.         Annual Sales  

6.3.                  Late Stage Drug Profiles

6.4.                  RG7716 / RO6867461 / Faricimab (Roche / Genentech)    

6.4.1                Drug Overview          

6.5.                  Ozoralizumab / TS-152 / ATN103 (Ablynx / Eddingpharm / Taisho Pharmaceuticals)      

6.5.1                Drug Overview          

6.6.                  ABT-165 (AbbVie)   

6.6.1                Overview of Drug, Current Development Status and Clinical Results          

6.7.                  ABY-035 (Affibody) 

6.7.1.               Drug Overview          

6.8.                  AFM13 (Affimed)     

6.8.1                Drug Overview          

6.9.                  AMG 570 / MEDI0700 (Amgen)      

6.9.1.               Drug Overview          

6.10.                KN026 (Alphamab)   

6.10.1.             Drug Overview          

6.11.                KN046 (Alphamab)

6.11.1.             Drug Overview          

6.12.                M1095 / ALX-0761 (Merck / Ablynx / Avillion)     

6.12.1.             Drug Overview          

6.13.                M7824 / Bintrafusp Alfa (Merck / GlaxoSmithKline)           

6.13.1.             Drug Overview          

6.14.                MCLA-128 (Merus)  

6.14.1.             Drug Overview          

6.15.                MEDI3902 / Gremubamab (MedImmune /AstraZeneca)

6.15.1.             Drug Overview          

6.16.                Drug Overview          

6.17.                REGN1979 (Regeneron)       

6.17.1.             Drug Overview           6.18.    ZW25 (Zymeworks)  

6.18.1.             Drug Overview

7                      KEY INSIGHTS

7.1.                  Chapter Overview

7.2.                  Bispecific Antibody Therapeutics: Analysis by Therapeutic Area and Phase of Development

7.3.                  Bispecific Antibody Therapeutics: Spider-Web Analysis based on Mechanism of Action      

7.4.                  Bispecific Antibody Therapeutics: Two-Dimensional Scatter Plot Analysis based on Target Combinations

7.4.1                Key Parameters         

7.5.                  Logo Landscape: Analysis of Developers by Company Size    

8                      BENCHMARK ANALYSIS: BIG PHARMA PLAYERS

8.1.                  Chapter Overview

8.2.                  Top Pharmaceutical Companies

8.2.1.               Analysis by Target Antigen

8.2.2.               Analysis by Type of Antibody Format

8.2.3.               Analysis by Mechanism of Action

8.2.4.               Analysis by Therapeutic Area

8.2.5.               Analysis by Type of Partnership

9                      PARTNERSHIPS AND COLLABORATIONS

9.1.                  Chapter Overview

9.2.                  Partnership Models

9.3.                  Bispecific Antibody Therapeutics: Partnerships and Collaborations

9.3.1.               Analysis by Year of Partnership

9.3.2.               Analysis by Type of Partnership

9.3.3.               Analysis by Therapeutic Area

9.3.4.               Most Active Developers: Analysis by Number of Partnerships

9.3.5.               Most Active Contract Manufacturers: Analysis by Number of Manufacturing Agreements        

9.3.6.               Regional Analysis

9.3.7.               Intercontinental and Intracontinental Agreements

10                    CONTRACT SERVICES FOR BISPECIFIC ANTIBODY THERAPEUTICS     

10.1.                Chapter Overview

10.2.                Manufacturing of Bispecific Antibody Therapeutics

10.2.1.             Key Manufacturing Considerations and Challenges 

10.2.2.             Contract Manufacturing Organizations (CMOs)

10.2.2.1.          Introduction to CMOs

10.2.2.2.          Bispecific Antibody Therapeutics: List of CMOs     

10.2.3.             Contract Research Organizations (CROs)

10.2.3.1.          Introduction to CROs 

10.2.3.2.          Bispecific Antibody Therapeutics: List of CROs      

10.3.                Key Considerations for Selecting a Suitable CMO / CRO Partner

11                    CLINICAL TRIAL ANALYSIS

11.1.                Chapter Overview

11.2.                Methodology

11.3.                Bispecific Antibody Therapeutics: Clinical Trial Analysis         

11.3.1.             Analysis by Trial Registration Year

11.3.2.             Analysis by Trial Recruitment Status

11.3.3.             Analysis by Trial Phase

11.3.4.             Analysis by Trial Design

11.3.5.             Analysis by Disease Indication

11.3.6.             Analysis by Therapeutic Area

11.3.7.             Most Active Players

11.3.8.             Analysis by Number of Clinical Trials and Geography

11.3.9.             Analysis by Enrolled Patient Population and Geography

12                    CASE STUDY: REGULATORY GUIDELINES FOR BISPECIFIC ANTIBODIES 

12.1.                Chapter Overview

12.2.                Guidelines Issued by Regulatory Authorities

12.2.1.             US Food and Drug Administration (FDA)

12.2.1.1.          Pharma Companies Response to the FDA Draft Guidance        

12.2.2.             World Health Organization (WHO)

12.2.3.             The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use    

13                    CASE STUDY: PROMOTIONAL / MARKETING STRATEGIES

13.1.                Chapter Overview

13.2.                Overview of Channels Used for Promotional Campaigns

13.3.                Summary: Product Website Analysis

13.4.                Summary: Patient Support Services and Informative Downloads

13.5.                Promotional Analysis: Blincyto™

13.5.1.             Drug Overview

13.5.2.             Product Website analysis

13.5.2.1.          Messages for Healthcare Professionals         

13.5.2.1.1.       For MRD Positive B‑cell precursor ALL      

13.5.2.1.2.       For Relapsed or Refractory B-cell precursor ALL    

13.5.2.2.          Message for Patients  

13.5.3.             Patient Support Services and Informative Downloads

13.5.4.             Other Promotional Strategies

13.5.4.1.          Presence in Conferences        

13.6.                Promotional Analysis:  Hemlibra®

13.6.1.             Drug Overview

13.6.2.             Product Website Analysis

13.6.2.1.          Messages for Healthcare Professionals         

13.6.2.1.1.       For Hemophilia A without Factor VIII Inhibitors     

13.6.2.1.2.       For Hemophilia A with Factor VIII Inhibitors          

13.6.2.3.          Messages for Patients

13.6.3.             Patient Support Services and Informative Downloads

13.6.3.1.          Co-pay Program        

13.6.3.2.          Independent Co-pay Assistance Foundation 

13.6.3.3.          Genentech Patient Foundation          

13.6.4.             Other Promotional Strategies

13.6.4.1.          Presence in Conferences        

14                    SWOT ANALYSIS

14.1.                Chapter Overview

14.2.                Strengths

14.3.                Weaknesses

14.4.                Opportunities

14.5.                Threats

14.6.                Concluding Remarks

15                    MARKET FORECAST AND OPPORTUNITY ANALYSIS

15.1.                Chapter Overview

15.2.                Scope and Limitations

15.3.                Forecast Methodology and Key Assumptions

15.4.                Overall Bispecific Antibody Therapeutics Market, 2019-2030

15.4.1.             Bispecific Antibody Therapeutics Market: Analysis by Therapeutic Area

15.4.2.             Bispecific Antibody Therapeutics Market: Analysis by Mechanism of Action

15.4.3.             Bispecific Antibody Therapeutics Market: Analysis by Target Antigen

15.4.4.             Bispecific Antibody Therapeutics Market: Analysis by Antibody Format

15.4.5.             Bispecific Antibody Therapeutics Market: Analysis by Key Players

15.4.6.             Bispecific Antibody Therapeutics Market: Analysis by Geography

15.5.                Bispecific Antibody Market: Value Creation Analysis

15.6.                Bispecific Antibody Therapeutics Market: Product-wise Sales Forecasts

15.6.1.             Blincyto

15.6.1.1.          Target Patient Population      

15.6.1.2.          Sales Forecast

15.6.1.3.          Net Present Value      

15.6.1.4.          Value Creation Analysis        

15.6.2.             Hemlibra

15.6.2.1.          Target Patient Population      

15.6.2.2.          Sales Forecast

15.6.2.3.          Net Present Value      

15.6.2.4.          Value Creation Analysis        

15.6.3.             RG7716

15.6.3.1.          Target patient Population      

15.6.3.2.          Sales Forecast

15.6.3.3.          Net Present Value      

15.6.3.4.          Value Creation Analysis        

15.6.4.             Ozoralizumab

15.6.4.1.          Target Patient Population      

15.6.4.2.          Sales Forecast

15.6.4.3.          Net Present Value      

15.6.4.4.          Value Creation Analysis        

15.6.5.             ABY-035

15.6.5.1.          Target Patient Population      

15.6.5.2.          Sales Forecast

15.6.5.3.          Net Present Value      

15.6.5.4.          Value Creation Analysis        

15.6.6.             AFM13

15.6.6.1.          Target Patient Population      

15.6.6.2.          Sales Forecast

15.6.6.3.          Net Present Value      

15.6.6.4.          Value Creation Analysis        

15.6.7.             M1095

15.6.7.1.          Target Patient Population      

15.6.7.2.          Sales Forecast

15.6.7.3.          Net Present Value      

15.6.7.4.          Value Creation Analysis        

15.6.8.             MEDI3902

15.6.8.1.          Target Patient Population      

15.6.8.2.          Sales Forecast

15.6.8.3.          Net Present Value      

15.6.8.4.          Value Creation Analysis        

15.6.9.             ABT-981

15.6.9.1.          Target Patient Population      

15.6.9.2.          Sales Forecast

15.6.9.3.          Net Present Value      

15.6.9.4.          Value Creation Analysis        

15.6.10.           SAR156597   

15.6.10.1.        Target Patient Population      

15.6.10.2.        Sales Forecast

15.6.10.3.        Net Present Value      

15.6.10.4.        Value Creation Analysis        

16                    CONCLUDING REMARKS

17                    EXECUTIVE INSIGHTS   

17.1.                Chapter Overview      

17.2.                CytomX Therapeutics

17.2.1.                         Company Snapshot    

17.2.2.             Interview Transcript: Siobhan Pomeroy, Senior Director, Business Development (Q3 2017) 

17.3.                F-star  

17.3.1.                         Company Snapshot    

17.3.2.                         Interview Transcript: Jane Dancer, Chief Business Officer (Q3 2017)   

17.4.                Innovent Biologics    

17.4.1.                         Company Snapshot    

17.4.2.                         Interview Transcript: Yinjue Wang, Associate Director, Process Development (Q3 2017)   

17.5.                Synimmune    

17.4.1.                         Company Snapshot    

17.4.2.             Interview Transcript: Ludger Große-Hovest, Chief Scientific Officer, and Martin Steiner, Chief Executive Officer

18. APPENDIX 1: TABULATED DATA

19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

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