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Bispecific Antibody Therapeutics Market (4th Edition), 2019-2030

  • ID: 4988879
  • Report
  • January 2020
  • Region: Global
  • 410 Pages
  • Roots Analysis
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Overview

The first monoclonal antibody, Orthoclone OKT3®, was approved in 1986 by the FDA. Since then, a number of antibody therapeutics (more than 100) have been marketed for the treatment of patients suffering from various disease indications, primarily malignant tumors and other rare disorders. Despite the success, these drugs are associated with several limitations, such as increased patient resistance and a general lack of understanding of in vivo mechanisms of action. The aforementioned challenges and impending patent expiries of some of the blockbuster monoclonal antibodies have compelled the researchers and pharmaceutical companies to redesign these drugs and / or find new analogues. To further improve the specificity, efficacy and safety of monoclonal antibodies, the focus has gradually shifted towards the development of next generation recombinant antibodies, such as antibody-drug conjugates (ADCs), bispecific and multispecific antibodies, and antibody fragments and antibody-like proteins (ALPs).

Bispecific antibodies are a novel class of antibody therapeutics that act by simultaneously binding two separate and unique antigens (or different epitopes of the same antigen). The primary mechanism of action of these therapeutics involves redirection of immune effector cells for effective killing of cancer cells by antibody-dependent cell mediated cytotoxicity (ADCC) and other cytotoxic mechanisms, such as antibody dependent cellular phagocytosis (ADCP) and complement dependent cytotoxicity (CDC). Having unique biological and pharmacological properties, as well as their availability in different formats, bispecific antibodies have emerged as promising agents for therapeutic use. Advancements related to protein and antibody engineering techniques have led to the production of close to 50 new formats in the recent years.

Till date, two bispecific antibodies, namely Blincyto® (2014) and Hemlibra® (2017), have been approved for therapeutic use. It is worth mentioning that, in 2019 (till September), Blincyto® and Hemlibra® generated revenues worth USD 232 million and USD 930 million, respectively. The growing popularity and therapeutic potential of bispecific antibodies can also be correlated to an exponential increase in the number of clinical trials; the cumulative count of trials has increased from 51 studies in 2014 to over 300 studies in 2019 (till September). More than 300 bispecific drug candidates are currently in clinical/preclinical stages. In fact, multiple licensing agreements, between drug developers and technology providers, have also been inked in the past few years to advance the development of pipeline drug candidates.

Scope of the Report

The “Bispecific Antibody Therapeutics Market (4th Edition), 2019-2030” report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapeutics over the next decade. The study features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Amongst other elements, the report includes:

  • A detailed review of the overall landscape of bispecific antibody therapeutics, including information on drug developers, phase of development (marketed, clinical, and preclinical / discovery) of the pipeline candidates, target antigen, type of antibody format, mechanism of action, target disease indication(s), therapeutic area, broader disease segment, route of administration, mode of administration and patient segment.
  • A comprehensive list of novel technology platforms that are either currently available or being developed by various firms for the generation of bispecific antibody therapeutics, along with detailed profiles of key technologies. The chapter also includes an insightful competitiveness analysis, featuring a three-dimensional bubble representation that highlights the key technologies that are being used for the development of bispecific antibodies, taking into consideration the early stage (discovery, preclinical, IND and phase I) and late stage (phase II and above)development activity based on the technology (in terms of the number of drugs across different phases of development), number of partnerships established related to the technology and size of the developer company. In addition, it consists of a schematic world map representation, highlighting the geographical locations of technology developers engaged in this domain.
  • Detailed profiles of marketed and clinical stage (phase II and phase III) bispecific antibody therapeutics. Each profile features an overview of the drug, details of the developer, along with its financial performance, mechanism of action and targets, dosage information, current clinical development status, development process, as well as details on annual sales (wherever available).
  • Key takeaways from the bispecific antibody therapeutics pipeline, featuring a [A] grid analysis, representing the distribution of the pipeline (on the basis of mechanisms of action of product candidates) across different therapeutic areas and stages of development, [B] a five-dimensional spider-web analysis, highlighting the most popular mechanisms of action based on a number of relevant parameters, including number of bispecific antibodies in early stage (phase I) and late stage of development (phase II and above), number of ongoing clinical trials, target therapeutic areas and the number of companies that are developing these molecules, [C] a two-dimensional scattered plot competitiveness analysis, for the various target combinations for clinical-stage bispecific antibodies and [D] the chapter also includes an insightful summary representation using the logos of different industry stakeholders, highlighting the distribution of companies based on the company size.
  • An analysis of the big biopharma players engaged in this domain, featuring a heat map based on various parameters, such as number of bispecific antibody therapeutics under development, target antigen, type of antibody format, mechanism of action and, target therapeutic area.
  • An analysis of recent partnerships and collaboration agreements inked in this domain since 2016, covering research collaborations, product and technology licensing agreements, product development and commercialization agreements, manufacturing agreements, mergers / acquisitions, joint ventures, product development agreements and other deals.
  • A review on the key steps involved and challenges associated with the manufacturing of bispecific antibodies. In addition, it includes a list of contract manufacturing organizations (CMOs) and contract research organizations (CROs). The chapter also highlights the key considerations for bispecific antibody developers while selecting a suitable CRO / CMO.
  • A clinical trial analysis of ongoing and planned studies related to bispecific antibody therapeutics, taking into consideration a number of relevant parameters, including trial registration year, trial recruitment status, trial phase, trial design, disease indication(s), focus therapeutic area, most active industrial and non-industrial players, and geographical location of the trial.
  • A review of the key promotional strategies that have been adopted by the developers of the marketed bispecific antibodies, namely Blincyto® and Hemlibra®. It includes a detailed comparison of both the drugs based on the information available on their respective websites, such as patient support offerings, informative downloadable content, and product visibility in scientific conferences.
  • A discussion on important, industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis that highlights the relative impact of each SWOT parameter on the overall market.

One of the key objectives of the report was to estimate the existing market size and the future opportunity for bispecific antibody therapeutics, for the next decade. Based on multiple parameters, such as target patient population, likely adoption rates and expected pricing, we have provided an informed estimate on the evolution of the market for the period 2019-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] key therapeutic areas (genetic disorders, hematological malignancies, autoimmune disorders, infectious diseases, inflammatory disorders, eye disorders and skin disorders), [B] different mechanisms of action (T-cell retargeting / activation, cytokines retargeting / neutralization, dual ligands blocking and others), [C] key targets (CD3 x CD19, CD30 x CD16A, Factor IXa x Factor X, IL-13 x IL-4, IL-17A x Albumin, IL-17A x IL-17F, IL-1α x IL-1β, Psl x PcrV, TNF-α x HSA and VEGF-A x ANG-2), [D] type of antibody formats (asymmetric, fragments, symmetric and others), [E] key players (AbbVie, Affibody, Affimed, Amgen, AstraZeneca, Merck, Roche, Sanofi and Taisho Pharmaceutical) and [F] key geographical regions (North America, Europe and Asia Pacific). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in the report were also influenced by discussions held with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order):

  • Martin Steiner (Chief Executive Officer, Synimmune)
  • Ludger Große-Hovest (Chief Scientific Officer, Synimmune)
  • Jane Dancer (Chief Business Officer, F-Star)
  • Siobhan Pomeroy (Senior Director, Business Development, Cytom X)
  • Yinjue Wang (Associate Director, Process Development, Innovent Biologics)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Note: Product cover images may vary from those shown
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1. PREFACE
1.1. Scope of the Report
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
4.5.  Bispecific Antibody Therapeutics: Combination Therapy Candidates
4.6. Bispecific Antibody Therapeutics: Non-Industry Players
4.7. 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. MEDI7352 (AstraZeneca)
6.16.1. 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

List Of Figures

Figure 3.1. History of Evolution of Antibodies
Figure 3.2. Basic Structure of an Antibody
Figure 3.3. Mechanisms of Action of Antibody-based Therapeutics
Figure 3.4. Revenues of the Top 15 Drugs, 2018 (USD Billion)
Figure 3.5. Symmetric and Asymmetric Bispecific Antibodies
Figure 4.1. Bispecific Antibody Developers: Distribution by Year of Establishment
Figure 4.2. Bispecific Antibody Developers: Distribution by Company Size
Figure 4.3. Bispecific Antibody Developers: Distribution by Geographical Location
Figure 4.4. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Phase of Development
Figure 4.5. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Target Antigen
Figure 4.6. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Type of Antibody Format
Figure 4.7. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Mechanism of Action
Figure 4.8. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Disease Indication
Figure 4.9. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Therapeutic Area
Figure 4.10. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Broader Disease Segment
Figure 4.11. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Route of Administration
Figure 4.12. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Mode of Administration
Figure 4.13. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Patient Segment
Figure 4.14. Bispecific Antibody Therapeutics, Early Stage Pipeline: Distribution by Phase of Development
Figure 4.15. Bispecific Antibody Therapeutics, Early Stage Pipeline: Distribution by Target Antigen
Figure 4.16. Bispecific Antibody Therapeutics, Early Stage Pipeline: Distribution by Mechanism of Action
Figure 4.17. Bispecific Antibody Therapeutics, Early Stage Pipeline: Distribution by Disease Indication
Figure 4.18. Bispecific Antibody Therapeutics, Early Stage Pipeline: Distribution by Therapeutic Area
Figure 4.19. Bispecific Antibody Therapeutics, Early Stage Pipeline: Distribution by Broader Disease Segment
Figure 5.1. Structure of BiTE® Bispecific Antibody
Figure 5.2. Structure of DuoBody® Bispecific Antibody
Figure 5.3. Structure of Anticalin® Bispecific Fusion Proteins
Figure 5.4. Structure of Azymetric™ Bispecific Fusion Proteins
Figure 5.5  Bispecific Antibody Technology Providers: Geographical Distribution
Figure 5.6. Bispecific Antibody Technology Platforms: 3-Dimensional Comparative Bubble Analysis
Figure 6.1. Amgen: Annual Revenues, 2014-9M 2019 (USD Billion)
Figure 6.2. Blincyto®: Annual Sales, 2015-9M 2019 (USD Million)
Figure 6.3. Chugai Pharmaceutical: Annual Revenues, 2014-9M 2019 (JPY Billion)
Figure 7.1. Bispecific Antibody Therapeutics: Distribution by Therapeutic Area and Phase of Development
Figure 7.2. Bispecific Antibody Therapeutics: Spider-Web Analysis based on Mechanism of Action
Figure 7.3. Bispecific Antibody Therapeutics: Two-Dimensional Scatter Plot Analysis based on Target Combinations
Figure 7.4. Logo Landscape: Distribution of Developers by Company Size
Figure 8.1. Big Pharma Players: Heat Map Analysis of Top Pharmaceutical Companies
Figure 8.2. Big Pharma Players: Distribution by Type of Target Antigen
Figure 8.3. Big Pharma Players: Distribution by Type of Antibody Format
Figure 8.4. Big Pharma Players: Distribution by Mechanism of Action
Figure 8.5. Big Pharma Players: Distribution by Therapeutic Area
Figure 8.5. Big Pharma Players: Heat Map Analysis of Other Big Players
Figure 9.1. Partnerships and Collaborations: Cumulative Trend by Year, 2016-2019
Figure 9.2. Partnerships and Collaborations: Distribution by Type of Partnership
Figure 9.3. Partnerships and Collaborations: Distribution by Therapeutic Area
Figure 9.4. Partnerships and Collaborations: Most Active Industrial Players
Figure 9.5. Prtnerships and Collaborations: Most Active Non-Industrial Players
Figure 9.6. Partnerships and Collaborations: Most Active Contract Manufacturers
Figure 9.7. Partnerships and Collaborations: Regional Distribution
Figure 9.8. Partnerships and Collaborations: Intercontinental and Intracontinental Distribution
Figure 11.1. Clinical Trial Analysis: Distribution by Trial Registration Year, 2014-2019  
Figure 11.2. Clinical Trial Analysis: Distribution of Number of Trials and Patients Enrolled by Recruitment Status
Figure 11.3. Clinical Trial Analysis: Distribution of Number of Trials and Patients Enrolled by Phase of Development
Figure 11.4. Clinical Trial Analysis: Distribution by Trial Design
Figure 11.5. Clinical Trial Analysis: Distribution by Disease Indication
Figure 11.6. Clinical Trial Analysis: Distribution by Therapeutic Area
Figure 11.7. Clinical Trial Analysis: Most Active Industry Players
Figure 11.8. Clinical Trial Analysis: Most Active Non-Industry Players
Figure 11.9. Clinical Trial Analysis: Geographical Distribution of Number of Clinical Trials
Figure 11.10. Clinical Trial Analysis: Geographical Distribution of Enrolled Patient Population
Figure 12.1. FDA Considerations for Development of Bispecific Antibodies
Figure 13.1. Channels Used for Promotional Campaigns
Figure 13.2. Summary: Product Website Analysis
Figure 13.3. Summary: Patient Support Services and Informative Downloads
Figure 13.4. Blincyto®: Product Website Analysis (Messages for Healthcare Professionals, BLAST Study Results)
Figure 13.5. Blincyto®: Product Website Analysis (Messages for Healthcare Professionals, TOWER Study Results)
Figure 13.6. Blincyto®: Product Website Analysis (Messages for Healthcare Professionals, Ph (+) Relapsed / Refractory B-cell Precursor ALL)
Figure 13.7. Blincyto®: Product Website Analysis (Messages for Healthcare Professionals, Relapsed / Refractory B-cell Precursor ALL (Pediatrics))
Figure 13.8. Blincyto®: Product Website Analysis (Messages for Patients)
Figure 13.9. Blincyto®: Amgen Assist 360 Nurse Ambassador
Figure 13.10. Blincyto®: Presence in Conferences
Figure 13.11. Hemlibra®: Product Website Analysis (Messages for Healthcare Professionals, Hemophilia A without Factor VIII Inhibitors)
Figure 13.12. Hemlibra®: Product Website Analysis (Messages for Healthcare Professionals, Hemophilia A with Factor VIII Inhibitors)
Figure 13.13. Hemlibra®: Product Website Analysis (Messages for Patients)
Figure 13.14. Hemlibra®: Presence in Conferences
Figure 14.1. Bispecific Antibody Therapeutics: SWOT Analysis
Figure 14.2. Comparison of SWOT Factors: Harvey Ball Analysis
Figure 15.1. Overall Bispecific Antibody Therapeutics Market, 2019-2030: Base Scenario (USD Million)
Figure 15.2. Bispecific Antibody Therapeutics Market: Distribution by Therapeutic Area, 2019, 2025 and 2030 (USD Million)
Figure 15.3. Bispecific Antibody Therapeutics Market: Distribution by Mechanism of Action, 2019, 2025 and 2030 (USD Million)
Figure 15.4. Bispecific Antibody Therapeutics Market: Distribution by Target Antigen, 2019, 2025 and 2030 (USD Million)
Figure 15.5. Bispecific Antibody Therapeutics Market: Distribution by Antibody Format, 2019, 2025 and 2030 (USD Million)
Figure 15.6. Bispecific Antibody Therapeutics Market: Distribution by Key Players, 2019, 2025 and 2030 (USD Million)
Figure 15.7. Bispecific Antibody Therapeutics Market: Distribution by Geographical Regions, 2019, 2025 and 2030 (USD Million)
Figure 15.8. Blincyto® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 15.9. Hemlibra® Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 15.10. RG7716 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 15.11. Ozoralizumab Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 15.12. ABY-035 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 15.13. AFM13 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 15.14. M1095 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 15.15. MEDI3902 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 15.16. ABT-981 Sales Forecast (Till 2030): Base Scenario (USD Million)
Figure 15.17. SAR156597 Sales Forecast (Till 2030): Base Scenario (USD Million)

List Of Tables

Table 3.1. Isotypes of Mammalian Antibodies
Table 3.2. Mechanisms of Action of Therapeutic Antibodies
Table 3.3. Top Therapeutic Antibodies, 2018
Table 4.1. Bispecific Antibody Therapeutics: Information on Developer Specifications
Table 4.2. Bispecific Antibody Therapeutics: Information on Developer(s), Technology Used, Phase of development, Target antigens and Antibody Format
Table 4.3. Bispecific Antibody Therapeutics: Information on Mechanism of Action, Disease Indication, Therapeutic Area and Broader Disease Segment
Table 4.4. Bispecific Antibody Therapeutics: Information on Route of Administration, Mode of Administration and Patient Segment
Table 4.5. Bispecific Antibody Therapeutics: Information on Developer(s), Technology used, Phase of Development, Target Antigens, Mechanism of Action, Disease Indication, Therapeutic Area and Broader Disease Segment
Table 4.6. Bispecific Antibody Therapeutics: Combination Therapy Candidates Information on Developer(s), Drug Name and NCT Number
Table 4.7. Bispecific Antibody Therapeutics: Information on Non-Industry Players
Table 4.8 List of Other Emerging Multispecific Drug Candidates
Table 5.1. Bispecific Antibody Therapeutics: List of Technology Platforms
Table 5.2. BiTE® Bispecific Antibodies: Development Pipeline
Table 5.3. BiTE® Bispecific Antibodies: Partnerships and Collaborations
Table 5.4. DuoBody® Bispecific Antibodies: Development Pipeline
Table 5.5. DuoBody® Bispecific Antibodies: Partnerships and Collaborations
Table 5.6. XmAb™ Bispecific Antibodies: Development Pipeline
Table 5.7. Xmab™ Bispecific Antibodies: Partnerships and Collaborations
Table 5.8. WuXibodyTM Bispecific Antibodies: Development Pipeline
Table 5.9. WuXibodyTM Bispecific Antibodies: Partnerships and Collaborations
Table 5.10. Anticalin® Bispecific Fusion Proteins: Development Pipeline
Table 5.11. Anticalin® Bispecific Fusion Proteins: Partnerships and Collaborations
Table 5.12. Azymetric™ Bispecific Antibodies: Development Pipeline
Table 5.13. Azymetric™ Bispecific Antibodies: Partnerships and Collaborations
Table 6.1. Amgen: Bispecific Antibody Product Portfolio
Table 6.2. Chugai Pharmaceutical: Bispecific Antibody Product Portfolio
Table 6.3. Drug Profile: RG7716
Table 6.4. Drug Profile: Ozoralizumab
Table 6.5. Drug Profile: ABT-165
Table 6.6. Drug Profile: ABY-035
Table 6.7. Drug Profile: AFM13
Table 6.8. Drug Profile: AMG 570
Table 6.9. Drug Profile: KN026
Table 6.10. Drug Profile: KN046
Table 6.11. Drug Profile: M1095
Table 6.12. Drug Profile: M7824
Table 6.13. Drug Profile: MCLA-128
Table 6.14. Drug Profile: MEDI3902
Table 6.15. Drug Profile: MEDI7352
Table 6.16. Drug Profile: REGN1979
Table 6.17. Drug Profile: ZW25
Table 7.1. Bispecific Antibody Therapeutics: Spider-Web Analysis (Input Data)
Table 9.1. Bispecific Antibody Therapeutics: Partnerships and Collaborations, 2016-2019
Table 10.1. List of Bispecific Antibody CMOs: Information on Company Specifications
Table 10.2. List of Bispecific Antibody CMOs: Information on Scale of Operation
Table 10.3. List of Bispecific Antibody CROs: Information on Company Specifications
Table 10.4. List of Bispecific antibody CROs: Information Type of Service
Table 10.5 Comparison of Key Factors for the Selection of Contract Service Provider: Harvey Ball Analysis
Table 13.1. Blincyto®: Drug Overview  
Table 13.2. Hemlibra®: Drug Overview  
Table 14.1. Bispecific Antibody Therapeutics: List of CMOs
Table 17.1. CytomX Therapeutics: Key Highlights
Table 17.2. F-star: Key Highlights
Table 17.3. Innovent Biologics: Key Highlights
Table 17.4. Synimmune: Key Highlights
Table 18.1. Revenues of the Top 15 Therapeutic Antibodies, 2018 (USD Billion)
Table 18.2. Bispecific Antibody Developers: Distribution by Year of Establishment
Table 18.3. Bispecific Antibody Developers: Distribution by Company Size
Table 18.4. Bispecific Antibody Developers: Distribution by Geographical Location
Table 18.5. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Phase of Development
Table 18.6. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Target Antigen
Table 18.7. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Type of Antibody Format
Table 18.8. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Mechanism of Action
Table 18.9. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Disease Indication
Table 18.10. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Therapeutic Area
Table 18.11. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Broader Disease Segment
Table 18.12. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Route of Administration
Table 18.13. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Mode of Administration
Table 18.14. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Patient Segment
Table 18.15. Bispecific Antibody Therapeutics, Clinical Pipeline: Distribution by Dosing Frequency
Table 18.16. Bispecific Antibody Therapeutics, Early Stage Pipeline: Distribution by Phase of Development
Table 18.17. Bispecific Antibody Therapeutics, Early Stage Pipeline: Distribution by Target Antigen
Table 18.18. Bispecific Antibody Therapeutics, Early Stage Pipeline: Distribution by Mechanism of Action
Table 18.19. Bispecific Antibody Therapeutics, Early Stage Pipeline: Distribution by Therapeutic Area
Table 18.20. Bispecific Antibody Therapeutics, Early Stage Pipeline: Distribution by Broader Disease Indication
Table 18.21. Amgen: Annual Revenues, 2014-H1 2019 (USD Billion)
Table 18.22. Blincyto®: Annual Sales, 2015-H1 2019 (USD Million)
Table 18.23. Chugai Pharmaceutical: Annual Revenues, 2014-H1 2019 (JPY Billion)
Table 18.24. Partnerships and Collaborations: Cumulative Trend by Year, 2016-2019
Table 18.25. Partnerships and Collaborations: Distribution by Type of Partnership
Table 18.26. Partnerships and Collaborations: Distribution by Therapeutic Area
Table 18.27. Partnerships and Collaborations: Most Active Developers
Table 18.28. Partnerships and Collaborations: Most Active Contract Manufacturers
Table 18.29. Partnerships and Collaborations: Regional Distribution
Table 18.30. Partnerships and Collaborations: Intercontinental and Intracontinental Distribution
Table 18.31. Clinical Trial Analysis: Distribution by Trial Registration Year, 2014-2019  
Table 18.32. Clinical Trial Analysis: Distribution of Number of Trials and Patients Enrolled by Recruitment Status
Table 18.33. Clinical Trial Analysis: Distribution of Number of Trials and Patients Enrolled by Phase of Development
Table 18.34. Clinical Trial Analysis: Distribution by Trial Design
Table 18.35. Clinical Trial Analysis: Distribution by Disease Indication
Table 18.36. Clinical Trial Analysis: Distribution by Therapeutic Area
Table 18.37. Clinical Trial Analysis: Most Active Industry Players
Table 18.38. Clinical Trial Analysis: Most Active Non-Industry Players
Table 18.39. Clinical Trial Analysis: Geographical Distribution of Number of Clinical Trials
Table 18.40. Clinical Trial Analysis: Geographical Distribution of Enrolled Patient Population
Table 18.41. Overall Bispecific Antibody Therapeutics Market, 2019-2030: Conservative, Base and Optimistic Scenario (USD Million)
Table 18.42. Bispecific Antibody Therapeutics Market: Distribution by Target Antigen, 2019, 2025 and 2030 (USD Million)
Table 18.43. Bispecific Antibody Therapeutics Market: Distribution by Type of Antibody Format, 2019, 2025 and 2030 (USD Million)
Table 18.44. Bispecific Antibody Therapeutics Market: Distribution by Mechanism of Action, 2019, 2025 and 2030 (USD Million)
Table 18.45. Bispecific Antibody Therapeutics Market: Distribution by Therapeutic Area, 2019, 2025 and 2030 (USD Million)
Table 18.46. Bispecific Antibody Therapeutics Market: Distribution by Key Players, 2019, 2025 and 2030 (USD Million)
Table 18.47. Bispecific Antibody Therapeutics Market: Distribution by Geographical Regions, 2019, 2025 and 2030 (USD Million)
Table 18.48. Blincyto®: Sales Forecast, 2019-2030, Conservative, Base and Optimistic Scenario (USD Million)
Table 18.49. Hemlibra®: Sales Forecast, 2019-2030, Conservative, Base and Optimistic Scenario (USD Million)
Table 18.50. RG7716: Sales Forecast, 2019-2030, Conservative, Base and Optimistic Scenario (USD Million)
Table 18.51. Ozoralizumab: Sales Forecast, 2019-2030, Conservative, Base and Optimistic Scenario (USD Million)
Table 18.52. ABY-035: Sales Forecast, 2019-2030, Conservative, Base and Optimistic Scenario (USD Million)
Table 18.53. AFM13: Sales Forecast, 2019-2030, Conservative, Base and Optimistic Scenario (USD Million)
Table 18.54. M1095: Sales Forecast, 2019-2030, Conservative, Base and Optimistic Scenario (USD Million)
Table 18.55. MEDI3902: Sales Forecast, 2019-2030, Conservative, Base and Optimistic Scenario (USD Million)
Table 18.56. ABT-981: Sales Forecast, 2019-2030, Conservative, Base and Optimistic Scenario (USD Million)
Table 18.57. SAR156597: Sales Forecast, 2019-2030, Conservative, Base and Optimistic Scenario (USD Million)

Note: Product cover images may vary from those shown
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