Bispecific Antibodies Market (5th Edition): Distribution by Therapeutic Area (Autoimmune Disorders, Genetic Disorders, Hematological Malignancies, Ophthalmic Disorders, Skin Cancers And Solid Tumors), Mechanism of Action (Cytokines Retargeting / Neutralization, Dual Ligands Blocking, Resistance Factors Co-Targeting, Targeting Tumor Angiogenesis, T-Cell Retargeting / Activation and Others), Target Antigen (C5-Albumin, CD20 x CD3, CD3 x BCMA, CD3 x CD19, EGFR x cMET, EpCAM x CD3, Factor IXa x Factor X, gp100 x CD3, HER2 x HER2, PD-1 x CTLA-4, PD-L1 x TGF?, TNF-? x HAS, VEGF x DLL4 and VEGF-A x ANG2), Antibody Format (Asymmetric And Fragments), Key Players (Akeso Biopharma, Alexion, Amgen, Genmab, Immunocore, Janssen Research & Development, Linton Pharm, Merck, OncXerna Therapeutics, Pfizer, Roche, Taisho Pharmaceutical and Zymeworks) and Key Geographical Regions (North America, Europe, Asia and Rest of the World): Industry Trends and Global Forecasts, 2023-2035
The bispecific antibodies market is expected to reach USD 5.6 billion by 2023 and is anticipated to grow at a CAGR of 9.5% during the forecast period 2023-2035
Bispecific antibodies (BsAbs) represent an increasingly prominent category of immunotherapeutic agents adept at simultaneously engaging two distinct antigens or discrete epitopes on the same antigen. These biologics function by activating immune effector cells to effectively combat cancerous cells through various mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). Importantly, bispecific antibody drugs showcase unique biological and pharmacological characteristics, available in a diverse range of formats, promising significant potential for therapeutic applications.
As of recent approvals, regulatory authorities have granted authorization for nine bispecific antibodies for therapeutic use, listed chronologically by their most recent endorsements: Tecvayli™ (October 2022), Nanozora® (September 2022), AK104 (June 2022), Lunsumio® (June 2022), VABYSMO™ (February 2022), KIMMTRAK® (January 2022), RYBREVANT™ (May 2021), Hemlibra® (November 2017), and Blincyto® (December 2014). Furthermore, a notable surge in clinical trials investigating bispecific antibodies has emerged in recent years, driven by increasing favor and recognized therapeutic potential for such candidates. It is foreseeable that as more of these therapeutic contenders advance into clinical stages or gain regulatory endorsement, the market for bispecific antibody therapeutics is positioned for robust expansion and sustained growth.
Report Coverage
Bispecific antibodies (BsAbs) represent an increasingly prominent category of immunotherapeutic agents adept at simultaneously engaging two distinct antigens or discrete epitopes on the same antigen. These biologics function by activating immune effector cells to effectively combat cancerous cells through various mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). Importantly, bispecific antibody drugs showcase unique biological and pharmacological characteristics, available in a diverse range of formats, promising significant potential for therapeutic applications.
As of recent approvals, regulatory authorities have granted authorization for nine bispecific antibodies for therapeutic use, listed chronologically by their most recent endorsements: Tecvayli™ (October 2022), Nanozora® (September 2022), AK104 (June 2022), Lunsumio® (June 2022), VABYSMO™ (February 2022), KIMMTRAK® (January 2022), RYBREVANT™ (May 2021), Hemlibra® (November 2017), and Blincyto® (December 2014). Furthermore, a notable surge in clinical trials investigating bispecific antibodies has emerged in recent years, driven by increasing favor and recognized therapeutic potential for such candidates. It is foreseeable that as more of these therapeutic contenders advance into clinical stages or gain regulatory endorsement, the market for bispecific antibody therapeutics is positioned for robust expansion and sustained growth.
Report Coverage
- The report conducts an analysis of the bispecific antibodies market, focusing on various aspects such as therapeutic area, mechanism of action, target antigen, antibody format, key players, and geographical regions.
- It evaluates factors influencing market growth, including drivers, restraints, opportunities, and challenges.
- The report appraises the potential advantages and hurdles in the market, providing insights into the competitive landscape for leading market players.
- Forecasts are made regarding revenue for market segments across four major regions.
- An in-depth examination of the bispecific antibodies market landscape is presented, encompassing approved, in-development, and preclinical stage antibodies. The report explores historical context, structural variations, mechanisms of action, and diverse applications of bispecific antibodies. It encompasses an analysis of over 220 existing antibodies and 180 in preclinical stages, considering developer details, developmental stages, target antigens, and therapeutic applications.
- It outlines current market trends through graphical representations, illustrating development phases, disease segments, and headquarters' locations of these antibodies. Additionally, it evaluates more than 80 technology platforms used for bispecific antibody production, offering a comparative analysis based on development strength, company experience, size, and location.
- The report explores major pharmaceutical players in this sector, utilizing analyses like spider web and heat maps to assess competition, clinical trials, partnerships, and technology portfolios. Detailed profiles of key developers highlight their backgrounds, executive teams, financial information, drug portfolios, recent developments, and future prospects.
- Furthermore, it investigates partnerships within the domain, scrutinizing parameters such as partnership types, disease segments, payment models, deal amounts, and active players. It discusses challenges and considerations in the manufacturing process of bispecific antibodies, along with a list of pertinent contract manufacturing and research organizations.
- A comprehensive overview of ongoing and planned studies, regulatory guidelines by prominent agencies, and promotional strategies for approved antibodies like Blincyto® and Hemlibra® is provided. Finally, a market forecast analysis until 2035 presents sales projections based on therapeutic areas, mechanisms of action, target antigens, antibody formats, key players, and geographical regions.
- Summarizing industry trends, market drivers, and challenges within a SWOT framework provides a qualitative analysis using Harvey ball representations to delineate the relative impact of these parameters on the overall market.
- Akeso Biopharma
- Alexion
- Amgen
- Genmab
- Immunocore
- Janssen Research & Development
- Linton Pharm
- Merck
- OncXerna Therapeutics
- Pfizer
- Roche
- Taisho Pharmaceutical
- Zymeworks
1. PREFACE
1.1. Introduction
1.2. Key Market Insights
1.3. Scope of the Report
1.4. Research Methodology
1.5. Frequently Asked Questions
1.6. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Introduction to Antibodies
3.2.1. Structure
3.2.2. Functions
3.2.3. Mechanism of Action
3.3. Antibody Therapeutics
3.3.1. Historical Evolution of Antibody Therapeutics
3.3.2. Key Approved Antibody Therapeutics
3.3.3. Advanced Antibody Therapeutics
3.3.3.1. Fc Engineered and Glycoengineered Antibodies
3.3.3.2. Antibody Fragments
3.3.3.3. Fusion Proteins
3.3.3.4. Intrabodies
3.3.3.5. Bispecific Antibodies
3.4. Bispecific Antibody Formats
3.4.1. Single-Chain-based Formats (Fc Independent Antibody Formats)
3.4.1.1. Tandem scFvs (single-chain variable fragments) and Triple bodies
3.4.1.2. Bispecific Single-Domain Antibody Fusion Proteins
3.4.1.3. Diabodies / Diabody Derivatives
3.4.1.4. Fusion Proteins
3.4.1.5. Fusion Proteins Devoid of Fc Regions
3.4.2. Immunoglobulin G Based Formats (Fc Dependent Antibody Formats)
3.4.2.1. Quadromas
3.4.2.2. Knobs-Into-Holes
3.4.2.3. Dual Variable Domain Ig
3.4.2.4. IgG-scFv
3.4.2.5. Two-in-one or Dual Action Fab (DAF) Antibodies
3.4.2.6. Half Molecule Exchange
3.4.2.7. ??- Bodies
3.5. Mechanism of Action of Bispecific Antibody Therapeutics
3.5.1. Retargeting Immune Effectors (NK Cells and T Cells) to Tumor Cells
3.5.2. Directly Targeting Malignant / Tumor Cells
3.5.3. Retargeting of Toxins
3.5.4. Targeting Tumor Angiogenesis
3.5.5. Other Mechanisms
3.6. Applications of Bispecific Antibodies
4. MARKET LANDSCAPE OF APPROVED AND CLINICAL THERAPIES
4.1. Chapter Overview
4.2. Approved and Clinical Bispecific Antibody Therapeutics: Overall Market Landscape
4.2.1. Analysis by Phase of Development
4.2.2. Analysis by Target Antigen
4.2.3. Analysis by Type of Therapy
4.2.4. Analysis by Route of Administration
4.2.5. Analysis by Method of Administration
4.2.6. Analysis by Target Indication
4.2.7. Analysis by Therapeutic Area
4.2.8. Analysis by Disease Segment
4.3. Approved and Clinical Bispecific Antibody Therapeutics: Overall Developer Landscape
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Location of Headquarters
5. MARKET LANDSCAPE OF PRECLINICAL THERAPIES
5.1. Chapter Overview
5.2. Preclinical Bispecific Antibody Therapeutics: Overall Market Landscape
5.2.1. Analysis by Stage of Development
5.2.2. Analysis by Target Antigen
5.2.3. Analysis by Disease Segment
5.3. Preclinical Bispecific Antibody Therapeutics: Overall Developer Landscape
5.3.1. Analysis by Year of Establishment
5.3.2. Analysis by Company Size
5.3.3. Analysis by Location of Headquarters
6. KEY INSIGHTS
6.1. Chapter Overview
6.2. Approved and Clinical Stage Bispecific Antibody Therapeutics Landscape: Key Insights
6.2.1. Analysis by Phase of Development and Route of Administration
6.2.2. Analysis by Phase of Development and Disease Segment
6.2.3. Analysis by Phase of Development and Location of Developer’s Headquarters
6.3. Preclinical Stage Bispecific Antibody Therapeutics Landscape: Key Insights
6.3.1. Analysis by Stage of Development and Therapeutic Area
6.3.2. Analysis by Stage of Development and Location of Developer Headquarters
6.4. Bispecific Antibody Therapeutics Developers Landscape: Key Insights
6.4.1. Distribution by Stage of Development
6.4.2. Distribution by Stage of Development and Region of Developer Headquarters
7. TECHNOLOGY ASSESSMENT FRAMEWORK
7.1. Chapter Overview
7.2. Bispecific Antibody Therapeutics: List of Technology Platforms
7.3. Bispecific Antibody Technology Platforms: Comparative Analysis
7.3.1. Analysis by Technologies for Approved and Clinical Drugs
7.3.2. Analysis by Technologies for Preclinical Drugs
7.4. Most Popular Technology Platforms: Analysis by Stage of Development
7.5. Bispecific Antibody Technology Platform Developers: Analysis by Location of Headquarters
8. BIG PHARMA PLAYERS: BENCHMARKING ANALYSIS
8.1. Chapter Overview
8.2. Big Pharma Players: Benchmarking Analysis (Spider Web Representation)
8.3. Big Pharma Players: Comparative Clinical Pipeline Analysis
8.3.1. Analysis by Target Antigen
8.3.2. Analysis by Antibody Format
8.3.3. Analysis by Mechanism of Action
8.3.4. Analysis by Therapeutic Area
9. COMPANY PROFILES
9.1. Chapter Overview
9.2. Akeso Biopharma
9.2.1. Company Overview
9.2.2. Financial Performance
9.2.3. Drug Portfolio
9.2.4. Recent Developments and Future Outlook
9.3. Alphamab Oncology
9.3.1. Company Overview
9.3.2. Financial Performance
9.3.3. Drug Portfolio
9.3.4. Recent Developments and Future Outlook
9.4. Amgen
9.4.1. Company Overview
9.4.2. Financial Performance
9.4.3. Drug Portfolio
9.4.4. Recent Developments and Future Outlook
9.5. Merck
9.5.1. Company Overview
9.5.2. Financial Performance
9.5.3. Drug Portfolio
9.5.4. Recent Developments and Future Outlook
9.6. Regeneron
9.6.1. Company Overview
9.6.2. Financial Performance
9.6.3. Drug Portfolio
9.6.4. Recent Developments and Future Outlook
9.7. Roche
9.7.1. Company Overview
9.7.2. Financial Performance
9.7.3. Drug Portfolio
9.7.4. Recent Developments and Future Outlook
9.8. Xencor
9.8.1. Company Overview
9.8.2. Financial Performance
9.8.3. Drug Portfolio
9.8.4. Recent Developments and Future Outlook
10. PARTNERSHIPS AND COLLABORATIONS
10.1. Chapter Overview
10.2. Partnership Models
10.3. Bispecific Antibody Therapeutics: Partnerships and Collaborations
10.3.1. Analysis by Year of Partnership
10.3.2. Analysis by Type of Partnership
10.3.3. Analysis by Year and Type of Partnership
10.3.4. Analysis by Disease Segment
10.3.5. Analysis by Type of Payment Model Employed and Deal Amount
10.3.6. Analysis by Year of Agreement, Type of Payment Model Employed and Deal Amount
10.3.7. Analysis by Disease Segment, Type of Payment Model Employed and Deal Amount
10.3.8. Most Active Players: Analysis by Number of Partnership Instances
10.3.9. Most Popular Technologies: Analysis by Number of Partnership Instances
10.3.10. Analysis by Region
10.3.11. Intercontinental and Intracontinental Agreements
11. CONTRACT SERVICES FOR BISPECIFIC ANTIBODY THERAPEUTICS
11.1. Chapter Overview
11.2. Manufacturing of Bispecific Antibody Therapeutics
11.2.1. Key Considerations for Manufacturing and Associated Challenges
11.2.2. Contract Manufacturing Organizations (CMOs)
11.2.2.1. Bispecific Antibody Therapeutics: List of CMOs
11.2.3. Contract Research Organizations (CROs)
11.2.3.1. Bispecific Antibody Therapeutics: List of CROs
11.3. Key Considerations for Selecting a Suitable CMO / CRO Partner
12. CLINICAL TRIAL ANALYSIS
12.1. Chapter Overview
12.2. Key Assumptions and Methodology
12.3. Bispecific Antibody Therapeutics: Clinical Trial Analysis
12.3.1. Analysis by Trial Registration Year
12.3.2. Analysis of Enrolled Patient Population by Trial Registration Year
12.3.3. Analysis by Trial Phase
12.3.4. Analysis of Enrolled Patient Population by Trial Phase
12.3.5. Analysis by Trial Recruitment Status
12.3.6. Analysis by Trial Registration Year and Trial Recruitment Status
12.3.7. Analysis by Type of Study
12.3.8. Analysis by Study Design
12.3.9. Analysis by Type of Sponsor / Collaborator
12.3.10. Leading Industry Players: Analysis by Number of Registered Trials
12.3.11. Leading Non-Industry Players: Analysis by Number of Registered Trials
12.3.12. Clinical Trial Analysis: Key Focus Areas (Word Cloud Representation)
12.3.13. Analysis by Geography
12.3.14. Analysis by Trial Recruitment Status and Geography
12.3.15. Analysis of Enrolled Patient Population by Trial Recruitment Status and Geography
13. CASE STUDY: REGULATORY GUIDELINES FOR BISPECIFIC ANTIBODIES
13.1. Chapter Overview
13.2. Guidelines Issued by Regulatory Authorities
13.2.1. US Food and Drug Administration (FDA)
13.2.1.1. Pharma Companies’ Response to the FDA Draft Guidance
13.2.2. World Health Organization (WHO)
14. CASE STUDY: PROMOTIONAL / MARKETING STRATEGIES
14.1. Chapter Overview
14.2. Key Channels Used for Promotional Campaigns
14.2.1. Product Websites
14.2.2. Patient Assistance Programs
14.2.3. Participation in Conferences
14.2.4. Collaboration with Stakeholders
14.2.5. Drug Approval Across Multiple Geographies
14.3. Other Channels Used for Promotional and Marketing Strategies
14.4. Summary: Promotional and Marketing Strategy Leveraged by Bispecific Antibody Developers
14.5. Promotional Analysis: Blincyto®
14.5.1. Drug Overview
14.5.2. Product Website analysis
14.5.2.1. Messages for Healthcare Professionals
14.5.2.1.1. For MRD Positive B cell precursor ALL
14.5.2.1.2. For Relapsed or Refractory B-cell precursor ALL
14.5.2.2. Messages for Patients
14.5.3. Patient Support Services and Informative Downloads
14.5.4. Other Promotional Strategies
14.5.4.1. Presence in Conferences
14.6. Promotional Analysis: Hemlibra®
14.6.1. Drug Overview
14.6.2. Product Website Analysis
14.6.2.1. Messages for Healthcare Professionals
14.6.2.1.1. For Hemophilia A without Factor VIII Inhibitors
14.6.2.1.2. For Hemophilia A with Factor VIII Inhibitors
14.6.2.3. Messages for Patients
14.6.3. Patient Support Services and Informative Downloads
14.6.3.1. Co-pay Program
14.6.3.2. Independent Co-pay Assistance Foundation
14.6.3.3. Genentech Patient Foundation
14.6.4. Other Promotional Strategies
14.6.4.1. Presence in Conferences
15. MARKET FORECAST AND OPPORTUNITY ANALYSIS
15.1. Chapter Overview
15.2. Scope and Limitations
15.3. Forecast Methodology and Key Assumptions
15.4. Global Bispecific Antibody Therapeutics Market, 2023-2035
15.4.1. Bispecific Antibody Therapeutics Market: Analysis by Therapeutic Area, 2023 and 2035
15.4.2. Bispecific Antibody Therapeutics Market: Analysis by Mechanism of Action, 2023 and 2035
15.4.3. Bispecific Antibody Therapeutics Market: Analysis by Target Antigen, 2023 and 2035
15.4.4. Bispecific Antibody Therapeutics Market: Analysis by Antibody Format, 2023 and 2035
15.4.5. Bispecific Antibody Therapeutics Market: Analysis by Key Players, 2023 and 2035
15.4.6. Bispecific Antibody Therapeutics Market: Analysis by Geography, 2023 and 2035
15.5. Bispecific Antibody Market: Value Creation Analysis
15.6. Bispecific Antibody Therapeutics Market: Product-wise Sales Forecasts
15.6.1. AK104 (Akeso Biopharma)
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. Blincyto™ (Amgen)
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. Hemlibra® (Roche)
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. Kimmtrak® (Immunocore)
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. Lunsumio® (Roche)
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. Nanozora® (Taisho Pharmaceutical)
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. Rybrevant™ (Janssen Research & Development)
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. Tecvayli™ (Janssen Research & Development)
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. Vabysmo™ (Roche)
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. AK112 (Akeso Biopharma)
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
15.6.11. ALXN1720 (Alexion)
15.6.11.1. Target Patient Population
15.6.11.2. Sales Forecast
15.6.11.3. Net Present Value
15.6.11.4. Value Creation Analysis
15.6.12. GEN3013 (Genmab)
15.6.12.1. Target Patient Population
15.6.12.2. Sales Forecast
15.6.12.3. Net Present Value
15.6.12.4. Value Creation Analysis
15.6.13. Glofitamab (Roche)
15.6.13.1. Target Patient Population
15.6.13.2. Sales Forecast
15.6.13.3. Net Present Value
15.6.13.4. Value Creation Analysis
15.6.14. LP000 (Linton Pharm)
15.6.14.1. Target Patient Population
15.6.14.2. Sales Forecast
15.6.14.3. Net Present Value
15.6.14.4. Value Creation Analysis
15.6.15. M7824 (Merck)
15.6.15.1. Target Patient Population
15.6.15.2. Sales Forecast
15.6.15.3. Net Present Value
15.6.15.4. Value Creation Analysis
15.6.16. OMP 305B83 (Mereo BioPharma)
15.6.16.1. Target Patient Population
15.6.16.2. Sales Forecast
15.6.16.3. Net Present Value
15.6.16.4. Value Creation Analysis
15.6.17. PF-06863135 (Pfizer)
15.6.17.1. Target Patient Population
15.6.17.2. Sales Forecast
15.6.17.3. Net Present Value
15.6.17.4. Value Creation Analysis
15.6.18. ZW25 (Zymeworks)
15.6.18.1. Target Patient Population
15.6.18.2. Sales Forecast
15.6.18.3. Net Present Value
15.6.18.4. Value Creation Analysis
15.7. Concluding Remarks
16. SWOT ANALYSIS
16.1. Chapter Overview
16.2. Strengths
16.2.1. Enhanced Specificity
16.2.2. Diverse Application Areas
16.2.3. Lower Drug Resistance
16.2.4. Success of Approved Products
16.3. Weaknesses
16.3.1. Uncertainties with Safety of Therapeutic Candidates
16.3.2. Complex Purification and Downstream Processing
16.3.3. Dimerization in Antibodies with Fc-region
16.4. Opportunities
16.4.1. Life Cycle Management of Novel Therapies
16.4.2. Growing Number of High Value Partnerships
16.4.3. Expertise Available with Contract Manufacturing Organizations
16.4.4. Emergence of Advanced Technologies
16.5. Threats
16.5.1. Rise in Attrition Rate of Clinical Stage Candidates
16.6. Concluding Remarks
17. CONCLUDING REMARKS
18. EXECUTIVE INSIGHTS
18.1. Chapter Overview
18.2. CytomX Therapeutics
18.2.1. Company Snapshot
18.2.2. Interview Transcript
18.3. F-star
18.3.1. Company Snapshot
18.3.2. Interview Transcript
18.4. Immunai
18.4.1. Company Snapshot
18.4.2. Interview Transcript
18.5. Innovent Biologics
18.5.1. Company Snapshot
18.5.2. Interview Transcript
18.6. SYNIMMUNE
18.6.1. Company Snapshot
18.6.2. Interview Transcript
18.7. University of Freiburg
18.7.1. Company Snapshot
18.7.2. Interview Transcript
19. APPENDIX 1: TABULATED DATA
20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATION
1.1. Introduction
1.2. Key Market Insights
1.3. Scope of the Report
1.4. Research Methodology
1.5. Frequently Asked Questions
1.6. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Introduction to Antibodies
3.2.1. Structure
3.2.2. Functions
3.2.3. Mechanism of Action
3.3. Antibody Therapeutics
3.3.1. Historical Evolution of Antibody Therapeutics
3.3.2. Key Approved Antibody Therapeutics
3.3.3. Advanced Antibody Therapeutics
3.3.3.1. Fc Engineered and Glycoengineered Antibodies
3.3.3.2. Antibody Fragments
3.3.3.3. Fusion Proteins
3.3.3.4. Intrabodies
3.3.3.5. Bispecific Antibodies
3.4. Bispecific Antibody Formats
3.4.1. Single-Chain-based Formats (Fc Independent Antibody Formats)
3.4.1.1. Tandem scFvs (single-chain variable fragments) and Triple bodies
3.4.1.2. Bispecific Single-Domain Antibody Fusion Proteins
3.4.1.3. Diabodies / Diabody Derivatives
3.4.1.4. Fusion Proteins
3.4.1.5. Fusion Proteins Devoid of Fc Regions
3.4.2. Immunoglobulin G Based Formats (Fc Dependent Antibody Formats)
3.4.2.1. Quadromas
3.4.2.2. Knobs-Into-Holes
3.4.2.3. Dual Variable Domain Ig
3.4.2.4. IgG-scFv
3.4.2.5. Two-in-one or Dual Action Fab (DAF) Antibodies
3.4.2.6. Half Molecule Exchange
3.4.2.7. ??- Bodies
3.5. Mechanism of Action of Bispecific Antibody Therapeutics
3.5.1. Retargeting Immune Effectors (NK Cells and T Cells) to Tumor Cells
3.5.2. Directly Targeting Malignant / Tumor Cells
3.5.3. Retargeting of Toxins
3.5.4. Targeting Tumor Angiogenesis
3.5.5. Other Mechanisms
3.6. Applications of Bispecific Antibodies
4. MARKET LANDSCAPE OF APPROVED AND CLINICAL THERAPIES
4.1. Chapter Overview
4.2. Approved and Clinical Bispecific Antibody Therapeutics: Overall Market Landscape
4.2.1. Analysis by Phase of Development
4.2.2. Analysis by Target Antigen
4.2.3. Analysis by Type of Therapy
4.2.4. Analysis by Route of Administration
4.2.5. Analysis by Method of Administration
4.2.6. Analysis by Target Indication
4.2.7. Analysis by Therapeutic Area
4.2.8. Analysis by Disease Segment
4.3. Approved and Clinical Bispecific Antibody Therapeutics: Overall Developer Landscape
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Location of Headquarters
5. MARKET LANDSCAPE OF PRECLINICAL THERAPIES
5.1. Chapter Overview
5.2. Preclinical Bispecific Antibody Therapeutics: Overall Market Landscape
5.2.1. Analysis by Stage of Development
5.2.2. Analysis by Target Antigen
5.2.3. Analysis by Disease Segment
5.3. Preclinical Bispecific Antibody Therapeutics: Overall Developer Landscape
5.3.1. Analysis by Year of Establishment
5.3.2. Analysis by Company Size
5.3.3. Analysis by Location of Headquarters
6. KEY INSIGHTS
6.1. Chapter Overview
6.2. Approved and Clinical Stage Bispecific Antibody Therapeutics Landscape: Key Insights
6.2.1. Analysis by Phase of Development and Route of Administration
6.2.2. Analysis by Phase of Development and Disease Segment
6.2.3. Analysis by Phase of Development and Location of Developer’s Headquarters
6.3. Preclinical Stage Bispecific Antibody Therapeutics Landscape: Key Insights
6.3.1. Analysis by Stage of Development and Therapeutic Area
6.3.2. Analysis by Stage of Development and Location of Developer Headquarters
6.4. Bispecific Antibody Therapeutics Developers Landscape: Key Insights
6.4.1. Distribution by Stage of Development
6.4.2. Distribution by Stage of Development and Region of Developer Headquarters
7. TECHNOLOGY ASSESSMENT FRAMEWORK
7.1. Chapter Overview
7.2. Bispecific Antibody Therapeutics: List of Technology Platforms
7.3. Bispecific Antibody Technology Platforms: Comparative Analysis
7.3.1. Analysis by Technologies for Approved and Clinical Drugs
7.3.2. Analysis by Technologies for Preclinical Drugs
7.4. Most Popular Technology Platforms: Analysis by Stage of Development
7.5. Bispecific Antibody Technology Platform Developers: Analysis by Location of Headquarters
8. BIG PHARMA PLAYERS: BENCHMARKING ANALYSIS
8.1. Chapter Overview
8.2. Big Pharma Players: Benchmarking Analysis (Spider Web Representation)
8.3. Big Pharma Players: Comparative Clinical Pipeline Analysis
8.3.1. Analysis by Target Antigen
8.3.2. Analysis by Antibody Format
8.3.3. Analysis by Mechanism of Action
8.3.4. Analysis by Therapeutic Area
9. COMPANY PROFILES
9.1. Chapter Overview
9.2. Akeso Biopharma
9.2.1. Company Overview
9.2.2. Financial Performance
9.2.3. Drug Portfolio
9.2.4. Recent Developments and Future Outlook
9.3. Alphamab Oncology
9.3.1. Company Overview
9.3.2. Financial Performance
9.3.3. Drug Portfolio
9.3.4. Recent Developments and Future Outlook
9.4. Amgen
9.4.1. Company Overview
9.4.2. Financial Performance
9.4.3. Drug Portfolio
9.4.4. Recent Developments and Future Outlook
9.5. Merck
9.5.1. Company Overview
9.5.2. Financial Performance
9.5.3. Drug Portfolio
9.5.4. Recent Developments and Future Outlook
9.6. Regeneron
9.6.1. Company Overview
9.6.2. Financial Performance
9.6.3. Drug Portfolio
9.6.4. Recent Developments and Future Outlook
9.7. Roche
9.7.1. Company Overview
9.7.2. Financial Performance
9.7.3. Drug Portfolio
9.7.4. Recent Developments and Future Outlook
9.8. Xencor
9.8.1. Company Overview
9.8.2. Financial Performance
9.8.3. Drug Portfolio
9.8.4. Recent Developments and Future Outlook
10. PARTNERSHIPS AND COLLABORATIONS
10.1. Chapter Overview
10.2. Partnership Models
10.3. Bispecific Antibody Therapeutics: Partnerships and Collaborations
10.3.1. Analysis by Year of Partnership
10.3.2. Analysis by Type of Partnership
10.3.3. Analysis by Year and Type of Partnership
10.3.4. Analysis by Disease Segment
10.3.5. Analysis by Type of Payment Model Employed and Deal Amount
10.3.6. Analysis by Year of Agreement, Type of Payment Model Employed and Deal Amount
10.3.7. Analysis by Disease Segment, Type of Payment Model Employed and Deal Amount
10.3.8. Most Active Players: Analysis by Number of Partnership Instances
10.3.9. Most Popular Technologies: Analysis by Number of Partnership Instances
10.3.10. Analysis by Region
10.3.11. Intercontinental and Intracontinental Agreements
11. CONTRACT SERVICES FOR BISPECIFIC ANTIBODY THERAPEUTICS
11.1. Chapter Overview
11.2. Manufacturing of Bispecific Antibody Therapeutics
11.2.1. Key Considerations for Manufacturing and Associated Challenges
11.2.2. Contract Manufacturing Organizations (CMOs)
11.2.2.1. Bispecific Antibody Therapeutics: List of CMOs
11.2.3. Contract Research Organizations (CROs)
11.2.3.1. Bispecific Antibody Therapeutics: List of CROs
11.3. Key Considerations for Selecting a Suitable CMO / CRO Partner
12. CLINICAL TRIAL ANALYSIS
12.1. Chapter Overview
12.2. Key Assumptions and Methodology
12.3. Bispecific Antibody Therapeutics: Clinical Trial Analysis
12.3.1. Analysis by Trial Registration Year
12.3.2. Analysis of Enrolled Patient Population by Trial Registration Year
12.3.3. Analysis by Trial Phase
12.3.4. Analysis of Enrolled Patient Population by Trial Phase
12.3.5. Analysis by Trial Recruitment Status
12.3.6. Analysis by Trial Registration Year and Trial Recruitment Status
12.3.7. Analysis by Type of Study
12.3.8. Analysis by Study Design
12.3.9. Analysis by Type of Sponsor / Collaborator
12.3.10. Leading Industry Players: Analysis by Number of Registered Trials
12.3.11. Leading Non-Industry Players: Analysis by Number of Registered Trials
12.3.12. Clinical Trial Analysis: Key Focus Areas (Word Cloud Representation)
12.3.13. Analysis by Geography
12.3.14. Analysis by Trial Recruitment Status and Geography
12.3.15. Analysis of Enrolled Patient Population by Trial Recruitment Status and Geography
13. CASE STUDY: REGULATORY GUIDELINES FOR BISPECIFIC ANTIBODIES
13.1. Chapter Overview
13.2. Guidelines Issued by Regulatory Authorities
13.2.1. US Food and Drug Administration (FDA)
13.2.1.1. Pharma Companies’ Response to the FDA Draft Guidance
13.2.2. World Health Organization (WHO)
14. CASE STUDY: PROMOTIONAL / MARKETING STRATEGIES
14.1. Chapter Overview
14.2. Key Channels Used for Promotional Campaigns
14.2.1. Product Websites
14.2.2. Patient Assistance Programs
14.2.3. Participation in Conferences
14.2.4. Collaboration with Stakeholders
14.2.5. Drug Approval Across Multiple Geographies
14.3. Other Channels Used for Promotional and Marketing Strategies
14.4. Summary: Promotional and Marketing Strategy Leveraged by Bispecific Antibody Developers
14.5. Promotional Analysis: Blincyto®
14.5.1. Drug Overview
14.5.2. Product Website analysis
14.5.2.1. Messages for Healthcare Professionals
14.5.2.1.1. For MRD Positive B cell precursor ALL
14.5.2.1.2. For Relapsed or Refractory B-cell precursor ALL
14.5.2.2. Messages for Patients
14.5.3. Patient Support Services and Informative Downloads
14.5.4. Other Promotional Strategies
14.5.4.1. Presence in Conferences
14.6. Promotional Analysis: Hemlibra®
14.6.1. Drug Overview
14.6.2. Product Website Analysis
14.6.2.1. Messages for Healthcare Professionals
14.6.2.1.1. For Hemophilia A without Factor VIII Inhibitors
14.6.2.1.2. For Hemophilia A with Factor VIII Inhibitors
14.6.2.3. Messages for Patients
14.6.3. Patient Support Services and Informative Downloads
14.6.3.1. Co-pay Program
14.6.3.2. Independent Co-pay Assistance Foundation
14.6.3.3. Genentech Patient Foundation
14.6.4. Other Promotional Strategies
14.6.4.1. Presence in Conferences
15. MARKET FORECAST AND OPPORTUNITY ANALYSIS
15.1. Chapter Overview
15.2. Scope and Limitations
15.3. Forecast Methodology and Key Assumptions
15.4. Global Bispecific Antibody Therapeutics Market, 2023-2035
15.4.1. Bispecific Antibody Therapeutics Market: Analysis by Therapeutic Area, 2023 and 2035
15.4.2. Bispecific Antibody Therapeutics Market: Analysis by Mechanism of Action, 2023 and 2035
15.4.3. Bispecific Antibody Therapeutics Market: Analysis by Target Antigen, 2023 and 2035
15.4.4. Bispecific Antibody Therapeutics Market: Analysis by Antibody Format, 2023 and 2035
15.4.5. Bispecific Antibody Therapeutics Market: Analysis by Key Players, 2023 and 2035
15.4.6. Bispecific Antibody Therapeutics Market: Analysis by Geography, 2023 and 2035
15.5. Bispecific Antibody Market: Value Creation Analysis
15.6. Bispecific Antibody Therapeutics Market: Product-wise Sales Forecasts
15.6.1. AK104 (Akeso Biopharma)
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. Blincyto™ (Amgen)
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. Hemlibra® (Roche)
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. Kimmtrak® (Immunocore)
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. Lunsumio® (Roche)
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. Nanozora® (Taisho Pharmaceutical)
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. Rybrevant™ (Janssen Research & Development)
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. Tecvayli™ (Janssen Research & Development)
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. Vabysmo™ (Roche)
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. AK112 (Akeso Biopharma)
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
15.6.11. ALXN1720 (Alexion)
15.6.11.1. Target Patient Population
15.6.11.2. Sales Forecast
15.6.11.3. Net Present Value
15.6.11.4. Value Creation Analysis
15.6.12. GEN3013 (Genmab)
15.6.12.1. Target Patient Population
15.6.12.2. Sales Forecast
15.6.12.3. Net Present Value
15.6.12.4. Value Creation Analysis
15.6.13. Glofitamab (Roche)
15.6.13.1. Target Patient Population
15.6.13.2. Sales Forecast
15.6.13.3. Net Present Value
15.6.13.4. Value Creation Analysis
15.6.14. LP000 (Linton Pharm)
15.6.14.1. Target Patient Population
15.6.14.2. Sales Forecast
15.6.14.3. Net Present Value
15.6.14.4. Value Creation Analysis
15.6.15. M7824 (Merck)
15.6.15.1. Target Patient Population
15.6.15.2. Sales Forecast
15.6.15.3. Net Present Value
15.6.15.4. Value Creation Analysis
15.6.16. OMP 305B83 (Mereo BioPharma)
15.6.16.1. Target Patient Population
15.6.16.2. Sales Forecast
15.6.16.3. Net Present Value
15.6.16.4. Value Creation Analysis
15.6.17. PF-06863135 (Pfizer)
15.6.17.1. Target Patient Population
15.6.17.2. Sales Forecast
15.6.17.3. Net Present Value
15.6.17.4. Value Creation Analysis
15.6.18. ZW25 (Zymeworks)
15.6.18.1. Target Patient Population
15.6.18.2. Sales Forecast
15.6.18.3. Net Present Value
15.6.18.4. Value Creation Analysis
15.7. Concluding Remarks
16. SWOT ANALYSIS
16.1. Chapter Overview
16.2. Strengths
16.2.1. Enhanced Specificity
16.2.2. Diverse Application Areas
16.2.3. Lower Drug Resistance
16.2.4. Success of Approved Products
16.3. Weaknesses
16.3.1. Uncertainties with Safety of Therapeutic Candidates
16.3.2. Complex Purification and Downstream Processing
16.3.3. Dimerization in Antibodies with Fc-region
16.4. Opportunities
16.4.1. Life Cycle Management of Novel Therapies
16.4.2. Growing Number of High Value Partnerships
16.4.3. Expertise Available with Contract Manufacturing Organizations
16.4.4. Emergence of Advanced Technologies
16.5. Threats
16.5.1. Rise in Attrition Rate of Clinical Stage Candidates
16.6. Concluding Remarks
17. CONCLUDING REMARKS
18. EXECUTIVE INSIGHTS
18.1. Chapter Overview
18.2. CytomX Therapeutics
18.2.1. Company Snapshot
18.2.2. Interview Transcript
18.3. F-star
18.3.1. Company Snapshot
18.3.2. Interview Transcript
18.4. Immunai
18.4.1. Company Snapshot
18.4.2. Interview Transcript
18.5. Innovent Biologics
18.5.1. Company Snapshot
18.5.2. Interview Transcript
18.6. SYNIMMUNE
18.6.1. Company Snapshot
18.6.2. Interview Transcript
18.7. University of Freiburg
18.7.1. Company Snapshot
18.7.2. Interview Transcript
19. APPENDIX 1: TABULATED DATA
20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATION
