“Global Bispecific Antibody Market Opportunity & Clinical Trials Insight 2023” Report Highlights:
- Global Market Yearly & Quarterly Sales Insight (2018 Till Q1'2023)
- Global Market Forecast Till 2028
- Global & Regional Sales Insights By Drugs (2018 Till Q1'2023)
- Approved Bispecific Antibodies: 9
- Insight On Bispecific Antibodies In Clinical Trials: > 700 Bispecific Antibodies
- Global Bispecific Antibodies Clinical Trials By Company, Indication & Phase
- Fast Track Approval, Orphan Designation & Priority Status Insights
- Approved Bispecific Antibodies Pricing & Dosage Analysis
- Competitive Landscape: Top 50 Companies Developing Bispecific Antibodies
The introduction of antibody based therapeutics has been a game changer in the field of cancer therapy. Monoclonal antibodies have been around for decades and still there role has been ever so significant. However, with the rising clinically unmet medical needs, current efforts are focused on developing advanced forms of these biologics. The continued expansion in research and development of antibody biologics has brought in the era of bispecific antibodies.
These bispecific antibodies are capable of engaging or targeting two distinct targets and therefore are able to simultaneously perform multiple actions including; direct the immune cells to tumor cells, block two different pathways simultaneously and deliver cytotoxic payloads. Over the past few decades, there have been a number of difficulties with the production of bispecific antibodies; nevertheless, they have shown great potential as promising cancer therapeutics.
Bispecific antibodies are a fast growing engineered biologics that have significantly improved significant unmet medical needs. The fast approval of Columvi showed the urgency of this particular bispecific product. With the expansion of global pharmaceutical industry developing a robust clinical pipeline for the research and development of bispecific antibodies, there are numerous candidates currently undergoing clinical trials while several are being tested in preclinical studies.
The range of therapeutics has been increasing, similar to the rising demand of innovation in the pharmaceutical industry. This increase in the growing expansion of antibodies can be due to the increasing regulatory approvals. Recently, Roche's Glofitamab (Columvi), a bispecific T cell engager molecule (BiTE) was approved by Health Canada for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL).
The approval was based on the clinical study called NP30179 where more than 30% patients who received Glofitamab showed cancer disappearance. This marked the first ever approval for this CD20 x CD3 targeting bispecific antibody. . By simultaneously engaging the CD20 receptor on B cells and CD3 on the T cells, Glofitamab facilitates the development of an immunological synapse with following proliferation of T-cells and their activation, cytokine secretion, and release of cytolytic proteins that results in the killing of tumor cells which express CD20 surface receptor.
There are several factors that are driving the growth of bispecific antibody market which include; improved regulatory framework, persistent clinical trials having promising results and increasing investment with active assets. As the global pharmaceutical industry realizes the commercial as well as therapeutic potential of bispecific antibodies, we can expect an increase in the number of possible clinical candidates in the coming years.
Moreover, as the industry develops, there is also grows the number of competitors. A few years ago, there were only a handful of pharmaceutical players in the bispecific antibody market, however, now there are multiple stakeholders that are continuously working to develop novel bispecific antibodies. Furthermore, with eagerness to enter the market, several companies have also chosen the road to collaboration.
For instance, recently, ABL Bio, a South Korea based Biotech Company and Lonza, a Swiss multinational pharmaceutical manufacturing company have entered an agreement that will focus on the development and manufacturation of the former company's bispecific antibody product. The latter will provide ABL Bio will end to end solutions regarding early research and offer support for the potential Investigational New Drug (IND) application. With Lonza being a major leader with several bispecific and multispecific products in its pipeline, the collaboration will lead ABL Bio to a speedy road towards commercialization.
Overall, it is not hard to predict that the future of bispecific antibodies is very promising; however, more research needs to be conducted in order to fully determine the therapeutic potential and capability of this novel class of therapeutic biologics. Our report aims to provide a detailed overview about the mechanism of action of several approved bispecific antibodies in market, as well as highlights their patent, dosage and pricing in in major markets like that of the US. Additionally, the report also contains information about reimbursement policies respective to differnet bispecific antibodies and also presents information about bispecific antibodies currently in clinical pipeline.
Table of Contents
1. Introduction to Bispecific Antibody
- 1.1 Overview
- 1.2 Clinical Advancement of Bispecific Antibodies
2. Commercially Approved Bispecific Antibodies Insight: Company, Indication, Location & MOA
3. Global & Regional Bispecific Antibody Market Outlook (2018 till Q1'2023)
- 3.1 Yearly & Quarterly Sales Insight
- 3.2 Approved Bispecific Antibodies Reimbursement Policy
- 3.3 Global Bispecific Antibody Market Forecast 2028
4. Global Bispecific Antibody Market Trends
- 4.1 US
- 4.2 Europe
- 4.3 China
- 4.4 UK
- 4.5 Japan
- 4.6 South Korea
- 4.7 Australia
- 4.8 Canada
- 4.9 Latin America
5. Blincyto: 1st Approved Bispecific Antibody
- 5.1 Overview & Patent Insight
- 5.2 Pricing & Dosage Analysis
- 5.3 Sales Analysis
6. Hemlibra: 2nd Approved Bispecific Antibody
- 6.1 Overview
- 6.2 Dosage & Price Analysis
- 6.3 Sales Analysis
7. Rybrevant: 3rd Approved Bispecific Antibody
- 7.1 Overview
- 7.2 Dosage & Price Analysis
- 7.3 Sales Analysis
8. Kimmtrak: 4th Approved Bispecific Antibody
- 8.1 Overview
- 8.2 Pricing & Dosage Insight
- 8.3 Sales Analysis
9. Vabysmo: 5th Approved Bispecific Antibody
- 9.1 Overview
- 9.2 Dosage & Price Analysis
- 9.3 Sales Analysis
10. Lunsumio: 6th Approved Bispecific Antibody
- 10.1 Overview & Patent Insight
- 10.2 Dosage & Price Analysis
- 10.3 Sales Analysis
11. Cadonilimab: 7th Approved Bispecific Antibody
12. Tecvayli: 8th Approved Bispecific Antibody
- 12.1 Overview & Patent Insight
- 12.2 Pricing & Dosage Insight
13. Columvi: 9th Approved Bispecific Antibody
14. Global Bispecific Antibodies Clinical Pipeline Overview
- 14.1 By Phase
- 14.2 By Country/Region
- 14.3 By Company
- 14.4 By Indication
- 14.5 Orphan Designated Bispecific Antibodies
- 14.6 Patient Segment
15. Global Bispecific Antibodies Clinical Trials By Company, Indication & Phase
- 15.1 Research
- 15.2 Preclinical
- 15.3 Phase-I
- 15.4 Phase-I/II
- 15.5 Phase-II
- 15.6 Phase-II/III
- 15.7 Phase-III
- 15.8 Preregistration
16. Marketed Bispecific Antibodies Clinical Insight
17. Competitive Landscape
- 17.1 ABL Bio
- 17.2 Abzyme Therapeutics
- 17.3 Affimed Therapeutics
- 17.4 Akeso Biopharma
- 17.5 Alligator Bioscience
- 17.6 Amgen
- 17.7 Antibody Therapeutics
- 17.8 APITBIO
- 17.9 Aptevo Therapeutics
- 17.10 Astellas Pharma
- 17.11 AstraZeneca
- 17.12 BioAtla
- 17.13 Biosion
- 17.14 Biotheus
- 17.15 BJ Bioscience
- 17.16 EpimAb Biotherapeutics
- 17.17 FutureGen Biopharmaceutical
- 17.18 Genentech
- 17.19 Genmab
- 17.20 Gensun Biopharma
- 17.21 Harbour BioMed
- 17.22 IGM Biosciences
- 17.23 I-MAB Biopharma
- 17.24 ImmuneOnco Biopharma
- 17.25 ImmunoPrecise Antibodies
- 17.26 Innovent Biologics
- 17.27 Invenra
- 17.28 Janssen Biotech
- 17.29 Janssen Research & Development
- 17.30 Kenjockety Biotechnology
- 17.31 L and L Biopharma
- 17.32 LaNova Medicines Limited
- 17.33 Light Chain Bioscience
- 17.34 Linton Pharm
- 17.35 Lyvgen Biopharma
- 17.36 MacroGenics
- 17.37 Merus
- 17.38 NovaRock Biotherapeutics
- 17.39 OriCell Therapeutics
- 17.40 Pfizer
- 17.41 Phanes Therapeutics
- 17.42 Prestige BioPharma
- 17.43 Regeneron Pharmaceuticals
- 17.44 Revitope
- 17.45 Roche
- 17.46 Virtuoso Therapeutics
- 17.47 Xencor
- 17.48 Y-Biologics
- 17.49 Zhejiang Shimai Pharmaceutical
- 17.50 Zymeworks
List of Figures
- Figure 1-1: Bispecific Antibodies - Advantages
- Figure 2-1: Blincyto - Mechanism of Action
- Figure 2-2: Hemlibra - Mechanism of Action
- Figure 2-3: Rybrevant - Mechanism of Action
- Figure 3-1: Global - Bispecific Antibody Market Size (US$ Million), 2018-2023*
- Figure 3-2: Global - Bispecific Antibody Quarterly Market Size (US$ Million), Q1'2023
- Figure 3-3: Global - Bispecific Antibodies Sales by Drugs (US$ Million), Q1'2023
- Figure 3-4: Global - Bispecific Antibodies Sales by Drugs (%), Q1'2023
- Figure 3-5: Global - Bispecific Antibody Market Size by Region (US$ Million), Q1'2023
- Figure 3-6: Global - Bispecific Antibody Market Size by Region (%), Q1'2023
- Figure 3-7: Global - Bispecific Antibody Quarterly Market Size (US$ Million), 2022
- Figure 3-8: Global - Bispecific Antibodies Sales by Drugs (US$ Million), 2022
- Figure 3-9: Global - Bispecific Antibodies Sales by Drugs (%), 2022
- Figure 3-10: Global - Bispecific Antibody Market Size by Region (US$ Million), 2022
- Figure 3-11: Global - Bispecific Antibody Market Size by Region (%), 2022
- Figure 3-12: Global - Bispecific Antibodies Sales by Drugs (US$ Million), 2021
- Figure 3-13: Global - Bispecific Antibodies Sales by Drugs (%), 2021
- Figure 3-14: Global - Bispecific Antibody Market Size by Region (US$ Million), 2021
- Figure 3-15: Global - Bispecific Antibody Market Size by Region (%), 2021
- Figure 3-16: US - Bispecific Antibody Market Size (US$ Million), 2018 - 2023
- Figure 3-17: ROW - Bispecific Antibody Market Size (US$ Million), 2018 - 2023
- Figure 3-18: US - Bispecific Antibodies Quarterly Sales (US$ Million), 2022
- Figure 3-19: ROW - Bispecific Antibodies Quarterly Sales, 2022
- Figure 3-20: Blincyto - Total Treatment Cost & Reimbursement Cost
- Figure 3-21: Blincyto - In Pocket & Out of Pocket Cost of Treatment
- Figure 3-22: Hemlibra - Total Treatment Cost & Reimbursement Cost
- Figure 3-23: Hemlibra - In Pocket & Out of Pocket Cost of Treatment
- Figure 3-24: Rybrevant - Maximum Coverage by Medicaid (US$), 2023
- Figure 3-25: Rybrevant - Maximum Coverage by Private Insurance Coverage (US$), 2021
- Figure 3-26: Vabysmo - Total Treatment Cost & Reimbursement Cost
- Figure 3-27: Vabysmo - In Pocket & Out of Pocket Cost of Treatment
- Figure 3-28: Global - Bispecific Antibody Market Opportunity Assessment (US$ Billion), 2023 - 2028
- Figure 4-1: US - Bispecific Antibodies Approval
- Figure 4-2: Blincyto - US v/s ROW Sales (US$ Million), Q1'2023
- Figure 4-3: Blincyto - US v/s ROW Sales (US$ Million), Q1'2023
- Figure 4-4: Blincyto - US v/s ROW Sales (US$ Million), 2022
- Figure 4-5: Blincyto - US v/s ROW Shares (%), 2022
- Figure 4-6: Hemlibra - US v/s ROW Sales (US$ Million), Q1'2023
- Figure 4-7: Hemlibra - US v/s ROW Shares (%), Q1'2023
- Figure 4-8: Hemlibra - US v/s ROW Sales (US$ Million), 2022
- Figure 4-9: Hemlibra - US v/s ROW Shares (%), 2022
- Figure 4-10: Global - US v/s ROW Shares in Bispecific Antibodies Market (US$ Million), Q1'2023
- Figure 4-11: Global - US v/s ROW Shares in Bispecific Antibodies Market (%), Q1'2023
- Figure 4-12: Global - US v/s ROW Shares in Bispecific Antibodies Market (US$ Million), 2022
- Figure 4-13: Global - US v/s ROW Shares in Bispecific Antibodies Market (%), 2022
- Figure 4-14: Blincyto - Patent Filing & Expiration Years
- Figure 4-15: Blincyto -Patent Expiration In EU
- Figure 4-16: VABYSMO - Canada Patent Numbers Expiration & Approval Year
- Figure 4-17: Hemlibra - Canada Patent Numbers Approval & Expiration Year
- Figure 4-18: RYBREVANT - Canada Patent Numbers Approval & Expiration dates
- Figure 4-19: KIMMTRAK - Canada Patent Number Approval & Expiration Year
- Figure 5-1: Blincyto - Approval Years By Country
- Figure 5-2: Blincyto - Patent Filing & Expiration Years
- Figure 5-3: Blincyto Treatment Regimen Cycles (Weeks)
- Figure 5-4: Blincyto - Duration of Treatment Phase & Resting Phase in Induction & Consolidation Cycles for Treatment of MRD-Positive B-cell precursor (Days)
- Figure 5-5: Blincyto - Cost of Single Cycle & Treatment Course for the Treatment of MRD-positive B-cell Precursor ALL
- Figure 5-6: Blincyto - Recommended Number of Induction & Consolidation Treatment Cycle for Relapsed B-Cell Precursor ALL
- Figure 5-7: Blincyto - Duration of Single Induction, Consolidation, Continued Cycle & Full Treatment for Relapsed B-Cell Precursor ALL (Weeks)
- Figure 5-8: Blincyto - Cost of Single Cycle & Treatment Course for Treatment for Relapsed B-Cell Precursor ALL
- Figure 5-9: Global - Blincyto Sales Value (US$ Million), 2019 - 2023*
- Figure 5-10: Blincyto - US v/s ROW Share in Sales Value (US$ Million), Q1'2023
- Figure 5-11: Global - Blincyto Quarterly Sales (US$ Million), 2022
- Figure 5-12: Global - Blincyto Sales Value by Region (%), 2022
- Figure 5-13: US - Blincyto Sales Value (US$ Million), 2019-2023*
- Figure 5-14: ROW - Blincyto Sales Value (US$ Million), 2019-2023*
- Figure 6-1: Hemlibra - Approval Years
- Figure 6-2: Hemlibra - Cost for Single Unit of 30 mg/mL & 150 mg/mL Subcutaneous Injection (US$), May'2023
- Figure 6-3: Hemlibra - Recommended Loading & Maintenance Dose for Treatment of Hemophilia (mg/kg/Week)
- Figure 6-4: Global - Hemlibra Sales Value (US$ Million), 2019-2023
- Figure 6-5: Global - Hemlibra Sales Value by Region (US$ Million), Q1'2023
- Figure 6-6: Global - Hemlibra Sales Value by Region (%), Q1'2023
- Figure 6-7: Global - Hemlibra Quarterly Sales Value (US$ Million), 2022
- Figure 6-8: Global - Hemlibra Quarterly Sales Value by Region (US$ Million), 2022
- Figure 6-9: Global - Hemlibra Sales Value by Region (%), 2022
- Figure 6-10: US - Hemlibra Sales Value (US$ Million), 2019-2023*
- Figure 6-11: Europe - Hemlibra Sales Value (US$ Million), 2019-2023*
- Figure 6-12: Japan - Hemlibra Sales Value (US$ Million), 2019-2023*
- Figure 6-13: ROW - Hemlibra Sales Value (US$/ US$ Million), 2019-2023*
- Figure 7-1: Rybrevant - Price for 7 ml Supply & Price per Unit of 50 mg/ml Intravenous Solution (US$), May'2023
- Figure 7-2: Rybrevant - Recommended Dose Per Cycle by Body Weight (mg)
- Figure 7-3: Rybrevant - Dose Reduction in Patients with Weight Less Than 80 kg (mg)
- Figure 7-4: Rybrevant - Dose Reduction in Patients with Weight More Than 80 Kg (mg)
- Figure 8-1: Kimmtrak - Approval Years
- Figure 8-2: Kimmtrak - Cost Per Unit & Per Vial (US$), May'2023
- Figure 8-3: Global - Kimmtrak Sales (US$ Million), 2022
- Figure 8-4: Global - Quarterly Kimmtrak Sales (US$ Million), 2022
- Figure 8-5: Kimmtrak - Sales By Region (US$ Million), 2022
- Figure 8-6: US - Quarterly Kimmtrak Sales (US$ Million), 2022
- Figure 8-7: EU - Quarterly Kimmtrak Sales (US$ Million), 2022
- Figure 8-8 ROW - Quarterly Kimmtrak Sales (US$ '000), 2022
- Figure 9-1: Vabysmo - Approval Years
- Figure 9-2: Vabysmo - Price for 0.05 ml Supply & Price per Unit of 6mg/0.05ml Intravitreal Solution (US$), May'2023
- Figure 9-3: Global - Vabysmo Sales Value (US$ Million), 2022-2023*
- Figure 9-4: Global - Vabysmo Sales Value by Region (US$ Million), Q1'2023
- Figure 9-5: Global - Vabysmo Sales Value by Region (%), Q1'2023
- Figure 9-6: Global - Vabysmo Quarterly Sales Value (US$ Million), 2022
- Figure 9-7: Global - Vabysmo Quarterly Sales Value by Region (US$ Million), 2022
- Figure 9-8: Global - Vabysmo Sales Value by Region (%), 2022
- Figure 9-9: US - Vabysmo Sales Value (US$ Million), 2022-2023*
- Figure 9-10: Europe - Vabysmo Sales Value (US$ Million), 2022-2023*
- Figure 9-11: Japan - Vabysmo Sales Value (US$ Million), 2022-2023*
- Figure 9-12: ROW - Vabysmo Sales Value (US$ Million), 2022-2023*
- Figure 10-1: Lunsumio - Approval Years
- Figure 10-2: Lunsumio - Price & Price per unit for Supply of 30 mg/30 ml Intravenous Solution (US$), May'2023
- Figure 10-3: Global - Lunsumio Sales Value (US$ Million), 2022-2023*
- Figure 10-4: Global - Lunsumio Sales Value (US$ Million), 2022-2023*
- Figure 10-5: Global - Lunsumio Sales Value by Region (%), Q1'2023
- Figure 10-6: Global - Lunsumio Quarterly Sales Value (US$ Million), 2022
- Figure 11-1: Global - Cadonilimab Sales v/s Akeso Total Product Sales (US$ Million), 2022
- Figure 12-1: Tecvayli - Approval Years
- Figure 12-2: Tecvayli - Patent Acceptance & Expiration Years
- Figure 12-3: US - Cost of 10 mg/ ml Tecvayli Vial (US$), May'2023
- Figure 12-4: US - Cost of 90 mg/mL Tecvayli Vial (US$), May'2023
- Figure 12-5: EU - Cost of 10 mg/ml Tecvayli Vial (EUR v/s US$), May'2023
- Figure 12-6: EU - Cost of 153 mg/1.7 mL Tecvayli Vial (EUR v/s US$), May'2023
- Figure 14-1: Global - Bispecific Antibodies Clinical Pipeline by Phase (Numbers), 2023
- Figure 14-2: Global - Bispecific Antibodies in Clinical Pipeline by Country (Numbers), 2023
- Figure 14-3: Global - Bispecific Antibodies in Clinical Pipeline by Company (Numbers), 2023
- Figure 14-4: Global - Bispecific Antibodies in Clinical Pipeline by Indication (Numbers), 2023
- Figure 14-5: Global - Bispecific Antibodies in Clinical Pipeline by Orphan Status (Numbers), 2023
- Figure 14-6: Global - Bispecific Antibodies in Clinical Pipeline by Patient Segment (Numbers), 2023