Global Bispecific Antibody Market Opportunity & Clinical Trials Insight 2023

Abstract
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.

Content
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 Table
Table 2-1: Approved Bispecific Antibodies

Table 4-1: US – FDA IND Applications Accepted, May’2023
Table 4-2: Bispecific Antibodies In Late Stage Clinical Trials In Different Regions Of European Union
Table 4-3: Bispecific Antibodies Under Clinical Trials In Latin America, May’2023

Table 5-1: Blincyto – Active Patents
Table 5-2: Blincyto - Recommended Dosage & Schedule for the Treatment of MRD-positive B-cell Precursor ALL
Table 5-3: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL
Table 5-4: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL

Table 7-1: Rybrevant – Premedication
Table 7-2: Rybrevant - Dose Reductions for Adverse Reactions
Table 7-3: Rybrevant - Recommended Dosage Modifications for Adverse Reactions

Table 8-1: Kimmtrak - Recommended Dosage for Treatment of Unresectable or Metastatic Uveal Melanoma
Table 8-2: Kimmtrak - Dose Modifications for Adverse Reactions

Table 10-1: Lunsumio – Treatment Cycles
Table 10-2: Lunsumio - Premedications
Table 10-3: Lunsumio - Recommendations for Management of Cytokine Release Syndrome

Table 12-1: Tecvayli - Dosing Schedule
Table 12-2: Tecvayli - Recommended Dosage Modifications for Adverse Reactions