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Global Bispecific Antibody Market Opportunity, Drug Sales, Price  & Clinical Trials Insight 2028

Global Bispecific Antibody Market Opportunity, Drug Sales, Price & Clinical Trials Insight 2028

"Global Bispecific Antibody Market Opportunity, Drug Sales, Price and Clinical Trials Insight 2028" Report Highlights:

• Global Bispecific Antibody Market Opportunity Assessment: > US$ 30 Billion
• Global Bispecific Antibody Market Cumulative Sales Since 2016: > 8 Billion
• Global Bispecific Antibody Market Growth Rate: 100% CAGR (2016 -2021)
• Approved Bispecific Antibodies In Market: 7 Antibodies
• Comprehensive Clinical Trials Insight On More Than 600 Bispecific Antibodies In Clinical Trials
• Comprehensive Clinical Trials Insight By Phase, Indications, Organization, Patent
• Detailed Market Sales and Trends Insight Till 2028
• Quarterly & Yearly Sales Insight Of Approved Antibodies From 2066 Till Q2 2022
• Global & Regional Market Analysis
• Ongoing Clinical Trials Assessment by Status, Phase and Region

The use of antibodies as therapeutic drugs has significantly shifted the landscape of treatment in many areas of medicine including oncology, viral infections and auto-immune diseases. Over last two decades, the idea of bispecific antibody was developed and is used extensively to overcome the limitation of monoclonal antibodies. Bispecific antibodies are dual targeting modalities and can simultaneously combine two epitopes. Their novel binding efficacy has prompted significant interest for a number of therapeutic conditions, both in cancer as well as other diseases. The growing interest in the therapeutic antibodies along with the rapid progress in antibody engineering has enabled the development of wide range of bispecific formats.

Recently, Janssen Pharmaceutical has developed Teclistamab which is an investigational, fully humanized, T-cell redirecting, IgG4 bispecific antibody targeting both BCMA (B-cell maturation antigen) and CD3, the T-cell receptor. Preclinical studies have shown that Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumor cells. In July 2022, company has announced that it has received conditional marketing approval from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Teclistamab in patients with multiple myeloma. In addition to this, the company has also submitted Biologics License Application (BLA) to US FDA seeking approval for its novel drugs. The approval is based on the positive results of late stage clinical trial which has suggested enhancing its survival rates. It is expected that the drug will be available in the market by end of 2022 and will be sold under the brand name Tecvalyi.

Currently, the novel bispecific antibody is present in various monotherapy and combination studies. For instance, researchers are currently conducting phase-I clinical trial evaluating the role of Teclistamab in combination with Darzalex Faspro in patients with relapsed or refractory multiple myeloma (RRMM). The result from the study has demonstrated safety and encouraging response of the novel combination, which led to initiation of further clinical trials. The coming years is expected to witness rapid approval of the drug in various regions as monotherapy or combination therapy which will have a positive impact on the growth of market.

Apart from this, 6 other bispecific antibodies have gained market authorization for various indications including Hemlibra for hemophilia, Blincyto for acute lymphoblastic leukemia, Rybrevant for non-small cell lung cancer, Vabysmo for Neovascular (Wet) Age‑related Macular Degeneration (AMD) and Diabetic Macular Edema (DME), Cadonilimab for cervical cancer, and Lunsmio for follicular lymphoma. Since 2017, bispecific antibodies have rapid been developed and granted approval to target the chronic diseases owing to their high efficacy and ability to target the multifactorial nature of the disease. In short span of time, the cumulative sales of the bispecific antibodies have surpassed US$ 9 Billion by first quarter of 2022, thus showing high adoption rates.

The encouraging response of bispecific antibodies has also gained a lot of investment from the pharmaceutical companies. In last few years, there has been upsurge in the number of pharmaceutical deals which will have a positive impact on the growth of market. For instance, Xencor and Janssen Biotech have entered an exclusive collaboration and global license agreement for the development and commercialization of plamotamab and XmAb CD28 bispecific antibody combinations to treat patients with B-cell malignancies. As per our report findings, the global bispecific antibody market is expected to surpass US$ 30 Billion and the cumulative sales are expected to surpass US$ 90 Billion by 2028. This is mainly attributed to increasing adoption of bispecific antibodies and lack of competition from the biosimilar drugs. Moreover, 3-5 bispecific antibodies are expected to gain approval during the forecast period which will drive the market.
Table of Contents

1. Introduction to Bispecific Monoclonal Antibody

2. Advantage of Bispecific Antibodies Over Monospecific Monoclonal Antibodies

3. Bispecific Antibodies - Development Process & Mechanism of Action
3.1 Development of Bispecific Antibodies Similar to IgG
3.2 Development of Small Bispecific Antibodies
3.3 General Mechanism of Bispecific Antibodies

4. Approved Bispecific Antibodies Mechanism of Action
4.1 Hemlibra
4.2 Blincyto
4.3 Reybrevant
4.4 Vabysmo
4.5 Lunsumio

5. Application of Bispecific Antibodies in Cancer
5.1 Cancer Diagnosis
5.2 Cancer Targeting By Blocking Signaling Pathways
5.3 Targeting Tumor Angiogenesis for Cancer Treatment

6. Miscellaneous Application of Bispecific Antibodies
6.1 Diagnosis of Microbial Infectious Diseases
6.2 Specific Delivery of Effector Compounds to Targets
6.3 Bispecific Antibodies as Genetic Antibody Therapy

7. Global & Regional Bispecific Antibody Market Outlook
7.1 Yearly & Quarterly Market Size Indicators
7.2 Approved Bispecific Antibodies Reimbursement Policy
7.2.1 Blincyto Reimbursement Policy
7.2.2 Hemlibra Reimbursement Policy
7.2.3 Rybrevant Reimbursement Policy
7.2.4 Vabysmo Reimbursement Policy
7.3 Global Bispecific Antibody Market Future Prospects

8. Blincyto: First Approved Bispecific Antibody 2015
8.1 Dosage & Price Analysis
8.2 Global & Regional Sales Analysis

9. Hemlibra: Second Approved Bispecific Antibody 2018
9.1 Dosage & Price Analysis
9.2 Global & Regional Sales Analysis

10. Rybrevant: Third Approved Bispecific Antibody 2021
10.1 Dosage & Price Analysis
10.2 Global & Regional Sales Analysis

11. Vabysmo: Forth Approved Bispecific Antibody 2022
11.1 Dosage & Price Analysis
11.2 Global & Regional Sales Analysis

12. Lunsumio: Fifth Approved Bispecific Antibody 2022

13. Cadonilimab: Sixth Approved Bispecific Antibody 2022

14. Tecvayli: Seventh Approved Bispecific Antibody 2022

15. Global Bispecific Antibodies Clinical Pipeline Overview
15.1 By Phase
15.2 By Country/Region
15.3 By Company
15.4 By Indication
15.5 Orphan Designated Bispecific Antibodies
15.6 Patient Segment

16. Global Bispecific Antibodies Clinical Pipeline By Company, Indication & Phase
16.1 Research
16.2 Preclinical
16.3 Phase-I
16.4 Phase-I/II
16.5 Phase-II
16.6 Phase-II/III
16.7 Phase-III
16.8 Registered

17. Marketed Bispecific Antibodies Clinical insight

18. Competitive Landscape
18.1 Ablynx
18.2 Adimab
18.3 Affimed Therapeutics
18.4 Amgen
18.5 AstraZeneca (MedImmune)
18.6 Chugai Pharmaceutical
18.7 Eli Lilly
18.8 EMD Serono
18.9 Emergent BioSolutions
18.10 Genentech
18.11 Genmab
18.12 Immunomedics
18.13 Jounce Therapeutics
18.14 MacroGenics
18.15 Merus
18.16 Neovii Biotech
18.17 NovImmune SA
18.18 OncoMed Pharmaceuticals
18.19 Pieris
18.20 Regeneron Pharmaceuticals
18.21 Roche
18.22 Sanofi

List of Figures

Figure 2-1: Advantages of Bispecific Antibodies

Figure 3-1: Types of Approaches to Form IgG like Bispecific Antibodies
Figure 3-2: Method of Formation of Hybrid Hybridoma
Figure 3-3: Limitations of Hybrid Hybridoma
Figure 3-4: Steps involved in “Knobs into Holes” Approach
Figure 3-5: Three different CrossMabs are Obtained by Three Different Modifications
Figure 3-6: Method for formation of Dual-Variable-Domain Immunoglobulin
Figure 3-7: Advantages of Dual Variable Domain Immunoglobulin approach
Figure 3-8: Types of Bispecific Antibodies
Figure 3-9: Bispecific Antibodies – General Mechanism of Action
Figure 3-10: Bispecific Antibodies: Pathways for Induction of Cytotoxicity

Figure 4-1: Hemlibra - Mechanism of Action
Figure 4-2: Blincyto - Mechanism of Action
Figure 4-3: Rybrevant - Mechanism of Action

Figure 5-1: Application of Bispecific Antibodies in Cancer

Figure 7-1: Global – Bispecific Antibody Market Size (US$ Million), 2016 – 2022*
Figure 7-2: Global – Bispecific Antibody Market Size (US$ Million), Q1’2022 & Q2’2022
Figure 7-3: Global - Bispecific Antibody Market Size by Region (US$ Million), H1’2022
Figure 7-4: Global - Bispecific Antibody Market Size by Region (%), H1’2022
Figure 7-5: Global - Bispecific Antibody Market Size by Region (US$ Million), 2021
Figure 7-6: Global - Bispecific Antibody Market Size by Region (%), 2021
Figure 7-7: US – Bispecific Antibody Market Size (US$ Million), 2016 - 2022
Figure 7-8: US – Bispecific Antibody Market Size (US$ Million), Q1’2022 & Q2’2022
Figure 7-9: ROW – Bispecific Antibody Market Size (US$ Million), 2016 – 2022*
Figure 7-10: ROW – Bispecific Antibody Market Size (US$ Million), Q1’2022 & Q2’2022
Figure 7-11: Bispecific Antibody Market Size by Region (US$ Million), 2020
Figure 7-12: Bispecific Antibody Market Size by Region (%), 2020
Figure 7-13: Global – Bispecific Antibody Market Size (US$ Million) by Products (Blincyto & Hemlibra), 2018 - 2021
Figure 7-14: Bispecific Antibody Market Size by Product (%), 2021
Figure 7-15: Bispecific Antibody Market Size by Product (%), 2020
Figure 7-16: Bispecific Antibody Market Size by Product (%), 2019
Figure 7-17: Blincyto - Total Treatment Cost & Reimbursement Cost
Figure 7-18: Blincyto – In Pocket & Out of Pocket Cost of Treatment
Figure 7-19: Hemlibra - Total Treatment Cost & Reimbursement Cost
Figure 7-20: Hemlibra – In Pocket & Out of Pocket Cost of Treatment
Figure 7-21: Global – Rybrevant Maximum Coverage by Medicaid (US$), 2021
Figure 7-22: Global – Rybrevant Maximum Coverage by Private Insurance Coverage (US$), 2021
Figure 7-23: Vabysmo - Total Treatment Cost & Reimbursement Cost
Figure 7-24: Vabysmo – In Pocket & Out of Pocket Cost of Treatment
Figure 7-25: Global - Bispecific Antibody Market Opportunity Assessment (US$ Billion), 2022 - 2028

Figure 8-1: Blincyto – Recommended Number of Induction & Consolidation Cycles for
Treatment of MRD+ B-cell precursor ALL
Figure 8-2: Blincyto – Duration of Treatment Phase & Resting Phase in Induction &
Consolidation Cycles for Treatment of MRD+ B-cell Precursor ALL (Days)
Figure 8-3: Blincyto – Cost of Single Cycle & Full Treatment Cost of MRD+ B-Cell
Precursor ALL (US$), August’2022
Figure 8-4: Blincyto – Recommended Number of Induction & Consolidation Treatment
Cycle for Relapsed B-Cell Precursor ALL
Figure 8-5: Blincyto – Duration of Single Induction, Consolidation, Continued Cycle &
Full Treatment for Relapsed B-Cell Precursor ALL (Weeks)
Figure 8-6: Blincyto – Cost of 1st & 2nd Induction Cycle for Treatment of Relapsed B-
Cell Precursor ALL (US$), August’2022
Figure 8-7: Blincyto – Cost of Different Treatment Phases & Full Treatment Cost for
Relapsed B-Cell Precursor ALL (US$), August’2022
Figure 8-8: Global – Blincyto Sales Value (US$ Million), 2015 – 2022*
Figure 8-9: US – Blincyto Sales Value (US$ Million), 2016 – 2022*
Figure 8-10: ROW – Blincyto Sales Value (US$ Million), 2016 – 2022*
Figure 8-11: Blincyto - US v/s Rest of World Share in Sales Value (US$ Million), H1’2022
Figure 8-12: Global – Blincyto Sales Value (US$ Million), Q1’2022 & Q2’2022
Figure 8-13: Global – Blincyto Sales Value by Region (US$ Million), Q2’2022
Figure 8-14: Global – Blincyto Sales Value by Region (%), Q2’2022
Figure 8-15: Global – Blincyto Sales Value by Region (US$ Million), Q1’2022
Figure 8-16: Global – Blincyto Sales Value by Region (%), Q1’2022
Figure 8-17: Global – Blincyto Quarterly Sales Value (US$ Millions), Q1-Q4’2021
Figure 8-18: US – Blincyto Quarterly Sales Value (US$ Millions), Q1-Q4’2021
Figure 8-19: ROW – Blincyto Quarterly Sales Value (US$ Millions), Q1-Q4’2021
Figure 8-20: Blincyto - US v/s Rest of World Share in Sales Value (US$ Million), 2021
Figure 8-21: Blincyto - US v/s Rest of World Share in Sales Value (%), 2021
Figure 8-22: US – Blincyto Half Yearly Sales (US$ Millions), H1’2021 & H1’2022
Figure 8-23: ROW – Blincyto Half Yearly Sales (US$ Millions), H1 2021 & H1 2022
Figure 8-24: Global – Blincyto Quarterly Sales Value (US$ Millions), 2020
Figure 8-25: Blincyto – Quarterly Sales Value (US$ Million), 2019
Figure 8-26: Blincyto – Quarterly Sales Value (US$ Million), 2018
Figure 8-27: Blincyto - US v/s Rest of World Share in Sales Value (%), 2020
Figure 8-28: Blincyto - US v/s Rest of World Share in Sales Value (%), 2019
Figure 8-29: Blincyto - US v/s Rest of World Share in Sales Value (%), 2018

Figure 9-1: Hemlibra – Cost for Single Unit of 30mcg & 150mcg Subcutaneous Injection (US$), August’2022
Figure 9-2: Hemlibra – Recommended Loading & Maintenance Dose for Treatment of
Hemophilia (mg/Kg/Week)
Figure 9-3: Hemlibra – Average Monthly & Annual Cost for Treatment of Hemophilia A
(US$), August’2022
Figure 9-4: Global – Hemlibra Sales Value by Region (US$/ CHF Million), H1’2022
Figure 9-5: Global – Hemlibra Sales Value by Region (US$/ CHF Million), H1’2022
Figure 9-6: Global – Hemlibra Sales Value by Region (US$/ CHF Million), Q1’2022
Figure 9-7: Global – Hemlibra Sales Value by Region (US$/ CHF Million), Q1’2022
Figure 9-8: Global – Hemlibra Sales Value by Region (US$/ CHF Million), Q2’2022
Figure 9-9: Global – Hemlibra Sales Value by Region (US$/ CHF Million), Q2’2022
Figure 9-10: Global – Hemlibra Quarterly Sales Value (US$/ CHF Million), Q1-Q4’ 2021
Figure 9-11: US – Hemlibra Quarterly Sales Value (US$/ CHF Million), Q1-Q4’ 2021
Figure 9-12: Europe – Hemlibra Quarterly Sales Value (US$/ CHF Million), Q1-Q4’2021
Figure 9-13: Japan – Hemlibra Quarterly Sales Value (US$/ CHF Million), Q1-Q4’2021
Figure 9-14: ROW – Hemlibra Quarterly Sales Value (US$/CHF Million), Q1-Q4’2021
Figure 9-15: Global – Hemlibra Half Yearly Sales Value (US$/ CHF Million), H1 2020 &
H1 2021
Figure 9-16: Hemlibra – Annual Sales Value by Region (US$/CHF Million), 2021
Figure 9-17: Hemlibra – Annual Sales Value by Region (%), 2021
Figure 9-18: Hemlibra – Half Yearly Sales Value by Region (US$/CHF Million), H1 2021
Figure 9-19: Hemlibra – Half Yearly Sales Value by Region (%), H1 2021
Figure 9-20: Global – Hemlibra Sales Value (US$ Million), 2018 - 2021
Figure 9-21: US– Hemlibra Sales Value (US$ Million), 2018 - 2021
Figure 9-22: Europe– Hemlibra Sales Value (US$ Million), 2018- 2021
Figure 9-23: Japan– Hemlibra Sales Value (US$ Million), 2018 - 2021
Figure 9-24: Hemlibra – Sales Value by Countries (US$ Million), 2020
Figure 9-25: Hemlibra – Sales Growth by Countries (%), 2020
Figure 9-26: Hemlibra – Sales Growth by Countries (US$ Million), 2019
Figure 9-27: Hemlibra – Sales Value by Countries (US$ Million), 2018
Figure 9-28: Hemlibra – Sales Value Share by Countries (%), 2020
Figure 9-29: Hemlibra – Sales Value Share by Countries (%), 2019
Figure 9-30: Hemlibra – Sales Value Share by Countries (%), 2018
Figure 9-31: Global – Hemlibra Quarterly Sales Value (US$ Million), 2018
Figure 9-32: Global – Hemlibra Half Yearly Sales Value (US$ Million), 2018 & 2019
Figure 9-33: Hemlibra – Half Year Sales Value by Countries (US$ Million), 2018 & 2019
Figure 9-34: Hemlibra – Quarterly Sales Value (US$ Million), 2019
Figure 9-35: Hemlibra – 9 Months Sales Value by Countries (US$ Million), 2019
Figure 9-36: Hemlibra – 9 Month Sales Value Share by countries (%), 2019

Figure 10-1: Rybrevant – Price for 7ml Supply & Price per Unit of 50mg/ml Intravenous
Solution (US$), August’2022
Figure 10-2: Rybrevant – Recommended Dose Per Cycle by Body Weight (mg)
Figure 10-3: Rybrevant – Dose Reduction in Patients with Weight Less Than 80Kg (mg)
Figure 10-4: Rybrevant – Dose Reduction in Patients with Weight More Than 80Kg (mg)
Figure 10-5: Global – Rybrevant Sales Forecast (US$ Million), 2021-2028
Figure 10-6: US – Rybrevant Sales Forecast (US$ Million), 2021-2028
Figure 10-7: ROW – Rybrevant Sales Forecast (US$ Million), 2022-2028

Figure 11-1: Vabysmo – Price for 0.05ml Supply & Price per Unit of 6mg/0.05ml
Intravitreal Solution (US$), August’2022
Figure 11-2: Vabysmo – Cost of Single Cycle & Monthly Cost of Treatment (US$)
August’2022
Figure 11-3: Global – Vabysmo Sales Value by Region (US$/ CHF Million), Q2’2022
Figure 11-4: Global – Vabysmo Sales Value by Region (US$/ CHF Million), Q2’2022

Figure 15-1: Global - Bispecific Antibodies Clinical Pipeline by Phase (Numbers), 2021
till 2028
Figure 15-2: Global - Bispecific Antibodies in Clinical Pipeline by Country (Numbers),
2022 till 2028
Figure 15-3: Global - Bispecific Antibodies in Clinical Pipeline by Company (Numbers),
2022 till 2028
Figure 15-4: Global - Bispecific Antibodies in Clinical Pipeline by Indication (Numbers),
2022 till 2028
Figure 15-5: Global - Bispecific Antibodies in Clinical Pipeline by Orphan Status
(Numbers), 2022 till 2028
Figure 15-6: Global - Bispecific Antibodies in Clinical Pipeline by Patient Segment
(Numbers), 2022 till 2028

Figure 18-1: Ablynx - Clinical Pipeline
Figure 18-2: Affimed Therapeutics - Clinical Pipeline
Figure 18-3: Amgen - Clinical Pipeline
Figure 18-4: EMD Serono - Clinical Pipeline
Figure 18-5: Emergent Bioscience - Clinical Pipeline
Figure 18-6: Genmab - Clinical Pipeline
Figure 18-7: Jounce Therapeutics - Clinical Pipeline
Figure 18-8: MacroGenics - Clinical Pipeline
Figure 18-9: Merus - Clinical Pipeline
Figure 18-10: Novimmune - Clinical Pipeline
Figure 18-11: OncoMed - Clinical Pipeline
Figure 18-12: Pieris Pharmaceuticals - Clinical Pipeline
Figure 18-13: Roche - Clinical Pipeline

Report Title: Global Bispecific Antibody Market Opportunity, Drug Sales, Price & Clinical Trials Insight 2028


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