US Bispecific Antibodies Market & Clinical Pipeline Insight 2028

List of Tables

“US Bispecific Antibodies Market & Clinical Pipeline Insight 2028” Report Highlights:

US Bispecific Antibodies Market Opportunity: > USD 15 Billion By 2028
FDA Approved Bispecific Antibodies: 11 Antibodies
Approved Bispecific Antibodies Dosage, Price & Sales Insight
Bispecific Antibodies Reimbursement Medicare, Medicaid & Drug Specific Policy
Comprehensive Clinical Insight On Bispecific Antibodies In Pipeline: > 300 Antibodies
US Bispecific Antibodies Clinical Pipeline Insight By Company, Indication & Phase
Comprehensive Clinical Insight On Approved Bispecific Antibodies

In the realm of biopharmaceuticals, bispecific antibodies have emerged as a revolutionary class of therapies, opening new frontiers in precision medicine. These innovative molecules are designed to simultaneously target two distinct antigens, unlocking the potential for transformative treatment approaches across various diseases. From oncology to autoimmune disorders, infectious diseases to neurodegenerative conditions, bispecific antibodies offer a clinical perspective that is reshaping patient care and inspiring new possibilities for precision therapies. In respect to this, the US market has emerged as frontrunner in commercializing this transformative therapeutic modality, and is now leading the development of bispecific antibodies, with several US based drugs makers having innovative bispecific antibodies candidates under development.

One of the key clinical perspectives of bispecific antibodies is their precision targeting capabilities. By engaging two specific antigens simultaneously, bispecific antibodies can be tailored to address unique molecular signatures of diseases. This precision targeting allows for more effective therapeutic interventions, minimizing off target effects on healthy tissues and reducing adverse events commonly associated with traditional treatments. Researchers in the US were the first to hypothesize the use of bispecific antibodies in cancer treatment, and pursuant research and clinical studies demonstrated bispecific antibodies to revolutionize the approach to cancer treatment. By precisely engaging immune cells to target cancer cells, these therapies unleash potent immune responses against tumors while sparing healthy tissues, leading to improved tumor control and better patient outcomes.

Clinical trials have demonstrated remarkable success in hematological malignancies, such as acute lymphoblastic leukemia (ALL) and multiple myeloma, as well as solid tumors like breast cancer and melanoma. The US bispecific antibodies market has witnessed the approval of several groundbreaking therapies that have extended survival rates, improved response rates, and provided new treatment options for patients with refractory or relapsed cancers. The US bispecific antibody market has also shown promise in addressing infectious diseases. Bispecific antibodies can be engineered to simultaneously neutralize pathogens and stimulate the immune system, boosting the body's ability to fight infections effectively.

US is also paving the way for innovative therapies in neurological disorders. Bispecific antibodies are being explored to target misfolded proteins implicated in neurodegenerative conditions like Alzheimer's and Parkinson's disease. By specifically targeting these pathological proteins and facilitating their clearance, bispecific antibodies offer a potential disease-modifying approach. The clinical impact of these therapies could potentially slow disease progression and improve the quality of life for patients living with these devastating neurological disorders.

From a clinical perspective, bispecific antibodies also hold promise in addressing treatment challenges posed by traditional therapies. For instance, drug resistance is a major obstacle in cancer treatment. Bispecific antibodies, with their dual-targeting capabilities, can circumvent resistance mechanisms and offer new avenues for patients who have exhausted conventional therapies. Additionally, the ability of bispecific antibodies to penetrate specific tissues or cross the blood-brain barrier allows for more effective delivery of therapies to disease sites that were previously difficult to target. This opens up possibilities for addressing neurological disorders and other conditions with limited treatment options.

The US has been at the forefront of biopharmaceutical innovation, consistently driving advancements in the field of medicine. In recent years, the country's clinical development of bispecific antibodies has not only transformed patient care within its borders but has also had a profound impact on the global market. As the first country to approve several bispecific antibodies therapies, the US has set standard for global regulatory agencies. International regulators often align their evaluation processes with the FDA's standards, benefiting patients worldwide by expediting approvals and facilitating access to transformative treatments.

The influx of global investment further bolsters R&D efforts, creating a virtuous cycle of progress. This infusion of funds enables companies to expand clinical trials, explore new therapeutic applications, and develop a more diverse pipeline of bispecific antibodies with broad-reaching clinical implications. The US leadership in the clinical development of bispecific antibodies has sparked numerous collaborations and partnerships on an international scale. Research institutions, companies, and clinicians from around the world seek to collaborate with US based organizations to access expertise, technologies, and resources.

These collaborations foster knowledge-sharing and resource pooling, contributing to a collective effort in advancing the global understanding of bispecific antibodies. Such partnerships have resulted in joint clinical trials and the exploration of diverse therapeutic applications across different countries. As the US continues to lead in research, clinical trials, and regulatory approvals, the global market for bispecific antibodies expands, providing new hope for patients facing complex diseases worldwide. Through pioneering efforts, collaborations, and investments, the US has positioned itself as a driving force in the evolving landscape of precision medicine. The impacts of its clinical developments have the potential to revolutionize patient care on a global scale.

1. US Bispecific Antibodies Market Outlook

1.1. US Commercially Approved Bispecific Antibodies
1.2. US Bispecific Antibodies Market Current Scenario
1.3. US Bispecific Antibodies Clinical Development & Commercial Collaborative Perspective
1.4. US Bispecific Antibodies Market Future Outlook

2. US Bispecific Antibodies Market Trends by Indication

2.1. Cancer
2.2. Ophthalmology
2.3. Autoimmune & Inflammatory Diseases
2.4. Blood Disorders

3. US Bispecific Antibodies Reimbursement Scenario

3.1. Medicare
3.2. Medicaid
3.3. Private Insurers
3.4. Pharmaceutical Companies
3.5. Approved Bispecific Antibodies Reimbursement Policies

4. Blincyto: 1st Approved Bispecific Antibody

4.1. Overview & Patent Insight
4.2. Pricing & Dosage Analysis
4.3. Sales Analysis

5. Hemlibra: 2nd Approved Bispecific Antibody

5.1. Overview
5.2. Dosage & Price Analysis
5.3. Sales Analysis

6. Rybrevant: 3rd Approved Bispecific Antibody

6.1. Overview
6.2. Dosage & Price Analysis
6.3. Sales Analysis

7. Kimmtrak: 4th Approved Bispecific Antibody

7.1. Overview
7.2. Pricing & Dosage Insight
7.3. Sales Analysis

8. Vabysmo: 5th Approved Bispecific Antibody

8.1. Overview
8.2. Dosage & Price Analysis
8.3. Sales Analysis

9. Lunsumio: 6th Approved Bispecific Antibody

9.1. Overview & Patent Insight
9.2. Dosage & Price Analysis
9.3. Sales Analysis

10. Tecvayli: 7th Approved Bispecific Antibody

10.1. Overview & Patent Insight
10.2. Pricing & Dosage Insight

11. Columvi: 8th Approved Bispecific Antibody

11.1. Overview & Patent Insight
11.2. Pricing & Dosage Insight

12. Epkinly: 9th Approved Bispecific Antibody

12.1. Overview & Patent Insight
12.2. Pricing & Dosage Insight

13. Talvey: 10th Approved Bispecific Antibody

13.1. Overview
13.2. Pricing & Dosage Insight

14. Elrexfio: 11th Approved Bispecific Antibody

14.1. Overview
14.2. Pricing & Dosage Insight

15. US Bispecific Antibodies Clinical Pipeline Overview

15.1. By Phase
15.2. By Biomarker
15.3. By Company
15.4. By Indication
15.5. Patient Segment

16. US 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

17. US Marketed Bispecific Antibodies Clinical Insight By Company & Indication

18. Competitive Landscape

18.1. AbbVie
18.2. ABL Bio
18.3. Abpro Therapeutics
18.4. Abzyme Therapeutics
18.5. Affimed Therapeutics
18.6. Agenus
18.7. Amberstone Biosciences
18.8. Amgen
18.9. Antibody Therapeutics
18.10. Aptevo Therapeutics
18.11. Astellas Pharma
18.12. AstraZeneca
18.13. BioAtla
18.14. Boehringer Ingelheim
18.15. Bristol-Myers Squibb
18.16. Chugai Pharmaceutical
18.17. CytomX Therapeutics
18.18. Cytovia Therapeutics
18.19. Dren Bio
18.20. Elpis Biopharmaceuticals
18.21. EpimAb Biotherapeutics
18.22. Genentech
18.23. Genmab
18.24. GO Therapeutics
18.25. Harbour BioMed
18.26. IGM Biosciences
18.27. ImmunoPrecise Antibodies
18.28. Innovent Biologics
18.29. Integral Molecular
18.30. Invenra
18.31. Janssen Biotech
18.32. Kenjockety Biotechnology
18.33. L and L Biopharma
18.34. MacroGenics
18.35. Marengo Therapeutics
18.36. Memorial Sloan-Kettering Cancer Center
18.37. Merus
18.38. NovaRock Biotherapeutics
18.39. Pfizer
18.40. Phanes Therapeutics
18.41. QLSF Biotherapeutics
18.42. Regeneron Pharmaceuticals
18.43. Revitope
18.44. Roche
18.45. Surrozen
18.46. Talem Therapeutics
18.47. Virtuoso Therapeutics
18.48. Xencor
18.49. Zhejiang Shimai Pharmaceutical
18.50. Zymeworks

List of Tables

Table 1-1: US FDA - Approved Bispecific Antibodies
Table 4-1: Blincyto - Active Patents
Table 4-2: Blincyto - Recommended Dosage & Schedule for the Treatment of MRD-positive B-cell Precursor ALL, August'2023
Table 4-3: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL, August'2023
Table 4-4: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL, August'2023
Table 6-1: Rybrevant - Premedication, August'2023
Table 6-2: Rybrevant - Dose Reductions for Adverse Reactions, August'2023
Table 6-3: Rybrevant - Recommended Dosage Modifications for Adverse Reactions, August'2023
Table 7-1: Kimmtrak - Recommended Dosage for Treatment of Unresectable or Metastatic Uveal Melanoma, August'2023
Table 7-2: Kimmtrak - Dose Modifications for Adverse Reactions, August'2023
Table 9-1: Lunsumio - Treatment Cycles, August'2023
Table 9-2: Lunsumio - Premedications, August'2023
Table 9-3: Lunsumio - Recommendations for Management of Cytokine Release Syndrome, August'2023
Table 10-1: Tecvayli - Dosing Schedule, August'2023
Table 10-2: Tecvayli - Recommended Dosage Modifications for Adverse Reactions, August'2023
Table 11-1: Columvi Dosing Schedule (21-Day Treatment Cycles), August'2023
Table 11-2: Recommended Dosage for Restarting Columvi After Dose Delay, August'2023
Table 12-1: Recommended Epkinly Dosage Schedule, August'2023
Table 12-2: Recommendations for Restarting Therapy with Epkinly after Dose Delay,
Table 13 1: Talvey - Weekly Dosing Schedule
Table 13 2: Talvey - Biweekly (Every 2 Weeks) Dosing Schedule
Table 13 3: Talvey - Recommendations for Management of CRS
Table 14 1: Elrexfio - Dosing Schedule
Table 14 2: Elrexfio - Recommendations for Management of CRS

List of Figures

Figure 1-1: Blincyto - Mechanism of Action
Figure 1-2: Hemlibra - Mechanism of Action
Figure 1-3: Rybrevant - Mechanism of Action
Figure 1-4: US FDA - Approved Bispecific Antibodies
Figure 1-5: US - Bispecific Antibodies Market Annual Sales (US$ Million), 2014-2023*
Figure 1-6: US - Bispecific Antibodies Market Annual Sales Value By Drugs, 2022
Figure 1-7: US - Bispecific Antibodies Market Quarterly Sales Value, 2022
Figure 1-8: US - Bispecific Antibodies Market Sales Value By Drugs, 2023*
Figure 1-9: US - Bispecific Antibodies Market Opportunity Assessment (US$ Billion), 2023 - 2028
Figure 2-1: BCDI-XII Phase 1 Study - Initiation & Completion Years
Figure 3-1: Blincyto - Total Treatment Cost & Reimbursement Cost
Figure 3-2: Blincyto - In Pocket & Out of Pocket Cost of Treatment
Figure 3-3: Hemlibra - Total Treatment Cost & Reimbursement Cost
Figure 3-4: Hemlibra - In Pocket & Out of Pocket Cost of Treatment
Figure 3-5: Hemlibra - Maximum Coverage by NCDHHS (US$), 2023
Figure 3-6: Rybrevant - Maximum Coverage by NCDHHS (US$), 2023
Figure 3-7: Rybrevant - Maximum Coverage by Private Insurance Coverage (US$), 2021
Figure 3-8: Kimmtrak - Maximum Coverage by NCDHHS (US$), 2023
Figure 3-9: Vabysmo - Total Treatment Cost & Reimbursement Cost
Figure 3-10: Vabysmo - In Pocket & Out of Pocket Cost of Treatment
Figure 3-11: Lunsumio - Maximum Coverage by NCDHHS (US$), 2023
Figure 4-1: Blincyto - Approval Years By Country
Figure 4-2: Blincyto - Patent Filing & Expiration Years
Figure 4-3: Blincyto Treatment Regimen Cycles (Weeks), August'2023
Figure 4-4: Blincyto - Duration of Treatment Phase & Resting Phase in Induction & Consolidation Cycles for Treatment of MRD-Positive B-cell precursor (Days), August'2023
Figure 4-5: Blincyto - Cost of Single Cycle & Treatment Course for the Treatment of MRD-positive B-cell Precursor ALL, August'2023
Figure 4-6: Blincyto - Recommended Number of Induction & Consolidation Treatment Cycle for Relapsed B-Cell Precursor ALL, August'2023
Figure 4-7: Blincyto - Duration of Single Induction, Consolidation, Continued Cycle & Full Treatment for Relapsed B-Cell Precursor ALL (Weeks), August'2023
Figure 4-8: Blincyto - Cost of Single Cycle & Treatment Course for Treatment for Relapsed B-Cell Precursor ALL, August'2023
Figure 4-9: US - Blincyto Sales Value (US$ Million), 2014-2023*
Figure 4-10: US - Blincyto Quarterly Sales (US$ Million), 2023
Figure 4-11: US - Blincyto Quarterly Sales (US$ Million), 2022
Figure 5-1: Hemlibra - Approval Years
Figure 5-2: Hemlibra - Cost for Single Unit of 30 mg/mL & 150 mg/mL Subcutaneous Injection (US$), August'2023
Figure 5-3: Hemlibra - Recommended Loading & Maintenance Dose for Treatment of Hemophilia (mg/kg/Week), August'2023
Figure 5-4: US - Hemlibra Sales Value (US$ Million), 2018-2023*
Figure 5-5: US - Hemlibra Quarterly Sales (US$ Million), 2023
Figure 5-6: US - Hemlibra Quarterly Sales (US$ Million), 2022
Figure 6-1: Rybrevant - Price for 7 ml Supply & Price per Unit of 50 mg/ml Intravenous Solution (US$), August'2023
Figure 6-2: Rybrevant - Recommended Dose Per Cycle by Body Weight (mg), August'2023
Figure 6-3: Rybrevant - Dose Reduction in Patients with Weight Less Than 80 kg (mg) , August'2023
Figure 6-4: Rybrevant - Dose Reduction in Patients with Weight More Than 80 Kg (mg) , August'2023
Figure 7-1: Kimmtrak - Approval Years
Figure 7-2: Kimmtrak - Cost Per Unit & Per Vial (US$), August'2023
Figure 7-3: US - Annual Kimmtrak Sales (US$ Million), 2022 & 2023
Figure 7-4: US - Quarterly Kimmtrak Sales (US$ Million), 2023
Figure 7-5: US - Quarterly Kimmtrak Sales (US$ Million), 2022
Figure 8-1: Vabysmo - Approval Years
Figure 8-2: Vabysmo - Price for 0.05 ml Supply & Price per Unit of 6mg/0.05ml Intravitreal Solution (US$), August'2023
Figure 8-3: US - Vabsymo Sales Value (US$ Million), 2022-2023*
Figure 8-4: US - Vabysmo Quarterly sales (US$ Million), 2023
Figure 8-5: US - Quarterly Vabsymo Sales (US$ Million), 2022
Figure 9-1: Lunsumio - Approval Years
Figure 9-2: Lunsumio - Price & Price per unit for Supply of 30 mg/30 ml Intravenous Solution (US$), August'2023
Figure 9-3: US - Lunsumio Sales Value, 2023
Figure 9-4: US - Lunsumio Quarterly Sales (US$ Million), 2023
Figure 10-1: Tecvayli - Approval Years
Figure 10-2: Tecvayli - Patent Acceptance & Expiration Years
Figure 10-3: US - Cost of 10 mg/ ml Tecvayli Vial (US$), August'2023
Figure 10-4: US - Cost of 90 mg/mL Tecvayli Vial (US$), August'2023
Figure 10-5: EU - Cost of 10 mg/ml Tecvayli Vial (US$), August'2023
Figure 10-6: EU - Cost of 153 mg/1.7 mL Tecvayli Vial (US$), August'2023
Figure 12-1: Epkinly - Price per Unit for 4mg & 48 mg Subcutaneous Solution of 0.8mL, August'2023
Figure 15-1: US - Bispecific Antibodies Clinical Pipeline by Phase (Numbers), 2023
Figure 15-2: US - Bispecific Antibodies in Clinical Pipeline by Biomarker (Numbers), 2023
Figure 15-3: US - Bispecific Antibodies in Clinical Pipeline by Company (Numbers), 2023
Figure 15-4: US - Bispecific Antibodies in Clinical Pipeline by Indication (Numbers), 2023
Figure 15-5: Global - Bispecific Antibodies in Clinical Pipeline by Patient Segment (Numbers), 2023

US Bispecific Antibodies Market & Clinical Pipeline Insight 2028

Description

Table of Contents

List of Tables

Table of Contents

1. US Bispecific Antibodies Market Outlook

2. US Bispecific Antibodies Market Trends by Indication

3. US Bispecific Antibodies Reimbursement Scenario

4. Blincyto: 1st Approved Bispecific Antibody

5. Hemlibra: 2nd Approved Bispecific Antibody

6. Rybrevant: 3rd Approved Bispecific Antibody

7. Kimmtrak: 4th Approved Bispecific Antibody

8. Vabysmo: 5th Approved Bispecific Antibody

9. Lunsumio: 6th Approved Bispecific Antibody

10. Tecvayli: 7th Approved Bispecific Antibody

11. Columvi: 8th Approved Bispecific Antibody

12. Epkinly: 9th Approved Bispecific Antibody

13. Talvey: 10th Approved Bispecific Antibody

14. Elrexfio: 11th Approved Bispecific Antibody

15. US Bispecific Antibodies Clinical Pipeline Overview

16. US Bispecific Antibodies Clinical Pipeline By Company, Indication & Phase

17. US Marketed Bispecific Antibodies Clinical Insight By Company & Indication

18. Competitive Landscape

List of Tables

List of Figures