Future of Bispecific Antibody: Exploring the Rise in Approvals

Bispecific antibodies are a type of antibody that can bind to two different targets at the same time. They are designed to recognize and bind to two specific molecules, such as a tumor cell and an immune cell, or two different parts of the same molecule. This allows them to potentially be more effective in treating diseases by targeting multiple pathways simultaneously.

I, recently, worked on a market research report, titled Bispecific Antibodies Market, 2023-2035. During the research, I noticed a significant increase in the number of FDA approvals for bispecific antibodies in recent years. In fact, six bispecific antibodies have been approved in 2022.

Following table presents information on all the bispecific antibodies approved, till now, along with their approval dates and target indications. I would like to highlight that; I have also pasted information on the approved drugs that are currently being evaluated in Phase III trials for different target indications.

Sr. NoDrug CandidateDrug DeveloperPhase of DevelopmentTarget IndicationTherapeutic AreaApproval Year
1AK104Akeso BiopharmaApprovedRelapsed or Metastatic Cervical CancerSolid Tumors2022
Phase III1-L Locally Advanced Cervical CancerSolid Tumors2031
1-L Locally Advanced Unresectable or Metastatic Gastric CancerSolid Tumors2027
Locoregionally-advanced Nasopharyngeal CarcinomaSolid Tumors2029
2Blincyto™AmgenApprovedPhiladelphia Chromosome-Negative (Ph-) Relapsed or Refractory B-cell Precursor Acute Lymphoblastic LeukemiaHematological Malignancies2014
Philadelphia Chromosome-positive (Ph+) Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic LeukemiaHematological Malignancies2017
Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic LeukemiaHematological Malignancies2018
3Hemlibra®RocheApprovedHemophilia A With Factor VIII InhibitorsGenetic Disorders2017
Hemophilia A Without Factor VIII InhibitorsGenetic Disorders2018
4Kimmtrak®ImmunocoreApprovedMetastatic Uveal MelanomaSkin Cancers2022
5Lunsumio®RocheApproved2L+ Follicular LymphomaHematological Malignancies2022
Phase IIIRelapsed or Refractory Aggressive B-Cell Non-Hodgkin’s LymphomaHematological Malignancies2028
Follicular Lymphoma After At least One Line of Systemic TherapyHematological Malignancies2031
6Nanozora®Taisho PharmaceuticalApprovedRheumatoid ArthritisAutoimmune Disorders2022
7Rybrevant™Janssen Research & DevelopmentApprovedLocally advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion MutationsSolid Tumors2021
8Tecvyali™Janssen Research & DevelopmentApprovedRelapsed or refractory Multiple MyelomaHematological Malignancies2022
9Vabysmo™RocheApprovedDiabetic Macular EdemaOphthalmic Disorders2022
Neovascular Age Related Macular DegenerationOphthalmic Disorders2022
Note 1: Approval years of the approved drugs refers to the first approval received by the drug in any region
Note 2: Approval years of the clinical stage drug candidates have been calculated through proprietary criteria

As highlighted in the table above, it can be observed that seven bispecific antibodies have been approved since 2021. Such approvals have increased the interest and confidence of stakeholders and have helped validate the effectiveness of their drug, opening up new markets for their drug, potentially leading to further research and development opportunities.

In addition to approved therapies, I would like to mention that in terms of clinical development, the current pipeline of bispecific antibody therapeutics looks promising. Nearly 10% of the bispecific antibody drug candidates are currently being evaluated under phase III studies. Further, it is worth mentioning that over 45% of these drug candidates are being evaluated under phase I clinical studies.

Development stages of Bispecific Antibodies

In order to show a better overall perspective of clinical stage bispecific antibodies, I have pasted below a table that shows the information on bispecific antibodies currently being evaluated under phase III studies for various oncological / non-oncological target indications.

S. NoDrug CandidateDrug DeveloperPhase of DevelopmentTarget IndicationTherapeutic AreaApproval Year
1AK112Akeso BiopharmaPhase III1-L PD-L1(+) Non-small Cell Lung CancerSolid Tumors2027
EGFR-TKI Resistant Non-small Cell Lung CancerSolid Tumors2027
2ALXN1720AlexionPhase IIIGeneralized Myasthenia GravisAutoimmune Disorders2029
3GEN3013GenmabPhase IIIRelapsed or Refractory Follicular LymphomaHematological Malignancies2032
Newly Diagnosed Diffuse Large B-Cell LymphomaHematological Malignancies2032
4GlofitamabRochePhase III1-L+ Relapsed or Refractory Diffuse Large B-Cell LymphomaHematological Malignancies2027
5LP000Linton PharmPhase III3-L Gastric Cancer with Peritoneal MetastasisSolid Tumors2025
6M7824MerckPhase III1-L Non-small Cell Lung Cancer with High PD-L1-tumor ExpressionSolid Tumors2025
7OMP 305B83Mereo BioPharmaPhase IIIPlatinum Resistant Ovarian CancerSolid Tumors2026
8PF-06863135PfizerPhase IIIRelapsed/Refractory Multiple MyelomaHematological Malignancies2027
Newly Diagnosed Multiple MyelomaHematological Malignancies2030
Newly Diagnosed Multiple Myeloma After TransplantHematological Malignancies2030
9ZW25ZymeworksPhase IIIHER2-positive Gastric and Esophageal CancersSolid Tumors2027
Note: Approval years of the clinical stage drug candidates have been calculated through proprietary criteria

The future of bispecific antibodies seems to be highly promising, in fact, based on our proprietary market forecast estimates this domain is expected to grow at a CAGR of over 9.5% during the period 2023-2035. As technologies continue to advance, the potential applications for bispecific antibodies are expanding. One area of interest is in oncology, where bispecific antibodies can be used to target two different antigens at the same time, leading to improved efficacy and reduced toxicity compared to traditional chemotherapy. In addition to oncological disorders, bispecific antibodies have shown versatility in a variety of therapeutic areas including the treatment for autoimmune disorders, skin disorders and genetic disorders. As this domain continues to evolve, it is likely that we will see more bispecific antibody drugs being developed and approved for a wider range of diseases, leading to improved outcomes among patients.

For detailed insights about this domain, check out our report Bispecific Antibodies Market.