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. No | Drug Candidate | Drug Developer | Phase of Development | Target Indication | Therapeutic Area | Approval Year |
1 | AK104 | Akeso Biopharma | Approved | Relapsed or Metastatic Cervical Cancer | Solid Tumors | 2022 |
Phase III | 1-L Locally Advanced Cervical Cancer | Solid Tumors | 2031 | |||
1-L Locally Advanced Unresectable or Metastatic Gastric Cancer | Solid Tumors | 2027 | ||||
Locoregionally-advanced Nasopharyngeal Carcinoma | Solid Tumors | 2029 | ||||
2 | Blincyto™ | Amgen | Approved | Philadelphia Chromosome-Negative (Ph-) Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia | Hematological Malignancies | 2014 |
Philadelphia Chromosome-positive (Ph+) Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia | Hematological Malignancies | 2017 | ||||
Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia | Hematological Malignancies | 2018 | ||||
3 | Hemlibra® | Roche | Approved | Hemophilia A With Factor VIII Inhibitors | Genetic Disorders | 2017 |
Hemophilia A Without Factor VIII Inhibitors | Genetic Disorders | 2018 | ||||
4 | Kimmtrak® | Immunocore | Approved | Metastatic Uveal Melanoma | Skin Cancers | 2022 |
5 | Lunsumio® | Roche | Approved | 2L+ Follicular Lymphoma | Hematological Malignancies | 2022 |
Phase III | Relapsed or Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma | Hematological Malignancies | 2028 | |||
Follicular Lymphoma After At least One Line of Systemic Therapy | Hematological Malignancies | 2031 | ||||
6 | Nanozora® | Taisho Pharmaceutical | Approved | Rheumatoid Arthritis | Autoimmune Disorders | 2022 |
7 | Rybrevant™ | Janssen Research & Development | Approved | Locally advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations | Solid Tumors | 2021 |
8 | Tecvyali™ | Janssen Research & Development | Approved | Relapsed or refractory Multiple Myeloma | Hematological Malignancies | 2022 |
9 | Vabysmo™ | Roche | Approved | Diabetic Macular Edema | Ophthalmic Disorders | 2022 |
Neovascular Age Related Macular Degeneration | Ophthalmic Disorders | 2022 |
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.

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. No | Drug Candidate | Drug Developer | Phase of Development | Target Indication | Therapeutic Area | Approval Year |
1 | AK112 | Akeso Biopharma | Phase III | 1-L PD-L1(+) Non-small Cell Lung Cancer | Solid Tumors | 2027 |
EGFR-TKI Resistant Non-small Cell Lung Cancer | Solid Tumors | 2027 | ||||
2 | ALXN1720 | Alexion | Phase III | Generalized Myasthenia Gravis | Autoimmune Disorders | 2029 |
3 | GEN3013 | Genmab | Phase III | Relapsed or Refractory Follicular Lymphoma | Hematological Malignancies | 2032 |
Newly Diagnosed Diffuse Large B-Cell Lymphoma | Hematological Malignancies | 2032 | ||||
4 | Glofitamab | Roche | Phase III | 1-L+ Relapsed or Refractory Diffuse Large B-Cell Lymphoma | Hematological Malignancies | 2027 |
5 | LP000 | Linton Pharm | Phase III | 3-L Gastric Cancer with Peritoneal Metastasis | Solid Tumors | 2025 |
6 | M7824 | Merck | Phase III | 1-L Non-small Cell Lung Cancer with High PD-L1-tumor Expression | Solid Tumors | 2025 |
7 | OMP 305B83 | Mereo BioPharma | Phase III | Platinum Resistant Ovarian Cancer | Solid Tumors | 2026 |
8 | PF-06863135 | Pfizer | Phase III | Relapsed/Refractory Multiple Myeloma | Hematological Malignancies | 2027 |
Newly Diagnosed Multiple Myeloma | Hematological Malignancies | 2030 | ||||
Newly Diagnosed Multiple Myeloma After Transplant | Hematological Malignancies | 2030 | ||||
9 | ZW25 | Zymeworks | Phase III | HER2-positive Gastric and Esophageal Cancers | Solid Tumors | 2027 |
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.