Antibodies to watch in 2026.
The antibody therapeutics pipeline is expanding, with numerous products nearing regulatory review and a typical development period of around 6 years.
Where it sits
this study against the rest of the ace-031 (acvr2b-fc) corpusSummary and findings
The article provides an overview of the commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. It highlights the first marketing approvals granted to 19 antibody therapeutics in 2025 and discusses 26 molecules currently in regulatory review. The article also predicts which molecules might transition to regulatory review by the end of 2026.
Abstract
The Antibodies to Watch article series provides annual updates on commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. Since the first article was published in 2010, the late-stage pipeline has grown from 26 antibody therapeutics to over 200, while during the same time numerous molecules in late-stage studies either transitioned to regulatory review and were approved or were terminated. In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab. As antibody therapeutics development is a global enterprise, we also discuss trends in annual first approvals granted to antibody therapeutics in any country since 2010, stratified by the antibody's country of origin, documenting the notable increases in the total number of first approvals and those approved first in China. Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by their therapeutic area, mechanism of action, format, and country of origin. Our data show that the development and approval period were typically ~6 years, but on average this period was shorter for China-originated products.
Background
The article addresses the ongoing developments in antibody therapeutics, a rapidly growing field in biopharmaceuticals. Since 2010, the late-stage pipeline of antibody therapeutics has expanded significantly, reflecting increased interest and investment in this area. Understanding the trends in approvals and regulatory reviews is crucial for stakeholders in the pharmaceutical industry.
Methods
This is a review article that summarizes trends in antibody therapeutic approvals and regulatory reviews. It includes data on the number of approvals, molecules in review, and predictions for future transitions to regulatory review. The article also benchmarks the time required for clinical development and approval.
Results
The article reports that 19 antibody therapeutics received first marketing approvals in 2025, and 26 molecules are currently under regulatory review. It predicts that some of the 209 molecules in the late-stage pipeline will transition to regulatory review by the end of 2026. The development and approval period for these products is typically around 6 years, with a shorter period for products originating from China.
Interpretation
The findings indicate a robust pipeline of antibody therapeutics, with a significant number of products nearing regulatory review. The shorter development and approval period for China-originated products may reflect differences in regulatory processes or efficiencies. However, the article does not provide detailed clinical data or outcomes, limiting the ability to assess the clinical significance of these developments.
Key findings
- 19 antibody therapeutics received first marketing approvals in 2025.
- 26 molecules are currently in regulatory review.
- 209 molecules are in the commercial late-stage pipeline.
- 76% of late-stage pipeline molecules are for non-cancer indications.
- 62% of late-stage pipeline molecules have a conventional format.
- Development and approval period typically ~6 years.
Limitations
- Review article, no primary data.
- Focus on trends, not specific clinical outcomes.
- Predictions may not reflect actual future approvals.
- No detailed analysis of individual therapeutic efficacy.