Antibodies to watch in 2026

Area of Science:

• Biotechnology
• Pharmaceutical Sciences
• Oncology

Background:

• The 'Antibodies to Watch' series tracks antibody therapeutics in late-stage development.
• The pipeline has grown from 26 to over 200 antibody therapeutics since 2010.
• Many antibody therapeutics have transitioned to regulatory review, gained approval, or been terminated.

Purpose of the Study:

• To recap 2025 marketing approvals for antibody therapeutics.
• To discuss antibody therapeutics currently under regulatory review.
• To predict future regulatory submissions and analyze global approval trends and development timelines.

Main Methods:

• Recap of first marketing approvals in 2025.
• Discussion of molecules in current regulatory review.
• Prediction of molecules transitioning to regulatory review by end of 2026.
• Analysis of global approval trends by country of origin.
• Benchmarking of clinical development and regulatory review times.

Main Results:

• 19 antibody therapeutics received first marketing approval in 2025.
• 26 antibody therapeutics are currently under regulatory review.
• The late-stage pipeline includes 209 molecules, with a trend towards non-cancer indications and novel formats like antibody-drug conjugates.
• Notable increases in total first approvals and first approvals in China were observed.
• Average development and approval time is approximately six years, shorter for China-originated products.

Conclusions:

• The antibody therapeutics landscape continues to expand with diverse formats and indications.
• Global development and regulatory review processes show regional variations, particularly for China-originated products.
• Continued monitoring of the antibody therapeutics pipeline is essential for understanding industry trends and therapeutic advancements.