Antibodies to watch in 2022

Area of Science:

• Biologics and Biopharmaceuticals
• Drug Development
• Immunology

Background:

• The development of antibody therapeutics is a rapidly evolving field.
• 2021 saw significant regulatory activity, particularly for SARS-CoV-2 targeting antibodies.
• Global regulatory landscapes for antibody approvals are diverse.

Purpose of the Study:

• To review key commercial antibody therapeutics development events in 2021.
• To forecast potential developments in antibody therapeutics for 2022.
• To analyze the growth and trends in the late-stage antibody clinical pipeline.

Main Methods:

• Analysis of regulatory approvals (FDA, EMA, and other global agencies) in 2021.
• Tracking of antibody therapeutics in clinical development, focusing on late-stage pipelines.
• Review of commercial events and forecasts for 2022.

Main Results:

• Unprecedented regulatory pace for SARS-CoV-2 antibodies, leading to multiple Emergency Use Authorizations and approvals.
• Eleven novel antibody therapeutics received first approvals in the US or EU in 2021.
• Seven antibody products received their first global approvals outside the US and EU.
• At least 27 novel antibody therapeutics are currently under regulatory review globally.
• The late-stage commercial clinical pipeline, excluding COVID-19 antibodies, grew by over 30% in the past year.
• Marketing applications for at least 22 antibody therapeutics are anticipated by the end of 2022.

Conclusions:

• The field of antibody therapeutics continues to expand rapidly, driven by both infectious diseases and other therapeutic areas.
• Regulatory agencies worldwide are actively reviewing a substantial number of novel antibody candidates.
• Significant growth in the late-stage pipeline suggests a robust future for antibody-based medicines.