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Related Concept Videos

Antibody Structure01:10

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Antibodies, also known as immunoglobulins (Ig), are essential players of the adaptive immune system. These antigen-binding proteins are produced by B cells and make up 20 percent of the total blood plasma by weight. In mammals, antibodies fall into five different classes, which each elicits a different biological response upon antigen binding.
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Antibodies, or immunoglobulins, are critical players in the immune system's arsenal against invading pathogens. Produced by B cells and plasma cells, their primary role is to detect and bind to specific antigens, molecules found on the surface of pathogens like bacteria or viruses. Beyond antigen recognition, antibodies perform several vital functions that contribute to immune defense.
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Antibodies, also known as immunoglobulins, are produced by B cells in response to foreign substances, such as bacteria and viruses. These proteins are critical for recognizing and neutralizing these substances, protecting the body from potential harm.
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Antibodies to watch in 2026.

Silvia Crescioli1, Hélène Kaplon2, Alicia Chenoweth3

  • 1Independent Consultant, Business Intelligence, London, UK.

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|January 21, 2026
PubMed
Summary

The antibody therapeutics pipeline has expanded significantly, with 19 new drugs approved in 2025 and 26 under review. Development timelines average six years, with faster approvals for China-originated products.

Keywords:
Antibody therapeuticEuropean Medicines AgencyFood and Drug AdministrationNational Medical Products Administrationantibody-drug conjugatebispecificcancerimmune-mediated disordersmultispecific

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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.