Antibodies to watch in 2024
Silvia Crescioli1, Hélène Kaplon2, Alicia Chenoweth3
1Business Intelligence Research, The Antibody Society, Inc., Framingham, MA, US.
Mabs
|January 5, 2024
Summary
The biopharmaceutical industry shows robust antibody therapeutic development, with 16 new monoclonal antibody therapeutics approved in 2023. Success rates range from 14-32%, higher for non-cancer indications.
Area of Science:
- Biotechnology
- Pharmacology
- Immunotherapy
Background:
- The 'Antibodies to Watch' series annually tracks monoclonal antibody therapeutics.
- Focus on late-stage development, regulatory review, and recent first approvals.
Purpose of the Study:
- Summarize 16 antibody therapeutics approved in 2023.
- Review 26 candidates under marketing application review.
- Forecast 23 investigational therapeutics for 2024 regulatory review.
- Analyze clinical phase transition and approval success rates.
Main Methods:
- Data compilation from company disclosures and regulatory information.
- Analysis of approval success rates for antibody therapeutics.
- Categorization of antibody types including bispecific antibodies and antibody-drug conjugates.
Main Results:
- Sixteen antibody therapeutics received first approval in 2023.
- Nearly 50 product candidates are in late-stage development or review.
- Approval success rates for antibody therapeutics range from 14-32%.
- Non-cancer indications show higher approval success rates.
Conclusions:
- Antibody therapeutic development in the biopharmaceutical industry is robust and increasingly successful.
- Innovative formats like bispecific antibodies and antibody-drug conjugates are prominent.
- Approval success rates provide crucial insights for industry resource allocation.
Keywords:
Antibody therapeuticsCOVID-19European Medicines AgencyFood and Drug AdministrationSARS-CoV-2cancerimmune-mediated disordersMore Related Videos
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