A pipeline analysis of advanced therapy medicinal products

Georgina C Wilkins; Katherine Lanyi; Alexander Inskip; Oladapo J Ogunbayo; Petra Brhlikova; Dawn Craig

doi:10.1016/j.drudis.2023.103549

A pipeline analysis of advanced therapy medicinal products

Drug Discov Today. 2023 May;28(5):103549. doi: 10.1016/j.drudis.2023.103549. Epub 2023 Mar 22.

Authors

Georgina C Wilkins¹, Katherine Lanyi², Alexander Inskip², Oladapo J Ogunbayo², Petra Brhlikova³, Dawn Craig²

Affiliations

¹ NIHR Innovation Observatory at Newcastle University, The Catalyst, 3 Science Square, Newcastle Helix, Newcastle upon Tyne NE4 5TG, UK. Electronic address: Georgie.Wilkins@newcastle.ac.uk.
² NIHR Innovation Observatory at Newcastle University, The Catalyst, 3 Science Square, Newcastle Helix, Newcastle upon Tyne NE4 5TG, UK.
³ Population Health Sciences at Newcastle University, Baddiley-Clark Building, Newcastle upon Tyne NE2 4AX, UK.

PMID: 36963609
DOI: 10.1016/j.drudis.2023.103549

Abstract

Advanced therapy medicinal products (ATMPs) are innovative biological products categorised as either gene, somatic cell, tissue-engineered or combined therapies. As of March 2022, 12 ATMPs are marketed in the EU and UK. We identified 482 unique ATMPs within 616 technology records from the National Institute for Health and Care Research Innovation Observatory database, 4 of which are currently marketed. These 482 ATMPs were identified in 583 clinical trials. Of the 616 records, 57.1% were for gene therapies and 1.6% were for combined therapies. Records covered various indications, including 130 haematological malignancies and 60 genetic disorders. Marketing authorisation intelligence was included in 14% of records.

Keywords: ATMP; Innovative medicinal products; Pipeline analysis.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Biological Products* / therapeutic use
Genetic Therapy
Technology
Tissue Engineering*

Substances

Biological Products