New Drug Approvals and Their Contract Manufacture – 2022 Edition
In 2021, the FDA approved 122 New Drug Applications (NDAs) and Biologics License Applications (BLAs), including new molecular entities (NMEs), biologics approved as BLAs through the Center for Biologics Evaluation and Research (CBER), and new formulations of older drugs. The overall number of approvals is like 2020; however, the total number of innovative NME cell/gene therapy and non-NME NDAs has risen since 2020. There were four NME cell/gene therapy approvals in 2021, the highest over the last decade. These include two cell therapies and two gene-modified cell therapies.
NDA approvals were high in 2021 for small-cap and mega-cap companies compared to historic standards. This trend is potentially advantageous to CMOs, given that historically their clients are more likely to be smaller companies that are unable to invest in their facilities or enhance their capabilities. For small-cap company sponsors, the number of NDAs is the second-highest recorded over the last decade, with the highest occurring in 2018.
New drug approvals and their contract manufacture 2022 edition analyze the performance of the pharmaceutical CMO industry, using NDA and BLA approvals by the FDA and new active substance (NAS) approvals by the European Medicines Agency’s (EMA’s) central pathway as the primary indicators of performance. FDA NDA and BLA approvals include NMEs, as well as reformulations of previously approved APIs. The EMA approvals include all NAS. NAS are chemical substances not previously approved in the EU, or derivatives of previously approved APIs that differ significantly from the previously approved product in safety or efficacy.
What are the FDA NDA and BLA approval overviews in the new drug approvals and contract manufacture report?
The key FDA NDA and BLA approvals are NME small molecule, NME cell/gene therapy, NME biologic, and non-NME NDA approvals.
New drug approvals and contract manufacture, by FDA NDA and BLA approvals
For more insights on FDA NDA and BLA approvals, download a free report sample
What are the key sponsor types in the new drug approvals and contract manufacture report?
The key sponsor types for NDA approvals are small-cap companies, mega-cap companies, mid-cap companies, large-cap companies, and private companies.
NDA approvals were relatively high in 2021 for small-cap companies and mega-cap companies. However, the number of approved products sponsored by large and private companies decreased since 2020, varying markedly in the case of large cap, which had its lowest number of associated approvals recorded in the last decade. Mid-cap companies’ count of drugs increased very slightly from 2021 but they still tend to account for the fewest approvals as a group.
New drug approvals and contract manufacture, by sponsor types
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Which are the key CMOs and pharma companies that are making a mark in dose manufacturing?
Some of the key CMOs and pharma companies that are making a mark in dose manufacturing are Celgene Corp, Enzyvant Therapeutics Inc, Juno Therapeutics Inc, Mallinckrodt LLC, Merck Sharp & Dohme Corp, Pfizer Inc, ProMetic BioTherapeutics Inc, VBI Vaccines Inc, Almac, Catalent, PCI Pharma Services, Thermo Fisher Scientific (owner of Patheon), and Vetter.
Market report scope
| Key FDA NDA and BLA approvals | NME Small Molecule, NME Cell/Gene Therapy, NME Biologic, and Non-NME NDA |
| Key sponsor types | Small Cap Companies, Mega Cap Companies, Mid Cap Companies, Large Cap Companies, and Private Companies |
| Key CMOs and pharma companies | Celgene Corp, Enzyvant Therapeutics Inc, Juno Therapeutics Inc, Mallinckrodt LLC, Merck Sharp & Dohme Corp, Pfizer Inc, ProMetic BioTherapeutics Inc, VBI Vaccines Inc, Almac, Catalent, PCI Pharma Services, Thermo Fisher Scientific (owner of Patheon), and Vetter |
Scope
This 82-page report gives important, expert insight you won’t find in any other source. 11 tables and 30 figures throughout the report illustrate major points and trends. This report is required reading for:
- CMO executives must have a deep understanding of the injectables marketplace to make strategic planning and investment decisions.
- Sourcing and procurement executives must understand crucial components of the supply base to make decisions about supplier selection and management.
- Private equity investors need a deeper understanding of the market to identify and value potential investment targets.
Reasons to Buy
- Overview of NDA drug approvals and the levels of outsourcing associated with NDA sub-segments.
- Detailed view of CDMO performance by the number of approvals and an assessment of their sponsors market caps from GlobalData’s Contract Service Providers database.
- Outsourcing propensity for NMEs, different dosage forms and sponsor company cap have all been assessed.
- Analysis of NME special products approvals such as those with Orphan, Breakthrough, or Fast Track designations and assessment of outsourcing.
Key Players
Table of Contents
List of Tables
List of Figures
Frequently Asked Questions
The key FDA NDA and BLA approvals are NME small molecule, NME cell/gene therapy, NME biologic, and non-NME NDA approvals.
The key sponsor types for NDA approvals are small-cap companies, mega-cap companies, mid-cap companies, large-cap companies, and private companies.
Some of the key CMOs and pharma companies that are making a mark in dose manufacturing are Celgene Corp, Enzyvant Therapeutics Inc, Juno Therapeutics Inc, Mallinckrodt LLC, Merck Sharp & Dohme Corp, Pfizer Inc, ProMetic BioTherapeutics Inc, VBI Vaccines Inc, Almac, Catalent, PCI Pharma Services, Thermo Fisher Scientific (owner of Patheon), and Vetter.
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