GlobalData Plc: FDA Approved 122 New Drug Applications and Biologics License Applications in 2021

The total number of innovative NME cell/gene therapy and non-NME NDAs has risen since 2020

LONDON, May 19, 2022 (GLOBE NEWSWIRE) — 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. 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.

The New Drug Approvals and Their Contract Manufacture – 2022 Edition report offered by GlobalData Plc analyzes 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.

Key Findings

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.

For more key findings on new drug approvals and contract manufacture, download a free report sample

FDA, NDA, and BLA Approvals Overview

• NME Small Molecule
• NME Cell/Gene Therapy
• NME Biologic
• Non-NME NDA Approvals

The overall number of approved biologic NMEs has been increasing, with 2021 seeing the highest number of advanced therapy medicinal product (ATMP) and traditional biologic NME approvals over the last 10 years, with approval numbers continuing to recover from a drop in 2019. Pharma companies are drawn to the development of biologics over small molecules, given biologics’ high profitability and additional exclusivity protection.

For more insights on FDA, NDA, and BLA approvals, download a free report sample

FDA NDA Approvals by Sponsor Type

• Small-Cap Companies
• Mega-Cap Companies
• Mid-Cap Companies
• Large-Cap Companies
• 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.

For more insights on sponsor types in new drug approvals and contract manufacture, download a free report sample

Leading CMOs and Pharma Companies Making a Mark in Dose Manufacturing

• Celgene Corp
• Enzyvant Therapeutics Inc
• Juno Therapeutics Inc
• Mallinckrodt LLC
• Merck Sharp & Dohme Corp
• Pfizer Inc
• ProMetic BioTherapeutics Inc
• VBI Vaccines Inc
• Almac
• Catalent

To know more about leading companies in new drug approvals and contract manufacture, download a free report sample

New Drug Approvals and Contract Manufacture Market Overview

New Drug Approvals and Contract Manufacture Market Report 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.

FAQs

What are the key FDA, NDA, and BLA approvals in the new drug approvals and contract manufacture market?

The key FDA, NDA, and BLA approvals are NME small molecule, NME cell/gene therapy, NME biologic, and non-NME NDA approvals.

What are the key sponsor types in the new drug approvals and contract manufacturing market?

The key sponsor types for FDA NDA approvals are small-cap companies, mega-cap companies, mid-cap companies, large-cap companies, and private companies.

Which are the key CMOs and pharma companies 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, and Catalent.

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About us

GlobalData is a leading provider of data, analytics, and insights on the world’s largest industries. In an increasingly fast-moving, complex, and uncertain world, it has never been harder for organizations and decision makers to predict and navigate the future. This is why GlobalData’s mission is to help our clients to decode the future and profit from faster, more informed decisions. As a leading information services company, thousands of clients rely on GlobalData for trusted, timely, and actionable intelligence. Our solutions are designed to provide a daily edge to professionals within corporations, financial institutions, professional services, and government agencies.

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