New Drug Approvals and Their Contract Manufacture – 2023 Edition
New Drug Approvals and their Contract Manufacture Report Overview
In 2022, the FDA approved 109 new drug applications (NDAs) and biologics license applications (BLAs). The overall number of approvals is eight lower when compared to 2021. Both small molecule and biologic new molecular entity (NME) approvals declined substantially, causing overall NDA approvals to drop, which meant fewer commercial-scale production contracts for the most innovative products compared to other recent years. Small cap companies’ (market cap $300M–2B) and private companies’ NDA approvals were relatively high in 2022, with 15 and 42 FDA approvals, respectively. In recent years, COVID-19 vaccine drives have allowed economies and societies to safely reopen during the pandemic. However, new challenges such as rising inflation will bring uncertainty to the ongoing global recovery. The pharma industry faces increasing cost pressures, shrinking consumer spending power, staff shortages, and geopolitical tensions.
The new drug approvals and their contract manufacture report is the 13th edition of a long-running analysis of the CMO industry, using the FDA’s NDA approvals as the primary indicator of performance. New Drug Approvals and Their Contract Manufacture (formerly called “CMO Scorecard”) is critical for benchmarking the performance of the contract manufacturing organization (CMO) industry and the relative performance of major CMOs. This year’s edition includes a discussion of Emergency Use Approvals for COVID-19 and how inflation has impacted pharma manufacturers.
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New Drug Approvals and their Contract Manufacture – Key Trends
The main trends that affected FDA drug approvals and their manufacturing in 2022 are classified into three categories: approval types, increased outsourcing, and changing business environment.
Approval types: Record cell/gene therapy approvals continue 2021’s strong performance, huge drop in FDA approvals for NMEs, and biologic NME approvals outnumbered small molecules in 2022 are some of the top approval type trends in new drug approvals and their contract manufacture study.
Increased outsourcing: Domination of dose outsourcing by a few key CMOs, higher biologic NME outsourcing than for small molecule equivalents, and more reliance on nano and micro cap sponsors on CMOs are some of the increased outsourcing trends boosting new drug approvals and their contract manufacture.
Changing business environment: The impact of inflation on pharma manufacturing and shifts in market demand are likely to impact the new drug approvals and their contract manufacture. In addition, although many of the vaccines will still generate blockbuster revenues, sales will decrease, as will the volumes of production. COVID-19 vaccines and treatments will still represent lucrative contracts for CMOs, but with production volumes dwindling and manufacturing relationships becoming well-established, are less profitable than in earlier stages of the pandemic.
For more insights on the new drug approvals and their contract manufacture trends, download a free sample report
New Drug Approvals and their Contract Manufacture Industry Analysis
New Drug Approvals and Their Contract Manufacture – 2023 Edition analyzes the performance of the pharmaceutical CMO industry, using NDA and BLA approvals by the FDA and new active substance (NAS) approvals by the EMA’s central pathway as the primary indicators of performance.
The new drug approvals and their contract manufacture report also covers –
- FDA NDA approvals overview
- US vs. EU approval performance
- FDA EUAs in 2022 for COVID-19
- FDA: outsourced dose manufacture
- Special product categories
- Outsourcing by company market cap
- CMO performance
- Outsourced API approvals
- ANDA approvals
- What it means
For more new drug approvals and their contract manufacture industry analysis, download free sample
New Drug Approvals and their Contract Manufacture – Value Chain Insights
The contract manufacturing industry’s value chain is simplified into three main segments, beginning with API, dose form manufacturing, and packaging. API is the starting point and can have big implications on which dosage forms or packaging are used later in the process. For instance, if there were a greater number of contract service agreements being made for biologic API manufacture, this would have major implications for injectable dose form manufacturing and packaging.
New Drug Approvals and their Contract Manufacture Value Chain Insights
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New Drug Approvals and their Contract Manufacture – Competitive Landscape
The key CMOs and pharma companies making a mark in dose manufacturing are CMOs Almac, Catalent, PCI Pharma Services, Thermo Fisher Scientific (owner of Patheon), and Vetter. Some other companies with Center for Biologics Evaluation and Research approvals are Ferring Pharmaceuticals Inc, CSL Behring LLC, bluebird bio Inc, GlaxoSmithKline LLC, Janssen Biotech Inc, and Moderna Inc.
For more insights on the sponsors and companies in new drug approvals and their contract manufacture report, download a free sample report
New Drug Approvals and their Contract Manufacture Outlook
| Page Count | 94 |
| Key Trends | Approval Types, Increased Outsourcing, and Changing Business Environment |
| Key Value Chain Components | API, Dose formation, and Packaging |
| Key Companies | CMOs Almac, Catalent, PCI Pharma Services, Thermo Fisher Scientific (owner of Patheon), and Vetter |
Scope
This report gives important, expert insight you won’t find in any other source. 11 tables and 34 figures throughout the report illustrate major points and trends. This report is required reading for –
- CMO executives who must have deep understanding of drug approvals and outsourcing to make strategic planning and investment decisions.
- Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.
- Private equity investors that need a deeper understanding of the market to identify and value potential investment targets.
Reasons to Buy
- Overview of NDA drug and vaccine approvals and the levels of outsourcing associated with NDA sub segments
- Detailed view of CDMO performance by number of drug and vaccine approvals
- An assessment of pharmaceutical companies’ propensity to outsource manufacture, by their market caps, based on GlobalData’s Contract Service Providers database
- Outsourcing propensity for New Molecular Entities (NMEs), different dosage forms, and other drug attributes.
- Analysis of NME special product approvals such as those with Accelerated Approval, Orphan, Breakthrough or Fast Track designations and assessment of outsourcing
Key Players
Table of Contents
List of Tables
List of Figures
Frequently Asked Questions
In 2022, the FDA approved 109 new drug applications (NDAs) and biologics license applications (BLAs).
The key trends in new drug approvals and their contract manufacture are approval types, increased outsourcing, and changing business environment.
The key value chain components in the new drug approvals and their contract manufacture industry are API, dose formation, and packaging.
CMOs Almac, Catalent, PCI Pharma Services, Thermo Fisher Scientific (owner of Patheon), and Vetter are some of the leading players in new drug approvals and their contract manufacture sector.
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