New Drug Approvals and Their Contract Manufacture - 2024 Edition
Summary
This report is the 14th edition of our 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 how inflation and increasing global conflict has impacted pharma manufacturers.
Scope
This 87-page report gives important, expert insight you won’t find in any other source. 18 tables and 25 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.
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
- About GlobalData
- Executive Summary
- Players
- Table Figure 1: Leading players for US new drug approvals and their manufacturing, 2023
- Technology Briefing
- Innovative drug approvals
- Dose outsourcing of drug approvals
- Trends
- Table Figure 2: Top drug approval trends, 2023
- Table Drug approval trends, 2023
- Industry Analysis
- Introduction
- FDA NDA approvals overview
- Table Figure 3: FDA NDA and BLA approvals, 2014-23
- Table Figure 4: FDA biologic NME approvals, 2014-23
- Cell and gene therapies
- First-in-class
- First-time approvals
- Predicted drug events for 2024
- Table Predicted drug events in 2024
- Sponsor trends
- Table Figure 5: FDA NDA approvals by sponsor type, 2014-23
- FDA: outsourced dose manufacture
- Table Figure 6: Share of FDA NDA approvals outsourced, 2014-23
- Table Figure 7: FDA NDA approvals outsourced, 2014-23
- Table Figure 8: Dose outsourcing of small molecule and biologic NMEs, 2014-23
- Dosage form outsourcing
- Table Outsourced NDA approvals by dosage form
- Table Figure 9: Dose outsourcing of FDA NME approvals by sponsor market cap
- Table Dose outsourcing relationships by sponsor market cap and FDA approval type, 2018-23
- Table Figure 10: Dose outsourcing of FDA non-NME approvals by sponsor market cap
- Special product categories
- Accelerated approvals
- Table Figure 11: Dose outsourcing of accelerated approval NMEs, 2014-23
- Orphan drug designation
- Table Figure 12: Dose outsourcing of FDA orphan NMEs, 2014-23
- Fast track designation
- Table Figure 13: Dose outsourcing of FDA fast track NMEs, 2014-23
- Breakthrough therapy designation
- Table Figure 14: Dose outsourcing of breakthrough therapy designation NMEs, 2014-23
- Containment
- Table Figure 15: NME approvals requiring special handling, 2014-23
- Accelerated approvals
- CMO performance
- Table Figure 16: Breakdown in composition of dose-outsourced NMEs, by sponsor market cap, 2014-23
- Table Figure 17: Breakdown in composition of dose-outsourced non-NMEs NDAs, by sponsor market cap, 2014-23
- Dosage form
- Table Figure 18: CMO market share of parenteral NME approvals, 2014-23
- Table Figure 19: CMO market share of parenteral non-NME NDA and biosimilar approvals, 2014-23
- Table Figure 20: CMO market share of solid dose NME approvals, 2014-23
- Table Figure 21: CMO market share of solid dose non-NME NDA approvals, 2014-23
- Outsourced API approvals
- Table Figure 22: API outsourcing of small molecule and biologic NMEs, 2014-23
- Table CMOs with API contracts for NMEs approved in 2023
- ANDA approvals
- Table Figure 23: ANDA approvals by dosage form, 2014-23
- Table Figure 24: ANDA approvals by route of administration, 2014-23
- What it means
- FDA approvals hit a record high, recovering from a slump in 2022
- Opportunities for injectable manufacturers
- Catalent acquisition shakes up both the pharma and CMO landscape
- Record ATMP approvals and gene therapy firsts
- A few large CMOs gain majority of dose contracts
- Increasing global conflict
- The future of manufacturing: AI, ESG, drug shortages, and personalized medicines
- Value Chain
- Table Figure 25: The contract manufacturing value chain
- Companies
- Table Companies with 2023 CBER approvals
- Table FDA and EMA drug filings rejected or withdrawn in 2023
- Table 2023 outsourced dose approvals
- Table CMOs receiving dose contracts for FDA approvals in 2014-23
- Table 2023 outsourced API approvals
- Table CMOs receiving dose contracts for FDA approvals in 2023
- Table Small, micro, and nano cap sponsors' dose outsourcing propensity for NMEs, 2014-23
- Table Small, micro, and nano cap sponsors' dose outsourcing propensity for non-NMEs, 2014-23
- Table Mid cap sponsors' dose outsourcing propensity, 2014-23
- Table Large cap dose outsourcing propensity, 2014-23
- Table Mega cap dose outsourcing propensity, 2014-23
- Table Private company dose outsourcing propensity, 2014-23
- Appendix
- Methodology
- Bibliography
- Primary research - key opinion leaders
- Further reading
- Table Further reading
- About the Authors
- Contact Us
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