This report is the 15th 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 86-page report gives important, expert insight you won’t find in any other source. 17 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.
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 the analyst'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
Table of Contents
- About the Analyst
- Executive Summary
- Players
- Technology Briefing
- Innovative drug approvals
- Dose outsourcing of drug approvals
- Trends
- Industry Analysis
- Introduction
- FDA NDA approvals overview
- Cell and gene therapies
- First-in-class
- First-time approvals
- Sponsor trends
- Dosage form outsourcing
- Special product categories
- Accelerated approvals
- Orphan drug designation
- Fast track designation
- Breakthrough therapy designation
- Containment
- CMO performance
- Dosage form
- Outsourced API approvals
- ANDA approvals
- What it means
- Biosimilar approvals hit record high
- Increased outsourcing of special product categories
- High levels of innovation in 2024’s approvals
- Trump’s tariffs and the Biosecure Act effect on trade with US
- FDA hit by DOGE layoffs
- Biotech investor confidence in 2025
- A few large CMOs gain majority of dose contracts
- Value Chain
- Companies
- Appendix
- Methodology
- Bibliography
- Further reading
- About the Authors
- Contact the Publisher
Table 1: Drug approval trends, 2024
Table 2: Outsourced NDA approvals by dosage form
Table 3: Dose outsourcing relationships by sponsor market cap and FDA approval type, 2019-24
Table 4: CMOs with API contracts for NMEs approved in 2024
Table 5: Companies with 2024 CBER approvals
Table 6: FDA and EMA drug filings rejected or withdrawn in 2024
Table 7: 2024 outsourced dose approvals
Table 8: CMOs receiving dose contracts for FDA approvals in 2015-24
Table 9: 2024 outsourced API approvals
Table 10: CMOs receiving dose contracts for FDA approvals in 2024
Table 11: Small, micro, and nano cap sponsors’ dose outsourcing propensity for NMEs, 2015-24
Table 12: Small, micro, and nano cap sponsors’ dose outsourcing propensity for non-NMEs, 2015-24
Table 13: Mid cap sponsors’ dose outsourcing propensity, 2015-24
Table 14: Large cap dose outsourcing propensity, 2015-24
Table 15: Mega cap dose outsourcing propensity, 2015-24
Table 16: Private company dose outsourcing propensity, 2015-24
Table 17: Further reading
List of Figures
Figure 1: Leading players for US new drug approvals and their manufacturing, 2024
Figure 2: Top drug approval trends, 2024
Figure 3: FDA NDA and BLA approvals, 2015-24
Figure 4: FDA biologic NME approvals, 2015-24
Figure 5: FDA NDA approvals by sponsor type, 2015-24
Figure 6: Share of FDA NDA approvals outsourced, 2015-24
Figure 7: FDA NDA approvals outsourced, 2015-24
Figure 8: Dose outsourcing of small molecule and biologic NMEs, 2015-24
Figure 9: Dose outsourcing of FDA NME approvals by sponsor market cap
Figure 10: Dose outsourcing of FDA non-NME approvals by sponsor market cap
Figure 11: Dose outsourcing of accelerated approval NMEs, 2015-24
Figure 12: Dose outsourcing of FDA orphan NMEs, 2015-24
Figure 13: Dose outsourcing of FDA fast track NMEs, 2015-24
Figure 14: Dose outsourcing of breakthrough therapy designation NMEs, 2015-24
Figure 15: NME approvals requiring special handling, 2015-24
Figure 16: Breakdown in composition of dose-outsourced NMEs, by sponsor market cap, 2015-24
Figure 17: Breakdown in composition of dose-outsourced non-NMEs NDAs, by sponsor market cap, 2015-24
Figure 18: CMO market share of parenteral NME approvals, 2015-24
Figure 19: CMO market share of parenteral non-NME NDA and biosimilar approvals, 2015-24
Figure 20: CMO market share of solid dose NME approvals, 2015-24
Figure 21: CMO market share of solid dose non-NME NDA approvals, 2015-24
Figure 22: API outsourcing of small molecule and biologic NMEs, 2015-24
Figure 23: ANDA approvals by dosage form, 2015-24
Figure 24: ANDA approvals by route of administration, 2015-24
Figure 25: The contract manufacturing value chain
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Fresenius Kabi USA LLC
- Sandoz Inc
- Alvotech SA
- Madrigal Pharmaceuticals
- Verona Pharma Inc
- ImmunityBio
- Geron Corporation
- Iovance Biotherapeutics Inc
- F. Hoffmann-La Roche Ltd
- Samsung Bioepis Co Ltd
- Thermo Fisher Scientific Inc
- Vetter Pharma
- Almac Group Ltd
- Catalent Inc
- Helix Biotech
- Minaris Advanced Therapies LLC
- National Resilience
- WuXi Advanced Therapies Inc
- The National Institute of Allergy and Infectious Diseases (NIAID)
- Stanford Medicine
- Garvan Institute of Medical Research
- Altaris Capital Partners LLC
- Mubadala Investment Company PJSC
