New Drug Approvals and Their Contract Manufacture: 2026 Edition

Description

List of Tables

This report is the 16th 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 the US onshoring push is creating billion-dollar manufacturing investments.

Scope

This 75-page report gives important, expert insight you won't find in any other source. 18 tables and 24 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.

Product Code: GDPS0053MAR

1 Executive Summary

2 Players

2.1 Pharma leaders
- 2.1.1 Johnson & Johnson
2.2 Pharma disruptors
- 2.2.1 Soleno Therapeutics
2.3 Contract manufacturing organization leaders
- 2.3.1 Patheon
2.4 Contract manufacturing organization disruptors
- 2.4.1 Halo Pharma

3 Technology Briefing

3.1 Innovative drug approvals
3.2 Dose outsourcing of drug approvals

4 Trends

5 Industry Analysis

5.1 Introduction
5.2 FDA New Drug Application approvals overview
- 5.2.1 Cell and gene therapies
- 5.2.2 First-in-class drugs
- 5.2.3 First-time approvals
5.3 Sponsor trends
- 5.3.1 FDA outsourced dose manufacture
- 5.3.2 Dosage form outsourcing
5.4 Special product categories
- 5.4.1 Accelerated approval
- 5.4.2 Orphan drug designation
- 5.4.3 Fast track designation
- 5.4.4 Breakthrough therapy designation
- 5.4.5 Containment
5.5 Contract manufacturing organization performance
- 5.5.1 Dosage form
5.6 Outsourced active pharmaceutical ingredient approvals
5.7 Abbreviated new drug application approvals
5.8 What it means
- 5.8.1 US onshoring push creates billion-dollar manufacturing investments
- 5.8.2 Biosimilars continue their long-term growth trajectory
- 5.8.3 US domestic needs filled by European manufacturers
- 5.8.4 The glucagon-like peptide-1 era approaches its pill phase
- 5.8.5 Volatility overshadows success in cell and gene therapy
- 5.8.6 Pharma and contract manufacturing organizations invest for future antibody-drug conjugate manufacturing
- 5.8.7 Most Favored Nation and investment negotiations interlock

6 Value Chain

7 Companies

8 Appendix

8.1 Methodology
8.2 Bibliography
8.3 Further reading
8.4 About the Authors

Product Code: GDPS0053MAR

List of Table

List of Tables

Table 1: Drug approval trends, 2025
Table 2: FDA biologic NME approvals, 2016-25
Table 3: Outsourced NDA approvals by dosage form
Table 4: Dose outsourcing relationships by sponsor market cap and FDA approval type, 2020-25
Table 5: CMOs with API contracts for NMEs approved in 2025
Table 6: Companies with 2025 CBER approvals
Table 7: FDA and EMA drug filings rejected or withdrawn in 2025
Table 8: Outsourced dose approvals, 2025
Table 9: CMOs receiving dose contracts for FDA approvals in 2016-25
Table 10: 2025 outsourced API approvals
Table 11: CMOs receiving dose contracts for FDA approvals in 2025
Table 12: Small, micro-, and nano-cap sponsors' dose outsourcing propensity for NMEs, 2016-25
Table 13: Small, micro-, and nano-cap sponsors' dose outsourcing propensity for non-NMEs, 2016-25
Table 14: Mid-cap sponsors' dose outsourcing propensity, 2016-25
Table 15: Large cap sponsors' dose outsourcing propensity, 2016-25
Table 16: Mega cap sponsors' dose outsourcing propensity, 2016-25
Table 17: Private companies' dose outsourcing propensity, 2016-25
Table 18: Further reading

List of Figure

List of Figures

Figure 1: Leading players for US new drug approvals and their manufacturing, 2025
Figure 2: Top drug approval trends, 2025
Figure 3: FDA NDA and BLA approvals, 2016-25
Figure 4: FDA NDA approvals by sponsor type, 2016-25
Figure 5: Share of outsourced FDA NDA approvals, 2016-25
Figure 6: Outsourced FDA NDA approvals, 2016-25
Figure 7: Dose outsourcing of small molecule and biologic NMEs, 2016-25
Figure 8: Dose outsourcing of FDA NME approvals by sponsor market cap
Figure 9: Dose outsourcing of FDA non-NME approvals by sponsor market cap
Figure 10: Dose outsourcing of accelerated approval NMEs, 2016-25
Figure 11: Dose outsourcing of FDA orphan NMEs, 2016-25
Figure 12: Dose outsourcing of FDA fast track NMEs, 2016-25
Figure 13: Dose outsourcing of FDA breakthrough therapy designation NMEs, 2016-25
Figure 14: NME approvals requiring special handling, 2016-25
Figure 15: Breakdown in composition of dose-outsourced NMEs, by sponsor market cap, 2016-25
Figure 16: Breakdown in composition of dose-outsourced non-NMEs, by sponsor market cap, 2016-25
Figure 17: CMO market share of parenteral NME approvals, 2016-25
Figure 18: CMO market share of parenteral non-NME approvals, 2016-25
Figure 19: CMO market share of solid-dose NME approvals, 2016-25
Figure 20: CMO market share of solid dose non-NME approvals, 2016-25
Figure 21: API outsourcing of small molecule and biologic NMEs, 2016-25
Figure 22: ANDA approvals by dosage form, 2016-25
Figure 23: ANDA approvals by route of administration, 2016-25
Figure 24: The contract manufacturing value chain

New Drug Approvals and Their Contract Manufacture: 2026 Edition

Description

Table of Contents

List of Tables

Scope

Reasons to Buy

Table of Contents

Table of Contents

1 Executive Summary

2 Players

3 Technology Briefing

4 Trends

5 Industry Analysis

6 Value Chain

7 Companies

8 Appendix

List of Table

List of Tables

List of Figure

List of Figures