New Drug Approvals and Their Contract Manufacture: 2026 Edition

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 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.