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New Drug Approvals and Their Contract Manufacture: 2025 Edition

Publisher GlobalData
Published Jul 14, 2025
Length 75 Pages
SKU # GBDT20265870

Description

New Drug Approvals and Their Contract Manufacture: 2025 Edition

Summary

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 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

Table of Contents

75 Pages
  • About GlobalData
  • Executive Summary
    • Pharma companies
    • Helix Biotech
    • Minaris Advanced Therapies
    • National Resilience
    • Innovative drug approvals
    • Dose outsourcing of drug approvals
    • Figure 2: Top drug approval trends, 2024
    • Drug approval trends, 2024
    • Introduction
    • FDA NDA approvals overview
    • Sponsor trends
    • Special product categories
    • CMO performance
    • Outsourced API approvals
    • ANDA approvals
    • What it means
    • Figure 25: The contract manufacturing value chain
    • Companies with 2024 CBER approvals
    • FDA and EMA drug filings rejected or withdrawn in 2024
    • 2024 outsourced dose approvals
    • CMOs receiving dose contracts for FDA approvals in 2015–24
    • 2024 outsourced API approvals
    • CMOs receiving dose contracts for FDA approvals in 2024
    • Small, micro, and nano cap sponsors’ dose outsourcing propensity for NMEs, 2015–24
    • Small, micro, and nano cap sponsors’ dose outsourcing propensity for non-NMEs, 2015–24
    • Mid cap sponsors’ dose outsourcing propensity, 2015–24
    • Large cap dose outsourcing propensity, 2015–24
    • Mega cap dose outsourcing propensity, 2015–24
    • Private company dose outsourcing propensity, 2015–24
    • Methodology
    • Bibliography
    • Further reading
  • About the Authors
  • Contact Us

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