Report cover image

New Drug Approvals and Their Contract Manufacture - 2024 Edition

Publisher GlobalData
Published Apr 16, 2024
Length 87 Pages
SKU # GBDT18789980

Description

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.
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

87 Pages
  • About GlobalData
  • Executive Summary
    • Figure 1: Leading players for US new drug approvals and their manufacturing, 2023
    • Innovative drug approvals
    • Dose outsourcing of drug approvals
    • Figure 2: Top drug approval trends, 2023
    • Drug approval trends, 2023
    • Introduction
    • FDA NDA approvals overview
    • FDA: outsourced dose manufacture
    • Special product categories
    • CMO performance
    • Outsourced API approvals
    • ANDA approvals
    • What it means
    • Figure 25: The contract manufacturing value chain
    • Companies with 2023 CBER approvals
    • FDA and EMA drug filings rejected or withdrawn in 2023
    • 2023 outsourced dose approvals
    • CMOs receiving dose contracts for FDA approvals in 2014-23
    • 2023 outsourced API approvals
    • CMOs receiving dose contracts for FDA approvals in 2023
    • Small, micro, and nano cap sponsors' dose outsourcing propensity for NMEs, 2014-23
    • Small, micro, and nano cap sponsors' dose outsourcing propensity for non-NMEs, 2014-23
    • Mid cap sponsors' dose outsourcing propensity, 2014-23
    • Large cap dose outsourcing propensity, 2014-23
    • Mega cap dose outsourcing propensity, 2014-23
    • Private company dose outsourcing propensity, 2014-23
    • Methodology
    • Bibliography
    • Primary research - key opinion leaders
    • Further reading
  • About the Authors
  • Contact Us

Pricing

Currency Rates
How Do Licenses Work?

How Do Licenses Work?

The primary function of a report license is to define how many people within a company are authorized to use the purchased report. This is separate to how a report might be delivered. Unless specifically identified otherwise, the purchase option is Single User. Below is a helpful description of that license, along with a sampling of others most commonly offered.

  • This license allows only one user to have access to and to use/read the report. It is not one user at a time or one user group; it is an individual who will be reading and utilizing the report.

  • This license allows for the entire purchasing company to read and use the report. This is the license level that would allow for a report to be placed on an internal company shared drive for access by all employees of that direct company. This license does not extend to parent or sister company use.

  • This license is designed to allow an entire department within a company full access to a report. The departmental license is a great option for companies that have more than one location and the department is spread out all over the country/world

  • This license is for companies that have one location where they want the report to be accessible by all employees within that physical location.

  • This is the most flexible of the licensing options. Some publishers will allow you to get a license for a preset number of people (typically 5). These licenses are ideal for small work groups.

License options are at the discretion of each publisher. As such, not all licenses indicated above are available for every product. If you are uncertain of the best license for your needs or would like a license that is not proactively available, please contact us and we will be happy to assist.

Head shot

Questions or Comments?

Our team has the ability to search within reports to verify it suits your needs. We can also help maximize your budget by finding sections of reports you can purchase.
Chat Now
Contact Us