Summary
This report is the 10th edition of our long running analysis of the CMO Industry, using NDA approvals as the primary indicator of performance. CMO Scorecard is critical for benchmarking the performance of the CMO industry and the relative performance of major CMOs.
Scope
This report is required reading for -
- - CMO executives who must have deep understanding of the injectables marketplace 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 approvals and the levels of outsourcing associated with NDA sub segments
- - Detailed view of CDMO performance by number of approvals and an assessment of their sponsors market caps from GlobalData's Contract Service Providers database
- - Outsourcing propensity for NMEs, different dosage forms and by sponsor company cap have all been assessed.
- - Analysis of NME special products approvals such as those with Orphan, Breakthrough or Fast Track designations and assessment of outsourcing
Table of content
1 Table of Contents
2 List of Tables
3 List of Figures
4 Executive Summary
5 Introduction
6 FDA NDA Approvals Overview
7 US vs. EU Approval Performance
8 FDA: Outsourced Dose Manufacture
9 Special Product Categories
10 Outsourcing by Company Market Cap
11 CMO Performance
11.1 Catalent
11.2 Patheon
11.3 Other Prominent CMOs
12 Outsourced API Approvals
13 What It Means
13.1 FDA Approvals Have Fallen but Are Still Strong Compared to Historical Standards
13.2 Drivers and Barriers for Outsourcing
13.2.1 Niche Technology
13.2.2 Small Volumes, Special Designations
13.2.3 Sponsor Market Cap Relationships to Outsourcing
14 Notes on Methodology
15 Appendix
15.1 Appendix Tables
15.2 Bibliography
15.3 Primary Research - Key Opinion Leaders in this Report
15.4 About the Authors
15.5 Contact Us
15.6 Disclaimer
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