CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance

CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2020 Edition

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 the publisher'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

1 Table of Contents2 List of Tables3 List of Figures4 Executive Summary5 Introduction6 FDA NDA Approvals Overview7 US vs. EU Approval Performance8 FDA: Outsourced Dose Manufacture9 Special Product Categories10 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 the Publisher
15.6 Disclaimer

List of Tables

Table 1: Outsourced NDA Approvals by Dosage Form
Table 2: Dose Outsourcing Relationships by Sponsor Market Cap and FDA Approval Type, 2014-2019
Table 3: API CMOs Obtaining Contracts for NME Approvals in 2019
Table 4: 2019 CBER Approvals Included in the Analysis
Table 5: 2019 Outsourced Dose Approvals
Table 6: Dose CMOs Receiving Contracts for FDA Approvals in 2010-2019
Table 7: API CMOs Receiving Approvals in 2019
Table 8: Dose CMOs’ Manufacturing NDAs Approved in 2019
Table 9: MHRA Approvals in 2019

List of Figures

Figure 1: FDA NDA and BLA Approvals, 2010-2019
Figure 2: FDA NDA Approvals by Sponsor Type, 2010-2019
Figure 3: EMA Approvals, 2012-2019
Figure 4: Share of FDA NDA Approvals Outsourced 2010-2019
Figure 5: NDA Approvals Outsourced 2010-2019
Figure 6: Dose Outsourcing of Small Molecule and Biologic NMEs, 2010-2019
Figure 7: Dose Outsourcing of FDA NME Approvals by Sponsor Market Cap
Figure 8: Dose Outsourcing of Non-NME NDA Approvals by Sponsor Market Cap
Figure 9: Outsourcing of FDA Orphan NMEs, 2010-2019
Figure 10: Dose Outsourcing of FDA Fast Track NMEs, 2011-2019
Figure 11: Dose Outsourcing of Breakthrough Therapy Designation NMEs, 2013-2019
Figure 12: NMEs Requiring Special Handling, 2010-2019
Figure 13: FDA Approval and Outsourcing of NMEs Utilizing Solubility Enhancement, 2011-2019
Figure 14: Small Cap Dose Outsourcing Propensity, 2010-2019
Figure 15: Mid Cap Outsourcing Propensity, 2010-2019
Figure 16: Large Cap Outsourcing Propensity, 2010-2019
Figure 17: Mega Cap Outsourcing Propensity, 2010-2019
Figure 18: Private Company Dose Outsourcing Propensity, 2010-2019
Figure 19: Breakdown in Composition of Dose-Outsourced NMEs, by Sponsor Market Cap, 2010-2019
Figure 20: Breakdown in Composition of Outsourced Non-NME NDAs, by Sponsor Market Cap, 2010-2019
Figure 21: CMO Market Share of Parenteral NME Approvals, 2010-2019
Figure 22: CMO Market Share of Parenteral Non-NME NDA Approvals, 2010-2019
Figure 23: CMO Market Share of Solid NME Approvals, 2010-2019
Figure 24: CMO Market Share of Solid Non-NME NDA Approvals, 2010-2019
Figure 25: API Outsourcing of Small Molecule and Biologic NMEs, 2010-2019
Figure 26: ANDA Approvals 2010-2019