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PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2018 Edition

Published By :

N/A

Published Date : Apr 2018

Category :

Pharmaceutical

No. of Pages : 43 Pages

PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2018 Edition

Summary

This report is the 8th 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.

Reasons to buy

This 43-page report gives important, expert insight you wont find in any other source. 28 tables and figures throughout the report illustrate major points and trends. 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.
Table of Contents
1. Executive Summary 5
2. Introduction 6
3. NDA Approvals Overview 6
4. US Versus EU Approval Performance 8
5. Outsourced Dose Manufacture 9
6. Special Product Categories 13
7. Outsourcing by Global Bio/Pharma Companies 17
8. CMO Performance 19
9. Outsourced API Approvals 21
10. What It Means 24
11. Notes on Methodology 25
12. Appendix 27

List of Tables
Table 1: Outsourced NDA Approvals by Dosage Form 12
Table 2: Outsourcing by Sponsor Type and FDA Approval Type 2012-2017 13
Table 3: API CMOs Receiving NME Approvals in 2017 23
Table 4: 2017 CBER Approvals Included in the Analysis 27
Table 5: 2017 Outsourced Dose Approvals 27
Table 6: Dose CMOs Receiving Contracts for FDA Approvals in 2008-2017 31
Table 7: 2017 Outsourced API Approvals 35
Table 8: Dose CMOs Manufacturing NDAs Approved 2017 39
Table 9: MHRA Approvals in 2017 42

List of Figures
Figure 1: NDA Approvals 2008-2017 7
Figure 2: NDA Approvals by Sponsor Type 2008-2017 8
Figure 3: EMA Approvals 2012-2017 9
Figure 4: Share of NDA Approvals Outsourced 2008-2017 10
Figure 5: NDA Approvals Outsourced 2008-2017 10
Figure 6: Dose Outsourcing of Small and Large Molecule APIs 2008-2017 11
Figure 7: Outsourcing of NME Approvals by Sponsor Type 12
Figure 8: Outsourcing of Non-NME NDA Approvals by Sponsor Type 13
Figure 9: Outsourcing of Orphan NMEs 2008-2017 14
Figure 10: Outsourcing of Fast Track NMEs 2011-2017 15
Figure 11: Outsourcing of Breakthrough NMEs 2013-2017 15
Figure 12: NMEs Requiring Special Handling 2008-2017 16
Figure 13: Approval and Outsourcing of NMEs Utilizing Advanced Formulation Technologies 2011-2016 17
Figure 14: Global Bio/Pharma Outsourcing Propensity 2008-2017 18
Figure 15: Trends in Global Bio/Pharma NDA Outsourcing 2008-2017 19
Figure 16: Breakdown in Composition of Outsourced NMEs 2008-2017 by Sponsor Type 20
Figure 17: Breakdown in Composition of Outsourced Non-NME NDAs 2008-2017 by Sponsor Type 21
Figure 18: Outsourcing of API for NME Approvals 2008-2017 22
Figure 19: ANDA Approvals 2008-2017 41

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