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

Market: Pharmaceuticals and Healthcare

Global, 43 pages report, published by GlobalData

Report ThumbnailApril-2018
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 won’t find in any other source. 28 tables and figures throu

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  • 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 1
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  • 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
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  • 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
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