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CMOのスコアカード:NDA承認のアウトソーシングとCMOの実績

PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2019 Edition

発行 GlobalData 商品コード 409613
出版日 ページ情報 英文 50 Pages
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CMOのスコアカード:NDA承認のアウトソーシングとCMOの実績 PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2019 Edition
出版日: 2019年03月29日 ページ情報: 英文 50 Pages
概要

当レポートでは、NDA (新薬承認申請) 承認による製剤のCMO (医薬品製造受託機関) 産業の実績について調査分析し、2016年にFDA (米国の食品医薬品局) のCDER (医薬品評価センター) に承認された91医薬品と1治療薬について、体系的な情報を提供しています。

目次

  • エグゼクティブサマリー
  • イントロダクション
  • NDA承認の概要
  • 米国 vs. EUの承認実績
  • 用量製造のアウトソーシング
  • 特殊製品カテゴリー
  • アウトソーシング:世界のバイオ/製薬会社別
  • 用量処方製造のアウトソーシング:国別
  • CMOの実績
  • API承認のアウトソーシング
  • まとめ
  • 注記
  • 付録
図表

List of Tables

  • Table 1: Outsourced NDA Approvals by Dosage Form 12
  • Table 2: Outsourcing by Sponsor Market Cap and FDA Approval Type, 2012-2018 13
  • Table 3: API CMOs Receiving NME Approvals in 2018 28
  • Table 4: 2018 CBER Approvals Included in the Analysis 34
  • Table 5: 2018 Outsourced Dose Approvals 35
  • Table 6: Dose CMOs Receiving Contracts for FDA Approvals in 2009-2018 38
  • Table 7: API CMOs Receiving NME Approvals in 2018 42
  • Table 8: Dose CMOs' Manufacturing NDAs Approved in 2018 44
  • Table 9: MHRA Approvals in 2018 45

List of Figures

  • Figure 1: NDA and BLA Approvals 2009-2018 6
  • Figure 2: NDA Approvals by Sponsor Type, 2009-2018 7
  • Figure 3: EMA Approvals, 2012-2018 8
  • Figure 4: Share of NDA Approvals Outsourced 2009-2018 9
  • Figure 5: NDA Approvals Outsourced 2009-2018 10
  • Figure 6: Dose Outsourcing of Small Molecule and Biologic NMEs 2009-2018 11
  • Figure 7: Outsourcing of NME Approvals by Sponsor Market Cap 13
  • Figure 8: Outsourcing of Non-NME NDA Approvals by Sponsor Market Cap 14
  • Figure 9: Outsourcing of Orphan NMEs 2009-2018 15
  • Figure 10: Outsourcing of Fast Track NMEs 2011-2018 16
  • Figure 11: Outsourcing of Breakthrough Therapy Designation NMEs, 2013-2018 17
  • Figure 12: NMEs Requiring Special Handling 2008-2018 18
  • Figure 13: Approval and Outsourcing of NMEs Utilizing Solubility Enhancement 2011-2018 19
  • Figure 14: Mega Cap Outsourcing Propensity 2008-2018 20
  • Figure 15: Breakdown in Composition of Outsourced NMEs, by Sponsor Market Cap, 2008-2018 21
  • Figure 16: Breakdown in Composition of Outsourced Non-NME NDAs, by Sponsor Market Cap, 2008-2018 22
  • Figure 17: CMO Market Share of Parenteral NME Approvals, 2009-2018 23
  • Figure 18: CMO Market Share of Parenteral Non-NME NDA Approvals, 2009-2018 24
  • Figure 19: CMO Market Share of Solid NME Approvals, 2009-2018 25
  • Figure 20: CMO Market Share of Solid Non-NME NDA Approvals, 2009-2018 25
  • Figure 21: API Outsourcing of Chemical and Biologic NMEs, 2008-2018 27
  • Figure 22: Innovator Drug Clinical Trials Versus FDA NDA/BLA Approvals, 2009-2018 29
  • Figure 23: ANDA Approvals 2009-2018 46
目次
Product Code: GDPS0025MAR

This report is the 9th 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 50-page report gives important, expert insight you won't find in any other source. 32 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.

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 PharmSource 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 Contents

1 Table of Contents 2

2 List of Tables 3

3 List of Figures 3

4 Executive Summary 4

5 Introduction 5

6 NDA Approvals Overview 5

7 US vs. EU Approval Performance 7

8 Outsourced Dose Manufacture 8

9 Special Product Categories 14

10 Outsourcing by Mega Cap Companies 19

11 CMO Performance 20

  • 11.1 Catalent 26
  • 11.2 Patheon 26
  • 11.3 Other Prominent CMOs 26

12 Outsourced API Approvals 27

13 What it Means 28

  • 13.1 Approvals Have Risen 28
  • 13.2 Drivers for Outsourcing 30
    • 13.2.1 Niche Technology 31
    • 13.2.2 Small Volumes, Special Designations 31

14 Notes on Methodology 33

15 Appendix 34

  • 15.1 Appendix Tables 34
  • 15.2 Bibliography 46
  • 15.3 Primary Research - Key Opinion Leaders in this Report 47
  • 15.4 About the Authors 48
  • 15.5 Contact Us 50
  • 15.6 Disclaimer 50
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