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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

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

発行 GlobalData 商品コード 409613
出版日 ページ情報 英文 53 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 CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2020 Edition
出版日: 2020年04月30日 ページ情報: 英文 53 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
  • 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
目次
Product Code: GDPS0031MAR

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

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