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CMO Industry Scorecard 2020: Outsourcing of NDA Approvals and CMO Performance – ResearchAndMarkets.com

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DUBLIN–(BUSINESS WIRE)–The “CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2020 Edition” report has been added to ResearchAndMarkets.com’s offering.

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.

Reasons to Buy

Key Topics Covered

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. (Read more…) 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

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

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/9g0dnn

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