目次

Table of Contents

1 Executive Summary

2 Players

3 Technology Briefing
3.1 Innovative Drug Approvals
3.2 Dose Outsourcing of Drug Approvals

4 Trends

5 Industry Analysis
5.1 Introduction
5.2 FDA NDA Approvals Overview
5.3 US vs. EU Approval Performance
5.4 FDA EUA Approvals in 2020 for COVID-19
5.5 FDA: Outsourced Dose Manufacture
5.5.1 Dosage Form Outsourcing
5.6 Special Product Categories
5.7 Outsourcing by Company Market Cap
5.8 CMO Performance
5.9 Outsourced API Approvals
5.10 ANDA Approvals
5.11 What It Means
5.11.1 Increased Innovative Approvals and Number of Outsourced Products
5.11.2 Drivers and Barriers

6 Value Chain

7 Companies

8 Appendix
8.1 Methodology
8.2 Bibliography
8.3 Primary Research - Key Opinion Leaders
8.4 Further Reading

9 About the Authors
Contact Us

List of Tables
Table 1: Drug Approval Trends, 2020
Table 2: Outsourced NDA Approvals by Dosage Form
Table 3: Dose Outsourcing Relationships by Sponsor Market Cap and FDA Approval Type, 2015-2020
Table 4: CMOs With API Contracts for NMEs Approved in 2020
Table 5: Companies with 2020 CBER Approvals
Table 6: 2020 Outsourced Dose Approvals by Company
Table 7: CMOs Receiving Dose Contracts for FDA Approvals in 2011-2020
Table 8: CMOs With API Contracts For Drug Approvals in 2020
Table 9: Dose CMOs Manufacturing NDAs Approved in 2020
Table 10: Further Reading

List of Figures
Figure 1: Leading Players for US New Drug Approvals and Their Manufacturing, 2020
Figure 2: Top Drug Approval Trends, 2020
Figure 3: FDA NDA and BLA Approvals, 2011-2020
Figure 4: FDA NDA Approvals by Sponsor Type, 2011-2020
Figure 5: EMA Approvals, 2012-2020
Figure 6: FDA Emergency Use Approvals for COVID-19 Contract Service Agreements, 2020
Figure 7: Share of FDA NDA Approvals Outsourced 2011-2020
Figure 8: NDA Approvals Outsourced 2011-2020
Figure 9: Dose Outsourcing of Small Molecule and Biologic NMEs, 2011-2020
Figure 10: Dose Outsourcing of FDA NME Approvals by Sponsor Market Cap
Figure 11: Dose Outsourcing of Non-NME NDA Approvals by Sponsor Market Cap
Figure 12: Outsourcing of FDA Orphan NMEs, 2011-2020
Figure 13: Dose Outsourcing of FDA Fast Track NMEs, 2011-2020
Figure 14: Dose Outsourcing of Breakthrough Therapy Designation NMEs, 2013-2020
Figure 15: NME Approvals Requiring Special Handling, 2011-2020
Figure 16: FDA Approvals and Outsourcing of NMEs Utilizing Solubility Enhancement, 2011-2020
Figure 17: Small Cap Sponsors’ Dose Outsourcing Propensity, 2011-2020
Figure 18: Mid Cap Sponsors’ Dose Outsourcing Propensity, 2011-2020
Figure 19: Large Cap Dose Outsourcing Propensity, 2011-2020
Figure 20: Mega Cap Dose Outsourcing Propensity, 2011-2020
Figure 21: Private Company Dose Outsourcing Propensity, 2011-2020
Figure 22: Breakdown in Composition of Dose-Outsourced NMEs, by Sponsor Market Cap, 2011-2020
Figure 23: Dose-Outsourced Non-NME NDAs, by Sponsor Market Cap, 2011-2020
Figure 24: CMO Market Share of Parenteral NME Approvals, 2011-2020
Figure 25: CMO Market Share of Parenteral Non-NME NDA Approvals, 2011-2020
Figure 26: CMO Market Share of Solid Dose NME Approvals, 2011-2020
Figure 27: CMO Market Share of Solid Dose Non-NME NDA Approvals, 2011-2020
Figure 28: API Outsourcing of Small Molecule and Biologic NMEs, 2011-2020
Figure 29: ANDA Approvals 2011-2020
Figure 30: The Contract Manufacturing Value Chain