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

11.1 Catalent 26
11.2 Patheon 26
11.3 Other Prominent CMOs 26

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

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

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

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