PharmSource-CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance-2017 Edition

PharmSource-CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance-2017 Edition

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  • Pages: 42
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Executive Summary

PharmSource-CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance-2017 Edition


Where's your place in the CMO hierarchy?

Find out in the CMO industry's authoritative analysis of manufacturing of NDA approvals. This CMO scorecard was compiled through hundreds of professional hours of research and analysis, and is presented in a 40-page report with over 30 graphs and tables. Only CMO Scorecard enables the CMO industry to benchmark its performance over time, and CMOs to benchmark their performance against the industry.

Our research team crunched the numbers on 2016 drug approvals authorized by FDA's CDER, CBER, Fast Track and Breakthrough drugs, and selected EMA approved drugs. For the first time, we are including information on the location of outsourced dose manufacturing facilities.

Reasons to buy

This report is required reading for -

CMO executives and strategic decision-makers who seriously follow the global CMO industry, including dose and API manufacturers.

Bio/Pharma sponsors that buy contract manufacturing services and need to understand contract manufacturing industry drivers.

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Ken Research
Ankur Gupta, Head Marketing & Communications


1 Table of Contents

Executive Summary


NDA Approvals Overview

US vs. EU Approval Performance

Outsourced Dose Manufacture

Special Product Categories

Outsourcing by Global Bio/Pharma Companies

Outsourced Dose Form

Manufacture by Country

CMO Performance

Outsourced API Approvals

What It Means

Note on Methodology


1.2 List of Figures

Figure 1 NDA Approvals 2007-2016

Figure 2 NDA Approvals by Sponsor Type 2007-2016

Figure 3 EMA Approvals 2012-2016

Figure 4 Share of NDA Approvals Outsourced 2007-2016

Figure 5 Absolute Numbers of Outsourced NDA Approvals 2007-2016

Figure 6 Outsourcing of Small and Large Molecule API NMEs 2007-2016

Figure 7 Outsourcing of NME Approvals by Sponsor Type

Figure 8 Outsourcing of Non-NME NDA Approvals by Sponsor Type

Figure 9 Outsourcing of Orphan NMEs 2007-2016

Figure 10 Breakthrough NME Drug Approvals 2013-2016

Figure 11 Fast Track NME Drug Approvals 2001-2016

Figure 12 NMEs Requiring Special Handling 2007-2016

Figure 13 Approval and Outsourcing of Advanced Formulation Technologies 2011-2016

Figure 14 Global Bio/pharma Outsourcing Propensity 2007-2016

Figure 15 Manufacturing Location for Outsourced Non-NME NDA Dose Manufacturing 2007-16

Figure 16 Manufacturing Location for Outsourced NME Dose Manufacturing 2007-2016

Figure 17 Manufacturing Location for In-House NME Dose Manufacturing 2007-2016

Figure 18 Manufacturing Location for In-House Non-NME NDA Dose Manufacturing 2007-2016

Figure 19 CMO Market Share of Parenteral NME Approvals 2007-2016

Figure 20 CMO Market Share of Parenteral Non-NME NDA Approvals 2007-2016

Figure 21 CMO Market Share of Solid NME Approvals 2007-2016

Figure 22 CMO Market Share of Solid, Non-NME Approvals 2007-2016

Figure 23 Outsourced NME API Manufacture 2007-2016

1.1 List of Tables

Table 1 Approvals by Dosage Form

Table 2 Outsourced NDA Approvals by Dosage Form

Table 3 Outsourcing by Sponsor Type and FDA Approval Type 2011-2016

Table 4 Dose CMOs Receiving Approvals in 2016

Table 5 API CMOs Receiving NME Approvals in 2016

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