Summary
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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1 Table of Contents
Executive Summary
Introduction
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
Appendix
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
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
