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PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2016 Edition

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Published Date : Mar 2016

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PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2016 Edition


Our research team crunched the numbers on 2015 drug approvals authorized by FDAs CDER, CBER, Fast Track and Breakthrough drugs, and selected EMA approved drugs. The bottom line of this report is that a shrinking number of CMOs are getting the lions share of the contract manufactured new products.

We identified at least three harbingers of a likely sustained increase in NME approvals in coming years -
1. Total approvals using a CMO grew, but the share of NDA that are outsourced was flat in 2015
2. The number of NDA approvals will continue to grow, which is good news for CMOs
3. But outsourcing by global bio/pharma companies may be on the decline


- PharmSources data-rich Trend Report, CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2016 Edition, concludes that these factors will provide both headwinds and tailwinds for the CMO industry.

Reasons to buy

- The report includes data that is valuable to CMOs offering dose manufacturing services
Table of Contents
Executive Summary 1
Introduction 3
NDA Approvals Overview 4
Outsourced Dose Manufacture 7
Special Product Categories 11
Outsourcing by Global Bio/Pharma Companies 15
CMO Performance 17
Outsourced API Approvals 19
What It Means 21
Note on Methodology 24
Appendix 25
2015 CBER Approvals Included in the Analysis 25
2015 Outsourced Dose Approvals 26
ANDA Approvals 2006-2015 29

List of Tables
Table 1 Approvals by Dosage Form
Table 2 Outsourced NDA Approvals by Dosage Form
Table 3 Dose CMOs Receiving Approvals in 2015
Table 4 API CMOs Receiving NME Approvals in 2015
Table 5 NDA and BLA Filings to the FDA FY 2013-2015
Table 6 Breakdown of Prescription-only MHRA Approvals in 2015

List of Figures
Figure 1 NDA Approvals 2006-2015
Figure 2 NDA Approvals by Sponsor Type 2006-2015
Figure 3 Share of NDA Approvals Outsourced 2006-2015
Figure 4 Outsourcing of Large and Small Molecule API NMEs 2006-2015
Figure 5 Outsourcing of NDA Approvals by Sponsor Type
Figure 6 Outsourcing of NME Approvals by Sponsor Type
Figure 7 Outsourcing of Non-NME NDA Approvals by Sponsor Type
Figure 8 Outsourcing of Orphan NMEs 2008-2015
Figure 9 Breakthrough of Drug Approvals 2013-2015
Figure 10 Fast Track Approvals 2011-2015
Figure 11 NMEs Requiring Special Handling 2006-2015
Figure 12 Outsourcing of Advanced Formulation Technologies 2010-2015
Figure 13 Global Biopharma Outsourcing Propensity 2006-2015
Figure 14 Global Bio/pharma Outsourcing Propensity 2006-2015
Figure 15 Proportion of Approvals Captured by Leading 10% of CDMOs 2006-2015
Figure 16 Outsourced NME API Manufacture 2011-2015
Figure 17 ANDA Approvals 2006-2015

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