CMO Market Penetration as Evidenced by Outsourced NDA Approvals, 2014 Edition

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*This report is included at no extra cost for STRATEGIC ADVANTAGE clients, and is accessible in the Trend Reports section here. Learn more about PharmSource STRATEGIC ADVANTAGE outsourcing intelligence portal.

Dose-CMOs-2013Geared to bio/pharma contract manufacturers, as well as to bio/pharmaceutical company procurement executives making sourcing decisions, this proprietary 82012 NDA briefing-page analysis reveals that CMOs failed to gain share of outsourced NDA approvals in 2013. It examines NDA activity as an indicator of global bio/pharmaceutical outsourcing behavior, and analyzes related trends for the 2006-2013 period.

Order this report now to see PharmSource’s expert analysis of several leading indicators including:

  • Approvals by dosage form, including solid dose, injectable and semisolid/liquid. Data for 2013 is compared against the 2006-2012 trends.
  • Analysis of the distribution of approvals by sponsor type (small, generic, self-sustaining, global), including data on sponsor types for large molecule vs. small molecule approvals. It includes data on the share of approvals type that were outsourced in 2013 for each sponsor, as well as the 2006-2012 average.
  • The share of NDA approvals that were outsourced over the period from 2006 to 2013, including a comparison of new molecular entities (NMEs) vs. other NDAs.
  • Data on the top 19 CMOs that received NDA approvals in 2013, and their comparative approval performance during the 2004-2013 period.
  • 2012 NDA approvals with dose CMOs, including 34 products by sponsor, dosage form, approval type, dose contractors and API contractors.

Who should buy this report?

The 8-page report provides important insight that you won’t find in any other source. 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.

Published April 2014