CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2016 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.

Our research team crunched the numbers on 2015 drug approvals authorized by FDA’s 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 lion’s 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

PharmSource’s 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.

The report includes data that is valuable to CMOs offering dose manufacturing services.

Who should buy this report?

The 30-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 March 2016