CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance

List Price: US $1,250
Client Price: US $997*
Delivery format: Electronic PDF delivery upon payment.

*This report is included at no extra cost for Strategic Advantage clients, and is accessible in the Trend Reports section here.

Our research team crunched the numbers on 2014 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 the number of NMEs approved last year are a positive indication for the CMO sector. We identified at least three harbingers of a likely sustained increase in NME approvals in coming years:

1. 2014 produced the second largest total of outsourced NDAs since 2004
2. regulatory changes like the 2012 FDA Safety and Innovation Act
3. advances in oncology research

 
PharmSource’s data-rich Trend Report, CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance, concludes that these factors will drive outsourcing, even in the absence of changes in market penetration.

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

 
 
 
Who should buy this report?

The 21-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.

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