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