PharmSource Report: CMOs Fail to Gain Share of NDA Approvals

Dose-CMOs-2013Market Intelligence Briefing from PharmSource says CMO share of NDA approvals declined in 2013

FAIRFAX, VA. April 8, 2014 – CMOs took a step backward in 2013 in their effort to gain a greater share of bio/pharmaceutical manufacturing.

That’s the conclusion of a new Market Intelligence Briefing just published by PharmSource, the bio/pharmaceutical industry’s principal source of market intelligence on contract drug development and manufacturing. The Briefing, entitled “Outsourced NDA Review, 2014 Edition” is the result of PharmSource’s ongoing research on contract manufacturing industry trends and is the fourth edition in an on-going series of tracking NDA approvals.

“Outsourced NDA Review, 2014 Edition” is an in-depth, data-driven analysis that is indispensable to contract manufacturing executives, as well as to bio/pharma company executives making sourcing strategy decisions. This proprietary 8-page analysis gives critical insight into evolving contract manufacturing trends and developments, and examines several key outsourcing indicators including:

  •  Contract manufactured NDA approvals by dosage form and sponsor type.
  •  Contract manufactured orphan drug approvals and products requiring special handling (cytotoxics, controlled drugs, etc.).
  •  CMO recipients of NDA approvals in 2013 and over the 2004-2013 period.
  •  Propensity to outsource dose manufacturing for 43 bio/pharma companies with five or more approvals during the past 10 years.

This report is available by subscription to PharmSource’s STRATEGIC ADVANTAGE platform, which includes access to PharmSource’s intelligence briefings and in-depth syndicated reports, as well as to its global database of contract manufacturers. It also is available as a stand-alone report. For more information, contact PharmSource directly at +1-703-383-4903 /