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March 2015

Welcome to the March 2015 issue of CMC Market Outlook

This monthly e-newsletter provides valuable insights for both buyers and sellers of CMC drug development services. Our coverage will help you identify and understand market trends that will inform your strategic business perspective.

Enjoy the March issue!

The PharmSource Team


How big is the market for…?

This is a handy guide to frequently requested data about the bio/pharma contract services industry.

The market for total global bio/pharmaceutical R&D spending:

Market Size Source
2014: $125 billion
2020: $148 billion
Icon plc
Presentation at JP Morgan Conference
January 2015
2014: $160 billion Catalent Pharma Solutions
Presentation at JP Morgan Conference
January 2015

Read more about the size of the contract services market for various segments.

Recent Deals Highlight Threat to CMO Supply Base

Uncertainty is creeping into the supply of contract injectables manufacturing capacity as bio/ pharmaceutical companies continue to buy up CMOs. With biopharmaceuticals approaching 50% of the expanding new product pipeline, biopharma companies may be facing challenges in arranging for launch capacity.

Two deals have been announced in the past month that continue the trend of CMOs being acquired by product companies. The largest and most significant is… read on

Gauging the CMO Biosimilar Opportunity

by Jim Miller, President, PharmSource

The establishment of a regulatory pathway for approval of biosimilars in the United States has generated a great deal of excitement within the CMO industry. The passage of the Biologics Price Competition and Innovation Act (BPCI Act) in 2010 and issuance of related FDA guidance unleashed a flurry of… read on

Global Bio/pharma Plays Favorites with CMOs

Global bio/pharma companies don’t outsource the drug product manufacture for their new molecular entities (NMEs) very often, but when they do there are only a few select CMOs they appear willing to work with.

That insight was revealed in PharmSource’s just-published Trend Report, CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance. The report does a deep-dive into… read on

PharmSource Research Identifies Winners in CMO Derby

Dose CMOs had more launches in 2014, thanks to a big jump in NDA approvals. But they aren’t making much headway in convincing bio/pharma companies to abandon in-house manufacture. For the most part the industry is dependent on the ebb and flow of the NDA tide. Find out what this means for your business.

Jim Miller and the PharmSource intelligence team have identified some other critical trends for the CMO industry:

  • Global bio/pharma companies don’t outsource many NMEs, but when they do they have a few favorite CMOs.
  • NMEs tend to get approved by FDA before being approved by EMA, which may have implications for European CMOs.
    • What dose forms and API types are
      most likely to be outsourced?


      Bio/Pharmaceutical Outsourcing Report – Special DCAT Edition

      PharmSource will publish a special DCAT Edition of our proprietary industry newsletter, Bio/Pharm-
      aceutical Outsourcing Report.

      This monthly report covers deals and happenings throughout the industry. It provides expert insight into the significance of industry trends and what they mean for your business.

      Find out what’s happening in commercial and clinical dose manufacturing and packaging, API small and large molecule, captive capacity, regulatory developments and more.

      Get your copy from the PharmSource team at DCAT. Or click here to download a complimentary copy.


      Let PharmSource be your market intelligence guide.

      PharmSource’s STRATEGIC ADVANTAGE service is the industry’s most respected outsourcing information web portal for serious consumers of information on contract drug development and manufacturing. Developed from PharmSource’s expert proprietary research, you won’t find this information in any other resource.

      See for yourself how this resource gives you vital tools for understanding the industry.

      To request a test-drive today, contact Nathaniel Celentano at / 1-703-383-4903, ext. 112 (ET USA).