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March 2016

Welcome to the March 2016 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


Trial Registrations Steady, Uptick Expected

Registrations of new clinical trials hewed to recent trends in 2015, with nearly 4,600 new Phase I-III trials registered in Phase I trial registrations dropped to 1,789 from 2014’s 2,366, but the number of 2014 Phase I registrations was far above average for the previous 2008-2013 period, for unknown reasons. The number of Phase I registrations in 2015 was much more in line with the longer-term trend.

Phase II clinical trial registrations seem to have stabilized after… read on

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

A shrinking number of CMOs are getting the lion’s share of the contract manufactured new products. Jim Miller and the PharmSource intelligence team 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 just-released Trend Report, CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2016 Edition, concludes that these factors will provide… read on

Global Conflicts and CMO Impacts

by Jim Miller, President, PharmSource

Bio/pharmaceutical companies, and the companies that serve them, tend to think they are immune from broader macroeconomic and political developments. As populations age, emerging middle classes expand, and scientific knowledge progresses, research on new drugs and demand for new therapies seem to follow an inexorably upward trend.

However, the global financial crisis of 2008 demonstrated that the industry is not isolated from macro events. Early-stage companies, which drive the early development engine, had great difficulty raising money as the availability of… read on

Bio/Pharmaceutical Outsourcing Report – Special DCAT Edition

Check out the special DCAT Edition of PharmSource’s proprietary industry briefing.

This monthly publication reports on and analyzes major developments throughout the CMO industry. It provides expert insight into the significance of industry trends and what they mean for your business.

Deepen your understanding of what’s happening in commercial and clinical dose manufacturing and packaging, API small and large molecule, captive capacity, regulatory developments and more.

Click here to download your complimentary copy.

PharmSource Strategic Advantage

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).