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April 2016

Welcome to the April 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 April issue!

The PharmSource Team


2015 Financial Results Underscore Industry Trends

Publicly traded pharmaceutical services companies have reported generally good financial results for 2015. But segment results varied considerably.

Custom manufacturers of Active Pharmaceutical Ingredients (APIs) and intermediates were best performers, with the seven reporting companies averaging 11.2% growth for the year. Notably, the strong performance reflects strength in custom manufacturing of small molecule products, as only two of the seven companies that have reported thus far have biologics manufacturing businesses and one of those is too small to affect the outcome. New product launches, as well as… read on

CMC Development is Hot

by Jim Miller, President, PharmSource

Early development services are not the most glamorous segment of the contract development and manufacturing organization (CDMO) industry, but these days they may be the hottest. Booming market demand is driving record growth, expansion, and acquisition activity.

Formulation development and manufacturing of early-phase clinical trial materials (CTM) historically have been some of the least attractive segments of the contract services industry from a business standpoint. Typically, price points were low relative to larger-scale manufacturing services, and client churn was high because… read on

Pharma Investment in Russia Continues Despite Economic Downturn

Forecasts for the Russian pharmaceutical market have taken a nosedive in early 2016 compared to the third and fourth quarters of 2015. At a recent DCAT event, IMS Health’s Graham Lewis forecast negative (-3%) to flat growth in the Russian pharma market through 2019.

This stands in sharp contrast to estimates published in late 2015. IMS Health had estimated in a report last year that the Russian pharma market rose about 12% over 2014. And forecasts by Deloitte Consulting had estimated the market could grow at about 10%/year through 2018, potentially reaching… 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

Contract Services Market: 2016 Update

PharmSource president, Jim Miller, will give an overview of the contract services market at INTERPHEX 2016.

For more information click here.

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