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October 2015

Welcome to the October 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 October issue!

The PharmSource Team


Small-Molecule API CMOs Are Thriving

by Jim Miller, President, PharmSource

It has been the general consensus among bio/pharmaceutical industry participants, investors, and observers that small-molecule drugs are becoming obsolete as the industry focuses on biologics. To paraphrase what Mark Twain allegedly said about his own situation, reports of the death of small-molecule drugs are greatly exaggerated.

Small-molecule pharmaceuticals accounted for 82% of all new drug application (NDA) approvals in 2014 and 60% of all new molecular entities. Further, they represent two-thirds of the drug-development pipeline. While there can be no doubt that the number and share of large-molecule therapeutics is increasing, small-molecule drugs are… read on

Vietnam Market Lacks CMOs Despite Local Content Requirements

While its rapid growth has made Vietnam an attractive target for bio/pharmaceutical companies, local content restrictions pose a challenge to entry into the market. At least one CMO has made a commitment to the country, but bio/pharmaceutical companies looking to do business in Vietnam may need to partner with one of the relatively unsophisticated local drug manufacturers.

The population of Vietnam is growing at a slow 1% annually but is expected to reach 96 million by 2019, but the economy is growing at a healthy 6.5% p.a., according to US Chamber of Commerce data. The Vietnamese bio/pharmaceutical market grew to… read on

New Report Available: PharmSource CMO Industry Analysis

Our just-released 2015 Contract Dose Manufacturing Industry by the Numbers report is an indispensable resource for understanding the competitive environment faced by dose manufacturers, and provides critical insights for your strategic planning efforts. The report will enable you to:

  • Benchmark your performance against other CMOs in the industry
  • Understand what strategies CMOs are pursuing for profitable growth
  • Grasp CMO business challenges affecting bio/pharmaceutical negotiations

Thanks to our deep expertise and ongoing research, Contract Dose Manufacturing Industry by the Numbers is the most authoritative and reliable portrait of the CMO industry available to the bio/pharmaceutical industry today.

Our proprietary model and assumptions are fully explained so you can understand how we arrived at our analysis and conclusions.

You won’t find this mission-critical information in any other source. Click here for more information or to order this report today.

Hepalink to Acquire Cytovance

Cytovance Biologics, Inc., a contract biomanufacturer, will be acquired by Hepalink USA, the wholly-owned subsidiary of Shenzhen Hepalink Pharmaceutical Co., Ltd., for $205.7 million. The deal is expected to close in October 2015. Cytovance offers process development and manufacturing services for large molecule pharmaceuticals using mammalian cell culture and microbial fermentation technologies.

Shenzhen Hepalink’s primary business is supply of heparin sodium API. It was founded in 1998 and went public on the Shenzhen Stock Exchange in 2010. In 2014, it acquired Scientific Protein Labs (SPL), a US supplier of heparin sodium, pancreatin USP, and pancrelipase USP, for $337.5 million. Hepalink had revenues of… read on


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