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Welcome to the July 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 July issue!
CFDA Approvals See First Increase Since 2011
Reversing the trend seen over the last few years, approvals for new drug products and clinical trials in China rose in 2014.
The increase could represent less a true increase and more a normalization of review and approval rates, suggested Carl Williams, a former US FDA investigator with experience in China. The CFDA’s increased attention to GMP compliance likely was the source of the decreases in approvals seen since 2011, he said. Chinese regulators seem to be growing more adept at enforcing GMP compliance in alignment with the US and EU; likewise, manufacturers in China are… read on
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 CMC development – outsourced spending:
|2014: $6.72 billion (30% of total)||Catalent Pharma Solutions
Presentation at William Blair 35th Annual Growth Stock Conference
Read more about the size of the contract services market for various segments.
No Guidance Yet, But FDA Begins Clarifying Quality Metrics Program
The FDA will soon expect pharmaceutical manufacturers to collect certain data related to their quality systems under its burgeoning quality metrics program and submit those to the FDA for review. CMOs will be required to collect these data for their own facilities; whether they will need to provide those data to their clients or directly to the FDA is unclear.
While the agency has been tight-lipped about what exactly the quality metrics will entail, some FDA officials have begun discussing… read on
PharmSource Strategic Advantage User Tip
Looking for a Manufacturer for Cytotoxic Injectable Products?
PharmSource Strategic Advantage, the biopharmaceutical industry’s outsourcing intelligence portal, offers two avenues for identifying CMOs and pharmaceutical companies that manufacture cytotoxic injectable products.
Subscribers can use the “CMO Capabilities” approach, using the Refine Search capability to identify injectables manufacturers that can handle cytotoxic products.
Alternatively, premier-level subscribers can use the “Product Search” approach. They can specify cytotoxic injectable products from the Product Search screen and see a list of cytotoxic injectable products and the companies that are manufacturing them.
The CMO Capabilities approach will generally deliver more details on manufacturer capabilities because CMOs usually reveal more information about their facilities than pharmaceutical companies do about their captive facilities.
The Product Search approach will provide a broader sense of the entire universe of manufacturers capable of producing cytotoxic injectables, including pharma companies with captive capacity, as well as CMOs. This could be useful for searching for manufacturers in emerging market countries where the network of CMOs is usually very limited.
For questions about this feature or any other inquiries regarding PharmSource Strategic Advantage, please contact our Director of Account Management, Blythe Moore, at +1.703.383.4903, ext. 104 | firstname.lastname@example.org.
PharmSource STRATEGIC ADVANTAGE
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 email@example.com / +1-703-383-4903, ext. 112 (ET USA).