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Outsourcing of NDA Approvals and CMO Performance Remains Sluggish

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Published on : May 18, 2017

Albany, New York, May 18, 2017: The report provides in-depth analysis of recent drugs approved by FDA Center for Drug Evaluation and Research (CDER) and evaluates their demand in the near future. The report has been developed to serve as a credible business document for all stockholders involved in the pharmaceutical industry, including the distributors and suppliers of drugs. 

As many as 91 drugs were approved by the CDER in 2016, while one therapeutic drug was given green signal by CBER (FDA Center for Biologics Evaluation and Research). The report observes that 2016 was not a very prosperous year for the pharmaceutical industry players with merely 25 new medical entities (NME) gaining approvals since 2010. 

The report has detected that pharmaceutical companies across the globe gained 22 approvals in the year 2016, out of which 24 percent were all NDAs. This was about 10 percent reduction to the average for the duration of 2011-2015. This fall is primarily a reflection of small commercial companies gaining 23 percent approvals (21 in total). This shift is an apparent difference when outsourcing propensity of NME drugs are compared with Non-MNE drugs. As little as 13 percent of NMEs were sponsored by global biopharmaceutical companies. That being said, the most prominent vendors escalated their outsourcing of Non-NME drugs considerably in 2016 at 57%, up from 32% during 2011-2015.

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The report also finds that with only 92 NDAs and BLAs approved by the FDA in 2016, the decrease has reached 25% with 122 approvals in 2015. This overall is a 5 percent reduction from 2011 to 2025 average, which was 97. Moreover, according to the estimations provided by the report, 48 percent NMEs were outsourced as opposed to 64 percent NDA products. Two vendors, Patheon and Vetter, collective accounted for 7 out of 12 NMEs that were outsourced, while no other vendor managed more than solitary NME approval for contract manufacturing. However, DPT and Catalent were credited for 7 Non-NME NDA drugs.

The report contains dedicated chapters on NDA approvals in 2016, the approval performance of the U.S. vs European Union, outsourced dose manufacture, special product categories, outsourcing by global Bio/Pharma companies, manufacture by country, CMO performance, and outsourced API approvals.

According to the findings of the report, the competitive landscape of CMO is distributed between four players: Baxter, Patheon, Catalent, and Vetter. These four reserved 30 percent of all NDA approvals during the period of 2007 and 2016. On the other hand, parenteral NME outsourcing is dominated by Patheon, Baxter, and Vetter, who collectively manufacture 47% of overall drugs, while rest of the market is distributed among 28 other vendors.

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