DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2017 Edition" report to their offering.
The report examines 91 drugs approved by the FDA Center for Drug Evaluation and Research (CDER) in 2016 along with 1 therapeutic drug approved by the FDA Center for Biologics Evaluation and Research (CBER) under the BLA process.
PharmSource's data-rich Trend Report, CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2017 Edition, has ascertained that 2016 was not a halcyon year for new drug approvals with only 25 NMEs being approved since 2010.
Global bio/pharma companies received 22 approvals in 2016 (24% of all NDAs), 10% below their 2011-2015 average. Small commercial companies were responsible for 21 approvals (23% of the total), some 5% above their five-year average. There was a clear difference between outsourcing propensity of NME and Non-NME drugs. Only 13% of NMEs sponsored by global bio/pharma companies were outsourced compared with an average of 28% from 2011-2015. However, the largest companies increased their outsourcing of Non-NME drugs from an average of 32% in 2011-2015 to 57% in 2016.
In 2016, the FDA approved 92 NDAs and BLAs including new molecular entities (NMEs), therapeutic drugs approved through CBER and new formulations of older drugs. This figure represents a 25% decrease from 2015 (122) and is also 5% less than the 2011-2015 average of 97. Furthermore, 48% of NMEs were outsourced compared to 64% of Non-NME NDA products. 28 dose CMOs garnered approvals in 2016 although two companies, Vetter and Patheon, won 7 out of the 12 NMEs that were outsourced. No other company secured more than a single NME approval for contract manufacturing, although Catalent and DPT were responsible for 7 Non-NME NDA drugs.
The CMO landscape is dominated by the quartet of Patheon, Baxter, Vetter and Catalent, which collectively accounted for over 30% of all NDA approvals between 2007-2016. Parenteral NME outsourcing is dominated by the first three of these, which are responsible for manufacturing 47% of all drugs, with the remainder split between 28 other companies.
In depth, this report provides the following:
- Provides the detailed analysis of drugs examined by the European Medicines Agency (EMA). The centralized procedure is mandatory for all New Active Substances, as well as Biosimilar drugs and certain generics depending on their therapeutic category.
- Analyzes propensity to outsource by dosage form, sponsor type, nature of API and special handling requirements. In addition, it includes information on product approvals, which have utilized formulation technologies such as amorphous solid dispersion (ASD), hot melt extrusion (HME) and jet milling.
- Helps for CMO executives and strategic decision-makers who seriously follow the global CMO industry, including dose and API manufacturers.
Key Topics Covered:
- Executive Summary
- NDA Approvals Overview
- US vs. EU Approval Performance
- Outsourced Dose Manufacture
- Special Product Categories
- Outsourcing by Global Bio/Pharma Companies
- Outsourced Dose Form
- Manufacture by Country
- CMO Performance
- Outsourced API Approvals
- What It Means
- Note on Methodology
For more information about this report visit http://www.researchandmarkets.com/research/9b6jb9/pharmsource_cmo