Report Highlights Supply, Demand Of CMO Cytotoxic Injectables Manufacturing
By Cyndi Root
PharmSource issued a report on the supply and demand outlook for contract manufacturing of cytotoxic injectable drugs. The new report titled, “The Demand and Supply for Contract Manufacturing of Injectable Drugs Through 2019,” is a 34-page complement to a report on conventional injectables.
Jim Miller, president of PharmSource, stated that the information in the report should push pharma companies to focus more closely on their sourcing. He said, “The information should prompt bio/pharmaceutical companies to reconsider their sourcing strategies and assess the adequacy of the CMO industry to manufacture products in pipeline. It also should help CMOs make strategic investment decisions when it comes to producing cytotoxic injectable drugs.”
Report on Cytotoxic Injectable Drugs
Authors of the report on cytotoxic injectable drugs formulated their opinions based on evidence from CMO closures and expansions, FDA submissions and approvals, and investigational drugs in the pipeline. The report states that the pipeline for cytotoxic products like ADCs (antibody drug conjugates) is limited and only five CMOs have the capabilities to be effective in this category. PharmSource states that while 21 CMOs claim to have the facilities, personnel, and market focus to produce cytotoxic injectables, only five actually do. The capacity at those five qualified CMOs is tight but their capacity expansions should cover projected cytotoxic injectable approvals through 2019. Other CMOs may be able to respond to demand for generics and new formulations.
According to the report, the pipeline of high value ADCs is limited as late stage drugs are only likely to be approved at a rate of one per year. This average approval rate is expected to hold true for at least the next five years. Report authors state that the current supply and demand environment is favorable for CMOs as they should be able to keep price levels steady and possibly improve as drug sponsors realize that advance contracting for space and services is necessary.
Cytotoxic Injectable Drug CMOs
Due to the rise in cancer rates and the promise of cytotoxic therapies in oncology treatment programs, cytotoxic injectable drug CMOs are investing in their facilities. In the news lately have been announcements from Lonza, a Swiss manufacturer, and Novacep, a French CMO, both of which are expanding their manufacturing facilities. Baxter also announced that it is adding a 1,750-square-meter addition to its cytotoxic manufacturing plant in Halle, Germany. Just last week, Oasmia contracted with Baxter for manufacturing of its oncology product.