Contract Manufacturing Organizations (CMOs) continue to make progress as they climb out of the malaise caused by both the financial collapse in late 2008 and the ongoing challenge to utilize their excess capacities. As Big Pharma continues to outsource more API manufacturing, the large CMO players are well positioned to capture more of these opportunities.
In 2012 a number of Western CMOs have stated that business has started to migrate back from Asia because of continued quality and environmental concerns. Both generic and traditional pharmaceutical companies are demanding more accountability from their Asian CMOs particularly in safety, health and environmental issues for both employees as well as in the communities where their plants are located.
Congress has recently passed expanded legislation and funding to empower the FDA to “Level the Playing Field” as it pertains to GMP inspections of foreign Active Pharmaceutical Ingredients (APIs) CMOs. Recent trends are the manufacture of APIs for biosimilars, niche generics, cytotoxics, antibody drug conjugates (ADCs) and the more efficient syntheses of large scale generics utilizing proprietary manufacturing technologies.
Brocair tracks the leading CMO’s worldwide and stays abreast of recent market developments. There continue to be opportunities worldwide for synergistic acquisitions or strategic divestitures in the CMO space and Brocair is well positioned to assist our clients regardless of their interest.