The high capital requirement poses a major challenge for the growth of the fill finish manufacturing market. Setting up facilities for biologics manufacturing is an extremely capital-intensive process which requires investments running into hundreds of millions of dollars. This is because biologics manufacturing facilities need to meet stringent regulatory standards and require advanced technologies and critical, specialized equipment to facilitate aseptic fill finish processes. The costs associated with ensuring required cleanroom specifications, prevention of contamination, and validation of equipment is very high.
Market Opportunities – Expanding Contract Service Capacity
Expanding contract service capacity in biologics fill finishing can tap into significant opportunities in the global market. As biopharmaceutical development continues to grow in complexity, an increasing number of drug manufacturers are outsourcing non-core functions to contract service providers. Fill finishing, being a highly technical late-stage process in biologics production, is well-suited for outsourcing.
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