BioPharm International - February 2020

BioPharm-Outsourcing eBook

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Page 15 of 29

16 BioPharm International eBook February 2020 Lyophilization Services Gain Ground Amid Growing Biologics Market The need for lyophilization services is growing as a burgeoning pipeline of new biologics matures. A g row i ng pip el i ne of biolog ic s t hat encompass therapeutic antibodies, pro- teins, and emerging therapies is driving the demand for more lyophilization. As a result, biopharmaceutical companies are increasingly outsourcing lyophilization operations to contract manufacturing organizations (CMOs) and contract development and manufacturing organiza- tions (CDMOs). It is estimated that the market for lyophilization services for biopharmaceuticals will grow by 9.5% annually between 2017 and 2027, and that North America and Europe will continue to dominate the market over the next decade (1). Biologics accounted for approximately 25% of total new drugs approved by FDA in the last three years (2–4), and over the next decade, more new biologics are expected to enter the market. More than 50% of new drug clinical trials consist of biologics (1). It is likely that new biologic drugs and emerging therapies will be more targeted therapies with smaller patient populations and small batch sizes, notes Wendy Saffell-Clemmer, lead scientist and senior director at Baxter BioPharma Solutions. "Gene therapy products are expected to be curative, again reducing manufacturing scale. The Gene Therapy Roadmap (5) published by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) in 2017 motortion - FELIZA MIRASOL Partnerships for Outsourcing Manufacturing

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