16 BioPharm International eBook February 2020 www.biopharminternational.com
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
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FELIZA MIRASOL
Partnerships for Outsourcing Manufacturing
