Two-thirds of pharmaceutical manufacturing is outsourced, ISR Reports

By Melissa Fassbender

- Last updated on GMT

(Image: iStock)
(Image: iStock)

Related tags Pharmacology

Only one-third of manufacturing is currently conducted in-house, from development stages to after commercial launch, according a recent report.

The report, published by Industry Standard Research (ISR)​, explained that the majority of work is outsourced – and mainly to preferred providers, who are netting the largest portion of work.

According to Kate Hammeke, Vice President of Market Research at Industry Standard Research, this puts a high level of demand on contract manufacturing organization services, in particular areas such as specialty dosage forms.

"Some of the many surprising findings came from ISR's investigation into how internal resources like available capacity and staff scientific expertise influence the decision or requirement to outsource​,” Hammeke told us.

To me, the surprise here comes from the realization that there are very few drug products or drug components that sponsor organizations have both adequate capacity and adequate experience in order to manufacture in-house​,” she said.

Hammeke explained she also found it surprising how an outsourced manufacturing projects’ total cost broken out by activity varies greatly depending on molecule type, stage of development, and supplier role.

Demand changes

As previously reported​, the demand for finished dosage formulations is having an impact on several aspects of the CMO industries.

In order to ensure a piece of the finished dosage formulations (FDF) market share, CMOs have adjusted their service offerings, mainly to broaden their capabilities.

Another trend in the industry has been more CMOs offering both finished dosage form and the active ingredient – making many full-service providers.

In this model a company can take its molecule to a supplier where its API process is scaled-up and converted to the dosage form at a single manufacturing organization.

Related topics Contract Manufacturing & Logistics

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