Finished dosage formulations demand driving changes for CMOs

17-May-2016 - Last updated on 23-May-2016 at 07:17 GMT

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As “one of the fastest growing areas in pharma,” 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.

“The largest CMOs have more dosage forms and will typically have facilities on multiple continents so they can both operate on a more global basis and can service more of the pipeline that they could in the past,” said Jim Miller, founder and president of PharmSource Information Services, Inc, at the CPhI Worldwide Finished Dosage Formulation (FDF) event in London, UK.

According to Miller, 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.

“That’s been a relatively recent development in the industry – we’ll see how important it actually becomes,” he added. “I think it also has a lot to do with reliability, quality, and depth of capability that the CMO industry is a lot more sophisticated today than it was 10-15 years ago.”

How is demand for FDFs affecting consolidation among CMOs?

Miller explained that demand is have a big effect on consolidation, as much of the industry’s M&A activity is being driven by companies looking to acquire technologies to expand their capabilities to address the issue.

A few examples Miller gave included Catalent acquiring Micron Technologies, a micronization specialist and Capsugel buying Bend Research, a spray-drying technology company.

Most recently, Aptuit announced it acquired Kucept, which expanded the company’s capabilities in formulation development to include specialist pre-formulation, formulation prototyping and formulation development services.

According to Aptuit, the acquisition, announced May 10, was in response to a “strong customer demand,” for these services.

“Certainly reaching for the technology has been a big driver of the M&A activity,” added Miller, “and then you have a situation with Consort Medical which has tried to combine its device capabilities with a contract manufacturing capability [Aesica] so it can offer a full-service device and filling offering to the market.”