Changes in the European Sterile Industry


At a cursory glance, the European sterile industry seems to have changed significantly recently, with acquisitions and exits dominating the headlines. But how much has really changed?

The demand for sterile injectable manufacturing is clear. The development of oncology therapies and an increase in the number of large-molecule drugs under development, which require administration by injection, is fueling this demand.

In response to rising demand, market growth has stimulated some notable activity lately, including AMRI’s 2015 acquisition of the Aptuit fill/finish facility in Glasgow. “We are well established with fill/finish and parenteral capabilities in North America, but we want to extend our reach into mainland Europe, as well,” said CEO William Marth.

The acquisition will not likely affect the European market significantly, as it does not actually increase the number of drug development countries or the number of manufacturing facilities providing sterile injectable drugs or sterile equipment. While the move toward consolidation is clear, especially considering AMRI’s acquisition of OsoBio in 2014, the aseptic manufacturing market continues to be fragmented, with a number of large and small companies.

Further deals between large contract development and manufacturing organizations, or CDMOs, are likely with the continual evolution of the competitive landscape within the European sterile market. While these deals will certainly grab headlines, they will probably not change the market significantly, other than perhaps giving clients fewer choices between the large CDMOs and specialist sterile manufacturing providers. Symbiosis and other specialist contract manufacturing organizations, or CMOs, typically offer greater operational flexibility and can therefore move clients through the development stages faster than the larger CMO/CDMOs.

The Big Change in the European Sterile Industry Is Its Small Players

As the European sterile industry continues to grow and develop, players of all sizes in the sterile industry must offer a high level of service excellence to their customers. This is especially true when it comes to demonstrating regulatory compliance to the highest standards. While larger companies grab the headlines, small companies may have a unique advantage for growth.

Many European customers now prefer the freedom to choose from a variety of smaller sterile equipment makers as a time- and cost-efficient way of reaching drug-development milestones and generating corporate value. This trend will likely perpetuate the growth of the smaller specialist companies in a way that ensures healthy corporate competition.

The keys to growth for smaller companies in the European sterile industry will be remaining focused on their primary manufacturing goals and delivering precisely what their customers need.

While perhaps not deserving of the headlines it receives with major acquisitions and exits, the European sterile industry is making incremental changes that will forever alter sterile manufacturing in Europe.


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