Hurdles and opportunities in the pharmaceutical outsourcing industry

The past decade has seen vast growth across the CDMO market, says Andrew Henderson, Sales and Marketing Director, Sterling Pharma Solutions

In fact, Market&Markets predicts that there will be a US$96 billion strategic outsourcing industry by 2025. This has been driven by the complexity of new molecules entering the drug development pipeline, increased demand for personalised therapies and the need to get drugs to market quickly, efficiently and at minimal cost.

Many large pharma firms are moving towards the outsourcing model for large-scale manufacturing requirements. This is partly because of the need for specialist knowledge and expertise, which CDMOs such as Sterling have developed through years of experience.

This would require significant investment in training or resourcing should Big Pharma companies look to develop this in-house. Outsourcing their requirements also allows for greater flexibility around product supply and demand … and enables them to refocus their own efforts on their core capabilities, including R&D and exploring new molecules.

We’ve also seen a rise in small, virtual pharma companies in recent years. These companies need to outsource all of their requirements as, by their very nature, they have no internal capabilities. In this instance, CDMOs that can provide a full-service offering often find themselves at a competitive advantage.

Logistically, virtual companies often don’t want to have multiple companies in their supply chains as this can lead to additional project management, extend a product’s time to market and increase costs.

Andrew Henderson, Sales and Marketing Director, Sterling Pharma Solutions

As a result of this increased demand for a single partner with multiple services, we are increasingly seeing CDMOs consolidating their offerings through merger and acquisition (M&A) activity. At Sterling, we recently acquired the CiVentiChem cGMP facility in Cary (NC, US) to offer a local presence to our customers in the US market and meet demand for our small-scale API development and manufacturing capabilities.

We are also seeing increasingly complex molecules entering the drug pipeline; CDMOs must have a range of capabilities to accommodate this. For example, Sterling is experiencing high demand for its hazard evaluation and process design capabilities, which often allow us to handle complex molecules more efficiently.

Discussing opportunities for growth in the CDMO space, Andrew explains that firms that continue to innovate and develop their offerings to provide new technologies or solutions will inevitably have a competitive advantage. These CDMOs will be able to offer solutions to key problems in the industry, such as exploring ways to handle certain hazardous chemicals more safely.

As M&A activity continues across the industry, CDMOs that provide high quality services, competitive offerings and strive to understand specific customer needs will be able to leverage their capabilities in multiple markets.

Challenges in the CDMO market certainly exist and there is growing demand for more streamlined processes that will help to improve efficiencies and ultimately get drugs to market as quickly as possible. Sterling has been exploring a number of technologies that could benefit customers, including continuous flow processing.

The procedure is run through a continuous reactor, a complex network of pipes with a small internal volume-to-surface-area ratio that theoretically enables manufacturers to achieve previously unattainable conditions, allows them to handle more volatile chemistries and access molecules faster and more efficiently.

In addition, because reactions take place on a smaller scale, only a small amount of product would be lost in the event of a pipe failure, which could save a huge amount of money and raw materials.

Using continuous flow processing could allow CDMOs to address the increasing pressure to drive down the cost of pharmaceuticals and reduce the risk of costly batch dumping.

The procedure can also help to mitigate the risks associated with potent products and chemistries. Because smaller product quantities are being handled, the potential for adverse reactions owing to fluctuating conditions is reduced; plus, as it’s also possible to quench by-products as they appear, these hazardous chemistries can be handled in a safer way.

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Sterling Pharma Solutions (more information, website)