Staying ahead of the competition and government regulations while meeting customer demands in today’s ‘fast and furious’ world of drug development and manufacturing is no easy challenge. And making the cut as a contract service provider keeps getting more and more difficult.

This is especially true as pharma and biopharma companies look to consolidate the number of contract manufacturers they engage. Large to mid-sized pharma may have up to 400 individual suppliers for a product, let alone intermediates! Even small virtual companies with a fairly limited portfolio may have over 100 different touch points with service providers.

As a result, there is a push to reduce the number of contractors.

Sponsors today demand quality, reliability and technical expertise from their service providers. Add to that the increasing demands for flexibility and responsiveness as clinical timelines accelerate, and also the ability to handle more complex molecules.

The challenge of delivering high quality product on time, or ahead of schedule, is daunting. But, for the service providers who are up to the task, opportunity abounds.
The biopharma market is growing at between 10-15% annually in sales of biologics, which are in excess of $200 billion. But it’s the strong interest in biosimilars that is really fueling growth. The global biosimilars market was worth about $20 billion by the end of last year and could exceed $55 billion by 2020.

Add to this the fact that the percentage of facilities performing all production in-house shifted from 57% in 2006 to 35% in 2015, the lowest point in a decade, according to industry sources. There is tremendous opportunity in the biopharma contract manufacturing industry as the demand for outsourced services increases, but only for those service providers who are up to the task.

The CMOs we spoke to for this issue’s Bio CMO Report, all said that better customer service coupled with manufacturing quality products on time and within budget are the hallmarks of success in today’s market.

In addition, externalizing key aspects of a biologic product’s development and manufacturing takes a certain degree of trust to be established with a partner. One CMO said that biopharma companies are becoming increasingly comfortable working with external partners for these services and every time they are able to execute on time or successfully apply their technology or expertise to solve a development challenge, trust is built that encourages future collaborations.

Tim Wright, Editor
twright@rodmanmedia.com