Single-use tech will impact the 'extremely consolidated' bio-CMO space, expert

Speaking at this year’s CPhI Worldwide Pre-Connect Congress Monday, founder of PharmSource Information Services Jim Miller said while the small molecule contract manufacturing organisation (CMO) sector is extremely fragmented, the contract biopharma space is “extremely consolidated” ​and dominated by just two companies.

“In a sense it was born that way, with Lonza and Boehringer-Ingelheim being very early participants in the large molecule manufacturing industry having made the biggest investments in capacity and scale across multiple sites.”​

Over 50% of the market​

Both firms have invested heavily in their networks:

Lonza has four mammalian bioproduction sites (New Hampshire (US), Spain, UK and Singapore, microbial and ADC production in Switzerland​, and cell and gene therapy capabilities in Maryland​ and Texas​.

And through its BioXcellence contract manufacturing division, B-I offers 300,000 liters of cell culture capacity across two sites in Germany and the US​, a single-use GMP facility in China​ and 12,000L of microbial space in Vienna​.

“If you look at it from a revenue stand point and a capacity stand point they clearly dominate the industry, and the next level players like Fujifilm and CMC Biologics are significant but have relatively few NDA/BLA approvals at this point, and don’t have the large scale capacity,”​ Miller said.

According to his statistics, Lonza and B-I together are responsible for over half of all biologics made commercially by third-parties volume and revenue-wise, but this dominance could be challenged through the heavy investments being made by Korea’s Samsung Biologics.

“Samsung only has a small slither today but in terms of total capacity it has made a major commitment to the industry,”​ he said, though questioned how much of the expected 360,000L of capacity​ will be used for its own biosimilar-developing spin-out company Samsung Bioepis​.

[The Korean CMO recently told us it is not yet producing commercial product for Samsung Bioepis, a venture with Biogen which it has a 91% stake in. The CMO is working with Roche​ and Bristol-Myers Squibb​, however.]

Single-use, higher yields​

But what will likely change the industry, according to Miller is the move away from high-volume drugs coupled with the adoption of new technologies, such as single-use.

“Disposables and improved yields on cell culture are kind of changing the dynamics​,” he told the crowd in Barcelona. “You can participate at a much smaller scale than you used to be able to.”​

His comments somewhat justify a string of investments in single-use technologies by smaller CMOs. CMC Bio recently upped its offering​ by investing in several Thermo Fisher 2,000L single-use bioreactors configured to offer commercial production.

Meanwhile WuXi – which boasted to us of being selected ahead of B-I and Lonza to service a mAb contract on behalf of Taimed Biologics in 2014​ – recently opened a commercial-scale single-use plant in Shanghai, China​.