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.