Report: Biopharma Industry’s Growth Driven By mAb Development
The report from BioPlan Associates found that as mAbs saw more than $14bn in revenue growth between 2009 and 2012, they are “increasingly perceived as a relatively secure investment, with antibodies being very targeted/specific, relatively non-toxic, and an increasing number of antibody design and genetic engineering/expression system platforms becoming available,” Eric Langer, partner at BioPlan, told BioPharma-Reporter.
The 10th annual report on biomanufacturing was derived from a survey of 238 corporate executives at biopharmas, 158 employees of industry vendors and direct suppliers of materials, services and equipment, and 10 years of data.
Manufacturing Investments
As far as what biopharma companies are looking to invest in, a near majority of the industry expects to see 100% fully disposable facilities in operation within five years.
In fact, single use systems growth is seen as similar to that of the biopharma industry overall, which means the industry is “effectively doubling every 5 years,” according to the report.
More specifically, companies said they are investing in new technologies to increase productivity. These increases include a reported average 5.5% increase in process development budgets; 4.9% increase in budgets for both upstream and downstream manufacturing technologies and; 4.7% increase for new capital equipment.
2013’s top four projected single-use budget expenses per facility include:
- Single-use depth filters ($204,000);
- Depth filters ($174,000);
- Bioreactors ($169,000); and
- Buffer containers ($158,000).
In terms of specific single-use bioreactors, batch-fed bioreactors was the most commonly cited bioreactor for adoption, although significantly fewer respondents said the same for commercial manufacturing jobs. Single-use perfusion bioreactors were also less frequently cited by respondents.
In addition, “new facility construction ranked at the very bottom in terms of areas” that companies sought to spend their funds on with budget increases.
Modular Bioprocessing Facilities
In order to speed construction of bioprocessing facilities, a number of equipment, technology developers and vendors are developing modular approaches, even for commercial manufacturing.
Such facilities may involve situating prefabricated bioprocessing modules or suites within their own portable trailer- or shipping container-based clean rooms or isolator units. Companies would then be able to assemble bioprocessing systems using customizable modules.
According to the report, GE is among the leaders in developing these technologies, and its acquisition of Xcellerex, which was previously the largest single-use systems manufacturer, will likely accelerate GE’s control of this area of the market.
Supplier, CMO Areas of Interest
When asked, “What are the top five areas you want your suppliers to focus their development efforts on?” nearly half of respondents said disposable products, which included “bags and connectors” (44%, up from 40% in 2012), followed by “probes and sensors” (40% vs. 36% last year), “single-use bioreactors” (34% vs. 32% last year), and “Single-use purification products” (34% vs. 29% in 2012).
Despite these interests, the survey suggests the rate of outsourcing is slowing as industry is likely “running out of tasks susceptible to outsourcing.”
CMOs (contract manufacturing organizations), however, were found to have double the interest in improved single-use purification products when compared with developers, which may sugguest some areas left to be outsourced.
Among CMOs, Lonza was cited as having the largest mammalian cell culture capacity in terms of cumulative bioreactor volumes, and is followed by Boehringer Ingelheim and Celltrion.
