Growth will be driven by the development of new mAbs and vaccines; an increasing number of biosimilar approvals; an expansion of manufacturing in emerging markets; an increasing local self-sufficiency for blood plasma production; and the development of vaccines for flu and other global pandemics, according to the TriMark Publications’ report, exclusively viewed by BioPharma-Reporter.com.
New advances in cell cultures are causing downstream bottlenecks that make it difficult to purify high levels of protein. Now companies are turning to new technologies to improve downstream processing.
Designing a downstream process is difficult because “the ability to characterize the identity and structure and measure the activity of the clinically active component is limited,” according to the report. As it can take an average of 15 years and between $1B and $2B to develop a new biologic, more manufacturers are looking to new solutions to increase their efficiencies.
The global bioseparation market is controlled by five companies, which collectively have 69% of the market share: GE Healthcare Life Sciences (23%), Merck Millipore (17%), Pall Corporation (16%), Sartorius (7%) and 3M Cuno (6%). GE is also the leader in chromatography offerings, with the company claiming that their media and columns are used in 90% of all biopharma manufacturing.
The breakdown of the other particular markets within the bioseparation systems includes:
- Chromotography columns and media, representing 50% of the bioseparation market, or $1.63B, and projected to grow at an annual rate of 10.5% through 2018;
- Membranes and filters: $1.24B, growing at an annual rate of 12%; and
- Centrifuges: $390M, with a growth rate of about 6%.
Pall and Merck Millipore, however, dominate the market for filters, tangential flow and hollow fibers membranes and systems. Sartorius, a leader in membrane chromatography, is “becoming a strong competitor in the US and Asia,” according to the report, while 3M Cuno is known for their depth filters, positively charged filters and viral reduction filters.
Almost half of the world’s biomanufacturing facilities are in North America, while 28% are in western Europe and 23% in Asia. Bristol-Myers Squibb, Eli Lilly, Abbott and Baxter BioScience are the companies most heavily investing in manufacturing capacity.
Single-use bioseparation systems are catching on slowly, however, because scaling up the technology is limited to the size of the bioreactor. For instance, disposable bags for bioreactors are designed for up to 2,000 L cell culture volume for the production of clinical or pilot scale quantities. Larger bags are not feasible because they are difficult to handle and not cost-effective for large batches, according to the report.
Various examples of companies that use single use bioseparation systems include:
- CMO Renschler Biotechnologie uses two 1,000 L single-use batch fed bioreactors with CHO cells to produce a mAb titer;
- Novavax for its vaccine development;
- Pall Alegro and Merck Millipore Mobius use single-use systems for tangential flow, depth filtration, viral clearance and chromatography; and
- Sartorius has led the way with the first disposable membrane absorber to replace ion exchange chromatography in producing a US FDA-approved mAb therapeutic.
A number of vendors, including Merck Millipore and Sartorius, also offer single-use depth filter systems for clarification of up to 12,000 L bioreactor scale volumes.
The $3,400 report also includes an in-depth breakdown of a number of the different major and minor companies involved in the bioseparations business.