Predicting the demand for cell culture products is not hard as the segment is, for the most part, closely tied to the biopharmaceutical market. When there is interest in biopharmaceuticals, there should be interest in the materials needed to make them. It is not surprising then that the more than 400 biopharmaceutical products in clinical trials are driving growth in the cell culture products market. When one considers the current industry focus on three product categories—vaccines, stem cell therapeutics, and biosimilars—all of which will rely on cell culture products, prospects for growth in cell culture sales seem especially sanguine.
Many biopharmaceuticals are produced by bacteria, others by yeast, and still others in hamster ovaries or other animal cells. These cells deteriorate, die, and disintegrate without the proper nutrients and conditions. Nutrients are provided to cultivated cells in the form of a medium. Different kinds of cells require different cell culture products. In addition to the nutritive elements, media sometimes contains additives designed to improve the fermentation process.
There are three categories of cell culture products on the market—media, sera and reagents. Media represents the largest portion, about 40% of the marketplace. Serum-based media is widely used to grow a broad range of animal cell types and cell lines such as Chinese hamster ovaries or murine myeloma cells. The most common media used for microorganisms, primarily used for the growth of bacteria, is Lysogeny broth, a nutritionally rich medium.
Most animal cell-based cultures require serum supplementation, which is commonly used as a supplement to growth medium. Serum binds or neutralizes toxic components in the growth milieu and raises the buffering capacity of the medium. The selection of a serum supplement for cell culture applications depends on the chemical composition of the basal medium, the type of cell to be grown, and the culture system being employed.
As a result of the shift from traditional serum-supplemented media to serum-free and animal product-free media, sera sales are decreasing. Sales in this segment once enjoyed increases of about 10% annually, but are now slowing to annual increases of only about 3%.
Reagents, or cell culture media components, represent about 38% of product sales in the sector. In addition to maintaining the culture environment at a stable pH and temperature, cells require growth factors and other nutrient components. To establish the optimum environment for cells, cell culturists use a wide variety of reagents. A particular cell line dictates the exact combination and type of reagents chosen.
The reagents segment of the cell culture market is poised to experience big gains. Companies and research laboratories that work with cell culture want to grow cells cost efficiently, at the same levels as are possible with sera products but in serum-free environments. Typically, this requires the addition of growth factors, lipids, substitutes for transferrin to replace its iron-carrying function, alternatives to albumin that can replace its carrier properties, compounds that can replace the detoxification properties of serum, and specific attachment factors.
Traceability of Media Components
Biopharmaceutical manufacturers, at the urging of the FDA and EMEA, are concentrating on higher levels of compliance earlier in the drug-discovery process. To this end, manufacturers are requesting that their suppliers provide specific information, i.e., what is in the media, and also requesting an accounting of viral inactivation steps. This, in turn, is driving suppliers to pay closer attention to traceability of media components, which is being achieved through more frequent audits of vendors to determine the source materials and processes used to develop the product.
Serum-free media is proving to be a viable alternative to traditional serum-containing media for the cultivation of cells. It has several marked advantages, including better definition of the composition, reduced contamination by adventitious and infectious agents, and lower cost. However, switching to serum-free products often involves hefty expenditures of time, capital, and experimentation before desired results are achieved.
As cell culture suppliers continue to make the transition to serum-free products, the number of effective serum-free and specialty cell cultures on the market is rapidly increasing. New products introduced under the major brands are all serum-free formulations.