January 15, 2010 (Vol. 30, No. 2)

Transgenic Animal and Plant Production Is the Only Obstacle to Rapid Growth Through 2013

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.

Cell culture by market segment

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.

World Market

The world cell culture market is expanding at double-digit rates and is expected to maintain this momentum through 2013. Worldwide sales are estimated to have reached $1.87 billion in 2008, up 12% from 2007. Cell culture sales are expected to increase at a compound annual rate of 13% over the forecast period, 2003–2013, to reach $3.4 billion in 2013.

As a result of considerable ongoing consolidation activity among cell culture suppliers, the market is dominated by a handful of large companies. The market leaders in the cell culture supply market have well-respected, long-standing reputations and brand names. These market leaders have broad and deep product lines, as well as extensive worldwide distribution systems, which sets the bar high for new, smaller companies to enter this market. However, for large competitors there is one certain route of entry into the cell culture market—acquire a brand name.

Vaccines, Stem Cells, and Biosimilars

In March 2009, President Obama lifted the Bush administration’s restrictions on federal funding of human embryonic stem cell research. This should advance development of novel approaches to treating illnesses for which there are currently few if any therapeutic options. The development of culturing protocols and technologies for stem cells will, in turn, boost the cell culture market.

The cell culture market will continue to be strengthened by biomedical research. In cell biology research, cell-screening technology is important in finding high-producing cell lines, and research is now focused on how to predict growth characteristics of cells at an earlier stage. Progress in the future will come from processes  such as metabolic engineering that will aid in improving cell lines. Going forward,  cell-line improvement will continue to be a main focal point of research. Biomedical research and bioprocessing have a wide range of supply needs, including high-quality media and reagents for fermentation and cell culture.

Stem cell research will also add to the robust growth of the cell culture market. The growing use and diverse applications of stem cells are having a significant impact on the media market, as companies work to understand how best to optimize their growth. For stem cell applications, serum-free media that lacks growth factors, cytokines, or artificial stimulators of proliferation will play an increasingly important role.

An additional driver of the cell culture market will be generic biopharmaceuticals, also referred to as biosimilars, follow-on proteins, biogenerics, comparable biologics, follow-on biologics, or generic biologics.

A possible threat to the future of the cell culture market is the production of biopharmaceuticals in transgenic animals and plants. Transgenic domestic animals and plants as a manufacturing method for biopharmaceuticals has the potential to improve scalability and yield of cell culture and fermentation systems, which will reduce the cost of producing biopharmaceuticals. In recent years, the number of proteins developed, as well as the types of transgenic platforms used for production, have increased significantly.

Finally, a greater call for a faster vaccine-production method is predicted. The distribution complications associated with H1N1 vaccines, which are still egg-based and labor-intensive, made it abundantly clear that alternative methods are necessary. Vaccines produced using cell culture will be an important driver of the market in the near future.

Bruce Carlson ([email protected]) is publisher at Kalorama Information. More information on Cell Culture: The Market for Media, Sera, and Reagents can be found at www.kaloramainformation.com.

Previous articleReporting from J.P. Morgan Healthcare Conference
Next articleStem Cell Utility Limited by Lack of Ethnic Diversity