Biomanufacturing Morphs

Among the 186 vendors and suppliers we surveyed, single-use bioreactors were the area where the largest portion, 40.5%, reported working, at least in some way, on new technologies and products. Thus, improvements and innovations can be expected in coming years.

A trend in bioprocessing technology to watch is the development and adoption of perfusion bioreactors, which appear on track to revolutionize biopharmaceutical manufacturing. Perfusion bioreactors involve cells growing at up to 1,000 times higher concentration than batch-fed bioreactors; they require less space and offer related cost savings. Perfusion is not new, with a number of companies offering these bioreactors back in the 1970s and 1980s, mostly for hybridoma (monoclonal antibody) culture, but these were abandoned when recombinant manufacturing became dominant in the 1980s and 1990s.  

Biosimilars: More Products, More Companies
Perhaps the most disruptive emerging trend involves the introduction of biosimilar products (including biogenerics and biobetters). As these are introduced, they may significantly increase the number of drug products and companies in coming years. Last year, the U.S. joined other major market countries in establishing a biosimilar approval mechanism, although it will take FDA a few more years to fully implement. Already, over a dozen biosimilars have been approved in the European Union.

Compared to generic drugs, biosimilars are likely to be much less of a threat to established manufacturers. Unlike generic drugs, few true biogenerics (i.e., products presumed to be the same, with automatic substitution for their reference products allowed) will be approved in the U.S. and other major markets in coming years. Most highly-regulated countries expect to have difficulties with approvals of biosimilars, which are not presumed to be identical for prescription purposes. And price discounts by biosimilars will be much smaller, because biologics tend to be more expensive to manufacture than generic small-molecule drugs. Thus, biosimilars will not dramatically disrupt established biopharmaceutical markets the way generic small molecule drugs have done.   

Despite this, biosimilars will result in a significant expansion of the number of biopharmaceutical products and companies. For every successful product coming off-patent, there will likely be multiple biosimilars in the marketplace. This will result in an increase in biopharmaceutical manufacturers and marketers worldwide, and a higher demand for experienced staff, equipment, and management. Further, biosimilars are seen by many companies, including generic drug and foreign companies, as a relatively easy way to enter the U.S. and other major markets. This includes a number of companies in India and China likely to seek approval of biosimilars in the U.S. and other major markets.  

However, getting biosimilars to the market will not be an easy task. With few precedents, regulatory approvals are not assured. Other threats to biosimilars could include older reference products being withdrawn from the market, or replaced, as biosimilar competition approaches. This may make comparative testing difficult, resulting in the need for clinical trials for biosimilar approval. As a result, the biosimilar version may require a full approval, involving higher expenses. Other problems for biosimilars include there simply being too many competing products. With companies seeing biosimilars as a way to enter major markets, competitive pressures may disrupt markets and reduce profitability.  

Summary
Trends in biologics today point toward increased growth and profitability, in contrast with some mainstream small-molecule-oriented pharmaceutical industry segments. Major trends affecting the biopharmaceutical industry include increasing company budgets; the adoption of single-use/disposable equipment and other bioprocessing advances that improve cost-savings, quality, productivity, and flexibility in manufacturing; and the advent of biosimilars increasing in the number of biopharmaceutical products and companies present in the market in coming years.

There are currently about 425 biopharmaceuticals in the major U.S. and European Union markets. And there are around 60 product applications either pending or expected to soon be filed with FDA [2]. With ever-increasing knowledge, technological advances, successful products and companies, and improving manufacturing economics, biopharmaceuticals are a bright spot within the pharmaceutical industry. Biopharmaceuticals currently provide around 15% of pharmaceutical industry revenue. This will increase rapidly in coming years, with an estimated 40% of pharmaceuticals currently in development being biopharmaceuticals.

About the Author
Eric S. Langer is president and managing partner at BioPlan Associates, Inc., a Rockville, MD-based biotechnology and life sciences marketing research and publishing firm established in 1989. He can be reached at elanger@bioplanassociates.com or 301-921-5979.

References
1.    Langer, E., 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production:  BioPlan Associates, April 2011, 490 pages, www.bioplanassociates.com.
2.    Rader, R.A., BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets, online database, www.bioplanassociates.com/biopharma.