This article is part of a special issue on Bioprocessing and Sterile Manufacturing
Biopharmaceuticals continue to be the hot growth sector, and most revenue projections suggest that biopharmaceuticals will occupy an increasing number of spots in the top 10 highest revenue generators in coming years. Nevertheless, the results from the third annual Pharmaceutical Technology Bioprocessing survey indicate a slowdown in new entrants to the market. In 2009, more than 50% of respondents said they were entering the biopharmaceutical manufacturing arena for the first time. In 2010, only 23% did. But new entrants and veterans alike all face significant challenges and opportunities, and 249 respondents, representing firms large and small told us about them throughout March 2011.
Just as in years past, slightly under half of respondents (48%) produce biopharmaceuticals only, with the remainder working for companies that produce both traditional small-molecule pharmaceuticals as well as biopharmaceuticals. As in the past, there is a dramatic division in company revenues—the majority of respondents producing biopharmaceuticals only work at companies with revenues under $10 billion; the majority of respondents producing both biopharmaceuticals and traditional small-molecule drugs work for companies with revenues above $10 billion. Half of all respondents added biopharmaceutical manufacturing capacity this year, but they come from companies of all revenue classes, with 86% of respondents from companies with revenues up to $1 billion and 88% of respondents from companies with revenues more than $50 billion saying their companies increased capacity. Fifty-seven percent of respondents increased capacity because they added new products to their line (about 72% of those were products developed internally), and 52% increased production of an existing product. Approximately 18% of respondents acquired a company with a biomanufacturing program, and an equal number in-licensed a biopharmaceutical product that necessitated a capacity increase. Among those who decreased their capacity, 31% decreased production of an existing product, and an equal number outsourced production of a product that had previously been manufactured in house.
Figure 1: What class(es) of biopharmaceutical does your company manufacture? (multiple responses allowed)
Therapeutic proteins other than monoclonal antibodies (mAbs) continue to constitute the largest product class, produced by 51% of respondents, followed by monoclonal antibodies (45%), and vaccines (29%). These percentages reflect some interesting changes from last year's product mix. The percentage of respondents involved in monoclonal antibody production is up slightly, about five percent over last year, while vaccine manufacturing is down about seven percent. The percentage of respondents involved in nucleic acid products remained virtually unchanged—14% this year, versus 12% last year, while there was a slight uptick in the number of respondents producing cells for cell and tissue therapies, 14% this year compared with 10% last year. Forty-five percent of respondents say their companies plan to produce follow-on biologics, up slightly from last year's 41%. The remainder either will not (21%) or don't know (34%). Eleven percent of respondents say their companies produce only follow-on biologics right now, while 23% say they produce both follow-on and branded products.
Among those who manufacture proteins, producing adequate yields and purifying them remain the two most vexing problems, with an equal number—41%—of respondents identifying these as challenges. However, if we look closer, we find that 47% of those producing non-mAb proteins saying that purifying product is a challenge (versus 40% who produce mAbs). About equal numbers (45% of mAb producers; 43% of non-mAb producers) say producing high enough yields is a challenge. In general, the challenges in protein production are similar regardless of the type of protein produced, with about 44% of respondents of both classes of proteins saying they have problems with protein aggregates, and a slightly lower percentage expressing concern over protein stability.
Figure 2: What kind of equipment do yo uhave in your biopharmaceutical manufacturing facility right now?
Purification and stability are also issues for manufacturers of nucleic acids, with 47% of respondents identifying each of these as key challenges. At 33%, scale up is also a challenge for nucleic acid manufacturers. Process development is the major challenge for 43% of producers of cells for cell and tissue therapies, followed by cell stability (36%) and process scale up (34%).