This article is part of PharmTech's supplement "Bioprocessing and Sterile Manufacturing 2010."
Figure 1: Companies producing small molecules and biopharmaceuticals versus biopharmaceuticals only.
It is hard to ignore the asendancy of biopharmaceuticals within the pharmaceutical industry. First, there were the megamerg-ers:
Pfizer-Wyeth, Merck-Schering-Plough, and Roche-Genentech, motivated in part by Pfizer, Merck, and Roche s desire to improve
their biopharmaceutical positions. Then there was the defection of Roche from the Pharmaceutical Research and Manufacturers
of America (PhRMA) to the Biotechnology Industry Organization (BIO) to better brand itself as a biopharmaceutical manufacturer.
Finally, we have the results from our 2010 Bioprocessing Survey: Practically a quarter of respondents say their companies
just entered the biopharmaceutical manufacturing space in 2009, and over 50% of respondents report that their companies added
biopharmaceutical manufacturing capacity in 2009. We reached out to the readers of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International to take the pulse of the biopharmaceutical sector. More than 380 industry insiders, representing small biotechs and large
pharmaceutical companies with revenues ranging from under $50 million to over $50 billion, in the US and abroad, completed
the survey in January. What follows is a snapshot of the current biopharmaceutical industry—its products, challenges, triumphs,
Products and processes
Almost 48% of respondents work for companies that produce biopharmaceuticals exclusively; the remaining 52% work for companies
that produce both small-molecule drugs and biopharmaceuticals (see Figure 1). Twenty-five percent of respondents just entered
the biopharmaceutical space in 2009, and 56% of all respondents report that their companies increased their biomanufacturing
capacity within the past year.
There was a clear pattern, in terms of the revenue levels of companies adding biopharmaceutical capacity. About a quarter
of those adding capacity work for companies with annual revenues under $250 million, suggesting that these small-cap companies
are late-stage biotech startups installing capacity for their first few products. The percentages dip down among the mid-cap
companies and then rises again, to about 27% of respondents from large-cap companies with annual revenues in excess of $10
billion adding capacity. These numbers may well reflect capacity acquired through this year s megamergers.
Among those adding capacity this year, 51% increased production of an existing product (versus 59% last year); 53% added new
products to their line. Twenty-one percent added capacity through the acquisition of a new company with a biomanufacturing
program (down from 28% last year), and 20% in-licensed drug products (down from 24% last year) (see Figure 2)
Figure 3: Classes of compounds produced by respondents (multiple answers allowed).
Respondents produce the same product classes as last year and in approximately the same relative proportions (see Figure 3).
Nevertheless, some product classes have seen small declines over last year's levels, possibly reflecting the fact that companies
are shelving some riskier product lines. At 54%, the highest product class remains protein-based drugs other than monoclonal
antibodies (mAbs). mAbs came in second, with 40%, followed closely by vaccine production, at 36%. This year, only 12% of respondents
say their companies produce nucleic-acid based products, down from 18% last year, and 10% say their companies are involved
in the production of cells for tissue- and/or cell-based therapies, a drop of 7% from last year's level. Forty-one percent
of respondents anticipate that their companies will manufacture follow-on biologics, while 22% say their companies will not.
The remainder do not know.
Figure 4: Current technical challenges confronting manufacturers of protein-based drugs (multiple answers allowed).
Protein producers continue to grapple with problems producing high-enough yields (49% of respondents who produce protein-based
products), purifying the high yields they do produce (47%), and stabilizing the product (43%). Formulation (29%) and regulatory
issues (29%) are also problems for respondents (see Figure 4). For those working with nucleic-acid-based drugs, delivery and
purification top the list of challenges, with each of those troubling about 40% of respondents. And nearly 40% of respondents
also had problems with regulatory issues, stability, or formulation. In fact, for producers of nucleic-acid-based drugs, the
only thing that seemed not to be a challenge was expression levels, with only 20% reporting some difficulty.
Process development and scale-up were the two largest challenges confronting manufacturers of cells-for-tissue and cell-based
therapies, with about 45% reporting difficulty with each of these two aspects. Other challenges included formulation (confronting
a little over 40% of respondents), followed by stability, regulatory, and cost issues for about 30% of respondents each.
Vaccine manufacturers prefer cell-to egg-based production systems about 2 to 1, and 30% of those using egg-based systems plan
on changing to cell-based systems. Those who don't plan to switch cite higher product yields and lower costs as reasons. However,
almost 70% say they'd consider moving to an egg-based system if the costs of retrofitting an egg-based operation to accommodate
a cell-based process were sufficiently low.