Patricia Van Arnum
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Continuing growth in biopharmaceutical product revenues and pipeline candidates bodes well for the contract biologics market. Worldwide revenues
for biopharmaceutical products is estimated to exceed $65 billion in 2007, and the proportion of pharmaceutical revenues from
biotechnology drugs is estimated to surpass 10% of the total market (1).
Growth in contract manufacturing
Global spending on biopharmaceutical contract production was estimated at $2.1 billion in 2006, according to a recent study
by HighTech Business Decisions (San Jose, CA) (1). This level is expected to rise to $2.8 billion in 2008 and $4.3 billion by 2009.
A 2500-L mammalian cell culture bioreactor in one of Laureate Pharma's manufacturing suites. Photo: Laureate PHARMA
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On a supply level, between 2004 and 2008, worldwide contract manufacturing capacity for biopharmaceuticals is expected to
grow by approximately 40% (1). Measuring capacity in tank liters under the two broad categories of microbial fermentation
and mammalian cell culture, the study shows that biopharmaceutical contract manufacturers' installed capacity for microbial
fermentation will reach 300,000 tank liters by 2008, an increase of 15% from two years ago. Biopharmaceutical contract manufacturers
also plan additional follow-on capacity expansions throughout the next five years. (This estimate includes capacity for biopharmaceutical
production only; microbial capacity that is used for microbially produced small molecules or products such as antibiotics
is not included.)
Market growth for monoclonal antibodies
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Worldwide outsourced mammalian cell-culture capacity is expected to reach 670,000 tank liters by 2008, a 21% increase from
two years ago, according to HighTech Business Decisions (1). As with microbial-fermentation capacity, biopharmaceutical contract
manufacturers plan follow-on capacity expansions during the next five years.
Inside Big Pharma: Ramping up internal biologics capacity
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Capacity utilization. Biopharmaceutical contract manufacturers report average utilization rates of 72-87% for microbial fermentation production
capacity. Average capacity utilization rates for mammalian cell-culture production vary from 65% to more than 90%. In both
instances, capacity utilization rates are expected to increase during the next two years and then drop slightly as current
and planned capacity expansions come on line (1).
Investments by top players
Several top CMOs are expanding capacity. Based on revenues, the top biopharmaceutical CMOs include Avecia Biologics (Billingham, United Kingdom), Boehringer Ingelheim (Ingelheim, Germany), Diosynth Biotechnology (Morrisville, NC), Lonza (Basel, Switzerland), and Sandoz (Holzkirchen, Germany), according to HighTech Business Decisions.
Lonza. Reflecting strong growth in its biopharmaceutical business, Lonza is investing in microbial and mammalian cell-culture production.
Following its $460-million acquisition of Cambrex's (East Rutherford, NJ) bioproducts and biopharmaceutical business in February,
Lonza named Hopkinton, Massachusetts, as the global US headquarters for its microbial biopharmaceutical business and announced
plans to invest more than $30 million in its Hopkinton site to support growth plans for microbial process development and
manufacturing. The Cambrex acquisition gave Lonza additional biopharmaceutical services capabilities and small-and mid-scale
microbial manufacturing capacity to complement existing microbial capacity in Visp, Switzerland. Lonza started producing current
good manufacturing practices (CGMP) batches at a new 15,000-L microbial biopharmaceutical line in Visp earlier this year,
and a second line is now operational.
