Biologics Manufacturing Grows, But Small Firms Won't Benefit
By Nuala Moran
BioWorld International Correspondent
GLASGOW, SCOTLAND – The global capacity for manufacturing biologics is growing, but most facilities are controlled by a few major companies and used for their own products, creating difficulties for smaller biotechs with products that are approaching commercialization.
In addition, existing facilities are tailored for manufacturing blockbuster monoclonal antibodies, and therefore unsuited for novel, niche products coming through development such as antibody drug conjugates, antibody fragments, gene therapies or low-volume personalized treatments, according to Howard Levine, president of BioProcess Technology Consultants (BPTC), a firm that advises on biopharmaceutical manufacturing strategies.
BPTC, of Woburn, Mass., just completed a survey of commercial mammalian cell culture facilities worldwide.
"It's two-and-a-half years since our last survey, and one of the things we noticed was the concentration of capacity in a small number of companies: The top five now control 70 percent of capacity worldwide," Levine told BioWorld International. "People see lots of capacity, but they are misled – if you drill down and take captive capacity off the table, it's a very difference scenario."
Levine's advice for companies with biologics coming through their pipelines is to keep an eye on the situation. "We've been through a crisis of capacity shortage once before. Looking at data like ours, I'd say people will need to build more. In the next two to three years, we will start to see announcements," Levine said.
"If I were a CMO [contract manufacturing organization] I would be optimistic about the future and looking for opportunities to expand," he added.
The good news is that a combination of factors means the likely capital cost of building facilities is falling, Levine told delegates at the bioProcessUK conference in Glasgow, Scotland, last week.
While previously expression levels of 0.5 g to 1 g per litre were the norm, process improvements have driven that to 5 g per litre. The increase has been further augmented by better downstream processing.
At the same time, lower-cost, disposable bioreactors are now available at up to 2,000 litres, which may provide enough capacity for commercializing niche products, especially given that more targeted products mean doses are going down. Levine noted that Shire plc recently opened a new facility that uses only disposable bioreactors.
"At the 2,000 litre-scale, the increased cost of operation and the reduction in cost of building balance each other out. Operating costs are higher, but for a multiproduct facility, disposable bioreactors make more sense because change-over is easier," Levine said.
The last few years have seen a dramatic increase in the number of biopharmaceuticals that have been approved, and they now represent a large share of the total pharmaceuticals market worldwide. That growth is driven largely by monoclonal antibodies, with sales of recombinant proteins leveling off. Seven of the top 10 best-selling biologics are monoclonals, sales of which grew by 40 percent per annum between 2001-2010.
The top five product companies (Genentech Inc., a member of the Roche Group; Genzyme Corp., a Sanofi SA subsidiary; Johnson & Johnson; Pfizer Inc.; and Amgen Inc.) are sitting on sufficient capacity to accommodate future growth. But for the rest of the industry, with smaller-scale manufacturing, or relying on CMOs, the outlook is somewhat different, with capacity use heading to 75 percent by 2016.
"This would make you nervous, there's not enough room for tuning up, or failure in a production run," Levine noted.
Another factor to feed into the supply and demand equation is the growth of biosimilars. The 14 approved to date in Europe and in other markets are recombinant proteins, but monoclonal antibodies are starting to come off patent.
"In existing markets, I don't expect much impact because there will be substitution. But where I do see potential for a significant impact is in new markets, leading to an increase in demand for manufacturing," Levine said.
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