Global biological-therapies manufacturing capacity is slated to double “by 2020,” writes analyst Paul Knight, in a report to clients of Janney Montgomery Scott, the Philadelphia investment bank and brokerage.
One clear sign: “From 2000-2013, Biological License Applications made up 11 percent of all (U.S. Food and Drug Administration) approvals for New Molecular Entities” — but since 2014, similar approvals have more than doubled, to 29 percent. And most of the approvals are now in the first cycle, which means there’s a fat pipeline of future products in the works, according to the report.
“We attribute this development to the targeted nature of biological therapies,” Knight added. “This gives BioPharma a higher level of confidence in potential FDA approval in comparison to a small molecule therapy and creates a virtuous cycle whereby BioPharma will increasingly invest in biologics due to their increased likelihood of success.”
Among the growth stories Janney lists in its report is WuXi Biologicals, an affiliate of China-based WuXi AppTech, which has R&D labs at the Philadelphia Navy Yard office development. WuXi Biologicals earlier this month raised $511 million in an initial public stock offering (IPO) on the Hong Kong exchange for its contract development and management organization, notes analyst Knight in his report.
WuXi Biologics went public on the Hong Kong Stock Exchange on June 12 at HKD$20.60 a share. It rose 37 percent to about HKD$28 in its first day’s trading, and traded above HKD$30 for the first time on July 5. (1 HKD$ = about $. 12)
WuXi Pharma also has operations at the Yard.
WuXi has a commanding 36 percent of the China biologics outsourcing market, which is growing at more than 18 percent a year and is expected to triple to over $3 billion from 2005 to 2020, according to Frost and Sullivan researchers cited in the Janney report.
“The company is adding 30,000 (liters/year) of manufacturing capacity” at WuXi, in Jiangsu province north of Shanghai, and another 7,000 at Shanghai, according to the report.