CHINESE PHARMA MOVES TO BIOLOGICS
With the new State Drug Administration (SDA) reforms streamlining the approval process of new drugs originating overseas and the launch of biosimilar versions of mAbs by domestic companies, the structure of China’s pharmaceutical consumption will shift toward a greater market share of biological therapeutics, especially more complex molecules. Although China is still an under developed market in this sector, the penetration rate, especially of the more complex biologics, will increase. Multiple sales statistics show that the biopharma market grows faster than the pharma industry as a whole, and that mAb therapeutics market grows faster than the biopharma market. BioPlan’s internal research also shows that China is likely to approve new gene therapy/cell therapy products in the next decade, since dozens of them are already at the clinical trial stage, although possibly only after the approval of such products in the U.S. and EU.
CHINA'S EXPORT AMBITION
Besides the growth of China’s domestic market, biopharma manufacturers are strongly motivated to export their products to the global market, including the regulated market in the U.S. and EU. BioPlan’s 2017 research, including interviews with 50 biopharmal manufacturing executives in China, confirmed that the country is making efforts to become a global contract bio-processing hub.4 Multiple executives from CDMOs in the industry, including Dr. Li Zhiliang, CEO/founder of AutekBio, are confident that biopharmaceutical will be the next sector that China will lead as a contract manufacturer. As Zhiliang puts it, “This industry is not unique at all. What has already happened in the textile, toy, and mobile industries will happen in the biopharmaceutical sector as well.”
With government subsidies and an influx of returning scientists, contract manufacturing of biologics in China has the potential to offer a cost advantage for global biopharma companies, which will see multiple therapeutic biologics go off-patent in the next decade. Outsourcing the manufacturing of these older products will also enable companies to focus on developing core products.
Despite its relatively late start, a number of major driving forces are pushing the robust growth of China’s biopharma industry, as well as driving the country’s efforts to become a global contract bioprocessing hub.
1. Xia, V.Q., et al, Advances in Biopharmaceutical Technology in China, 2nd edition; Society of Industrial Microbiology and Biotechnology and BioPlan Associates, Inc., October 2018.
2. Trading Economics. China GDP. 2018.
3. Barton, Dominic, et al, Mapping China’s Middle Class. McKinsey Quarterly, June 2013.
4. Langer, E.S., et al., 15th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates, Inc., April 2018.