There has been a barrage of investment in flexible single-use capacity in the burgeoning China market. But as the sector matures and projects move to commercial, developers are likely to opt for fixed stainless-steel facilities, says BioPlan Associates.
Biomanufacturing in China is blossoming, driven by changing regulations and a surge in investment, which have created a pathway for Market Authorization Holders (MAHs) and domestic third-party manufacturers alike.
In the recent CPhI Worldwide annual report, Vicky Qing XIA, senior project manager at life science analysis firm BioPlan Associates, wrote that Chinaâ€™s biologics market has grown from under $1 billion (â‚¬900 million) in 2012 to a projected $50 billion in 2021.
With a CAGR of 16%, it is no surprise that news channels are full of articles about investments in facilities and infrastructure to support the growing biopharma space. But most of the stories being reported focus on single-use capacity investments.
Recent investments in Chinese facilities come from drugmaker BeiGene and contract manufacturer Lonza, both of which harnessed GE Healthcareâ€™s prefabricated KUBio platform based on single-use equipment, as did JHL BiotechÂ andÂ Pfizer before them. Boehringer Ingelheim recently expanded its single-use facility in Shanghai, adding two 2,000 L single use bioreactor manufacturing lines. Meanwhile, WuXi Biologics is undergoing huge investments across China (and overseas) to build its capacity, with all of its ten facilities based on disposable technologies.
â€śYou see a lot of news on single-use technology in China, which is natural, as it is more trendy especially if a company starts a pilot-scale facility, it may be 100% single use,â€ť XIA told Bioprocess Insider.
â€śAt the current stage, most of the single-use technology are adopted by CMOs for both clinical and commercial scale manufacturing, or by biopharma developers for clinical manufacturing.â€ť
But while the future of Chinaâ€™s biopharma market is bright, it is also likely to be stainless, XIA said.
â€śWhen biopharma developers consider commercial scale bio-production, they tend to prefer stainless steel as it is cheaper. As more projects go to the clinical stage or even to the market, we will see more stainless-steel facilities being constructed or expanded.â€ť
Despite the headlines, numerous biopharma companies are already using stainless steel technology, she continued. 3S Guojianâ€™s 38,000-liter mAb facility in Shenyang and Qilu Pharmaâ€™s new facility in Jinan are examples, but more information can be found in BioPlan Associatesâ€™ Top 60 China Biopharma Directory.
â€śAll the insulin makers use stainless steel bioreactors,â€ť she continued, adding that â€ścases of commercial scale bioproduction by domestic biopharma companies being solely dependent upon single use technology are very rare, if they do exist.â€ť
According to Xia, Chinese developers tend to manufacture in-house when they reach the commercial stage, and as product success becomes more assured, Chinese investors want to guarantee capacity while keeping long-term costs lower and will therefore look to fixed facilities.
â€śWe see many developers outsource pilot-scale production but would plan to build their own facilities when their project goes to late clinical stage.
â€śWhen Chinese developers build commercial scale facilities, they witness a high preference of stainless-steel bioreactors over single use ones. Therefore, there are industry-insiders who believe the growth rate for stainless steel bioreactors may go up while the market for single use technology cools down in the next decade.â€ť