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 China’s biologics market has grown from under $1 billion (€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 Healthcare’s prefabricated KUBio platform based on single-use equipment, as did JHL Biotech and 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.
“You 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,” XIA told Bioprocess Insider.
“At 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.”
But while the future of China’s biopharma market is bright, it is also likely to be stainless, XIA said.
“When 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.”
Despite the headlines, numerous biopharma companies are already using stainless steel technology, she continued. 3S Guojian’s 38,000-liter mAb facility in Shenyang and Qilu Pharma’s new facility in Jinan are examples, but more information can be found in BioPlan Associates’ Top 60 China Biopharma Directory.
“All the insulin makers use stainless steel bioreactors,” she continued, adding that “cases of commercial scale bioproduction by domestic biopharma companies being solely dependent upon single use technology are very rare, if they do exist.”
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.
“We see many developers outsource pilot-scale production but would plan to build their own facilities when their project goes to late clinical stage.
“When 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.”