Frankfurt, 31st November 2019: CPhI Worldwide – the world’s largest pharma event, taking place in Frankfurt, Germany (5-7 November, 2019) – releases the third part of its annual report focussed on bio in China and advanced biologicals.
The report highlights growing opportunities for CDMOs in cell and gene therapies, as well as the needed capacity expansions to meet China’s burgeoning demand. Two annual report experts, Michael E. Ultee of Ulteemit BioConsulting and Vicky Qing Xia of BioPlan Associates, outline their expert perspectives on the likely opportunities and challenges in the coming 5-years ahead.
Ultee forecasts that manufacturing in biopharma is now entering a new age of advanced processes whereby the overall cost of production could potentially begin to fall. He added that in five-year’s time with the new processes now being applied, “manufacturing will become more efficient and cost savings will be delivered. Furthermore, economic pressure from biosimilars will push manufactures of these types of therapeutics towards lower costs.”
In advanced therapies, a lack of cell and gene expertise is now already causing potential issues in the clinical progress of many therapies, and there is a scramble for the most capable development partners, despite many CDMOs investing in capabilities. “There is already a shortage of CDMO services for this type of work. I expect it to continue for the next few years until more development and manufacturing scientists are trained in this new discipline and CDMOs expand their offerings,” added Ultee.
In her near- and medium-term predictions, Vicky Qing Xia explores the huge changes currently underway in China, with single-use reactors currently rapidly on the rise. In fact, by 2021 at a CAGR of 16%, the biologics market in China may reach $50bn. Qing Xia attributes this growth to several advanced players (primarily serving western customers) – notably WuXi Biologics, MabPlex, CMab and JHL biotech.
“The case for single use bioreactors is particularly strong for two groups: early stage mAb developers and biologics contract manufacturers. For mAb developers, single use technology offers the key advantages of less capital investment during project development stage as well as time-reduction in facility construction.” commented Qing Xia.
However, Qing Xia also believes there may be a good degree of flux in the market predictions, particularly as new products transition between clinical and commercial supply, adding: “Many of the VC-backed developers would seek IPO, and Chinese investors are known to value fixed assets such as land, facility over IP and product portfolio. We see many developers outsource pilot-scale production, but they would then plan to build their own facilities when their project goes to late clinical stage.”
The complete findings of the CPhI Annual Report will be made available for free on the CPhI website.
