CPhI Report Predicts Cell and Gene Expertise Shortfall and Growth in China Bio

November 1, 2019

According to the third part of the CPhI annual report, a lack of cell and gene expertise may be a drag factor on the sector and a spike in biological therapeutics development is driving bio demand in China.

According to the third part of the CPhI annual report, a lack of cell and gene expertise may be a drag factor on the sector and a spike in biological therapeutics development is driving bio demand in China.

Two experts, Michael E. Ultee (Ulteemit BioConsulting) and Vicky Qing Xia (BioPlan Associates), have given their perspectives on the potential opportunities and challenges for the next five years in the report. Highlights for Ultee and Xia are opportunity growth for contract development and manufacturing organizations (CDMOs) in cell and gene therapies and the requirement of capacity expansions to meet bio demand in China.

Specifically looking at advanced therapies, Ultee reported that there is already a shortfall in cell and gene expertise that is causing potential issues in the clinical progress of many therapies.“There is already a shortage of CDMO services for this type of work,” he said in an Oct. 31, 2019 press release. “The high valuations shown by recent acquisitions of CDMOs, such as Brammer Bio and Paragon Bioservices, bear this out. I expect the shortage to continue for the next few years until more development and manufacturing scientists are trained in this new discipline and CDMOs expand their offerings.”

For Qing Xia, the near- and medium-term will encompass a rapid rise in single-use reactors within China as a result of the increasing biologics market in the region. “The case for single-use bioreactors is particularly strong for two groups: early stage mAb [monoclonal antibodies] 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. As most mAb developers in China are working on biosimilar/biobetter versions of mAbs against several established targets including TNF-alpha, PD-1, Her-2 or EGFR with usually multiple companies for each target, the time to clinical development can mean life or death for a project,” she noted in the press release. “Less capital investment during development is also extremely important for the small- to medium-sized biotech companies, as more often than not they are cash-strapped without enough resources for facility construction. With both mAb development and outsourced bio-manufacturing on the rise in China, there is no surprise that single-use technology is getting more popular, enjoying double digit (some even project over 30% CAGR) growth in recent years.”

“What our expert’s analysis shows is that we are at a really significant point for the supply chain, as new technologies help bring about improved manufacturing processes,” added Tara Dougal, head of content at Informa, in the press release. “It is also a big focus at both CPhI Worldwide and BioProduction this year and much of our content and, of course, our networking opportunities are designed to empower both exhibitors and attendees to meet partners that will help them prepare and deliver new solutions to help the industry expand in the next few years. Additionally, P-MEC is also showcasing all of the global technologies to help deliver new manufacturing methodologies and sustain the growth predicted in contract services for both solid dose and biological drugs.”

Source: CPhI