The topic will be the focus of a webinar discussion at 2pm-3pm (CET) on Wednesday, October 7, involving Oxford Biomedica among others.
The past few years have seen a continued flow of mergers and acquisitions within pharma and life sciences, many of which centered around cell and gene therapy development, such as Catalent’s acquisition of MaSTherCell in early 2020.
That particular deal provided an example of a trend within a trend, whereby a bigger CDMO snatches up smaller cell and gene therapy specialists.
Catalent, itself, secured a $1.2bn deal for Paragon last year, then immediately followed it up with an asset purchase from Novavax.
Rivals in the space have also executed similar takeovers, such as Thermo Fisher acquiring Brammer Bio. While investment firms have noted the speed of development in the area, which has seen the establishment of a $1.1bn cell and gene therapy service provider.
Such activity is all directly related to the burgeoning pipeline of therapies in the cell and gene space, which is creating a capacity bottleneck, as CDMOs struggle to meet the rising demand.
Cell and gene therapy represent novel overlapping biomedical fields to treat, prevent, and remediate underlying causes of inherited and acquired diseases. Using different mechanisms of action, both therapies are poised to continue to make revolutionary advances over the next five to ten years, particularly for disorders with shorter-term mortality rates, such as lymphoma and leukemia, finds market insights provider, Edgemont.
As the biopharma sector strives to develop new labels for dire unmet medical needs, expands the number and scope of clinical trials, and delivers treatments to patients around the world in a cost-effective manner, one of the daunting challenges for the industry is to find the means to manufacture these highly complex and personalized therapies at scale, said the analysts.
Process and technological innovations, including identification of failure modes and workflow improvements, such as the use of one-time sterile-fluid transfers, will help advance the sector, but a massive build-out of commercial-scale manufacturing capabilities will be required.
Over the past year alone, the clinical pipeline of cell and gene therapies has increased by 25%, resulting in significant capacity constraints for biopharmaceutical companies and CDMOs, noted the Edgemont team.
M&A and investment implications
This need for manufacturing capacity will drive rapid growth for cell and gene therapy CDMO services, as well as heightened M&A activity at premium valuations, they wrote.
They anticipate that the industry will continue to see massive capital investments in new cell and gene therapy production facilities and delivery logistics systems, such as Pfizer’s $500m investment in a new North Carolina facility in mid-2019.
“CDMO players with advanced manufacturing capabilities stand to benefit from these strong industry tailwinds given their ability to accelerate the commercialization and delivery of these game-changing therapies.”