StemCell Therapy

The first part of the CPhI Annual Report 2020, released ahead of the CPhI Festival of Pharma (taking place online October 5-16) predicts dramatic growth of new mAb production in China. It also forecasts capacity shortages for cell and gene therapies in the US, as well as widespread global adoption of single-use technologies, with only limited continuous bioprocessing.

In the document, CPhI experts from BioPlan Associates (Vicky Qing XIA, senior project manager; Leo Cai Yang, project manager; and Eric Langer, president and managing partner) delve into the rapidly evolving biologics markets. The report highlights implications for contract outsourcing and Chinas continually increasing presence emergence as a hub for both bio innovation and contract services.

The report predicts rapid bio growth in China to continue, forecasting that more than 10 new mAbs likely will be launched each year by 2025. Overall, the authors estimate the total market size will quadruple by 2025, reaching nearly $18b (120b RMB) by that point and rising to more than $28b (190b RMB) by 2030.

As most early-stage biotech in China lack manufacturing facilities, the need for contract manufacturing services is rising quickly, and has been accelerated further by the 2016 MAH reforms, XIA commented.

According to the report, bioprocessing outsourcing in China is currently highly stratified with four tiers and just one domestic company in tier one (WuXi Biologics), with a number of international CDMOs (including BI, Lonza and Merck).

However, by 2025 the report anticipates as many as five more domestic CDMOs may have reached tier one status, with US Food and Drug Administration (FDA) and EU facility approvals. Significantly, pending regulatory changes for contract vaccine production will likely spur further rapid growth amongst the existing tier one CDMOs.

WuXi Biologics in 2019 realized 35.3% of its total revenue of USD 0.57 billion from China, which is ~USD 0.2 billion and would translate to ~35% of the total biopharma outsourcing service market in China1. However, despite sizable growth in revenue, its overall share of the market will now fall, as the mAb market expands rapidly, added XIA.

Langer explained, Because preclinical and clinical pipeline products require flexible manufacturing, SUS lends itself to these scales, but many of these will fail as they progress through the pipeline. This means that while more commercial-scale biologics are going to be made in SUS platforms, or hybrid systems, over the next 2+ years, stainless platforms are, and will remain, critical to bioprocessing as well.

The report also suggested that in the US and European markets will likely ocme under a cell and gene therapy capacity crunch by 2025, seeing CDMOs investing in this area already expanding in an attempt to meet the pipelines impending demand.

However, capacity alone is not the biggest challenge as there is a shortage of both specialized platforms, and trained personnel to operate them. Significantly, for some facilities in these emerging areas the equipment required for expansion and up-scaling may not yet exist, nor are regulatory authorities fully aligned with issues around patient treatments which could slow approvals.

Tara Dougal, head of content at CPhI Festival of Pharma, explained, The cell and gene therapy space is hugely fast-moving and we will run a session on the potential for M&As as both manufacturers and CDMOs try to buy-in expertise rather than build. More generally, our report also points to sustained bio growth in China, almost universal adoption of single use technologies, with continuous processing growing but from a far lower base."

Dougal added that CPhI has engaged Jefferson Institute for Bioprocessing to expand on the topic, exploring current strategies and looking ahead at future approaches.

Langer is scheduled to participate in a panel discussion on M&A activity in the cell and gene sector, taking place at CPhI Festival of Pharma October 6, 2 to 3 pm CET.

The CPhI Festival of Pharma takes place digitally October 5 to 16. For more information about the program or to register, go to https://www.cphi.com/festival-of-pharma/en/home.html.

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CPhI: cell and gene therapy capacity shortages on the horizon - OutSourcing-Pharma.com

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