CPhI Report predicts CGT capacity shortages in the USA and mAb approvals in China

Continuous bioprocessing is growing quickly ... but from a low base ... with virtually all manufacturers now using at least some single-use technologies

The CPhI Annual Report – launched ahead of the first CPhI Festival of Pharma (5-16 October, 2020), the world’s largest digital pharma Expo – predicts dramatic growth of new mAb production in China, capacity shortages for cell and gene therapies in the USA and the widespread global adoption of single-use technologies ... but only limited continuous bioprocessing.

Three CPhI experts from BioPlan Associates – Vicky Qing XIA, Leo Cai Yang and Eric Langer – explore the rapidly changing global biologics markets, with special reference to the implications for contract outsourcing and China’s continued emergence as a hub for both bio innovation and contract services.

Remarkably, China is predicted to continue its rapid bio growth rates, with more than 10 new mAbs predicted to be launched per year in the country by 2025. In fact, the total market size will quadruple by 2025, reaching 120 billion RMB, and rising further to 190 billion 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,” commented Vicky XIA, Senior Project Manager at BioPlan Associates.

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

However, by 2025 it is anticipated that as many as five more domestic CDMOs may have reached tier one status, with 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 realised 35.3% of its total revenue of $0.57 billion from China, which is approx. $0.2 billion and would translate to ~35% of the total biopharma outsourcing service market in China. However, despite sizeable growth in revenue, its overall share of the market will now fall, as the mAb market expands rapidly,” added XIA.

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In terms of global manufacturing, Single-Use Systems (SUS) are now far and away the leader at both preclinical and clinical stages, with nearly 85% now involving a substantial SUS component. Yet, whilst its usage continues to grow, continuous bioprocessing is not anticipated to be in mainstream usage by 2025.

Eric Langer, President and Managing Partner of BioPlan Associates, adds: “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, during the next 2+ years, stainless platforms are, and will remain, critical to bioprocessing as well.

The report also suggested that in the United States and Europe there is likely to be a cell and gene therapy capacity crunch by 2025, with CDMOs investing in this area already expanding to try and meet the pipeline’s 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, commented: “This first part of the CPhI Annual Report arrives at a very poignant moment as the CPhI Festival of Pharma launches next month."

"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."

"In fact, we have invited the Jefferson Institute for Bioprocessing to expand on this theme, as they will explore both current strategies and look ahead at future approaches for bio manufacturing. It’s one of the reasons we are so excited about the CPhI Festival of Pharma, as it provides a vital platform to meet and exchange ideas – at a time when the industry is changing quickly.”

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