Global Drug Product Capacity Surplus?-Newsroom

#1 Sales Restrictions Due to Insufficient Capacity

On 25 June 2024, the 'weight-loss version' of semaglutide was approved in China. By 27 June, news emerged of its "sales restrictions" in China, highlighting the severity of semaglutide's capacity shortage.

As early as 2021, a filling line for semaglutide faced a supply crisis lasting two years due to inadequate management and control.

Aseptic drug product filling, being the final step in biologics GMP production, requires a high-standard sterility assurance system throughout this complex, continuous process. It involves multiple steps: thawing and mixing drug substance, sterilising filtration, vial washing, filling and stoppering, lyophilisation, capping, inspection, and packaging. Each step directly impacts the final product quality.

#2 Is Capacity Really Sufficient?

Let's estimate using a GLP-1R product as an example: Currently, there are over 1 billion obese patients globally. Assuming a relatively low drug penetration rate of 10%, 100 million patients would require medication, translating to approximately 4.8 billion pre-filled pens needed annually to meet market demand. If calculated based on the US penetration rate of 25%, global demand would exceed 12 billion pens per year.

Currently, fewer than 20 companies globally have GLP-1R products marketed or under regulatory review. Can their combined capacity meet this enormous demand? Although MNCs with blockbuster products emphasise sufficient supply, frequent capacity expansion investments and M&A activities by Lilly and Novo Nordisk in recent years clearly suggest that "insufficient capacity" is the underlying reality.

#3 Current Domestic Filling Capacity

Currently, customised CDMO service providers capable of offering strategic partnerships tailored to the specific R&D processes and production steps of biologics remain scarce in the domestic market.

• Intellective Bio: Can support production of up to 100 million assembled auto-injectors annually.

• WuXi Biologics: MFG5 can support production of 17 million pre-filled syringes annually^[1].

• BioWorkshops: 20 million pre-filled syringes^[2].

Chinese pharmaceutical companies also lack sufficient production capacity. Among the leading companies known to have GLP-1R pipelines in Phase III clinical trials or commercialisation process, their existing capacity still lags significantly behind international MNCs.

[1] https://www.wuxibiologics.com.cn/mammalian/drug-product-fill/
[2] https://www.bioworkshops.com/cn/cgmp/pre-filled.html