What to Expect in Pharma Contract Manufacturing in 2022

Contract manufacturers for pharmaceutical companies continue to adjust to the disruptions brought about by the COVID-19 pandemic.

Clinical trials delayed due to the pandemic are kicking-off again, along with new trials that were in the pre-clinical phase. The manufacturers are now balancing the demand for COVID-19 as well as non-COVID-related therapies.

In 2021, contract development and manufacturing organization (CDMO) were competing with one another to bring COVID-19 vaccines to the market while also facing supply shortage for vials and single-use components such as filters and bags. Even today, items such as single-use plastic bags used in reactors that which could be shipped in weeks before the pandemic take more than a year to procure.

The manufacturers are also facing shortage of chemistry, manufacturing and controls professionals.

To combat these challenges, CDMOs has been forced to re-evaluate its sourcing strategies, risk management and seek partnerships.

For instance, Samsung Biologics’ approach includes investments into plant expansion, the launch of a new R&D Centre in the U.S. and mRNA vaccine fill/finish services. Vibalogics and some other CDMOs have taken steps to expand capacity and use existing resources to adjust the business for vaccines and next-generation modalities.

In addition, CDMOs, which operated on a procure-as-needed approach, have shifted to warehousing to mitigate the pandemic impact.

The way ahead for CDMOs

According to CPhI 2022 Outlook, capacity constraints for biologics, advanced therapies and APIs is likely to continue for the whole of 2022.

Moreover, a shortage of chemistry, manufacturing and controls personnel could last for the next two years, slowing down development timelines, according to the report.  

The pharma industry is also likely to see higher costs, delayed deliveries for raw materials along with limited availability in the first half of 2022.

The pressure on the supply chain is not expected to subside with more than 30 COVID-19 vaccines and therapies approved so far. As the pandemic enters its third year, realistic and agile approaches to supply chain issues will continue.

Author: Manasi Baswe

Learn more about GEP’s supply chain solutions for the pharmaceutical industry.

Sources and references:

https://www.biospace.com/article/cphi-predictions-for-2022-high-manufacturing-demand-to-constrain-global-ingredients-partnering-options-and-available-cdmo-capacity/?s=61

https://www.bioprocessonline.com/doc/the-impact-of-covid-cdmo-capacity-and-supply-chain-disruption-0001

https://bioprocessintl.com/bioprocess-insider/global-markets/incredible-demand-for-talent-leaving-gaps-throughout-bio-outsourcing-space/

https://www.pharmtech.com/view/balancing-pressing-priorities