CSAs have been disrupted by COVID-19

The COVID-19 pandemic has caused some disruptions in Contract Manufacturing Service Agreements (CSAs), says GlobalData, a leading data and analytics company.

Johanna Swanson, Product Manager at GlobalData, comments: “For 2018 to 2019, oncology was the most common therapy area for a drug CSA, followed by central nervous system and infectious disease therapies. The greatest proportion of disrupted clinical trials is in oncology, and many contract manufacturing organizations will be affected by their sponsors’ inability to progress with these clinical trials.”

Infectious disease CSAs will likely improve their ranking in 2020, given the focus on COVID-19 and its disruption to non-coronavirus-related clinical trials. There have been a high number of COVID-19 related CSAs reported from March to June 2020. There were six CSAs related to COVID-19 in April alone.

Swanson continues: “A large number of COVID-19 patients and survivors may have reduced lung function that will require inhalation therapies. Gilead Science’s FDA-approved COVID-19 treatment remdesivir may be administered as an inhaler, if found to be successful in clinical trials that have recently started testing its efficacy as an inhaled drug. If it gains approval, this could be a predictor for the success of other inhalational pipeline drugs.

“Additionally, a number of Chinese contract manufacturing organizations experienced slowed production due to the pandemic but have been returning to normal. WuXi Biologics’ three operating sites in China—Wuxi, Shanghai, and Suzhou—resumed operations on February 11, 2020, after temporarily closing in response to COVID-19.”

Since the pandemic began, companies have been focused on obtaining COVID-related Prescription Drug User Fee Act (PDUFA) dates from the FDA, but that may also result in increased timelines and delays in the approval process of non-COVID-related drugs and treatments for diseases with unmet needs.

Swanson concludes: “While infectious disease CSAs are being ranked comparatively higher than other CSA types in 2020 due to the COVID-19 pandemic, this demand may not be sustained in future, whereas oncology CSAs will retain their high ranking in the mid- to long-term future.”

More Media