COVID-19: Current Impact of the Pandemic on Pharmaceutical Companies

May 2020

Nishika Bhan, MSc, Shweta Dudeja, MSc and Aviral Maheshwari, MBA, MS, MBBS

Note: Given that the situation is continually evolving, the thoughts and opinions are formulated to keep the current situation in mind.

COVID-19 Transmission Centers

Although COVID-19 transmission could be at a mature stage in Japan, the situation has not stabilized across the US and Europe

Source: WHO COVID-19 Status Update

Impacted Aspects

The impact of COVID-19 on clinical and regulatory affairs, manufacturing and supply chains, and stakeholder engagements has slowed the ever-growing pharmaceutical industry.

Due to the rapidly changing COVID-19 environment, there have been abrupt changes across the various functional domains of the pharmaceutical industry
The unprecedented situation arising from the pandemic has resulted in the halting of clinical trials, delays to product approvals and disruptions to supply chains

The pandemic has forced pharmaceutical companies and regulatory agencies to adopt innovative strategies to mitigate the challenges observed across various functional domains and support accelerated development efforts

Key Impacts on the Pharmaceutical Industry Due to COVID-19

With the FDA halting foreign inspections, a delay of 4-6 weeks is anticipated for regulatory decisions of applications that have been already filed.

Mitigation Strategies Adopted by Pharmaceutical Companies and Regulatory Agencies

Pharmaceutical companies and regulatory agencies are making various efforts to mitigate the disruption caused by travel restrictions due to COVID-19.

The Impact of COVID-19 on HCP Engagement

The decline in HCP engagement is significant and is not expected to recover fully after the crisis.

Near-to-Long-Term Impact on HCP Pharma Engagement:

The COVID-19 crisis is expected to have a lasting impact on HCPs’ willingness to meet pharmaceutical representatives in person
After the crisis, remote engagement with pharmaceutical representatives will be a more prominent part of the interaction mix
Given the declining trend in overall HCP-representative interactions, pharmaceutical companies need to innovate and develop virtual engagement models

Strategies to Mitigate the Impact of COVID-19 on HCP Engagement

From restructuring commercial teams for customer centricity to upskilling those on the frontline, pharmaceutical companies have deployed various tactics and strategies around HCP engagement.

The Impact of COVID-19 on Manufacturing and Supply Chains

Manufacturing and supply chains may face constraints for some time, which could lead to price increases.

Sources: FDA press release (March 17, 2020); EPR-EMA recommendations (March 17, 2020)

Although most manufacturing and supply chains have been resilient to the impact of COVID-19, there may be some near-to-long-term effects.

Pharma manufacturing plants registered to supply APIs worldwide:
The US remains home to the most registered API manufacturing plants worldwide, with the EU a close second; India and China contribute 31%.

Near-to-Long-Term Impact on Manufacturing and Supply Chains:

Companies sourcing APIs from China and India are likely to face supply chain issues if the outbreak continues
Short-term scarcities affect certain products, and a few have already been reported by the FDA
Some manufacturers may see a shift in demand, both as antiviral use rises and as other chronic conditions are left untreated by patients due to concerns regarding exposure to COVID-19

Strategies to Mitigate the Impact on Manufacturing and Supply Chains

Companies have provided conducive work environments for workers at manufacturing sites and are exploring alternate supply models.

Key Considerations for Companies

Answers to the following questions may help reduce “blind spots” and refine product strategies.

During COVID-19

After COVID-19

The evolving guidelines will have an impact on ongoing and planned trials, data assessments, milestone thresholds and clinical development plans for products in the pipeline. Keeping a close eye on the evolving guidelines and monitoring the changes is critical for biopharmaceutical companies to refine and formulate their clinical and regulatory strategies. Effective measures to ensure patient safety, remote monitoring of clinical trials and documentation will be key to successfully conducting clinical trials during the COVID-19 pandemic.