In May 2020, as the US’s Covid-19 death toll fast approached 100,000,1 a sense of urgency swept through Washington DC’s policymakers as it became clear that action was needed — sooner rather than later.

Enter Operation Warp Speed. The program, launched in tandem with the private sector in order to overcome the pandemic, was named as such in recognition of the fact that anything less than a rapid response was not an option. Among its many objectives, some of Operation Warp Speed’s most critical goals were related to manufacturing and distributing vaccines as quickly and safely as possible.2

As the past year has shown, the ability to be both malleable and swift is a powerful asset in the face of virulent diseases, but it also helps to ensure sufficient preparedness in case of another public health shock.

The industry has shown that it can move with speed on manufacturing, but new research suggests that that is not always the case.

Cytiva’s Global Biopharma Resilience Index assesses the strength of five areas (‘pillars’) of the biopharma industry based on a survey of more than 1,100 pharma and biopharma executives and healthcare policymakers from 20 countries.

Domestic capacity at risk

There is a clear bright spot in the index: manufacturing agility. As we would expect, many high-income countries did well here, with the likes of the US, UK and Switzerland all scoring more than seven out of 10 on this index pillar (see chart 1), but many lower to middle-income countries, such as China, India and Russia, proved that they could keep pace too.

But there are some areas that need work. Domestic pharma firms have some doubts about their capacity to meet their own nation’s needs for a number of drugs, scoring less than five out of 10 on this index indicator. Take insulin and vaccines, for example. Respondents say they would only be able to meet 75% of local needs in the event of a surge in demand. That drops to just 58% for other biopharmaceuticals. This highlights the lack of capacity and speed with which countries can currently respond to demand fluctuations.

Chart 1. Manufacturing agility index scores by gross national income per capita

manufacturing agility graph

Pharma and biopharma executives recognize this weakness. Fewer than 3 in 10 describe the manufacturing processes of their organization as something that offers a competitive advantage, and increases in manufacturing agility emerge as the number one priority for firms.

But to achieve this goal there are impediments in domestic markets that need to be addressed. Among the top three outlined by executives are a lack of skills within companies to drive the manufacturing speed desired, geopolitical developments that could impact the rollout of a drug and crucially, a lack of agility among suppliers.

Picking up the pace

Perhaps the most important suppliers for pharma and biopharma firms are the contract manufacturing organizations or contract development and manufacturing organizations (CMOs or CDMOs). These are external firms to which pharma and biopharma businesses can outsource critical stages of drug development and manufacturing.

One solution to concerns about speed has been the rise of firms that can work with CMOs to offer rapidly scalable manufacturing facilities that reduce the need for a large upfront investment, enabling a much quicker process — particularly in smaller countries where that might not be feasible.

However just a quarter of executives rated CMOs as being “very good” on adaptability and cost-effectiveness, despite a generally positive sentiment towards their performance (in the index, CMO performance scored 7.39 out of 10). This shows that if CMOs and pharma firms can work in tandem to adapt facilities for the manufacture of one drug or vaccine to another, it would help to drive down costs and shorten a process that can otherwise create significant delays. It also suggests that manufacturers will need to develop their own scalable and flexible facilities to meet demand — even when they are not expecting it.

“We are looking at transforming the entire manufacturing process. If you look at the chemicals and petroleum industry, all manufacturing is continuous, but the pharma industry is batch processed,” says Dr Chris Chen, chief executive of WuXi Biologics, a Chinese CDMO. “So we believe the next stage is to go from batch to continuous. If you look at the petroleum industry, if they went to batch processing they would go bankrupt because they have to rely on very high efficiency.”

Executives are keen for more innovative technologies too. Less than one in five are in strong agreement with the idea that frontier technologies such as artificial intelligence are being widely adopted in a widespread way to support the automation of certain processes that could speed things up.

Chart 2. Manufacturing agility could make gains with development of scalable facilities and more investment in technology

Key Biopharma Resilience findings

Overall, the index findings lay a clear roadmap for pharma and biopharma firms looking to bring agility that want to make their manufacturing operations more agile: think strategically about the role of rapidly scalable operations that reduce upfront costs, and be bolder with adopting technology.

More key insights from the BioPharma Resilience Index and expert panelists on BioPharma manufacturing agility

Video: Biopharma Resilience Index: Manufacturing Agility

Article: Manufacturing agility on the ground

Article: The Manufacturing Agility Challenge in Biopharma: Expert Panel Q&A