Inoculating children and booster jabs will further fuel CDMO demand argues GlobalData’s Fiona Barry, who adds industry’s reliance on third-party manufacturers will not abate post-pandemic.

Since the start of the pandemic, biopharma’s efforts and determination in developing and producing billions of vaccines and therapeutics have led to some companies and sectors benefitting from a COVID-19 windfall.

The contract development and manufacturing organization (CDMO) sector is one such group, with both drug substance and drug product capacity proving crucial in the rapid scale-up of products.

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Just months into the pandemic back in April 2020, CDMOs such as Lonza and Thermo Fisher were describing an ‘unprecedented’ (remember that word?) number of enquiries for their services to support vaccine and therapy manufacturing. And since then both firms have won major contracts with some of the main vaccine players: Lonza is producing upwards of 400 million of Moderna’s vaccine, while Thermo Fisher is supporting fill/finish for both the Moderna and Pfizer jabs.

And they are just two examples. Catalent claimed to have been awarded more than 80 COVID-19-related contracts from customers including J&J and Moderna; Fujifilm Diosynth Biotechnologies is supporting Novavax’s vaccine candidate and Eli Lilly’s COVID mAb cocktail; Emergent BioSolutions won a handful of contracts with both AstraZeneca and J&J’s vaccines on the roster. Smaller players too have seen their capacity grabbed: Rovi’s production of the Moderna vaccine; Rentschler’s support for the Pfizer jab… the list is extensive.

Second windfall?

And now the robust CDMO space is set to receive a second COVID lift, with multiple jurisdictions looking at administering booster shots and rolling out vaccines to children.

According to a report from data and analytics company GlobalData entitled ‘COVID-19: Contract Pharmaceutical Development and Manufacturing Relationships’, these coming changes will raise the manufacturing demand above the billions of doses that are already contracted, causing biopharma to again turn to CDMOs for supply.

Even if new vaccine production requirements replace the capacity already used to double jab significant swathes of the population, billions more doses will be required over the next few years, according to Fiona Barry, associate editor of GlobalData PharmSource.

“So far, 2.7 billion people worldwide have been fully vaccinated (not counting the latest round of ‘booster’ shots), according to GlobalData figures, so that leaves another 5 billion people who have not yet received their first one or two doses,” she told BioProcess Insider, stressing that the world has an obligation to vaccinate low- and middle-income countries.

“Manufacturing capacity is clearly still constrained: the WHO has called for a moratorium on ‘booster’ shots until at least the end of the year, so that at least 40% of the population of low-income countries can be vaccinated.”

With more than 1,000 vaccines and therapies in development for COVID-19 (and over 30 approved, or granted Emergency Use Authorization), she predicted biopharma will both increase the size of existing vaccine contracts and create new ones with CDMOs.

Barry also dismissed the threat of overcapacity leaving the CDMO sector vulnerable if and when the pandemic subsides.

“Firstly, it’s not clear that the need for COVID-19 jabs will disappear in the near-future. It is possible that the ‘booster’ doses being rolled out now will not be the last; if future data support a regular, seasonal immunization program like flu shots, this will further increase manufacturing demand.”

She cited Pfizer’s CEO, Albert Bourla, who has said it’s likely that a variant will eventually emerge that is resistant to current vaccines, which would lead to the tweaking of formulations and a new round of shots.

Furthermore, long COVID could lead to the growth in demand for CDMOs specializing in inhalational products, as many COVID-19 survivors suffer from long-term decreased lung capacity.

Beyond COVID

“But if we’re more optimistic about how fast we can end the pandemic, there’s still an opportunity to use newly created capacity to make other products,” Barry said.

“For instance, I’m very excited about the possibilities for mRNA’s use in oncology, now that it has been successfully used in Pfizer and Moderna’s vaccines. And more generally, many of the high-tech facilities currently making vaccines could later switch to cell and gene therapies – there is a huge lack of capacity in this area, and we expect to see a surge in advanced therapy approvals in the next few years, based on late-stage clinical pipelines.”

She also pointed to President Biden’s intentions to prepare the US to be better able to manufacture during future pandemics, adding a further opportunity for CDMOs going forward.

“The administration is pumping billions of dollars into ‘hot’ manufacturing capacity that can be used on standard anti-infective vaccines and cancer vaccines during normal times, and redirected to specific diseases during pandemics.”