CDMOs: ‘Invest in bio capacity now to meet surging demand over next 5 years’

With new targets coming from smaller biotech, there are huge opportunities for contract manufacturers that can invest today in anticipation of the demand tomorrow, says GlobalData.

Ahead of his presentation at Connect to Frankfurt (opening September 28^th) – a new digital platform accompanying CPHI Worldwide in Frankfurt, Germany – BioProcess Insider spoke with Quentin Horgan, associate director, Pharmaceutical Data & Analytics at analytics and consultancy firm GlobalData.  

He looks ahead to what are likely to be the biggest selling drugs in the next few years, before forecasting further the longer-term changes underway in the industry leading up to 2028.

Image: DepositPhotos/ra2studio

BioProcess Insider (BPI): In terms of the biggest immediate sale growth areas, what do you see for the next one to two year?

Quentin Horgan (QH): We are still not quite out of the pandemic and its influence on pharma, so while the majority of nations have now delivered multiple doses of the vaccines, the next couple of years will still see very strong sales for covid related therapies. The haematological space will also see a strong increase in sales, with AstraZeneca’s Ultomiris (ravulizumab LA) leading the way here. Overall infectious disease sales will remain strong, but still behind oncology, which will grow at around 12%. Significantly, unlike the preceding two years, the majority of growth in covid is actually driven by therapies rather than vaccines which have peaked and are gradually reducing – so we expect strong sales for Pfizer’s Paxlovid and Merck’s Lagevrio (molnupiravir).

Merck for example, is expected to return over 5bn in sales next year up from just a few hundred million this year, thanks to their oral antiviral Lagevrio for COVID-19.

In terms if oncology, Keytruda will overtake Humira next year and we expect this to be the world’s top selling drug in dollar value.”

BPI: Can we expect any news on mRNA cancer vaccines?

QH: We don’t expect any sales next year and, despite the covid based interest, these trials are now running at the more standard oncology pace, with the most advanced candidates still only in phase II. So right now, it’s still very hard to get a clear picture on what their future sales potential is?

BPI: What is the biggest longer-term trend you see – maybe looking 5 years ahead?

QH: Overall, the biggest trend is the shift towards biologics and, while small molecules still dominate approvals and sales now, as soon as 2028 we are forecasting biologics will account for 55% of all drugs sales. Monoclonal antibodies (MAbs) being a key product class within biologics driving this growth, with 46% of total biologics sales attributed to MAbs.”

In fact, in 2028 biologics will have sales of 190bn over and above those of small molecule drugs.

BPI: Any other trends we have missed?

QH: Despite the current high-level sales within the mRNA vaccine space, these sales are being driven wholly by COVID-19 vaccine sales. And as mentioned with other alternate mRNA vaccines eg cancer vaccines still in development, we will see a significant decline in forecast sales for these drug types. With COVID-19 mRNA Vaccine accounting for 15% of all biologic sales in 2021 to only 2% in 2028 according to forecast sales, as mass vaccination campaigns decline and COVID declines from a pandemic to a more conventional infectious disease

BPI: What effect will these shifts have on manufacturing?

QH: This is potentially a very significant shift as these newer biologics will of course need specialist facilities to be made and on ever increasing scales than we have at present. The other factor is that a large number of innovators in the space are made up of smaller biotech companies less likely to have the manufacturing and CMC experience in house – so outsourcing will play a much larger part in production in 2028 than today. We have seen a steady rise in the number of approvals from smaller companies between 2012 and 2021 and all the data we have suggests this will continue increasing through until 2028.

For bio contract specialists this is naturally a big opportunity for growth over the next 5-years. In fact, contract development and manufacturing organizations (CDMOs) will need to be building and investing in facilities now so that production is ready and they can benefit as the products come through development and towards commercial launch

Connect to Frankfurt is specifically designed for CPHI attendees to get the most out of their CPHI Frankfurt experience – even before they attend – it presents more than 30 on-demand webinars, and offers a head start on networking, meetings, and understanding the very latest in pharma industry developments.

The online platform is accessible to anyone registered for CPHI Frankfurt (November 1-3, 2022) – the world largest pharma event – and will remain open post event until 18^th November.

A detailed analysis of biologics CDMO manufacturing capacity will also be presented in the CPHI Annual Report 2022 – released during CPHI Frankfurt – with implications for the 2023 and beyond.