CPHI Report: Biologics, Tides Approvals Will Surpass Small Molecules by 2027

In advance of CPHI Milan, which will take place Oct. 8–10, 2024, new data gleaned from the CPHI Annual Industry Survey indicates that for the first time, within the next three years, approvals for complex molecules will outpace those of small molecules, as detailed in a press release from CPHI on Sept. 12, 2024 (1).

This information is built on trends observed in 2023, when CPHI said 17 biologics and nine tides (five peptides and four oligonucleotides) jointly accounted for nearly half of 55 new drug approvals (1).

Additionally, the press release said, contract development and manufacturing organizations (CDMOs) focused on biologics and tides are projected to be the fastest-growing sector in the pharmaceutical industry in the next five years (1). Biologics (53%) and tides (43%) were surveyed to be the best choices for CDMO investment, ahead of small molecules (35%) and antibody-drug conjugates, which CPHI said finished a surprising last of the choices in this category, polling at just 15%.

“We are observing this trend firsthand at CPHI Milan, both in terms of exhibitor evolution and in the demand for increased biological and complex therapy focused content,” Tara Dougal, CPHI Milan brand and content director, said in the press release. “Notably, there has been no contraction in the small-molecule CDMO space. Instead, we've seen a steady influx of new CDMOs at CPHI, with many mid- and large-sized CROs [contract research organizations] and CDMOs also investing in capacity for both tides and mAbs [monoclonal antibodies].”

In the survey, 62% of industry experts said they felt that continuous bioprocessing was the technology that would most help to lower mAb production costs between now and the end of the decade, leapfrogging previously prevalent methods like new cell lines (27%) and perfusion (7%) (1).

“CPHI Milan is now an integral component of the industry’s development pathway, and we are consistently looking at new ways for both our attendees and exhibitors to meet more potential partners,” Dougal said.

CPHI Milan marks its 35th anniversary in 2024 and is expected to draw 62,000 attendees and 600 CDMOs from 170 countries, with more than 150 speakers, 2500 exhibitors, and 100 content sessions—billing itself as the largest annual gathering for the contract services market (1–2). Organizers have pointed to the Next-Gen Bio Theatre as a highlight of the upcoming event, where sessions will be hosted on topics such as messenger RNA vaccines for advancing immunity and global trends in biomanufacturing.

“We’re seeing that alongside changes in the drug discovery pipeline, our bio exhibitor base at CPHI Milan is growing,” Dougal said in the release. “With newer modalities requiring sophisticated manufacturing approaches and a high level of technical expertise, choosing the right outsourcing partner is extremely important for the road to commercialization. It’s why we have seen many new audiences at the event as these drugs are often developed by biotechs and/or in smaller collaborations that need wider contract services networks to advance.”

References

1. CPHI. CPHI Annual Report 2024: CPHI Milan Report Predicts BLA and Tides Approvals Will Surpass Small Molecules Within the Next Three Years. Press Release. Sept. 12, 2024.
2. CPHI Milan. At the Heart of Pharma–CPHI Milan. CPHI.com/europe/en/home.html (accessed Sept. 12, 2024).