Japanese pharma firms turn to CDMOs early as peptide complexity rises

Neuland Laboratories reported an uptick in peptide-related engagements from Japanese companies, particularly at the preclinical and early clinical stages

Japanese pharmaceutical companies are increasingly engaging contract development and manufacturing organisations (CDMOs) earlier in the drug development cycle, as rising complexity in peptide programmes places pressure on internal capabilities, according to Neuland Laboratories.

The company, which is participating in CPHI Japan, said it has seen a shift in demand over the past 12–24 months, with a growing number of early-stage programmes seeking external support.

This trend is partly driven by increased activity from venture-backed biotech firms and spinouts emerging from large pharmaceutical R&D organisations. As these programmes progress into clinical development, demand for specialised CDMO services is rising.

Neuland noted an uptick in peptide-related engagements from Japanese companies, particularly at the preclinical and early clinical stages, where technical requirements are more intensive.

Compared to traditional small molecules, peptide development involves greater analytical complexity, making characterisation, impurity detection and purity assessment more challenging. Scale-up also remains constrained by the availability and quality of protected amino acids, impacting timelines, costs and overall development outcomes.

Regulatory requirements further add to the burden. Demonstrating consistency, purity and process control to authorities such as Pharmaceuticals and Medical Devices Agency requires extensive data, while evolving regulatory expectations can complicate approval pathways.

At the same time, pricing pressures in Japan, including periodic drug price revisions, are pushing companies to improve cost efficiency, strengthening the case for outsourcing development and manufacturing activities.

“The bottleneck isn’t discovery anymore, it’s execution,” said Sharadsrikar Kotturi, Chief Scientific Officer at Neuland Laboratories. “In peptides, programmes are running into challenges around analytical complexity, scale-up and the availability of key raw materials such as protected amino acids.”