Japanese pharmaceutical companies are engaging contract development and manufacturing organisations (CDMOs) earlier in their product development cycle, according to research from Neuland Laboratories.
The company said the shift is due to peptide programmes becoming more complex, placing greater strain on in-house capabilities and added that there has been a notable shift in demand during the past 12-24 months, with more early-stage programmes seeking external support.
This trend is being driven in part by growing activity from venture-backed biotech companies and spinouts emerging from large pharmaceutical R&D organisations and, as these programmes advance into clinical development, demand for specialised CDMO capabilities is increasing.
Neuland also observed a rise in peptide-related engagements from Japanese companies, particularly at the preclinical and early clinical stages, where technical requirements are more demanding.
Peptide development poses unique challenges compared to traditional small molecules.
Analytical complexity makes characterisation and impurity detection difficult, while scaling up production is limited by the availability and quality of protected amino acids, affecting timelines, costs and success rates.
Regulatory expectations also add to the burden. Demonstrating purity, consistency and process control to authorities (such as Japan's Pharmaceuticals and Medical Devices Agency) requires extensive data, while shifting requirements introduce additional hurdles during development and approval.
At the same time, Neuland found that pricing and regulatory pressures in Japan are also increasing the operational load on drug developers.
Frequent price revisions are prompting companies to improve cost efficiency, thereby strengthening the case for outsourcing.
"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.
Neuland said its work in Japan is focused on custom development and manufacturing programmes, including complex APIs, new chemical entities across the clinical lifecycle and peptide synthesis.