Japanese pharmaceutical companies are engaging contract development and manufacturing organisations (CDMOs) earlier in the development cycle, as increasing complexity in peptide programmes places greater strain on in-house capabilities, according to Neuland Laboratories.
The company reports a shift in demand over the past 12–24 months, with more early-stage programmes seeking external support.
The trend is being driven in part by growing activity from venture-backed biotech companies and spinouts emerging from large pharmaceutical R&D organisations. As these programmes advance into clinical development, demand for specialised CDMO capabilities is increasing.
Neuland said it has 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 presents several challenges compared with traditional small molecules. Analytical complexity remains a key issue, with structural characteristics making characterisation, impurity detection and purity assessment more difficult. Scale-up is also constrained by the availability and quality of protected amino acids, which can affect manufacturing timelines, cost and success rates.
Regulatory expectations further 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, pricing and regulatory pressures in Japan are increasing the operational load on drug developers. Frequent drug price revisions are pushing companies to improve cost efficiency, reinforcing 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