Japanese pharma outsources earlier as peptide development challenges grow
pharmafile | April 29, 2026 | News story | | Peptide therapies, peptide
Japanese pharmaceutical companies are increasingly engaging contract development and manufacturing organisations (CDMOs) earlier in the drug development process, as the complexity of peptide-based medicines places pressure on in-house capabilities.
According to Neuland Laboratories, demand for external support has shifted over the past one to two years, with more companies seeking assistance at the preclinical and early clinical stages.
This trend is partly linked to growing activity from venture-funded biotechs and spinouts from large R&D organisations, which are progressing into clinical development, suggests the CDMO.
Peptide therapies are an expanding area of research but present distinct technical challenges compared with traditional small molecule drugs. These include difficulties in analysing and characterising compounds, as well as identifying impurities and ensuring consistent quality.
Manufacturing also poses challenges for developers. Scaling up production can be constrained by the availability and quality of key raw materials, such as protected amino acids, which can affect timelines and costs.
Regulatory requirements add further complexity. Companies must generate extensive data to demonstrate purity and consistency to authorities such as Japan’s Pharmaceuticals and Medical Devices Agency, while evolving expectations can create additional uncertainty during development.
At the same time, pricing pressures in Japan are encouraging companies to improve efficiency, with regular drug price revisions prompting closer attention to development costs.
Sharadsrikar Kotturi, Chief Scientific Officer at Neuland Laboratories, said peptide programmes are increasingly encountering challenges beyond discovery.
“In peptides, programmes are running into challenges around analytical complexity, scale-up and the availability of key raw materials,” he said.
Neuland said it is seeing increased demand for custom development and manufacturing services, including support for complex active pharmaceutical ingredients and peptide synthesis across the clinical lifecycle.
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