Gaps, Drivers and Developments for Contract Research Organizations in India and Southeast Asia
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By Lauren Milligan
The crop protection and crop nutrition sectors in India and Southeast Asia are undergoing significant transformations. Dr. Piyatida Pukclai, Regional Sales & Regulatory Policy Manager (Asia-Pacific) at knoell, says that contract research organization (CRO) growth is expected in India and Southeast Asia due to three main drivers.
Dr. Piyatida Pukclai: knoell
“First, regulatory modernization—such as India’s digitalization of submissions under CIB/CROP and reforms across SEA—will require more local data and regulatory support,” says Pukclai. “Second, the rapid growth of biopesticides and biostimulants will necessitate specialized trial designs, efficacy studies, and data packages tailored to novel regulatory pathways.
Pukclai continues, “Third, the increasing adoption of precision agriculture will push companies to seek CROs that can integrate digital technologies, including drone-based monitoring, IoT-enabled sensors, and advanced data analytics, into their trial programs.”
With these mentioned drivers, Pukclai gives her top three developments for CROs in these regions.
India |
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Government advancement of the digitalization of regulatory processes through the CIB/CROP system.
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Refined government guidance for biological products.
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Several CROs are expanding their good lab practice (GLP) capacity and adding services in formulation development and broader research support.
Southeast Asia |
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CROs are expanding regional networks and forming partnerships to manage diverse regulatory systems across multiple countries.
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Faster adoption of precision agriculture tools—such as UAVs and remote sensing—in field trial designs.
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For export-oriented companies, CROs are generating data packages that can support multiple jurisdictions
Gap in Services
One of the biggest shifts in the region is the production of biological products. With more companies diversifying their portfolios with more sustainable products, CROs need to be able to provide the support. However, there are several CRO that also lack expertise in biologicals.
“While infrastructure exists, GLP-compliant trial sites and multi-location networks are unevenly distributed, limiting the robustness of bio-efficacy and residue data,” says Pukclai. “There is also a shortage of CROs with deep expertise in biopesticides, biostimulants, and environmental studies.
Pukclai continues, “Furthermore, many providers are still reliant on conventional field trial methods, with slower adoption of precision agriculture tools such as UAVs, sensors, and digital analytics. Combined with limited availability of experienced study directors and regulatory writers, these gaps present opportunities for CROs that can offer higher-quality, specialized, and technology-enabled services.” •
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Dr. Piyatida Pukclai: knoell