Bharat Parenterals Limited (BPL) is significantly expanding the ambition of its upcoming Savli manufacturing facility, with its wholly owned subsidiary Varenyam Biolifesciences upgrading the project to include biologics and biosimilar CDMO services.
The company has revised the Phase 1 capital expenditure to Rs. 300 crore from the earlier Rs. 150 crore, following a recent Board resolution passed by Varenyam Biolifesciences Private Limited.
The Savli facility was initially planned as a regulated Rest-of-World (RoW)-focused plant, with an infrastructure profile similar to Innoxel Lifesciences. Under the revised plan, the facility will combine biologics and biosimilar manufacturing capabilities with its existing small-molecule oncology line, creating a broader platform aimed at regulated global markets.
The strategic shift comes as biotech innovators and specialty generics companies increasingly rely on CDMOs to bridge the gap between clinical-stage development and commercial-scale manufacturing.
Companies developing monoclonal antibodies and other biologics often lack the internal process development, analytical and GMP-compliant manufacturing infrastructure required to take products from clinical supply to commercial production. Varenyam Bio intends to target this scale-up segment by offering development and manufacturing capabilities under one roof.
The company believes the upgraded facility can help it become a longer-term manufacturing partner for innovator and specialty-generics customers, potentially allowing it to capture a larger share of customers' CDMO spending while reducing the need for technology transfers between multiple manufacturing partners.
Management also expects biologics CDMO contracts to offer a more durable and relationship-driven revenue opportunity than the facility's earlier RoW-focused model, given the higher technical and regulatory barriers involved in biologics manufacturing.
The upgraded design will expand Varenyam Bio's addressable market beyond its original RoW mandate.
The company plans to pursue USFDA, EU-GMP and ANVISA approvals, enabling the facility to target customers across the United States, European Union and SRA Rest-of-World markets.
The project will feature two dedicated blocks: one for biologics and biosimilars and another for small-molecule oncology products.
Construction is targeted for completion by Q2 2028, subject to regulatory approvals and commissioning timelines.
"The global biologics and biosimilar CDMO market is estimated at approximately USD 24-27 billion currently, with various third-party industry estimates (including Precedence Research and others) projecting growth of 7.1% to 15.5% CAGR to reach approximately USD 38.3 billion to USD 94.1 billion by the early 2030s.
"North America currently holds the largest market share, at an estimated 34%-43%, while Asia Pacific is seen as the fastest-growing region. We are confident that our revised strategy will help Varenyam Biolifesciences benefit from this opportunity," said Bhahim B. Desai, Director - Strategy & IR, Bharat Parenterals Limited.
