CDMOs gear up for peptide boom amid rising demand for weight-loss drugs

Business Standard

7 hours ago

As global demand for next-generation weight-loss and diabetes therapeutics surges, India's contract development and manufacturing organisations (CDMOs) are strategically positioning themselves to capture a bigger share of the peptide market, particularly in anticipation of key patent expiries such as that of semaglutide—a blockbuster GLP-1 receptor agonist.
India is poised to play a critical role in the global manufacturing of GLP-1 drugs, driven by soaring demand for therapies like semaglutide and tirzepatide. The GLP-1 market is projected to exceed $150 billion by 2030.
India's peptide CDMO market, currently estimated at around $80 million, is expected to grow at a CAGR of 14 per cent until 2030. Though the country currently accounts for just 3 per cent of the global peptide CDMO space—valued at $190 billion—the growth momentum is unmistakable, according to Nilaya Varma, Co-founder and Group CEO of Primus Partners. Top Indian players in the space include Glenmark, Cipla, Divi's Laboratories, Themis Medicare, Peptomer Therapeutics, Syngene International, and Sai Life Sciences.
Semaglutide patent expiry fuels strategic activity
Semaglutide, the active ingredient in drugs such as Ozempic and Wegovy, is owned and produced by Novo Nordisk and is set to go off-patent in India in March 2026. Leading pharmaceutical companies, including Dr Reddy's Laboratories, Sun Pharma, Cipla, Mankind Pharma, Natco Pharma, Lupin, and Biocon, are preparing to launch drugs in this category. These companies are investing in R&D, manufacturing capacity, and collaborations to compete in this rapidly growing market.
Anthem Biosciences is experiencing a surge in inquiries for peptide active pharmaceutical ingredients (APIs), including those related to weight loss. 'Semaglutide can be produced through total synthesis or biosynthetic routes. Very few companies in India can manage biosynthetic production—and we are one of them,' said Ganesh Sambasivam, Promoter and Chief Scientific Officer at Anthem. While he declined to confirm whether semaglutide is in active production at Anthem, he hinted that it may be among the peptides currently in development.
Syngene highlights technical edge in peptide trials
Jayashree Aiyar, Chief Scientific Officer at Syngene International, sees opportunities not just in manufacturing, but also in preclinical and clinical development. 'We've already supported preclinical studies on semaglutide and recently helped a global pharma company with a bioequivalence study using pre-filled pens,' Aiyar said. These studies included developing and validating sensitive LC-MS/MS methods to measure semaglutide plasma levels—a significant technical challenge for peptides.
Syngene's case study on semaglutide demonstrates the rigorous planning and execution required for clinical bioequivalence trials involving peptides. With gastrointestinal side effects common among test subjects, the company had to implement robust risk management and continuous patient support mechanisms. On the analytical front, it overcame complex challenges like autosampler carryover and low detection limits through custom-developed chromatography and mass spectrometry protocols.
'While we are not currently manufacturing GLP-1 APIs, we are well-equipped with peptide scale-up and fill–finish capabilities. We continue to invest in technologies to meet future market needs,' Aiyar added.
Production and compliance challenges persist
However, peptide manufacturing comes with its own set of challenges. 'There are production hurdles involving the availability of protected amino acids, coupling reagents, and advanced purification protocols, particularly for bulk APIs,' Varma noted. These challenges, combined with high utility costs and stringent environmental controls, add pressure to meet international compliance standards. Schemes such as the 2024 Production Linked Incentive (PLI) and Greenfield Bulk Drug Park initiatives are expected to ease some of these bottlenecks.
While some CDMOs are already entrenched in the space, others are evaluating the landscape. Kashmik Formulations, for instance, is not currently working on semaglutide or related APIs, nor has it received client inquiries. However, the company sees the patent expiry of semaglutide as a potential inflection point. 'We're open to collaborations with larger players who can provide validated processes,' the company said in a statement.
Diabetes burden drives urgency for scalable solutions
The spike in demand is closely linked to a global epidemic of lifestyle diseases. Arushi Jain, Director at Akums Drugs & Pharmaceuticals, underscores this urgency. 'Over 100 million Indians are living with diabetes, underlining the need for scalable therapeutic solutions that address root causes such as obesity.' Akums is actively tracking developments in weight-loss APIs.
As patents for semaglutide and similar molecules expire, Indian CDMOs are gearing up for a new wave of growth. Equipped with scientific expertise, evolving infrastructure, and an appetite for collaboration, the Indian peptide manufacturing ecosystem is emerging as a vital player in the global fight against obesity and metabolic diseases.