GLP-1 rush exposes capacity crunch at India's drug manufacturing firms

Demand for GLP-1 drugs such as semaglutide is exposing capacity gaps across peptide APIs, sterile fill-finish facilities, injector devices and glass cartridges

India's contract development and manufacturing organisations (CDMOs) are rapidly expanding capacity to meet soaring demand for GLP-1 drugs, such as semaglutide. 

 

However, industry executives warn that manufacturing infrastructure remains under pressure and supply bottlenecks could continue for at least two years.

 

The surge follows the expiry of semaglutide patents in several markets, triggering a rush by generic drugmakers to secure manufacturing partners. 

Industry executives said the challenge is no longer finding customers but finding enough compliant manufacturing capacity to meet demand. 

“The market will be constrained by supply, not demand,” said Neeraj Sharma, managing director (MD) and chief executive officer (CEO) of OneSource Specialty Pharma. According to Sharma, bottlenecks exist across the entire GLP-1 value chain, including peptide active pharmaceutical ingredients (APIs), sterile fill-finish facilities, injector devices, and specialised glass cartridges. 

 

He said the company has full order visibility for the next 12-18 months and expects capacity constraints to continue for at least two years despite ongoing expansion. 

The divergence comes at a time when trade data suggests the initial euphoria following semaglutide's patent expiry is beginning to moderate. 

After an aggressive stocking cycle ahead of generic launches, inventories have climbed across several brands as prescription growth has slowed. Industry executives attribute the softer offtake to more cautious prescribing by doctors and increased regulatory scrutiny around obesity therapies. 

However, CDMOs say this temporary slowdown in trade channels has not altered long-term demand forecasts. In fact, pharmaceutical companies are continuing to lock in manufacturing capacity well in advance. 

Saurabh Agarwal, director at HAB Pharma, said Indian pharmaceutical companies have already begun securing future manufacturing slots even before regulatory approvals are granted. 

The company is receiving letters of intent (LoI) tied to anticipated approvals. Enquiries are also rising from export markets, particularly Africa and West Asia, where buyers are seeking alternative suppliers amid global shortages. 

“Our visibility on demand over the next 12-24 months is encouraging,” Agarwal said, adding that commissioning a new GLP-1 fill-finish line is a lengthy process. 

Building a commercial facility typically takes about two years, followed by another three-six months for process validation and regulatory qualification before production can begin. 

The industry's challenges extend beyond physical manufacturing capacity. Hari Kiran Chereddi, MD and CEO of HRV Pharma, said regulatory infrastructure is becoming an equally significant bottleneck. 

According to Chereddi, even where peptide manufacturing capacity exists, companies cannot immediately supply regulated markets such as the United States and Europe without regulatory filings such as Drug Master Files (DMFs) and other approvals. 

The process typically takes 18-24 months. 

“The effective supply constraints in regulated markets will remain tight for at least two to three years,” he said. 

Supriya Lifescience also believes bottlenecks are becoming increasingly concentrated in downstream manufacturing. 

MD Saloni Wagh said upstream peptide API and intermediate production are expanding relatively quickly. 

However, specialised sterile fill-finish facilities and high-precision drug delivery devices, such as auto-injector pens, remain the industry's tightest constraints. 

“A new fully-qualified commercial peptide synthesis or sterile formulation line typically takes 18-24 months to commission because of long equipment lead times and rigorous regulatory validation cycles,” Wagh said. 

Industry executives said strong demand is no longer confined to India. Export enquiries are rising from Africa, Latin America, and West Asia as governments and pharmaceutical companies seek reliable suppliers amid persistent shortages of GLP-1 therapies globally. 

The executives also believe the basis of competition in the GLP-1 market is changing. 

Early success depended on product development and formulation capabilities. However, future growth will increasingly depend on manufacturing scale, regulatory compliance and the ability to reliably produce complex injectable drug-device combinations.

As more semaglutide manufacturers enter the market and additional GLP-1 therapies approach commercialisation, compliant CDMOs with validated peptide and sterile manufacturing capabilities are expected to emerge as one of the industry's most-critical competitive advantages. 

Slimming down 

• Constraints persist across peptide APIs, sterile fill-finish, injector devices, and cartridges, with shortages expected for at least two years
• Pharma companies are locking in manufacturing slots well ahead of regulatory approvals, ensuring demand visibility for 12-24 months
• Export enquiries also rising from Africa, West Asia, and Latin America as governments and pharmaceutical companies seek reliable suppliers