Can CDMOs keep up with the increasing demand for GLP-1 medications?
As demand continues to grow for glucagon-like peptide-1 (GLP-1) receptor agonists, contract development and manufacturing organizations (CDMOs) are looking to secure the materials needed to produce the wildly popular injectable drugs.
According to a RAND report published last month, nearly 12% of Americans have used GLP-1 drugs — including about one-fifth of women aged 50 to 64 — while 14% of survey respondents indicated they are interested in using the medications.
Amid capacity constraints for GLP-1s, CDMOs are working to ramp up their manufacturing capabilities to try to keep up with the surging demand. However, panelists at last week’s ChemOutsourcing pharmaceutical ingredients and services conference in Parsippany, New Jersey, warned that due to the explosive growth of GLP-1 drugs some materials are in short supply.
Andrew Good, strategic account executive for South Carolina-based chemical manufacturer Nova Molecular Technologies, flagged a worldwide shortage of acetonitrile — an indispensable solvent in pharmaceutical processes — as an area of concern.
With skyrocketing demand for GLP-1s and the geopolitical uncertainty from tariffs, Good said “we see a significant shortage in the acetonitrile market globally.” He noted that Nova Molecular is “one of the only manufacturers in the United States that actually produces acetonitrile.”
GLP-1 medications are administered using autoinjector pens, which is another supply chain concern. Robert Geiger, vice president of business development for India-based Lupin Manufacturing Solutions, commented that manufacturers “can have all the API in the world” but if they don’t have the self-injection pens, that is a significant challenge.
“That’s some of the motivation to try to get these [GLP-1s] into pills,” Geiger said. “We’ll start to see a lot more development on the oral side.”
In the meantime, Lupin in July received FDA approval for its Abbreviated New Drug Applications for liraglutide injection single-patient-use prefilled pens and glucagon for injection vials, both products will be manufactured at Lupin’s injectable facility in Nagpur, India.
Geiger noted that in late 2024 Novo Nordisk paid Novo Holdings $11 billion to take over three Catalent fill-finish sites in Belgium, Indiana, and Italy. He asked what would happen to the GLP-1 market if a major pen manufacturer is acquired by a large drugmaker such as Eli Lilly, Novo Nordisk, or another company making GLP-1s.
China and generic semaglutide
Connor Thompson, business development director of peptides for Sinopep-Allsino Biopharmaceutical, said that as a Chinese CDMO his company doesn’t have concerns about the supply of solvents or raw materials such as amino acids or reagents for making peptides.
“Maybe the situation’s different in the U.S. or EU, but in China we have the opposite problem — there’s an oversupply of manufacturers for these things,” Thompson said.
At the same time, Thompson noted that one potential area of supply chain risk for Chinese companies is plastic autoinjector pens.
“We are manufacturing generic semaglutide, at least we will be from 2026, and sourcing those pens is quite difficult right now,” he said.
Novo Nordisk’s semaglutide, marketed as Ozempic for diabetes and Wegovy for obesity, is facing a patent cliff which represents a major opportunity for companies in the Chinese generics market, according to data and analytics company GlobalData.
“While patents protect the drug until 2031-2032 in seven major markets, China’s patent expires much earlier, in March 2026,” GlobalData said in a report last week. “Chinese pharmaceutical companies are aggressively preparing their manufacturing capabilities and regulatory approvals to capitalize on this multi-billion-dollar market opportunity.”
Thompson told last week’s ChemOutsourcing conference that Sinopep-Allsino Biopharmaceutical is currently focused on generic APIs for the GLP-1 market.
“Right now, we’re gearing up for the launch of generic semaglutide in 2026 in some major markets like China,” Thompson said describing Sinopep as one of the world’s largest peptide producers.
Tim Nieters, senior vice president of strategic portfolio development at Chinese peptide manufacturer CPC Scientific, said that because his company is based in China it “has access to a lot of those raw materials, so that’s not a concern.”
CPC Scientific has invested in a new 41,000-square-foot active pharmaceutical ingredient (API) manufacturing facility in Rocklin, California, which is slated to be fully operational by the end of 2026, to produce clinical to commercial grade peptide products.
In recent years, peptide-based therapeutic candidates have been the fastest growing sector among all the chemical synthesized New Chemical Entities (NCEs) for new drug development, according to CPC Scientific. With manufacturing operations in Hangzhou, China, and Rocklin, California, the company contends these facilities will enable it to help meet the growing global demand for peptide-based therapeutics.
“Having the facility in the U.S. that will be going online at the end of next year, we are currently discussing what we will source locally and what will we bring in from China,” Nieters said.
