Initially approved for diabetes and obesity management, GLP-1 therapies have seen a dramatic increase in off-label use for cosmetic weight loss. This growing trend, particularly among individuals without obesity or related health issues, has significantly outstripped the available supply and led to important shortages.
How is the biotech industry responding to this shortage, and can supply really catch up with the demand for GLP-1 drugs? We asked experts in the field to answer this question.
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Biopharma companies scale up GLP-1 drug production
To mitigate drug shortage issues and boost GLP-1 manufacturing, biotechs are making substantial investments. The contract development and manufacturing organization (CDMO) Corden Pharma is among the drug makers doing so and has pledged to spend €900 million ($981 million) over the next three years to expedite GLP-1 drug production in Europe and the U.S.
“[This] will profoundly impact our ability to provide valuable and much-needed support to innovators in the GLP-1 space, for the benefit of their patients,” said Stephen Houldsworth, senior vice president and global head of Platform Management & Marketing at Basel-based CordenPharma. “CordenPharma will continue to invest heavily in the supply of GLP-1 peptides and their key building blocks to ensure supply chain security. Unfortunately, these investments take time, requiring the construction of new facilities with cutting-edge technologies and expert teams.”
Another biopharma pouring in money to bolster drug manufacture is one of the two dominant GLP-1 players in the market – Eli Lilly. The giant, which has a sizable piece of the pie – amassing $4.3 billion from its diabetes drug Mounjaro and weight loss drug Zepbound in the past three months – bought U.S.-based Nexus Pharmaceuticals’ plant to meet rising demands of the GLP-1 drugs. The facility in Wisconsin is set to begin production next year.
“Since 2020, Lilly has committed more than $18 billion to build, expand and acquire facilities in the U.S. and Europe. These facilities and investments will address growth from potential new medicines to treat diabetes and obesity, Alzheimer’s disease, cancer and autoimmune conditions. Our acquisition of the injectable manufacturing facility in Wisconsin is an excellent example of our strategy to meet those demands,” said a spokesperson from Lilly to Labiotech.
Another way drug companies are responding to the GLP-1 shortage is by bringing new therapeutic options to the market. For example, Eli Lilly’s Zepbound will soon be available in 2.5 mg and 5 mg single-dose vials offered at a 50% or greater discount compared to the list price of all other GLP-1 medicines for obesity. This new option aims to aid “millions of adults with obesity access the medicine they need,” including those who don’t have employer coverage, and those who need to self-pay outside of insurance.
“These new vials not only help us meet the high demand for our obesity medicine, but also broaden access for patients seeking a safe and effective treatment option,” added Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA, in a press release.
Moreover, Lilly’s main contender, the Danish multinational Novo Nordisk, is investing more than $4 billion in a facility in North Carolina to fill and finish its obesity and diabetes drugs Wegovy and Ozempic, which come in pre-filled pens. Fill and finish is a key step in the manufacture of biologics. As the name suggests, it involves filling containers with medicines and packaging them. The roof-top solar-paneled facility will double the space of its already-existing plants in the state, and add 1,000 jobs, on top of the nearly 2,500 people working in the region for the drugmaker.
This comes after Novo Holdings, the company that manages the assets of the Novo Nordisk Foundation, announced the $16.5 billion buyout of CDMO Catalent – a deal that sparked much attention – to ramp up GLP-1 production.
Another biotech that announced the launch of its facility to drive GLP-1 drug production is American manufacturer Simtra BioPharma. A 150,000 square-foot building dedicated to fill and finish GLP-1 drugs will be set up in Bloomington, Indiana as it aims to begin production in 2026.
In China, Aurisco Pharmaceutical has launched its facility in Yangzhou to enable multi-metric ton production of its generic GLP-1 peptides in a bid to increase drug access and expand its global footprint. To add to that, investors in China have also plowed $400 million into licensing obesity drugs from Shanghai-based Jiangsu Hengrui Pharmaceutical.
GLP-1 supply issues predicted to carry on
As GLP-1 supply issues wage on, European regulators have flagged this situation as a serious public health concern, warning that the shortage is unlikely to resolve within the year. The European Medicines Agency (EMA) has highlighted that the rising demand for these drugs, driven in part by their use for non-medical weight loss, is putting unprecedented pressure on suppliers. The EMA’s notice is partly tied to an increase in off-label prescriptions of these drugs for weight loss as well as its use for cosmetic weight loss by people without obesity and those who do not have weight-related health problems, burdening suppliers to meet fast-growing demands. In the U.K., the National Health Service (NHS) is also experiencing supply issues.
Although GLP-1 drugs have been around for many years to manage diabetes, they have a “much bigger impact on weight loss and on the comorbidities that arise from diabetes than the earlier products,” according to Houldsworth.
“This has led to a dramatic increase in their use, and has stimulated the development of numerous pipeline drugs, both oral and injectable, some of which target multiple receptors, not just that for GLP-1s,” said Houldsworth. “Some of these drugs are modified natural peptides, some fully synthetic peptides, others small molecules, and one product combines an antibody with a peptide.”
Yet GLP-1 medicines are the key driver in the peptide market. It mimics the action of a natural peptide hormone that is released when food is consumed. Stimulating the receptor of this hormone causes the pancreas to make more insulin, and the liver to make less glucose, Houldsworth explained. It also slows down food digestion, thus reducing appetite. As a result, GLP-1 agonists reduce both blood glucose and body weight.
While the shortage of these drugs is a global issue, the GLP-1 scarcity is even worse in low- and middle-income countries. According to the World Health Organization (WHO), this is likely to have disproportionate effects on people with type 2 diabetes. To add to that, a study published by Doctors Without Borders/Médecins Sans Frontières (MSF) earlier this year, found that unavailability coupled with limited access due to high costs already affect patients in these countries.
As overcoming these shortages is the only way forward, biotechs are spending on manufacturing to tackle current limitations and refine access as well as to circumvent future scarcity of these drugs that could lower the risk of life-threatening obesity-related complications for millions of people. But whether these efforts will be enough, only time will tell.