The development trend of glucagon-like peptide (GLP)-1 class obesity treatments is shifting from injectables to oral medications, prompting a rapid move to strengthen production capacity for market dominance. Oral medications are easier to take and have higher dosages, which could significantly increase demand for obesity treatments once commercialized. In this case, the production capacity of raw materials is expected to determine the corporations' competitiveness. Domestic contract manufacturing organizations (CMOs) are also making efforts to seize the obesity drug production market.
According to the pharmaceutical and biotechnology industry on the 31st, Denmark's Novo Nordisk and the U.S. Eli Lilly are focusing on securing production capacity ahead of the commercialization of oral GLP-1 class obesity medications. Novo Nordisk's Wegovy and Eli Lilly's Mounjaro had previously adjusted their launch speeds by country due to long-term production shortages. Therefore, their strategy is to sufficiently establish production capacity before the launch of oral obesity medications in order to quickly target the market.
Novo Nordisk is pushing for the approval of 'Rybelsus,' an oral version of the weight-loss drug Wegovy. Rybelsus received approval from the U.S. Food and Drug Administration (FDA) as a diabetes treatment in 2019. Novo Nordisk is currently conducting clinical trials to verify whether a high dose of Rybelsus is effective for obesity treatment. It is expected that Novo Nordisk will apply for market approval of Rybelsus within a few months.
Novo Nordisk is strengthening its production capacity in preparation for the launch of Rybelsus. Its holding company, Novo Holdings, acquired the U.S. CMO company Catalent last year. The acquisition amount was $16.5 billion (approximately 23.9 trillion won), the largest scale in mergers and acquisitions in the pharmaceutical and biotechnology industry last year.
Novo Nordisk's acquisition of the CMO company is a measure to address the issue of failing to respond to market demands in a timely manner in the past. Novo Nordisk launched Wegovy in 2021 but experienced supply shortages due to a surge in demand. The issue of Wegovy's supply shortage was only resolved last year, four years after its launch.
Eli Lilly is also reportedly stockpiling production in advance as it pushes for approval of the oral obesity medication 'orforglipron' next year. Unlike GLP-1 class obesity treatments, orforglipron consists of low molecular compounds similar to existing medications.
Eli Lilly promotes that orforglipron is more commercially viable in terms of supply as it is easier to synthesize and produce than peptide-based medications. Eli Lilly recently revealed a new investment plan of $550 million (approximately 800 billion won) to secure its own production capacity.
The commercialization of oral obesity medications is expected to begin as early as this year, likely exacerbating supply issues. While injectable obesity treatments are administered once a week, oral obesity treatments are being developed to be taken once a day. As the quantity consumed by patients increases during the same period, the demand for raw materials is also expected to surge.
According to market research firm GlobalData, there are currently 63 oral obesity treatments being developed. China's Hengrui Medicine is developing an oral obesity treatment candidate 'HRS-9531' and conducting a phase 3 clinical trial. In July last year, U.S. Pfizer resumed the development of the oral GLP-1 obesity treatment candidate 'Danuglipron.' In South Korea, Hanmi Pharmaceutical, D&D Pharmatech, and Sam Chun Dang Pharm are also developing oral obesity treatments.
Particularly as most corporations are developing oral obesity treatments based on peptides, concerns are rising that production may reach its limits quickly. Peptides refer to small units that make up proteins. Existing biological products are produced by culturing animal cells, whereas peptides are made by culturing microorganisms such as bacteria or yeast, or through chemical synthesis.
There are not many peptide CMO companies, limiting global production capacity. This is because there are few pharmaceuticals made from peptides, resulting in a small market overall. According to a report published by the market research agency Root Analysis in 2020, among global CMO companies, only 50 can produce peptides, but only 5% provide finished product services.
Domestic bio CMO companies are securing peptide production capacity to produce raw materials for GLP-1 class obesity treatments. John Lim, CEO of Samsung Biologics, noted at the JP Morgan Healthcare Conference held in San Francisco last January that "we are considering expanding our portfolio with peptides to find new growth engines" and added that "we have already recruited experts to secure peptide production technology."
SK Biopharm also announced facility investment plans to expand its peptide production capacity last year. In December, the company also signed a supply contract for raw materials for GLP-1 class obesity treatments worth up to 2 trillion won. This is a large contract that amounts to double SK Biopharm's annual revenue. The contracting company has not been disclosed, but the industry suspects it is Eli Lilly. Hanmi Pharmaceutical is also said to have peptide production capacity.