Celltrion Enters SC Formulation CMO Business, Challenging Halozyme-Alteogen Duopoly

Celltrion (068270.KS) is making a full-scale entry into the contract manufacturing organization (CMO) business that converts intravenous (IV) drug formulations to subcutaneous (SC) formulations.

The SC formulation conversion market has been dominated by U.S.-based Halozyme Therapeutics and Korea's Alteogen (196170.KQ). Industry observers are watching whether Celltrion, equipped with both product approval experience and mass production capabilities, will disrupt the market landscape.

According to biotech industry sources on Wednesday, Celltrion is pursuing an SC formulation conversion CMO business targeting products commissioned by external pharmaceutical companies. While Celltrion has previously applied SC conversion technology only to its own biosimilar products, the company now plans to provide formulation conversion services to external pharmaceutical companies, similar to Halozyme and Alteogen.

"We will pursue a phased growth strategy centered on SC technology based on three pillars: SC conversion of our own biosimilars, SC application to new drug pipelines, and expansion of CMO business for external customers," a company official said.

SC formulation conversion technology can reduce IV drug administration time from approximately 90 minutes (30 minutes for maintenance therapy) to under 5 minutes. Beyond improved dosing convenience, the technology has gained global attention for enhancing safety and efficacy in certain drugs.

Johnson & Johnson is currently pursuing approval for Rybrevant SC in collaboration with Halozyme, while MSD (Merck in the U.S.) has already completed SC formulation approval for blockbuster drug Keytruda with Alteogen. According to market research firm Precedence Research, the global SC formulation market is projected to grow from $36.12 billion in 2024 to $69.94 billion in 2034, at an average annual growth rate of 7.62%.

Celltrion has already commercialized various SC formulation biosimilars including Zymfentra (Remsima SC), an autoimmune disease treatment, and Aybintio SC. However, these products used proprietary technology rather than hyaluronidase-based technology. Since hyaluronidase technology is essential for fields requiring high-volume drug administration such as anticancer drugs, Celltrion has worked to internalize this technology and began clinical trials for Herzuma SC, an anticancer drug, in February this year.

"This means Celltrion has secured SC formulation technology capabilities covering both autoimmune diseases and anticancer drugs," an industry official explained.

The industry expects Celltrion's entry into the SC formulation market to shake up the global SC conversion market that Halozyme and Alteogen have dominated. Halozyme, the first company in the world to commercialize human hyaluronidase technology, has supported SC formulation development for numerous products including Darzalex, Herceptin, and Opdivo in collaboration with global pharmaceutical companies. Alteogen is also developing SC formulations for Keytruda and Enhertu, the world's first antibody-drug conjugate (ADC) medicine.

"Celltrion is the only company in Korea with a full value chain capable of handling the entire process from SC formulation drug development, approval, and mass production to global supply," a Celltrion official emphasized. "We have secured a structurally differentiated competitive advantage over companies that possess only single technologies."

However, patent hurdles remain a variable. There are assessments that Celltrion's SC formulation technology is similar to Halozyme's Enhanze technology, and the fermentation process patent related to Enhanze expires in 2030. Celltrion reportedly believes its technology has low relevance to Halozyme's fermentation process. Patent disputes are intensifying in the industry, as Halozyme recently won a preliminary injunction against MSD in a German court, halting Keytruda SC sales in Germany.

The patent duration of Celltrion's proprietary SC technology will also be important. "The reason global pharmaceutical companies utilize SC conversion technology goes beyond simple dosing convenience improvement—they can extend patent protection periods by the duration of SC formulation technology patents," a biotech industry official said. "If Celltrion wants to secure blockbuster-level drugs as CMO customers, its proprietary technology's patent period will be a competitive factor."

Halozyme recently acquired Electrophi, which holds patents through 2040, and Alteogen's Hybrozyme substance patent is known to remain valid until 2043. Meanwhile, in Korea, other latecomers including Huons Lab (243070.KQ) and Amicogen (092040.KQ) have also begun SC formulation development and are conducting early-stage research.