Pharmaceutical companies are rushing into the interstitial cystitis treatment market using pentosan polysulfate sodium (PPS), which had no new items for 13 years. After Hanmi Pharmaceutical received approval for "Hanmi Pentosan Capsule" in Mar., Dongkook Pharmaceutical also received approval for "Polmiron Capsule" last month.
It does not end with the entry of Hanmi Pharmaceutical and Dongkook Pharmaceutical. According to the industry on the 15th, three more companies, including DongKoo Bio&Pharma(006620), Ilyang Pharmaceutical(007570), and QL Pharma, are preparing to enter within the year. If products actually launch, the domestic PPS market will be reshaped into a structure where up to eight items compete.
◇ "90% female patients" chronic disease…first new entries in 13 years
Interstitial cystitis, also called "bladder pain syndrome," is a chronic disease. Even without a clear cause such as bacterial infection, pain appears as the bladder fills, and urination symptoms such as frequent urination, urgency, and nocturia repeat.
Because symptoms often improve and then worsen again, patients sometimes delay care, thinking they have gotten better. As the symptoms are similar to those of typical cystitis, it is sometimes mistaken for another disease. Women account for about 90% of patients, and for men, it is more difficult to diagnose because it must be distinguished from other causes such as prostate disease.
Treatment uses various methods such as drug therapy and behavioral therapy, depending on the patient's condition and symptoms. Among these, PPS is a representative oral therapy.
The representative original drug of PPS is "Elmiron" by Janssen in the United States. Elmiron was approved by the U.S. Food and Drug Administration (FDA) in 1996 as a treatment for interstitial cystitis.
As drugs with the same ingredient later appeared, products such as J. Tech Biopharm's "Jelmiron Capsule (2003)," Chong Kun Dang pharmaceutical's "Penpol Capsule (2011)," and Pharmbio Korea's "Gaegron Capsule (2012)" formed the market in Korea. Based on 2024 production and import performance, the combined results of these three items are about 25.5 billion won.
◇ As diagnosis threshold falls, the market expands…urology care base also changes
The number of interstitial cystitis patients in Korea is estimated at about 18,000.
Why are drugmakers rushing into this market, where the patient population is not that large?
Because the market itself is steadily growing. According to the pharmaceutical market research firm Ubist, the domestic PPS formulation market was 47.3 billion won last year, growing at an average annual rate of 20.7% over the past five years. PM Insight projects the domestic market size will reach about 60 billion won this year.
Changes in the diagnostic environment are cited as the backdrop for the market's expansion. The industry says that unlike in the past when invasive tests such as cystoscopy were important, diagnostic guidelines based on patients' subjective symptoms have recently taken hold, lowering the threshold for diagnosis. As it has become easier to identify potential patients, the PPS prescription market is also growing, it says.
Changes in the urology care environment are also mentioned as a factor supporting companies' market entry. Urology, which struggled in the past due to avoidance of residency applications, is stabilizing its clinical base on the back of an increase in patients as Korea enters a super-aged society and the spread of advanced medical technologies such as robotic surgery.
Han Deok-hyeon, director of academic affairs of the Korean Society of Endourology and Robotics (Department of Urology, Samsung Medical Center), said at a recent press briefing, "In urologic cancers such as prostate cancer and kidney cancer, robotic surgery has already become the standard treatment," adding, "Interest among young physicians is also high in future technologies such as physical AI and remote surgery."
All the latecomers entering the market this time share a common trait of having an existing urology sales base.
Hanmi Pharmaceutical has expanded its presence in the urology prescription market with erectile dysfunction treatments "Palpal" and "Gugu," and the benign prostatic hyperplasia treatment "Hanmi Tams." Dongkook Pharmaceutical has the benign prostatic hyperplasia combination therapy "Uresco Tab," and the prostate cancer treatments "Lorelina Depot Inj." and "Entamide."
◇ Filing bids backed by "urology lineups"…sales competition heats up
As same-ingredient products appear one after another, future market competition is expected to unfold around sales power. Because PPS requires long-term administration for three to six months, which product secures prescribing experience early after launch will be important.
Price is also a factor. Hanmi Pharmaceutical's Hanmi Pentosan Capsule, launched last month, is 2,000 won per capsule, lower than Penpol and Jelmiron at 2,264 won and Gaegron at 2,038 won. Dongkook Pharmaceutical, which is preparing to launch within the year, expects the price of Polmiron Capsule to be set at a level similar to existing products.
Existing companies are moving to defend their positions by emphasizing product differentiation.
Chong Kun Dang pharmaceutical, currently No. 1 in the market, cites the raw material as Penpol Capsule's strength. It produces with exclusive supply of active pharmaceutical ingredient (API) from Bene in Germany, and says it obtained reference drug status for PPS from the Ministery of Food and Drug Safety in 2024. The company said, "We are not considering an artificial price cut due to the entry of latecomers."
Attention is on whether the successive entries of new companies will end as a market share battle among existing players or become a catalyst to grow the market itself.
An industry official said, "As interstitial cystitis still has a fair number of undiagnosed patients, companies entering the market could help raise disease awareness and diagnosis rates," adding, "However, rather than the market size expanding significantly in the short term, prescription competition may heat up first."