Korean pharmaceutical companies are accelerating their efforts to dominate the potassium competitive acid secretion inhibitor (P-CAB) market. As new entrants continue to emerge, the domestic market remains limited compared to the global scale, prompting companies to expand indications and target overseas markets for growth.
On June 4, market research firm Wise Guy Report projected that the global P-CAB market could grow to $7.5 billion (approximately 11 trillion won) by 2035. Currently, the domestic P-CAB market is characterized by competition among HK inno.N's 'K-Cab', Daiwoo Pharmaceutical's 'Pecsuclew', and Onconic Therapeutics' 'Zacubo'. As of last year, the three domestically developed P-CAB drugs surpassed 300 billion won in annual prescriptions, but evaluations indicate that their global market presence remains limited.
Industry experts believe that differentiation through indication expansion and seizing overseas markets will be crucial for competitiveness. Given the limited efficacy differentiation among drugs in the same class, expanding the patient population is seen as a key variable.
Currently, HK inno.N's K-Cab leads the market. K-Cab has secured a total of five indications, including erosive and non-erosive gastroesophageal reflux disease, gastric ulcers, and Helicobacter pylori eradication therapy. Recently, it completed Phase 3 clinical trials for a sixth indication and is preparing for the approval process. This positions K-Cab as the P-CAB with the broadest prescription range in the country.
Prescription performance is also rapidly increasing. According to the pharmaceutical market research firm Ubiquitous, as of April, K-Cab's cumulative prescriptions reached 1.026 trillion won, marking the first instance of a domestically developed single drug surpassing 1 trillion won in cumulative prescriptions. Last year's annual prescription performance also exceeded 200 billion won, driving HK inno.N's growth.
K-Cab has received product approvals in 23 countries, including South Korea, and has entered 55 countries through technology exports and finished product exports. Its U.S. partner, Sebela Pharmaceuticals, submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in January.
Daiwoo Pharmaceutical's Pecsuclew is also focusing on expanding its indications. Launched in 2022, Pecsuclew surpassed 100 billion won in annual sales within two years, establishing itself as a blockbuster product. Recently, it received approval from the Ministry of Food and Drug Safety for an additional indication for antibiotic combination therapy for Helicobacter pylori eradication, bringing its total to four indications.
The company is also ramping up its efforts in the global market. Following its approval in China last year, Pecsuclew has entered the Indian market, marking the first launch of a domestic P-CAB in India. It is currently available in six countries, including Mexico, Chile, Ecuador, and the Philippines, and with technology exports and product approval applications, the number of countries it has entered has expanded to around 30.
A Daiwoo Pharmaceutical official stated, "We are preparing for a launch in China in the first half of next year, and India is also showing stable growth since its launch. Expanding indications is a strategy to address unmet treatment needs in actual clinical settings." He added, "As the treatment environment and unmet needs for gastrointestinal diseases differ by country, securing diverse clinical evidence and indications will enhance local medical professionals' trust and increase the likelihood of market establishment."
Onconic Therapeutics' Zacubo is rapidly expanding its overseas business. The company announced on June 2 that it successfully completed Phase 3 clinical trials for Zacubo in treating erosive gastroesophageal reflux disease (GERD) in India and has submitted for approval. In China, it is also progressing through the approval process for erosive gastroesophageal reflux disease in collaboration with local partner Livzon Pharmaceutical.
Market competition is expected to intensify further. Daewon Pharmaceutical is conducting Phase 3 clinical trials for its P-CAB new drug 'DW4421', aiming for a launch in 2028, and is considering expanding indications beyond gastroesophageal reflux disease. Additionally, generics of the original drug, Takeda Pharmaceutical's 'Bosunty', are being pursued by latecomers. Dongkwang Pharmaceutical's first generic has already received approval, followed by Mothers Pharmaceutical, Kyungbo Pharmaceutical, and Samik Pharmaceutical, with Donghwa Pharmaceutical also awaiting approval. So far this year, 34 related generics have received approval.
An industry insider noted, "As competition in the domestic P-CAB market becomes increasingly fierce, differentiation through simple launches is becoming more challenging. Ultimately, the speed of indication expansion and successful establishment in overseas markets will likely determine the market landscape."
* This article has been translated by AI.
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