Dongkook Pharmaceutical(086450) group is expanding its contrast agent business and speeding up its move to monopolize the domestic contrast agent market. It plans to move beyond a business centered on generic contrast agents, strengthen partnerships with new drug developers, and expand production capacity, while broadening into contract manufacturing (CMO) to leap forward as a "comprehensive platform" for contrast agents.
On the 25th, according to the pharmaceutical and biotech industry, Dongkook Pharmaceutical subsidiary Dong Kook Lifescience(303810) is working to strengthen its market dominance by securing new contrast agent drugs through open innovation and expanding its production and sales base.
◇ Domestic No. 1 Dongkook forms a "contrast agent alliance" with strategic investor Inventera
Contrast agents are pharmaceuticals that help interpretation by making organs, blood vessels and tissues appear more clearly in imaging tests such as magnetic resonance imaging (MRI) or computed tomography (CT).
The domestic contrast agent market is considered a saturated market with strong price-cutting pressure as numerous generic products compete. In the global market, Germany's Bayer leads, while in Korea, Dong Kook Lifescience, Taejoon Pharmaceutical and Daewoong Pharmaceutical(069620) compete.
Dong Kook Lifescience focuses on MRI and CT contrast agents and holds the No. 1 market share in the domestic contrast agent market. Market share steadily rose from 16.8% in 2021 to 20.3% in 2022, 21.4% in 2023 and 22.6% in 2024. The contrast agent business accounts for 67.6% of total sales.
Its main products, the nation's first generic X-ray contrast agent "Pami-Ray" and the MRI contrast agent "Uni-Ray," have been approved in 25 countries including Japan and Europe. It has 43 finished goods and five active ingredients, and has built a system that covers the entire contrast agent business, from active ingredient synthesis to finished product manufacturing and sales and distribution.
The area the company has particularly focused on recently is new contrast agent drugs. A key partner is Inventera(0007J0), in which Dongkook Pharmaceutical Group participated as a strategic investor in 2024. Dongkook Pharmaceutical and Dong Kook Lifescience each invested 1.5 billion won, for a total of 3 billion won, thereby securing about 3.6% equity in Inventera for the group.
Inventera developed the nano drug-delivery platform "Invinity" to improve the limitations of iron-based MRI contrast agents by encapsulating the iron component with polysaccharides (polymer carbohydrates). The method wraps the iron component like a protective shield so it acts more safely and stably in the body.
Inventera is developing the MRI contrast agent "INV-002 (NEMO-103)" using this technology. It is the world's first product dedicated to MR arthrography (MRA), which uses MRI to image the inside of joints. The company recently completed phase 3 trials and plans to apply for product approval with the Ministery of Food and Drug Safety within the year.
Currently, there are no MRA-dedicated approved products in Korea, so gadolinium-based intravenous contrast agents are diluted and injected into the joint cavity. This method carries an infection risk during dilution and has the limitation that the contrast agent can quickly leak out of the joint cavity, degrading image quality.
Inventera plans to first apply for approval targeting the shoulder joint, then expand the indication to the elbow, wrist and hip joints. The domestic market size is about 120 billion won, and the global market is projected to reach 8.6 trillion won by 2030.
In 2024, Dong Kook Lifescience also secured the production and distribution rights for NEMO-103, along with exclusive global sales rights in Japan, China and Southeast Asia. Inventera secures a stable production and sales base, while Dong Kook Lifescience adds a new drug to its contrast agent business, which had been centered on generics, creating a growth engine.
◇ Expanding production capacity through plant expansion… Beyond new drugs to CMO business
Dong Kook Lifescience is increasing production capacity in line with the expansion of its new drug business. At the same time, it plans to use the increased production headroom to expand into contract manufacturing (CMO), leveraging its production base as a new growth engine.
Its production base is the Anseong plant. It has built a system capable of carrying out the entire process in-house, from active ingredient synthesis to finished product manufacturing. The finished drug plant was acquired from Germany's Bayer in 2019, completed Good Manufacturing Practice (GMP) certification in 2021, and went into full operation in the second half of 2022. The active pharmaceutical ingredient plant was newly established in 2021 and has been operating since 2023.
Dong Kook Lifescience is investing 17 billion won in this plant to expand the production building. With this, it plans to boost finished drug production capacity from 2.19 million vials in 2024 to about three times that level by 2028. Active pharmaceutical ingredient production capacity will also increase 23.1% over the same period, from 268 tons (t) to 330 t. The expansion work is scheduled for completion and equipment installation in 2026, GMP approval in 2027, and the start of production in the first half of 2028.
The increased production headroom will also be used to expand the CMO business. Dong Kook Lifescience signed a five-year contract from 2026 to 2031 with a domestic pharmaceutical company for nonionic iodinated contrast agent injections, and a 10-year contract from 2026 to 2036 with another company for an antiplatelet active ingredient.
It is also expanding overseas operations. It has built an export network in 34 countries and exports contrast agents to Europe, Japan, Asia and South America. It also plans to speed up the global market entry of NEMO-103 by leveraging its existing overseas sales network.
It is also pushing into the Chinese market. Late last year, it signed a memorandum of understanding (MOU) in the contrast agent field with China's Tianyu Pharmaceutical and is discussing the signing of definitive agreements in seven areas, including joint development of an MRI contrast agent new drug, joint development of active pharmaceutical ingredients and export of finished drugs.
Dong Kook Lifescience previously said in IR materials, "We will improve product revenue in the contrast agent business and expand our portfolio, while strengthening new drug development and open innovation, and enhancing global exports and production capacity to increase market competitiveness."