The year 2023 marked significant transformations in the medical and pharmaceutical sectors. Despite facing resistance from the medical community, President Yoon Suk Yeol's administration declared its intention to increase the number of medical school seats starting in 2025. Additionally, 2023 witnessed the opening of the digital therapeutics market. The initiation of telemedicine this year led to an ongoing conflict between the medical community, opposing such practices, and the Ministry of Welfare, advocating for them, expected to persist into 2024. In the pharmaceutical industry, numerous domestic companies ventured into the global market. Korea Biomedical Review has compiled the 10 most noteworthy healthcare developments in 2023. -- Ed.

The contract development and manufacturing organization (CDMO) sector, which has established itself as a key pillar of the Korean pharmaceutical and biotech industry, maintained its brisk growth momentum this year.

Samsung Biologics, the market leader, achieved a significant milestone by signing a contract manufacturing agreement worth $897 million (about 1.2 trillion won) with Pfizer. At the same time, Lotte Biologics expanded production facilities to chase frontrunner Samsung.

Following a CMO contract with Pfizer in March, Samsung Biologics signed two more contracts in July, undertaking long-term contract manufacturing for Pfizer's diverse biosimilar portfolio, including cancer, inflammation, and immunotherapies, until 2029.

In November, Samsung Biologics announced one new and four expanded CMO contracts, bringing the total contract value to 760.8 billion won. The company's annual cumulative order amount exceeded 3.4 trillion won for the first time, doubling the previous year's 1.7 trillion won.

To meet the growing demand for biopharmaceutical CDMO, Samsung Biologics commenced the expansion of its fifth plant, with a capacity of 180,000 liters, in April.

This facility, part of the second Bio Campus in Songdo, Incheon, will be joined by a sixth plant by 2027 and seventh and eighth plants, plus a utility center by 2032. Upon completion in 2032, the total capacity of Samsung Biologics, including the two campuses, will increase to 1,324,000 liters.

With these aggressive expansions, Samsung Biologics is stepping closer to becoming the global leader in the CDMO market, aiming to surpass Swiss-based Lonza. This current market leader had a global CMO share of 20.7 percent as of last year.

Once the fifth plant is completed, Samsung Biologics will have a total production capacity of 784,000 liters, more than 300,000 liters than Lonza’s 460,000 liters.

“Maintaining a 30 percent share in the global CDMO market after the completion of the fifth plant is our goal,” a Samsung Biologics official said. “We aim to implement a ‘super-gap strategy’ with the construction of the sixth plant by 2027 and completion of the seventh and eighth plants and utility center by 2032."

Lotte Biologics, which has entered the CDMO market, was busy catching up with market leaders.

In January, it acquired a biopharmaceutical production plant in Syracuse, U.S., from global pharmaceutical company Bristol Myers Squibb (BMS) while retaining 99.2 percent of BMS employees.

Lotte Biologics has also initiated the construction of an antibody-drug conjugate (ADC) production line at the Syracuse plant, planning to invest $80 million and start production as early as 2025. The company plans to establish additional footholds in major regions of the U.S.

Lotte Biologics also announced the purchase of land in the Incheon Free Economic Zone Authority (IFEZ) to build three mega bio plants in the Songdo 11th District’s KI20 block by 2030.

The company expected to commence construction in March next year, with good manufacturing practice (GMP) production possible by the end of 2026 or early 2027.

"Owning a factory in the U.S. is crucial,” a Lotte Biologics official said, highlighting the strategic difference with Samsung Biologics. “Nothing is riskier than having pharmaceutical products flying back and forth aboard the airplane in the U.S. market. We are optimally positioned in this respect.”