Illustration = ChatGPT DALL-E 3

This year in the pharmaceutical and biotechnology market, glucagon-like peptide (GLP)-1 analogs, which have changed the paradigm of obesity treatment, and antibody-drug conjugates (ADCs), which reduce side effects while enhancing therapeutic efficacy, have received significant attention. By 2025, therapies in the GLP-1 class, ADCs, as well as cell and gene therapies utilizing artificial intelligence (AI) and gene-editing technologies are expected to become the core driving forces of the global pharmaceutical and biotechnology industry.

①“The influence of AI in new drug development is growing”

The U.S. accounting and consulting group Deloitte predicted on the 10th that "digital innovation will bring more changes to the pharmaceutical and biotechnology market in 2025," emphasizing that AI is a key factor. Deloitte noted that "in the next five years, investments in AI technologies by pharmaceutical and biotechnology corporations could generate values of up to 11% of their revenue," adding that "in some cases, the introduction of AI could lead to cost savings of up to 12% of total revenue within the next 2 to 3 years."

Currently, major pharmaceutical and biotechnology corporations at home and abroad are actively investing in AI companies and technologies because they can drastically shorten the time required for drug candidate discovery and development. Samsung Life Science Fund announced this month that it decided to invest in Generate Biomedicine, a U.S. company with protein design technology using generative AI and machine learning.

South Korean medical AI corporation Lunit has signed a collaboration agreement this year with British global pharmaceutical company AstraZeneca to develop AI technology that identifies patients suitable for non-small cell lung cancer treatments. Swiss global pharmaceutical company Novartis has also announced plans to actively utilize AI throughout the entire process of new drug development.

Medical devices and healthcare services that enhance diagnostic accuracy and therapeutic efficacy using AI are also on the rise. South Korean company Vuno has seen its sales increase consecutively for each quarter since the first quarter of 2023. Cumulative sales for the first to third quarters of this year are approximately 18.8 billion won, surpassing last year’s annual sales of 13.3 billion won. Its flagship product is the AI-based medical device "VunoMed DeepCaus" that monitors the risk of cardiac arrest.

Research Institute Jin Ji-hoon of LS Securities stated, "AI will gradually become an indispensable element in the healthcare industry," adding that "it is important to pay attention to the U.S. Food and Drug Administration (FDA) approval of Lunit's VunoMed DeepCaus, which has proven its competitiveness through collaboration with AstraZeneca."

Graphic = Jeong Seo-hee

②ADC clinical trial results expected to pour in

The trend of developing ADCs, known as precision-guided missiles for capturing cancer cells, is expected to continue. ADCs are a therapeutic technology that delivers drugs specifically to cancer cells by attaching them to antibodies. This technology reduces negative effects on healthy cells while maximizing therapeutic efficacy. The anticancer drug "Enhertu," jointly marketed by Daiichi Sankyo and AstraZeneca, is a representative ADC product. Sales of Enhertu approached 4 trillion won this year.

According to a report by market research firm Research Market, 140 pharmaceutical and biotechnology corporations were pursuing ADC new drug development last year. Daiichi Sankyo and AstraZeneca are conducting various clinical trials to use ADCs in early-stage cancer treatment. U.S. companies Merck (MSD), Pfizer, and AbbVie are also developing ADC anticancer agents, with results from their clinical trials in phases 1, 2, and 3 expected to be released in 2025.

Domestic companies such as Ligand Pharmaceuticals and ABL Bio are also being recognized for their ADC technology in the global market. Ligand's ADC candidate LCB84 is currently undergoing clinical phase 1 trials, with expectations to enter clinical phase 2 in 2025. At the end of last year, Ligand signed a technology transfer agreement with Janssen Biotech, a subsidiary of Johnson & Johnson in the U.S., for the development and commercialization of LCB84. Dong-A ST also acquired ADC specialist Aptitude last year, securing not only ADC candidates but also linkers that combine the desired amount of drugs to antibodies.

According to a report published this year by global market research firm Evaluate, the global ADC market is projected to grow from last year's $10 billion (approximately 14.49 trillion won) to $28 billion (approximately 40.67 trillion won) by 2028. As the number of ADC medications increases, contract development and manufacturing organizations (CDMOs) are also preparing for this. Samsung Biologics is establishing dedicated ADC production facilities at its bio-campus in Songdo, Incheon, with the goal of completing them within this year. Lotte Biologics is expanding its ADC production facilities at its Syracuse, U.S. plant.

A picture that virtually implements gene scissors technology. Although it does not use scissors like this picture, it is called gene scissors for the technology that cuts specific gene segments using enzymes. /Courtesy of Chosun DB

③Cell and gene therapies pave a new path for disease treatment

Cell and gene therapies (CGT) are regarded as treatment methods that surpass the limitations of existing medications. Novartis's Kymriah and the U.S. Gilead's Yescarta, known as miraculous anticancer drugs, are typical examples. CAR (Chimeric Antigen Receptor)-T modifies T cells, the patient's immune cells, by extracting them and adding genes to make them target cancer cells. This approach enhances the therapeutic effect while reducing side effects by primarily attacking cancer cells while leaving normal cells unharmed.

The materials for CAR-T therapies are also being expanded. This year, a joint research team from Shanghai Changzheng Medical College and East China Normal University announced in the international journal 'Cell' that they successfully cured three patients using CAR-T cell therapies made from the immune cells of healthy donors.

The research team confirmed the effectiveness of treatment in visibly healing patients' skeletal muscle and skin damage within 3 to 6 months after administration. This marks the first time that treatments made from other people's cells, rather than the patient's cells, have confirmed therapeutic efficacy.

JD Vance, the vice-presidential nominee and running mate of U.S. President Donald Trump, has experience working as a venture capitalist (VC). He is known to have supported the development of innovative medical technologies by investing in healthcare startups, including cell and gene therapies.

④The evolution of obesity treatments continues

The development of metabolic disease treatments in the GLP-1 class is expected to be active again next year. The human GLP-1 hormone promotes the secretion of insulin, which regulates blood sugar levels. At the same time, it regulates nerve cells in the hypothalamus of the brain to decrease appetite after meals and induce a feeling of fullness. GLP-1 class therapeutics are drugs that mimic this function. Currently, Denmark's Novo Nordisk and the U.S. Eli Lilly have successfully commercialized diabetes and obesity injectable medications Ozempic, Wegovy, Monjaro, and Zepbound, leading this market.

This year, research results have continuously emerged indicating that GLP-1 class therapies can expand their indications to not only diabetes and obesity but also cardiovascular and kidney diseases, metabolic dysregulated fatty liver (MASH), sleep apnea, and osteoarthritis. It is expected that similar achievements will continue next year. Moreover, there have been ongoing efforts to overcome the limitations of existing treatments, such as side effects like muscle loss, nausea, and vomiting, as well as the yo-yo effect, where weight regains after treatment is halted. Research is also ongoing to extend dosing intervals from once a week to once a month or more, or to switch from subcutaneous injection formulations to oral formulations.

Clinical trial results for next-generation obesity drug candidates are also expected to be announced next year. Research Institute Kim Jun-young analyzed, "The key investment points for obesity treatments are becoming segmented around three axes: significant efficacy improvement, enhanced convenience, and expanded indications, unlike the previous focus on high weight loss efficacy."

Amgen in the U.S. is developing a monthly injectable obesity drug, while Viking Therapeutics is working on an oral obesity medication. In South Korea, Hanmi Pharmaceutical is expected to announce the clinical phase 1 results of its obesity drug candidate HM15275 next year. Additionally, the interim results of clinical phase 1 for DD02S, which D&D Pharmatech is developing as an oral obesity medication, and for DA-1726, an obesity drug candidate developed by Dong-A ST's subsidiary Metabio, are also set to be announced next year.