A New Turning Point in the Biotech Revolution: How the Fusion of Personalized Medicine and AI in 2025 is Transforming the Industry Landscape
Editor
As of December 2025, the global biotechnology industry is experiencing a fundamental paradigm shift with the fusion of artificial intelligence and personalized medicine. According to the latest report by McKinsey, the personalized medicine market grew by 15.6% from $789 billion in 2024 to $912 billion in 2025, with AI-based drug development platforms accounting for 23% of this market. Particularly, the gene and cell therapy sector is driving the overall growth of the biotech market with an annual growth rate of 32.4%. This growth is attributed to the combination of accumulated mRNA technology and advancements in AI algorithms following the COVID-19 pandemic.
The Korean biotech industry is also emerging as a key player in this global trend. According to the third-quarter statistics of 2025 released by the Korea Biotechnology Association, the total revenue of domestic biotech companies increased by 28.3% year-on-year to 18.7 trillion won, with the biopharmaceutical sector accounting for the largest share at 12.1 trillion won. Samsung Biologics, headquartered in Seongnam, Gyeonggi Province, achieved sales of 2.8 trillion won in the first half of 2025, securing a 4.2% share in the global CDMO (Contract Development and Manufacturing Organization) market, solidifying its position as the third-largest globally. Celltrion in Songdo, Incheon, generated annual sales of 2.1 trillion won with its nine developed biosimilar products, capturing a 12.7% market share in the European biosimilar market.
Strategic changes among global pharmaceutical giants are also noteworthy. Johnson & Johnson, headquartered in New Brunswick, New Jersey, announced an additional $3.5 billion investment in its AI-based drug development subsidiary ‘Janssen AI Labs’ in the second half of 2025. This investment accounts for 18% of its existing R&D budget, with the company aiming to bring 15 AI-discovered candidate substances into clinical trials by 2028. Roche in Basel, Switzerland, secured 2.8 million cumulative patient data through its personalized cancer treatment platform ‘Foundation Medicine’ in 2025, reporting a 41% increase in companion diagnostic service sales to $1.2 billion compared to the previous year.
Technological Innovations and Market Dynamics in AI-Integrated Biotech
The biggest driving force behind the current changes in the biotech industry is the integration of machine learning and deep learning technologies into the drug development process. Traditionally, drug development took an average of 12-15 years and cost $2.6 billion, but with AI platforms, this period can be reduced to 8-10 years, and costs can be lowered to $1.8 billion, according to industry consensus. DeepMind’s AlphaFold3, developed in Cambridge, UK, has increased protein structure prediction accuracy to 95.2%, with the number of drug candidate discoveries using this technology increasing by 340% compared to 2024, as reported by the journal Nature Biotechnology.
AI’s role is rapidly expanding in the field of personalized medicine. The concept of ‘Precision Medicine 2.0’, which integrates and analyzes patient genomic, proteomic, and metabolomic data to suggest optimal treatments, is entering a practical stage. Moderna in Cambridge, Massachusetts, announced a 67% success rate in Phase 2 clinical trials of its personalized cancer vaccine platform combining mRNA technology and AI. This is more than double the 31% success rate of traditional cancer drug clinical trials, serving as evidence of the efficacy of personalized treatments. The company reported $420 million in sales from this platform in 2025, with projections to expand to $1.2 billion by 2026.
Innovative advancements continue in the field of gene therapy. With improved precision of CRISPR-Cas9 technology and the commercialization of next-generation base editing and prime editing technologies, the success rate of treating single-gene disorders has increased to over 85%. Vertex Pharmaceuticals in Emeryville, California, achieved $800 million in sales with its sickle cell disease treatment ‘Casgevy’ in 2025 and is conducting clinical trials to expand indications to beta-thalassemia. Industry experts predict the CRISPR-based therapy market will grow to $4.7 billion by 2026.
In Korea, the development of gene therapy technology is also accelerating. ToolGen in Gangnam, Seoul, obtained FDA approval for Phase 1 clinical trials of its hereditary blindness treatment developed using its CRISPR platform, while Genexine in Daejeon announced a 78% complete remission rate, the first in Korea, in CAR-T cell therapy development. Based on these achievements, the Korean gene therapy market is projected to grow from 210 billion won in 2025 to 780 billion won in 2028, with an average annual growth rate of 54%, according to the Korea Research Institute of Bioscience and Biotechnology.
Analysis of Global Competitive Landscape and Market Opportunities
The current competitive landscape of the global biotech market is divided into three main axes. The first is the US-centered innovation ecosystem, with the Boston-San Francisco-San Diego biotech cluster attracting 42% of global biotech investments. The second is the mature market led by European pharmaceutical giants, with companies like Roche and Novartis in Switzerland and Novo Nordisk in Denmark expanding investments in next-generation technologies based on stable revenue foundations. The third is the emerging Asian market, with Korea, China, and Japan each integrating into the global value chain based on different strengths.
In terms of market share, AbbVie in Abbott Park, Illinois, maintained its global leadership with total sales of $63.8 billion in 2025, driven by its rheumatoid arthritis treatment ‘Humira’ and next-generation product line. Pfizer in New York achieved total sales of $58.2 billion, strengthening its oncology portfolio despite a decline in COVID-19 vaccine and treatment sales. Meanwhile, Novartis in Basel, Switzerland, recorded $51.5 billion in sales, showing differentiated growth with innovative treatments like the CAR-T cell therapy ‘Kymriah’ and the spinal muscular atrophy treatment ‘Zolgensma’.
In the Asian market, the rise of Korean companies is notable. Samsung Biologics solidified its position as the third-largest in the global CDMO market, following Lonza (Switzerland) and Catalent (USA), achieving an order backlog of 15.7 trillion won in 2025. The company expanded its annual production capacity to 360,000 liters with the completion of its fourth plant in Songdo, Incheon, and plans to begin constructing its first overseas production base in Texas, USA, in 2026. Celltrion continues to expand its market share in Europe with its biosimilar products, achieving annual sales of over 2 trillion won, particularly leveraging price competitiveness with antibody treatments priced 30-40% lower than original drugs.
Analyzing investment trends, global biotech venture investment in 2025 totaled $18.7 billion, a 23% increase from the previous year. AI-based drug development platforms accounted for the largest share with $4.2 billion, followed by cell and gene therapy at $3.8 billion, and digital healthcare at $3.1 billion. In Korea, the government’s K-Bio Belt project and private investment expansion led to a total biotech investment of 3.2 trillion won in 2025, a 35% increase from the previous year. Particularly, the bio cluster connecting Osong, Daejeon, and Chuncheon saw the establishment of over 200 new startups, revitalizing the innovation ecosystem.
Changes in the regulatory environment also significantly impact market dynamics. The US FDA finalized its ‘AI-Enabled Drug Development Guidance’ in 2025, providing clear guidelines for AI-based drug development. As a result, the clinical trial approval process for AI-discovered drug candidates was shortened from the existing 8-12 months to 5-8 months, and the use of AI predictive models in clinical trial design was officially permitted. The European Medicines Agency (EMA) also announced similar guidelines in November 2025, achieving global regulatory harmonization. The Korean Ministry of Food and Drug Safety revised its ‘Advanced Biopharmaceutical Review Guidelines’ in 2025, simplifying approval procedures for CAR-T and gene therapies.
Amid these changes, biotech companies are exploring new business models. Moving away from the traditional blockbuster drug development strategy, the ‘Precision Medicine as a Service’ model, focusing on treatments for rare diseases or personalized therapies for small patient groups, is spreading. This strategy involves high treatment costs per patient but reduces development risks and accelerates market entry. In fact, of the 68 new drugs approved by the FDA in 2025, 31 were treatments for rare diseases, with an average annual treatment cost of $420,000. In contrast, the development period averaged 7.2 years, 40% shorter than traditional drugs.
The growth outlook for the biotech industry is very positive. Global consulting firm McKinsey predicts that the biotech market will grow at an average annual rate of 11.3%, reaching a scale of $2.8 trillion by 2030. The advancement of AI and big data technologies is expected to improve the success rate of drug development from the current 12% to 25% by 2030, leading to improved profitability across the industry. The Korean biotech industry is also expected to achieve a bioeconomy scale of 100 trillion won by 2030, supported by active government support and collaboration with global companies. This growth is the result of three megatrends: the popularization of personalized medicine, the advancement of AI technology, and the increasing global demand for healthcare, leading the biotech industry to experience unprecedented innovation and growth over the next five years.
