A New Turning Point in the Biotechnology Market: The Innovation Landscape of 2025 Shaped by the Fusion of AI and Gene Therapy
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A New Paradigm in AI-Based Drug Development
The biotechnology industry stands at the center of fundamental change as we enter 2025. The global biotechnology market is expected to grow by 18%, from $1.1 trillion in 2024 to $1.3 trillion in 2025, driven by the innovative changes brought about by the fusion of artificial intelligence and gene therapy technologies. Notably, the AI-based drug development market has grown to $34 billion in 2025, marking a sharp 43% increase from the previous year. This growth goes beyond mere market expansion, fundamentally redefining the approach and business models across the biotechnology industry.
Gilead Sciences, headquartered in South San Francisco, California, announced in its third-quarter 2025 earnings report that it invested a total of $2.7 billion in its AI-based drug development pipeline. This figure represents a 156% increase compared to the same period last year, with the goal of reducing drug development time from the traditional 10-15 years to 6-8 years through molecular design and clinical trial optimization using AI algorithms. Gilead’s CEO Daniel O’Day explained, “Through AI technology, we are understanding complex disease mechanisms that were previously impossible and developing treatments with more precise targeting.” In fact, three Alzheimer’s treatment candidates being developed by Gilead using AI are all set to enter Phase 2 clinical trials in the second half of 2025, significantly advancing a development schedule that would have taken at least two more years using traditional methodologies.
South Korea’s biotechnology industry is also experiencing rapid growth in line with these global trends. Samsung Biologics, headquartered in Songdo, Incheon, announced a 1.2 trillion won investment in building an AI-based biopharmaceutical production optimization system by 2025. This system is expected to optimize cell culture conditions in real-time using machine learning algorithms, improving production yield by 35% compared to existing methods. Samsung Biologics’ third-quarter 2025 revenue was 2.1 trillion won, a 28% increase from the same period last year, with AI-based production optimization services accounting for 15% of the total. A company representative emphasized, “Through AI technology, we are evolving beyond a simple contract manufacturing organization to a comprehensive solution provider that creates added value throughout the entire biopharmaceutical development process.”
Accelerating Commercialization and Market Expansion of Gene Therapy
The most notable field in the biotechnology industry in 2025 is the commercialization of gene therapy technologies. The global gene therapy market size reached $18.9 billion in 2025, a 52% increase from 2024. This rapid growth is attributed to improvements in the accuracy and cost reduction of CRISPR-Cas9 technology, as well as the simplification of approval procedures by regulatory authorities. In particular, the U.S. FDA approved 17 gene therapies in the first half of 2025 alone, surpassing the total of 12 approvals in 2024. The European Medicines Agency (EMA) showed a similar trend, approving 11 gene therapies.
Moderna, headquartered in Cambridge, Massachusetts, is securing new growth drivers through its mRNA-based gene therapy platform in 2025. The company is focusing on developing treatments for rare diseases using mRNA technology accumulated from its COVID-19 vaccine, with 23 mRNA-based therapeutic candidates in its pipeline as of the third quarter of 2025. Moderna’s CEO Stéphane Bancel predicted, “Our mRNA platform will become a new standard for personalized gene therapy beyond simple vaccine technology.” In fact, Moderna’s personalized cancer vaccine mRNA-4157 showed a 44% improvement in survival rates compared to existing treatments in Phase 3 clinical trials for melanoma patients, with commercialization targeted for 2026.
Celltrion, headquartered in Incheon, is also showcasing a unique approach in the gene therapy field. The company is investing 800 billion won in developing CAR-T cell therapies by 2025, focusing on developing treatments tailored to Asians, differentiating itself from Western pharmaceutical companies. Celltrion’s researchers have developed more effective CAR-T cell design methods by analyzing genetic differences between Asians and Westerners, and a blood cancer treatment based on this is set to enter Phase 1 clinical trials in the second half of 2025. A company representative explained, “We are demonstrating new possibilities for ‘Made in Asia’ gene therapies in the global market.” Celltrion’s third-quarter 2025 R&D expenditure was 420 billion won, accounting for 18% of total revenue, with 60% focused on the gene therapy field.
With the advancement of gene therapy technologies, the concept of personalized medicine is also rapidly spreading. Eli Lilly, headquartered in Indianapolis, Indiana, is presenting a new business model through its personalized diabetes treatment program in 2025. The company has started a service that provides optimized treatment protocols for individuals by comprehensively analyzing patients’ genetic information, lifestyle patterns, and blood sugar changes. The blood sugar control effect for patients participating in this program improved by an average of 34% compared to standard treatments, while treatment costs were reduced by 22%. Eli Lilly’s diabetes division revenue increased by 41% in the third quarter of 2025 compared to the same period last year, reaching $8.7 billion, with personalized treatment services accounting for 28% of the total.
Changes in the biotechnology industry are fundamentally impacting the business models of existing pharmaceutical companies. Novo Nordisk, headquartered in Bagsværd, Denmark, is focusing on developing integrated solutions combining digital healthcare and biotechnology in 2025. The AI-based blood sugar management app linked to the company’s flagship diabetes treatment Ozempic secured 2.8 million users worldwide in the first half of 2025 alone. This app monitors patients’ meals, exercise, and stress levels in real-time and provides personalized treatment recommendations. Novo Nordisk’s CEO Lars Fruergaard Jørgensen explained, “We are evolving from a simple drug provider to a healthcare partner managing the entire treatment journey of patients.” In fact, Novo Nordisk’s digital healthcare-related revenue in the third quarter of 2025 was $3.4 billion, accounting for 15% of total revenue and establishing itself as a new growth driver.
Roche Holding, headquartered in Basel, Switzerland, is securing a unique position in the biotechnology market with its precision medicine solutions integrating diagnostics and treatment. The company launched a comprehensive diagnostic platform in 2025, combining next-generation gene sequencing technology and AI-based biomarker analysis. This platform provides a service that analyzes patients’ genetic information within 24 hours and suggests optimal treatment methods for individuals. Roche’s diagnostics division revenue was $15.6 billion in the third quarter of 2025, a 31% increase from the same period last year, with AI-based precision diagnostics services accounting for 42% of the total. A company representative emphasized, “The boundaries between diagnostics and treatment are disappearing, and we are leading this change by providing integrated solutions.”
Along with these technological innovations, investment patterns in the biotechnology industry are also significantly changing. The global biotech venture capital investment size reached $48.7 billion in 2025, a 23% increase from 2024. Investments in startups combining AI and gene therapy accounted for 38% of the total, showing the highest proportion. In South Korea, biotechnology investments reached a total of 3.8 trillion won by the third quarter of 2025, a 67% increase from the same period last year, attributed to the synergy between the government’s K-Bio Belt project and private investments.
However, the biotechnology industry also faces significant challenges alongside this rapid growth. The most pressing issues are the complexity of the regulatory environment and ethical concerns. With advancements in gene editing technology making the possibility of human embryo gene manipulation a reality, governments and international organizations are working to establish stricter guidelines. The U.S. FDA announced that from the second half of 2025, the safety monitoring period for gene therapies will be extended from the current five years to ten years, impacting the development costs for related companies. Additionally, the protection of large amounts of patient data generated during AI-based drug development is emerging as a critical issue.
The future outlook for the biotechnology industry remains highly positive. Global market research institutions predict that the biotechnology market size will reach $2.4 trillion by 2030, representing an average annual growth rate of 13%. Particularly, the fields of personalized medicine and AI-based drug development are expected to continue high growth with average annual growth rates of 25% and 31%, respectively. South Korea’s biotechnology industry has set a goal to expand its global market share from the current 3.2% to 7.5% by 2030, with plans for a total investment of 50 trillion won by the government and private sector. If these investments and technological innovations continue, biotechnology is expected to establish itself as a key industry responsible for the health and well-being of humanity in the 21st century.
*This analysis is based on publicly available information and industry trends. Additional research and expert consultation are recommended for investment decisions. The stock prices or performance of the mentioned companies may fluctuate depending on market conditions.*
