A New Turning Point in Biotechnology Innovation: The Rapid Growth of AI-Based Drug Development and Gene Therapy by 2025
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The Revolution in Drug Development Driven by AI and Biotech Fusion
As of the end of 2025, the biotechnology industry is experiencing a fundamental paradigm shift through its integration with artificial intelligence technology. The global biotech market size has reached $1.24 trillion this year, marking a 12.8% growth compared to the previous year. Among this, the AI-based drug development sector has shown a remarkable 45% growth, leading the market. Notably, the traditional drug development process, which typically took 10-15 years, has been shortened to an average of 7-9 years with the introduction of AI technology, significantly improving the pharmaceutical industry’s return on investment (ROI).
Venture capital firms based in California, USA, have invested a total of $18 billion in AI-based biotech startups this year alone, a 65% increase from last year. This surge in investment is largely attributed to the commercialization of protein structure prediction AI like Google’s AlphaFold, which has improved the accuracy of drug target discovery from 30% to 85%. In fact, Roche, headquartered in Basel, Switzerland, announced that three candidate substances from its AI-based drug development pipeline entered Phase 2 clinical trials in the third quarter of this year, showing progress 2.5 years faster than traditional methodologies.
Korea’s biotech industry is also rapidly growing in line with these global trends. Samsung Biologics, headquartered in Songdo, Incheon, recorded sales of 3.21 trillion won this year, a 28% increase from the previous year, and improved production efficiency by 35% with the introduction of an AI-based biopharmaceutical production optimization system. Additionally, Celltrion, located in Yeonsu-gu, Incheon, invested 120 billion won this year in developing biosimilars using AI, with plans to secure 10 new biosimilar candidates by 2026.
Accelerating Commercialization of Gene and Cell Therapies
Another notable advancement in the biotechnology field is the full-scale commercialization of gene and cell therapy technologies. The global gene therapy market has grown to $34 billion by 2025, with a compound annual growth rate (CAGR) of 24.2%. Particularly, the CAR-T cell therapy sector has formed an $8.5 billion market this year, demonstrating remarkable results by improving the 5-year survival rate in blood cancer treatment from 45% to 78% compared to traditional chemotherapy.
Gilead Sciences, headquartered in Foster City, California, recorded total sales of $5.2 billion this year through its CAR-T therapies ‘Yescarta’ and ‘Kymriah’, a 38% increase from the previous year. Notably, Gilead succeeded in developing a next-generation CAR-T therapy applicable to solid tumors in the latter half of this year, expanding the market application range from blood cancer to lung and breast cancers. Consequently, the potential market size for CAR-T therapy is projected to reach $45 billion by 2030.
In the gene therapy sector, the commercialization of CRISPR-Cas9 technology is accelerating. This year, the US FDA approved two CRISPR-based gene therapies for sickle cell disease and beta-thalassemia, and over 120 CRISPR-based clinical trials are currently underway worldwide. Notably, the treatment cost has decreased by 43%, from an initial $1.5 million to $850,000, significantly improving accessibility. This cost reduction is analyzed as a result of the combined effects of manufacturing process automation and economies of scale.
In the mRNA technology field, Moderna, headquartered in Cambridge, Massachusetts, which gained attention for its COVID-19 vaccine, has made groundbreaking progress in developing personalized mRNA vaccines for cancer this year. Moderna announced that in Phase 2 clinical trials for melanoma patients, it reduced the recurrence rate by 44% compared to existing treatments, aiming for commercialization by 2026. Additionally, Moderna recorded $2.7 billion in sales this year with its respiratory syncytial virus (RSV) vaccine, demonstrating the diverse disease application potential of the mRNA platform.
Another innovative example in gene therapy is Novo Nordisk’s diabetes treatment development, headquartered in Bagsværd, Denmark. Novo Nordisk achieved total sales of $24 billion this year through its GLP-1 receptor agonists ‘Ozempic’ and ‘Wegovy’, a 31% increase from the previous year. Notably, these treatments have shown an average weight loss effect of 15-20% in obesity treatment as well as diabetes, establishing a new standard in the global obesity treatment market. Currently approved as obesity treatments in 12 countries worldwide, the market size is projected to reach $54 billion by 2026.
In the field of precision medicine and personalized treatment, advancements in next-generation sequencing (NGS) technology are gaining attention. Illumina, headquartered in San Diego, California, launched its new NGS platform ‘NovaSeq X’ this year, successfully reducing the cost of whole-genome analysis to $200. This represents a 15-million-fold decrease from the $3 billion cost at the completion of the Human Genome Project in 2003, accelerating the popularization of personalized medicine. Illumina recorded $4.8 billion in sales this year, with the liquid biopsy market in oncology growing at an annual rate of 28%, serving as a major growth driver.
With the growth of the biotechnology industry, the regulatory environment is also rapidly changing. The US FDA simplified the approval process for AI-based medical devices and digital therapeutics through the amendment of the ’21st Century Cures Act’ this year, and the European Medicines Agency (EMA) announced similar guidelines. The Korean Ministry of Food and Drug Safety also revised the ‘Advanced Biopharmaceuticals Approval and Review Guidelines’ this year to support the swift market entry of gene and cell therapies. These improvements in the regulatory environment are accelerating the pace of innovation for biotech companies.
From an investment perspective, the biotechnology field presents high growth potential along with associated risks. This year, the Nasdaq Biotechnology Index (NBI) rose by 18.2% compared to the beginning of the year, but the stock price volatility of individual companies averaged 45%, indicating high risk. Particularly, the stock price fluctuation at the time of clinical trial result announcements averages ±35%, requiring cautious approaches from investors. Nevertheless, from a long-term perspective, biotechnology is evaluated as an investment destination that aligns with megatrends such as population aging and the increase of chronic diseases, with major investment banks projecting an annual growth rate of 15-20% over the next five years.
In conclusion, the biotechnology industry in 2025 is undergoing rapid changes centered around three key trends: the fusion with AI technology, the commercialization of gene therapy, and the expansion of personalized medicine. Particularly, Korean biotech companies are securing competitiveness in the global market, and the government’s K-Bio Belt project and Biohealth New Deal policy are positively impacting the development of the industry ecosystem. The next 2-3 years are expected to be a turning point towards a new growth phase for the biotechnology industry, and it is time for investors and companies to strategically respond to these changes.
This information is provided for informational purposes only and is not intended as investment advice. Investment decisions should be made based on individual careful judgment.
