The Integration of AI in the Biotechnology Industry and an Analysis of South Korea’s Global Competitiveness

A New Paradigm of AI-Based Biotechnology

As of November 2025, the global biotechnology market stands at the forefront of unprecedented change. According to the latest report from McKinsey & Company, the AI-based biotechnology market size has increased by 34.7% compared to 2024, reaching $428 billion, and is projected to maintain an annual growth rate of 12.3% to reach $1.2 trillion by 2030. This rapid growth is driven by the innovative achievements of machine learning and deep learning technologies in drug development, gene therapy, and personalized medicine.

Notably, Korean biotech companies are at the forefront of this transformation. Seoul-based Celltrion recorded a 28.4% increase in biosimilar sales in the third quarter of 2025 compared to the same period last year, reaching 1.34 trillion won, capturing a 6.7% share of the global biosimilar market. This places it third after Switzerland’s Roche at 12.3% and the United States’ AbbVie at 9.8%. More impressively, Celltrion has reduced the drug development period from the traditional 7-10 years to 4-5 years by adopting an AI-based antibody design platform.

The integration of AI and biotechnology goes beyond mere efficiency improvements, opening up possibilities for entirely new treatments. The AlphaFold project by DeepMind, based in Cambridge, UK, has increased protein structure prediction accuracy to over 90%, prompting over 2,000 biotech companies worldwide to embark on new drug development. In South Korea, the AI-based protein design platform jointly developed by Sungkyunkwan University and Samsung Biologics has received FDA designation as an innovative medical device, proving its global competitiveness.

From an investment perspective, the AI integration in the biotech sector is garnering significant interest. According to CB Insights data, global investment in AI biotech startups reached $18.7 billion in the first half of 2025, a 42.3% increase from the same period last year. Investment in bio AI startups is also surging in South Korea, with the average market capitalization of KOSDAQ-listed biotech companies rising by 56.8% compared to 2024, reaching 2.46 trillion won. This investment growth indicates a shift in the biotech industry from simple manufacturing to a data-driven, knowledge-intensive industry.

Global Competitive Landscape and South Korea’s Strategic Position

The current global biotech market’s competitive landscape is divided into three main axes. The first is the US-centered innovation ecosystem, represented by companies like Gilead Sciences in California, Biogen in Massachusetts, and Regeneron in Texas. These companies lead the development of next-generation gene therapies and immuno-oncology drugs with annual R&D investments exceeding $20 billion. Notably, Gilead maintained a dominant position with $4.7 billion in CAR-T cell therapy sales in 2025.

The second axis consists of Europe’s traditional pharmaceutical powerhouses, including Switzerland’s Novartis and Roche, and Germany’s Bayer, which are strong in biosimilars and precision medicine. Novartis recorded $13.4 billion in biopharmaceutical sales in the third quarter of 2025, accounting for 73.2% of its total sales. These European companies are characterized by stable growth based on a deep understanding of regulatory environments and global market experience.

The third axis comprises emerging biotech powerhouses in the Asia-Pacific region. Notable companies include China’s BeiGene and WuXi Biologics, Japan’s Takeda, and South Korea’s Celltrion and Samsung Biologics. Korean companies, in particular, are expanding their presence in the global market through unique strategies. Incheon-based Samsung Biologics recorded 2.87 trillion won in contract development and manufacturing (CDMO) sales in 2025, capturing a 12.4% share of the global CDMO market. This ranks second after Switzerland’s Lonza at 15.7%, making it the largest among Asian companies.

The competitive advantage of South Korea’s biotech industry is based on manufacturing capabilities and cost efficiency. For instance, Samsung Biologics’ production costs for biopharmaceuticals are 30-40% lower than in Europe, while meeting both FDA and EMA quality standards. Leveraging this competitiveness, they have secured long-term contracts with global pharmaceutical companies, with a contract backlog exceeding 14 trillion won as of 2025. Celltrion has also established a unique positioning in the biosimilar sector, offering equivalent efficacy at 40-60% lower prices than original drugs, rapidly expanding its market share in Europe and the US.

However, Korean biotech companies face significant challenges. They still lag behind US and European companies in innovative drug development capabilities, particularly in basic research investment. The average R&D investment ratio of Korean biotech companies is 8.3% of sales, significantly lower than the US average of 15.7%. To bridge this gap, the South Korean government plans to increase the annual R&D budget for the biotech sector to 2.5 trillion won from 2025 and enhance tax benefits to attract private investment.

Technological Innovation and Market Outlook

One of the most notable technological innovations in the biotechnology field is the commercialization of CRISPR gene-editing technology. As of 2025, the CRISPR-based therapeutics market size is $4.7 billion and is expected to grow at an annual rate of 43.2% to reach $34 billion by 2030. Boston-based Editas Medicine and California-based Intellia Therapeutics are leading this field, with FDA approvals for treatments for beta-thalassemia and hereditary amyloidosis, respectively.

CRISPR technology development is also active in South Korea. Seoul-based ToolGen has begun developing treatments for hemophilia and Duchenne muscular dystrophy using its proprietary CRISPR technology, receiving approval for Phase 1 clinical trials in the second half of 2025. ToolGen’s patent portfolio consists of over 130 patents in 40 countries, with 12 key patents protected until the 2030s. A company representative stated, “Our CRISPR technology boasts an accuracy of 99.7% compared to existing methods, with a side effect occurrence rate of less than 0.3%.”

Another area of innovation is biomarker-based precision medicine. The early cancer diagnosis market through liquid biopsy technology is expected to grow from $6.3 billion in 2025 to $18.5 billion by 2030. California-based Guardant Health is a leader in this field, possessing technology that can diagnose over 50 types of cancer with over 90% accuracy from a single drop of blood. Guardant’s third-quarter 2025 sales were $423 million, a 38.7% increase from the same period last year, with their testing services used by over 10,000 hospitals worldwide.

In South Korea, innovation in precision medicine is accelerating. Bundang-based Macrogen has developed a personalized cancer treatment solution based on next-generation sequencing (NGS) technology, performing over 15,000 genetic tests in the first half of 2025 alone. Macrogen’s test accuracy exceeds international standards at 99.9%, with testing costs 50-60% lower than in the US. Leveraging this competitiveness, they are actively expanding into Southeast Asian and Middle Eastern markets, with overseas sales accounting for 34.2% of total sales in 2025.

Innovative advancements are also continuing in the regenerative medicine field. The stem cell therapy market is expected to grow from $8.9 billion in 2025 to $24.7 billion by 2030, with an annual growth rate of 22.6%. California-based Bluerock Therapeutics received FDA fast-track designation for its dopamine neuron transplantation therapy for Parkinson’s disease, with 70% of patients showing improved motor function in Phase 2 clinical trials.

Korean regenerative medicine companies are also making their mark in global competition. Seongnam-based Pharmicell has demonstrated clinical efficacy in treating Crohn’s disease and rheumatoid arthritis with its proprietary mesenchymal stem cell therapy. Pharmicell’s stem cell therapy has a 15% lower side effect rate compared to existing biologics, with equivalent or superior therapeutic effects. The company plans to submit a marketing authorization application to the European Medicines Agency (EMA) in the second half of 2025, aiming for annual sales of 500 billion won upon approval.

Another factor shaping the future of the biotechnology industry is its integration with digital healthcare. The preventive medicine market, combining real-time biometric data collection through wearable devices and AI analysis, is rapidly growing, expected to expand from $34 billion in 2025 to $89 billion by 2030. California-based Tempus operates a platform that analyzes genetic and clinical data of cancer patients using AI to propose optimal treatment methods, recording $780 million in sales in 2025.

Despite these technological innovations and market growth, the biotechnology industry faces significant challenges. Increasing regulatory complexity, rising clinical trial costs, and ethical controversies are prominent issues. Particularly, ethical concerns related to CRISPR gene editing have sparked heated global debates, with market growth potentially influenced by each country’s regulatory direction. Additionally, the high prices of biopharmaceuticals continue to raise accessibility issues, necessitating urgent solutions.

From an investment perspective, the biotechnology industry presents significant risks alongside high growth potential. The success rate of new drug development remains around 10%, with frequent stock price drops due to clinical trial failures. However, the rewards of success are substantial, with annual sales reaching billions of dollars, especially for orphan drugs or innovative mechanism drugs. Given these characteristics, biotechnology investment requires a diversified portfolio and a long-term investment approach.

As of the second half of 2025, the outlook for the biotechnology industry is generally positive. The advancement of AI and big data technologies is significantly enhancing drug development efficiency, and the growing demand for personalized treatment is strengthening market growth drivers. Korean biotech companies are also expected to solidify their position in the global market based on their manufacturing competitiveness. However, sustainable growth will require regulatory system adjustments and the establishment of ethical guidelines in line with the pace of technological innovation.

This analysis is intended for general informational purposes and should not be interpreted as advice for specific investment or medical decisions. Always consult with a professional before making investment or medical-related decisions.