A New Turning Point in the Biotechnology Market: Rapid Expansion of AI-Based Drug Development and Personalized Medicine
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The AI Revolution Redefining the Biotechnology Ecosystem
As of the end of 2025, the biotechnology industry is undergoing fundamental changes with the full-scale adoption of artificial intelligence and machine learning technologies. The global biotechnology market size grew by 22.8%, from $985 billion in 2024 to $1.21 trillion in 2025, with the AI-based drug development sector alone reaching $34 billion. Notably, the traditional drug development timeline of 10-15 years is being reduced to 7-9 years with the introduction of AI technology. This shift goes beyond mere efficiency improvements, fundamentally altering the business models of biotech companies.
In a joint study by California-based Genentech and Switzerland’s Basel-based Roche Holding AG (ROG), it was announced that the time to discover cancer treatment candidates using AI algorithms was reduced by 65% compared to traditional methods. In the first half of 2025 alone, they identified 12 new pipelines based on AI, with three entering Phase 1 clinical trials. Meanwhile, Korea’s Samsung Biologics (207940) has implemented an AI-based biopharmaceutical production system at its fourth plant in Songdo, Incheon, improving production efficiency by 35%. The company is expected to achieve sales of 3.2 trillion won in 2025, a 28% increase from the previous year.
Innovative advancements are also continuing in the field of personalized medicine. As the cost of genetic analysis has dropped from $1,000 in 2020 to $150 in 2025, the development of treatments tailored to individual genetic characteristics is becoming a reality. The U.S. FDA approved 47 personalized medicines in 2025 alone, a 46% increase from 32 in 2024. Particularly noteworthy are treatments combining CAR-T cell therapy and gene editing technologies, which are achieving remission rates of over 90% in blood cancer treatments.
Strategic Competitive Landscape of Global Biotech Companies
Currently, the global biotech market is witnessing fierce competition among companies from the U.S., Europe, and Asia. New York-based Pfizer Inc. (PFE) announced an investment of $13 billion in research and development for 2025, a 15% increase from the previous year. The company is particularly focused on developing cancer vaccines using mRNA technology, with its melanoma mRNA vaccine showing positive results in Phase 3 clinical trials. Meanwhile, New Jersey-based Johnson & Johnson (JNJ) is investing a total of $8.5 billion in Alzheimer’s treatment development through its subsidiary Janssen, with clinical results expected in the fourth quarter of 2025.
In the European market, Basel-based Novartis AG (NVS) is leading in the digital therapeutics sector. The company recorded $2.3 billion in sales from its digital healthcare division in 2025, accounting for 4.8% of its total sales. Novartis’s digital therapeutics platform has shown an average improvement of 1.2% in HbA1c levels in diabetes patient management. Additionally, Darmstadt-based Merck KGaA is expanding its patent portfolio related to CRISPR gene editing technology, with related sales expected to reach €1.8 billion in 2025.
In Asia, Korean companies are showing particularly remarkable achievements. Incheon-based Celltrion (068270) ranks third in global market share in the biosimilar market, with projected sales of 4.1 trillion won in 2025. The company’s flagship product, Truxima (rituximab biosimilar), has secured over 30% market share in Europe and is accelerating its entry into the U.S. market. Hyundai Bio (048410) is expanding the production of COVID-19 treatments at its facility in Ochang, Chungbuk, with expected sales of 1.2 trillion won in 2025.
Chinese biotech companies are also experiencing rapid growth. Shanghai-based WuXi Biologics holds a 12% global market share in the CDMO (Contract Development and Manufacturing Organization) sector, achieving sales of $3.5 billion in 2025. The company has secured a competitive edge in ADC (Antibody-Drug Conjugate) production technology and has signed long-term contracts worth a total of $18 billion with global pharmaceutical companies.
The funding environment for biotech companies is also significantly improving. Global biotech venture capital investment reached $42 billion in 2025, an 18% increase from 2024. Notably, AI-based drug development startups accounted for 35% of total investments, drawing significant interest from investors. In Korea, government investment in the biotech sector reached 1.8 trillion won in 2025 under the K-Bio Belt project, a 25% increase from the previous year.
Changes in the regulatory environment are also having a significant impact on the industry. The U.S. FDA announced new digital therapeutics approval guidelines in 2025, which are expected to reduce the approval process time by 30%. The European Medicines Agency (EMA) has also established new evaluation criteria for AI-based drug development, offering new opportunities for Asian biotech companies seeking to enter the European market. The Korean Ministry of Food and Drug Safety announced that it would reduce the review period for biopharmaceutical approvals from 310 days to 280 days in 2025, which is expected to enhance the product launch speed of domestic biotech companies.
In the field of production technology innovation, continuous manufacturing technology is gaining attention. Bioproduction facilities that have adopted this technology can improve production efficiency by 40-50% compared to traditional batch production methods and reduce production costs by 25-30%. Samsung Biologics has applied this technology at its Songdo Plant 4, expanding its annual production capacity to 360,000 liters, the largest among single biopharmaceutical production facilities worldwide. Celltrion is also set to establish a continuous manufacturing facility at its Incheon Plant 2, with full-scale operation expected to begin in 2026, reducing production costs by over 20%.
Future Outlook and Investment Opportunity Analysis
Industry experts forecasting 2026 predict that the biotechnology market will maintain its growth trajectory. According to a recent report by McKinsey & Company, the global biotech market is expected to reach $1.45 trillion by 2026, with the Asia-Pacific region accounting for 28% of the total market. Particularly, the personalized medicine market is projected to grow at an average annual rate of 32%, expanding to $280 billion by 2026.
The global competitiveness of Korean biotech companies is also continuously strengthening. According to the Korea Biotechnology Industry Organization, the domestic biotech industry’s production value reached 18.5 trillion won in 2025, a 22% increase from the previous year. Notably, biopharmaceutical exports amounted to $8.9 billion, a 35% increase from the previous year, signifying Korea’s entry into the top five global biopharmaceutical exporting countries. Samsung Biologics plans to establish a total of five additional production facilities by 2026, expanding its annual production capacity to 1 million liters.
From an investor’s perspective, the biotech sector presents significant growth potential along with considerable risks. According to Goldman Sachs, the biotech IPO market reached $18 billion in 2025, with 75% of these achieving successful listings. However, the risk of clinical trial failures and regulatory uncertainties remain major investment risk factors. Industry data indicates that the overall success rate from Phase 1 to Phase 3 clinical trials remains at 12%, with the success rate for central nervous system disorder treatments like Alzheimer’s being particularly low at less than 5%.
Nevertheless, advancements in AI-based drug development and personalized medicine show potential to significantly improve these success rates. Research by Accenture indicates that clinical success rates for AI-driven drug development projects are 2.5 times higher than traditional methods. This is because AI can more accurately predict drug-target interactions and optimize patient selection. In Korea, as part of the government’s Digital New Deal policy, a total of 500 billion won will be invested in AI R&D in the biotech sector by 2026, significantly contributing to the technological competitiveness of domestic biotech companies.
From an environmental, social, and governance (ESG) perspective, biotechnology plays a crucial role. Amid the increasing risk of new infectious diseases due to climate change, the pandemic response capabilities of biotech companies are emerging as key elements of social value creation. The World Health Organization (WHO) announced the ‘100-Day Mission’ for Disease X in 2025, aiming to develop vaccines within 100 days of discovering a new pathogen. Achieving this goal requires the establishment of AI-based rapid vaccine development platforms and global production networks, with Korean companies expected to play a significant role in this field.
In conclusion, as of the end of 2025, the biotechnology industry is at a turning point with simultaneous technological innovation and market expansion. The convergence of AI and personalized medicine is providing new growth drivers, and Korean companies are strengthening their competitiveness in line with these global trends. Considering the high growth potential and the possibility of creating social value, biotechnology is expected to continue attracting the attention of investors and policymakers in the coming years. However, a cautious approach considering high technical risks and regulatory uncertainties is necessary, with a particular emphasis on developing long-term investment strategies.
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**Disclaimer**: This analysis is intended for informational purposes only and is not a solicitation or advice for investment. Investment decisions should be made at one’s own discretion and responsibility, and no liability is assumed for investment losses based on this content.
