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A New Turning Point in the Biotechnology Revolution: Market Changes Driven by the Fusion of Precision Medicine and AI in 2026

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A New Paradigm Shift in the Biotechnology Industry

As of January 2026, the global biotechnology industry is undergoing fundamental changes through the integration of artificial intelligence and precision medicine. According to the latest report from market research firm McKinsey, the global biopharmaceutical market size is projected to grow by 8.3%, from $480 billion in 2025 to $520 billion in 2026. The key drivers of this growth are the accelerated commercialization of personalized therapies and AI-based drug development platforms. Notably, the Asia-Pacific region is leading with an annual growth rate of 12.5%, surpassing North America and Europe.

A New Turning Point in the Biotechnology Revolution: Market Changes Driven by the Fusion of Precision Medicine and AI in 2026
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Korea’s biotechnology ecosystem is at the heart of these global trends. According to data released by the Korea Biotechnology Industry Organization for the first quarter of 2026, the total revenue of domestic biotech companies increased by 18.7% year-on-year, reaching 42 trillion won. This indicates the fruition of the K-Bio Belt project and the government’s Biohealth New Deal policy. Samsung Biologics, located in Songdo, Incheon, achieved sales of 1.2 trillion won in the fourth quarter of 2025, capturing a 15.2% share of the global biopharmaceutical contract manufacturing (CMO) market, ranking second worldwide after Switzerland’s Lonza, which holds 18.3%.

In the field of precision medicine, technologies that analyze individual genetic information and lifestyle patterns to provide optimized treatments have entered the commercialization phase. The U.S. FDA approved 47 personalized therapies in 2025, a 67% increase from the previous year. CAR-T cell therapies and gene-editing technologies are particularly gaining attention. Novartis, headquartered in Basel, Switzerland, recorded global sales of $850 million for its CAR-T therapy Kymriah in 2025, establishing itself as a leader in the field.

The adoption of AI and machine learning technologies is revolutionizing the drug development process. The traditional drug development period of 10-15 years is being reduced to 7-10 years through AI technology, and development costs are also being cut by over 30%, from an average of $2.6 billion to $1.8 billion. DeepMind’s AlphaFold project, based in Cambridge, UK, has increased the accuracy of protein structure prediction to over 90%, significantly enhancing the research and development efficiency of pharmaceutical companies worldwide.

Changes in Global Competitive Dynamics and Market Dynamics

The global competitive landscape of the biotechnology industry is becoming multipolar, shifting from the traditional U.S. and Europe-centric model to the rise of Asian countries. China recorded a biopharmaceutical market size of $120 billion in 2025, rising to second place globally, while Korea maintained its sixth position with $45 billion. Japan’s Takeda Pharmaceutical recorded sales of $30.8 billion in 2025, solidifying its status as Asia’s largest pharmaceutical company. Meanwhile, Johnson & Johnson in the U.S. achieved pharmaceutical sales of $47.2 billion, maintaining its global leadership even after the spin-off of its medical device division.

Korean companies are also accelerating their global expansion. Celltrion, headquartered in Incheon, achieved annual sales of 3.2 trillion won in 2025, capturing a 22% global market share in the biosimilar market. The company’s performance in the European market is particularly noteworthy, with Celltrion’s biosimilar products expanding market share at prices 40-50% lower than original drugs in Germany and France. Yuhan Corporation, based in Seoul, recorded sales of 280 billion won for lazertinib in the fourth quarter of 2025, emerging as a new powerhouse in the lung cancer treatment market.

The U.S. pharmaceutical industry is facing a revenue cliff due to patent expirations. Pfizer’s sales of COVID-19 vaccines and treatments plummeted from $28 billion in 2024 to $5 billion in 2025, but the company limited the total sales decline to 5.2% by strengthening its cancer treatment portfolio. Conversely, Switzerland’s Roche focused on investing in the personalized diagnostics market, with its diagnostics division sales increasing by 12.3% year-on-year to $15.8 billion in 2025. This demonstrates that the convergence of therapies and diagnostic technologies is establishing a new revenue model.

Venture capital and private equity investments in biotechnology are also active. The global investment in the biotechnology sector reached $124 billion in 2025, with 42% focused on AI-based drug development platforms and precision medicine technologies. Notably, Singapore’s Government Investment Corporation (GIC) and Japan’s SoftBank Vision Fund are significantly increasing their investments in Asian biotechnology startups. In Korea, the government-led K-Bio Lagrange Fund was established with a total of 2 trillion won in 2025, contributing to the activation of the domestic bio-venture ecosystem.

Changes in the regulatory environment are also having a significant impact on the industry. The U.S. FDA announced new approval guidelines for AI-based medical devices in 2025, and the European Medicines Agency (EMA) introduced expedited approval procedures for personalized therapies. Korea’s Ministry of Food and Drug Safety will relax biosimilar approval standards to international levels starting in 2026, supporting the enhancement of domestic companies’ global competitiveness. These regulatory relaxations are expected to accelerate the commercialization of innovative biotechnology while significantly improving patient access to treatments.

Supply chain diversification is also emerging as a major trend. Following the COVID-19 pandemic, the pharmaceutical industry is pursuing strategies to reduce dependence on China and diversify supply chains. Samsung Biologics began constructing a $1.7 billion production facility in Texas, USA, at the end of 2025, with completion expected in 2027. This aims to strengthen competitiveness in the North American market while mitigating geopolitical risks. In Europe, biopharmaceutical production hubs are expanding, centered on Germany and Ireland, accelerating the reorganization of the global biotechnology ecosystem.

Future Outlook and Investment Opportunities

The outlook for the biotechnology industry from 2026 to 2030 is very positive. Global consulting firm Boston Consulting Group (BCG) predicts that the biopharmaceutical market will grow at an average annual rate of 8.7%, reaching $780 billion by 2030. The key drivers of this growth are the aging population, the increase in chronic diseases, and the rising demand for personalized medicine. The Asian market, in particular, is expected to show a high growth rate of 11.2% annually due to the expansion of the middle class and improved healthcare accessibility.

Gene therapy and cell therapy fields are being highlighted as the next-generation growth engines. Market research firm Grand View Research predicts that the global gene therapy market will grow rapidly from $7.8 billion in 2025 to $24.5 billion by 2030. Gilead Sciences’ CAR-T therapy Yescarta surpassed $1 billion in sales in 2025, with an expected average annual growth rate of 25% over the next five years through expanded indications. In Korea, companies like Pharmicell and Anterogen are accelerating the development of stem cell therapies, with the implementation of the Advanced Regenerative Medicine Act by the government speeding up commercialization.

The convergence of digital healthcare and biotechnology is also creating new investment opportunities. Preventive medicine solutions that combine real-time biometric data collection through wearable devices with AI analysis are gaining attention. Apple’s healthcare division recorded sales of $18 billion in 2025, with blood glucose monitoring and ECG measurement functions as key growth drivers. Korean digital healthcare startups like MediBloc and Huray Positive are also accelerating their entry into the global market with blockchain-based medical data management platforms.

However, the biotechnology industry still carries high risks. The success rate of new drug development remains below 10%, and there is a significant risk of loss due to clinical trial failures. Additionally, regulatory approval delays, patent disputes, and manufacturing quality issues are major risk factors. In 2025, global pharmaceutical companies incurred total losses of $42 billion due to clinical trial failures. This implies that investors need to approach portfolio diversification and risk management with greater caution.

ESG (Environmental, Social, and Governance) factors are also becoming important considerations in biotechnology investments. Efforts by pharmaceutical companies to improve drug accessibility, adopt environmentally friendly production processes, and disclose transparent research and development processes are influencing investment decisions. Novartis invested $1.2 billion in a drug accessibility program for developing countries in 2025, resulting in long-term brand value enhancement and market expansion effects. Korean companies are also strengthening ESG management in line with these global trends, positively impacting foreign investment attraction and global partnership building.

In conclusion, the biotechnology industry in 2026 is at a turning point where technological innovation and market expansion are occurring simultaneously. The fusion of AI and precision medicine, the rise of the Asian market, and the commercialization of new therapies are acting as major growth drivers. For investors, the market presents significant growth potential along with considerable risks, but it offers meaningful investment opportunities that contribute to improving human health and quality of life from a long-term perspective. In particular, the strengthening of global competitiveness by Korean biotechnology companies and the government’s proactive support policies present even more attractive opportunities for domestic investors.

This analysis is intended for general informational purposes only and does not constitute investment advice or stock recommendations. All investment decisions should be made at the individual’s discretion and responsibility, and thorough review and consultation with experts are advised before investing.

#Samsung Biologics #Celltrion #Yuhan Corporation #Johnson & Johnson #Pfizer #Roche #Novartis

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