A New Turning Point in the Biotech Revolution: An Analysis of the Biotechnology Industry in 2026 Driven by AI-Based Drug Development and Gene Therapy
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At the beginning of 2026, the global biotechnology industry is experiencing an unprecedented wave of innovation through the convergence of artificial intelligence and gene editing technologies. According to the latest report from McKinsey Global Institute, the global biotech market is expected to grow by 23.5%, from $980 billion in 2025 to $1.21 trillion in 2026. The commercialization of AI-based drug development platforms and the expanded clinical application of gene editing technologies like CRISPR are the main drivers of this growth. Particularly, South Korea’s biotech industry is projected to grow by 24%, from 17 trillion won in 2025 to 21 trillion won in 2026, with leading domestic companies like Samsung Biologics and Celltrion solidifying their positions in the global market.
The most notable trend in AI-based drug development is the combination of large language models (LLM) and molecular structure prediction algorithms. AlphaFold3, developed by the UK’s DeepMind, predicted the structures of over 200 million proteins by the end of 2025, with over 1,200 drug development projects utilizing these predictions globally. Boston-based Recursion Pharmaceuticals announced that its cancer drug candidate, developed through its AI platform, received FDA Phase 2 clinical approval in the fourth quarter of 2025, reducing the drug development period by 40% compared to traditional methods. These achievements are fundamentally changing the traditional drug development paradigm and accelerating the adoption of AI technologies by big pharma companies.
In the field of gene therapy, next-generation gene editing technologies surpassing CRISPR-Cas9 are entering the commercialization phase. ‘Lyfgenia’, a beta-thalassemia treatment jointly developed by Editas Medicine in California and Novartis in Basel, Switzerland, received approval from the European Medicines Agency (EMA) in 2025, setting a new standard in the high-cost gene therapy market with a treatment cost of $2.8 million per patient. Meanwhile, Prime Medicine in Massachusetts, which developed Prime Editing technology, raised $310 million in a Series C round in December 2025, valuing the company at $1.5 billion.
Strengthening the Global Competitiveness of South Korea’s Biotech Ecosystem
In 2026, South Korea’s biotechnology industry is significantly elevating its status in the global value chain. Samsung Biologics recorded an order backlog of 44 trillion won as of the fourth quarter of 2025, maintaining its number one position with a 17.2% market share in the global biopharmaceutical contract manufacturing (CMO) market. The completion of the fourth plant in Songdo, Incheon, in December 2025 expanded its annual production capacity to 360,000 liters, the largest for a single site worldwide. The company plans to add a dedicated mRNA vaccine production line in the first half of 2026, significantly enhancing its pandemic response capabilities.
Celltrion is accelerating its entry into the biobetter market, leveraging its leading position in the biosimilar field. Its next-generation antibody-drug conjugate (ADC) platform ‘CT-P71’ successfully completed FDA Phase 1 trials in 2025, demonstrating a 35% improvement in drug delivery efficiency compared to existing ADCs. Celltrion plans to increase its R&D investment by 28% year-on-year to 780 billion won in 2026, with 60% focused on developing next-generation biopharmaceuticals. Additionally, the company plans to expand its production capacity by 80% by 2027 through the second phase expansion of its production base in Wuxi, China.
The domestic biotech venture ecosystem is also experiencing remarkable growth. According to the ‘2026 Biotech Industry Status Report’ by the Korea Biotechnology Industry Organization, domestic biotech venture investment increased by 26%, from 2.3 trillion won in 2025 to 2.9 trillion won in 2026. AI-based drug development startups are particularly gaining attention, with Standigm raising 35 billion won in a Series B round in November 2025, valuing the company at 150 billion won. The company’s AI drug development platform ‘Standigm ASK’ is currently engaged in collaborative projects with 12 global pharmaceutical companies, with three drug candidates expected to enter preclinical trials in the first half of 2026.
Strategic Responses and Market Restructuring by Global Big Pharma
The global pharmaceutical industry is accelerating large-scale mergers and acquisitions and strategic partnerships to respond to biotech innovations. Roche in Basel, Switzerland, completed the acquisition of US gene therapy specialist Spark Therapeutics in December 2025, with the acquisition amount of $4.7 billion being the largest biotech M&A in 2025. Through this acquisition, Roche significantly expanded its rare disease gene therapy portfolio, particularly strengthening its market dominance in hemophilia and lysosomal storage disorders. The company announced that its gene therapy division’s revenue is expected to increase by 180% year-on-year to $3.5 billion in 2026.
Johnson & Johnson in New Jersey, USA, is significantly expanding its investment in AI-based drug development. The company entered into a strategic partnership with Google in 2025 to launch drug development projects using Google Cloud’s AI platform, with plans to invest $1.2 billion over the next five years. Dr. Paul Stoffels, head of J&J’s innovation division, stated, “We aim to increase the success rate of drug development from the current 12% to 25% by 2030 through AI technology.” The company announced that three Alzheimer’s treatment candidates developed using AI are expected to enter Phase 2 clinical trials in the first half of 2026.
Pfizer is expanding its mRNA technology platform beyond COVID-19 vaccines to cancer and rare disease treatments. Through its partnership with Germany’s BioNTech, Pfizer announced that its personalized cancer vaccine ‘BNT122’ reduced recurrence rates by 44% compared to existing treatments in a Phase 3 trial for melanoma patients by the end of 2025. Based on these achievements, Pfizer plans to invest $3.5 billion in the mRNA therapeutics division in 2026, accounting for 28% of its total R&D budget. The company also announced plans to initiate a Phase 1 trial for an mRNA therapeutic for autoimmune diseases in the second half of 2026.
Moderna is significantly expanding the application scope of its mRNA platform, building on the success of its COVID-19 vaccine. As of the fourth quarter of 2025, the company is developing 38 mRNA therapeutic candidates, with 15 in clinical trial stages. Particularly, the RSV vaccine ‘mRNA-1345’ received FDA approval in 2025 and achieved commercial success, with first-quarter 2026 sales expected to reach $800 million. Moderna’s CEO, Stéphane Bancel, projected, “We aim to achieve annual sales of $30 billion by 2030, with 70% generated from mRNA therapeutics beyond COVID-19.”
The rapid development of the biotech industry also brings new challenges. The most significant issue is the accessibility of high-cost gene therapies and personalized medicines. According to a 2025 report by the Institute for Clinical and Economic Review, the average treatment cost of currently approved gene therapies is $1.8 million, which is difficult for most insurance systems to cover. Consequently, governments and the pharmaceutical industry are developing new payment models, with outcome-based payment methods gaining attention.
Changes in the regulatory environment are also a major concern for the industry. The US FDA released ‘AI-Based Drug Development Guidelines’ in December 2025, proposing a regulatory framework to enhance the transparency and verifiability of AI algorithms. The European Union, under the ‘AI Act’ effective from 2026, will classify medical AI systems as high-risk areas, applying strict regulations. South Korea’s Ministry of Food and Drug Safety also revised the ‘Biopharmaceutical Approval Review Guidelines’ in 2025 to strengthen safety evaluation standards for gene editing therapies. While these regulatory enhancements may increase development costs in the short term, they are expected to contribute to enhancing industry credibility and establishing a sustainable growth foundation in the long term.
The outlook for the biotech industry in 2026 is generally optimistic. Global investment bank Goldman Sachs announced that it expects the biotech sector to grow by 28% in 2026, particularly highlighting the growth potential of AI-based drug development and gene therapy. Deloitte’s ‘2026 Global Life Sciences Outlook Report’ forecasts that the biotech industry will grow at an average annual rate of 22% over the next five years, reaching a market size of $2.8 trillion by 2030. This growth is analyzed to be driven by the aging population, increasing demand for personalized medicine, and advancements in AI and digital technologies. South Korea’s biotech industry is also expected to continue growing in line with these global trends, with the global competitiveness of K-Bio anticipated to be further strengthened.
This analysis is based on publicly available information and market data and is not intended as investment advice or a recommendation for specific companies. Please consult with a professional before making investment decisions.
