A New Turning Point in Biotech Innovation: The 2025 Biotech Landscape Shaped by AI and Gene Editing
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As of the end of 2025, the global biotechnology industry is undergoing a fundamental paradigm shift driven by the rapid advancement of artificial intelligence and gene editing technologies. According to the latest report from market research firm McKinsey & Company, the global biotechnology market size reached $1.2 trillion in 2025, marking a 15.3% growth compared to the previous year. The key drivers of this growth are AI-based drug development platforms and next-generation gene editing technologies beyond CRISPR-Cas9, which have begun to show tangible results in clinical stages.
A particularly noteworthy change is the blurring of boundaries between traditional pharmaceutical companies and biotech startups, leading to the emergence of new business models through technological convergence. California-based Moderna (MRNA) reported $3.4 billion in revenue in the third quarter of 2025 from the personalized cancer vaccine sector utilizing mRNA technology, a 127% increase compared to the same period last year. South Korea’s Samsung Biologics (207940) solidified its position as the global leader with a 23.7% market share in the global CMO (Contract Manufacturing Organization) market, and is projected to achieve annual sales of 4.8 trillion won in 2025.
Behind this growth is the maturation of AI-based drug development technology. AlphaFold3, developed by Google’s subsidiary DeepMind, increased the accuracy of protein structure prediction to 95.2% after its release in the first half of 2025, and over 2,400 drug development projects worldwide are utilizing this technology. Massachusetts-based Moderna announced that it successfully reduced the drug development period from the traditional 10-15 years to 3-5 years using this technology.
Acceleration of Gene Editing Technology Commercialization
Next-generation gene editing tools beyond CRISPR technology have entered the full-scale commercialization stage in 2025. Prime Editing and Base Editing technologies, in particular, are showing high success rates in Phase 3 clinical trials, driving innovative changes in the treatment of rare diseases. The beta-thalassemia treatment ‘CTX001’, jointly developed by Boston-based Editas Medicine and London-based CRISPR Therapeutics, received FDA approval in 2025 and was priced at an annual treatment cost of $2.8 million, garnering attention.
In South Korea, ToolGen’s next-generation gene editing platform is providing new momentum to the domestic biotech ecosystem. Celltrion (068270) began full-scale development of CAR-T cell therapies through a strategic partnership with ToolGen in the second half of 2025, achieving a 40% higher remission rate compared to existing treatments in early clinical results. This is expected to play a key role in achieving Celltrion’s 2026 sales target of 4.5 trillion won.
Along with the advancement of gene editing technology, ethical and regulatory frameworks are also being rapidly organized. The European Union announced the ‘Gene Editing Medical Technology Guidelines’ in October 2025, simplifying the approval process for somatic cell editing while specifying strict restrictions on embryo editing. The U.S. FDA introduced a fast-track approval process for gene editing therapies, reducing the average approval period from 18 months to 12 months.
Digital Transformation of Biomanufacturing and Global Competitive Landscape
In the biomanufacturing sector, the adoption of Industry 4.0 technologies is bringing revolutionary changes to productivity and quality control. Samsung Biologics established a fully automated AI-based production system at its fourth plant in Incheon in 2025, improving production efficiency by 35%. This system achieved a batch failure rate reduction to 0.3% through real-time quality monitoring and predictive maintenance. The annual production capacity is 360,000 liters, the largest for a single facility in the global CMO market.
Competitors are also making large-scale investments in response. Swiss Lonza is investing $4.5 billion in a new facility in Singapore to establish a biopharmaceutical production hub in the Asia-Pacific region, scheduled to be operational in 2026. China’s WuXi Biologics is expanding production facilities in Ireland and Germany with a total investment of $2.8 billion, accelerating its entry into the European market. This global expansion of production capacity is interpreted as part of a strategy to secure supply chain stability and respond to regional regulations for biopharmaceuticals.
Significant changes are also occurring in the biosimilar market. Celltrion’s Herceptin biosimilar ‘Herzuma’ recorded global sales of 1.2 trillion won in 2025, significantly improving patient accessibility with prices 40-50% lower than the original drug. Notably, the performance in emerging markets such as India and Brazil stood out, with Celltrion’s overseas sales accounting for 73% of the total. Israel’s Teva Pharmaceutical (TEVA) achieved $4.8 billion in sales in the third quarter of 2025, a 12% increase compared to the same period last year, by expanding its biosimilar portfolio.
Meanwhile, there is increasing interest in the sustainability and environmental impact of the biomanufacturing sector. Denmark’s Novo Nordisk completed a carbon-neutral production facility in 2025, successfully reducing carbon emissions from the biopharmaceutical manufacturing process by 90%. As ESG investment criteria are strengthened, these eco-friendly manufacturing technologies are emerging as new competitive factors for biotech companies.
In the diagnostic technology field, liquid biopsy and multi-omics technologies are establishing themselves as key tools for personalized medicine. The ‘NovaSeq X Plus’ next-generation sequencing platform from U.S. Illumina (ILMN) reduced genome sequencing costs to below $100 after its release in 2025, marking a turning point for popularization. South Korea’s Macrogen is using this technology to build an Asian genome database, currently holding genomic information of 500,000 people, enhancing the accuracy of precision medicine services.
In the cell therapy sector, the expansion of indications for CAR-T cell therapy and cost reduction in manufacturing have emerged as major challenges. Kite Pharma, a subsidiary of U.S. Gilead Sciences (GILD), operated an automated CAR-T manufacturing facility in 2025, reducing the production period of therapies from 21 days to 7 days. The treatment cost was also lowered from $470,000 to $320,000, improving patient accessibility. This technological advancement contributed to the CAR-T therapy market growing to $8.6 billion in 2025, with an expected annual growth rate of 28% until 2030.
In the field of regenerative medicine, clinical achievements in stem cell therapies and tissue engineering technologies are gaining attention. Japan’s Fujifilm Holdings announced that the clinical Phase 2 of its iPS cell-based Parkinson’s disease treatment showed an average 35% improvement in patients’ motor functions. In South Korea, CHA Biotech’s umbilical cord blood stem cell therapy showed groundbreaking results in cerebral palsy treatment, with commercialization expected in 2026. The global regenerative medicine market grew to $38 billion in 2025, with the Asia-Pacific region showing a high annual growth rate of 22%.
The investment environment in the biotech industry is also undergoing significant changes. Global biotech venture investment reached $42 billion in 2025, an 18% increase compared to the previous year. Notably, investments in AI-based drug development and gene editing fields accounted for 45% of the total. The South Korean government executed a 2 trillion won investment in biotech R&D through the ‘K-Bio Grand Challenge’ program in 2025, with 40% allocated to AI and digital healthcare fields.
Changes in the regulatory environment are also having a significant impact on industry development. The U.S. FDA revised the ‘AI-based Medical Device Approval Guidelines’ in 2025, introducing a new approval pathway that allows continuous learning of machine learning algorithms. The European Medicines Agency (EMA) is preparing a similar regulatory framework, scheduled for implementation in 2026. These regulatory innovations are acting as catalysts to accelerate the commercialization of AI-based biotechnologies.
As of the end of 2025, the biotech industry is experiencing a unique period where technological innovation and commercial success occur simultaneously. The convergence of AI and gene editing technologies, the digital transformation of biomanufacturing, and the popularization of personalized medicine are acting as new growth drivers, fundamentally changing the paradigm of the traditional pharmaceutical industry. South Korean biotech companies are also demonstrating unique strengths in global competition, expanding their market share, and are expected to play an important role in the global biotech landscape in the future.
From an investor’s perspective, the biotech industry in 2026 is expected to be led by companies with both technological maturity and commercial execution capabilities. Companies with AI-based drug development platforms and those commercializing next-generation gene editing technologies are analyzed to have high growth potential. However, it is also a time to consider risk factors such as regulatory changes, technological uncertainties, and high R&D costs.
The opinions and forecasts expressed in this article are the author’s personal views and should be used for reference only when making investment decisions. Investments carry the risk of principal loss, so please make careful judgments.
