A New Turning Point in the Biotechnology Industry: The Medical Revolution of 2025 Shaped by AI and Gene Therapy
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Biotech Innovation Driven by AI-Based Drug Development
As of the end of 2025, the global biotechnology industry is experiencing unprecedented changes through the integration of artificial intelligence and machine learning technologies. The global biotech market is projected to grow by 24.9%, from $985 billion in 2024 to $1.23 trillion in 2025. This growth is primarily attributed to the commercialization of AI-based drug development platforms and the rapid spread of personalized therapies. Notably, the use of generative AI models in molecular design technology is reducing drug development timelines from the traditional 10-15 years to 5-7 years, fundamentally reshaping R&D strategies across the pharmaceutical industry.
Recursion Pharmaceuticals, based in Boston, USA, gained industry attention in the first half of 2025 when three of its cancer drug candidates developed through its AI platform received FDA Phase 2 clinical trial approval. The company automates over 2 million biological experiments weekly, using the accumulated data to train AI models to discover new therapeutic targets. This approach has demonstrated a 67% higher success rate in the initial discovery phase compared to traditional drug development methods, and it has proven to reduce development costs by an average of 40%. Exscientia in London, UK, and Preferred Networks in Tokyo, Japan, have also achieved notable results in developing mental disorder and rare disease treatments, respectively, through similar AI-based platforms.
The South Korean biotech ecosystem is rapidly evolving in line with these global trends. Samsung Biologics, based in Seongnam, recorded a revenue of 892 billion won in the third quarter of 2025, marking a 31.2% increase from the same period last year. The company notably improved its biopharmaceutical production efficiency by 22% by introducing an AI-based process optimization system. Celltrion in Incheon discovered five autoimmune disease treatment candidates through its proprietary AI drug discovery platform ‘CelliGen,’ with two of them expected to enter Phase 1 clinical trials by the end of the year. These achievements demonstrate that Korean biotech companies are building capabilities for innovative drug development beyond merely developing biosimilars.
Market analysts predict that the AI-based drug development market will grow from $7.8 billion in 2025 to $42 billion by 2030, with an average annual growth rate of 40.1%. This figure significantly surpasses the traditional pharmaceutical industry growth rate of 6-8% annually, indicating that AI technology is establishing itself as a new growth driver for the biotech industry. As the accuracy of deep learning-based protein structure prediction and virtual screening technologies improves to over 90%, the adoption of AI platforms by pharmaceutical companies is accelerating. According to a recent report by McKinsey & Company, 85% of the top 20 global pharmaceutical companies plan to fully operate AI-based drug development programs by 2025.
Commercial Breakthroughs in Gene and Cell Therapy
In 2025, the field of gene therapy is surpassing critical thresholds in terms of technological maturity and commercial viability. The global gene therapy market grew by 38.9%, from $28 billion in 2024 to $38.9 billion in 2025, primarily driven by the clinical success of CAR-T cell therapies and gene editing technologies. The U.S. FDA approved a total of 23 gene therapies in 2025, a 43.8% increase compared to 16 in 2024. Particularly in the rare disease treatment sector, gene therapies are providing new hope to patients who previously had no treatment options, driving market expansion.
Roche, based in Basel, Switzerland, announced that global sales of its gene therapy ‘Roctavian’ for hemophilia A surpassed $1.5 billion in the first half of 2025. This therapy restores patients’ blood clotting ability to over 80% of normal levels with a single intravenous injection, reducing annual treatment costs by 60% compared to traditional clotting factor replacement therapies. Johnson & Johnson’s subsidiary Janssen, based in New Jersey, USA, improved the five-year survival rate for multiple myeloma patients from 35% to 73% with its CAR-T cell therapy ‘Carvykti,’ achieving cumulative sales of $2.8 billion by the third quarter of 2025. These successes demonstrate that gene therapies are transitioning from experimental treatments to standard care options.
CRISPR-Cas9-based gene editing technology also began achieving commercial success in 2025. ‘Casgevy,’ a sickle cell disease treatment jointly developed by Vertex Pharmaceuticals in Boston, USA, and CRISPR Therapeutics in Zug, Switzerland, recorded $800 million in sales in its first year, effectively preventing vaso-occlusive crises in over 95% of patients. This treatment involves collecting a patient’s own hematopoietic stem cells, correcting the genes using CRISPR technology, and reinjecting them, offering lifelong effects with a single treatment. Although the treatment cost is high at $2.2 million, it is considered economically superior to existing treatments when lifetime medical costs are considered.
South Korea’s gene therapy sector is also making noteworthy progress. ToolGen, based in Seoul, secured a foothold for global market entry when its gene therapy for hereditary blindness, developed using proprietary CRISPR technology, received orphan drug designation from the U.S. FDA. Additionally, GC Cell in Seongnam has secured unique technology in developing CAR-NK (Natural Killer) cell therapies, offering solutions to the limitations of CAR-T therapies, such as immune rejection and high manufacturing costs. The company’s CAR-NK therapy can use cells from allogeneic donors, reducing manufacturing time to less than two weeks and cutting treatment costs by 70% compared to CAR-T therapies.
Industry experts predict that the growth of the gene therapy market will accelerate further beyond 2026. Particularly, with advancements in in vivo gene editing technology, therapies that directly inject gene editing tools into patients are expected to become commercialized, significantly improving accessibility and cost-effectiveness by eliminating the complex cell processing steps of the current ex vivo methods. According to a recent analysis by Deloitte, the gene therapy market is expected to grow at an average annual rate of 34.2% to reach $120 billion by 2030, with over 70% of this growth occurring in the treatment of cancer, rare diseases, and genetic disorders.
Future Prospects and Investment Opportunities in the Biotech Industry
As of the end of 2025, the biotechnology industry is experiencing a golden era where technological innovation and commercial success are occurring simultaneously. Global biotech investment reached $142 billion in 2025, an 18.3% increase from 2024, with a focus on AI-based drug development and gene therapy. Venture capital and private equity firms are particularly expanding investments in platform-based biotech companies, as these companies possess technology platforms applicable to various diseases, offering advantages in risk diversification and profitability.
Moderna, based in Massachusetts, USA, achieved a third-quarter revenue of $13.4 billion in 2025, thanks to the success of its mRNA platform diversification strategy. This was a result of expanding its product portfolio beyond COVID-19 vaccines to include flu, RSV, and CMV vaccines. Notably, in the personalized cancer vaccine field, the company demonstrated a 44% reduction in recurrence rates in Phase 3 trials for melanoma patients, successfully extending the application of mRNA technology from vaccines to therapeutics. Gilead Sciences, based in California, acquired Germany’s MorphoSys for $11.8 billion in the first half of 2025 to strengthen its HIV treatment portfolio and secure antibody-drug conjugate (ADC) technology capabilities. This was the largest M&A deal in the biotech industry in 2025, demonstrating that existing pharmaceutical companies are actively pursuing M&A strategies to secure innovative technologies.
The South Korean biotech ecosystem is experiencing rapid growth, supported by the government’s K-Bio Belt project and increased private investment. In 2025, South Korea’s biohealth industry revenue increased by 28.4% year-on-year to 47 trillion won, primarily driven by increased biopharmaceutical exports and the global clinical success of domestic biotech companies. Particularly, the bio cluster centered around the Songdo Biocomplex has grown to become the largest in Asia, serving as an R&D hub for global pharmaceutical companies in the region. Samsung Biologics completed the construction of its fourth plant, expanding its total production capacity to 360,000 liters, the largest for a single site globally. This expansion of production capacity is a key factor enhancing South Korea’s competitiveness in the global biopharmaceutical contract manufacturing (CMO) market.
However, alongside the growth of the biotech industry, several challenges are also emerging. The most significant issue is the increasing complexity of the regulatory environment. For AI-based drug development and gene therapies, the existing regulatory frameworks are inadequate for proper safety and efficacy evaluations, prompting the U.S. FDA and the European Medicines Agency (EMA) to establish new guidelines. Particularly, as demands for transparency and explainability of AI algorithms increase, biotech companies must enhance their regulatory response capabilities alongside technology development. Additionally, the high prices of gene therapies raise issues regarding insurance coverage and patient accessibility, which require ongoing discussion.
Market experts anticipate that the biotech industry will establish a more robust growth foundation based on technological maturity and commercial viability by 2026. According to a recent report by PwC, the global biotech market is expected to grow at an average annual rate of 15.7% to reach $2.8 trillion by 2030. Of this, AI-based drug development is expected to account for 30%, gene and cell therapies for 25%, and personalized medicine for 20%, with the remainder occurring in areas such as biosimilars, digital therapeutics, and biomarker diagnostics. For investors, it will be important to evaluate the scalability of technology platforms, the likelihood of regulatory approval, and commercialization capabilities to construct portfolios from a long-term perspective.
*This analysis is intended for general informational purposes only and is not intended as investment advice or a recommendation of specific stocks. Investment decisions should be made based on the judgment and responsibility of individual investors.*
