A New Turning Point in the Biotech Revolution: The 2026 Medical Paradigm Shaped by AI and Gene Therapy
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The Great Transformation of the Biotech Industry Driven by the AI Revolution
As of 2026, the global biotech industry is experiencing unprecedented changes due to the convergence of artificial intelligence and gene therapy technologies. According to the latest report from the market research firm McKinsey, the global biotech market is expected to reach $1.24 trillion by 2026, reflecting an 18.3% growth compared to the previous year. Particularly, the AI-based drug development sector is leading the industry’s growth with an explosive annual growth rate of 32.5%. This growth signifies a fundamental shift in the medical paradigm beyond mere technological advancement.
Korea’s Samsung Biologics, based in Incheon, stands at the forefront of this transformation. In its Q4 2025 earnings report, the company announced a revenue of 3.12 trillion won, marking a 28.4% increase from the same period the previous year. The introduction of an AI-based biopharmaceutical production optimization system has improved production efficiency by 35%, becoming a key factor in securing additional orders from global pharmaceutical companies. Simultaneously, Celltrion, also based in Incheon, has demonstrated the global competitiveness of Korean biotech firms by reducing the development period from 5-7 years to 2-3 years through its AI-based antibody design platform.
In the U.S. market, Gilead Sciences, based in Foster City, California, has established a leading position in AI-based drug development. As of January 2026, the company’s AI drug development pipeline includes 47 candidate substances, with 12 entering Phase 2 clinical trials. Notably, the AI-designed HIV treatment under development has shown a virus suppression effect of over 95% compared to existing treatments, aiming for FDA approval in the second half of 2026. This is a symbolic example of AI becoming a core engine in drug development rather than just an auxiliary tool.
Moderna, based in Cambridge, Massachusetts, is pioneering the era of personalized vaccines through the combination of mRNA technology and AI. The clinical results of its personalized cancer vaccine, announced in December 2025, showed an impressive 44% improvement in survival rates compared to standard treatments. Based on these achievements, Moderna’s stock price has risen by 73% in 2026, with a market capitalization of $185 billion. The company announced plans to invest $3.2 billion in AI-based drug development in 2026, accounting for 68% of its total R&D budget.
Commercialization and Market Expansion of Gene Therapy
The year 2026 is regarded as the true inaugural year of commercialization in the gene therapy sector. The global gene therapy market has grown to $18.7 billion in 2026, a 142% increase from 2023. CAR-T cell therapies and gene editing therapies are particularly driving market growth. The U.S. FDA approved 27 gene therapies in 2025 alone, more than doubling the number from 2024. This rapid increase in approvals reflects a shift in regulatory perception and the secured safety of clinical data.
Swiss company Novartis, based in Basel, has shown the most advanced achievements in the gene therapy field. The company’s CAR-T cell therapies, Kymriah and Yescarta, recorded combined sales of $8.9 billion in 2025, a 156% increase from the previous year. Notably, Kymriah achieved a complete remission rate of 91% in pediatric acute lymphoblastic leukemia patients, a significant improvement compared to the 23% of traditional chemotherapy. Novartis plans to invest $4.5 billion in the gene therapy sector in 2026, focusing 60% on developing next-generation CAR-T technologies.
Roche, also based in Basel, Switzerland, continues to make aggressive investments in the gene therapy field. The next-generation gene editing platform announced by the company in December 2025 improved accuracy to 99.7% compared to existing CRISPR technology, reducing the incidence of side effects to 0.3%. Based on this technological innovation, Roche plans to initiate clinical trials for three gene therapies targeting rare diseases in the first half of 2026. The company’s gene therapy division recorded $6.7 billion in revenue in 2025, accounting for 11.2% of its total revenue.
Interest and investment in gene therapy are also surging in the Korean market. According to the Korea Biopharmaceutical Association, domestic investment in gene therapy reached 890 billion won in 2025, a 234% increase from the previous year. Notably, Celltrion began Phase 1 clinical trials of its self-developed CAR-T cell therapy in the second half of 2025, showing a promising response rate of over 70% in initial results. The domestic regulatory environment is also improving, with the Ministry of Food and Drug Safety announcing plans to shorten the gene therapy approval process from 18 months to 12 months starting in 2026.
Biogen, based in Cambridge, Massachusetts, is attempting to integrate gene therapy and AI technology in the Alzheimer’s treatment field. The next-generation Alzheimer’s treatment under development analyzes patients’ genetic characteristics through AI algorithms to provide personalized gene therapy. In the interim results of Phase 2 clinical trials in 2025, it showed a 78% reduction in the rate of cognitive decline, more than five times the improvement compared to existing treatments. Biogen announced plans to invest $2.8 billion in the commercialization of this treatment in 2026.
The economic impact of gene therapy in the global pharmaceutical industry is also noteworthy. According to the latest analysis by the Boston Consulting Group, the average treatment cost of gene therapies shows a long-term reduction of 67% compared to traditional chronic disease treatments. This is because fundamental treatment is possible with a single or short-term treatment. For instance, while the lifetime treatment cost for sickle cell disease is an average of $1.6 million per patient, gene therapy costs $2.1 million for a single administration but results in long-term savings of over $500,000.
Market Outlook and Investment Opportunity Analysis
The investment environment in the biotech industry in 2026 is more active than ever. According to venture capital research firm PitchBook, global venture investment in the biotech sector reached $43.2 billion in 2025, a 28% increase from 2024. Investments in AI-based drug development startups accounted for 34% of the total, representing the largest share. In the Asian region, investments increased by 56% from the previous year to $8.9 billion, with Korea recording $2.3 billion, the second-largest after China.
From a technological perspective, the biotech industry is experiencing several innovative changes. The commercialization of AlphaFold, an AI for protein structure prediction, has reduced the time required for the initial stages of drug development from an average of 18 months to 6 months. Additionally, molecular simulation technology utilizing quantum computing has entered a practical stage, enabling accurate predictions of complex biochemical reactions. Google’s quantum computing division announced in December 2025 that it had partnered with five pharmaceutical companies to launch quantum computing-based drug development projects.
Changes in the regulatory environment are also positively impacting industry growth. The U.S. FDA plans to introduce new guidelines for AI-based drug development starting in 2026 to streamline the approval process. Specifically, drugs designed by AI will be subject to an approval process shortened by 30% compared to existing procedures. The European Medicines Agency (EMA) announced similar policies, and major Asian countries are joining this trend. The Korean Ministry of Food and Drug Safety announced plans to implement the ‘AI Drug Approval Special Act’ in the first half of 2026.
However, alongside industry growth, challenges also exist. The most significant concern is the high cost of gene therapies. The average price of currently marketed gene therapies ranges from $1.5 million to $3 million, sparking social discussions about insurance coverage and patient accessibility. In the U.S. healthcare system, the surge in gene therapy costs led to a 12% average increase in insurance premiums in 2025, evolving into a political issue. Additionally, issues of algorithm bias and transparency in AI-based drug development are continuously raised, necessitating ongoing discussions between regulatory authorities and the industry.
In terms of competitive dynamics, the boundaries between traditional large pharmaceutical companies and emerging biotech firms are becoming blurred. As traditional pharmaceutical giants make large-scale investments in AI and gene therapy, competition with startups is intensifying. Simultaneously, mergers and acquisitions (M&A) activities are becoming more active, with the total M&A transaction value in the biotech sector reaching $189 billion in 2025. This represents a 45% increase from the previous year, indicating accelerated industry consolidation and technology integration.
The rise of the Asian market is also a noteworthy trend. As Chinese biotech companies begin to expand globally, competition with Western companies is intensifying. Supported by the Chinese government’s policies to foster the biotech industry, the R&D investment scale of Chinese companies is rapidly increasing. In 2025, the total R&D investment by Chinese biotech companies reached $28.7 billion, surpassing the growth rate of U.S. companies’ investments. Korea is also focusing on building a biotech ecosystem through the K-Bio Belt project, with a total of 15 trillion won in government and private investments planned by 2026.
Looking ahead, the clinical Phase 3 results of AI-designed drugs are expected to be announced in earnest from the second half of 2026, which is anticipated to become a new turning point in the market. Additionally, efforts to reduce the cost of gene therapy technology are expected to become visible. With the development of next-generation gene delivery systems and mass production technologies, the production cost of gene therapies is projected to decrease by over 60% compared to current levels. These changes are analyzed to be key drivers supporting the sustained growth of the biotech industry.
This article is intended for informational purposes only and does not constitute investment solicitation or advice. Investment decisions should be made at one’s discretion and responsibility.
