A New Turning Point in Biotech Innovation: Rapid Growth of Precision Medicine and Gene Therapy Markets by 2026
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Paradigm Shift in the Biotechnology Industry: The Fusion of AI and Precision Medicine
As of January 2026, the global biotechnology industry is entering an unprecedented era of innovation through the fusion of artificial intelligence and precision medicine. The global biotechnology market is projected to grow from $758 billion in 2025 to $842 billion in 2026, marking an 11.1% increase. Particularly, the precision medicine sector is expected to grow at an annual rate of 13.8%, reaching a market size of $320 billion. This rapid growth is driven by the commercialization of AI-based drug development platforms and the expanded clinical application of personalized treatments. Notably, the combination of next-generation gene-editing technology CRISPR 3.0 and AI-based protein structure prediction technology, which began in earnest in the latter half of 2025, is bringing about transformative changes by reducing drug development timelines from the traditional 10-15 years to 5-7 years.
South Korea’s biotechnology ecosystem is also rapidly evolving in line with these global trends. The K-Bio clusters concentrated in Pangyo and Songdo house a total of 847 biotech companies as of 2026, with their total revenue increasing by 23.4% year-on-year to 18.2 trillion won. A noteworthy point is the remarkable overseas expansion achievements of domestic biotech companies. In 2025, the total value of overseas technology export contracts by Korean biotech firms reached $4.7 billion, an 89% increase from the previous year. This growth is attributed to the synergy between the Korean government’s K-Bio Grand Project and the activation of private investment.
Looking at global biotech investment trends, venture capital investment in the biotech sector worldwide totaled $28.7 billion in 2025, with 42% or $12.1 billion focused on precision medicine and AI-based drug development. While the United States still leads with 58% of total investments, China (18%) and Europe (16%) are rapidly catching up. South Korea recorded $920 million, accounting for 3.2% of total investments, ranking third in the Asia-Pacific region after China and Japan. Notably, 67% of biotech investments in South Korea came from foreign investors, indicating the global competitiveness of Korean biotechnology.
From a market segmentation perspective, the biotechnology market in 2026 is composed of therapeutic development (42%), diagnostic technology (28%), medical devices (18%), and agricultural biotech (12%). Within therapeutic development, there is a particular focus on cancer and rare disease treatments, which account for 34% of the overall drug development pipeline. Immunotherapy methods like CAR-T cell therapy are expected to grow from a global market size of $8.9 billion in 2025 to $12.7 billion in 2026, a 42.7% increase, and are gaining attention as next-generation treatments that can overcome the limitations of traditional cancer therapies.
Strategic Positioning and Competitive Landscape of Key Companies
The competitive landscape of the global biotechnology market is characterized by a complex interplay of collaboration and competition between established pharmaceutical giants and innovative biotech ventures. Gilead Sciences, based in California, recorded an annual revenue of $27.1 billion as of Q4 2025, maintaining a dominant position in the antiviral treatment sector. Notably, its HIV treatment Biktarvy achieved an annual revenue of $7.9 billion, marking one of the highest performances for a single product in the industry. Gilead recently announced a $1.5 billion investment in AI-based drug development and plans to unveil its first clinical trial drug developed through its proprietary AI platform in the first half of 2026.
Amgen, also based in California, continues its innovation in the biopharmaceutical sector. With an annual revenue of $28.8 billion in 2025, Amgen has built a strong portfolio in oncology, and its recently approved KRAS G12C inhibitor Lumakras achieved $1.2 billion in sales in its first year. Amgen’s biosimilar division recorded $4.7 billion in sales in 2025, a 34% increase from the previous year, indicating the rapid adoption of biosimilar versions of expired biologics in the market. The company plans to secure additional growth drivers through the launch of three next-generation bispecific antibody therapies in the second half of 2026.
Roche Holding, based in Basel, Switzerland, maintains a leading position in personalized medicine. With an annual revenue of 63.4 billion Swiss francs (approximately $69.2 billion) in 2025, Roche’s diagnostics division achieved a revenue of 18.7 billion Swiss francs, an 18.2% increase from the previous year. Roche’s subsidiary Foundation Medicine recorded $2.3 billion in revenue through comprehensive genomic profiling tests in 2025, providing services in 85 countries worldwide. Notably, Roche plans to commercialize an AI-based pathology diagnostic platform in 2026, with a total investment of $2.8 billion.
Novo Nordisk, based in Copenhagen, Denmark, continues its innovative growth in the diabetes and obesity treatment markets. With an annual revenue of 145.6 billion Danish kroner (approximately $21.3 billion) in 2025, Novo Nordisk leads the obesity treatment market through its GLP-1 receptor agonists Ozempic and Wegovy. Wegovy’s 2025 sales reached $13.4 billion, an 89% increase from the previous year. With the global obese population exceeding 800 million, Novo Nordisk’s next-generation oral GLP-1 treatment is undergoing Phase 3 clinical trials, targeting a launch in the second half of 2026, and is expected to achieve annual sales of over $20 billion upon commercialization.
South Korean biotech companies are also achieving notable success on the global stage. Samsung Biologics, headquartered in Songdo, Incheon, recorded an annual revenue of 3.12 trillion won in 2025, establishing itself as the world’s largest biopharmaceutical contract manufacturing organization (CMO). With the commencement of operations at its fourth plant in the second half of 2024, its total production capacity reached 364,000 liters, accounting for approximately 18% of the global biopharmaceutical CMO market. Samsung Biologics has signed a total of 47 long-term supply contracts with global pharmaceutical companies such as Eli Lilly, GSK, and Novartis, with a total contract value of 18.5 trillion won.
Celltrion, located in Yeonsu-gu, Incheon, has grown into a global leader in the biosimilar market. With an annual revenue of 3.84 trillion won in 2025, Celltrion has shown strong growth, particularly in the European and American markets. Its flagship product, Remsima (Remicade biosimilar), achieved 1.23 trillion won in sales in 2025, and the recently launched Vegzelma (Avastin biosimilar) recorded 780 billion won in sales within two years of its launch, demonstrating rapid market penetration. Celltrion plans to start Phase 1 clinical trials of a next-generation antibody-drug conjugate (ADC) therapy in the first half of 2026, aiming to expand its business scope from biosimilars to innovative drug development.
Future Outlook and Investment Opportunities: New Value Created by Technological Convergence
When forecasting the future of the biotechnology industry in 2026, the most noteworthy trend is the emergence of next-generation therapies through the convergence of AI, robotics, and nanotechnology. Particularly, AI-based drug development platforms are fundamentally transforming traditional research and development methods. The protein structure prediction using DeepMind’s AlphaFold technology, based in London, UK, can now accurately predict over 200 million protein structures, reducing the time for drug candidate exploration from the traditional 2-3 years to 6-12 months. The global AI-based drug development market is projected to grow from $6.7 billion in 2025 to $41.2 billion in 2030, with an average annual growth rate of 44.3%, exceeding the overall biotechnology market growth rate by more than three times.
The gene therapy market is also experiencing rapid growth. The global gene therapy market size is expected to grow from $8.9 billion in 2025 to $12.7 billion in 2026, a 42.7% increase. Particularly in the field of rare disease treatment, the clinical success rate of gene therapies has significantly improved, with 73% of the 67 gene therapies in Phase 3 clinical trials in 2025 achieving primary efficacy endpoints, a notable improvement from the previous 28%. This improvement is attributed to advancements in vector technology and the refinement of target gene selection techniques. The U.S. FDA approved 14 gene therapies in 2025, a 56% increase from the previous year’s nine approvals.
In the cell therapy sector, next-generation technologies beyond CAR-T cell therapy are gaining attention. CAR-NK (Natural Killer) cell therapy and TCR-T (T-Cell Receptor-T) cell therapy are showing promising results in clinical trials. As of 2025, there are a total of 2,847 cell therapies undergoing clinical trials worldwide, with 52% focused on oncology. The cell therapy market is projected to grow from $18.9 billion in 2025 to $58.7 billion in 2030, with an average annual growth rate of 25.4%. Technological breakthroughs in solid tumor treatment are expected to be the key drivers of market growth.
From an investor’s perspective, the biotechnology sector in 2026 offers selective investment opportunities. Companies with AI-based drug development platforms and those specializing in next-generation therapy development are attracting investor attention. Venture capital investment trends indicate that the average investment size for Series A stage biotech companies increased by 23% to $34 million in 2025, while Series B stage investments increased by 34% to $78 million. This expansion in investment size suggests that investors are focusing more on companies at more mature stages, alongside rising clinical trial costs.
Positive changes are also emerging in the regulatory environment. The U.S. FDA released new guidelines for AI-based drug development in 2025, proposing measures to ensure transparency and reproducibility in the drug candidate exploration process using AI algorithms. The European Medicines Agency (EMA) is also expected to release similar guidelines in the first half of 2026, creating an environment where global biotech companies can invest more actively in AI-based drug development. The Korean Ministry of Food and Drug Safety is also promoting regulatory innovation by reducing the approval process for AI-based medical devices and digital therapeutics from the existing 12-18 months to 6-9 months through the expedited review system for innovative medical technologies starting in the second half of 2025.
In conclusion, the biotechnology industry in 2026 is entering a new growth trajectory through the convergence of technologies and the commercialization of personalized treatments. The biotechnology industry, which has grown to a global market size of $842 billion, is expected to maintain sustained growth with the expanded clinical application of innovative technologies such as AI, gene editing, and cell therapy. Particularly, the accelerated global expansion of Korean biotech companies and the government’s support for K-Bio policies are expected to drive more dynamic development in the domestic biotech ecosystem. For investors, innovative companies with technological superiority and successful global market entry by Korean biotech companies are emerging as attractive investment targets, with their growth potential expected to continue for the next 3-5 years.
*This report is intended for general informational purposes only and should not be interpreted as advice for specific investment or medical decisions. Please consult a professional when making investment decisions.*
