A New Turning Point in Biotech Innovation: Analysis of the Rapid Growth in Precision Medicine and Gene Therapy Markets by 2026
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Paradigm Shift and Market Dynamics in the Biotechnology Industry
As of 2026, the global biotechnology industry is experiencing an unprecedented inflection point. The global biopharmaceutical market size has surpassed $547 billion, marking an 8.2% growth compared to the previous year, with the fields of precision medicine and gene therapy driving overall growth. The introduction of AI-based drug development platforms has shortened the drug development period from the traditional 10-15 years to 7-10 years, significantly improving the investment efficiency of biotech companies. This technological advancement goes beyond mere efficiency improvements, fundamentally transforming the accessibility and affordability of biopharmaceuticals.
The growth of the Korean biotech industry is particularly noteworthy. By 2025, the Korean biopharmaceutical market exceeded 14 trillion won, becoming the second-largest in the Asia-Pacific region after Japan. Samsung Biologics, headquartered in Seongnam, Gyeonggi Province, recorded sales of 1.24 trillion won in the fourth quarter of 2025, securing a 15.2% share in the global CDMO (Contract Development and Manufacturing Organization) market. This places it second globally, following Switzerland’s Lonza at 18.7%. Celltrion, located in Incheon, also showed strong growth in the biosimilar market, with annual sales surpassing 3.5 trillion won in 2025, a 22% increase from the previous year, driven mainly by market share expansion in Europe and the United States.
Global pharmaceutical companies are accelerating their strategies to enter the Asian market. Johnson & Johnson, headquartered in New Jersey, announced an additional $500 million investment in its Korean R&D center by 2025, while Switzerland’s Roche is strengthening its market penetration in Korea and Japan through its Asia-Pacific headquarters in Singapore. These investment expansions are largely aimed at creating synergies through cooperation with local biotech companies, in addition to the growth potential of the Asian market. Korea’s excellent bio-manufacturing infrastructure and the government’s K-Bio Belt project are significant factors influencing foreign companies’ investment decisions.
Technological advances in the field of precision medicine are driving market growth. With the cost of next-generation sequencing (NGS) technology decreasing by 70% over the past five years, the commercialization of personalized treatments is becoming a reality. As of 2026, approximately 8.5 million people worldwide are receiving precision medicine-based treatments, a 340% increase compared to 2022. Moderna, headquartered in Massachusetts, announced that its personalized cancer vaccine using mRNA technology demonstrated a 70% recurrence prevention effect in Phase 2 clinical trials. This achievement is significantly higher than existing standard treatments, clearly demonstrating the commercial value of precision medicine.
Accelerating Commercialization of Gene and Cell Therapies
The explosive growth of the gene therapy market is reshaping the landscape of the entire biotechnology industry. In 2025, the global gene therapy market size reached $18.7 billion, and it is projected to maintain an average annual growth rate of 31.2%, reaching $98 billion by 2030. Notably, innovative achievements in the field of immunocellular therapies like CAR-T cell therapy are being announced in succession. Existing CAR-T therapies such as Novartis’ Kymriah and Gilead Sciences’ Yescarta are showing stable performance in the market, intensifying the competition for the development of subsequent products.
Korean companies are also achieving remarkable results in this field. Aptabio, a KOSDAQ-listed company, has laid the foundation for global expansion as its CAR-T therapy ‘APT-1011’ for solid tumors received orphan drug designation from the U.S. FDA. Additionally, Green Cross Cell’s NK cell therapy demonstrated safety in Phase 1 clinical trials in the second half of 2025, showcasing the potential of next-generation immunocellular therapies. These achievements indicate that Korea is emerging as a bio powerhouse developing innovative therapeutic technologies beyond merely being a biopharmaceutical production base.
The advancement of CRISPR-Cas9 gene editing technology is also accelerating market growth. By the end of 2025, over 280 CRISPR-based clinical trials were underway globally, with 15% having entered Phase 2 or higher stages. Particularly, CTX001, co-developed by CRISPR Therapeutics and Vertex Pharmaceuticals, demonstrated over 95% therapeutic efficacy in treating sickle cell disease and beta-thalassemia, clearly proving the commercial potential of gene editing technology. This therapy received approval in Europe in December 2025, with U.S. approval expected in the first half of 2026.
In the field of cell therapy, the diversification of stem cell therapies is prominent. As treatments for degenerative arthritis using mesenchymal stem cells are successively launched in the market, the paradigm of arthritis treatment is shifting from symptomatic treatment to fundamental treatment. Medipost’s ‘Cartistem,’ developed in Korea, successfully entered the Japanese market in 2025, securing a leading position in the Asian stem cell therapy market. The launch of this product in Japan is considered a symbolic case demonstrating that the technological capabilities of Korean biotech companies have reached a global level.
Innovations in biomanufacturing technology are also supporting market growth. With the introduction of continuous manufacturing technology, the production efficiency of biopharmaceuticals has improved by 30-40%, achieving both cost reduction and supply stability. Samsung Biologics completed a continuous manufacturing facility in Songdo, Incheon, in 2025, further solidifying its technological superiority in the global CDMO industry. This facility boasts an annual production capacity of 360,000 liters, 40% more efficient than traditional batch manufacturing methods.
The application of artificial intelligence and machine learning technologies in the bio field is revolutionizing the drug development process. The success rate of new drug development using AI-based drug design platforms has improved from the traditional 5-10% to 15-20%, significantly enhancing the R&D investment efficiency of pharmaceutical companies. AI drug development specialists like Exscientia in the UK and Atomwise in the U.S. are continuously developing innovative therapies through partnerships with existing pharmaceutical companies. Particularly in the field of rare diseases, the utilization of AI is increasing, opening up the possibility of developing treatments that were previously difficult to pursue due to a lack of economic viability.
Changes in the regulatory environment are also promoting market growth. The ‘Bio Innovation Pathway’ introduced by the U.S. FDA in 2025 reduced the approval period for innovative biopharmaceuticals from the existing 12 months to 8 months. The European Medicines Agency (EMA) is also lowering market entry barriers by easing regulatory guidelines for gene therapies. The Korean Ministry of Food and Drug Safety enacted the ‘Advanced Biopharmaceuticals Special Act’ in 2025 to support the rapid market entry of innovative therapies. These regulatory improvements positively influence the investment decisions of biotech companies and accelerate market growth.
The proportion of the Asia region in the global biopharmaceutical market is continuously expanding. In 2025, the biopharmaceutical market size in the Asia-Pacific region reached $124 billion, accounting for 22.7% of the total market. This is a 4.4 percentage point increase from 18.3% in 2020. Particularly, the growth of China, Korea, and Japan is remarkable, and India and Southeast Asian countries are also emerging as biopharmaceutical manufacturing hubs. In the case of China, the biopharmaceutical market size exceeded $58 billion in 2025, becoming the third-largest market in the world after the U.S. and Europe.
The maturation of the biosimilar market is also a noteworthy change. In 2025, the global biosimilar market size reached $28 billion, growing 18.5% compared to the previous year. The expiration of patents for blockbuster biopharmaceuticals like Adalimumab (Humira) and Bevacizumab (Avastin) is rapidly expanding the biosimilar market. Celltrion’s Truxima (Rituximab biosimilar) recorded $3.2 billion in global sales in 2025, achieving the highest sales for a single biosimilar product worldwide. This achievement is considered a representative case demonstrating the technological prowess and global competitiveness of Korean biotech companies.
Future Outlook and Investment Opportunity Analysis
The future outlook for the biotechnology industry in 2026 is very positive. According to the latest report by global consulting firm McKinsey, the biotechnology market is expected to grow at an average annual rate of 9.8% by 2030, reaching a size of $850 billion. The fields of precision medicine, gene therapy, and immunocellular therapy are expected to drive overall growth. This growth signifies a fundamental change in the medical paradigm beyond mere market expansion. As the shift from ‘one-size-fits-all treatment’ to ‘personalized treatment’ accelerates, treatments optimized for individual patients’ genetic and disease characteristics are expected to become mainstream.
From an investment perspective, the biotechnology sector presents significant growth potential along with considerable risks. In 2025, global venture investment in the biotechnology sector reached $43 billion, a 15% increase from the previous year. Investments are particularly concentrated in AI-based drug development platforms and the gene therapy field, and foreign investment in Asian biotech companies is also increasing significantly. In Korea, foreign direct investment in the bio sector reached $2.8 billion in 2025, a 45% increase from the previous year. This indicates growing trust from global investors in the technological capabilities and growth potential of Korean biotech companies.
However, the challenges facing the biotechnology industry are not insignificant. The high failure rate of new drug development, long development periods, and enormous development costs remain major risk factors in the industry. Additionally, regulatory uncertainties, intellectual property disputes, and global supply chain instability are challenges that companies need to address. In particular, concerns about safety persist in the fields of gene and cell therapy, complicating the approval process by regulatory authorities. Adverse event cases in some gene therapy clinical trials in the second half of 2025 highlighted the ongoing importance of ensuring safety in this field.
Changes in the competitive environment are also noteworthy. As the boundaries between traditional large pharmaceutical companies and emerging biotech firms blur, M&A and strategic partnerships are becoming more active. In 2025, the transaction value of M&A in the bio sector reached $185 billion, the second-highest level in history. Companies with AI drug development platforms and those developing innovative therapeutic technologies are particularly attracting attention as acquisition targets. These M&A activities are accelerating innovation across the industry through technology integration and synergy creation.
Geopolitical factors also have a significant impact on the biotechnology industry. As the U.S.-China technology hegemony competition extends to the bio field, regulations on technology transfer and investment are being strengthened. The U.S. is restricting cooperation with Chinese biotech companies through the ‘Biosecurity Act’ in 2025, and China is also strengthening measures to prevent the overseas leakage of its biotechnology. In this situation, biotech companies in countries like Korea and Europe, located in intermediate zones, are increasingly likely to serve as hubs for global cooperation. In particular, Korea’s excellent manufacturing infrastructure and neutral position are expected to enhance its role in the global bio ecosystem.
In conclusion, as of 2026, the biotechnology industry is experiencing a golden era where technological innovation and market growth are progressing simultaneously. The commercialization of core technologies such as AI-based drug development, precision medicine, and gene therapy is accelerating, forming a new treatment paradigm that offers better treatment options for patients and new growth opportunities for investors. The global expansion achievements of Korean biotech companies and the increased investment of foreign companies in Asia demonstrate that this region is emerging as a key axis of the global bio ecosystem. This growth trend is expected to continue over the next few years, with innovative developments anticipated particularly in the fields of personalized treatment and rare disease therapies.
