The Turning Point of the Biotechnology Industry in 2025: Accelerating Commercialization of AI Integration and Personalized Medicine
Editor
As of the end of 2025, the biotechnology industry is experiencing unprecedented changes through the integration of artificial intelligence (AI) technology. The global biotech market size reached $1.52 trillion in 2025, growing by 11.3% compared to the previous year. Companies utilizing AI-based drug development platforms are entering clinical trials 30-40% faster than traditional pharmaceutical companies, accelerating the paradigm shift in the industry. The U.S. FDA approved 72 new drugs developed using AI technology in 2025, a 180% increase from the previous year.
With the full-scale commercialization of personalized medicine, the market size for gene analysis-based therapies reached $480 billion in 2025. Particularly, CAR-T cell therapies and treatments utilizing CRISPR-Cas9 gene editing technology are driving the market with an annual growth rate of over 25%. South Korea’s Samsung Biologics recorded sales of 3.2 trillion won in the third quarter of 2025, securing a 16% share in the global biopharmaceutical contract development and manufacturing organization (CDMO) market. This is due to the company’s four production plants in Incheon, Gyeonggi Province, which have an annual production capacity of 620,000 liters, operating as the world’s largest single bio-production facility.
Celltrion is also showing strong performance in the biosimilar market. Headquartered in Songdo, Incheon, Celltrion achieved annual sales of 4.1 trillion won in 2025, capturing a 12.3% share of the global biosimilar market. Notably, its flagship product, Remsima (infliximab biosimilar), secured over 40% market share in Europe, significantly improving patient accessibility with prices 30-50% lower than original drugs. In the U.S. market, Celltrion’s biosimilar products recorded $1.5 billion in sales in 2025, growing by 85% compared to the previous year.
Innovation and Market Impact of AI-Based Drug Development
The introduction of AI technology is fundamentally changing the drug development process. Traditionally taking 15-20 years, the drug development period is reduced to 8-12 years when utilizing AI platforms, and development costs are cut by over 40%, from an average of $2.6 billion to $1.5 billion. As of 2025, AlphaFold3, developed by the UK’s DeepMind, can predict the structures of over 200 million proteins, with more than 1,200 drug development projects utilizing this technology worldwide.
Biotech company Moderna, headquartered in Cambridge, Massachusetts, has achieved significant success with mRNA vaccine development using AI technology. In 2025, the company’s annual sales reached $18.7 billion, with 60% coming from mRNA therapies other than COVID-19. Moderna is currently developing 15 mRNA vaccines targeting respiratory syncytial virus (RSV), cytomegalovirus (CMV), Zika virus, among others, with 8 of them in phase 3 clinical trials. In the personalized cancer vaccine field, Moderna’s mRNA-4157 has shown a 44% reduction in the recurrence risk for melanoma patients, with commercialization expected in 2026.
Roche, headquartered in Basel, Switzerland, invested $4.5 billion in 2025 in AI-based diagnostic platforms and personalized therapy development. Its subsidiary, Foundation Medicine, provides services recommending optimal treatments for patients through comprehensive genomic profiling (CGP) tests, with over 500,000 cancer patients worldwide using the service in 2025. Roche’s HER2-positive breast cancer treatment Kadcyla recorded $6.8 billion in sales in 2025, growing by 23% compared to the previous year through a personalized treatment approach.
Regional Competitive Landscape of the Global Biotech Ecosystem
The Asia-Pacific region is emerging as a new growth engine for the global biotech industry. In 2025, the biotech market size in the Asia-Pacific region reached $380 billion, with an annual growth rate of 12.8%, significantly outpacing North America (7.2%) and Europe (8.9%). China’s biotech market grew to $120 billion in 2025, with over 700 biotech companies concentrated in bio-clusters centered around Shanghai and Beijing. According to China’s ’14th Five-Year Plan,’ the annual investment in the bio industry reached $28 billion, a 35% increase from the previous year.
Japan shows unique strengths in regenerative medicine and cell therapy. The Japanese government invested $1.8 billion in regenerative medicine in 2025, leading the world in developing therapies using iPS cells. The Center for iPS Cell Research and Application (CiRA), founded by Kyoto University’s Shinya Yamanaka, is conducting clinical trials for 12 iPS cell-based therapies targeting Parkinson’s disease, macular degeneration, myocardial infarction, and more as of 2025. Particularly, the iPS cell-derived dopamine neuron transplantation for Parkinson’s disease showed over 30% improvement in patients’ motor functions in phase 2 clinical trials.
South Korea is establishing global leadership in the biopharmaceutical CDMO sector. The market size of South Korea’s CDMO reached $12 billion in 2025, accounting for 6.7% of the global CDMO market ($180 billion). In addition to Samsung Biologics, LG Chem Life Sciences, the life sciences division of LG Chem, recorded sales of 850 billion won in 2025, showing strong competitiveness in the ADC (antibody-drug conjugate) contract manufacturing sector. The South Korean government is creating bio-clusters in Osong, Daedeok, and the Hwaseong-Pyeongtaek area through the ‘K-Bio Belt’ project, attracting a total investment of 2 trillion won by 2025.
In the European market, Switzerland and Germany are leading biotech innovation. Novartis, located in Basel, Switzerland, achieved $4.5 billion in sales through CAR-T cell therapies Kymriah and Tisagenlecleucel in 2025, a 67% increase from the previous year. Germany’s BioNTech is showing results in cancer therapy development using mRNA technology, with 35% of its $8.9 billion annual sales in 2025 coming from mRNA therapies other than COVID-19. BioNTech’s personalized cancer vaccine BNT122 showed a 40% improvement in survival rates for pancreatic cancer patients in phase 2 clinical trials, with commercialization targeted for 2026.
The United States remains the center of the global biotech industry. In 2025, the U.S. biotech market size reached $620 billion, accounting for 41% of the global market. The Boston-Cambridge biotech cluster hosts over 800 biotech companies, with venture capital investment reaching $18 billion in 2025. Genentech, a Roche subsidiary headquartered in South San Francisco, California, recorded $45 billion in oncology sales in 2025, with the PD-L1 inhibitor Tecentriq generating $12 billion in sales.
Examining investment trends in the biotech industry, global biotech venture capital investment reached $42 billion in 2025. Although this represents a 15% decrease from the previous year, it remains historically high. 40% of the investment focused on AI-based drug development platforms and personalized therapy development, with a surge in investments in gene editing technologies such as CRISPR, base editing, and prime editing. U.S. gene editing specialists like Editas Medicine, Intellia Therapeutics, and CRISPR Therapeutics attracted a total of $8.5 billion in investments in 2025.
Changes in the regulatory environment also significantly impact the development of the biotech industry. The U.S. FDA announced ‘AI-Based Drug Development Guidelines’ in 2025, establishing a regulatory framework to enhance the transparency and verifiability of AI algorithms. The European Medicines Agency (EMA) simplified the approval process for personalized therapies, reducing the approval period for gene analysis-based therapies from an average of 18 months to 12 months. The Korean Ministry of Food and Drug Safety (MFDS) introduced a ‘Special Approval System for Advanced Biopharmaceuticals,’ allowing conditional approval to accelerate market entry for innovative biopharmaceuticals.
One of the major challenges facing the biotech industry is the high development cost and risk of failure. The success rate from clinical trials to final approval remains below 10%, with neurodegenerative disease treatments like Alzheimer’s having a success rate of less than 3%. However, the adoption of AI technology is improving this situation. Exscientia, headquartered in Cambridge, UK, demonstrated the potential of AI-based drug development with positive results in phase 2 clinical trials for the obsessive-compulsive disorder treatment DSP-1181, developed using an AI platform. This treatment completed the candidate discovery process in 8 months, a process that traditionally takes 4-5 years.
Another major trend in the biotech industry in 2025 is the commercialization of ‘biofoundry’ technology. A biofoundry is a platform that optimizes the production of chemicals using microorganisms through automated biological design, build, test, and learn processes. Zymergen, headquartered in Emeryville, California (now acquired by Ginkgo Bioworks), uses this technology to produce pharmaceuticals, agricultural chemicals, industrial enzymes, and more, recording $1.2 billion in sales in 2025. In South Korea, LG Chem plans to expand its bio-based chemical production capacity to 500,000 tons annually by establishing a biofoundry facility in Ochang, Chungbuk.
The future outlook for the biotech industry is very bright. Global consulting firm McKinsey predicts that the biotech market size will reach $2.4 trillion by 2030, with AI-based drug development and personalized therapies driving market growth. The gene therapy market is expected to grow to $120 billion by 2030, and the CAR-T cell therapy market is projected to grow at an annual rate of 25%, reaching $40 billion. This growth will be driven by the advancement of aging societies, the increase in chronic diseases, and the growing demand for personalized medicine.
For investors, the biotech industry is a typical field of high risk and high return. However, the introduction of AI technology is increasing the success rate of drug development and shortening development periods, gradually reducing investment risk. Companies with platform technologies can apply them across multiple therapeutic areas, diversifying their portfolios and spreading risk. South Korean biotech companies are expected to continue growing based on their strong competitiveness in the global CDMO market and the government’s active support policies. Starting from 2025, the biotech industry can be evaluated as entering a new phase that balances technological innovation and commercialization, simultaneously enhancing human health and creating economic value.
*This content is provided for informational purposes only and is not intended as investment solicitation or advice. Please conduct thorough reviews and consult experts when making investment decisions.*
