The Biotechnology Revolution: Realizing Personalized Medicine by 2025 and Market Disruption
Editor
As of the end of 2025, the global biotechnology industry is at an unprecedented inflection point. The advancement of artificial intelligence and machine learning is fundamentally restructuring the drug development process, reducing the traditional 10-15 year timeline to 5-7 years. The global biotech market size is projected to reach $1.24 trillion in 2025, with an annual growth rate of 11.2%. Notably, the personalized medicine sector alone is expected to exceed $320 billion in market size for the year 2025, accounting for 25.8% of the entire biotech market.
This rapid growth is driven by the commercialization of gene-editing technologies like CRISPR-Cas9 and the improved cost efficiency of next-generation sequencing (NGS) technologies. As of 2025, the cost of whole-genome analysis has dropped to around $500, marking the beginning of the widespread adoption of personalized treatments. According to the latest report from the National Institutes of Health (NIH), 32% of new drugs approved by the FDA in the first half of 2025 were biomarker-based personalized therapies, a 127% increase from the same period last year.
The Korean biotech ecosystem is also experiencing rapid growth. Samsung Biologics, headquartered in Seongnam, recorded a revenue of 3.12 trillion won in the third quarter of 2025, a 34% increase from the same period last year. The increase in orders in the Antibody-Drug Conjugate (ADC) contract manufacturing sector is particularly notable, as the intense competition among global pharmaceutical companies to develop next-generation cancer treatments has led to a surge in demand for the high-tech production of ADCs. Samsung Biologics’ Plant 4 in Songdo began full-scale operations in the second half of 2025, expanding its annual production capacity to 240,000 liters, the largest in the world for biopharmaceutical production.
Realization of AI-Based Drug Development and Market Impact
The most noteworthy change in the biotech industry in 2025 is the commercialization of AI-based drug development platforms. DeepMind’s AlphaFold3, based in London, UK, achieved a protein structure prediction accuracy of 97.2%, rapidly altering the traditional drug development paradigm. Recursion Pharmaceuticals in Boston, USA, discovered 14 drug candidates through its AI platform in 2025, with three entering Phase 2 clinical trials. This process, which traditionally takes at least 5-7 years, was completed in just two years.
In Korea, the competition for AI-based drug development is also accelerating. Standigm, headquartered in Pangyo, raised 120 billion won in a Series C investment in 2025, recognizing a corporate value of 1.2 trillion won. Standigm’s AI platform ‘Standigm ASK’ specializes in discovering new indications for existing approved drugs, with 17 drug candidates currently in the preclinical stage as of 2025. Notably, the Alzheimer’s treatment candidate ST-101 is set to begin Phase 1 clinical trials in the fourth quarter of 2025 and is in licensing negotiations with three global pharmaceutical companies.
The spread of AI-based drug development is also bringing significant changes to the traditional pharmaceutical industry structure. Pfizer, headquartered in New York, announced a $5 billion investment in AI drug development in 2025, while Roche in Basel, Switzerland, spent $3.2 billion on acquiring AI biotech startups in the same year, a 180% increase from the previous year, indicating aggressive investments by global pharmaceutical companies to secure AI technology.
In Korea, Celltrion, headquartered in Songdo, is focusing on AI-based biosimilar development. Celltrion announced in 2025 that it successfully reduced the development period for biosimilars of existing biopharmaceuticals by 30% using its proprietary AI platform. The company is particularly prominent in the oncology biosimilar sector, with 23 biosimilar candidates in the pipeline as of the third quarter of 2025, eight of which are in Phase 3 clinical trials.
Commercialization of Personalized Treatments and New Business Models
The most notable trend in the biotech industry in 2025 is the full-scale commercialization of personalized treatments. Genentech (a Roche subsidiary), headquartered in South San Francisco, California, recorded $1.8 billion in sales in the first year of launching its personalized cancer treatment ‘Tecentriq Personalized’ in 2025. This treatment analyzes the tumor genetic profile of individual patients to provide optimized immunotherapy combinations, showing an average 42% improvement in treatment efficacy compared to standard therapies.
The spread of personalized treatments is leading to the emergence of new business models. The ‘Outcome-based Pricing’ model is a representative example, where drug prices are differentiated based on treatment effectiveness. Novartis in Switzerland introduced a conditional pricing policy for its CAR-T cell therapy ‘Kymriah,’ receiving full payment only if the treatment effect lasts more than six months. This reduces the burden on patients and insurers while allowing pharmaceutical companies to secure stable revenue based on the actual effectiveness of the treatment.
In Korea, the development of personalized treatments is also active. SK Biopharm, headquartered in Daejeon, completed the development of a personalized version of its epilepsy treatment ‘Cenobamate’ in 2025. This approach determines the optimal dosage and administration interval by analyzing the patient’s genetic polymorphism, minimizing side effects while maximizing treatment efficacy. SK Biopharm submitted personalized epilepsy treatment guidelines to the US FDA in the fourth quarter of 2025, expecting an additional $500 million in annual sales if approved.
Innovative advancements are also continuing in the field of gene therapy. Editas Medicine, headquartered in Cambridge, Massachusetts, announced the results of Phase 3 clinical trials for its CRISPR-based gene-editing therapy ‘EDIT-101’ in 2025. This treatment for Leber congenital amaurosis showed vision improvement in 73 out of 87 patients (84%), with no serious side effects reported, marking an important milestone in proving the safety and efficacy of gene-editing technology.
Domestic gene therapy development is also showing notable achievements. GeneMatrix, headquartered in Ansan, announced positive results from Phase 2 clinical trials of its gene therapy ‘JMT-101’ in 2025. This gene therapy for Parkinson’s disease delivers dopamine-producing genes directly to the brain, showing a 65% higher improvement in motor function compared to existing drug therapies. GeneMatrix aims to enter Phase 3 clinical trials in the first half of 2026 based on these results and is actively discussing partnerships with global pharmaceutical companies.
With the rapid advancement of the biotech industry, the regulatory environment is also changing. The US FDA released the ‘AI-Assisted Drug Development Guidance’ in 2025, clarifying the regulatory framework for AI-based drug development. According to this guidance, clinical trial periods can be shortened by up to 30% compared to existing standards if the transparency and reproducibility of AI algorithms can be guaranteed. The European Medicines Agency (EMA) is also expected to release similar guidelines in the second half of 2025, further accelerating the global competition in AI drug development.
However, there are challenges accompanying this rapid advancement. The high development costs and complex manufacturing processes of personalized treatments are major issues. According to a 2025 report by McKinsey Consulting, the average development cost of personalized therapies is 2.3 times higher than that of traditional drugs, and the treatment cost per patient averages $150,000 to $500,000 even after commercialization. This raises concerns about treatment accessibility, with governments and insurers worldwide grappling with new payment systems.
Data security and privacy issues are also emerging as critical challenges. Personalized treatments require detailed genetic information and medical data from patients, increasing security risks during the collection and utilization of such sensitive information. In the first half of 2025 alone, data breaches occurred at 12 global biotech companies, exposing the information of 1.8 million patients. Consequently, governments are strengthening bio-data security regulations, and companies are significantly increasing their security investments.
From an investment perspective, global biotech venture investments in 2025 increased by 23% from the previous year, reaching $48.7 billion. Investments were particularly concentrated in AI-based drug development and personalized treatment sectors, with $20.5 billion, or 42% of total investments, directed towards these two areas. In Korea, biotech venture investments reached a record high of 3.2 trillion won, a 67% increase from the previous year, attributed to the government’s K-bio policy and expanded private investments.
As of the end of 2025, the biotech industry stands at a turning point where technological innovation and commercial success are achieved simultaneously. The advancements in AI and gene-editing technologies are opening up possibilities for treating previously incurable diseases, and the commercialization of personalized treatments is fundamentally changing the medical paradigm. Korean biotech companies are accelerating innovative technology development and overseas expansion in line with these global trends and are expected to play a significant role in the global biotech ecosystem over the next 5-10 years. However, continuous industry-wide efforts and government policy support are needed to address challenges such as high development costs, regulatory complexity, and data security.
