Samsung Biologics and others to benefit from regulatory innovation law promoting global clinical trials and CDMO leadership in gene therapy
US-China geopolitical tensions and supply chain diversification create opportunities
The increasing visibility of the US BIOSECURE Act and its potential impact on Chinese CDMOs is prompting global pharmaceutical companies to diversify their supply chains. Samsung Biologics, with its benefits under the Korea-US FTA (15% tariff reduction) and strong regulatory compliance, is emerging as a key alternative. The deepening geopolitical risks are driving a broader shift towards building stable partnerships centered on allied nations, going beyond simple production relocation. Furthermore, the collaboration between Songdo C-Labs Outside and Eli Lilly and Company is poised to stimulate both domestic and international bio-ecosystems.
Abu Dhabi's genomics-based precision medicine strategy
As a rising power in the Middle East, Abu Dhabi is fostering the bio-industry as a future growth engine to reduce its reliance on oil. The Biobank, established in April, can store up to 5 million biological samples, making it a crucial infrastructure for global precision medicine research. The Abu Dhabi Department of Health (DoH) is connecting the ecosystem through the HELM cluster and has established a multi-year partnership with Boehringer Ingelheim. The region's high rate of consanguineous marriages, leading to a higher incidence of rare diseases, provides a unique value as a global 'living lab' for the development of ultra-precision gene therapies.
Brazil's population diversity and regulatory innovation in clinical research
Brazil, the largest country in South America with a population of 213 million and diverse genetic backgrounds, is rapidly emerging as a hub for global clinical trials. The new clinical research law passed in 2024 simplifies administrative procedures and clarifies post-trial drug access obligations, reducing barriers to entry for global pharmaceutical companies. As a result, Brazil's ranking in global new clinical trials is expected to rise significantly from 18th in 2024 to 12th in 2026. Local bio-builders like Vesper Biotechnologies are accelerating the attraction of multinational sponsors by leveraging low research costs and access to diverse patient populations.
South Korea's institutional support and accelerating new ecosystem
The South Korean government plans to further strengthen institutional support through the 'Bio-Pharmaceutical CDMO Regulatory Support Special Act,' scheduled to take effect on December 31, 2026. This act simplifies customs procedures and minimizes administrative burdens for CDMO companies, providing a strong incentive to ensure business continuity. Samsung Biologics is expanding its global presence by opening an office in Amsterdam later this year, in addition to its existing offices in the US and Japan. This will solidify South Korea's leading position in the global CDMO market, which is projected to reach approximately $211 billion by 2026.
With the increasing visibility of the US BIOSECURE Act, Samsung Biologics, which benefits from the 15% tariff reduction under the Korea-US FTA, is experiencing increased global orders, leading to short-term improvements in financial performance. In the medium to long term, the passage of Brazil's new clinical research law in 2024 is expected to boost its ranking in global clinical trials to 12th, accelerating the distribution of multinational pharmaceutical companies' Phase 1/2/3 trials in South America and significantly reducing new drug development costs. Abu Dhabi, with its Biobank of 5 million samples and strategic partnership with Boehringer Ingelheim, is poised to accelerate its efforts to capture a share of the global precision medicine and gene therapy market, which is expected to grow at an annual rate of over 10%. The implementation of South Korea's Bio-Pharmaceutical CDMO Regulatory Support Special Act and the opening of Samsung Biologics' global offices will solidify its leading position in the CDMO market, which is projected to reach approximately $211 billion by 2026. As a result, the existing R&D ecosystem, which has been centered on North America and Europe, is being reshaped into a decentralized, multi-polar system through the institutional incentives and regulatory easing of emerging hubs.
Source: FierceBiotech (rss)
https://www.fiercebiotech.com/biotech/three-regions-fighting-their-place-future-biotech