"Securing global CDMO foundation in KOR"

The Korea Pharmaceutical and Bio-Pharma Healthcare Alliance, an assembly of eight organizations, held the 2nd Forum

In response to global manufacturing competition, the industry alliance proposes 'strengthening regulatory rationalization·manufacturing-based structure'

(from left) Yong Ki Park (Project Manager, Samsung Biologics), Yoon Hee Choi (Senior Research Fellow, KIET), Sun Hee Lee (Professor, Ewha Womans University), Tae-kyu Lee (CEO, Scale Up Partners), Tong Kook Lee (Attorney, Dongin Law Group Lawyer), Kang Seop Im (Head, Ministry of Health and Welfare's Division of Health Industry Promotion)

The Korea Pharmaceutical and Bio-Pharma Healthcare Alliance, an assembly of organizations representing South Korea's domestic pharmaceutical, bio, and medical device sectors, held its second official Forum. At the event, the industry voiced for regulatory rationalization and expanded nation-level investment in manufacturing infrastructure to elevate domestic capabilities to a global standard.

The Korea Pharmaceutical and Bio-Pharma Healthcare Alliance hosted its 2nd Forum on December 11 at the National Assembly Hall, focusing on the topic of 'manufacturing innovation strategy for the healthcare industry to enhance global competitiveness'.

The Korea Pharmaceutical and Bio-Pharma Healthcare Alliance is a healthcare consultative body formed by key associations representing the South Korean healthcare industry, including pharmaceuticals, medical devices, regenerative medicine, and digital health. Nine organizations have joined the alliance, including the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), Korea Biomedicine Industry Association, Korea Pharmaceutical Traders Association(KPTA), Korea Drug Research Association (KDRA), Council for Advanced Regenerative Medicine (CARM), Korea Digital Health Industry Association(KoDHIA), Korea Medical Devices Industry Association (KMDIA), and Korea Biotech Industry Organization.

The forum was attended by heads of alliance member institutions, including Yunhong Noh (President, KPBMA), Jung Jin Kim (Chairman, KDRA), Jeong Seok Lee (Chairman, KBMIA), Young Min Kim (Chairman, KMDIA), Byoung-jun Bae (Chairman, CARM), Ki-yoon Yoo (Executive Director, KoDHIA), and Dong Hee Lee (Vice President, KPTA).

Panelists included Sun Hee Lee (Professor, Ewha Womans University), Yong Ki Park (Project Manager, Samsung Biologics), Tong Kook Lee (Attorney, Dongin Law Group Lawyer), Tae-kyu Lee (CEO, Scale Up Partners), Kang Seop Im (Head, Ministry of Health and Welfare's Division of Health Industry Promotion), and Yoon Hee Choi (Senior Research Fellow, KIET), discussing strategies for domestic healthcare manufacturing innovation and strengthening national Contract Development and Manufacturing Organization (CDMO) competitiveness. 

 

The Korea Pharmaceutical and Bio-Pharma Healthcare Alliance hosted its 2nd Forum on December 11 at the National Assembly Hall, focusing on the topic of 'manufacturing innovation strategy for the healthcare industry to enhance global competitiveness'.

Jung Woon Chun, a researcher at the KPBMA, assessed that domestic pharmaceutical and bio manufacturing and quality competitiveness remain at an early stage, with distinct disparities by company size. Researcher Chun noted, "According to a survey conducted by the association involving 45 companies and 61 plants, the automation level of domestic companies remains at the MES/ERP implementation stage (Level 2), with only 18% reaching Level 3 or higher, which enables data linkage between processes or predictive analytics." He added that the adoption of smart manufacturing and AI-based process technology is generally slow due to regulatory uncertainty and a lack of specialized personnel.

To reduce the gap with global standards, Chun proposed establishing a national manufacturing and quality innovation roadmap and providing institutional support. He proposed several measures, including ▲Introducing manufacturing innovation incentives (tax benefits, subsidies, drug price preference) ▲Expanding field-based specialized workforce training programs ▲Establishing smart factory guidelines ▲Expanding public-private cooperation and sharing successful cases ▲Improving regulations for continuous manufacturing and Quality by Design (QbD).

Chun added, "Securing global-level manufacturing competitiveness cannot be achieved solely through the efforts of individual companies." He emphasized, "As the industry aims to invest in AI and digital-based quality management, the government must promptly establish regulatory guidance and eliminate investment uncertainty for manufacturing innovation to realize."

Hyun Soo Cho, a Manager at the Korea Biomedicine Industry Association, said that the CDMO industry needs to be developed by the government as a strategic industry. Cho noted, "The global biopharmaceutical market is being reshaped around manufacturing and quality capability, granting strategic advantage to countries that secure production infrastructure," and asserted, "Since South Korea already possesses the foundation for becoming a global CDMO hub, with the world's largest single production cluster (2.14 million liters) and large-scale facility capacity projected by 2030."

Cho projected that the recently enacted 'Special Act on Regulatory Support for Biopharmaceutical Contract Development and Manufacturing Organizations (CDMO Special Act)' will be a turning point for the Korean CDMO industry. The CDMO Special Act, passed by the National Assembly on December 2, is a state-level industrial promotion law designed to help biopharmaceutical CDMOs meet global manufacturing/quality requirements and support exports/regulatory responses. Cho explained that institutional mechanisms such as the introduction of an export manufacturing registration system, quality management conformity certification, and raw material certification will further enhance the competitiveness of the domestic CDMO industry.

Additionally, Cho emphasized the need to expand large-scale production bases, secure specialized personnel, and foster technology-focused CDMOs focused on next-generation modalities such as mRNA, cell/gene therapies, and ADCs. He stated, "It is urgent to expand the ecosystem to support successful companies and cultivate mid-sized and venture CDMOs as growth engines," and concluded, "For Korea to become a global production hub, support for process development, financial/tax incentives, and strengthening global certification capabilities must be pursued simultaneously."

At the forum, policy directions for manufacturing, quality innovation, and enhancing global competitiveness were also discussed. In particular, the industry called for expanding the ecosystem, including the regular sharing of best practices in manufacturing/quality, customized professional workforce training, and matching support for joint development and process development between mid-sized/venture CDMOs and global companies.

Yong Ki Park pointed out, "If the CDMO Special Act is the starting point for institutional foundation, then effective tax support and reform of the liability structure must follow in the subsidiary regulations," and criticized the current structure, which unilaterally transfers domestic liability to the manufacturer, saying it "does not align with global standards and could weaken competitiveness." Park stressed, "The establishment of a dedicated center for CDMO workforce training is urgent." He emphasized, "A national infrastructure must be established to systematically cultivate experts in GMP, process engineering, and quality who can be immediately deployed in the field, enabling the country to maintain its status as a global production hub."

Yoon Hee Choi also argued that policy establishment is essential to strengthen R&D capabilities and transition to smart manufacturing. Choi advised, "A bold national strategy is required, including support for digital and AI-based process innovation in mid-sized and small companies, expansion of tax/subsidy incentives for nurturing technology-specialized CDMOs, and investment in professional infrastructure." Cho recommended, "It is necessary to support the growth of mid-sized and small CDMOs capable of customized biomanufacturing, such as cell and gene therapies, and establish collaboration platforms for process development and building track records between large corporations and ventures."