K-Bio Pharmaceutical Industry to Accelerate Innovation to Become a Global Top Five Power

- Inter-ministerial roundtable with bio-pharmaceutical companies to gather industry feedback -

- Government aims to double bio-pharmaceutical exports by 2030 and develop three blockbuster new drugs, backed by bold regulatory reforms and support for industrial growth -

- Approval review periods for biosimilars to be cut from 406 to 295 days; health insurance listing expedited from 330 to 150 days to accelerate market entry -

The government held the Bio Innovation Roundtable on September 5 at Songdo Convensia in Incheon under the theme “K-Bio: Accelerating Innovation.” The Ministry of Food and Drug Safety, the Ministry of Health and Welfare, the Ministry of Economy and Finance, the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, and the Ministry of SMEs and Startups participated alongside leaders of Korea’s bio-pharmaceutical industry, associations, and organizations, with about 130 participants in attendance.

The bio-pharmaceutical industry is emerging as a critical sector across multiple dimensions: economic (a new engine of growth), social (directly linked to health and life), and security (pandemic preparedness and supply-chain resilience). The roundtable served as a platform for government, industry, universities, research institutes, and investors to share views and explore strategies for securing global leadership in the bio-pharmaceutical market.

To gather perspectives from across the industry, representatives from large corporations, mid-sized firms, SMEs and venture companies, venture capital, associations, organizations, and academia participated in the roundtable. They engaged in a lively open discussion on the future direction of the K-Bio pharmaceutical industry. Prior to the discussion, the government announced the Leapfrog Strategy for the K-Bio Pharmaceutical Industry, developed jointly by relevant ministries.

Leapfrog Strategy for the K-Bio Pharmaceutical Industry

The global pharmaceutical market reached USD 1,748.7 billion in 2023—three times the size of the semiconductor market—and continues to grow, with an annual increase of 4.7 percent projected through 2028. Within this, the bio-pharmaceutical market, valued at USD 564.9 billion in 2023, is expanding even faster, at an annual growth rate of 11.9 percent through 2028. Korea, with its world-class CDMO (Contract Development and Manufacturing Organization) capabilities and biosimilar blockbusters generating over KRW 1 trillion in annual sales, ranked among the world’s top ten bio-pharmaceutical exporters in 2024, reaching USD 5.8 billion.

The government has set its vision of “K-Bio Pharmaceuticals: Leaping to Become a Global Top Five Power” and will accelerate innovation to achieve by 2030 the goals of doubling bio-pharmaceutical exports, creating three blockbuster new drugs, and ranking third worldwide in clinical trials.

First, the government will shift toward user-centered regulatory reform to drive progress. It will proactively adapt regulations to support the rapid release of new medicines developed with advanced technologies and will ease Phase 3 clinical requirements for biosimilars. AI will also be applied to the review process, and review staff will be significantly expanded to shorten approval timelines by about four months. By 2027, a system will be institutionalized to conduct approval, reimbursement assessment, and price negotiations simultaneously, dramatically reducing the time required for health insurance listing.

Second, the government will accelerate growth by connecting technology, talent, and capital. It will support the development of AI-based drug discovery, AI- and robotics-driven automated laboratories, and gene and cell therapies to drive a major transformation in AI–bio-pharmaceutical technology. The government will also establish biomedical big data from one million Koreans and advance a platform for its integration and sharing. In addition, it will train 110,000 field-ready specialists and expand government funds to strengthen the bio-pharmaceutical investment market across the full new drug development cycle.

Third, the government will enhance global competitiveness by fostering mutual growth between anchor companies and biotech firms. It will mobilize support across infrastructure, finance, taxation, and workforce development to secure unassailable leadership in CDMO and bio-manufacturing, while raising localization rates for materials, parts, and equipment. The government will also support the scaling-up of bio-ventures so that their original technologies can be translated into finished products through open innovation.

Roundtable with Bio-Pharmaceutical Companies

The open discussion was divided into two sessions—Regulatory Innovation and Growth and Global Competitiveness—to facilitate in-depth debate on the challenges facing bio-pharmaceutical companies. The roundtable was broadcast live nationwide via KTV, allowing the public to follow the discussions in real time.

The government stated that the opinions gathered during the roundtable will be promptly reflected in the implementation of the Leapfrog Strategy for the K-Bio Pharmaceutical Industry. It also pledged to swiftly improve related policies and regulations to address industry concerns and to mobilize the combined strengths of the public and private sectors, enabling the bio-pharmaceutical industry to grow as a global leader and a sustainable engine of future growth. 

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