Biopharmaceutical Industry in Korea

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Status of Biopharmaceutical market

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The biopharmaceutical industry is getting attention globally as the future growth engine. The importance of biopharmaceutical is the future of the pharmaceutical market and central within the context of the Fourth Industrial Revolution.

Korean government proposes to become the seventh-largest of the total global market by 2020. According to a report by GlobalData, the Korea’s Biopharmaceutical market is expected to rise to reach $20.4 billion in value by 2020. Korea’s biopharmaceutical market is worth about $1.5 billion in 2015, accounting for 8.5% share of the Korea’s pharmaceutical market worth $17.0 billion as of 2015. (Source: MFDS Yearbook 2016)

Korea is in a unique position in terms of biopharmaceutical development. The world’s first stem cell therapy was approved in Korea (’11) and world’s first biosimilar antibody was approved in EU(’12).

Status of Clinical Trials in Korea

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The Korean government has promoted the biopharmaceutical industry and provides significant support to the clinical trial industry. With it high quality clinical research infrastructure, well-defined regulatory and review processes, Korea has become a global clinical hub over the past decade.

Clinical trials for biopharmaceuticals are conducted quite actively in Korea. For the last 5 years, the number of clinical trial approvals for biological products has increased continuously. 226 clinical trials for biopharmaceutical products were approved in Korea in 2016.

The number of approvals for biopharmaceuticals is the highest for gene recombinant products(151) followed by biological products such as vaccines and blood products(33), cell therapy products(33), and gene therapy products(9) in 2016.

※ The number of approvals for clinical trials for biopharmaceuticals

Year Recombinant DNA product Cell therapy product Biologics Gene therapy product Total
2014 110 24 29 7 170
2015 158 25 14 5 202
2016 151 33 33 9 226

Source: Notice of Clinical Trial Approval Results (Mar. 2017), MFDS