Biopharmaceutical Industry in Korea

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Status of Biopharmaceutical market

Sources  [ www.mfds.go.kr  ]

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 $2.3 billion in 2017, accounting for 12.8% share of the Korea’s pharmaceutical market worth $18.0 billion as of 2017. (Source: MFDS Yearbook 2018)

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

Sources  [ www.mfds.go.krwww.mfds.go.kr  ]

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. 213 clinical trials for biopharmaceutical products were approved in Korea in 2017.

Value 2015 2016 2017
Total 674 628 658
Biopharmaceuticals 202 226 213
Pharmaceuticals 451 387 422
Herbal 21 15 23

The number of approvals for biopharmaceuticals is the highest for gene recombinant products(153) followed by biological products such as vaccines and blood products(31), cell therapy products(30), and gene therapy products(9) in 2017.

Color Title Number %
Recombinant DNA product 153 72%
Gene therapy product 9 4%
Biologics 31 15%
Cell therapy products 20 9%

※ The number of approvals for clinical trials for biopharmaceuticals

Year Recombinant DNA product Cell therapy product Biologics Gene therapy product Total
2015 158 25 14 5 202
2016 151 33 33 9 226
2017 153 20 31 9 213

Source: Notice of Clinical Trial Approval Results (Mar. 2018), MFDS