Status of BiopharmaceuticalIndustry in Korea

I Status of Biopharmaceutical companies are making increased investment in biological productsin

Industry in Korea Korea.
- Korea Biomedicine Industry Association ‌Korean companies are competing to secure a lead in the biological products
ㆍ‌
market by increasing investment in R&D. The number of bio-venture companies
has grown by 180% in the past ten years.
- ‌Major domestic companies such as CJ Healthcare, Celltrion and SK Chemical
1 Status of Domestic Industry are now leading domestic market through steady R&D investment, based on
stable revenue
(Market size) The Korean biopharmaceutical market (approx. 2.2 billion * ‌R&D investment by major companies: Celltrion 167.7 billion KRW (’13), LG 75 billion
KRW (’13), SK 59.5 billion KRW (’13), Samsung 2.2 trillion KRW (~’16)
USD) accounts for about 11.4% of total Korean pharmaceutical market
* ‌The number of Bio-venture companies has increased 1.8 times (738 (2003) -> 1,317
(approx. 18.8 billion USD), showing gradual increase. (2013))
ㆍ‌‌The market share of biological products: 6.1%(2007) -> 6.9%(2009) -> 11.4% ‌Korean biopharmas have strengthened their capacity by developing the
ㆍ‌
(2013) world’s first stem cell product and gaining approval for the world’s first
biosimilar antibody product from MFDs and EMA.
Biopharmaceutical market size in Korea (Unit: Million KRW, %) * ‌The world’s first stem cell product was developed by FCD Pharmicell as of Jul 2011. The
world’s first biosimilar antibody product, Remsima inj (Celltrion) was approved by MFDS
Variables 2007 2008 2009 2010 2011 2012 2013 and EMA as of Jul 2013.
- ‌Total of 60 products including vaccine, biosimilar, cell therapy products are now in
Production 8,243 9,490 12,919 15,064 11,950 17,313 18,654
clinical trials. Additional 32 domestic products will be launched in the future (as of 2014).
Export 2,230 3,199 4,322 3,343 2,550 3,753 4,044 * ‌Total of 839 biological products have been approved (555 domestically manufactured items,
Biological Import 3,235 3,390 3,957 5,547 6,366 5,988 7,358 284 imported items) : vaccines 35.8%, plasma derivatives 35.9%, antitoxins 2.6%, recombinant
products products 23.8%, cell therapy products 1.9%
Trade balance -1,004 -190 365 -2,204 -3,815 -2,235 -3,314
Current status of domestic biologic product pipelines (as of 2014)
Market size 9,247 9,680 12,553 17,268 15,765 19,548 21,968
Number of
Market Size of total
pharmaceuticals
150,620 169,576 179,700 189,084 189,438 188,900 193,365 Number of products expected
Development Clinical trial Clinical trial
Share of Biological products in stage (Phase I, II) (Phase III)
approved to be launched
6.1 5.7 6.9 9.1 8.3 10.3 11.4 products (Cumulative, as of
total pharmaceutical market
Note: ‌1) The amount of Export/Import was calculated by using the annual average exchange rate of KRW/USD from 2018)
the Bank of Korea; 2) Trade Balance = Export (amount) – Import (amount); 3) Market Size = Production +
Import – Export
Biosimilars 9 6 4 4 7
Sources: ‌The trade balance and market size were calculated based on figures of the Production, Export, and Import of Stem cell therapy 7 17 2 4 6
Biological products included in the Annual Statistical Report of Food and Drug, 2014.
Gene therapy 5 11 1 0 1
(Market trend) Both major enterprises and existing pharmaceutical Vaccines 10 5 5 4 18
Total 31 39 11 12 32
Sources: Minister of Food and Drug Safety (Feb 2015)

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