![\"null](\"https:\/\/www.europesays.com\/korea\/wp-content\/uploads\/2026\/09\/news-g.v1.20260902.7a18e69fb10f43b99d29017e5dd3d237_P1.jpg\"\/ "\\"Korea")
<\/p>\nMajor South Korean biopharmaceutical companies are expected to join the 5 trillion won revenue club this year, yet the country relies on foreign suppliers for nearly all of the materials, parts and equipment needed for biomanufacturing. Industry officials warn that raw material procurement could become the sector’s Achilles’ heel if a supply chain crisis like the COVID-19 pandemic recurs, and say localization must be expanded because these inputs account for as much as 20% of biopharmaceutical production costs.<\/p>\n
Domestic bio companies imported more than 95% of the raw materials and components needed for production as of 2024, according to the Ministry of Trade, Industry and Energy on the 2nd. The import share is understood to be even higher for high-value core items such as culture media and filters. Sung Hye-jin, vice president of the Korea Pharmaceutical Industry Strategy Institute, said the domestic bio industry is vulnerable to global supply chain issues on the raw materials side. “Raw materials and components account for 15 to 20% of biopharmaceutical production costs, so there is a need to promote localization,” she said.<\/p>\n
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A lack of track record is cited as the main reason domestic companies find it difficult to enter the bio raw materials market. Companies seeking to enter global markets must undergo review by overseas regulators such as the U.S. Food and Drug Administration, and using raw materials without a track record requires them to additionally prove the impact of those inputs on product quality and safety.<\/p>\n
Because of such barriers, the global single-use bioprocessing market is dominated by a handful of players \u2014 Thermo Fisher Scientific and Cytiva of the United States and Merck and Sartorius of Germany \u2014 which together hold 55% of the market. An official in the bio raw materials industry said buyers must accept new risks if they change suppliers. “Contract development and manufacturing organizations have to use the materials their clients specify, and biosimilar and new drug developers also prefer products that have already been validated,” the official said.<\/p>\n
There are, however, cases of successful localization. Japan has no large raw materials company spanning everything from culture media to fill-finish processes, but it built competitiveness by acquiring foreign companies that had their own technology and references. On that basis, Japanese firms now supply key inputs, with Asahi Kasei providing virus filters and Fujifilm Irvine Scientific supplying culture media.<\/p>\n
Some domestic materials companies are also building references through partnerships with large corporations. Bion Pack, Hanil Chemical Rubber Industrial, E-Cell and Biox supply packaging materials and cleaning agents to major Korean bio companies including Samsung Biologics and Celltrion.<\/p>\n
Critics note, however, that these remain low-value items with relatively low entry barriers and limited impact on production processes. A bio industry official said a system in which the government directly certifies manufacturing and quality would partly compensate for the thin track records of domestic materials suppliers. “It would help improve competitiveness both at home and in global markets,” the official said.<\/p>\n
In response, the government plans to expand certification support to core process items such as culture media, filters and resins. A key measure is the raw material manufacturing and quality certification system, a subordinate regulation under the special act on contract development and manufacturing organizations set to take effect late this year, under which the Ministry of Food and Drug Safety would directly certify the manufacturing and quality of core raw materials. A bio industry official added that buyers face costs because they must run new internal tests to adopt domestic materials. “If benefits extend beyond simple certification to include tax incentives, that would help adoption,” the official said.<\/p>\n","protected":false},"excerpt":{"rendered":"Major South Korean biopharmaceutical companies are expected to join the 5 trillion won revenue club this year, yet…\n","protected":false},"author":2,"featured_media":140430,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[19],"tags":[71458,71461,2578,71459,71457,127,505,71460],"class_list":["post-140429","post","type-post","status-publish","format-standard","has-post-thumbnail","category-samsung-biologics","tag-biomanufacturing-localization","tag-cdmo-special-act","tag-celltrion","tag-fda-review","tag-korea-bio-raw-materials","tag-samsung","tag-samsung-biologics","tag-single-use-bioprocessing"],"_links":{"self":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts\/140429","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/comments?post=140429"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts\/140429\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/media\/140430"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/media?parent=140429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/categories?post=140429"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/tags?post=140429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}