[Edaily Reporter Hong Ju-yeon ] Approximately $520 billion (about 800 trillion won) as of 2025. A forum was held for K-Bio companies to explore strategies for tapping into the U.S. biotech market, the world’s largest for any single country. On the 15th, PharmEdaily hosted the “Seminar on Strengthening the Competitiveness of K-Bio and Healthcare Exports to the U.S.” at Harmony Hall in KG Tower, the Edaily headquarters in Seodaemun-gu, Seoul. A total of 120 representatives from 80 companies in the industry attended to share strategies for exporting to the U.S.

Hosted by Pharm eDaily—eDaily’s premium bio content service—and co-sponsored by the Korea Medical Device Industry Association (KMDIA) and Wise birds Inc.(273060), this seminar was specially organized to assist domestic pharmaceutical, biotech, and medical device companies that have entered or are preparing to enter the U.S. market.

"Regulatory Compliance Must Be Combined with Precision Targeting… Verifying Top-Tier Partners Is Essential"

In his presentation titled “A Guide to Selecting Marketing Partners When Entering the U.S. Market,” Choi Ho-jun, CEO of Wise birds Inc., emphasized, “The biggest obstacles domestic biotech ventures face when entering the U.S. market are astronomical offline marketing costs and complex local regulatory barriers,” adding, “By strategically utilizing social media, even small and medium-sized biotech ventures can boost sales with a minimal budget.”

CEO Choi cited the following as common mistakes made by Korean companies: △failed localization due to relying solely on literal translations; △exposure to regulatory risks related to the U.S. Food and Drug Administration (FDA) and the Health Insurance Portability and Accountability Act (HIPAA); △ad spending without media optimization; and △delays in responding to time zone differences. In particular, he warned that since the FDA applies its “fair balance” principle—which requires equal disclosure of a product’s efficacy and potential risks—to social media posts as well, failure to ensure compliance in advance could result in the campaign being suspended.

As a solution, he proposed verifying the “digital media partnership level” of marketing partners. CEO Choi advised, “To prevent cost leakage, you must select a partner capable of activating direct communication channels with the platform’s headquarters to resolve issues within a day when ad rejections occur.” He also recommended adopting AI risk management tools to pre-screen compliance risks.

"Social Media Is the Core of U.S. DTC Marketing… Must Drive Action, Not Just Exposure"

Kim Ye-eun, Vertical Head at TikTok Korea, emphasized in her presentation titled “Success Stories of U.S. Local Marketing by Global Pharmaceutical and Biotech Companies via TikTok” that “in the U.S. pharmaceutical and biotech market, the core of direct-to-consumer (DTC) marketing is no longer TV or traditional media, but social media,” adding, “What matters is not just exposure, but driving consumer action.”

Kim noted that the era of separating branding and performance marketing is over, and proposed a “full-funnel” strategy that naturally connects consumers from the moment they discover a product through to the purchase.

Kim also recommended utilizing TikTok Shop. “With the recent introduction of the L2L (Local to Local) model for Korean sellers, the door has opened for them to join the platform using a Korean passport and a domestic contact number,” he said.

“Established in the U.S. in Just One Year… The Secret Is Thorough Localization”

Kim Rae-hee ( CLASSYS Inc.(214150), Head of the Marketing Division, shared CLASSYS Inc.’s experience entering

the U.S. market

. “The key to entering the U.S. market is

thorough

preparation and strategic execution tailored to the local market,” said Kim. “CLASSYS Inc. achieved all key milestones in its first year of launch, from obtaining FDA approval to securing a premium market position.”

CLASSYS Inc., a global medical aesthetics company, operates in over 80 countries worldwide and has established a global installed base of more than 45,000 units. The company spent over two years preparing for its full-scale entry into the U.S. market in 2024, investing more than a year in market research alone to formulate its Go-to-Market (GTM) strategy.

“Just because a brand is successful in Korea doesn’t mean it will be successful overseas,” said Director Kim, emphasizing localized branding—which involves reimagining the brand in the language of U.S. consumers rather than simply translating Korean messages—and pricing strategies tailored to the local competitive environment. He added, “In the U.S., marketing takes precedence over sales, and the key is to build initial market trust by combining KOLs, influencers, localized targeting, and education.” CLASSYS Inc. selected local distributors based on seven key criteria, including sales organization, marketing capabilities, KOL networks, and financial stability, and plans to expand its entry into global markets, including China, by the end of this year based on this experience.

“An Integrated Operational System Linking Approval to Post-Market Surveillance Is Key”

Ji Seung-kwon, CEO of Next Customs Corporation, who served as a speaker, emphasized, “The U.S. market is a market of opportunity, but for unprepared companies, it is a market with the highest barriers,” adding, “The key to entering the U.S. market lies in establishing an integrated operational system that links approval, customs, logistics, customs clearance, and post-market surveillance.”

CEO Ji pointed out that, as a starting point for preparing to enter the U.S. market, products must be reviewed simultaneously from the perspectives of both FDA classification and customs classification, as FDA classifications and HS codes differ. For example, in vitro diagnostic medical devices are classified as medical devices under FDA regulations but may be classified as diagnostic reagents (HS Code 3822) for customs purposes.

CEO Ji also cited the utilization of the Korea-U.S. Free Trade Agreement (FTA) as a key variable. While pharmaceuticals and medical devices are often subject to a zero basic tariff rate in the U.S., he explained that companies must secure supporting documentation for origin verification and maintain consistency between customs clearance documents and origin labeling in case they are excluded from the agreement’s scope. CEO Ji also highlighted as points of caution the fact that the customs clearance process involves a combined review by U.S. Customs and Border Protection (CBP) and the FDA, and that even if the base tariff rate is zero, fees such as the Merchandise Processing Fee (MPF) may still apply. He advised, “It is effective to bundle and utilize government support programs, such as FDA strategies, quality documentation, customs strategies, and buyer identification.”