[E-Daily Reporter YU JIN-HEE ] “The biggest obstacles domestic pharmaceutical, biotech, and medical device (hereinafter “bio”) startups face when entering the U.S. market are astronomical offline marketing costs and complex local regulatory barriers. However, by clearly understanding media policies and strategically utilizing social media, even small and medium-sized bio startups can find an innovative breakthrough to maximize brand trust and boost sales with a minimal budget.”

Choi Ho-jun, CEO of Wise birds Inc.(273060), emphasized this point on the 15th at the “Seminar on Strengthening the Competitiveness of K-Bio and Healthcare Exports to the U.S.,” held at Harmony Hall in KG Tower, the E-Daily headquarters in Seodaemun-gu, Seoul.

Organized by “Pharm eDaily,” eDaily’s premium bio content service, and co-sponsored by the Korea Medical Device Industry Association (KMDIA) and Wise birds Inc., this seminar was specially planned to assist domestic biotech companies seeking to enter the U.S. market.

Opportunities in the 285 trillion won U.S. Market... A Major Shift Toward the “Digital Purchase Journey” Era

CEO Choi took the stage as a speaker for the first session, “A Guide to Selecting Marketing Partners When Entering the U.S. Market.” He shed light on the U.S. market’s current standing within the global biotech industry from a macro perspective. According to global market research firm Precedence Research and others, the U.S. medical device market is projected to reach approximately $191 billion (about 285 trillion won) by 2025, making it the most fiercely competitive market among individual countries, accounting for 40% of the global market. The compound annual growth rate (CAGR) from this year through 2035 is forecast to reach 6.9%.

CEO Choi explained, “The traditional, offline-centric sales structure—which used to involve visiting hospitals or buyers—has rapidly shifted to a digital-centric customer journey that encompasses search engines, webinars, and social media channels,” adding, “We must clearly understand the trend where both healthcare professionals (HCPs) and general consumers (patients) pre-explore and consume medical information on digital platforms.”

He expressed concern over the phenomenon of companies entering the U.S. market without a clear analysis of its structure, resulting in the waste of substantial budgets.

He pointed out four major mistakes commonly made by Korean companies: △failure to localize content beyond simple literal translation; △exposure to regulatory risks due to ignorance of U.S. Food and Drug Administration (FDA) and Health Insurance Portability and Accountability Act (HIPAA) regulations; △indiscriminate advertising spending without media optimization; and △loss of local responsiveness due to delays in addressing time zone differences. In particular, CEO Choi emphasized the need to clearly recognize the fundamental differences between marketing for general consumer goods (e-commerce) and marketing for the biotech sector.

“While general consumer goods target a single consumer group with emotionally driven copy to drive short-term conversions, medical device and pharmaceutical platforms must be grounded in clinical evidence and academic credibility,” he said. “It requires the wisdom to operate a sophisticated dual-track approach, distinguishing between business-to-business (B2B) transactions with experts and business-to-consumer (B2C) transactions with patients.”

He also highlighted the increasingly stringent oversight by U.S. regulatory authorities as a key issue. The FDA strictly regulates even prescription drug advertisements under its own “labeling” regulations. It applies the “Fair Balance” principle—which requires that a product’s efficacy and potential risks be disclosed with equal weight—to social media posts as well. In fact, in 2025 alone, more than 200 warning letters were issued for violations of advertising guidelines. The U.S. Federal Trade Commission (FTC) is also building a tight network to crack down on false and exaggerated advertising. The Health Insurance Portability and Accountability Act (HIPAA)—which restricts the collection of personal health information using data pixels and lead forms—will be further strengthened after 2025. Failure to ensure compliance in advance could lead to a catastrophe where the campaign itself is halted at its source.

“Actively Utilize ‘Top-Tier Partners’ Who Understand Media Policies and AI Assets”

CEO Choi proposed thorough verification of “digital media partnership levels” as the key solution to breaking through these invisible barriers in U.S. marketing. Major global platforms such as TikTok, Meta, Google, and Linked Inc. operate very strict pre-approval (allowlisting) procedures for the biotech category or impose strict restrictions on user targeting based on sensitive information.

CEO Choi advised, “When an ad is rejected, you must select a partner that can immediately activate a direct communication channel (hotline) with the platform’s headquarters—without going through a third-party distributor—to quickly correct and resolve the issue within a day. This is the only way to prevent cost leakage and maintain optimal media share.”

He also strongly recommended adopting artificial intelligence (AI) solutions, which have recently emerged as a major trend in the marketing industry. By implementing AI risk management tools that pre-screen compliance risks, companies can secure safe ad copy and creative assets that reflect the latest regulatory changes in real time at an early stage. At the same time, the “context-defined AI search optimization” technique—which involves sophisticatedly analyzing thousands of contexts and situations presented by users within large language model (LLM) environments like ChatGPT to ensure the company’s products are recommended as the optimal solution—has emerged as a crucial future key to entering the U.S. market.

To address these challenges faced by domestic biotech companies, Wise birds Inc. has secured top-tier official partnerships with 11 key global platforms, including Meta, Google, and TikTok. In particular, the company recently established a dedicated task force specializing in direct-to-consumer (DTC) biotech advertising targeting U.S. consumers, successfully establishing stable processes for regulatory compliance reviews and managing the time difference with North America. As of 2025, the total advertising revenue handled by Wise birds Inc. and its subsidiaries reached 579.2 billion won, securing the top position among purely independent digital marketing companies—excluding in-house full-service agencies affiliated with large conglomerates.

Concluding his presentation, CEO Choi remarked, “While the U.S. market is vast, it is a unique market where precise digital audience segmentation aligns statistically with reality.” He added, “If you hope to achieve meaningful marketing results and secure sales data, I strongly recommend allocating a marketing budget of at least 100 million won to proactively verify statistical significance.”