Bringing Biotech Innovation Across Borders

Ed Ahn, CEO, MEDIPOST, Inc.

Expanding a biotechnology company across geographic borders is no easy task—especially for a midsized business bringing a first-in-kind, live-cell therapy to new markets. The challenges are significant: navigating regulatory requirements, establishing manufacturing capabilities, ensuring product viability across borders, and finding the right partners to make it all work.

Through our own global expansion efforts, MEDIPOST has learned firsthand that several factors are critical to navigating this process successfully: choosing the right markets, cultivating a strong manufacturing and logistics ecosystem, adapting to evolving regulatory standards, and leveraging agility as a competitive advantage.

Most of all, as a midsized company, success doesn’t come from outspending competitors. It comes from being intentional with every move you make.

Preparing to compete on the world stage

MEDIPOST’s global headquarters is located in Korea, where Cartistem, its allogeneic stem cell therapy for the treatment of knee osteoarthritis, has been approved since 2012.

While the company is well-recognized domestically, Korea’s biotech industry as a whole has historically faced challenges in gaining global recognition. Despite producing groundbreaking science, Korean biotech companies have often had to work harder to establish credibility and attract international investment than their US, European, and Chinese counterparts.

A lack of global recognition can be an early hurdle for many midsized biotechs. Expanding beyond an initial market requires not only proving the efficacy of a therapy but also demonstrating that a company can compete on the world stage.

Tip 1: Choose the right markets

Global expansion isn’t about going everywhere at once. It requires making deliberate choices based on factors such as regulatory feasibility, reimbursement potential, and market demand. When evaluating international expansion, companies must weigh the opportunities and challenges of each market carefully.

Europe and China can be appealing due to their large populations. However, Europe’s fragmented healthcare system and complex reimbursement structures can create hurdles for market entry. In China, IP security risks and regulatory unpredictability add layers of uncertainty that may complicate long-term growth.

Japan and the US tend to be attractive opportunities: Japan has established reimbursement structures for advanced therapies, and despite regulatory complexities, the US offers a well-defined approval pathway, strong commercial potential, and a path to long-term growth in one of the largest healthcare markets in the world.

Population demographics related to specific treatments may also influence expansion choices. But it’s critical for a midsized company to choose its markets wisely because it won’t have the resources to be everywhere at once.

Tip 2: Cultivate a strong manufacturing and logistics ecosystem

Manufacturing and logistics are among the most significant challenges regarding global biotech expansion. Each market requires a unique and personalized strategy to ensure regulatory compliance, supply chain efficiency, and patient access.

In smaller global markets, a centralized manufacturing model can work efficiently. A single facility can serve as transport hub to production and supply facilities nationwide and even across borders in some cases.

However, as commercialization approaches, scalability becomes a key concern—especially when dealing with complex treatments such as live-stem cell therapies, which have a limited window of viability and must be distributed quickly. The ability to manufacture, release, and distribute products within each market often proves to be the most efficient and sustainable path. Regulatory requirements, geographic scale, and logistical constraints must all be factored into expansion decisions, and establishing regional manufacturing hubs via strategic partnerships can be critical to maintaining efficiency.

Tip 3: Adapt to evolving regulatory standards

Global expansion requires continuous adaptation to evolving regulatory standards. What was acceptable a decade ago may no longer meet today’s heightened expectations. Standards vary from one region to another. As companies expand into new markets, they must anticipate that compliance is a moving target and be willing to make ongoing adjustments to processes, documentation, and quality control measures.

While clinical trial requirements have remained relatively stable over the past decade, the most significant regulatory shifts have occurred in how products are produced, tested, and released. Standards for quality control and consistency have become more stringent, and companies that fail to proactively refine their strategies risk falling behind regulatory expectations. Staying ahead means monitoring regulatory trends, investing in updated compliance processes, automation and building flexibility into manufacturing, and testing systems to accommodate future changes.

Tip 4: Leverage agility and intentionality as strategic advantages

When a midsized biotech expands into new markets—without the vast resources of a large pharmaceutical company—two strategic advantages emerge as critical to success: agility and intentionality.

Agility: moving quickly in an evolving field

Large pharmaceutical companies may seem to have the upper hand in global expansion, with well-established processes and deep institutional knowledge to guide them forward. However, those same elements can also be a hindrance, especially in rapidly evolving fields such as regenerative medicine.

As the science changes, all of us—researchers, regulators, and biotech leaders—learn more every day. There is no clear roadmap to follow, and success often depends on the ability to adapt, test assumptions, and pivot when necessary.

For a midsized biotech, that agility can be a strength. Being able to move quickly, refine strategies, and make real-time decisions without the burden of rigid legacy systems is a competitive advantage. It’s also critical to embrace a mindset of humility and adaptability, recognizing that even what we think we know must be constantly reassessed.

Intentionality: Making every decision count

Midsized companies must make the most of their limited resources. Success comes from being intentional about where to expand, how to structure operations, and which strategic partnerships to develop.

A lack of capital can be countered by choosing the right people with deep expertise and significant experience. Don’t overlook personal networks and relationships as an avenue to find and bring in the right talent. Similarly, thoughtfully selecting partners that are flexible and willing to work with a mid-size company can be the difference between a failed and successful relationship.

Being strategic about regulatory strategy is also crucial.

Every decision counts for more when resources are scarce, but with the right choices, you can effectively do more with less.

Ed Ahn is CEO of MEDIPOST, Inc.