The U.S. Market: A Cornerstone of Global Expansion

For pharmaceutical and biotech companies, global expansion is not just an opportunity—it’s a necessity for long-term survival and growth. As they scale their operations and develop new products, companies must look beyond their domestic markets to establish a truly global footprint. For many, the U.S. is not only the largest and most lucrative market but also a critical launchpad for international success. The country provides the infrastructure, resources, and ecosystem that companies need to grow and evolve from regional players to global industry leaders.

The U.S. market offers unique strategic advantages: a large patient population, cutting-edge research institutions, and a regulatory framework that sets the gold standard worldwide. Establishing a foothold in the U.S. gives foreign pharmaceutical and biotech firms access to these critical resources, often marking a significant turning point in their development. Several prominent examples illustrate just how vital the U.S. market is in facilitating this growth:

• Takeda, Japan’s largest pharmaceutical company, began its transformation into a global powerhouse in 1985 when it secured FDA approval for Lupron, a groundbreaking treatment for prostate cancer. This marked Takeda’s first major breakthrough in the tightly regulated U.S. market. The success of Lupron not only allowed the company to build a solid foundation in North America but also enhanced its global reputation, leading to further innovations and partnerships. Over time, this initial success helped propel Takeda to become one of the top pharmaceutical companies in the world.
• Sanofi, the French pharmaceutical giant, solidified its global presence through the U.S. market by acquiring Genzyme, a Massachusetts-based biotechnology firm specializing in rare diseases, in 2011. The acquisition gave Sanofi access to the U.S. biotech ecosystem, as well as a significant foothold in the U.S. orphan drug market. This acquisition marked a pivotal step in Sanofi’s evolution from a traditional pharmaceutical company into a global leader in biotechnology. Genzyme’s expertise in rare diseases and Sanofi’s global reach created a powerful synergy that would shape Sanofi’s future.
  
• Roche, the Swiss multinational, expanded its global influence by heavily investing in U.S. operations. In 2009, Roche completed its acquisition of Genentech, a pioneering biotech company based in California. Genentech’s cutting-edge research in oncology and molecular biology allowed Roche to enhance its portfolio of biologics, particularly in cancer treatment. The acquisition gave Roche a commanding position in the U.S. market and was instrumental in the company’s transformation into one of the world’s leading biotechnology companies. This move helped Roche shift from being seen primarily as a pharmaceutical firm to one at the forefront of biotech innovation.

 

While each company’s strategy differed, the U.S. market was central to their global ambitions. As the world’s largest and most lucrative healthcare market, the U.S. accounts for nearly 50% of global pharmaceutical sales. In 2022 alone, the U.S. pharmaceutical market generated over $560 billion in revenue, underscoring its importance as a target for global expansion. But beyond sheer size, the U.S. regulatory environment plays a unique role. The U.S. Food and Drug Administration (FDA) is widely regarded as the gold standard for drug and medical device regulatory procedure. Securing FDA approval not only provides access to the vast U.S. market but also opens doors to international markets that recognize and often adopt FDA standards.

Additionally, the U.S. is a global leader in research and development (R&D), with biotech and pharmaceutical companies collectively spending more than $120 billion annually on R&D initiatives. This intense focus on innovation creates a dynamic ecosystem for clinical trials, product development, and commercialization, making the U.S. an indispensable part of any company’s global strategy.

 

Choosing the Right U.S. Hub for Market Entry

For any company, entering a foreign market involves significant investment and risk. Establishing operations in the U.S. can be particularly challenging due to its regulatory complexity and competitive landscape. However, one of the most critical—and often overlooked—factors in this process is the choice of location. The U.S. is a large and diverse country, and not all regions offer the same opportunities or support for foreign bio and pharma companies.

When deciding on a location for U.S. operations, companies must consider a variety of factors, including access to talent, proximity to research institutions, and the availability of investment capital. Companies also need to think long-term, selecting locations that will continue to offer growth opportunities as the industry evolves.

A key aspect of modern business strategy is the concept of the “industrial ecosystem.” Unlike in the past, when companies would simply expand by relocating to larger facilities in suburban areas, today’s enterprises are increasingly opting to base themselves within well-established ecosystems that foster industrial growth. These ecosystems, found in major cities and regional hubs, offer the infrastructure needed to support sustainable business development and helping companies stay at the forefront of industry trends.

One of the most well-known and successful industrial ecosystems in the life sciences sector is Boston, which has become the world’s largest biocluster. Boston has attracted more than 1,000 pharmaceutical and biotech companies, along with hospitals and research institutions, creating an economic impact exceeding $2 trillion. The Cambridge Innovation Center (CIC) serves as the hub of this ecosystem, and the region’s robust academic and research institutions, such as Harvard and MIT, provide a steady stream of talent and innovation. The presence of major players in the industry, combined with a favorable research environment, has made Boston a magnet for companies looking to establish a U.S. presence. Even the Korean government has recognized Boston’s strategic importance, with the Korea Health Industry Development Institute (KHIDI) establishing an office in the city to support Korean biopharma companies entering the U.S. market.

Another key region for foreign companies is the New York-New Jersey corridor. For Korean biotech and pharma companies, this area is even more favorable. Many of Korea’s leading conglomerates, such as Samsung, LG, and SK, have set up their U.S. headquarters in this area. The Korean Chamber of Commerce and Industry in the U.S. (KOCHAM), based in Manhattan, connects over 100 Korean companies, fostering cooperation and advocating for their interests with the U.S. government. Many Korean pharmaceutical and biotech companies have also chosen to establish operations in this region, attracted by the large Korean communities, the availability of scientific talent, and partnerships with local research institutions. SK Life Sciences and Celltrion, both of which have their U.S. headquarters in New Jersey, are already making significant progress in the U.S. market, with many other Korean companies following their lead.

Securing the Right Partners for Success

While choosing the right location is crucial, it is only one part of the equation. Successfully entering and expanding in the U.S. market requires companies to form deep, trust-based relationships with experienced U.S. partners. These partners can provide invaluable guidance on navigating the complex U.S. regulatory environment, building strong networks, and tapping into local industrial ecosystems.

In today’s rapidly changing global healthcare landscape, organizations that can anticipate and adapt to these shifts are better positioned for long-term success. Companies need partners who can help them navigate these complexities, providing the strategic insights and connections necessary to thrive in a highly competitive market.

Securing the right partnerships, selecting the ideal location, and forming meaningful connections in the U.S. are not just operational considerations—they are essential components of any company’s strategy for global growth. With the right approach, companies can unlock sustainable growth, establish themselves as leaders in the global biotech and pharmaceutical sectors, and make a lasting impact on human health.