Enduring Appeal of Japan's Healthcare Sector for Global Business

Kiran Mazumdar-Shaw
Executive Chairperson
Biocon

February 2025

Biocon, a pioneer in biosimilars and generics, is expanding its global presence with a strategic entry into Japan's dynamic pharmaceuticals market. By establishing a local office with a view to competing in the generic active pharmaceutical ingredient (API) sector, Biocon is set to redefine its role in one of the world's most competitive and rewarding healthcare landscapes. Kiran Mazumdar-Shaw, Executive Chairperson of Biocon, outlines the rationale behind this move and why Japan remains a compelling destination for investment and collaboration.

"Japan is a very, very interesting country for us for many reasons," Mazumdar-Shaw explains. "With the pharmaceutical market valued at 62 billion US dollars, it offers exciting opportunities for companies like ours."

What makes Japan particularly attractive is its approach to healthcare costs. "Spiraling drug costs are compelling advanced economies to look at generic medicines and biosimilars," she notes. "In Japan, the penetration of generic medicines is almost 80% by volume and a little over 50% by value." These figures are notably higher than those in many other countries. She elaborates, "In other markets, generic medicines often see steep price declines, but in Japan, the pricing remains stable because the market is well protected. From that point of view, it makes it an ideal environment for a company like ours to build in a strategic way."

Reflecting on Biocon's initial entry into Japan in 2016 with its biosimilar insulin glargine, she characterizes it as "a big milestone for us and a very proud moment because it meant we could navigate the Japanese regulatory system and lay the foundation for deeper engagement."

Japan's pharmaceutical regulatory framework, renowned for its rigor, has evolved significantly in recent years. Mazumdar-Shaw acknowledged the complexities of entering the market early on. "In 2016, those were the early days of biosimilars, so it was that much more complicated," she explains. "But the fact that we made it across the line tells you how strong our science and commitment to quality is. Now things are simpler."

Today, Japan offers a more predictable and supportive regulatory environment. "The system has matured significantly, and companies like ours can now navigate it with greater ease," she says. She also notes that the aging population in Japan drives demand for cost-effective yet high-quality medicines, a trend that aligns well with Biocon's expertise, adding, "Japan needs these low-cost medicines, especially because of its aging population."

Partnerships have been central to Biocon's strategy in Japan, enabling the company to overcome market challenges and deliver tailored solutions. "We've collaborated with companies like Otsuka, FUJIFILM Pharma, and FKB," Mazumdar-Shaw shares. "These partnerships helped us navigate the regulatory landscape and achieve critical milestones."

One notable success was the collaboration with FUJIFILM Pharma, which played a key role in the approval of Biocon's biosimilar insulin glargine. "Their understanding of the regulatory pathway was instrumental in our success," she explains.

Mazumdar-Shaw also expresses optimism about future collaborations in innovative fields. "Japan has world-class expertise in biologics, antibody-drug conjugates, and cell and gene therapies," she says. "These are exciting fields where we can collaborate to drive meaningful innovation."

Establishing a local office in Japan is more than just a logistical move—it's a declaration of Biocon's commitment to becoming a global leader. "This is now the time when we have to start going global as a front-facing company," Mazumdar-Shaw states. "We're focused on building the Biocon brand as a trusted name in Japan."

She highlights insulins and GLP-1s as key areas of focus for Biocon in Japan. "We're the third-largest producer of insulins globally^*1, and as some companies pivot to GLP-1s, we see an opportunity to lead in this space," she says. "The area of diabetes management is critical—not just for Japan but for the world—given its impact on diseases like cardiac and kidney conditions, and even Alzheimer's."

On earning trust in the Japanese market, Mazumdar-Shaw remarks, "Japan sets the gold standard for quality and reliability. If we succeed here, it speaks volumes about our ability to excel globally."

Biocon's expansion into Japan marks a significant step in its journey toward global leadership. By combining its expertise in biosimilars and generics with Japan's innovation-driven market, the company is poised to play a transformative role in the country's healthcare ecosystem.

As Mazumdar-Shaw concludes, "Japan offers a unique blend of stability, innovation, and opportunity. For companies willing to invest in understanding the market and building relationships, the rewards are immense. At Biocon, we're excited to be part of this journey and contribute to Japan's vision for affordable, high-quality healthcare."