Why Japan Matters: PLG’s Strategic Expansion in the World’s Third-Largest Pharma Market

On September 4^th, 2025, ProductLife Group announced the opening of its newest office in Tokyo, Japan, a major step forward in its journey of global expansion.

This step reinforces PLG’s commitment to serving clients in the world’s most critical life sciences markets, offering solutions that combine global expertise with local insights.

“Expanding into new global markets is not just a growth strategy—it’s a commitment to accelerating the development of life-changing drugs and devices,” said PLG. “By broadening our reach, we’re able to bring innovative solutions to more patients, faster, and deliver on our promise to improve health outcomes worldwide.”

Japan is not only the third-largest pharmaceutical market in the world, valued at around USD 82–86 billion in 2024, but also a global innovation hub. While overall market growth is projected to remain moderate (CAGR ~2.5% to 2033), segments such as biologics, patented therapies, and biotechnology are expanding rapidly.

The biotechnology market alone — including gene therapies, regenerative medicine, and advanced diagnostics — is expected to grow from USD 23.9 billion in 2024 to nearly USD 39 billion by 2035.

Several factors make Japan a cornerstone for PLG’s strategy:

• Market opportunity: Patented and innovative drugs are forecast to reach ¥11 trillion (~USD 70 billion) by 2027, representing a high-value growth segment.
• Demographic demand: With 29% of the population aged over 65 and 16% over 75, Japan faces unprecedented healthcare needs. In 2022, total medical expenditure reached ~USD 306.5 billion, with more than 40% spent on patients over 75.
• Innovation hub: Japan has a strong R&D infrastructure, world-class universities, and government incentives for biotech and digital health. This makes the country a leader in regenerative medicine, cell and gene therapies, and diagnostics.
• Regulatory support: Recent reforms by the Pharmaceuticals and Medical Devices Agency (PMDA) have streamlined approval timelines and expanded the use of real-world data in clinical and regulatory decision-making. Combined with the universal National Health Insurance (NHI) system, these measures create both opportunities and accelerated access for innovative therapies.

Together, these conditions create fertile ground for PLG to deliver its expertise and support life sciences companies in bringing new solutions to patients.

Tanya van der Wall, Managing Director, JAPAC, will play a pivotal role in shaping PLG’s success in Japan. Reflecting on this milestone, she said: “It is fantastic to now be able to support our global clients across our service areas for such an important global market as Japan. Whether companies already have a presence in Japan, or are looking to enter, local expertise is critical to navigating this complex environment. We are asked all the time if we have local experts on the ground in Japan — and we are now very pleased to be able to say yes!” Tanya emphasized that PLG Japan will initially focus on safety & vigilance entrustment services and regulatory affairs, while progressively expanding to cover the full range of PLG’s services, including digital transformation projects. She noted: “Our immediate priority is to build a strong, locally rooted team that embodies PLG’s values while meeting the demand of our clients in Japan. These services are only the beginning — our goal is to establish PLG Japan as a trusted partner providing comprehensive support across the product lifecycle.”

She also reflected on the unique challenges of the Japanese life sciences market, pointing to its dual-agency regulatory system (PMDA and MHLW), strict language requirements, and unique approval pathways that often require local clinical data. Frequent regulatory changes, a centralized pricing system with biennial revisions, and a strong post-market safety framework add further complexity. Tanya explained: “Success in this market requires a Japan-specific strategy, strong local partnerships, and continuous adaptation to evolving regulatory and reimbursement settings. Having local, experienced professionals who know how to navigate these processes is critical — and this is exactly the value PLG Japan brings to our clients.”

Collaboration, she stressed, is another cornerstone: “Our Tokyo office is already working closely with colleagues from Commercial Eyes in Australia and PLG teams worldwide on multi-market safety & vigilance programs. This spirit of collaboration will be key to helping clients from the US, Europe, and beyond successfully enter and grow in Japan.

Looking ahead, Tanya summarized the significance of this opening in one word: “Milestone.” She added: “This year we have navigated the legal, regulatory, quality, and business environment to establish the company and meet strict requirements. Collaborating with local partners to help overcome language and cultural barriers has been challenging but also rewarding and working with our Japanese colleagues is a real pleasure. There is still plenty to do, learn, build, and achieve — but we are excited for the future.”

With its expansion into Japan, ProductLife Group strengthens its role as a global strategic partner for life sciences companies, supporting them throughout the product lifecycle, from regulatory approvals and market access, to safety & vigilance and  compliance

Japan’s sophisticated healthcare environment offers immense opportunities locally while also serving as a gateway for innovation and global validation.

By combining local expertise with its worldwide network, PLG is well-positioned to help clients navigate complexity, seize opportunities, and deliver life-changing solutions to patients.