Japan is the world’s third-largest economy, with a mature healthcare system, generous R&D subsidies, and an aging population actively seeking innovation, making it an attractive market for US biotech companies. And yet, many struggle to gain traction.
Not because of product quality or market demand, but because they don’t fully understand how Japan operates when it comes to regulatory frameworks, partnerships, and business culture. In this article, we’ll walk through what US biotech startups need to know, especially when moving from FDA approval to navigating Japan’s PMDA.
We’ll cover the most common challenges teams face, how others have succeeded, and how tools like GlobalDeal are helping biotech companies expand globally without unnecessary friction or cost.
Why Japan Is on Many Biotech Startup’s Radar
Japan is a large and strategically important market. Consider these factors:
A life sciences sector valued in the hundreds of billions of dollars
A rapidly aging population, with nearly one-third of citizens over age 65 by 2030
High trust in science, clinical data, and government-regulated products
Strong public and private investment in biotech innovation
With these strengths in mind, it’s no surprise that biotech founders are drawn to Japan. But the reality of market entry is more demanding than most expect.
FDA vs. PMDA: The Regulatory Realities
Most US biotech companies are deeply familiar with FDA protocols. But Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) operates under its own set of expectations.
Here’s how the two compare:
Category | FDA (US) | PMDA (Japan) |
Language | English | Japanese (full localization required) |
Clinical Data | US-based trials are often sufficient | Local clinical trials typically require |
Approval Pathways | Multiple (e.g., 510(k), BLA) | Similar structure, often with longer timelines |
Local Legal Entity | Not required | Requires a Japanese Marketing Authorization Holder (MAH) |
Consultation Process | Optional | Strongly encouraged early in the process |
Even if your product has cleared the FDA, Japan may require additional in-country data, localized documentation, and regulatory approval through its own channels. Without early preparation, this can add significant delays—often measured in many months—to market entry.
Beyond Regulation: What Makes Japan So Challenging?
The regulatory system is just one part of the picture. Many US companies also struggle with how business gets done in Japan.
1. Trust Comes First
Business in Japan is built on long-term relationships. Cold outreach rarely works. Founders who rely on unsolicited emails or “spray and pray” strategies are often ignored, no matter how impressive the product is.
Warm introductions carry weight. Companies that build credibility through trusted networks or local intermediaries are far more likely to open doors.
2. Distribution Is Heavily Gatekept
Japan’s distribution ecosystem is tightly controlled. Many distributors and clinical partners will only work with referred companies, especially in sensitive sectors like biotech. Getting access often requires a trusted local node.
3. Messaging Must Be Culturally Aligned
It’s not enough to translate your pitch deck and marketing materials. Japanese buyers expect a tailored, respectful approach that demonstrates a genuine understanding of the local market. Aggressive sales tactics or overly casual language can do more harm than good.
4. Decision Timelines Are Longer
While Japanese companies may take more time to evaluate new partnerships, once a decision is made, it tends to be more stable. Patience is a competitive advantage here.
Case Study: Moderna’s Regulatory and Ecosystem Alignment in Japan
These challenges are not theoretical; they are visible even in the most well-funded biotech platforms.
Moderna’s COVID-19 vaccine was authorized for emergency use in Japan in May 2021 after review by the Pharmaceuticals and Medical Devices Agency (PMDA), alongside other global approvals.
Rather than relying solely on global data, Moderna’s Japan presence has involved strategic collaboration with Takeda Pharmaceutical Company and government agencies to ensure vaccine supply, distribution, and public health alignment — including delivery of tens of millions of doses under government frameworks.
In addition, Moderna has engaged in local licensing agreements and regulatory filings for next-generation mRNA products, reflecting ongoing adaptation to Japan’s health priorities and regulatory expectations.
Although plans for a dedicated mRNA manufacturing plant were shelved in 2025 due to evolving business conditions, Moderna’s continued regulatory submissions and IP positioning show how biotech platforms integrate into Japan not just through technology, but through institutional and commercial alignment.
What Most Business Leaders Get Wrong About Japan
Some of the most common misconceptions include:
“We just need a translator.”
In reality, translation is only the start. You need someone who understands how to position your solution for a Japanese audience—factually, culturally, and strategically.
“We’ll find a distributor, and they’ll handle the rest.”
Without clear support and onboarding, even the best distributors will deprioritize your product. They want to see commitment, preparation, and a go-to-market plan that makes sense in Japan.
“It’s the same as our previous market entries.”
It’s not. Japan has distinct regulatory systems, sales cycles, and partnership norms. Treating it like a typical expansion market often leads to missteps that are hard to recover from.
How GlobalDeal Helps: A Framework for Smart Expansion
At GlobalDeal, we’ve worked with over 100 companies entering high-barrier markets across healthcare, biotech, and regulated industries. Based on that experience, we use a three-part framework designed to make expansion more effective:
1. Partner Discovery with Context
Our AI-driven matching process doesn’t just look at industry keywords. It evaluates partner fit based on company size, product type, risk profile, and expansion readiness.
2. Localized Outreach That Gets Responses
We create your messaging to reflect Japanese business etiquette and priorities, as well as highlighting the mutual benefits of a business relationship. This helps you get noticed and taken seriously, even as a small team with no prior local presence.
3. Regulatory Roadmapping
We help you map your PMDA pathway early. That includes flagging what clinical data you’ll need, what category your product likely falls into, and what kind of partner or MAH structure makes sense.
Getting Started: Expansion That Works
The global demand for biotech innovation is high, and Japan is one of the most promising markets for the right companies. But success requires more than ambition: it takes preparation, cultural understanding, and the right local connections. If you’re thinking about entering Japan within the next 6 to 12 months, the best time to start preparing is now.
You’ll need to evaluate if Japan is the right fit for your product and growth goals, map regulatory requirements, and identify high-fit potential partners.
GlobalDeal is built to help lean teams do just that. We simplify global expansion through smart partner discovery, personalized outreach strategies, and automated compliance workflows—all designed for resource-constrained teams. You don’t necessarily need a local consultant to enter Japan. You need a reliable system.
Ready to Bridge the Gap from FDA to PMDA?
Let us help you launch, grow, and scale your biotech business in Japan.
Schedule a call with GlobalDeal to learn how we can support your expansion goals.
