Optimizing your biotech launch in Japan and beyond

Japan is the third largest pharma market globally, and the second largest when considering protected drugs only [1]. Yet for biotechs lacking local expertise and infrastructure, it can be perceived as a complex and intimidating market to launch products in.

But despite the apparent barriers to entry, Japan is a stable, attractive market with plenty of growth opportunities for innovative drugs and healthcare solutions, and continues to be a top priority launch market for any new drug. By choosing the right multi-specialized partner with the broad experience required, biotechs entering the Japanese market can craft a strategic plan that addresses all complexities.

Here, Martin Miguel, Regional President of Japan and the rest of the world (RoW) at Inizio Engage, shares his thoughts on how biotechs can optimize their launch into Japan and ensure their therapies reach more patients.

The challenges of launching in Japan

Japan is in many ways a very different market to the U.S. and is arguably closer to European markets when it comes to healthcare systems and drug launches.

The healthcare system is universal, meaning National Health Insurance (NHI) covers the entire population, with a small co-pay to be borne by patients, simplifying and expanding access to healthcare. This makes market access much simpler and boils it down to meeting the regulatory requirements set by the Pharmaceuticals and Medical Devices Agency (PMDA) [2] when filing for approval, as well as navigating the drug pricing process.

Drug prices are not set freely by pharma companies. They are decided by the Central Social Insurance Medical Council (Chuikyo), an advisory council to the Ministry of Health, Labour, and Welfare (MHLW) [3], and thereafter follow what is de facto an annual price revision system.

In the Japanese market, drug prices are typically revised down according to a set of policies aimed at reducing pressure on the healthcare system affected by growing costs and a declining and aging population. This exposure to price cuts may be perceived by biotechs as a significant risk when assessing the attractiveness and potential of the Japanese market.

However, the extent of these cuts is limited to drugs that exceed a certain sales threshold. In addition, innovative drugs (the kind that you might expect from new biotech market entrants) may also be eligible for a Price Maintenance Premium (PMP), which protects them from annual price revisions. Japan also holds policies aimed at incentivizing innovation and market entry, such as the Sakigake designation, by which the designated drug can go through accelerated regulatory review and enjoy a longer period of exclusivity once launched, and the Conditional Approval System by which the drug may be exempt of Phase III trials when filing for NDA.

Ultimately, it is crucial for biotech companies to recognize the undeniable advantages and incentives of launching in this expansive market, despite the apparent obstacles that may accompany market entry.

However, launch complexity is not limited to regulatory requirements and pricing. Once a drug nears approval and is ready to be launched, building the right commercial infrastructure is critical yet also challenging, certainly posing greater difficulty than it does in the U.S. The Japanese pharmaceutical industry continues to be fiercely competitive for talent, grappling with a shortage of available professionals within a labor market governed by employment laws that are notably less flexible than in the U.S. Attracting the right individuals while keeping the flexibility needed to adjust to launch needs and minimizing risk in light of market eventualities is a challenge encountered by every new market entrant.

These challenges, combined with cultural nuances and language barriers, make it even more essential for biotechs to work with an experienced partner with the right capabilities and network who can offer specialized support outside of the U.S.

How can a multi-specialized partner help?

With a great number of factors to consider before launch, biotechs must seek expert guidance on the best strategies for launching their products in the Japanese market.

Working with a multi-specialized partner, such as Inizio, from the early stages of launch activities will provide valuable expertise in building the necessary commercial infrastructure companies need for launch. Additionally, these partners can help provide comprehensive assistance across areas such as medical affairs and medical information, as well as patient education and support.

When it comes to attracting the right talent and engaging the right stakeholders, a strategic partner can be invaluable. Through targeted brand development and customized commercial strategies, the partner can empower biotech companies to build a robust local presence that delivers tangible results.

Deciding whether to launch products independently or enter into co-promotions or licensing agreements with established pharmaceutical companies in Japan is a key aspect of launching in this market. Experienced partners can offer consultancy services that enable biotechs to make informed choices.

Additionally, aspects such as market forecasting and gaining access to the right physicians play a pivotal role in streamlining the launch process in Japan. Collaborating with partners who actively invest in areas such as global data, analytics and digital engagement resources ensures a comprehensive approach that positions biotechs for commercial launch success.

Looking ahead

Over the next few years, we can expect advancements in technologies such as artificial intelligence and machine learning to increasingly shape the industry. These technologies, further boosted by expert talent, will help throughout the entire spectrum of functions and tasks required to successfully launch a new drug, such as gathering and analyzing information on patients and HCPs, transforming it into actionable insights and supporting decision-making, enabling companies to maximize outcomes and better deliver life-saving treatments to patients.

Ultimately, the core needs of pharmaceutical companies in the Japanese market, much like any other global market, are likely to remain consistent, with a primary focus on addressing patient needs and engaging with all relevant stakeholders to make sure the treatments reach those patients and deliver the expected outcomes.

As biotechs navigate this dynamic landscape, it is crucial to establish strategic partnerships early on. These partnerships will provide access to specialized capabilities, such as robust data analytics, advanced medical information solutions and comprehensive patient support services — delivered by expert professionals and enhanced by continuously improving technological advances.

By leveraging these specialized resources, biotechs can gain a significant competitive advantage and better navigate the complexities of the market.

Discover how Inizio can help you streamline your launch into new territories by speaking with one of our experts today: https://inizio.health/contact/