As one of the world’s leading economies, Japan offers life science organizations the unique opportunity to expand their market potential within a supportive regulatory environment. According to the recent news released by MixOnline, Japan’s domestic pharmaceutical market reached an unprecedented high of 11.3707 trillion yen for the fiscal year 2023 (April 2023 – March 2024), marking a 3.7% increase from the previous year. Significant expansions in the oncology, diabetes, chronic kidney disease, influenza, and COVID-19 antiviral treatment markets drove this growth.

Top Performing Products

Keytruda (Pembrolizumab) reclaimed the top sales position, surpassing Opdivo (Nivolumab), which experienced a 4.2% revenue decline in Q1 2024 due to a 15% price cut in April.

Oncology Market Dominance

The oncology market grew by 9.8% to nearly 2 trillion yen, representing 17% of the domestic market. Keytruda led with a 22.5% increase to 164.8 billion yen. Opdivo grew by 3.5% to 164.5 billion yen but fell to second place due to market recalculation impacts. Imfinzi (Durvalumab) posted a 116% growth, reaching 120.7 billion yen, following new cancer indications.

Significant Growth in the Following Therapeutic Areas

  • Diabetes Treatments: Up 7.1% to 723.7 billion yen, with a solid performance from Forxiga (Dapagliflozin) and Jardiance (Empagliflozin).
  • Immunosuppressants increased 8.6% to 621.4 billion yen, led by Dupixent (Dupilumab).
  • Antivirals: Grew by 48.6% to 530.6 billion yen, driven by Lagevrio (Molnupiravir) and other antivirals.

Corporate Performance

Chugai Pharmaceutical and AstraZeneca topped the sales charts, each exceeding 500 billion yen. Chugai led for the third consecutive year with 539.8 billion yen in sales, while AstraZeneca’s sales surged by 12.6% to 513.1 billion yen. MSD climbed to third place with a 30.2% increase to 497.2 billion yen, thanks to Keytruda and Lagevrio.

Growth Factors

At $95 billion in value, Japan is the third-largest pharmaceutical market in the world, behind only the United States and China. What factors contribute to Japan’s growing market?

Growing Market Demand: An aging society and growing life expectancy, combined with Japan’s population size, drive demand for medical product development.

Regulatory Optimization: Accelerated approval pathways, including the Sakigake Designation Scheme, have helped expedite the regulatory process.

Support for Innovation: The Japanese government actively fosters an environment of innovation by reducing past barriers and creating incentives for life science innovators.

Global Harmonization: Japan’s harmonization with international regulatory standards has simplified the global development process for life science companies.

Enhanced IP Protections: New intellectual property protections benefit life science innovators by safeguarding investments in innovation.

Entering Japan’s Life Sciences Market

To ensure success in today’s global life sciences industry, companies must recognize and be prepared for a dynamic regulatory landscape. Guided by decades of regulatory and clinical experience, ELIQUENT Japan partners with innovators to develop a synchronized, global go-to-market approach that unlocks the full potential of the Japanese market.

ELIQUENT’s premier team of globally-minded, bilingual experts have the specialized skills to assist innovators across therapeutic areas, modalities, and markets. Clients turn to ELIQUENT for our deep command of Japan’s regulatory requirements, and our unrivaled ability to partner and communicate with Japan’s local constituencies. This unique blend of strategic guidance and technical skill aligns with your goals to unlock regulatory success. 

Learn more about ELIQUENT Japan’s capabilities.