Year in Review

Japan Drug Approvals Grow: Fueled by Streamlined Regulatory Processes

Overview of New Drug Approvals
According to the report (2024年 国内新薬承認取得数ランキング…最多は11承認のアストラゼネカ、新規有効成分はファイザーがトップ | AnswersNews) published by AnswersNews on Feb/25/2025, a total of 56 companies received approval for new pharmaceuticals in Japan in 2024, an increase of seven from the previous year. In total, 148 new drugs were approved, including 66 new active ingredients and 82 other approvals. AstraZeneca led in total approvals, while Pfizer had the highest number of new active ingredient approvals.

Leading Companies in Drug Approvals
AstraZeneca secured the most approvals, with 11 total approvals (three new active ingredients and eight others). Pfizer followed closely with ten approvals, including seven new active ingredients—the highest among all companies. Other top-ranking companies included Eli Lilly Japan, Takeda, and Novartis, with strong performances in both innovative and supplementary approvals.

Growth in New Active Ingredient Approvals
The number of approved new active ingredients reached 66, with Pfizer leading at seven approvals. Takeda followed with six, while Eli Lilly Japan and Janssen each secured four. The continued growth in new active ingredient approvals highlights Japan’s increasing contribution to global pharmaceutical innovation.

Expansion of Oncology Drug Approvals
Cancer treatments represented a significant portion of new approvals, with approximately 30% of all new active ingredient approvals falling into the oncology category. This trend reflects the ongoing investment in cancer research and the accelerated approval processes for innovative oncology treatments.

Regulatory Trends and Implications
The 2024 approval trends suggest that Japan continues to streamline drug review processes, leading to an increase in both innovative and supplementary drug approvals. The growing acceptance of global pharmaceutical companies in the Japanese market highlights the potential for future regulatory harmonization and faster access to new treatments.

Conclusion
Japan’s pharmaceutical landscape saw significant growth in new drug approvals in 2024, with key global players leading the charge. The increase in approvals, particularly in oncology and innovative treatments, signals a dynamic and evolving regulatory environment. As Japan continues to refine its approval processes, pharmaceutical companies can expect more efficient pathways for bringing new treatments to market.