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2024年 6月 の投稿一覧

  • 2024.06.26

Record-Breaking Growth in Japan’s Pharmaceutical Market for FY2023

Introduction to Market Growth

According to the news (23年度国内医療用薬市場　最高額の11兆3707億円に　製品売上１位はキイトルーダ　オプジーボに買控えか | ニュース | ミクスOnline (mixonline.jp)) released by MixOnline on 22/05/2024, IQVIA announced that 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.

 

Conclusion

Japan’s pharmaceutical market demonstrated robust growth in FY2023, driven by advancements in oncology and other therapeutic areas. New drug developments and broader indications for existing treatments are anticipated to continue expanding the market.

  • 2024.06.04

Increased Frequency of Drug Price Listing Reviews in Japan

Introduction to Regulatory Changes

According to the news (【中医協】薬価収載「年7回」に　　従来は年4回、25年1月から開始 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO as of 15/May/2024, the Japanese Ministry of Health, Labour and Welfare announced at the Central Social Insurance Medical Council (Chuikyo) general assembly a significant change in the pharmaceutical regulatory landscape. In response to altering the approval timings for manufacturing and marketing of drugs, the ministry has decided to increase the frequency of Chuikyo’s drug price listing reviews from four to seven times a year, starting January 2025.

 

Historical Review and Approval Process

Historically, the Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) two divisions have convened bi-monthly over four sessions per year – January & February, April & May, July & August, and October & November –, with March, June, September, and December serving as the “approval months.” Typically, products reviewed in, for instance, the January & February sessions, would be collectively approved in March. Subsequently, according to the “60-day & 90-day rules,” these products would undergo price listing discussions by Chuikyo, aligning with the quarterly approval schedule.

 

New Operational Procedures from 2025

With the new operational changes set for January 2025, reviews will follow each bi-monthly session in January, February, April, May, July, or August within three weeks respectively, with an additional combined session for approvals in October and November. Thus, the Health Insurance Bureau anticipates seven drug price listings per year. The Bureau aims to expedite regulatory approval and drug price listing processes to enable quicker patient access to new drugs.

 

Committee Perspectives on Faster Drug Access

Committee member Matsumoto Masato from the Federation of Health Insurance Societies emphasized the benefits of faster access to new drugs for patients and argued for increased frequency in special price recalculations. He highlighted the importance of timing over frequency in listing new drugs to quickly mitigate the financial impact on patients and health insurance. The Health Insurance Bureau acknowledged these points as subjects for future consideration.