Introduction to Japan’s 2025 Honebuto Policy According to a news article (製薬協 費用対効果評価「現行の枠組みにとらわれない新たな制度のあり方含め検討を」 骨太方針2025受け | ニュース | ミクスOnline) published by MIX Online on June 13, 2025, the Japanese government approved the “Basic Policy on Economic and Fiscal Management and Reform 2025” (Honebuto Policy), which outlines key healthcare priorities, including the reinforcement of cost-effectiveness evaluation (CEE) and potential […]
Introduction to the 2024 Pharmaceutical Market According to the article (24年度国内医療用薬市場 ２年連続で11兆円台、会計年度でも最高額更新 キイトルーダ1900億円超え | ニュース | ミクスOnline) published by MixOnline, Japan’s pharmaceutical market for FY2024 (April 2024 – March 2025) reached 11.4874 trillion yen (based on NHI price), representing a 1.0% increase from the previous year. This marks the second consecutive year the market has remained above 11 […]
Introduction to Legislative ProgressAccording to news (薬機法等改正法案 参院厚労委で賛成多数で可決 15項目の附帯決議採択 14日にも成立へ | ニュース | ミクスOnline) released by MIX Online on May 14, 2025, Japan’s House of Councillors Health, Welfare and Labour Committee passed significant amendments to the Pharmaceutical and Medical Device Act (PMD Act). The bill, supported by ruling and opposition parties, is expected to be formally enacted by […]
Overview of the AcquisitionAccording to news (塩野義製薬 JT傘下の鳥居薬品の買収を決議 買収総額は約1600億円規模 JTは医薬事業から完全撤退へ | ニュース | ミクスOnline) released by MIX Online on May 7, 2025, Shionogi & Co., Ltd., a leading Japanese pharmaceutical company, announced it will acquire 100% of Torii Pharmaceutical Co., Ltd. from Japan Tobacco (JT) through a tender offer. The deal also includes acquiring Akros Pharma Inc., JT’s […]
Introduction to the Drug Loss IssueAccording to news (厚労省 ドラッグ・ロス86品目で「医療上必要性特に高い」医薬品14品目 類薬あり至急の開発不要品目も | ニュース | ミクスOnline) released by MIX Online on April 1, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) has completed an evaluation of 86 overseas-approved drugs that remain unapproved in Japan—a problem often referred to as “drug loss.” The review identified 14 drugs as […]
Introduction to Regulatory UpdateAccording to the news (PMDA 成人対象の治験相談でも「小児用医薬品の開発計画の有無を資料に記載」日薬連等に留意事項通知 | ニュース | ミクスOnline) released by Mixonline on March 29, 2025, the Pharmaceuticals and Medical Devices Agency (PMDA) has notified relevant industry groups that documentation submitted for clinical trial consultations for adult drug development must now include a statement on the presence or absence of pediatric drug […]
2024 Market Overview According to MIX Online (24年国内医療用薬市場 11兆5000億円突破で最高額を更新 ワクチン大幅伸長 1000億円超に８製品 | ニュース | ミクスOnline) published by AnswersNews as of March/05/2025, Japan’s domestic prescription drug market grew by 2.0% year-on-year in 2024, reaching a record-high of ¥11.5 trillion. This marks the second consecutive year of record-breaking growth. The expansion was driven mainly by a substantial increase in vaccine […]
Overview of New Drug ApprovalsAccording 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. […]
Introduction to Astellas’ Pioneering Regulatory Submission According to the news (News | Astellas Pharma Inc.) released by Astellas Pharma on Feb/05/2025, they have submitted a manufacturing and marketing approval application in Japan for avacincaptad pegol (ACP), branded as IZERVAY, targeting geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Notably, this application is under Japan’s […]
Overview of Japan’s Pharmaceutical Market in 2024 According to the news (【2024年国内医薬品売上高トップ10】キイトルーダ、1851億円で首位…2位にリクシアナ、「共連れ」のオプジーボは3位 | AnswersNews) released by AnswersNews on 01/27/2025, In 2024, MSD’s immune checkpoint inhibitor, Keytruda, led Japan’s pharmaceutical market with sales reaching ¥185.1 billion. Following closely, Daiichi Sankyo’s anticoagulant, Lixiana, secured the second position with ¥147.7 billion in sales, slightly surpassing Ono Pharmaceutical’s Opdivo, […]