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, […]
Japanese Pharmaceutical and Medical Device Act revisions aim to establish a pharmaceutical industry that ensures stable and reliable access to medicines for the public.
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% […]
New Consultation Center for Pediatric and Rare Disease Drugs Launched in Japan Introduction to the New Regulatory Initiative According to the news (小児薬の同時開発、新相談枠活用を PMDA、新センターが始動 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO on 07/05/2024, on July 1st, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan launched the “Pediatric and Rare Disease Drug Consultation Center.” […]
Japan Revises Regulations on Post-Marketing Surveillance Introduction to Regulatory Changes According to the news (厚労省、全例調査の除外規定を事務連絡 Q＆Aを一部改正 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO on 07/19/2024, significant changes have been made regarding the requirement for All Case Surveillance (ACS) as a condition for drug approval, and ACS will no longer be uniformly required. Instead, exceptions are now […]
Key Regulatory Review Systems for Pharmaceuticals in Japan Overview: Japan’s Ministry of Health, Labour, and Welfare (MHLW) has developed specific regulatory pathways to expedite the review and approval of innovative drugs. These systems aim to address unmet medical needs and provide patients quicker access to essential treatments. Ow, we explore three key systems: Orphan Drug Designation, […]
MHLW FY2025 Budget Proposal for the Establishment of Infrastructure to Implement the FIH (First-In-Human) Trial for Global Development Introduction to Japan’s New Drug Development Initiative According to the news (FIH試験体制整備、29年度稼働目指す 世界の創薬シーズ呼び込む構想、厚労省 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO on Sep/04/2024, the Japanese Ministry of Health, Labour and Welfare (MHLW) has recently announced an ambitious […]