According to the news article (厚労省・薬事検討会が議論開始 オーファン指定の基準明確化、早期化で「３割増」と試算 | ニュース | ミクスOnline (mixonline.jp)) released by MixOnline on 11th of July, 2023, the Ministry of Health, Labour and Welfare’s “Study Group on the Drug Regulatory System to Enhance Drug Discovery and Ensure Stable Supply” initiated discussions aimed at clarifying the criteria for designating. The committee broadly agreed to clarify the criteria and accelerate the designation of orphan drugs. The MHLW also estimates that clarifying the requirements for the designation would increase the number of orphan-designated drugs by about 30%. On the other hand, it was also proposed that priority review, one of the preferential measures for orphan designation, shouldn’t be applied to items subject to the relaxed requirements until the PMDA’s review system is fully expanded. The study group will summarize ideas by the end of the year or the end of the fiscal year (the end of March). The committee intends to implement those items that can be put into operation before the summary is announced and to make improvements through notices, Q&A, and any other means.
According to the news article “PMDA米国拠点、ラグ/ロス解消が使命 藤原理事長、日本の薬事制度を周知・浸透へ | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)” released by THE NIKKAN YAKUGYO on July 07, 2023, Yasuhiro Fujiwara, the President of the Pharmaceuticals and Medical Devices Agency (PMDA), has announced plans to establish their overseas operation bases in the United States and Asia to disseminate information about Japan’s pharmaceutical regulations. The US base aims to enhance collaboration between regulatory authorities in Japan and the United States, raise awareness of Japan’s pharmaceutical regulations among local companies and stimulate new drug development. This movement is also intended to diminish the “drug lag and loss” issue that is currently becoming a problem in Japan’s healthcare industry. These new overseas bases, planned for Washington, the US and Bangkok, Thailand, are set to start operations in the fiscal year 2024. While PMDA does not have a European base, they dispatch personnel to the European Medicines Agency (EMA) for information exchange. President Fujiwara expressed his intention to strengthen relationships through face-to-face meetings, acknowledging the time differences as a challenge. Furthermore, he emphasized the need for seamless transmission of vital information on Japanese pharmaceutical policies and guidelines to global stakeholders. This ensures more timely and effective communication for those involved in pharmaceutical development. The US base aims to showcase the appeal of Japan’s pharmaceutical regulations, attract the interest of US companies, and redirect their focus towards the Japanese market, thereby contributing to the resolution of “drug lag and loss in Japan.”
As described in the news article “国内医療用医薬品市場 27年度まで５年平均成長率、特許期間中の市場はプラス6.5～7.5％ IQVIA | ニュース | ミクスOnline (mixonline.jp)” released by MixOnline on June 26, 2023, IQVIA announced on June 23, 2023, the outlook for Japan’s pharmaceutical market for the fiscal year 2027. The compound annual growth rate (CAGR) of the pharmaceutical market segment which is under patent protection from 2022 to 2027, is projected to be between 6.5% and 7.5%, pushing the market segment up by 1.7 to 1.8 trillion Japanese yen (about 12 billion US dollars when the exchange rate for 1 US dollar is 145 yen) over the five years. Additionally, the market size of newly launched drugs from 2023 until 2027 is estimated to be around 1.1 to 1.2 trillion yen, contributing to an overall market expansion of 2.8 to 3.0 trillion yen (about 20 billion US dollars) when combined with patented drugs.
The report highlights the potential rise of Japan’s total pharmaceutical market, estimating it to reach the 11 trillion yen (about 76 billion US dollars) range by 2027, and Japan is described as the world’s second-largest market after the United States in terms of a market composed of new and patented drugs. The market driven by new and patented drugs will expand through biopharmaceuticals and specialty drugs, continuing to be an attractive market. However, for continued investment in new drug development in Japan, it was emphasized that “an environment that promotes innovation is essential.”