Fast Time to Marketの重要性
筆者が初めて製薬業界の仕事をするようになったおおよそ28年前に、Fast Time to Market(1日でも早く新薬を上市すること)という言葉を習った。
医薬品の開発において、Fast Time to Marketは重要である。
一般の製品では、時期尚早ということもあり得る。時宜を得て製品を市場に投入することが必要な場合もあり得るのである。
しかしながら、医薬品の場合は1日でも早く開発を終え、新薬を上市することが求められる。
ある研究者が新しいコンパウンドを発見したとしよう。しかしながら、おそらく世界中では100人もの他の研究者が同じことに気が付いているといわれている。
![](https://rkcl-ibis.s3-ap-northeast-1.amazonaws.com/a13.hm-f.jp/226/html_upload/img_226_20220119_083602_Ig545.png)
新薬開発には、100億~200億円のコストがかかり、10年から15年の期間を要する。
医薬品の上市において、上市の順が1番と2番では、薬価に大きな違いが生じることもあり得る。
新薬が上市されるまでには、製薬会社側での研究開発期間(申請書の作成)と、規制当局による審査期間が含まれ、そのどちらをも短縮することが急務である。
上図において、Aは研究開発中:上市前)であり、Bは上市後である。Bの面積(売上)からAの面積(研究開発費)を引いたものが製薬企業の利益となる。
![](https://rkcl-ibis.s3-ap-northeast-1.amazonaws.com/a13.hm-f.jp/226/html_upload/img_226_20220119_083955_SqQki.png)
利益の最大化のためには、開発期間の短縮がとても重要である。
例えば、年間360億円を売上げる薬剤の場合、研究開発にかかる時間を1日短縮すれば、1億円の利益につながるのである。
つまりFast Time to Marketが重要となる。(上図)
![](https://rkcl-ibis.s3-ap-northeast-1.amazonaws.com/a13.hm-f.jp/226/html_upload/img_226_20220119_084136_czrKG.png)
新薬が上市されるまでには、製薬会社側での研究開発期間(申請書の作成)と、規制当局による審査期間が含まれ、そのどちらをも短縮することが急務である。
(1)研究開発により、各種報告書が作成される期間の短縮
・各種法規制(ガイドライン)の遵守
i.e. GLP、GCP、GMP
・ドキュメントの管理
(2)新薬申請書が作成される期間の短縮
・Dossier(申請資料)の管理
・パブリッシュ
・世界同時申請
・電子申請(Electronic Submission)
・eCTD
(3)当局により、新薬が審査される期間
・照会事項の減少、照会事項への回答の迅速さ
![](https://rkcl-ibis.s3-ap-northeast-1.amazonaws.com/a13.hm-f.jp/226/html_upload/img_226_20220119_084357_yOD1c.png)
製薬業界における克服すべき課題
しかしながら、新薬開発には多くの課題もある。
・後発品の発売までの期間が短期化している
・ジェネリック品による侵食が加速している
・新世代のセラピーも次々と開発されている
これらの状況の変化により、利益は圧迫されつづけている。
現在の特許法では、取得した特許権の存続期間を出願から20年と定めている。通常、治験を行う前の段階で特許の出願を行うので、その後の開発・審査に10~15年ほどかかることを差し引けば、製薬会社が実際に新薬を独占販売できる期間は5~10年ほどに過ぎないことになる。
(ただし、新薬の開発・審査には安全性の確保などのため相当な時間を割かなくてはならない状況を配慮して、国は、製薬会社が申請すれば、「特許発明の実施をすることができない期間」として5年を上限に特許の延長を認めている。)
新薬の物質特許が切れた後、通常、後発医薬品メーカーは、新薬と同じ有効成分で効能・効果、用法・用量が同一で新薬に比べて低価格な医薬品、いわゆる「ジェネリック医薬品」を発売することになる。
![](https://rkcl-ibis.s3-ap-northeast-1.amazonaws.com/a13.hm-f.jp/226/html_upload/img_226_20220119_084537_2h1mY.png)
Fast Time to Peak Sales
現在では多くの製薬会社の戦略は、Fast Time to MarketからFast Time to Peak Salesへと遷り変っている。つまりいかに早く最高売り上げを達成するかということである。
![](https://rkcl-ibis.s3-ap-northeast-1.amazonaws.com/a13.hm-f.jp/226/html_upload/img_226_20220119_084633_pkfRP.png)
関連商品
[blogcard url=https://xn--2lwu4a.jp/qms-alex/ title=”QMS(手順書)ひな形 医薬品関連” ]
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