SCUEL — Japan pharmaceutical data

Japan market screening · Molecule

Montelukast Sodium

モンテルカストナトリウム · JAN (Japanese Accepted Name)

Other antiallergic agents · 6 presentations · oral  ·  Supply status as of 28 Aug 2026  ·  Prescription data FY2024 (Apr 2024 – Mar 2025)

45 Normal supply 18 Limited supply 10 Supply suspended

One block is one marketed product. Every company that markets this molecule in Japan reports its supply status to the Ministry of Health, Labour and Welfare, and we publish that report the day it changes.

¥32.8bn Annual demand FY2024, valued at NHI list price. Not actual transaction value.
+32% Volume growth FY2024 against FY2022. 1.00 billion units dispensed.
28 of 73 Products constrained Limited supply or supply suspended, across 6 of 6 presentations.

Demand is growing, and supply is not keeping up

National dispensed volume, FY2014 – FY2024. Source: NDB Open Data.

3.9
4.3
4.4
3.9
4.1
4.2
3.8
4.6
7.6
8.7
10.0
14
15
16
17
18
19
20
21
22
23
24

Figures are in hundreds of millions of units. The reporting scope was widened in FY2022, so levels before and after that year are not directly comparable — the step up between FY2021 and FY2022 is partly definitional. Demand peaks in March every year.

What each supply status means

These are Japanese regulatory categories. They do not map one-to-one onto the FDA or EMA definition of a shortage, and the difference matters.

StatusProductsJapanese term
Normal supply Shipping without restriction. 45通常出荷
Limited supply Shipments are being restricted or allocated. The product is still available, but a buyer cannot get as much as they ask for. Japan reports the cause separately: a problem at the company itself, demand shifted from a competitor's product, or another cause. 18限定出荷
Supply suspended Shipments have stopped. This is not discontinuation — supply may resume. A product that is being withdrawn for good is reported separately as 販売中止 (discontinued). 10供給停止

Where it is used

Share of national dispensed volume by prefecture, FY2024. Estimated from NDB Open Data.

PrefectureShareUnits
Tokyo14.2%140m
Kanagawa8.9%88.8m
Osaka6.3%63.5m
Saitama5.9%58.6m
Aichi5.7%56.7m

Raw prefecture volume mostly reflects population. To see where this molecule is used more than the country as a whole would predict, ask us for the location quotient — it is part of the screening dataset below.

Why we do not publish brand-level market share for Japan

Most generic products in Japan are listed under a unified non-proprietary name (統一名収載): several companies' products share a single code on the national price list. Public statistics are aggregated at that code, so volume and value cannot be split back out by company or by brand. Anyone offering you Japanese brand share is either using proprietary distributor sales data, or estimating. We tell you which of the two it is before you buy.

The rest of the screening dataset

Available as a commissioned extract, delivered in Excel. One row per molecule, 24 fields, plus a detail sheet per molecule.

  • Three-year CAGR and the direction of the last 24 months Whether the growth above is still running, or has already turned.
  • Number of suppliers, and how many hold the largest presentation How crowded the molecule actually is, beyond the 73 product count.
  • Reported production volume by generic manufacturer, three years From Form 4, the capacity report. Shows which incumbents are pulling back.
  • Supply instability index and the stated reasons For this molecule the most common reason for suspension is increased demand.
  • Regional concentration (location quotient) and the top three prefectures Where the molecule is over-used relative to the national pattern.
  • Market size by presentation, and the generic share of each Which strength or form is worth entering, not just the molecule.

Other molecules in this class

Other antiallergic agents, ranked by annual demand at NHI list price.

Fexofenadine Hydrochlorideフェキソフェナジン塩酸塩 Olopatadine Hydrochlorideオロパタジン塩酸塩 Bepotastine Besilateベポタスチンベシル酸塩 Pranlukast Hydrateプランルカスト水和物

Pages for these are in preparation. In the meantime, the molecule list shows how many products compete for each and how many of them are currently constrained.

Screening a therapeutic area in Japan?

Tell us the molecules or the area you are looking at. We will tell you what the public data can and cannot answer before you commission anything.

Send an enquiry

Our Database Division replies in English within three business days (Japan time).