Industry Monthly
September 2026 Industry Monthly
A monthly digest of policy, market, and technology developments across the pharmaceutical industry, based on public sources.
Policy & Pricing
MHLW's FY2027 Budget Request Includes Over 256.1 Billion Yen for Hospital DX; Total Reaches Record 36.58 Trillion Yen
The Ministry of Health, Labour and Welfare's FY2027 budget request allocates over 256.1 billion yen to hospital DX measures, including 60.4 billion yen to support adoption of cloud-native electronic medical record (EMR) systems. The overall budget request rose 1.537 trillion yen year on year to a record 36.580 trillion yen. On EMRs, the ministry has set a goal of eliminating non-adoption at hospitals with 200 or more beds by FY2028, and aims by the end of 2030 to (1) reach roughly 100% EMR penetration, (2) implement cybersecurity measures at regional hub hospitals, and (3) create an environment in which large hospitals can adopt cloud-native EMR and departmental systems.
Source: All Japan Hospital Association News No. 1109 (September 15, 2026 issue), pages 1 and 3Expert's View
While EMR adoption targets have been set, whether frontline staff actually experience efficiency gains depends on how the systems are operated. Cloud-native migration can look like a vendor-driven conversation, but it also bears on data portability and business continuity during disasters — matters that affect patients too. The budget figures alone don't tell us who the DX push ultimately serves. It's also worth noting that the "zero non-adoption" target applies only to hospitals with 200 or more beds — smaller hospitals and clinics fall outside this goal, meaning the benefits of EMR adoption will likely reach different scales of provider in sequence rather than all at once.
Japan Biosimilar Association Publishes Comparison of EU, US, and Japan Biosimilar Approval Guidelines
A comparison document published by the Japan Biosimilar Association (JBSA), "Comparison of the Guidelines on Biosimilars in the EU, US, and Japan," sets out how each jurisdiction handles bridging studies (quality, nonclinical, and clinical PK/PD) when a biosimilar developer uses an overseas-approved product as the reference. In Japan, applicants must demonstrate equivalence between the domestically approved and overseas-approved products based on quality comparability data, among other evidence, while the EU and US frameworks rely primarily on analytical comparability data with the scope of required clinical bridging assessed case by case. Note that this is JBSA's own Japanese translation and summary of multiple regulators' guidelines, that the document itself cautions it "does not necessarily accurately reflect the original text," and that it is a standing reference resource rather than a new publication tied to this specific month.
Source: Japan Biosimilar Association (biosimilar.jp; the document states it is based on information as of July 2026)Expert's View
The scope of required bridging studies is what really drives biosimilar development cost, so differences across the three jurisdictions shape development strategy directly. For patients in Japan, this is ultimately a supply question — how quickly, and at what cost, products already available overseas become accessible domestically. What looks like a technical regulatory debate is, underneath, a question of patient access — though it's worth keeping in mind that this document is the association's own translation and summary, not the regulators' primary statements themselves.
Market & Business
Japan's Drug Market Falls 7.5% Month-on-Month to 918.5 Billion Yen in August 2026; Keytruda Tops Rankings for 35th Straight Month
According to Encise Inc.'s Monthly Snapshot (on an NHI drug price basis, released September 4, 2026), Japan's domestic prescription drug market totaled 918.5 billion yen in August 2026, down 7.5% from the prior month but up 2.0% year on year (versus 900.9 billion yen in August 2025). The fiscal year-to-date total (April-August) reached 4,780.8 billion yen, running ahead of the same period last year (4,618.2 billion yen). Among the top 20 products by single-month sales, Keytruda (an anti-PD-1 antibody) remained in first place with 19.2 billion yen, followed by Mounjaro at 15.7 billion yen and Dupixent at 12.5 billion yen. Trade publication Nikkan Yakugyo reported that this marks Keytruda's 35th consecutive month at the top of the same dataset. Note that the growth figure shown for each product (CMGR) is not a month-on-month rate but a trailing 12-month compound monthly growth rate.
Source: Encise Inc., "Monthly Snapshot (August 2026)"; Nikkan Yakugyo, "Keytruda Tops Rankings for 35th Consecutive Month" (headline and lead only verified; article is paywalled)Expert's View
An isolated 7.5% month-on-month decline might look like a setback, but the market was actually up 2.0% year on year, so this isn't evidence of a shrinking market. What's more notable is that Mounjaro, in the obesity/diabetes category, has climbed to 15.7 billion yen in a single month — a sign that the top of the rankings is gradually tilting toward metabolic disease products.
Tanabe Pharma Completes Transfer of Worldwide Rights to Rare-Disease Drug Dersimelagon to LEO Pharma; FDA Accepts Application
Tanabe Pharma announced that the US FDA has accepted, under priority review, the new drug application for MT-7117 (dersimelagon), under development for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), and that it has completed a contract transferring worldwide development and commercialization rights for the drug to LEO Pharma. Tanabe Pharma will receive up to $435 million in upfront and near-term milestone payments, plus additional milestone payments and tiered sales-based royalties going forward. The FDA decision is expected around the end of February 2027.
Source: Mixonline, "Tanabe Pharma Completes Global Rights Transfer of EPP/XLP Candidate Dersimelagon to LEO Pharma" (September 18, 2026)Expert's View
The decision to transfer worldwide rights to an overseas company just as the FDA accepted the filing illustrates how, in rare disease drug development, the work of discovering a compound and the work of getting it approved and supplied across many countries are increasingly carried out by different companies. For patients, what matters is not who holds development and marketing rights but how quickly the medicine reaches the countries that need it after approval — worth tracking as LEO Pharma's global rollout proceeds.
Patient & Consumer Health Behavior
Influenza Treatment Prescriptions Surge to 37,000 Patients per Week in Late August — Second Only to the Record 2023 Season
According to the headline and subtitle of a news release published by Intage Healthcare on September 11, 2026, the number of patients prescribed influenza treatments surged to roughly 37,000 per week in late August 2026 — second only to the record 2023 season. The subtitle notes that the spread is earlier than in a typical year and that trends from autumn onward will bear watching. We were unable to confirm details such as survey methodology or the age breakdown beyond the headline and subtitle.
Source: Intage Healthcare (September 11, 2026; headline and subtitle only verified)Expert's View
A prescription surge earlier than usual tends to coincide with periods of increased school activity and travel, putting pressure both on clinic capacity and on managing severe cases at home. We were not able to confirm the detailed epidemic curve or age breakdown, so the headline figure alone does not support concluding that this year is more severe than a typical one.
Clinic Visit or Over-the-Counter Medicine? Intentions Diverge by Symptom Severity (Tokyo and Kansai Metro Survey)
A survey of 2,523 men and women aged 16-79 residing in the greater Tokyo (Keihin) and Kansai (Keihan-Shin) metropolitan areas, conducted by Intage Healthcare between April 8 and May 20, 2026, found that stated intentions to "see a doctor" versus "use over-the-counter medicine" vary sharply by symptom type and severity. 84.2% of respondents said they would see a doctor for a high fever, while 62.5% said they would rely on over-the-counter medicine for an occasional headache, and 56.5% said they would still see a doctor for chronic headaches or migraines. Among those who named a temperature threshold for seeking care, "38.0°C or above" was the most common answer, at 41.3%. Note that the survey captures stated intentions — what respondents said they think they would do — rather than observed actual behavior.
Source: Intage Healthcare (September 16, 2026)Expert's View
There is considerable variation, by symptom type, between the policy direction of promoting self-medication and the threshold at which consumers actually feel comfortable managing symptoms with over-the-counter medicine rather than seeing a doctor. Rather than issuing a blanket message of 'treat mild symptoms yourself,' this points to a need for information design that clarifies, symptom by symptom, where self-judgment is actually reasonable. Because the survey covers residents of the greater Tokyo and Kansai areas only, and measures stated intentions rather than observed behavior, it should not be equated with actual nationwide health-seeking behavior.
* This report is edited by Yap Inc. based on publicly available sources. “Expert’s View” reflects the perspective of CEO Masaya Yamamoto (a NewsPicks Expert). Please refer to the original source for details on each item.
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