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Pharma and healthcare groups · Japan

Ono Pharmaceutical

ono.co.jp ↗

Japanese pharma known for Opdivo (with BMS) and oncology/immunology drugs.

Losing its protection
Assessed 25 July 2026 · Evidence as of 25 July 2026
The structural protection is eroding.
On the recordSince 25 July 2026 · Checkable from around July 31, 2026 · Every call on the record Checkpoint: Q1 FY2027 earnings plus Japan regulatory decision on ripretinib (QINLOCK) filing
The call

Ono is profitable and patent-protected today, but Opdivo is losing ground to Merck's Keytruda while it races to scale Deciphera's overseas drugs before the 2028 biosimilar cliff.

Ono Pharmaceutical makes cancer medicines and has been profitable for decades, but its top drug Opdivo is losing patients to Merck's Keytruda and will face cheap copycat versions by late 2028. The company bought Deciphera to add new drugs and expand overseas, which showed strong growth last year, but nobody knows yet if that move will work fast enough to replace the money Opdivo is losing. The next earnings report in July 2026 and a regulatory decision on a new Japanese cancer drug will show whether Ono's plan is actually working or just buying time.

Why
01
AI pressure: None apparent. AI drug-discovery labs like Isomorphic Labs could speed rivals' pipelines, but none is shown displacing Ono's programs today. Could AI do the core job? Unlikely.
02
Bigger players: Merck & Co. (Keytruda). Keytruda passed Opdivo in Japan sales around 2022, and Opdivo domestic sales fell another 5% in FY2025 to ¥114.3B. Could a giant copy it? No, they are blocked.
03
What protects it. Patent-protected drugs, regulatory approvals, and ¥103.5B in core profit fund new bets like Deciphera's overseas oncology line.
What would change this call
Domestic Opdivo sales trend in Ono's Q1 FY2027 earnings (~July 31, 2026). Shows whether Keytruda's share gains against Opdivo are accelerating or stabilizing.
Japan regulatory decision on ripretinib (QINLOCK) filing submitted March 2026. Indicates whether Deciphera-derived drugs can offset Opdivo losses domestically.
ROMVIMZA sales trajectory vs Daiichi Sankyo's Turalio in TGCT through FY2026. Reveals whether Ono can win share from a same-industry Japanese rival in a new drug class.
Key numbers
  • FY2025 revenue ¥515.8B, up 5.9% (2026-03-31)
  • Domestic Opdivo sales down 5.0% to ¥114.3B (2026-03-31)
  • Overseas sales up 56.5% to ¥61.2B on QINLOCK (2026-03-31)
Named risks
  • Opdivo biosimilar entry expected around December 2028 threatens core franchise inside hold window. Severity: high
  • FY2026 revenue guided down 11.8% to ¥455.0B due to Forxiga co-promotion ending. Severity: high
  • US Medicare price negotiation rule (June 2026) may target subcutaneous Opdivo/Keytruda in 2029. Severity: medium
  • Deciphera integration and pipeline execution (tirabrutinib, bispecifics) remain unproven offsets. Severity: medium
  • Merck royalty rate under PD-1 settlement stepped down from 6.5% to 2.5% through Dec 2026. Severity: medium
Rivals, as read in July 2026
RivalDirectionEvidence
Merck & Co. (Keytruda)losing toOpdivo domestic sales fell 5.0% to ¥114.3B in FY2025 amid 'intensified competitive environment'
Daiichi Sankyo (Turalio)contestingOno's ROMVIMZA (approved Feb 2025) directly challenges Daiichi's Turalio in the TGCT market
AstraZenecalosing toForxiga co-promotion agreement with AstraZeneca ends, cutting FY2026 revenue guidance by ¥60B-plus
Chugai PharmaceuticalcontestingRoche-affiliated peer competing broadly in Japanese oncology/biologics as of 2026
Questions people ask
Is Ono Pharmaceutical profitable in 2026?
Yes. For FY2025 (ended March 31, 2026) Ono reported consolidated core-basis revenue of ¥515.8B, up 5.9% YoY, and core profit attributable to owners up 14.5% to ¥103.5B, both record highs, per its March 30, 2026 IR release.
Is Ono Pharmaceutical's Opdivo losing to Merck's Keytruda?
Yes, domestically. Ono's FY2025 results (as of March 31, 2026) show Opdivo's Japan sales fell 5.0% to ¥114.3B due to 'intensified competitive environment,' and third-party analysis says Keytruda overtook Opdivo in Japan sales rankings around 2022.
Could AI replace Ono Pharmaceutical's drug development work?
Not the core business. AI vendors like Iktos, InveniAI, Receptor.AI and Congruence (expanded March 3, 2026) assist Ono's early molecule design, but patents, PMDA/FDA approvals, insurance reimbursement, and manufacturing licenses remain untouched by AI.
Why did Ono Pharmaceutical's revenue guidance drop for FY2026?
Ono guided FY2026 revenue down to ¥455.0B, an 11.8% decline, primarily because its Forxiga co-promotion agreement with AstraZeneca is ending, compounding domestic Opdivo erosion, per a May 8, 2026 investor summary.
What did Ono Pharmaceutical get from acquiring Deciphera?
Ono completed a roughly $2.4B cash tender-offer acquisition of Deciphera Pharmaceuticals in June 2024, gaining QINLOCK and ROMVIMZA; overseas product sales then jumped 56.5% to ¥61.2B in FY2025, led by QINLOCK's 50.6% growth.
When will Opdivo face biosimilar competition and hurt Ono Pharmaceutical?
Analyst commentary dated July 9, 2026 expects biosimilar entry for Opdivo and Keytruda around December 2028, a cliff Ono aims to offset with Deciphera products and pipeline assets like tirabrutinib and ripretinib before that date.
Timeline
  • 2026-07-09Analysts flag pipeline execution as central to bull case; fair-value estimates span ¥1,275 to ¥3,648 per share
  • 2026-06-15US Medicare price-negotiation rule published, may target subcutaneous Opdivo and Keytruda in 2029 round
  • 2026-05-08Ono guides FY2026 revenue down 11.8% to ¥455.0B as Forxiga co-promotion with AstraZeneca ends
  • 2026-03-30FY2025 results: record revenue ¥515.8B, core profit ¥103.5B, but domestic Opdivo sales down 5.0%
  • 2026-03-26Ono files Japan application for ripretinib (QINLOCK)
  • 2026-03-03Ono expands Congruence Therapeutics AI partnership into neurology and immunology discovery
  • 2026-03-02Ono divests legacy products Opalmon and Prostandin to Daito Pharmaceutical
  • 2026-02-16FDA accepts tirabrutinib NDA for relapsed/refractory PCNSL
  • 2025-02-28ROMVIMZA (vimseltinib) approved by FDA for TGCT; EU CHMP gives positive opinion
  • 2024-06-11Ono completes ~$2.4B acquisition of Deciphera Pharmaceuticals
Revision history
25 July 2026
First assessed. Losing its protection. The text above is fixed as of this date and is not edited afterwards.
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