TXP Medical Publishes Whitepaper "The State of Japanese Real-World Evidence," Analyzing the Current State of Real-World Evidence (RWE) in Japan

～ EMR-derived data market to grow from approx. ¥3.9 billion (2025) to approx. ¥25 billion (2035) ～

～ RWD/RWE use in new approvals up from 18.1% (2019) to 30.4% (2024) ～

～ Claims/DPC and EMR data: complementary roles clarified for Medical Affairs ～

TOKYO, Nov. 3, 2026 /PRNewswire/ -- TXP Medical Co., Ltd. (Representative Director and CEO: Tomohiro Sonoo; "TXP Medical") has published the Whitepaper "The State of Japanese Real-World Evidence," a comprehensive analysis of how real-world data (RWD) and real-world evidence (RWE) are used in Japan today. The Whitepaper is the first report from the company's owned media "Medical Data Lab," which was relaunched under a new structure on October 1, 2026. It targets pharmaceutical Medical Affairs (MA) departments and explains how to choose between claims/DPC (Diagnosis Procedure Combination) data and EMR-derived data, drawing on market size, regulatory trends, and use cases.

Japan's market for secondary use of healthcare data is projected to grow from approx. ¥35 billion in 2025 to approx. ¥85 billion in 2035. Over the same period, the share of EMR-derived data is expected to rise from 11% (approx. ¥3.9 billion) to 29% (approx. ¥25 billion). From 2025 to 2030, the analysis estimates a compound annual growth rate of approx. 26% for EMR-derived data, versus 8% for claims data. In addition, RWD/RWE were used in 30.4% (38 of 125) of new drugs and regenerative medical products approved in 2024, up significantly from 18.1% (21 of 116) in 2019.

• Background of the Whitepaper

Japan is one of the world's leading pharmaceutical markets, and its universal health insurance system continuously generates longitudinal claims data on approximately 120 million people. Turning these data into more clinically refined evidence requires EMR data, which captures what claims alone cannot, such as disease severity, biomarker findings, and the reasons behind treatment choices. It also requires infrastructure that enables cross-institutional research use.

As of 2023, EMR adoption in Japan was 65.6% among general hospitals overall and 93.7% among hospitals with 400 or more beds. The government aims for nearly all medical institutions to have introduced electronic medical records that allow patient information to be shared by 2030. Meanwhile, secondary use of medical information under the Next Generation Medical Infrastructure Act (NGMIA) remains limited in scale. As of September 2026, there were 4 certified operator groups and 170 cooperating facilities, and the 3 operators that reported figures had provided data in 135 cases cumulatively.

Against this background, TXP Medical published this Whitepaper. Its view is that the key to RWE in Japan is not a binary choice between claims and EMR, but a "Fit for Purpose" perspective: choosing the right data source for the clinical question at hand.

• Main Contents

The Whitepaper is organized around four themes central to pharmaceutical Medical Affairs: understanding patient treatment pathways, quantifying unmet needs and care gaps, evaluating real-world effectiveness and safety after launch, and generating evidence through prospective and hybrid study designs. For each, it sets out the strengths and limitations of claims/DPC data and EMR data.

It also explains that EMR data has distinct value in three situations, including review cases such as the pertuzumab + trastuzumab combination therapy approved in 2022:

1. When clinical characteristics specific to Japanese patients affect treatment choices and outcomes (e.g., the high rate of EGFR mutation positivity in non-small cell lung cancer).
2. When Japan-specific reimbursement and care-delivery systems determine access to testing and treatment (e.g., the designated core-hospital system for cancer genomic medicine).
3. When real-world practice in Japan may differ from overseas evidence.

The paper also presents practical methods for EMR-based research, including feasibility assessments, study-site selection, and clinical phenotyping, which identifies and classifies patients from symptoms and test results. It also covers the latest regulatory developments, including the Step 4 adoption of ICH E6 (R3) Annex 2 (June 2026).

• The Role of TXP Medical's Healthcare Data Platform

The Whitepaper draws on insights from the healthcare data platform that TXP Medical has built in partnership with 56 university hospitals and regional core hospitals nationwide.

As of September 2026, the platform covers over 26 million patients. It holds more than 15 years of clinical data integrating 900+ standardized lab parameters, vital signs, full-text clinical notes, and DPC data. TXP Medical has worked with more than 40 pharmaceutical and medical device companies, including more than half of the top 20 domestic pharmaceutical companies. An in-house team of 50+ specialist physicians supports clients end to end, from study design to manuscript preparation.

• New Leadership at Medical Data Lab and Outlook

Effective October 1, 2026, TXP Medical appointed Tymo Nakao as Head of Medical Data Lab. Dr. Nakao is a physician who supported pharmaceutical and medical device clients on business strategy at McKinsey & Company before joining TXP Medical, where he led its international expansion. This Whitepaper is the first publication since his appointment.

Comment from Tymo Nakao, MD, Head of Medical Data Lab:
"RWD and RWE use in Japan is at a turning point, moving from an either/or choice between claims and EMR toward a 'Fit for Purpose' mindset in which the data source is chosen to fit the clinical question. We hope this Whitepaper serves as a foundation for Medical Affairs professionals as they think through their evidence strategies."

Through the Medical Data Lab, TXP Medical will continue to research and publish on RWD/RWE use in Japan. Through dialogue with pharmaceutical companies and industry organizations, it will keep supporting evidence generation across a wide range of therapeutic areas, from rare diseases to oncology.

TXP Medical Co., Ltd. — Mission: "Saving Lives with Medical Data"

TXP Medical Co., Ltd. is a healthcare data company that promotes the use of EMR-derived real-world data (RWD), with the mission of "Saving Lives with Medical Data." It has data-use agreements with 56 university hospitals and regional core hospitals nationwide and has built a network of partner facilities centered on large hospitals of around 650 beds. The platform covers over 26 million patients and draws on 15+ years of historical data, including 900+ standardized lab parameters, rich clinical-note text, and detailed structured acute-care data accumulated through the "NEXT Stage" series.

The company supports problem-solving across therapeutic areas including acute care, rare diseases, and oncology. With a team that includes 50+ physicians, it provides end-to-end services covering data analysis, study protocol development, clinical research support, observational research, clinical trial support, and manuscript preparation. It has worked with more than 40 pharmaceutical and medical device companies.

• Company name: TXP Medical Co., Ltd.
• Address: 2F AKIHABARA CENTRAL SQUARE, 3-21-24 Kanda Sakumacho, Chiyoda-ku, Tokyo
• CEO: Tomohiro Sonoo
• Established: August 2017
• Business: Acute care medical data platform, AI technology, RWD utilization services
• Related URLs: as in the original

Inquiries about this Whitepaper
Whitepaper download: https://medical-dataservice.txpmedical.jp/document

SOURCE TXP Medical Co., Ltd.