TOKYO – November 03, 2026 -- Japan's market for EMR-derived healthcare data is projected to grow from about ¥3.9 billion in 2025 to about ¥25 billion in 2035, according to a whitepaper from TXP Medical Co., Ltd. The report, "The State of Japanese Real-World Evidence," targets pharmaceutical Medical Affairs departments. It is the first publication from the company's relaunched "Medical Data Lab" media unit.

EMR data share to rise from 11% to 29% of Japan's secondary-use market

The overall market for secondary use of healthcare data is forecast to grow from about ¥35 billion in 2025 to about ¥85 billion in 2035. EMR-derived data is expected to climb from 11% of that market to 29% over the period.

TXP Medical estimates a compound annual growth rate of about 26% for EMR-derived data from 2025 to 2030, against 8% for claims data. Regulators are already drawing on real-world data: RWD/RWE were used in 30.4% (38 of 125) of new drugs and regenerative medical products approved in 2024, up from 18.1% (21 of 116) in 2019.

Claims data covers 120 million people but lacks clinical detail

Japan's universal health insurance system generates longitudinal claims data on about 120 million people. Claims data cannot capture disease severity, biomarker findings or the reasons behind treatment choices, which EMR data can.

EMR adoption stood at 65.6% among general hospitals in 2023 and 93.7% among hospitals with 400 or more beds. The government aims for nearly all medical institutions to have EMRs that allow patient information to be shared by 2030.

Secondary use under the Next Generation Medical Infrastructure Act remains small. As of September 2026, there were 4 certified operator groups and 170 cooperating facilities. The 3 operators that reported figures had provided data in 135 cases cumulatively.

Whitepaper urges "Fit for Purpose" data selection across four Medical Affairs use cases

The report rejects a binary choice between claims/DPC and EMR data. It advises matching the data source to the clinical question across four themes: patient treatment pathways, unmet needs and care gaps, post-launch effectiveness and safety, and prospective and hybrid study designs.

It identifies three situations where EMR data has distinct value:

• Japan-specific patient characteristics affect treatment, such as the high rate of EGFR mutation positivity in non-small cell lung cancer.
• Japan-specific reimbursement and care-delivery systems determine access to testing and treatment, such as the designated core-hospital system for cancer genomic medicine.
• Real-world practice in Japan may differ from overseas evidence.

The paper cites review cases including the pertuzumab + trastuzumab combination therapy approved in 2022. It also covers feasibility assessments, study-site selection and clinical phenotyping, and the Step 4 adoption of ICH E6 (R3) Annex 2 in June 2026.

TXP Medical's platform covers 26 million patients across 56 hospitals

The analysis draws on a platform built with 56 university hospitals and regional core hospitals. As of September 2026, it covers more than 26 million patients and holds more than 15 years of data. The data integrates 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. A team of 50+ physicians supports clients from study design to manuscript preparation.

Former McKinsey consultant Tymo Nakao takes over Medical Data Lab

TXP Medical appointed Tymo Nakao as Head of Medical Data Lab effective October 1, 2026. Nakao is a physician who advised pharmaceutical and medical device clients on business strategy at McKinsey & Company. He later led TXP Medical's international expansion.

Nakao said RWD and RWE use in Japan is at a turning point, moving toward a "Fit for Purpose" mindset in which the data source fits the clinical question. The Medical Data Lab will continue to publish research on RWD/RWE use in Japan, with a focus on therapeutic areas from rare diseases to oncology.