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Japan Market Overview

Japan’s MedTech market is an enormous opportunity

Japan is the world’s

second largest single country MedTech market with roughly 7% of worldwide revenues, accounting for a higher proportion of global profit.

Structure of the Japanese Medical Device Market

  • The total medical device market in Japan (not including IVD) is 3 trillion JPY (28B USD)

  • Imports account for more than half the market

  • Therapeutic (treatment) devices are the most attractive opportunity

  1. Largest segment at 58% of total

  2. High growth rate (6% per year)

  3. High import ratio (70%)

Examples of Treatment Devices



Artificial Joint

Characteristics of the Market

  • Single payer system, universal access, high utilization

  • 7,353 general hospitals, compared to 5,530 in the US

  • Over 28% of Japan’s population is over 65, accelerating need for medical innovation

  • Regulatory approval speed has improved dramatically over the last decade

Japan Market Entry Options

Healthcare System:  Overview

Healthcare System: Medical fee - Patient burden

Meetings with MHLW

Companies need to go through a series of meetings with MHLW

in order to gain reimbursement approval in Japan

Reimbursement Pathway for New Medical Devices

HekaBio K.K.

Nihonbashi Muromachi Bldg. 8F

3-3-16 Nihonbashihongokucho, Chuo-ku

Tokyo 103-0021  Japan  日本   +81-3-6205-7585


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