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
-
Largest segment at 58% of total
-
High growth rate (6% per year)
-
High import ratio (70%)
Examples of Treatment Devices

Pacemaker


Catheter
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
