How is the market performance of innovative medical device products? —— Data observation from domestic breast DR
Innovative medical devices refer to those that legally hold invention patents for core product technologies in China. The main working principles or mechanisms of action of the products are first developed domestically. The product performance or safety has been fundamentally improved, and the technology is at the international leading level. They have significant clinical application value and have basically finalized products.
As of the end of 2024, the number of innovative medical devices approved by the National Medical Products Administration had exceeded 300. According to the degree of innovation, we have classified the innovative products into different levels. Among them
i. “Filling the domestic gap”: For products for which foreign-funded brands have been registered and sold in China at the time of registration, after their launch, they face the competitive pressure of monopolization by existing foreign-funded brands and the potential entry of domestic brands.
ii. “Filling the domestic gap”: There are products sold in the international market, but there are no products registered and sold by domestic and foreign brands in the domestic market. After being launched, market cultivation and promotion and application in leading hospitals are urgently needed.
iii. “Global Product Premiere”: The world’s first product with significant improvements in performance parameters, application scenarios, or techniques compared to existing products.
iv. “Global technological first”: Products whose surgical techniques or mechanisms are the first in the world globally have huge commercialization opportunities.
To monitor and track the terminal market performance of innovative medical devices, this issue focuses on the level of “filling domestic gaps”. Innovative products (mammography DR) in the medical imaging field, which have a high degree of innovation and have been commercialized for more than 5 years, are selected for analysis to gain insights into market performance, characteristics, and trends.
Ⅰ. In 2019, the first domestic 3D breast DR was approved as an innovative product.
As of the end of March 2025, a total of 68 registration certificates for breast DR products have been approved in China. Among them, the proportion of registered domestic breast DR products is approximately 80%, and the proportion of registered 3D breast DR products is approximately 30%.
As of now, there is only 1 breast DR that has obtained approval for the registration application of innovative products through the National Medical Products Administration. This product is a 3D breast DR, and the registration certificate includes 3 models. Among them, the uMammo 890i is the first domestic high-definition low-dose 3D breast DR. It is innovatively equipped with the Starlight 3D imaging platform and U-View intelligent fusion 2D technology, which greatly improves the detection rate of early occult lesions and can reduce the dose by 41%.
Ⅱ. Since the approval of the innovative product, it has led the growth of the domestic 3D breast DR market.
Affected by factors such as the anti – corruption campaign in the medical field, the domestic breast DR market faced short – term pressure in the first half of 2024. In the second half of the year, with the gradual implementation of favorable policies such as “equipment renewal”, the situation has improved significantly. However, the market size still showed a downward trend throughout 2024.
Continuing the positive impact of “equipment update”, the market size of breast DR in the first quarter of 2025 achieved a high year – on – year growth (over 90%), among which 3D breast DR grew even faster (+96%). It is expected that the year – on – year growth rate of the breast DR market size for the whole year of 2025 will exceed 37%.
In the past two years, the proportion of 3D products in the domestic breast DR market has been increasing significantly. In the first quarter of 2025, it exceeded three – quarters.
In 2024, the sales volume of innovative products in 3D breast DR accounted for nearly a quarter, a slight decrease compared with 2023.
The innovative product uMammo 890i quickly opened up the domestic market with its high cost – performance ratio of local production. However, with the localization advancement of foreign – funded brands such as GE Healthcare and Siemens Healthineers, the cost – performance advantage of the domestically – innovated products has weakened. At the same time, domestic competing products have been launched one after another, intensifying market competition. Therefore, innovative products have a certain “newcomer protection period”, but the growth of market share does not continue indefinitely. It still needs to rely on continuous innovation and improvement.
Ⅲ. The localization costs of foreign-funded brands have dropped significantly, and innovative products have passed the “newcomer protection period”.
In 2024, the localization rate of the domestic breast DR market declined, mainly affected by 3D products.
Specifically, in 2023, the “registration for approval” certificates of the 3D products of foreign-funded brands, Senographe Pristina (GE Healthcare) and MAMMOMAT Revelation (Siemens Healthineers), were approved. In 2024, with a price reduction of over 20%, their market shares increased significantly. United Imaging Healthcare’s uMammo 870i entered the market in 2024 and squeezed into the top five with higher cost performance. Compared with the high – priced uMammo 890i, hospitals have more choices.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
Source： MDDI
Translated & edited：Bradyknown
