From following to running side by side, 784 categories have achieved domestic production, 30 gaps have been filled, and 70% of the market has changed hands

Ten years ago, almost all the high-end equipment in hospitals was labeled as "foreign". Now, the market share of domestic medical devices has approached 70%, and in some fields, it has even forced foreign giants to retreat step by step.

But how well did this "breakthrough battle" go? Which devices have achieved a breakthrough from nothing to something? In which fields can we already compete with imported brands? Which technologies are still at the "bottleneck" stage? Today, let's use plain language to help you understand the "battle situation" of domestic medical devices!

From "zero" to "having", the ice-breaking action of domestic medical devices

Ten years ago, there were no domestic registration certificates for many high-end medical devices. Now, this number is rapidly decreasing. As of 2024, among the 1,170 secondary categories (excluding in vitro diagnostic reagents) in the "Medical Device Classification Catalogue", the proportion of domestic registration certificates in categories exceeding 75% has reached 67.01%, which means that 784 categories have basically achieved domestic production.

More importantly, the number of categories where domestic registration certificates account for ≥50% has increased from 872 in 2020 to 1,011 in 2024. This indicates that in an increasing number of fields, domestic products can now share the market equally with imported ones.

However, there are still 30 categories of medical devices for which no domestic products have been approved so far. They mainly focus on active implants (such as defibrillation electrodes for the heart), radiotherapy equipment (such as proton therapy systems), and high-end imaging equipment (such as high-end MRI). The technical barriers in these fields are extremely high, and foreign brands have long monopolized them.

But the good news is that compared with 2020, this figure has decreased by 37 items, indicating that domestic enterprises are gradually tackling the "tough nuts".

In 2024, there will be six categories where domestic products have achieved a "zero breakthrough" for the first time, such as intravascular ultrasound diagnostic equipment and high-frequency surgical equipment. Additionally, there are 29 categories where although there are domestic products, only one enterprise can produce them at present, such as artificial blood vessels and neurosurgical navigation systems. These data indicate that the progress of domestic medical devices is not a "rush", but rather a steady and solid approach, gradually filling the gaps.

Mature market: Domestic products have taken the lead, and the market worth hundreds of billions of yuan is being reshuffled

In some fields, domestic substitution has entered the "deep water zone" and has even begun to dominate the market.

Low-value consumables: With a domestic production rate exceeding 90%, it's all about cost performance.

Syringes, infusion sets and medical dressings, these "small items", have low technical barriers and the domestic production rate has long exceeded 90%. For instance, Weikang Medical's medical consumables business grew by 17.3% in 2023, thanks to its price advantage and the support of centralized procurement policies. This market has entered a mature stage. What matters is not technology but who can keep costs lower.

High-value consumables: The domestic production rate of heart stents is 80%, and centralized procurement has made a significant contribution.

In the past, stents for heart surgery often cost tens of thousands of yuan. Now, domestic stents have been purchased through centralized procurement, and their prices have dropped to the thousand-yuan level, with their market share directly surging to 80%! Domestic brands like Lepu Medical and Microport Medical not only offer low prices but also have clinical effects that are no less than those of imported products.

Another typical case is the hemoperfusion device, which is used for blood purification in patients with uremia. The domestic production rate is as high as 90%, and foreign brands have almost been squeezed out of the market.

Break through in the mid-range market.

In the mid-range market, the domestic production rate of monitors and biochemical diagnostic reagents stands out.

The domestic production rate of monitors is approximately 70%. Brands like Mindray and Yuyue have captured a large share of the market by relying on remote monitoring and AI early warning.

The domestic production rate of biochemical diagnostic reagents is 60% to 70%, mainly benefiting from the hierarchical medical treatment policy. Grassroots hospitals are more willing to use domestic products with high cost performance.

The foreign monopoly on high-end equipment has been broken, and domestic enterprises have begun to "counterattack".

In the high-end sector, foreign brands remain strong, but domestic enterprises have already found a breakthrough:

Medical imaging equipment, such as CT and MRI directions. In the past, CT and magnetic resonance imaging (MRI) in tertiary hospitals were almost entirely dominated by GE, Siemens and Philips, with a domestic production rate of only 10% to 20%. But now, the market share of United Imaging's PET-CT in the domestic new market has exceeded 30%, and it has even started to be exported to Europe and America in reverse!

Angiography machines (DSA), these "big devices" that cost tens of millions of yuan, once had a foreign market share of over 90%. However, domestic enterprises like Neusoft Medical first captured primary hospitals and then gradually expanded into top-tier hospitals, achieving remarkable results.

The rapid rise of domestic medical devices is largely attributed to policy support

The government has explicitly demanded that "domestic products be given priority for procurement." In 2023, the Ministry of Finance and the Ministry of Industry and Information Technology issued a document, requiring that 137 types of medical devices must be 100% domestically purchased, directly forcing hospitals to switch to domestic equipment.

The "bargaining" in centralized procurement forced foreign capital to withdraw. After the centralized procurement of heart stents, the price dropped by 80%. Many foreign brands felt that it was not profitable and simply gave up the mid-to-low-end market. Domestic enterprises took the opportunity to rise to the top.

The approval process has been expedited, and innovative products are being launched at an accelerated pace. Previously, it took several years for a new device to be launched on the market. Now, the "green channel" can shorten the approval time by 30%. In 2024, 62 domestic innovative products will be approved through this channel.

The Belt and Road Initiative helps domestic products go global. In 2023, China's medical equipment exports increased by 18%, with Southeast Asia becoming the main market. Domestic brands began to compete head-on with giants like Siemens and Medtronic on the international stage.

In the next five years, domestic medical devices will focus on replacing high-end equipment. Among them, high-end CT, MRI and surgical robots in tertiary hospitals will be the next breakthrough. Another issue is the localization of core components, such as CT tubes and ultrasound probes, which still rely on imports at present and must be overcome. At the same time, domestic enterprises should also have a global layout perspective. They should not only capture the domestic market but also strive for market share overseas.

Over the past decade, domestic medical devices have evolved from looking up to foreign capital to looking on an equal footing and even partially surpassing it. Although there are still shortcomings, the trend is clear: In the future, more and more high-end equipment in Chinese hospitals will be labeled as "Made in China".

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