Current status of China’s reusable endoscope market

1. Basic concepts and technical principles of multiplex endoscopes

A multiplexed endoscope is a reusable medical device that enters the human body through the natural cavity of the human body or a small incision in minimally invasive surgery to help doctors diagnose diseases or assist in surgery. The medical endoscope system consists of three core parts: the endoscope body, the image processing module and the light source module. The endoscope body also contains key components such as imaging lenses, image sensors (CCD or CMOS), acquisition and processing circuits. From the perspective of technological generations, multiplexed endoscopes have evolved from rigid endoscopes to fiber endoscopes to electronic endoscopes. Fiber endoscopes are made using the principle of optical fiber conduction. They are composed of tens of thousands of orderly arranged glass fiber filaments to form a reflective beam, and the image is transmitted without distortion through repeated refraction. Modern electronic endoscopes use micro-image sensors and digital signal processing technology to significantly improve imaging quality and diagnostic accuracy.

2. Market situation of reusable endoscopes

1) Global market: Olympus monopolizes the market for soft lenses (60%), while the market for hard lenses grows steadily (US$7.2 billion). Fluorescent technology and 4K3D become the direction of innovation.

2) China Market: Regional differences: Guangdong has the highest purchase amount, coastal provinces are dominated by imported brands, and domestic substitution is accelerating in the central and western regions. Domestic breakthrough: The localization rate of hard lenses is 51%, and soft lens openings/Australia and China account for 21% in total. Policies promote high-end substitution. Hospital stratification: Tertiary hospitals prefer imported equipment (65% share), and secondary hospitals have become a breakthrough for domestic brands.

3.Advantages and challenges of reusable endoscopes

4.Market Status and Major Manufacturers

The current global endoscope market presents the following characteristics:

Market structure:

Foreign brands dominate: International giants such as KARL STORZ and Olympus still occupy the main market share. Taking hysteroscopes as an example, the top three sales rankings in 2024 are all foreign brands, accounting for a total of 53.05%.

The rise of domestic brands: According to Zhongcheng Digital Technology data, the market share of domestic endoscopes has increased from less than 10% in 2019 to 26% in 2022, with an average annual growth rate of more than 60%. Representative companies include Mindray, sonoscape, Aohua, etc.

Technical competition focus:

‌Imaging technology: 4K resolution, CMOS sensor replacing CCD, EDOF depth of field extension technology, etc.

‌Modular design‌: The replaceable probe design extends the service life of core components.

‌Intelligent cleaning: A new cleaning system that combines AI visual recognition with dynamic proportioning of multi-enzyme cleaning agents.

5.Core technology progress

1) Narrow-band imaging (NBI): Narrow-band imaging is an advanced optical digital method that significantly enhances the visualization of mucosal surface structures and microvascular patterns through the application of specific blue-green wavelengths. Clinical studies have shown that NBI has increased the overall diagnostic accuracy of gastrointestinal lesions by 11 percentage points (94% vs 83%). In the diagnosis of intestinal metaplasia, the sensitivity has increased from 53% to 87% (P<0.001). It has become an important tool for early gastric cancer screening, which can assist in distinguishing benign and malignant lesions, targeted biopsy, and delineating resection margins.

2) EDOF extended depth of field technology: The EDOF technology developed by Olympus achieves extended depth of field through light beam splitting: two prisms are used to split the light into two beams, focusing on near and far images respectively, and finally merging them into a clear and delicate image with a wide depth of field on the sensor. In the observation of gastrointestinal mucosa, the entire lesion area can be clearly presented, significantly improving the lesion detection rate.

3) Multimodal imaging system

The EVIS X1™ system integrates multiple advanced imaging modes: TXI technology: improves adenoma detection rate (ADR) by 13.6%; RDI technology: enhances the visibility of deep blood vessels and bleeding points; NBI technology: optimizes the observation of mucosal and vascular patterns; transforms endoscopy from an “observation tool” to an “auxiliary diagnosis platform”.

6.Policy environment and industry orientation

Key policies that will affect the endoscopy industry in 2024-2025 include:

‌Equipment update policy: The March 2024 “Action Plan for Promoting Large-Scale Equipment Updates and Consumer Goods Replacement” encourages medical institutions to accelerate the update and transformation of medical imaging equipment.

Domestic substitution: The 2021 policy requires 100% procurement of domestic products for 3D laparoscopes, choledochoscopes, and intervertebral foramina.

Approval optimization: Medical endoscopes are adjusted from Class III to Class II medical devices, and the registration period is shortened from more than 3 years to 1-2 years.

These policies have significantly promoted the R&D innovation and market access of domestic endoscopes, creating a favorable development environment for the industry.

7. Future development trends and expert opinions

1) Technology integration and innovation

‌Dual-scope joint technology‌: Laparoscope (hard scope) and endoscope (soft scope) collaborate in surgery to solve complex clinical problems.

‌Artificial intelligence assistance‌: AI algorithms assist in lesion identification and diagnostic decision-making.

Material science breakthrough‌: Development of new scope materials that are more durable and easier to clean.

2) Market differentiation and development

Experts believe that disposable endoscopes and reusable endoscopes will coexist for a long time:

Disposable products: suitable for infection-sensitive scenarios (such as emergency, pediatrics) and primary medical institutions.

Reusable products: maintain cost and technical advantages in high-frequency use scenarios in large hospitals.

Mole Medical Analysis pointed out that for institutions with an average daily usage of more than 50 units, the comprehensive cost of reusable instruments is lower.

3) Domestic substitution is accelerating

The domestic share has increased from 10% in 2020 to 26% in 2022, and is expected to continue to increase. In the fields of fluorescence endoscopes and confocal microendoscopy, my country’s technology is already internationally advanced. Driven by policies, it is “only a matter of time” to complete domestic substitution.

4) Balance between environmental and economic benefits

Reusable endoscopes can theoretically reduce resource consumption by 83%, but the problem of chemical wastewater treatment in the disinfection process needs to be solved. The research and development of biodegradable materials is an important direction in the future.

Table: Comparison between reusable and disposable endoscopes

Conclusion: In the future, endoscopic technology will show a development trend of “precision, minimally invasive, and intelligent”, and reusable endoscopes will still be the core carrier in this evolution process.

We, Jiangxi Zhuoruihua Medical Instrument Co.,Ltd., is a manufacturer in China specializing in the endoscopic consumables, such as biopsy forceps, hemoclip, polyp snare, sclerotherapy needle, spray catheter, cytology brushes, guidewire, stone retrieval basket, nasal biliary drainage catheter,ureteral access sheath and ureteral access sheath with suction etc. which are widely used in EMR, ESD, ERCP. Our products are CE certified, and our plants are ISO certified. Our goods have been exported to Europe, North America, Middle East and part of Asia, and widely obtains the customer of the recognition and praise!