2021年中国AI医疗器械行业市场规模及驱动因素（图）

2021 Market Size and Driving Factors of China's AI Medical Devices (with Figure)

中商情报网讯：通过从提供医疗服务过程中产生的大量数据中获得重要的新见解，AI和ML技术有潜力实现医疗保健变革。医疗器械制造商正在使用该等技术来进行产品创新，从而更好地帮助医疗从业者及改善病患照护水平。

According to the China Business Intelligence Network Resport: Artificial Intelligence (AI) and Machine Learning (ML) technologies hold the potential to advance health care reform by unlocking key new insights from vast volumes of data generated during medical services delively. Meanwhile ,medical device manufacturers are leveraging these technologies to innovate their products---ultimately to better support medical practitioners and enhance patient care standards.

市场规模

Market Size

中国AI医疗器械市场起步较晚，目前市场仍处于初级阶段。近年来，中国AI医疗器械的市场高速发展，市场规模由2019年的124.7百万元大幅增加至2020年的291.8百万元，同比增长134%，预计2021年将继续大幅增长，达到506.8百万元。

China's AI-Powered medical device market emerged late and remains in its early stages. However, it has experienced rapid growth in recent years: its market size grew substantially from 124.7 million yuan in 2019 to 291.8 million yuan in 2020, respresenting a 134% year-on-year increase. Looking ahead, It is expected to grew futher to 506.8 million yuan in 2021.

数据来源：Frost& Sullivan、中商产业研究院整理

Source: Frost & Sullivan, collated by the China Business Industry Research Institute

驱动因素

Driving Factors

中国AI医疗器械市场增长潜力巨大，主要由以下因素驱动。就医疗器械软件（SaMD）在中国获接受程度而言，截至最后实际可行日期，SaMD在中国已于疾病筛查、诊断及治疗等领域获广泛应用。然而，采用深度学习技术的AI医疗器械（如我们的AI医疗器械产品及在研产品）仍限于中国顶尖医院。现在，中国5%至10%的二级及三级医院已采用应用了深度学习技术的AI医疗器械。

China's AI medical device market boasts significant growth potential, with its growth primarily fueled by the following factors. In term of SaMD (Software as a Medical Device) acceptance in China, as of the latest available date, SaMD has been widely adopted in disease screening, diagnosis, and treatment across the country. However, AI medical devices leveraging deep learning technology--such as our own AI medical devices and those currently in development—remain limited to China’s top-tier hospitals. Currently, only 5% to 10% of the country's secondary and tertiary hospitals have implemented such deep learning-enabled AI medical devices.

1.对医疗保健的需求与日俱增

1. The demand for health care is increasing day by day.

人们一直希望以AI医疗器械解决医疗资源短缺问题，同时应对不断增加的新挑战（如社会迅速老龄化等）所带来的压力。AI医疗器械预计也将在加速创新和重新定义医疗从业人员及机构价值等方面带来变革。

People have long sought to address the shortage of medical resources through AI medical devices, while also tackling the pressures posed by emerging challenges--such as society’s rapid aging. Additionally, AI Medical Devices are expected to accelerate medical innovation and redefine the value of both medical practitioners and institutions.

2.对AI赋能解决方案优势的认识增加

2. Increasing awareness of the advantages of AI enabling solutions

随着AI技术进一步发展，预计人们将通过验证AI技术产生可靠及可预测的输出，建立对该技术的信任。随着更多AI技术投入使用，医生和患者将愈来愈能体验到AI赋能的解决方案的进步和效率所带来的好处。

With the further advancement of AI technology, trust in AI is expected to grow as its ability to deliver reliable, predictable outputs is verified. As more AI technologies are deployed, doctors and patients alike will increasingly experience the benefits of AI-enabled solutions—specifically those stemming from their technological advancements and efficiency.

3.国家出台各种有利政策

3. The State has issued various favorable policies,

中国颁布了一系列旨在鼓励在医疗器械行业中应用AI技术的政策。例如，于2017年，国务院颁布新一代人工智能发展规划，就下一代AI的发展提供清晰方向。同年，国家药监局更新了《医疗器械分类目录》，将AI医疗器械列为第二类或第三类医疗器械。于2019年7月，国家药监局发布了《深度学习辅助决策医疗器械软件审评要点》，阐明了基于深度学习的医疗器械的临床试验要求和审批程序。2021年7月1日，国家药监局发布了《人工智能医用软件产品分类界定指导原则》，为AI医疗器械的分类提供进一步指导。

China has rolled out a series of policies aimed at encourage the application of AI technology in the medical device industry. For instance, in 2017, the State Council Promulgated the Development Plan for the Next Generation of Artificial Intelligence, laying out a clear direction for the advancement of the next-generation of AI. In the same year, the State Council Promulgated also updated the Catalogue of Medical Devices,classifying AI medical devices as Category II or Category III medical devices. Subsequently，in July 2019, it issued the Key Points for Evaluation Deep Learning-Assisted Decision-Making Medical Device Sofeware, clarifying the clinical trial requirements and approval procedures for deep learning-based medical devices.To further standardize the industry， on July 1, 2021, the State Council Promulgated released the Guiding Principles for the Classification and Definition of Al-Based Medical Software Products, which provides more detailed guidance on the classification of AI medical devices.

更多资料请参考中商产业研究院发布的《中国医疗器械服务行业市场前景及投资机会研究报告》，同时中商产业研究院还提供产业大数据、产业情报、产业研究报告、产业规划、园区规划、十四五规划、产业招商引资等服务。

For more information, please refer to the Research Report on Market Prospects and Investment Opportunities of China's Medical Device Service Industry, published by the China Business Industry Research Institute. Additionally, the Institute offers a comprehensive suite of services, including industrial big data analytics, industrial intelligence solutions, industrial research reports, industrial planning, park development planning, 14th Five-Year Plan consulting, and industrial investment promotion .

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