Abstract:CT equipment is one of the most common medical imaging equipment in clinical application, which is the largest market segment of the medical imaging equipment market due to its high imaging density resolution, convenient examination, ability to overcome the problem of overlapping traditional X-ray images, and can be used for the examination of various diseases. With the aging of the population and the increase in the number of chronic diseases, the clinical demand for CT examination in the society continues to grow, the advantages of CT equipment in disease screening and diagnosis and the necessity of equipment are more prominent, and the procurement demand for CT equipment from medical institutions at all levels continues to grow, which promotes the rapid growth of the CT equipment market in mainland China. In 2023, the number of CT equipment in mainland China will reach 47,375 units.
1. Definitions and Classification
CT equipment, that is, computed X-ray tomography equipment, is a device that uses X-rays to scan the human body by tomography, and then turns the analog signal r received by the detector into a digital signal, calculates the attenuation coefficient of each pixel by an electronic computer, and then reconstructs the image, and can display the tomography structure of various parts of the human body. CT equipment can be divided into ordinary CT, spiral CT, electron beam CT, energy spectrum CT and PET-CT.
Second, industry policies
1. Competent authorities and regulatory system
The competent authorities for CT equipment include the National Development and Reform Commission, the Ministry of Industry and Information Technology, the National Health Commission, and the State Drug Administration. Industry self-regulatory organizations include the China Association for Medical Devices and the China Association for Medical Equipment.
The National Development and Reform Commission is mainly responsible for formulating and organizing the implementation of national economic and social development strategies, medium- and long-term plans, and annual plans, and for putting forward macroeconomic regulation and control policy proposals. The Ministry of Industry and Information Technology of the People's Republic of China is mainly responsible for formulating and organizing the implementation of plans, policies and standards for high-tech industries such as biomedicine and medical devices, and guiding technological innovation and technological progress in the industry. The National Health Commission is mainly responsible for organizing the formulation of national health policies, formulating draft laws and regulations, policies and plans for the development of health undertakings, formulating departmental rules and standards, and organizing their implementation. The National Medical Products Administration is mainly responsible for the safety supervision and management of medical devices. Formulate supervision and management policy plans, organize the drafting of draft laws and regulations, formulate departmental rules, and supervise their implementation. Research and formulate management and service policies to encourage new technologies and new products of medical devices.
China Association for Medical Devices Industry is mainly responsible for carrying out investigation and research on the development of the medical device industry, providing opinions and suggestions on policies and legislation to the State Drug Administration and other relevant government departments, organizing the formulation and supervision of industry policies, promoting the healthy development of the industry, and participating in the formulation, revision, publicity and promotion of national standards, industry standards and quality standards. The China Association of Medical Equipment is mainly responsible for carrying out academic and technical exchanges, promoting new technologies, new products and suitable medical equipment technologies, and promoting scientific and technological innovation and effective application of medical equipment.
2. Industry-related policies
CT equipment belongs to the medical equipment industry, and product quality and reliability are closely related to people's life and health safety. The mainland implements strict supervision and management of the medical device industry, including the classification management system, product filing and registration management system, production management system, operation management system, etc., covering product registration, production and circulation. According to the Measures for the Supervision and Administration of Medical Device Business (Order No. 54 of the State Administration for Market Regulation), medical device registrants and record-filing persons do not need to apply for medical device business licenses or filings when they sell medical devices registered or filed at their domicile or production address, but they shall meet the prescribed business conditions; At present, the mainland's large-scale medical devices have not yet been promoted in the country with volume procurement, but the government has carried out centralized procurement, and vigorously promote the localization of substitution, the future government procurement will be one of the important sales sources of domestic CT equipment enterprises. The introduction and implementation of policies such as the "14th Five-Year Plan" for the Development of Medical Equipment Industry and the Action Plan for Comprehensively Improving Medical Quality (2023-2025) have created good development opportunities for local enterprises.
3. Industry barriers
1. Technical barriers
CT equipment is a technology-intensive industry, involving clinical medicine, precision machinery, applied physics, electronic devices, materials science, computer software and hardware and other disciplines, with a high threshold and long cycle for product research and development. For example, the centimeter-level expansion of the aperture of the scanning frame will produce a series of changes in the design of core components such as detectors and X-ray tubes, as well as a series of changes such as positioning adjustment and calibration, which have high technical barriers.
2. Talent barriers
The interdisciplinary and cross-technical characteristics of CT equipment R&D technology require enterprises to have strong comprehensive R&D capabilities and technical experience, and a R&D team with strong professional technology, multidisciplinary combination and rich industrial experience is an important source for enterprises to maintain innovation vitality. With the continuous development of medical imaging technology in mainland China, CT equipment will gradually move from basic to mid-to-high-end, putting forward higher requirements for R&D capabilities, so the demand for high-level and experienced technical talents will continue to increase. However, it is often difficult for new entrants in the industry to establish a mature R&D team in a short period of time, so they face high talent barriers.
3. Financial barriers
CT equipment has the characteristics of long R&D cycle and large R&D investment, which requires a large amount of scientific research funds to introduce advanced talents and equipment, conduct industry development research, and design and development of new products. The market recognition of new entrants is relatively low, and they rely on their own funds and bank loans in terms of equipment procurement, talent introduction, product research and development, etc., and the financing channels are relatively single. As a result, financial strength constitutes an important barrier to entry into the industry.
Fourth, the industrial chain
1. Analysis of the industry chain
The upstream of the CT equipment industry chain mainly includes hardware suppliers such as X-ray tubes, flat panel detectors, and high-voltage generators, as well as software suppliers who provide various image processing software and computing and storage services. As one of the core components of CT equipment, X-ray tube is a high-value consumable with high technical barriers, and its performance directly affects the inspection effect and service life of CT examination. In complex CT equipment, the X-ray tube is more susceptible to damage and malfunction as the number of exposures increases. The global X-ray tube market pattern is highly concentrated, with foreign manufacturers such as GE, Philips, Siemens, and Canon occupying the main market share. At the same time, with the support of relevant national policies, a number of X-ray tube companies have also emerged in the mainland, such as Kunshan Yiyuan, Dianke Ruishi, etc., gradually narrowing the technical gap with the industry's leading enterprises, and the upstream supply is increasingly sufficient and tends to be localized, promoting the stable development of CT equipment.
The downstream of the CT equipment industry chain mainly includes medical institutions, mainly public hospitals, private hospitals, independent medical imaging diagnostic centers, as well as third-party testing institutions and third-party laboratories. With the promotion of the national "hierarchical diagnosis and treatment" policy, the market demand for primary medical imaging equipment will continue to increase, boost the CT equipment market sinking, and gradually realize all-round coverage of counties, towns and regions. At the same time, the emergence of independent medical imaging diagnosis centers not only relieves the pressure of imaging centers in large hospitals, reduces the corresponding human and material costs, but also provides patients with examination convenience and saves treatment time, which is expected to become an effective supplement to multi-level medical resources in the mainland, so as to tap the potential market increment of CT equipment. The industrial chain of China's CT equipment industry is shown in the figure below:
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