Abstract:The main application fields of disposable medical needles in China are infusion therapy, vaccination, diagnostic examination and specialized diagnosis and treatment. Infusion therapy is the most commonly used and basic treatment method in clinical practice, so disposable medical needle consumables have a large rigid demand, and the market consumption is huge, driving the market scale up, data show that the market size of China's disposable medical needle industry in 2022 will be about 20.271 billion yuan.
1. Definitions and Classification
Disposable medical needles are a typical medical puncture instrument with low-value medical consumables that are ready to use and discarded after use. Medical puncture instruments are divided into medical puncture needles and medical puncture devices, some medical puncture needles can be used independently, and some need to be used with devices, and medical puncture needles and supporting devices are combined together, called medical puncture devices. Disposable medical needles include injections, infusions, blood draws, bone marrow aspirateesis, anesthesia, needle knives, subcutaneous injections, spinal taps, gastric lavage, puncture catheters and guide needles, and amniocentesis, among others, each category has special designs and uses to meet different medical scenarios and needs.
Second, industry policies
The medical industry is related to the safety of national life and has always been the key industry in the process of national development, but in recent years, some medical consumables prices are inflated, excessive use and other problems have frequently appeared, and the medical consumables market is chaotic, in order to ensure the orderly development of the industry towards the trend of standardization, the state has issued a series of measures to supervise the medical consumables industry, providing a good policy environment for the development of the industry. At the same time, it also drives the development of China's disposable medical needle industry. In 2023, the "Opinions on Strengthening the Protection of Intellectual Property Rights in the Field of Centralized Pharmaceutical Procurement" was promulgated, and the policy pointed out that the products involving intellectual property risks in the large-scale and high-attention drugs and medical consumables that are planned to be purchased in a centralized manner will be focused on.
3. Industry barriers
1. Industry access barriers
Internationally, governments around the world have strict regulations and regulations on the market access of medical device products. The EU requires that products must pass third-party CE product certification, and the product can only be sold after the product is filed in the EU; The U.S. government requires products to be registered with the U.S. FDA before they can enter the market, and the U.S. FDA will conduct an on-site review of the manufacturer after the product enters the market; Health Canada requires that products must be certified by a third party before entering the market, and then the product is registered with the local government and the product registration code is obtained before it can be sold locally.
2. Intellectual property barriers
The medical device industry is a technology-intensive industry, with a large number of patents involved in the products, and a long patent protection period, a certain complexity of intellectual property rights, and high imitation barriers. Medical devices involve intellectual property rights not only including hardware parts and operating systems, but also software copyrights, and the number of related patents and copyrights is also more than that of innovative drugs and other products, which has a high difficulty in imitation and avoids the impact of product imitation after the expiration of patents. Leading companies in the industry have carried out patent protection for their main product technologies, forming certain patent barriers, and potential entrants in the industry need a long time of technology accumulation to enter the field.
Fourth, the industrial chain
The upstream of the disposable medical needle industry chain includes steel, biomedical coatings, sterilization materials, packaging materials, etc.; The downstream of the industrial chain is hospitals, clinics and other application fields. With the increase in the number of domestic medical institutions, the increase in the number of visits and hospitalizations, and the rapid growth of per capita medical expenditure, the demand for disposable medical needles in domestic medical institutions continues to expand.
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