1.Technical barriers to auto injector

The parts of an auto injector are generally less than 20, and the structure is relatively simple, so breaking through the original auto injector patent is the core barrier of the industry. In addition, due to the early appearance of injector, there are currently more than 40,000 insulin pen patents accumulated worldwide, of which more than 1,500 are core pen structure patents, and most of them are registered by some international companies . As of 2022, YPS, the world’s largest OEM manufacturer, has 2,162 patents worldwide. Overseas pharmaceutical companies including Eli Lilly, Novo Nordisk, Sanofi and other companies have not only accumulated a large number of injection pen-related patents for product strategy considerations, but also developed auto injector pens for their own drugs to achieve cost-effective sales.

• At present, China’s auto injector pens face the following pain points:
  • The patent density is high and the breakthrough difficulty is high;Because the structure is relatively simple, and the simpler the structure, the fewer options there are in terms of solutions; plus international companies started research and development very early and have already laid out basic feasible solution patents, so it is extremely difficult to break through the patents.
  • Patent study requires high time costs, requires large investment in special R&D equipment, and takes a long time;
  • As customers’ drug development, clinical trials, approval and marketing progress, there is a risk that progress may not be as expected.

At present, if Chinese drug and medicine manufacturers need auto injector pens, there are two options: Option 1, cooperate with auto injector manufacturers with independent intellectual property rights. For example, choose to cooperate with YPS; but its high-end, cost-effective products are often used by giants, leaving few auto injector options for biopharmaceutical manufacturers, and this situation has led to a reduction in the cost-effectiveness of pharmaceutical drugs. Option 2, choose to cooperate with domestic auto injector manufacturers . Under such conditions, the quality of the auto injector pen product itself may not be effectively guaranteed; even if pharmaceutical companies use domestically made subcutaneous injection, they can only promote them in China and underdeveloped regions where the awareness of intellectual property protection is not strong, and cannot promote them in developed markets in Europe and the United States with higher consumption capacity.

However, both of the above solutions will further restrict the development of enterprises. Moreover, each manufacturer’s auto injector can only be used with its own manufacturer’s insulin pen cartridge. In order to make the adjusted insulin dose injection more accurate, control the patient’s blood sugar level, avoid serious consequences of blood sugar disorders in the future, and ultimately improve the patient’s quality of life, long-term mixed use of different injection pens should be avoided. Therefore, in terms of patent breakthroughs, Chinese companies still need more time to polish.

2.The industry chain of auto injector

At present, the resources of auto injector accessories in China are relatively abundant, with sufficient mold and injection molding capacity, and the precision standards are gradually improving. There are relatively few companies that provide the auto injector’s own shell/power components, both at home and abroad. The main ones abroad are Ypsomed, SHL and BD, and the main one in China is Healthy Tree Medical.

In China, currently the automated production equipment for injection pens is mainly imported, mainly from Italy’s Mikron. Currently, only Maide Medical and Healthy Tree Medical in China provide fully automatic injector production lines . In terms of auto injector brands, except for Novo Nordisk, Eli Lilly and BD, most companies need to customize injector products from large injector manufacturers such as YPS or SHL. In addition, domestic insulin manufacturers customized products from large manufacturers such as YPS in the early stages, such as Tonghua Dongbao’s Xiulin Pen. Currently, domestic newly established injector pen companies are mainly produced by employees who have resigned from large auto injector manufacturers and set up new companies in China. They do not have complete intellectual property rights and will face greater intellectual property risks in the case of large-scale shipments or overseas shipments. Therefore, with a large number of domestic biopharmaceutical products and different demands, companies with the ability to develop auto injector production equipment and original research capabilities and independent intellectual property rights will have a significant voice in the entire auto injector industry.

As the comprehensive provider of self-medication solutions, Healthy Tree Medical has obtained 5 invention patents for its self-developed cartridge-type automatic injector, 29 invention patents are being accepted, and 3 PCT patent applications; it was approved for NMPA Class II in July 2023, and is expected to expand production to 100 million units in 2024. The company has broken through the patents of BD’s anti-needlestick device, SHL’s PFS auto injector, and Novo’s cartridge injection pen, which have monopolized the industry for many years , and has independent technical barriers and global competitiveness .

HealthyTree autoinjector products

Healthy Tree Medical has an integrated industrial chain of design, R&D, production and sales, and has the ability to independently develop auto injector production, assembly and testing equipment, including fully automatic power component lines, fully automatic assembly lines, semi-automatic assembly lines, injection pen testing machines, light inspection machines, nasal spray pressing devices, twist rod labeling machines, etc. The company can provide customized equipment and injection pens according to customer needs. Healthy Tree Medical adheres to the technical concept of “letting professionals do professional things” and is committed to providing pharmaceutical companies with self-administration devices and corresponding injection solutions.