In Vitro Diagnostic Reagents Seeking Localization

Some leading in vitro diagnostic reagent companies in Guangdong Province are accelerating the implementation of product serialization, diagnostic accuracy, and reagent instrument integration. Some products have gone abroad and are actively exploring the international market

June 11-12, under the guidance of the Medical Device Supervision Department of the State Food and Drug Administration, sponsored by the China Medical News Information Association, and undertaken by the Guangdong Food and Drug Administration and the Zhuhai Food and Drug Administration, the “In Vitro Diagnostic Reagent Quality Journey” event Started in Zhuhai. This event focused on the quality and safety of in vitro diagnostic reagents that belong to the scope of medical device supervision, and the theme was “Reasonable Use of Devices, Healthy Life”.

　　In recent years, with the continuous development of the medical device industry, the phenomenon of low market concentration and uneven product quality has become increasingly prominent. The problems in the production, operation and use of in vitro diagnostic reagents are still prominent.

From following to beyond

The relevant person in charge of the Guangdong Provincial Bureau and the Zhuhai Municipal Bureau said, “This in-vitro diagnostic reagent quality tour will combine legal and regulatory consultation, identification of counterfeit and inferior products, display of brand-name and high-quality products, public interactive experience, and free consultations in medical institutions to carry out popular science promotion; Organize a symposium to invite regulatory authorities, key production and operation companies, testing institutions, and practitioners to conduct face-to-face communication to understand the status quo of industrial development, promote typical experience and effectiveness; conduct in-depth investigations into the production process of in vitro diagnostic reagent enterprises in Zhuhai, and understand the production varieties and industries Status, corporate quality and safety management level, etc.”

The food and drug regulatory authorities at all levels in Guangdong Province always attach great importance to the product quality of in vitro diagnostic reagents, and strive to build and consolidate the special governance of “multi-party participation, combination of combat and prevention, combination of construction and construction, public benefit, and industry development” in the quality supervision of in vitro diagnostic reagents. New model.

　　 According to incomplete statistics, there are currently 142 in vitro diagnostic reagent manufacturers in Guangdong Province, with about 1,400 product registration certificates, and well-known companies such as Shenzhen Mindray, Daan Gene, and Zhuhai Livzon Reagent. Guangdong Province ranks among the top in the country in terms of the number of in-vitro diagnostic reagent production and operation enterprises, gross production value, and supervision and sampling qualification rate. The in vitro diagnostic reagent industry in Guangdong Province is developing from “following” to “surpassing” foreign companies. Some leading companies are accelerating the implementation of product serialization, diagnostic accuracy, and reagent instrument integration. Some products have gone abroad and actively explored the international market.

Among them, the in vitro diagnostic reagent industry in Zhuhai has shown a good momentum of development in terms of production, sales, research and development, and benefits. There are nearly 20 in vitro diagnostic reagent manufacturers in the city, with an output value of nearly one billion yuan. In recent years, Livzon reagents, High-tech enterprises such as Deere Biology, Lituo Development, Yinke Biology, Besso Biology, Haitai Technology, and Celec Biology.

　　 At the symposium between the regulatory authorities and the companies, relevant persons in charge of nearly 20 companies spoke. A person in charge of an enterprise believes that “In the past, IVD was based on the management standards of drugs or medical devices, and the development of the industry needs to be more in line with the quality standards of in vitro diagnostic reagents and better graded management. The innovation and quality of in vitro diagnostic reagents is the enterprise The core competitiveness and the standard management within the company are also very important. Moreover, companies need to continue R&D, innovate in technology, and improve the after-sales service system.” Particularly worthy of attention is that IVD will directly enter families and communities in the future. Diagnostics and in vitro diagnostic reagents OTC will be the development trend.

　　 At the same time, they also called for “domestic products need fairer opportunities for competition. Nowadays, bidding and procurement are winning bids at low prices, and high-quality products are crowded out by low-priced products. Purchasing behavior should guide industry standards and encourage high-quality products to win bids.”

International market contest

　　 Subsequently, the reporter and the regulatory authorities investigated and interviewed several in vitro diagnostic reagent companies in Zhuhai. According to Livzon Reagent, a leading enterprise in the reagent industry in Zhuhai, from the perspective of growth trends, personal IVD costs have a lot of room for growth, and the entire IVD industry will maintain a 15% growth rate. At present, about 37% of the market share of China’s IVD industry is occupied by five multinational companies: Roche, Beckman, Sysmex, Siemens and Abbott. The high-end and small-scale market is monopolized by multinational companies. The main driving forces of the market are the low-end market represented by biochemical testing and the high-end market represented by chemiluminescence testing. Under relevant policies, domestic substitution of imported products will become the future development trend.

Regarding the domestic substitution, Sun Yifeng, general manager of Zhuhai Yinke Medical Engineering Co., Ltd., said that the company recently learned that in a tertiary hospital, a Yinke equipment is obviously more advanced in detection principles than the new generation abroad, and the price is It is only one-tenth of the price of the foreign product, but the hospital still chooses to purchase imported brands. “In fact, some domestic products are completely comparable in quality to foreign products, but hospitals habitually purchase imported products. At present, domestic products can only gain users and patients when they are better than foreign products and have more competitive prices. Recognition.”

　　 Although it will take time to replace domestically produced products, domestically produced products have already achieved breakthroughs in some segments. As one of the few independent R&D high-tech enterprises in the field of microbiological medical instruments and related diagnostic reagents in China, Xie Yanchi, deputy general manager of Deere Biotech, proudly said, “For more than ten years, Deere has participated in the construction of more than 3,000 hospitals at all levels in China Every second, on average, one product is used by users.” The company has some unique products nationwide and even globally. In order to break the monopoly of foreign-funded enterprises, the company finds the best hospitals for fair comparison and uses the results to prove its strength. Recently, the company’s export achievements have been remarkable, and Deere wants to conduct inspections in the international market and export better inspection products.

　　 In addition to working hard to improve the level and quality of product research and development, domestic companies are also actively seeking cooperation with international high-end companies. Li Lin, general manager of Livzon Reagents, told reporters, “Recently, the company signed a framework agreement with Cynvenio of the United States to actively develop and deploy tumor genetic testing and emerging business areas of precision medicine.” It is understood that the founder of Cynvenio is a Nobel Prize winner in 2000. The company’s main business is to provide patients with non-invasive and comprehensive tumor genetic testing services.