Kidney sufficiency: import substitution of dialysis machines in Russia
The first fully domestic production of dialysis machines will appear in Russia: Pharmasintez received a loan of 1 billion rubles from the Industrial Development Fund (IDF). Now the Russian market of such devices is controlled by foreign companies. But the establishment of the plant in Kaluga will allow to increase the share of domestic products in this market up to 80% by 2030, noted in the IDF. It is planned to start production of the devices by the end of 2025. On how in Russia import substitution of dialysis equipment, - in the material "Izvestia".
Equipment replacement
The Supervisory Board of the Industrial Development Fund approved the provision of 1 billion rubles for the opening of Russia's first integrated production of medical equipment and consumables for dialysis, told "Izvestia" director of theIndustrial Development Fund Roman Petruta. Pharmasintez-Medtech received financial support to set up the plant at the rate of 3% per annum for a period of five years.
Water treatment department at the outpatient dialysis center in the Sverdlovsk region
The total investment in the project to create the plant will exceed 2 billion rubles. The opening of the plant at the Rosva Industrial Park in Kaluga will help to increase the share of domestic products in a number of products up to 80%.
- The creation of the new plant is designed to reduce Russia's dependence on foreign suppliers and provide patients with quality medical products and effective therapy," said Roman Petruta.
According to FRP, after reaching full capacity, the enterprise will be able to annually produce more than 1.5 thousand devices for various types of dialysis, 7 million units of hemodialysis consumables and about 20 million consumables for the equipment.
Itis planned to start production of the full list of products for dialysis by the end of 2025, said Nikolay Panikarovsky, General Director of Pharmasintez-Medtech.
But the creation of the plant is only the first stage of the company's import substitution program, it intends to allocate more than 20 billion rubles for this purpose until 2030, said the president of Pharmasintez Group of Companies Vikram Punia.
- After the sudden withdrawal of the American company Baxter from the Russian market, our GC took emergency measures to launch production and supply of dialysis solutions. Taking into account that supplies of equipment and consumables from unfriendly countries are unstable, we decided to make Russia absolutely independent from supplies of foreign equipment and consumables for dialysis, - he said.
As it was specified in the press-service of the company, the production capacity will allow to cover the entire need of Russian patients in consumables and medical equipment for permanent outpatient and automated peritoneal dialysis, as well as from 75 to 100% of the need in medical equipment and consumables for hemodialysis.
Now on the Russian market there are "Malakhit" and "Malakhit 2", created on the platform of devices from Nipro (Japan). And, as the company noted, its strategic task is to establish the production of dialysis apparatus from 100% domestic components.
"90% of dialysis procedures in our country are now carried out on imported medical devices and equipment, a large proportion of which are "closed systems" operating only on consumables of one company, - said in the press service of "Pharmasintez". - This is how Western manufacturers are trying to protect their position in the market".
Galina Goretskaya, the chairman of the board of the patient organization Nephro-Liga, explained to Izvestia that about 54 thousand people in Russia are on hemodialysis and about 2 thousand - on peritoneal dialysis (when the procedure is carried out at home).
What is the difference between the Russian device
Now the prototype of the Russian device for peritoneal dialysis is developed, it is being tested, told "Izvestia" in the company "Novadial" - the official distributor of solutions.
- The domestic device displays all the necessary information on the screen. The patient can see the duration of treatment, familiarize himself with the scheme of the prescribed therapy, it is displayed how long the solution will be dripped and the volume of its pouring - listed the representative of the company. - All information is entered by the doctor, junior staff can change it only if they have a password and login to enter the system.
With the help of this device, the doctor will be able to remotely monitor the patient's condition and make timely adjustments to the treatment, Nikolay Panikarovsky added.
Chinese components were used in the development of the device, but in the next two to three years it is planned to produce the device mainly from Russian components, added Farmasintez-Medtech CEO.
- We have every opportunity to achieve technological sovereignty in the field of peritoneal dialysis," he said.
Equipment and drugs market
Until 2022, the needs in this equipment and products were mainly met by supplies of the American company Baxter. Now the main foreign players in the Russian dialysis market are products of the German company Fresenius and B.Braun, said Oleg Volkov, medical director of the domestic manufacturer of unique embolization particles and silicone implants "Plastis-M".
According to the analytical company "Kontur", in 2023 Fresenius supplied to the market of devices and consumables for dialysis for almost 2.4 billion rubles, Baxter - for 957 million and B.Braun - almost 783 million rubles. At that time, Fresenius held 33% of the market, Baxter - almost 14%, B.Braun - 11.1%.
In January-June 2024, Fresenius supplied the Russian market with devices and other medical devices for almost 1.7 billion rubles, B.Braun - for 467 million rubles, Baxter - for 207 million rubles. The share of the first company in the Russian market amounted to 35.5%, the second - almost 10%, the third - 4.3%. In fourth place is the Russian company Efferon: it produces disposable devices for extracorporeal blood purification and held 4.2% of the market, and in 2023 - 2.7%.
Drugs for dialysis in Russia now import substitution is more active than equipment, admitted Nikolay Bespalov, development director of the analytical company RNC Pharma.
According to his data, 6.1 million vials of hemodialysis drugs will be produced in 2024, which is 19% more than in 2023. Polysan is the main player in this area. In 2024, according to RNC data, it supplied the market with almost 6 million packs of infusion therapy drug with the active ingredient meglumine sodium succinate. This, according to Nikolai Bespalov, is almost 33% more than in 2023. Also small volumes of drugs for hemodialysis, he added, were produced by KHFK Mir and Kursk Biofactory.
The market received 2.3 million packs of peritoneal dialysis drugs in 2024. According to the RNC, this is 15% less than in 2023.
Nikolay Bespalov added that there are four companies working in this area in Russia and Fresenius is the leader. It provided 1.4 million drug packages in 2024 and their volume grew by almost 7% over the year. The second place goes to the Russian company Pharmasintez. It produced 723 thousand packages of drugs and increased their production volume 29 times.
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