Effective manufacture of vaccines: the market of biopharmaceuticals in figures
In Minpromtorg of Russia, a workshop on technology solutions for effective manufacture of vaccines is taking place. Equipment vendors, process engineers, developers of novel bioproducts as well as regulators discuss and share the experience of manufacture of such effective biotech products which allow for prevention, diagnostics and treatment of infectious and invasive diseases.
Today, the topic of vaccines is placed great focus on. And it’s no wonder. The dynamics of the market of vaccines, based on the 2lec(prom) statistics reporting form, demonstrates an increased rate of manufacture of this type of bioproducts. The result for 2018 in Russia was RUB 15,520,804,144.597. The majority of domestic manufacturing sites focus on manufacture of vaccines for prevention of influenza, yellow fever, pneumococcal infections, and tick-borne encephalitis. As for manufacturing steps, it can be concluded that 79.1% (in packs) of the total amount of vaccines and anatoxins holding the Marketing Authorization and listed in the National Register of Drugs are products with their full-cycle localized in our country. Vaccines without local manufacture in Russia are only 1.7% of packs of bioproducts (14.5% are sites localized in Russia and manufacturing finished dosage forms, while 4.7% are sites executing packaging of vaccines in Russia.) or RUB 1,610,583,544.7072.
As it was reported by the Director of FSI «SID & GP» Mr. Vladislav Shestakov in his welcome word towards the participants of the workshop «Advanced technology solutions for effective manufacture of vaccines» held by Minpromtorg of Russia, today, the leading exporters among the Russian companies manufacturing vaccines and supplying them to the countries of the EAEU, CIS, Latin America an Africa are as follows:
- FSBI Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of the Russian Academy of Sciences, which last year supplied 319,776 packs of vaccines for prevention of yellow fever and tick-borne encephalitis for the total amount of RUB 1,948,083,032.99
- NPO Petrovax Pharm Ltd. and FSBI SPbSRIVS of the Federal Medical and Biological Agency, which exported 2,681,056 and 143,048 packs of vaccines for prevention of influenza
- Various manufacturing sites of FSBI NPO Microgen supplying vaccines for prevention of tick-borne encephalitis, influenza, tularemia, and anatoxins – diphtheritic and tetanic, tetanic, and diphtheritic
- JSC Binnopharm, which exported 1,936 packs of vaccines for prevention of viral hepatitis B.
«It is not a coincidence that I provide these data – they bear witness that, on one hand, domestic vaccines are popular not only within the CIS and the EAEU territory, but their quality, compliance with GMP standards upon manufacture of Russian vaccines satisfy regulators from other countries,» emphasized Mr. Vladislav Shestakov.
On the other hand, considering the Russian market, the TOP-10 manufacturers of vaccines are on a par with domestic pharmaceutical companies and Big Pharma companies exercising mostly technology transfer from the sending sites to manufacturing sites in Russia: NPO Microgen, Pfizer, SANOFI-AVENTIS, FSBI Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products of the Russian Academy of Sciences, MARATHON PHARMA, NPOPetrovax Pharm, GlaxoSmithKline and Merck Sharp and Dohme.
- The Formulary of Russian pharmaceutical manufacturers by SID & GP is a tool much in demand by the industry
- A business meeting between the EAEU’s ISPE and the senior management of ISPE was held in Dublin
- Based on the results for 2018, 0.11% is the share of the drugs imported from Latin America
- The Russian GMP inspectorate signed an Agreement on Cooperation with the Cuban CECMED
- The Russian «Data Integrity & Computer System Validation» Guidelines were presented at the ISPE session