Medicinal Isotopes in Russia and the world: Production, Market and Forecast (6 edition)

Annotation

 

List of abbreviations

 

Introduction

 

1. Use of isotopes in medicine

1.1. Main areas of medical application of radionuclides

1.1.1. Isotopes for diagnostics

Single photon emission computed tomography (SPECT)

Positron emission tomography (PET)

Markers for biochemical analysis

1.1.2. Therapeutic radionuclides

Radionuclide therapy (RNT)

Implantable radioisotope current sources

Radionuclide therapy in rheumatology. Radiosynovectomy

1.2. Main Medical Applications of Stable Isotopes

1.2.1. Diagnostic applications of stable isotopes

1.2.2. Therapeutic applications of stable isotopes

 

2. Methods for obtaining medical isotopes in Russia

2.1. Production of PET radiopharmaceuticals and GMP rules

2.2. Basic methods for obtaining stable isotopes

2.3. Basic methods for obtaining radionuclides

2.3.1. Production of radionuclides in nuclear reactors

2.3.2. Obtaining radioisotopes at particle accelerators

2.3.3. Radionuclide generators

 

3. Manufacturers of medical isotope products in 2018-2022

3.1. The largest foreign producers of medical isotopes

3.2. Main Russian producers of medical isotopes in 2018-2022

PET centers

Rusatom Healthcare JSC (Moscow)

JSC V/O Izotop (Moscow)

JSC NIFHI im. L. Ya. Karpova (Obninsk, Kaluga region)

Federal State Unitary Enterprise "FTsPRYAM" / Plant "Medradiopreparat" (Moscow)

Pharm-Sintez JSC (Moscow)

Bebig LLC (Moscow)

OOO "Diamed" (Moscow)

FSUE PA Mayak (Ozersk, Chelyabinsk region)

JSC "SSC RIAR" (Dimitrovgrad, Ulyanovsk region)

JSC "Institute of Reactor Materials" (Zarechny, Sverdlovsk region)

JSC "Production Association "Electrochemical Plant" (Zelenogorsk, Krasnoyarsk Territory)

Federal State Unitary Enterprise Electrokhimpribor Plant (Lesnoy, Sverdlovsk Region)

Leningrad Nuclear Power Plant (Sosnovy Bor, Leningrad region)

JSC "SSC RF-IPPE" A. I. Leipunsky "(Obninsk, Kaluga region)

ZAO Cyclotron (Obninsk, Kaluga region)

JSC Radium Institute named after V. G. Khlopin (St. Petersburg)

JSC "Ritverts" (St. Petersburg)

JSC "Siberian Chemical Plant" (Seversk, Tomsk region)

RNTSRHT them. Ak. A. M. Granova (St. Petersburg)

NMITs them. V. A. Almazova (St. Petersburg)

Institute of Physical Chemistry and Electrochemistry. A.N. Frumkin RAS (Moscow)

Tomsk NIMC RAS (Tomsk)

Tomsk Polytechnic (Tomsk)

Federal Biomedical Agency of Russia (Moscow)

Center for the Development of Nuclear Medicine LLC (Moscow)

Institute for Nuclear Research RAS (Moscow)

Other

 

4. Export and import of medical isotopes in Russia in 2018-2022

4.1. Peculiarities of export-import deliveries of isotopes

4.2. Export-import of the main medical isotopes in 2018-2022

Anonymous (unidentified isotopes)

Actinium-225

Actinium-227

Americium-241

Bor-10

Tungsten-188

Gadolinium-153

Helium-3

Germanium-68

Iridium-192

Iodine-125

Iodine-131

Oxygen-18

Cobalt-60

Lutetium-177

Molybdenum-99

Palladium-103

Radium-223

Radium-224

Ruthenium-106

Strontium-89

Strontium-90

Carbon-13

Carbon-14

Phosphorus-32

Phosphorus-33

Cesium-131

Cesium-137

 

5. Price analysis of medical isotopes in the Russian Federation in 2007-2022.

5.1. Raw isotope prices

5.2. Prices for isotope generators

5.3. Prices for isotope radiation sources

5.4. Prices for radiopharmaceuticals

 

6. Analysis of the state of the modern market for medical isotopes

6.1. Foreign countries

6.2. Russian market in 2022

 

7. Consumption of medical isotopes in the Russian Federation in 2022

 

8. Forecast of production and consumption of medical isotopes in the Russian Federation for 2023-2030

 

Appendix 1: TOR for the construction of the Center for Nuclear Medicine in Obninsk

Appendix 2: Contact information of the main Russian producers and traders of medical isotope products

Appendix 3: Contact information of the main Russian consumers of medical isotope products

Appendix 4: List of main references

Table 1: Major foreign players in the nuclear medicine market in 2022

Table 2: Main players in the market of medical isotope products in the Russian Federation in 2022

Table 3: Level of production of medical isotope products in the Russian Federation in 2020 and 2022, Ki, kg, million rubles (without VAT)

Table 4: Financial performance of V/O Izotop JSC (Moscow) in 2018-2022, million rubles

Table 5: List of radiopharmaceuticals produced by JSC NIFHI im. L. Ya. Karpova»

Table 6: Main financial indicators of JSC NIFKhI im. L. Ya. Karpov” in 2018-2022, million rubles

Table 7: RFLP nomenclature at the projected site of the Medradiopreparat Plant (Moscow)

Table 8: Nomenclature for the supply of reagents for the production of radiopharmaceuticals to the Federal State Budgetary Institution “RNTsRHT them. Ak. A. M. Granov" 11.03.2022

Table 9: Key financial indicators of Pharm-Sintez JSC in 2018-2022, million rubles

Table 10: Financial performance of Bebig LLC in 2018-2022, million rubles

Table 11: Nomenclature of radiopharmaceuticals based on technetium-99 manufactured by Diamed LLC (Moscow)

Table 12: Financial performance of Diamed LLC in 2018-2022, million rubles

Table 13: Main financial indicators of FSUE PA Mayak in 2018-2022, million rubles

Table 14: Main financial indicators of JSC "SSC RIAR" in 2018-2022, million rubles

Table 15: Key financial indicators of IRM JSC in 2018-2022, RUB mln

Table 16: Key financial indicators of PA ECP JSC in 2018-2022, million rubles

Table 17: Products for nuclear medicine of the Physico-Energy Institute. A. I. Leipunsky in 2019

Table 18: Main financial indicators of JSC "SSC RF-IPPE" in 2018-2022, million rubles

Table 19: Key financial indicators of CJSC Cyclotron in 2018-2022, million rubles

Table 20: Key financial indicators of JSC “Radium Institute named after A.I. V. G. Khlopin" in 2018-2020, million rubles

Table 21: Key financial indicators of Ritverts JSC in 2018-2022, RUB mln

Table 22: Main financial indicators of SGChE JSC in 2018-2022, billion rubles

Table 23: Financial performance of CRYAM LLC in 2018-2022, million rubles

Table 24: Financial performance of Bebig Isotopen LLC in 2018-2022, million rubles

Table 25: Raw isotopes, export leaders in value terms in 2007-2022, thousand $

Table 26: Export of sealed radiation sources for medical purposes in 2007-2022, thousand $

Table 27: Imports of sealed sources and isotope generators for medical purposes in 2007-2022, thousand $

Table 28: Anonymous companies in export and import declarations in 2018-2022

Table 29: Russian exports of the raw isotope actinium-225 produced by the IPPE through V/O Isotope in 2018-2022, mCi, thousand $

Table 30: Export of raw material isotope tungsten-188 produced by SSC RIAR in the form of sodium tungstate solution in 2018-2022, Ci, thousand $, thousand $/Ci

Table 31: Export of the raw isotope gadolinium-153 produced by the State Research Center RIAR in Russia in 2018-2022, Ki, thousand $

Table 32: Exports of helium-3 isotope of the highest grade (B) with 99.99% of the isotope and grade 1A with 99.8% of the isotope produced by FSUE PA Mayak Russia in 2018-2022, g, thousand $

Table 33: Export of the raw isotope germanium-68 produced by CJSC Cyclotron in Russia in 2018-2022, Ki, thousand $

Table 34: Export of gallium-68 generators based on germanium-68 isotope by Russia in 2018-2022, units, Ki, thousand $

Table 35: Import of sources for gamma therapy from the isotope iridium-192 by Russia in 2018-2022, Ki, thousand $

Table 36: Export of raw isotope iodine-125 by Russia in 2018-2022, Ki, thousand $, thousand $/Ci

Table 37: Import of radioimmune kits based on iodine-125 isotope by Russia in 2018-2022, mCi, thousand $, units, thousand $/mCi, $/unit

Table 38: Imports of iodine-125 by Russia for the production of microcapsules for brachytherapy in 2018-2022, Ki, thousand $, thousand $/Ci

Table 39: Import of RF microcapsules for brachytherapy based on iodine-125 isotope in 2018-2022, Ci, thousand $, units, $/Ci, $/unit

Table 40: Export of raw isotope iodine-131 by Russia in 2018-2022, Ki, thousand $, $/Ki

Table 41: Russia imports of iodine-131 isotope in carbonate buffer for intravenous injection in 2018-2022, Ci, thousand $, thousand $/Ci

Table 42: Import of Medsnab LLC of unregistered drug 131I-MIBG manufactured by the Institute of Isotopes (Hungary) in 2018-2022, Ki, thousand $, thousand $/Ki

Table 43: Export of water enriched with oxygen-18 isotope, Russia in 2018-2022, kg, thousand $, $/g

Table 44: Export of the raw isotope cobalt-60 in 2018-2022, thousand Ci, thousand $, $/Ci

Table 45: Export of sources based on the isotope cobalt-60 by Russia in 2007-2022, thousand Ci, thousand $, $/Ci

Table 46: Russia's imports of sealed sources with cobalt-60 isotope for medical equipment in 2018-2022, Ki, thousand $

Table 47: Export of the raw isotope lutetium-177 by Russia in 2018-2022, Ki, thousand $, thousand $/Ci

Table 48: Export of molybdenum-99 isotope by Russia in 2018-2022, Ki, thousand $, $/Ki

Table 49: Import of technetium-99 generators on the molybdenum-99 isotope in 2018-2022, units, Ki, thousand $, thousand $/unit

Table 50: Export of raw isotope palladium-103 in the form of chloride by Russia in 2018-2022, Ki, thousand $, thousand $/Ci

Table 51: Imports by Russia of the Xofigo drug based on the radium-223 isotope in 2018-2022, units, mCi, thousand $

Table 52: Export of raw isotope ruthenium-106 in the form of chloride produced by RIAR Russia in 2018-2022, Ki, thousand $, thousand $/Ci

Table 53: Import of ophthalmic applicators based on ruthenium-106 isotope in 2018-2022, units, mCi, thousand $, thousand $/unit

Table 54: Export of raw isotope strontium-89 in the form of chloride produced by RIAR in 2018-2022, Ci, thousand $, thousand $/Ci

Table 55: Export of raw isotope strontium-90 by Russia in 2018-2022, Ki, thousand $, thousand $/Ci

Table 56: Russian exports and imports of gaseous carbon dioxide enriched in 13С isotope in 2018-2022, kg, thousand $, thousand $/kg

Table 57: Export of the raw carbon-14 isotope by Russia in 2018-2022, Ci, thousand $, thousand $/Ci

Table 58: Export of the raw isotope phosphorus-32 by Russia in 2007-2018, Ki, thousand $

Table 59: Export of the raw isotope cesium-131 in 2018-2022, Ci, thousand $, thousand $/Ci

Table 60: Export of reagents based on the isotope cesium-137 by Russia in 2018-2022, Ci, thousand $, thousand $/Ci

Table 61: Export of sealed sources based on the cesium-137 isotope for medical gamma devices by Russia in 2018-2022, units, Ci, thousand $, thousand $/Ci

Table 62: Average export prices for crude medical isotopes in 2007-2022, $/Ci

Table 63: Average export prices for medical isotope generators in 2007-2021, $/Ci, $/unit

Table 64: Average domestic prices for purchases of OBP technetium generators from V/O Izotop in 2011-2021, thousand rubles/unit VAT included

Table 65: Price level for a PET examination in April 2023 in Moscow, thousand rubles

Table 66: Consumption of isotope medical devices in the Russian Federation in 2021, million rubles

Table 67: The general structure of the use of medical isotopes in the Russian Federation in 2022, thousand units, billion rubles

Figure 1: Estimated shares of Russian manufacturers in the production of medical and dual-use isotopes in 2020-2022, %

Figure 2: Dynamics of export and import of medical and dual-use isotopes in 2018-2022, $ million

Figure 3: Shares of the main foreign companies-buyers of Russian isotope medical products in 2015, %

Figure 4: Shares of the main foreign companies-buyers of Russian isotope medical products in 2019, %

Figure 5: Shares of the main foreign companies-buyers of Russian isotope medical products in 2021, %

Figure 6: Shares of the main foreign companies-buyers of Russian isotope medical products in 2022, %

Figure 7: Geographic structure of Russian exports of medical isotopes in 2015, %

Figure 8: Geographic structure of Russian exports of medical isotopes in 2019, %

Figure 9: Geographic structure of Russian exports of medical isotopes in 2021, %

Figure 10: Geographic structure of Russian exports of medical isotopes in 2022, %

Figure 11: Dynamics of Russian exports of isotope medical products in 2007-2022, $ million

Figure 12: Imports of isotope medical products in 2007-2022, $ million

Figure 13: Shares of the main foreign companies supplying medical isotope products to Russia in 2015, %

Figure 14: Shares of the main foreign companies supplying isotope medical products to Russia in 2019, %

Figure 15: Shares of the main foreign companies supplying isotope medical products to Russia in 2021, %

Figure 16: Shares of the main foreign companies supplying isotope medical products to Russia in 2022, %

Figure 17: Dynamics of the average export price for Russian helium-3 grade "1A" (99.8%) in 2007-2021, thousand $ / gram

Figure 18: Dynamics of the average export price of water with 97% oxygen-18 isotope in 2007-2022, thousand $/kg

Figure 19: Dynamics of the average export price for carbon dioxide enriched in 13C over 99% produced by JSC "PA "Electrochemical Plant" in 2007-2018, thousand $/kg

Figure 20: Dynamics of the average export and import price for the iodine-131 isotope in 2014-2022, thousand $/Ci

Figure 21: Dynamics of the average price for imported microcapsules for brachytherapy based on the isotope iodine-125 in 2007-2022, $

Figure 22: Structure of consumption of isotope medical products in the Russian Federation in 2021, %

Figure 23: Forecast of the production of raw medical isotopes in the Russian Federation for 2023-2027, billion rubles

Figure 24: Forecast of the production of medical isotope products (radiopharmaceuticals, isotope generators, radiation sources, calibration sources, working gases for MRI) in the Russian Federation for 2023-2030, billion rubles

Figure 25: Number of procedures with medical isotopes in Russia in 2007-2022 and forecast for 2023-2030, thousand units in year