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    Medicinal Isotopes in Russia: Production, Market and Forecast (4th edition)

    Number of pages: 236 Number of tables: 79 Number of figures: 21
    Language: Russian + English
    Released: 16.12.2019
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    This report is available both in Russian and English versions

     

    This review is the 4th edition of the study of the Russian market for medical isotopes.

    The purpose of the study is the analysis of the Russian market for medical isotopes.

    This market has been monitored since 2007.

    The object of the study are isotopes used in medicine, in particular: tungsten-188, gadolinium-153, helium-3, germanium-68, iridium-192, yttrium-90, iodine-124, iodine-125, iodine-131, oxygen- 18, cobalt-57, cobalt 60, lutetium-177, molybdenum-99, palladium-103, ruthenium-106, samarium-153, strontium-82, strontium-89, strontium-90, carbon-13, carbon-14, phosphorus -32, phosphorus-33, cesium-131, cesium-137.

    Chronological scope of the study: 2007-2019, forecast - 2020-2025.

    Research geography: Russian Federation - a comprehensive detailed analysis, the whole world - a brief description.

    This work is a desk study. As sources of information, we used data from Rosstat, the Federal Customs Service of the Russian Federation, scientific and technical literature, industry, regional and international press, as well as Internet sites of enterprises - manufacturers and consumers of isotope products.

     

    The report consists of an introduction and 5 chapters, contains 236 pages, including 79 tables, 21 figures and 2 appendices.

    The first chapter is devoted to the study of the main areas of medical use of radioactive and stable isotopes. This chapter describes the stable isotopes and radionuclides that are most widely used for diagnostic and therapeutic purposes, discusses the basic methods of nuclear medicine, and presents the most promising isotopes for the further development of nuclear biomedical technologies.

    The second chapter of the report describes the main methods for producing radionuclides and stable isotopes. This chapter discusses the most widely used methods of isotope separation in industry, describes the most important biomedical reactor and cyclotron radionuclides, the main nuclear reactions to produce them, and describes the generators of short-lived radionuclides currently used for medical purposes in Russia and abroad.

    The third chapter is devoted to manufacturers of medical isotopes and radiopharmaceuticals; the main nomenclature of their medical-isotopic products is described. Estimates of the production in the Russian Federation of both raw medical isotopes and isotope products (in kind and in value terms) are given and the shares of the main producers are indicated.

    The fourth chapter discusses Russian foreign trade operations with radiopharmaceutical products and medical isotope raw materials.

    In the fifth chapter, a study is made of the state of the modern market for medical isotopes. The forecast of development in 2020-2025 is given.

    The appendices to the report provide contact details of the largest Russian manufacturers and traders of medical isotope products, there is an alphabetical list of foreign partners in export-import operations and a list of the main literature used.

     

    The report features a detailed analysis of the dynamics of Russian export-import supplies of medical isotopes over the past 13 years in physical and monetary terms, a detailed description of the range of export and import products, detailed information about the main exporters and importers of medical isotope products in Russia.

     

    The target audience of the study:

    - medical isotope market participants - manufacturers, consumers, traders;

    - potential investors.

     

    The proposed study claims to be a reference tool for marketing services and specialists making managerial decisions working in the market for medical isotopes.

    Annotation

     

    Introduction

     

    1. The use of isotopes in medicine

    1.1. The main areas of medical use of radionuclides

    1.1.1. Diagnostic radionuclides

    Single Photon Emission Computed Tomography (SPECT)

    Positron Emission Tomography (PET)

    Markers for biochemical analysis

    Magnetic Resonance Imaging (MRI)

    1.1.2. Radionuclides for therapeutic use

    Radionuclide Therapy (RNT)

    Open sources of radiation

    Implantable radioisotope current sources

    Radioiodine therapy for thyroid cancer

    Radioiodine therapy for thyrotoxicosis

    Radionuclide therapy in the treatment of patients with bone metastases

    Radionuclide therapy in rheumatology. Radiosynovectomy

    1.2. Main medical applications of stable isotopes

    1.2.1. Diagnostic use of stable isotopes

    1.2.2. Therapeutic use of stable isotopes

    1.2.3. The use of stable isotopes to produce radionuclides

     

    2. Methods for producing medical isotopes in Russia

    2.1. Production of PET radiopharmaceuticals and GMP regulations

    2.2. The main methods for producing stable isotopes

    2.3. The main methods for producing radionuclides

    2.3.1. Production of radionuclides in nuclear reactors

    2.3.2. Production of radioisotopes at charged particle accelerators

    2.3.3. Radionuclide generators

     

    3. Manufacturers of medical isotope products

    3.1. The largest foreign manufacturers of medical isotopes

    3.2. The main Russian manufacturers of medical isotopes

    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)

    FSUE "Combine" Electrochemicalpribor "(Forest Sverdlovsk region)

    Leningrad Nuclear Power Plant (Sosnovy Bor, Leningrad Region)

    JSC “SSC RF - Physics and Energy Institute named after A. I. Leipunsky ”(Obninsk, Kaluga Region)

    JSC "NIFHI im. L. Ya. Karpova ”(Obninsk, Kaluga Region)

    CJSC Cyclotron (Obninsk, Kaluga Region)

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

    JSC Siberian Chemical Plant (Seversk, Tomsk Region)

    Federal State Unitary Enterprise “Federal Center for Design and Development of Nuclear Medicine Facilities” FMBA of Russia

     

    4. Export and import of medical isotopes in Russia in 2007-2019.

    4.1. Features of export-import supplies of isotopes

    JSC Techsnabexport

    JSC "V / O" Isotope "

    4.2. Export-import of major isotopes in 2007-2019

    Anonymous (or unidentified isotopes)

    Tungsten-188

    Gadolinium-153

    Helium 3

    Germanium-68

    Iridium-192

    Yttrium-90

    Iodine-125

    Iodine-131

    Oxygen 18

    Cobalt 57

    Cobalt 60

    Lutetium-177

    Molybdenum 99

    Palladium 103

    Radium-223

    Ruthenium-106

    Samaria-153

    Strontium-82

    Strontium-89

    Strontium-90

    Carbon 13

    Carbon-14

    Phosphorus 32

    Phosphorus 33

    Cesium-131

    Cesium-137

     

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

    5.1. Foreign countries

    5.2. Russian market

     

    Appendix 1. Address book of the main Russian manufacturers and traders of medical isotope products

    Appendix 2. List of foreign partners

    List of main used literature

    Table 1: The main characteristics of radionuclides - γ-emitters for use in diagnostic purposes

    Table 2: The main characteristics of radionuclides - emitters of positrons

    Table 3: Key Features of Open Source Radionuclides

    Table 4: Stable Isotopes Used to Produce Biomedical Radioisotopes

    Table 5: The Most Important Reactor Biomedical Radionuclides

    Table 6: Cyclotron Radionuclides

    Table 7: Target devices for ultra-short-lived β + emitters

    Table 8: Reactions for the production of cyclotron radionuclides for which an isotopically enriched target is required

    Table 9: Medical Radionuclide Generators

    Table 10: Major Foreign Players in the Nuclear Medicine Market in 2019

    Table 11: The level of production of medical isotope products in the Russian Federation in 2019, Ki, kg, million rubles. (without VAT)

    Table 12: The main Russian manufacturers of medical isotopes and the range of products

    Table 13: Main financial indicators of FSUE Mayak Production Association in 2007-2019, million rubles

    Table 14: Key financial indicators of JSC “SSC RIIAR” in 2007-2019, million rubles

    Table 15: Key financial indicators of IRM JSC in 2009-2019, million rubles

    Table 16: Key financial indicators of JSC “PA“ ECP ”in 2007-2019, million rubles

    Table 17: Products for nuclear medicine of the Physics and Energy Institute named after A.I. Leipunsky in 2019

    Table 18: Key financial indicators of JSC “SSC RF-IPPE” in 2014-2019, million rubles

    Table 19: The list of radiopharmaceuticals produced by JSC "NIFHI im. L. Ya. Karpova "

    Table 20: Key financial indicators of JSC NIFHI im. L. Ya. Karpova "in 2014-2019, million rubles.

    Table 21: Key financial indicators of JSC Radium Institute named after V. G. Khlopin "in 2012-2019, million rubles.

    Table 22: Key financial indicators of SCC in 2008-2019, billion rubles

    Table 23: Raw isotopes, export leaders in value terms in 2007-2019, thousand $

    Table 24: Export of sealed radiation sources for medical purposes in 2007-2019, thousand $

    Table 25: Import of sealed sources and isotope generators for medical purposes in 2007-2019, thousand $

    Table 26: Financial indicators of JSC “V / O Isotope” in 2007-2019, million rubles

    Table 27: Organizations that do not always indicate specific isotopes in export and import declarations in 2007-2019.

    Table 28: Export of the raw material isotope tungsten-188 produced by RIIAR in the form of a solution of sodium tungstate in 2007-2019, Ki, thousand $

    Table 29: Export of rhenium-188 generators based on the tungsten-188 isotope produced by the IPPE (Obninsk) in 2015-2019, Ki, thousand $

    Table 30: Export of the raw isotope of gadolinium-153 produced by RIIAR by Russia in 2007-2019, Ki, thousand $

    Table 31: Export of sealed sources based on the gadolinium isotope 153 of type FG153M13.410 manufactured by NIIAR by Russia in 2007-2019, units, Ki, thousand $

    Table 32: Russian imports of sealed sources based on the gadolinium-153 isotope from the USA manufactured by Eckert & Ziegler Isotope Products in 2010-2019, units, Ki, thousand $

    Table 33: Characteristics of 4 grades of helium-3 produced by Mayak

    Table 34: Export of helium-3 isotope of highest grade (B) with 99.99% isotope and grade 1A with 99.8% of the isotope produced by Mayak Russia by Russia in 2007-2019, g, thousand $

    Table 35: Characteristics of Germany-68 manufactured by ZAO Cyclotron

    Table 36: Export of the germanium-68 feedstock isotope produced by Cyclotron CJSC by Russia in 2014-2019, Ki, thousand $

    Table 37: Export of gallium-68 generators based on germanium-68 isotope by Russia in 2007-2019, units, Ki, thousand $

    Table 38: Import of mini-generators with germanium-68 isotope in 2007-2019, Ki, thousand $

    Table 39: Export of needles from the iridium-192 isotope for medical purposes, RIIAR production in 2007-2019, Ki, thousand $

    Table 40: Import of sources for gamma therapy from the iridium-192 isotope by Russia in 2007-2019, Ki, thousand $

    Table 41: Export of the yttrium-90 isotope for medical purposes (in the form of a chloride solution) produced by NIIAR by Russia in 2007, Ki, thousand $

    Table 42: Export of the raw iodine-125 isotope by Russia in 2007-2019, Ki, thousand $, thousand $ / Ki

    Table 43: Import of radioimmune kits based on the iodine-125 isotope by Russia in 2007-2019, mCi, thousand $, units

    Table 44: Russia's imports of iodine-125 for the production of microcapsules for brachytherapy in 2014-2019, Ki, thousand $

    Table 45: Import of RF microcapsules for brachytherapy based on iodine-125 isotope in 2007-2019, Ki, thousand $, units

    Table 46: Export of the raw isotope iodine-131 by Russia in 2009-2019, Ki, thousand $

    Table 47: Russian imports of the iodine-131 isotope in 2014-2019, Ki, thousand $

    Table 48: Russian imports of unregistered drug 131I-MIBG in 2014-2019, Ki, thousand $

    Table 49: Russian exports of a drug based on the iodine-131 isotope in 2018-2019, Ki, thousand $

    Table 50: Export of water enriched with oxygen-18 isotope, Russia in 2007-2019, kg, thousand $

    Table 51: Russian imports of the oxygen-18 isotope in 2008-2019, kg, thousand $

    Table 52: Export of the V / O Isotope of the cobalt-57 feedstock isotope in the form of chloride produced by Cyclotron CJSC in 2014-2019, Ki, thousand $

    Table 53: Import of the raw isotope cobalt-57 in 2014-2019, Ki, thousand $

    Table 54: Export of the raw cobalt-60 isotope in 2007-2019, thousand ki, thousand $

    Table 55: Export of sources based on the cobalt-60 isotope by Russia in 2007-2019, thousand ki, thousand $

    Table 56: Russian imports of sealed sources with the cobalt-60 isotope for medical equipment in 2008-2019, Ki, thousand $

    Table 57: Export of the raw isotope of lutetium-177 by Russia in 2007-2019, Ki, thousand $

    Table 58: Export of the molybdenum-99 isotope by Russia in 2009-2019, Ki, thousand $

    Table 59: Import of the raw material isotope molybdenum-99 produced by NTP Radioisotopes (South Africa) to the V / O Isotope in 2007-2009, Ki, thousand $

    Table 60: Import of technetium-99 generators on the molybdenum-99 isotope in 2014-2019, units, Ki, thousand $

    Table 61: Export of the raw isotope palladium-103 in the form of chloride by Russia in 2007-2019, Ki, thousand $

    Table 62: Russia's import of the drug "Alfaradin" based on the radium-223 isotope in 2014-2019, units, mCi, thousand $

    Table 63: Export of the raw isotope of ruthenium-106 in the form of chloride produced by RIIAR by Russia in 2008-2019, Ki, thousand $

    Table 64: Import of ophthalmic applicators based on the ruthenium-106 isotope manufactured by Eckert & Ziegler Bebig (Germany) by Russia in 2008-2019, units, mCi, thousand $

    Table 65: Export of the raw isotope samarium-153 produced by NIFHI to Pars (Iran) in 2016-2019, Ki, thousand $

    Table 66: Export of the strontium-82 feedstock isotope in the form of irradiated rubidium targets manufactured by the Institute for Nuclear Research of the Russian Academy of Sciences at Los Alamos National Lab. (USA) in 2014-2017, Ki, thousand $

    Table 67: Export of the strontium-89 feed isotope in the form of chloride produced by NIIAR by Russia in 2007-2019, Ki, thousand $

    Table 68: Export of the strontium-90 feedstock isotope in different nomenclature by Russia in 2007-2019, Ki, thousand $

    Table 69: Russian exports and imports of gaseous carbon dioxide enriched in 13C isotope in 2007-2019, kg, thousand $

    Table 70: Characteristics of 2 grades of the carbon-14 isotope manufactured by Mayak

    Table 71: Export of the raw carbon-14 isotope by Russia in 2007-2019, Ki, thousand $

    Table 72: Export of the phosphorus-32 feedstock isotope by Russia in 2007-2018, Ki, thousand $

    Table 73: Import of phosphorus-32 feedstock isotope in the form of phosphoric acid by Russia in 2014-2015, Ki, thousand $

    Table 74: Export of the phosphorus-33 isotope feedstock as orthophosphoric acid produced by NIIAR by Russia in 2008-2012, Ki, thousand $

    Table 75: Export of the raw isotope of cesium-131 ​​in 2007-2019, Ki, thousand $

    Table 76: Export of reagents based on the cesium-137 isotope by Russia in 2007-2019, Ki, thousand $

    Table 77: Export of sealed sources based on the cesium-137 isotope for medical gamma devices by Russia in 2007-2019, units, Ki, thousand $

    Table 78: Import of sealed sources based on the cesium-137 isotope for medical purposes in 2010-2019, Ki, thousand $

    Table 79: Primary Isotope Therapies for High-Tech Care 

    Figure 1: Diagram of the main methods for producing isotopes

    Figure 2: The production cycle of radiopharmaceuticals

    Figure 3: Estimated shares of Russian manufacturers in the production of medical and dual-purpose isotopes in 2019,%

    Figure 4: Shares of the main foreign firms-buyers of Russian isotope medical products in 2015,%

    Figure 5: Shares of the main foreign buyers of Russian medical isotope products in 2019,%

    Figure 6: Structure of the Russian export of medical isotopes in 2015 by country,%

    Figure 7: Structure of the Russian export of medical isotopes in 2019 by country,%

    Figure 8: Dynamics of Russian exports of isotope-medical products in 2007-2019, million $

    Figure 9: Import of isotope medical products in 2007-2019, $ million

    Figure 10: Shares of the main foreign suppliers of medical isotope products to Russia in 2015,%

    Figure 11: Shares of the main foreign suppliers of medical isotope products to Russia in 2019,%

    Figure 12: Dynamics of export of the raw isotope of gadolinium-153 produced by RIIAR in 2007-2019, Ki

    Figure 13: Dynamics of export of helium-3 isotope (total grade “B”, grade “1A” and others) by Russia in 2007-2019, gram / year

    Figure 14: Average export price for Russian helium-3 grades “1A” (99.8%) in 2007-2019, thousand $ / gram

    Figure 15: Dynamics of the average price of imported microcapsules for brachytherapy based on the iodine-125 isotope in 2007-2019, $

    Figure 16: Dynamics of water exports with 97.0% of the 18О isotope 18О by Russia in 2007-2019, kg

    Figure 17: Export price of water with 97.0% of the oxygen-18 isotope in 2007-2019, thousand $ / kg

    Figure 18: Dynamics of export of the raw isotope of lutetium-177 produced by the RIIAR and IMR in 2007-2019, Ki

    Figure 19: Export price for carbon dioxide with 13С enrichment of more than 99% of the production of JSC “PO“ Electrochemical Plant ”in 2007-2018, thousand $ / kg

    Figure 20: Forecast of the production of raw medical isotopes in the Russian Federation for 2020-2025, billion rubles

    Figure 21: Forecast of production of medical isotope products (RFP, isotope generators, radiation sources, calibration sources, working gases for MRI) in the Russian Federation for 2020-2025, billion rubles.

     

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