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Medicinal Isotopes in Russia: Production, Market and Forecast (3rd edition)

Seitenzahl: 254 Anzahl der Tische: 95 Anzahl der Zeichnungen: 38
Report Sprache: Russian + English
Freigegeben: 25.05.2016
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This report is available both in Russian and English versions.

 

The present review is the 3rd edition of research of the Russian market of medical isotopes.

Research objective is the analysis of the Russian market of isotopes of medical purpose.

Monitoring of this market is conducted since 2007.

 

Object of research is the industrial isotopes used in medicine: Actinium-225, Americium-241, Boron-10, Tungsten-188, Gadolinium-153, Helium-3, Germanium-68, Iron-55, Iridium-192, Yttrium-90, Ytterbium-169, Iodine-124, Iodine-125, Iodine-131, Californium-252, Oxygen-18, Cobalt-57, Cobalt-60, Krypton-85, Xenon-129, Lutetium-177, Manganese-54, Molybdenum-99, Sodium-22, Nickel-63, Tin-117m, Palladium-103, Radium-223, Ruthenium-106, Samarium-153, Strontium-82, Strontium-89, Strontium-90, Carbon-13, Carbon-14, Phosphorus-32, Phosphorus-33, Caesium-131, and Caesium-137.

 

Chronological framework of research: 2007-2015, the forecast – 2016-2025.

 

Geography of research: the Russian Federation – the complex detailed analysis.

 

This work is desk research. As sources of information data of Rosstat, Federal Customs Service of the Russian Federation, scientific and technical literature, the industry, regional and international press, and also the websites of the enterprises − producers and consumers of medical isotope products were used.

 

The report consists of an Introduction and 5 Chapters, contains 247 pages, including 95 Tables, 38 Figures and 2 Appendices.

Chapter 1 is devoted to research of the main fields of medical application of radioactive and stable isotopes. This chapter describes the stable isotopes and radionuclides, which are most widely used for the diagnostic and therapeutic purposes, the main methods of nuclear medicine, and also gives the most perspective isotopes for further development of nuclear medical and biological technologies.

Chapter 2 of the report discusses the main methods of receiving radionuclides and stable isotopes. This chapter describes methods of the isotope separation, which are most widely used in the industry, the most important biomedical reactor and cyclotron radionuclides, gives the main nuclear reactions of their receiving, and also describes generators of short-lived radionuclides that are now used for medical purposes in Russia and abroad.

Chapter 3 is devoted to producers of medical isotopes and radiopharmaceuticals, and it describes the main nomenclature of the medical isotope products released by them. Estimates of production are given for the Russian Federation, both of raw medical isotopes, and isotope products (in natural and value terms), and shares of the main producers are specified.

Chapter 4 considers the Russian foreign trade operations with radio pharmaceutical products and isotope raw materials of medical purposes. Besides, this chapter analyzes dynamics of the Russian export-import supply of medical isotopes for the last 9 years in monetary terms, describes in detail the nomenclature of export and import products, and provides data on the main exporters and importers of medical isotope products in Russia.

Chapter 5 is devoted to the research of the modern market of medical isotopes. The forecast of development for 2016-2025 is given.

Appendices provide the text of the order of the Government of the Russian Federation about the concept of development of nuclear medicine till 2020, contact information of the largest Russian producers and traders of medical isotope products and the list of the main references used in the report.

 

Target audience of research:

- participants of the market of medical isotopes - producers, consumers, traders;

- potential investors.

The offered research can serve as a handbook for the services of marketing and for specialists making administrative decisions on the market of medical isotopes.

Annotation

 

Introduction

 

1. The use of isotopes in medicine

1.1. Main fields of medical application of radionuclides

1.1.1. Radionuclides for diagnostics

One-photon emission computer tomography (OPECT)

Positron-Emission Tomography (PET)

Markers for biochemical analysis

Magnetic Resonance Tomography (MRT)

1.1.2. Radionuclides of therapeutic purposes

Radionuclide therapy (RNT)

Open sources of radiation

Implanted radioisotope sources of current

Radioiodine therapy at cancer of the thyroid gland

Radioiodine therapy at thyrotoxicosis

Radionuclide therapy in treatment of  patients with metastases in bone

Radionuclide therapy in rheumatology. Radiosynovectomy

1.2. Main fields of medical application  of stable isotopes

1.2.1. Diagnostic application of stable isotopes

1.2.2. Therapeutic application of stable isotopes

1.2.3. Application of stable isotopes for producing radionuclides

 

2. Methods of producing medical isotopes in Russia

2.1. Production of PET radiopharmaceuticals

2.2. Production of PET radiopharmaceuticals and GMP rules

2.3. Registration of PET radiopharmaceuticals

2.4. Preclinical tests

2.5. Main methods of producing stable isotopes

2.6. Main methods of producing radionuclides

2.6.1. Production of radionuclides in nuclear reactors

2.6.2. Production of radioisotopes on accelerators of charged particles

2.6.3. Generators of radionuclides

 

3. Producers of medical isotope products

3.1. The largest foreign producers of isotopes  of medical purpose

3.2. Main Russian producers of medical isotopes

FSUE PO Mayak (Ozyorsk, Chelyabinsk region)

JSC GNTs NIIAR (Dimitrovgrad, Ulyanovsk region)

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

AO V.G. Khlopin Radium Institute (St. Petersburg)

AO Production Association Electrochemical Plant (Zelenogorsk, Krasnoyarsk Krai)

FSUE Elektrokhimpribor Plant  (Lesnoy, Sverdlovsk region)

Leningrad Nuclear Power Plant  (Sosnovyi Bor, Leningrad region)

JSC GNTs Fiziko-energetichesky institute of A.I. Leypunsky (Obninsk, Kaluga region)

The Obninsk branch of NIFKhI of L.Ya.Karpov

JSC Siberian Chemical Combine  (Seversk, Tomsk region)

JSC NIKIET (Moscow)

Federal State Budgetary Institution Research Center Kurchatov Institute (Moscow)

FSUE Federal Center for Design and Development of Objects of Nuclear Medicine FMBA of Russia

Federal State Budgetary Institution Russian Scientific Center of Radiology and Surgical Technologies (St. Petersburg)

Physics and Technology Institute at Tomsk Polytechnic University (Tomsk)

Ural federal university named after the first President of Russia B. N. Yeltsin (Yekaterinburg)

ZAO Tsiklotron

 

4. Export and import of isotopes of medical  purposes in Russia

4.1. Features of export-import supplies of isotopes

AO Tekhsnabeksport

JSC V/O Izotop

4.2. Export-import of separate isotopes in 2007-2015

Anonymous (or not identified isotopes)

Actinium-225

Americium-241

Boron-10

Tungsten-188

Gadolinium-153

Helium-3

Germanium-68

Iron-55

Iridium-192

Yttrium-90

Ytterbium-169

Iodine-124

Iodine-125

Iodine-131

Californium-252

Oxygen-18

Cobalt-57

Cobalt-60

Krypton-85

Xenon-129

Lutetium-177

Manganese-54

Molybdenum-99

Sodium-22

Nickel-63

Tin-117m

Palladium-103

Radium-223

Ruthenium-106

Samarium-153

Strontium-82

Strontium-89

Strontium-90

Carbon-13

Carbon-14

Phosphorus-32

Phosphorus-33

Caesium-131

Caesium-137

 

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

5.1. Foreign countries

5.2. The Russian market

 

Appendix 1: Plan of measures ("road map") "Development of the centers of nuclear medicine"

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

References  list

Table 1: Main characteristics of radionuclides – γ-emitters used for the diagnostic purposes

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

Table 3: Main characteristics of radionuclides for therapy  with open sources

Table 4: Stable isotopes used for producing radioisotopes of biomedical applications

Table 5: Most important reactor biomedical radionuclides

Table 6: Cyclotron radionuclides

Table 7: Target devices for receiving  ultrashort-lived β+-emitters

Table 8: Reactions of receiving cyclotron radionuclides,  for which the isotopically enriched target is necessary

Table 9: Generators of radionuclides of medical purpose

Table 10: Level of estimated production of the main medical isotopes in the Russian Federation in 2015, Ci, kg, million rubles (without the VAT)

Table 11: Level of estimated production of medical isotope products in the Russian Federation in 2015, Ci, kg, million rubles (without the VAT)

Table 12: Main Russian producers of medical isotopes  and product ranges

Table 13: Main financial performance indicators of JSC GNTs NIIAR in 2007-2015, million rubles

Table 14: Main financial performance of JSC IRM in 2009-2015, million rubles

Table 15: Financial performance indicators of PA Electrochemical Plant in 2008-2015, million rubles

Table 16: Products for nuclear medicine of Fiziko-energetichesky institute of A. I. Leypunsky in 2013

Table 17: List of RFP on which production the Obninsk branch of NIFKhI of Karpov has the license

Table 18: Main financial performance of JSC NIFKhI of Karpov in 2013-2015, million rubles

Table 19: Main financial performance of JSC Siberian Chemical Combine in 2007-2015, billion rubles

Table 20: Main financial performance indicators of JSC NIKIET in 2009-2015, million rubles

Table 21: Russian developers and producers of radiopharmaceuticals and main product range

Table 22: Raw isotopes, leaders in export in value terms (top-10) in 2007-2015, $thou.

Table 23: The summary table of export of the closed radiation sources for medical purposes in 2007-2015, $thou.

Table 24: Directions of export of isotopes and related medical products from Russia in 2007-2015, $thou.

Table 25: Summary table of import of the closed sources and generators of isotopes for medical purposes in 2007-2015, $thou.

Table 26: Directions of import of isotope medical products to Russia in 2007-2015, $thou.

Table 27: Financial performance indicators of JSC V/O Izotop  in 2008-2015, million rubles

Table 28: Organizations not always specifying particularc isotopes in export and import declarations in 2007-2015

Table 29: Characteristics of the raw isotope actinium-225 produced by FEI (Obninsk)

Table 30: Russian export of the raw isotope actinium-225 of production of FEI through V/O Izotop in 2014-2015, Ci, $thou.

Table 31: Export of americium-241 dioxide by Russia in 2007-2015, Ci, $thou.

Table 32: Specifications on the Russian isotope americium-241 sold through Raims (England) in 2016

Table 33: Import by Russia of the isotope boron-10 of production of  JSC National Center of High Technologies of Georgia  in 2007-2015, kg, $ thou.

Table 34: Export of raw isotope tungsten-188 of production of NIIAR in the form of the sodium tungstate solution in Russia in 2007-2015, Ci, $ thou.

Table 35: Export of generators of rhenium-188 on the basis of the isotope tungsten-188 of production of FEI (Obninsk) through V/O Izotop in 2015

Table 36: Export of the raw isotope gadolinium-153 of production of NIIAR by Russia in 2007-2015, Ci, $ thou.

Table 37: Export of the closed sources on the basis of the isotope gadolinium-153 of the FG153M13.410 type of production of NIIAR by Russia in 2007-2015, pieces, Ci, $ thou.

Table 38: Russian import of closed sources on the basis of the isotope gadolinium-153 from the USA of production of Eckert&Ziegler Isotope Products of the brand CAS:58023-33-9 and CAS:15756-77-1, in 2007-2015, pieces, Ci, $ thou.

Table 39: Export of the isotope helium-3 of the premium (V) grade with 99.99% of the isotope and of the 1A grade with 99.8% of the isotope of production of PO Mayak in Russia in 2007-2015, g, $ thou.

Table 40: Specification on the Russian helium-3 sold through the Russian firm Raims in 2016

Table 41: Characteristics of germanium-68 of production  of ZAO Tsiklotron

Table 42: Export of the raw isotope germanium-68 of production of ZAO Tsiklotron by Russia in 2007-2015, Ci, $ thou.

Table 43: Export of gallium-68 generators on the basis of the isotope germanium-68 by Russia in 2007-2015, pieces, Ci, $ thou.

Table 44: Import of generators with the isotope germanium-68 from Eckert & Ziegler Isotope Products GmbH (Germany) by Russia in 2007-2015, Ci, $ thou.

Table 45: Export of the raw isotope iron-55 Russia in 2007-2015, Ci, $ thou.

Table 46: Export of needles from the isotope iridium-192 for medical purposes by Russia in 2007-2015, Ci, $ thou.

Table 47: Import of sources for gamma therapy from the isotope iridium-192 by Russia in 2007-2015, Ci, $ thou.

Table 48: Export by Russia of the isotope of yttrium-90 for medical purposes (in the form of chloride solution) of productions by NIIAR in 2007, Ci, $ thou.

Table 49: Export of the raw isotope ytterbium-169 for medical purpose (in the form of solid oxide) of productions of NIIAR to Polatom institute (Poland) in 2007-2015, Ci, $ thou.

Table 50: Export of the raw isotope iodine-124 of production of ZAO Ritverc by Russia in 2007-2015, Ci, $ thou.

Table 51: Export of the raw isotope iodine-125 Russia in 2007-2015, Ci, $thou.

Table 52 Import of radio immune sets on the basis of the isotope iodine-125 by Russia in 2007-2015, mCi, $thou., pieces

Table 53: Import of iodine-125 by Russia in technical containers for production of microcapsules for brachytherapy in 2014-2015, Ci, $thou.

Table 54: Import of microcapsules by Russia for brachytherapy on the basis of the isotope iodine-125 in 2007-2015, Ci, $thou., pieces

Table 55: Export of the raw isotope iodine-131 of production of NIIAR by Russia in 2009-2010, Ci, $thou.

Table 56: Import by Russia of products on the basis of the isotope iodine-131 in 2014-2015, Ci, $thou.

Table 57: Export of the isotope californium-252 for medical purposes by Russia in 2008-2015, mcCi, $ thou.

Table 58: Export of water enriched with the isotope oxygen-18, production of ZAO Globalnye nauchnye tekhnologii by Russia in 2007-2015, kg, $ thou.

Table 59: Export of gamma sources on the basis of the isotope cobalt-57 by Russia in 2007-2015, Ci, $ thou.

Table 60: Export by V/O Izotop of the raw isotope cobalt-57 in the form of chloride of production of ZAO Tsiklon in 2014-2015, Ci, $ thou.

Table 61: Export of the raw isotope cobalt-60 of production of Leningrad NPP to the address of Nordion (Canada) in 2007-2015, thou. Ci, $ thou.

Table 62: Export of sources on the basis of the isotope cobalt-60 Russia in 2007-2015, thou. Ci, $ thou.

Table 63: Import by Russia of the closed sources with the isotope 60Co for the beam equipment in 2007-2015, Ci, $ thou.

Table 64: Export of the raw isotope krypton-85 of production of PO Mayak of Russia in 2007-2015, Ci, $ thou.

Table 65: Specifications on the Russian krypton-85 sold through Raims (England)

Table 66: Export of the isotope xenon-129 of production of EKhZ by Russia in 2007-2015, Ci, $ thou.

Table 67: Export of the raw isotope lutetium-177 by Russia in 2007-2015, Ci, $ thou.

Table 68: Export of the raw isotope manganese-54 of production of NIIAR by Russia in 2007-2015, Ci, $ thou.

Table 69: Export of the isotope molybdenum-99 by Russia in 2009-2015, Ci, $thou.

Table 70: Import of the raw isotope molybdenum-99 of production of NTP Radioisotopes (Republic of South Africa) to the address of V/O Izotop in 2007-2009, Ci, $thou.

Table 71: Import of generators of technetium-99 of the Polgentek brand of production of Polatom (Poland) in 2007-2015, pieces, kg, Ci, $ thou.

Table 72: Export of the isotope sodium-22 by Russia in 2008 and in 2010, Ci, $

Table 73: Import of calibration sources for PET/KT scanners on the basis of the sodium-22 isotope in 2009-2015, mCi, $

Table 74: Export of the raw isotope nickel-63 by Russia in 2007-2015, Ci, $ thou.

Table 75: Export of the raw isotope tin-117m in the chloride form of production of NIIAR by Russia in 2007-2009, Ci, $ thou.

Table 76: Export of the raw isotope palladium-103 in the chloride form by Russia in 2007-2015, Ci, $ thou.

Table 77: Import by Russia of Alfaradin medicine on the basis of the isotope radium-223 in 2014-2015, pieces, mCi, $ thou.

Table 78: Export of the raw isotope ruthenium-106 in the chloride form of production of NIIAR by Russia in 2008-2015, Ci, $ thou.

Table 79: Import of ophthalmicapplicators on the basis of the isotope ruthenium-106  of production Eckert & Ziegler, Bebig by Russia in 2008-2015, pieces, Ci, $ thou.

Table 80: Export of the raw isotope strontium-82 in the form of the irradiated rubidium target of production of Institute of nuclear studies RAS to Los Alamos National Lab. (USA) in 2014-2015, Ci, $ thou.

Table 81: Export of the raw isotope strontium-89 in the chloride form of production of NIIAR by Russia in 2008-2015, Ci, $ thou.

Table 82: Export of the raw isotope strontium-90 in the different nomenclature by Russia in 2007-2015, Ci, $thou.

Table 83: Standard specifications on the raw isotope strontium-90 in the form of carbonate of the Russian production from the English firm Raims Ltd.

Table 84: Russian export and import of gaseous carbon dioxide enriched with the isotope 13C in 2007-2015, kg, $ thou.

Table 85: Export of the raw isotope carbon-14 in the different nomenclature by Russia in 2007-2015, Ci, $thou.

Table 86: Export of the raw isotope phosphorus-32 by Russia in 2007-2012, Ci, $ thou.

Table 87: Import of the raw isotope phosphorus -32 in the form of orthophosphoric acid by Russia in 2014-2015, Ci, $ thou.

Table 88: Export of the raw isotope phosphorus-33 in the form of ortophosphoric acid of production of NIIAR by Russia in 2008-2012, Ci, $ thou.

Table 89: Export of the raw isotope caesium-131 of production of IRM and NIIAR to Isoray Medical Inc. (USA) in 2007-2015, Ci, $ thou.

Table 90: Export of reagents on the basis of the isotope caesium-137 by Russia in 2007-2015, Ci, $ thou.

Table 91: Export of the closed sources on the basis of the isotope caesium-137 production of PO Mayak for medical gamma devices Russia in 2007-2015, pieces, Ci, $thou.

Table 92: Average export price of the main sources of medical radiation on caesium-137 during 2007-2015, $thou./pieces

Table 93: Import of the closed sources on the basis of the isotope caesium-137 for medical purposes in 2010-2012, Ci, $ thou.

Table 94: Number of procedures of nuclear medicine, carried out  in some countries of the world (in year per 1000 people) in 2015

Table 95: Main types of therapy with the use of isotopes within hi-tech medical care

Figure 1: Scheme of the main methods of production of isotopes

Figure 2: Cycle of production of radiopharmaceuticals

Figure 3: Estimated shares of the manufacturing enterprises in production in Russia of isotopes of medical and dual purpose in 2015, %

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

Figure 5: Structure of the Russian export of medical isotopes in 2015 by the countries, %

Figure 6: Dynamics of the Russian export of isotope and medical products in 2007-2015, $thou.

Figure 7: Dynamics of the Russian import of isotope medical products in 2007-2015, $thou.

Figure 8: Shares of the main foreign firms-suppliers of isotope products of medical purpose to Russia in 2015, %

Figure 9: Main directions of import of medical isotopes to Russia in 2015, %

Figure 10: Commodity structure of export of medical products by V/O Izotop in 2015, %

Figure 11: Geography of export of medical products by V/O Izotop in 2015, %

Figure 12: Comparison of alpha- and beta-irradiation of cancer cells and healthy tissues

Figure 13: The scheme of monoclonal antibody with RFP on the basis of actinium-225

Figure 14: Average export price of americium-241 dioxide  of the brands "A" in 2007-2015, $ thou./Ci

Figure 15: Average import  price of the Georgian amorphous boron-10  with enrichment of 95.5% in 2007-2015, $ thou./kg

Figure 16: Dynamics of export of the raw isotope tungsten-188 of production of NIIAR by Russia in 2007-2015, Ci

Figure 17: Dynamics of export of the raw isotope gadolinium-153 of production of NIIAR by Russia in 2007-2015, Ci

Figure 18: Dynamics of export of the isotope helium-3 (together grades V, 1A and others) in Russia in 2007-2015, gram/year

Figure 19: Average export  price of the Russian helium-3 of the grade 1A (99.8%) in 2007-2015, $ thou./gram

Figure 20: Dynamics of a decrease in the average price of imported microcapsules for brachytherapy on the basis of the isotope iodine-125 in 2007-2015, $/piece

Figure 21: Dynamics of export of water with 97.0% of the isotope 18O by Russia in 2007-2015, kg

Figure 22: The export price of water with 97.0% of the isotope oxygen-18  in 2007-2015, $ thou./kg

Figure 23: Dynamics of the annual average export price of the raw isotope cobalt-57 in the form of chloride and on the products "gamma source", $thou./Ci

Figure 24: Dynamics of export the of isotope raw materials and the closed sources on basis of 60Co by Russia in 2007-2015, mln Ci/g

Figure 25: Dynamics of import of sources of radiations on the basis of 60Co by Russia for medical gamma-units in 2007-2015, thou. Ci/g

Figure 26: Dynamics of export of the raw isotope lutetium-177 of production of NIIAR and IMR in 2007-2015, Ci

Figure 27: Export prices of the isotope manganese-54 of production of NIIAR in 2007-2015, $thou./Ci

Figure 28: Structure of export of molybdenum-99 by countries of destination in 2015, %

Figure 29: Dynamics of the Russian export and import of molybdenum-99 in 2007-2015, Ci

Figure 30: Dynamics of import prices (from the Republic of South Africa) and average export prices of the Russian Federation on molybdenum-99 in 2007-2015 $/Ci

Figure 31: Export prices of molybdenum-99 delivered by NIIAR and NIFKHI in 2015, $/Ci

Figure 32: Dynamics of the Russian export and import of compounds with the isotope carbon-13 in 2007-2015, kg

Figure 33: The export price of carbon dioxide with enrichment on 13C of more than 99% of production of JSC PO Electrochemical Plant  in 2007-2015, $ thou./kg

Figure 34: Annual average export prices of the raw isotope carbon-14 of production of PO Mayak and AO Institute of Reactor Materials in 2007-2015, $thou./Ci

Figure 35: Dynamics of the export prices of the isotope caesium-131 of production of IRM and NIIAR in 2007-2015, $thou./Ci

Figure 36: Dynamics of export of the closed sources with caesium-137 of production of PO Mayak in 2007-2015, thou. Ci

Figure 37: Forecast of production of raw medical isotopes in the Russian Federation in 2016-2025, billion rubles

Figure 38: Forecast of production of isotope products of medical purposes (RFP, generators of isotopes, sources of radiations, calibration sources, working gases for MRT) in the Russian Federation in 2016-2025, billion rubles

 

Bald erscheinen

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