Market Overview
The global radiopharmaceutical market is expected to grow at a CAGR of 5.67% during the forecasting period (2020-2027).
Radiopharmaceuticals also known as Nuclear medicines are a group of pharmaceutical drugs which have radioactivity and can be used as diagnostic and therapeutic agents.
Radiopharmaceuticals emit radiation themselves, which is different from fluids within the body which absorb or alter external electromagnetism or ultrasound. This phenomenon helps to identify the various abnormalities such as cancer cells, within the human body.
Radiotherapy can be used to treat some medical conditions, especially cancer, using radiation to weaken or destroy particular targeted cells.
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Over 40 million nuclear medicine procedures are performed each year, and demand for radioisotopes is increasing at up to 5% annually.
Sterilization of medical equipment is also an important use of radioisotopes.
Globally, over 10,000 hospitals use radioisotopes in medicine, and about 90% of the procedures are for diagnosis.
Majority radioisotopes are made in nuclear reactors, some in cyclotrons. There are about 40 activation product radioisotopes and five fission product ones made in reactors.
Evolution towards centralized pharmacies, widespread availability of the SPECT and PET scanning machines, growing interest of investors of conventional pharmaceutical industries in the therapeutic area, increasing incidence of cancer and cardiovascular diseases are some of the factors that will drive the growth of radiopharmaceuticals market during the forecast period (2020–2027).
For some years, three-quarters of the Mo-99 was made in three reactors: NRU in Canada (30-40%), HFR in Netherlands (30%) and BR-2 in Belgium (10%).
Russia is keen to increase its share of world supply, and in 2012 some 66% of its radioisotope production was exported. For I-131, 75% is from IRE, 25% from NTP.
Market Dynamics
Increasing Number of PET and SPECT Scans
Widespread availability of the SPECT and PET scanning machines will result in to growing number of radio diagnostic and radio therapeutics events globally. For instance, the number of PET scanning machines installed per head in North America is more as compared to that installed in Europe, thus leading to increased usage of radiotracers in the region.
Single-photon emission computed tomography (SPECT) using technetium-99m (Tc-99m) tracer technology accounts for 80% of all nuclear medicine procedures worldwide. While making up around 50% of the global market, the United States (US) was solely dependent on international sources for Tc-99m’s parent isotope, molybdenum-99 (Mo-99 or moly), until recently.
According to the American Nuclear Society, 90% of the radioisotopes are used in gamma cameras or PET scan nuclear diagnostics. Remaining 10% are used in radioactive therapeutics drugs to treat diseases such as cancer, heart disease, gastrointestinal, endocrine, neurological disorders, etc.
Minimizing the Dose in Pediatric Nuclear Imaging
The volume of PET procedures in the United States is approximately two million per Year.
There are about 2,670 PET scanners in hospitals across the U.S. that collectively perform about 2 million scans per year.
Oncology accounts for more than 80% of the PET and PET/CT procedures performed, whereas cardiology and neurology account for about 5% each.
According to the National Oncology PET Registry, about 84% of the slightly more than 1,600 PET facilities in the United States have PET/CT systems.
In 2018, the number of PET and PET/CT scans performed in the U.S. is estimated at 2.093 million. This is a net increase of about 8% in just the last year. These scans were performed at approximately 2,500 sites using fixed PET, PET/CT or PET/MR scanners or mobile PET services.
In 2017, an estimated 1.9600 million clinical PET and PET/CT scans were performed in the US, a 14.2% increase in use compared to 2015. In 2015, it is estimated that over 1.7852 million clinical PET and PET/CT patient scans will be performed in U.S hospital and non-hospital locations in the United States.
Price sensitivity and lack of specified guidelines
Production of radiopharmaceuticals for diagnostics and therapeutic indication is on a relatively small scale unlike conventional pharmaceuticals production.
Therefore, implementation of the cGMP guidelines applicable for the radiopharmaceutical industry is both difficult and expensive particularly for small scale manufacturers.
By region, cancer incidence is highest in Asia compared to other regions. Contextually, the incidence population of cancers in Asia was 6.67 million in 2012 and is anticipated to reach 10.84 by 2030.
The cancer incidence in Asia is higher compared to cumulative incidence population of all other regions. In terms of growth rate too, incidence rate of cancers is growing at a notable CAGR of 2.7% in this region.
Europe has the second highest cancer incidence followed by North America. In terms of increase in cancer incidence, Europe is anticipated to have the slowest growth in forecast period.
In terms of growth of cancer incidence, Middle and North Africa and South America are considered to the top two regions with CAGR of 3.1% and 2.9%, during 2012 to 2030, respectively.
Segmentation Analysis
Technetium-99m
The Tec. 99 segment in global radiopharmaceutical market is expected to reach at a value of US$ 4,137.5 Mn by 2027 end at a CAGR of 6.01%.
The most common radioisotope used in diagnosis is technetium-99 (Tc-99), with around 40 million procedures every year, accounting for about 80% of all nuclear medicine procedures and 85% of diagnostic scans in nuclear medicine globally.
In developed countries, the frequency of diagnostic nuclear medicine is 1.9% per year, and the frequency of therapy with radioisotopes is about one-tenth of this.
In the USA there are over 20 million nuclear medicine procedures per year, and in Europe about 10 million. In Australia there are about 560,000 per year, 470,000 of these using reactor isotopes.
Every year, around 25 million procedures are carried out with Tec. 99m radiopharmaceuticals, and is projected to grow at a rate of about 15% per annum.
Technetium-99m radiopharmaceuticals are used in several diagnostic procedures, from the use of pertechnetate for thyroid uptake to the use of Tec 99m-octreotide derivatives for imaging neuroendocrine tumours. Owing to its multiple oxidation states, Tc-99m has a versatile chemistry, making it possible to produce a variety of complexes with specific desired characteristics, which is a major advantage of 99mTc for radiopharmaceutical development.
Geographical Analysis
The North America segment of Radiopharmaceutical Market is valued at US$ 2,810.3 Million in 2019 and is estimated to grow at a CAGR of 5.9% over the forecast period (2020-2027).
The use of radiopharmaceuticals in diagnosis is growing at over 10% per year. North America is the dominant market for diagnostic radioisotopes with close to half of the market share, while Europe accounts for about 20%.
The Europe Gallium 68 holds USD 55.4 Mn of the market value in 2019, and is expected to be 6.4% by 2027, for radiopharmaceuticals market by Region.
The North America Gallium 68 holds USD 81.4 Mn of the market value in 2019, and is expected to be 7.1% by 2027, for radiopharmaceuticals market by Region.
North America is estimated to account for the largest share of the market, owing to the advancements in technology, including hybrid imaging, the introduction of new radiopharmaceuticals for diagnosis, and the development of molecular imaging.
Canada is one of the largest producers of Technetium-99m. With the use of Tc-99m in radiopharmaceuticals, the market is expected to grow at a tremendous rate in Canada. It is also combined with a variety of biologically active molecules to perform non-invasive, real-time imaging of the human body.
New producers are using non-HEU methods, and the majority of current suppliers have already converted to non-HEU production of Mo-99.
On January 7th 2020, RadioMedix Inc. and its commercial partner Curium announced that the New Drug Application for copper Cu 64 dotatate injection was filed with the U.S. Food and Drug Administration (FDA). Copper Cu 64 dotatate injection is a PET diagnostic agent intended for somatostatin receptor (SSTR) expressing neuroendocrine tumors (NETs). The FDA previously granted Fast Track designation to copper Cu 64 dotatate injection.
NorthStar Medical Radioisotope’s (NorthStar) RadioGenix® System is a disruptive, innovative separation platform for processing non-uranium/non-highly enriched uranium-based Mo-99. NorthStar is the first US-based company to achieve production in more than 30 years, vertically integrated and ensures reliable Mo-99/Tc-99m US supply with predictable pricing for essential diagnostic imaging procedures while eliminating harmful radioactive waste, addresses moly availability, nuclear proliferation, and environmental concerns.
NorthStar plans to produce Mo-99 from Mo-100 in an accelerator, and in December 2016 received $11 million from NNSA for this. The award advances a $50 million cooperative agreement between the two organizations in which NorthStar raises $25 million, matched by NNSA upon full funding of the agreement.
Some of the major isotope suppliers worldwide are MDS Nordion (Canada), Curium (France & USA),), IRE (Europe), NTP (South Africa), Isotop-NIIAR (Russia), and ANM (ANSTO Australia).
The major demand is for of Mo-99 (for Tc-99m), and the world market is some $550 million per year. About 40% of it is supplied by MDS Nordion, 25% from Mallinckrodt (formerly Covidien), 17% from IRE, and 10% from NTP.
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