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Nuclear Medicine Equipment

As Covid recedes, the nuclear medicine equipment market bounces back

In India, the field of nuclear medicine is seeing relatively slower growth than other areas of medicine. The country needs to rationalize its use of resources, provide subsidies for radioisotopes and equipment, and have more skilled medical and non-medical personnel in nuclear medicine.

The field of nuclear medicine has been involved in a significant technological advancement, and in a tremendous progress in radiochemistry, that made way for new and fascinating diagnostic and therapeutic opportunities. The leap forward of stand-alone systems besides hybrid imaging design improvement and novel theragnostic methods development has made possible a wider use of nuclear medicine techniques in several diagnostic scenarios. Nuclear imaging technologies like positron emission tomography (PET) and single-photon emission computed tomography (SPECT) have advanced to the point where they can now be employed in fields other than oncology, cardiology, and neurology.

In addition, recent advancements in nuclear imaging equipment have resulted in a shift from standalone to hybrid modalities. This is attributed to the increased awareness of the potential of early and timely diagnosis for the management and treatment of diseases. The innovation of PET/CT modality has resulted in the success of hybrid PET/CT systems, hybrid PET/MRI, and SPECT/CT systems. The hybrid systems provide precise images with better resolution than standalone modalities. The development of cadmium-zinc-tellurium-based detector provides simultaneous viewing of physiological and anatomical structures. For instance, a SPECT/CT system offers accurate localization and improved specificity in skeletal evaluation.

Nuclear imaging equipment is a premium product and is, therefore, costly. This is because this advanced equipment requires high installation investments, which also increases the procedural cost for patients. The developing countries are unable to adopt novel nuclear imaging systems as most healthcare facilities cannot afford such expensive systems. The third-party payers aid healthcare facilities to purchase expensive systems by providing reimbursements for the costs incurred in the diagnostic, screening, and therapeutic procedures. The continuous cuts in reimbursements for diagnostic imaging scans are also hampering growth.

The Indian market for nuclear medicine equipment in 2021 is estimated at ₹164 crore, a 53-percent decline by value over 2020. Although the PET-CT scanners continue to dominate the segment, with a 64.2-percent share by volume, and 87.8-percent share, by value, it is this segment that led to the decline over 2020. Prices remained at the same level as in 2020 for all segments.

Eighteen PET scanners were procured in 2021, whereas the number was 38 units in 2020. The government stayed away from this segment this year too. Siemens did well in 2021 with its high-end digital PET scanner model Biograph Vision, the average unit price being ₹20 crore. The remaining machines were at an average unit price of ₹8 crore each, all bought by private institutions.

As the pandemic receded, demand picked up for PET scanners from September 2021 onwards. In the nine months, January–September 2022, 56 units have already been sold, major buyers being both, private hospitals and privately run diagnostic centers.

Indian nuclear medicine equipment market

Leading players – 2021
GE and Siemens
IBA, Belgium has presence in the cyclotron segment
ADI Media Research

The gamma cameras with SPECT tomography and integrated CT scanners, a declining segment over the last few years, held their ground in the Indian market with a 36-percent share by volume, and a 12-percent share by value, at 10 units, estimated at ₹20 crore in 2021. January–September 2022 has seen sales of 22 units of SPECT already.

No cyclotrons were sold in 2021. The first nine months of 2022 have seen two units of cyclotrons sold, one by GE to the three-member consortium led by Dr Ranjan Kabra in Jaipur, and the second by IBA, based in Belgium to a facility in Lucknow, average unit price being in the vicinity of ₹17 crore.

In India, over the years, GE has dominated the segment and shared the space with Siemens. GE and Siemens are now almost at par, the latter’s high-end digital PET scanner model being the reason for this success. IBA has an installation of about four cyclotrons in the country. The refurbished machines have exited this segment over the years.

The supply of key materials continues to be severely disrupted. Regional warehouse operations are not smooth and the transportation of raw materials between regions cannot be carried out successfully. The shortage of raw materials and components has consequently affected the supply chain of the global molecular imaging equipment market. The Indian vendors find that the earlier supplies that were delivered in three months, can now sometimes take 6–9 months. The issue has been compounded with the United States having banned Russian-affiliated ships from American ports.

The global nuclear medicine equipment market was valued USD 2.63 billion in 2021 and is expected to reach USD 3.56 billion by 2029 at a CAGR of 3.87 percent. Rising cancer prevalence, cardiovascular complications, and neurodegenerative problems; growing awareness about the importance of early disease diagnosis; the introduction of advanced nuclear medicine equipment into the market; and the increasing adoption of nuclear medicine appliances by end-users are major factors driving the market growth. However, the high cost of nuclear medicine equipment and radiopharmaceutical half-life is estimated to limit the market growth. Also, the increased usage of repurposed diagnostic imaging systems, as well as hospital budget constraints, pose a challenge to the industry growth. On the other hand, the market is likely to benefit from a solid product pipeline as well as growth and penetration prospects in the emerging markets.

The nuclear medicine equipment is designed to solve the diagnostic challenges, a medical image using a small amount of radioactive material to diagnose and control the severity of or for treating numerous diseases, for instance, cancer, heart diseases, neurological disorders, and other abnormalities within the body.

The increasing prevalence of diseases among the geriatric population, durable product pipeline, and a growing demand for nuclear medicine procedures in the emerging market are expected to fuel market growth in coming years. The high cost of nuclear medicine equipment and reduced half-life radiopharmaceuticals hamper the growth of the nuclear medicine equipment market globally. Furthermore, lack of effective data and evidence that supports nuclear medicine improves the patient’s outcome, less reimbursement of medical imaging, and lack of trained physicians and radiologists can restrain growth of global nuclear medicine equipment market.

Positron emission tomography dominated the industry in 2021 caused by high-resolution images provided by PET technology that is majorly used in oncology cases to obtain enhanced information about a tumor. PET is sub-segmented into standalone and hybrid. Cost-effectiveness of SPECT will significantly drive segment growth over the next 7 years. The use of SPECT enhances the accuracy of nuclear medicine imaging in the field of clinical oncology and diagnosis of brain tumor.

The oncology segment holds the largest market share in 2021, and cardiology is expected to witness the highest CAGR. Owing to rise in demand for more advanced technologies, such as nuclear medicine equipment to detect cancer at an early stage is increasing owing to the high prevalence rate of cancer in most developed countries like the US, thus fueling the market growth.

The diagnostic product segment held the highest market share in 2021 owing to the presence of a large patient base and the availability of advanced technologies, such as SPECT and PET. According to the World Nuclear Association Analysis 2021, about 40 million nuclear medicine procedures are performed annually, and the demand for radioisotopes increases by around 5 percent every year. The wide range of radiotracers that are currently employed in the diagnosis of tumors, coupled with technological advancements, are contributing to the growth of the nuclear medicine market.

The therapeutic segment is further divided into alpha emitters, beta emitters, and brachytherapy. The robust product pipeline, coupled with the approval and commercialization of nuclear medicine therapeutics, may fuel the segment growth. In October 2021, the US FDA approved and granted breakthrough designation to diffusing alpha-emitters radiation therapy (DaRT) for the treatment of patients suffering from recurrent glioblastoma multiforme (GBM). It is a standalone therapy when other therapies have failed to work in patients with GBM. Currently, radium (Ra-223) is the most widely used alpha emitter in therapeutics. Development of potential radioisotopes, such as Terbium (Tb-149), Bismuth (Bi-212), and Actinium (Ac-225) is expected to augment market growth.

The hospitals segment accounted for the largest market share in 2021, based on end users. This is attributed to the increased awareness about nuclear medicine therapies, high prevalence of chronic diseases, and shift from standalone to hybrid modalities. On the other hand, the hospitals and imaging centers segment is expected to grow with the highest CAGR with the increased awareness about nuclear medicine therapies, increased investment in research and development of nuclear imaging equipment, increased number of diagnostic institutions, and high volume of nuclear imaging procedures.

Region-wise, the Asia-Pacific is anticipated to register the highest CAGR of 10.5 percent. Demand for nuclear medicine is growing in emerging markets, such as China and India, due to increasing disposable income, improving healthcare standards, and favorable reforms in foreign policies. China is dominating the Asia-Pacific market and is likely to hold on to its leadership position through 2029.

The market is projected to gain traction in the developing regions of Asia-Pacific, Africa, and Latin America. The large pool of cancer population, rise in disposable income, and increase in awareness toward motion preservation device are expected to drive the market growth in these regions.

The practice of nuclear medicine in Japan has advanced significantly in recent years, with a significant increase in the frequency of hybrid SPECT/CT exams.

The key players operating in global nuclear imaging equipment market are Siemens Healthineers AG, GE Healthcare, Koninklijke Philips NV., Canon Medical Systems Corporation, Star Equity Holdings, SurgicEye GmbH, Mediso Ltd., Rigaku Corporation, MR Solutions, DDD-Diagnostics A/S, Segami Corporation, Mirion Technologies, CMR Naviscan, Positron Corporation, Neusoft Medical Systems, Fujifilm Holdings, Digirad Corporation, Bozlu Holding, IBA, and other prominent players. The key marketing strategies adopted by the players are facility expansion, product diversification, alliances, collaborations, and partnerships to expand their customer reach and gain a competitive edge in the overall market.

In March 2022, the US FDA approved Pluvicto (177Lu-PSMA-617) for the treatment of adults with metastatic prostate cancer. This approval is anticipated to drive market growth.

In March 2022, Penang Adventist Hospital (PAH) announced the launch of a private nuclear medicine center in the northern part of Malaysia. This launch is anticipated to have a positive impact on the regional market.

In January 2022, ITM Isotope Technologies Munich SE initiated COMPOSE phase 3 trial of 177lu-edotreotide to evaluate the viability of the product for treating patients with neuroendocrine tumors.

In November 2021, Siemens Healthineers launched the world’s earliest photon-counting CT scanner, Naeotom Alpha. It is highly superior in all technical parameters associated with image quality, and is cleared for all clinical applications in the US and Europe.

In September 2021, GE Healthcare acquired BK Medical, a leader in enhanced surgical imaging, from Altaris Capital Partners for USD 1.45 billion. In the same month, GE Healthcare announced the launch of a novel scanner with a new automated workflow feature that offers an exceptional view of cardiac anatomy and pathology.

In September 2021, BWX Technologies’ subsidiary, BWXT Medical inked an agreement with Bayer AG for developing and producing Ac-225 (Actinium-225), a highly powerful radioisotope utilized in targeted alpha therapies. This helped the firm leverage its differential strengths in nuclear medicine.

In June 2021, Curium bought the Austrian radiopharmaceutical business IASON to boost its diagnostic product line’s European footprint.

In May 2021, US FDA approved PYLARIFY injectable by Lantheus, a US diagnostic imaging agents and equipment firm. The injection is the first PSMA PET imaging agent for prostate cancer that is commercially accessible.

In March 2021, Bracco Diagnostics Inc. entered into a partnership with CardioNavix, LLC, aimed at improving the patient reach of the novel cardiac PET imaging system. This new initiative provides patients easy access to hospitals, physicians, and diagnostic centers, for cardiac PET imaging.

In January 2021, Eckert & Ziegler announced the development plan of a cGMP facility for contract manufacturing of radiopharmaceuticals in Boston, US. The facility will be dedicated to the production of late-investigational-stage and commercial-stage radioisotopes used in nuclear medicine, and can help address the increasing demand for radionuclides in the market.

Some of the recent advancements in imaging technology that are relevant to imaging radionuclide therapy include:
The advantages of PET/MRI over PET/CT are higher soft-tissue contrast that is essential for planning of treatment, dosimetry, and assessment post radionuclide therapies. Additionally, for accurate dosimetry, it is beneficial as it provides the simultaneous coregisteration of MR images. Also, MRI can be employed for determining the tolerable dose with the least organ-damaging activity of radionuclide. Along with it, anatomic and molecular images acquisition provides better motion correction. Integrating of PET and MRI modalities is challenging as there will be interference between both modalities. For instance, photomultiplier tubes that are present in PET detectors malfunction in magnetic fields exerted by MRI. In addition to this, PET module affects the radiofrequency signal associated with MRI. Due to this, the first generation of PET/MRI systems modalities were separated. Integration of PET detectors and MR scanner has been done to obtain PET and MR images simultaneously. Detector system is avalanche photodiodes types or SiPMs types, which are not sensitive to magnetic field. The simultaneous measurement provides better 4-dimensional acquisitions because of spatial agreement of PET and MRI data. Disadvantages associated with PET/MRI are high costs and the ferromagnetic metallic implants, which are used in contradictory to MRI. In addition to this it is challenging to correct attenuation of PET/MRI. For dosimetry, it is essential to have accurate attenuation correction. As CT images are electron-density images and MR images are proton-density images, CT images are better suited for attenuation correction. But MR images can be used for attenuation correction by using techniques, such as segmentation-based or template- or atlas-based, which derive electron density information from MR images. Alternatively, estimation of the attenuation maps can be done by employing algorithms, which use the time-of-flight emission or transmission data.

Over recent years, there has been growth in PET utilization in systemic infections and inflammation for diagnosis, assessment of disease activity, and therapy monitoring. FDG PET/CT can be used for diagnosis and follow-up in multiple inflammatory conditions including rheumatoid arthritis (RA), polymyalgia rheumatica, IgG4-related disease, large vessel vasculitis, and granulomatosis with polyangiitis, adult-onset Still disease, spondyloarthritis, chronic osteomyelitis, and multicentric reticulohistiocytosis. Increased FDG uptake in the tracheobronchial tree is a reliable sign of cartilage involvement in relapsing polychondritis. FDG PET/CT can be used for early diagnosis of RPC and follow-up. New specific PET tracers are being developed, for example, α5β1-integrin PET appears to be a promising tool for early diagnosis of RA and therapy monitoring.

Molecular imaging is used to investigate venous thrombosis including determination of thrombus activity and acuity, which may play an important role in patient management. 99mTc apcitide binds to glycoprotein receptor GPIIb-IIIa on the membrane of activated platelets. This can identify acute deep-venous thrombosis. This test has been approved by FDA, but is not widely used. An additional compound 99mTc-DI-DD3B6/22-80B3 (99mTc-DI-80B3 Fab’), a humanized monoclonal Fab’ fragment that binds to D-dimer, showed good safety profile and promising accuracy in phase I and II trials. PET tracers are also under active investigation, for example, 64Cu-DOTA fibrin-targeted probes, which have been tested in animal models.

Precision or personalized medicine is often described nearly exclusively in the context of genomics. Underlying this concept is the notion that actionable cancer cell mutations may represent a cancer’s Achilles heel. Such actionable mutations include those of the epidermal growth factor receptor, BCR-ABL, BRAF, and many others. It was the success of imatinib for the treatment of chronic myelogenous leukemia and gastrointestinal stromal tumors that raised the hope that single oncogenic drivers could be identified and targeted successfully for most cancers. The goal of precision oncology has thus far remained largely elusive. Nuclear medicine techniques and assays usually are not discussed in the context of precision medicine, defined as the right treatment (drug or others), for the right patient, at the right dose, at the right time. Nevertheless, no discipline other than nuclear theranostics can provide noninvasive readouts of target expression and address the target structure successfully.

Theranostics, a combination of therapeutic and diagnostic approaches, is one of the most exciting areas in molecular imaging. This refers to the idea of targeted molecular imaging, using radionuclide-labeled molecules not only for imaging but also for therapy delivery. Radionuclides with optimal decay characteristics can serve as delivery system for targeted radiation therapy. Radiation has proven to be a very useful treatment option for different cancers, but it is limited in that its source is external and the treatment affects all the tissue in the radiation field. With theranostics, the source of radiation is internalized, targeting specific malignant cells throughout the body, including micro-metastatic disease. Locally delivered radiation damages the DNA, triggering apoptosis in the targeted cells. Pre-treatment scans and therapy can use the same carrier; however, a different radionuclide attached to the carrier can be used for the imaging and therapy.

There are a total of 359 nuclear medicine departments in India as per the Atomic Energy Regulatory Board’s (AERB) recently released list (March 2021). India is estimated to have one PET-CT, one gamma camera, and one nuclear medicine department per 5 million population. However, it is an astonishing fact that nuclear medicine was established first in the government institutions, but there are merely 14 percent of nuclear medicine departments currently functioning in the government sector, maybe because primary healthcare has been the priority of the government.

Nuclear medicine is giving promising results for patients of prostate cancer, lung cancer, stomach cancer, and other types of cancer where surgery is not an option. However, starting a nuclear medicine department in a hospital or diagnostic center is a humongous effort, and investment is quite high. Also, returns are slow. For this reason, most nuclear medicine facilities are clustered in Tier I and Tier-II cities.

In smaller cities, revenue generation is a challenge, so the procedures tend to be costly and out-of-bound for most people. Due to this, nuclear medicine is seeing relatively slower growth in India compared to other branches of medical science.

To overcome this, India needs rationalization of resources, subsidization of equipment and radioisotopes, and training of more medical and non-medical personnel in nuclear medicine.

Today, India needs a ten-fold increase in facilities and labor to ensure that its population derives full benefits of this advanced field of medicine.

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