Nuclear medicine imaging continues to evolve as the industry rides the innovation wave ensuring high image quality, increased diagnostic confidence, improved treatment planning, and faster workflows.
Nuclear medicine imaging uses small amounts of radioactive materials called radiotracers that are typically injected into the bloodstream, inhaled, or swallowed. The radiotracer travels through the area being examined and gives off energy in the form of gamma rays, which are detected by a special camera and a computer to create images of the inside of a human body. Nuclear medicine imaging provides unique information that often cannot be obtained using other imaging procedures and offers the potential to identify disease in its earliest stages.
The field of nuclear medicine imaging has reached milestones with the advent of hybrid/fusion scanners and the flourishing PET/CT, SPECT/CT, and PET/MRI systems, paving a way to the new era of the field of imaging. The introduction of new radiation detector systems in nuclear medicine imaging has led to a multifold increase in sensitivity and energy resolution. With the use of CZT (cadmium zinc telluride) detectors, SPECT/CT is likely to become organ-specific. LSO or LYSO crystals and Time-of-Flight (ToF) technology permit PET/CT scans to be acquired in shorter times and at lesser doses of radioisotopes, leading to more patient comfort and less radiation exposure. These technological advancements allow for detection and localization of small lesions critical to drive early diagnosis.
As the field of imaging moves beyond anatomical imaging into functional and combination studies, researchers are able to use technologies like PET/MRI to identify new biomarkers that can help quantify various disease states. With rising concerns about radiation dose levels, the focus of market players has been on developing iterative reconstruction software to improve the image quality of lower-dose scans. PET/CT technology is moving toward low radiation and better imaging.
In the future, more multimodality imaging techniques may appear with various combinations of standalone diagnostic imaging modalities. This may further revolutionize the diagnostic imaging procedures and have a tremendous impact on the management of patients, and ultimately synergize healthcare in particular and research in general.
Indian Market Dynamics
The Indian nuclear medicine euipmentmarket is estimated at 290 crore. GE dominates the segment and considers only gamma cameras/SPECT to be classified strictly as nuclear medicine, where it has an 83 percent market share. Siemens is the other strong contender. We have conservatively included PET scanners, which may also be used for molecular imaging and cyclotrons also in this segment.
PET scanners have seen a major increase in demand from 10 units in 2015 to 36 in 2016, albeit the average unit prices have seen a decline. Cyclotrons continue to be procured as very discerning buys. This year two RF-based cyclotrons were procured, one in Bengaluru and the other in New Delhi.
Global Market Dynamics
The nuclear medicine and radiopharmaceuticals market is projected to reach USD 7.27 billion by 2021 from USD 4.67 billion in 2016, growing at a CAGR of 9.3 percent. SPECT gamma cameras used in nuclear medicine represent the largest share of the market for new and used equipment in this field, followed distantly by new PET/CT and SPECT/CT systems.
Globally, the segment is catered to by Philips Healthcare (Netherlands), GE Healthcare (UK), Siemens Healthcare (Germany), Mediso Medical Imaging Systems, Ltd. (Hungary), Digirad Corporation (US), Toshiba Medical Systems Corporation (Japan), DDD-Diagnostics A/S (Denmark), Neusoft Medical Systems Co. Ltd. (China), and SurgicEye GmbH (Germany), and CMR Naviscan Corporation (US).
The product segment of radiopharmaceuticals accounts for most of the demand and is expected to remain dominant over the period of next few years, which can be attributed to growing use of radioactive pharmaceutical drugs as nuclear imaging agents. The increasing use of various medical radioisotopes, such as copper-64, iodine-124, and FDG in molecular studies, is expected to boost the growth rate in the near future.
North America is the most lucrative region for the players owing to robust healthcare infrastructure and high adoptability of new technology. Europe serves the second-most demand as a regional market for nuclear medicine; however, Asia-Pacific is expected to extend the demand at the most prominent rate. This rising demand is primarily from the emerging economies of India, China, Australia, and Japan, wherein increased investment on healthcare has escalated in the recent times. Moreover, due to the presence of vast population, neurological and cardiovascular diseases as well as cancer cases are growing, which will further increment the demand in Asia-Pacific nuclear medicine market.
The latest mergers and acquisitions between the giant market players in the radiopharmaceutical and tracers segment mark the future of this segment in the global market.
- In May 2017, GE Healthcare has signed an agreement with HealthTrust, a group purchasing organization headquartered in Nashville, Tenn., to provide both low-energy (SPECT) and high-energy (PET) radiopharmaceuticals to HealthTrust members across the United States. The company has also signed a definitive license agreement withLantheus Holdings Inc. for the continued Phase-III development and worldwide commercialization of flurpiridaz F-18. F-18 is an investigational PET myocardial perfusion imaging agent that may improve the diagnosis of coronary artery disease.
- In April 2017, IBA Molecular has merged with previous acquisition Mallinckrodt Nuclear Medicine to form the new company Curium. Nuclear imaging will continue to be at the core of the enlarged organization as the business plans to invest further in organic and inorganic growth opportunities.
- In March 2017, the University of Missouri Research Reactor (MURR) and its partners Nordion and General Atomics (GA), have submitted a License Amendment Request (LAR) to the US Nuclear Regulatory Commission (NRC). This marks a critical step toward implementing domestic US production of molybdenum-99 (Mo-99). Once operational, production from this facility will be capable of supporting nearly half of US demand for Mo-99.
The clinical utility of SPECT, SPECT/CT, PET/CT, and general nuclear medicine remains a viable mainstay in assisting physicians and healthcare facilities with the care of their patients. Technical advances for nuclear medicine systems remain relatively the same. PET/MR is being investigated for clinical utility but is an expensive modality. Also, fusion imaging with SPECT/MR is being investigated. The adoption of SPECT/CT for clinical reasons and its replacement in the install base is a major recent development. Another SPECT/CT advance is quantification and the adoption of quantification for oncology and the growing application of radionuclide therapy.
The market is also seeing new SPECT/CT visualization techniques such as for bone imaging. One final SPECT/CT advance is the introduction of solid-state technologies, but they are principally for research purposes and have fairly narrow applications at present, for example, organ imaging and specific tracers.
On the PET side, there are new acquisition techniques that include continuous bed motion, which enables personalized acquisition and allows routine incorporation of respiratory motion correction. Another PET advance is the increasing adoption of large-bore PET, approaching 80 cm. These large-bore systems are being used for radiation therapy planning, which is becoming an increasing application for PET.
A primary advance for nuclear medicine lies with the development and implementation of radiopharmaceuticals that not only target specific diseases for diagnosis but also impact treatment of diseases, particularly cancer.
There has been a lot of buzz lately regarding solid-state gamma detection. While computing and radio pharmaceuticals have advanced considerably over the years, gamma scintillation technology has remained mostly idle. Solid-state detection is a significant technological leap, touting shorter acquisition times and better energy/spatial resolution. The downside is cost. The price point for solid state will render it out of reach for all but those departments with big budgets.
Nuclear myocardial perfusion imaging (MPI) with PET and SPECT have been the gold standard for noninvasive detection of coronary ischemia and infarcts. However, the high radiation doses patients receive are making some providers think twice before referring their patients for nuclear MPI. Newer dose-lowering technologies have helped reduce radiation dose by more than 50 percent for cardiac computed tomography angiography (CTA) scans, making it much more attractive as a diagnostic imaging modality. New CT technology – including perfusion imaging with advanced visualization software and CT-fractional flow reserve (FFR) imaging – may lead to increased use of CT. When 64-slice CT scanners were first introduced a decade ago, CTA dose was 20–30 mSv, but new reconstruction software, more sensitive detectors, and other technologies have reduced this below 10 mSv. With the newest scanners and software, it is now possible to perform CTA with about 1 mSv of dose. This new dose profile has made CTA much more attractive, and nuclear imaging now finds itself in the position as the high radiation dose technology being called into question.
As personalized medicine continues to influence how one delivers care, advances in nuclear medicine and molecular imaging technologies are making it more critical in the care continuum. First off, new radioisotope tracers represent a major development that will take nuclear medicine beyond the standard FDG (fluorodeoxyglucose), which will enable greater specificity to target individual tumors or disease processes. Second, advances in imaging equipment in digital technology such as digital PET/CT have demonstrated that they can provide approximately twice the volumetric resolution, sensitivity gain, and quantitative accuracy when compared to analog systems. Finally, in order for physicians to deliver personalized treatment, they need quantitative data and advances in nuclear medicine have given providers more access to actionable information and analytics.
Challenges and Opportunities
Despite the strides made in technologies, factors such as shorter half-life of radiopharmaceuticals and high cost of nuclear imaging equipment, coupled with unfavorable reimbursement initiatives, restrict market growth in developing regions. Higher costs of equipment cause the hospitals and imaging centers retain and utilize their existing nuclear medicine equipment for a longer period of time.
Manufacturers in the nuclear imaging equipment market also face the peculiar dynamics of the market as well as deal with challenges arising from the lack of novel imaging agents. Certain restrictions in nuclear medicine services such as shortage of radioactive isotopes, dearth of technical experts in hospitals, and high cost of materials continue to dampen growth significantly.
Molecular imaging, using high-resolution single-photon emission computed tomography (SPECT) and positron emission tomography (PET), has advanced elegantly and has steadily gained importance in the clinical and research arenas. Continuous efforts to integrate recent research findings for the design of different geometries and various detector technologies of SPECT and PET cameras have become the goal of both the academic community and nuclear medicine industry. As PET has recently become of more interest for clinical practice, several different design trends seem to have developed. Systems are being designed for low-cost clinical applications, very-high-resolution research applications, and just about everywhere in-between. Thus, many different design paths are being pursued. It will be interesting, indeed, to see which ones become mainstream for future commercial systems and which technologies emerge as the most popular.