The Future of the U.S. Molecular Imaging and Diagnostic Radiopharmaceutical Industry

New radiopharmaceuticals, technologies, products, and software are driving adoption in an increasingly uncertain healthcare environment.

June 02, 2017

Hybrid molecular imaging (and the use of accompanied radiopharmaceuticals) is poised to thrive under value-based healthcare by offering clinicians best-in-class image quality and accurate early disease diagnosis and staging. Market growth is also being driven by new radiopharmaceuticals that will enable PET/CT and SPECT/CT platforms to be used across new clinical areas such as neurology and orthopedics while allowing for more accurate staging of different tumor types in oncology. The launch of new cardiac radiopharmaceuticals such as flurpiridaz F-18 and ammonia N-13 will help in more precise imaging of cardiovascular diseases.  

Molecular imaging is also playing an important role in clinical trial efficiency by allowing for more accurate image staging to track the progression or regression of diseases, based on the efficacy of new drugs or interventions. Non-invasive imaging of tumor receptor expression by molecular imaging modalities will play a pivotal role in understanding tumor biology in order to develop targeted treatments. Molecular imaging also will aid in monitoring the pharmacologic effects of drugs on different tumor types to determine treatment efficacy.  

PET vs. SPECT: Improved Technologies and Software Redrawing the Molecular Imaging Landscape
SPECT/CT traditionally has been used primarily for cardiac imaging and PET/CT for oncology imaging, but shortages of Tc-99m used in SPECT/CT for cardiac imaging have led to a shift to PET myocardial perfusion imaging (MPI), which now accounts for two percent of all procedures. The benefits associated with PET, such as higher sensitivity and specificity, have contributed to this shift. However, stabilization of the Tc-99m supply, coupled with improved SPECT quantitation accuracy, will see SPECT regain lost ground. 

Quantitation accuracy has traditionally come at the expense of image quality, thus earning nuclear imaging the nickname “non-clear imaging” among radiologists. However, developments in quantitation software have improved accuracy in both SPECT/CT and PET/CT platforms without compromising imaging quality. While there have been greater advances in PET quantitation software development in the past, molecular imaging modality manufacturers and other molecular imaging software companies have made great strides in bridging the gap between SPECT and PET.

Improvements in Molecular Imaging Modalities 
Both SPECT/CT and PET/CT modalities have gone through quantum leaps in technological sophistication over the last few years. One example is Philips’ introduction of the first digital PET/CT. The Veroes system utilizes a digital photon counting technology to offer twice the sensitivity, quantitative accuracy, and volumetric resolution of analog scanners, resulting in improved lesion detectability, better image quality and contrast for heart scans, and higher anatomical detail to capture deep structures of the brain. Similar quantitation advancements are being developed by a handful of start-up companies.

Several other technologies are being developed for PET/CT and SPECT/CT:  

  • Lutetium-based scintillators such as LYO and LYSO are widely used in PET detectors due to their high stopping power for 511 keV gamma rays, high light yield, and short decay time. This offers a significant advantage over NaI and BGO PET scintillators. A drawback is that 2.6% of naturally occurring lutetium is Lu-176, a long-lived radioactive element that includes a beta decay and three major simultaneous gamma rays, which occasionally impacts the overall performance and imaging quality of PET scans.
  • A recent photo-detector development is the silicon photomultiplier (SiPM) sensor, which is compact, requires low operation voltage, and is insensitive to magnetic fields. The SiPM enables ease of segmentation for obtaining high spatial resolution, a critical requirement for obtaining high quality images at lower cost. Digital SiPM has recently emerged to address several issues of the analog SiPM, including noise susceptibility and power consumption.
  • In the next few years, cadmium zinc telluride (CZT)-based detectors will be more widely adopted over conventional sodium iodide cameras for SPECT/CT. CZT is not organ-specific and can be used for whole body imaging as well as detection of small lesions. This technology can also be used for simultaneous viewing of physiological and anatomical structures.

New Radiopharmaceuticals Driving Molecular Imaging Adoption
While Tc-99m and FDG remain the workhorse radiopharmaceuticals for SPECT and PET, respectively—accounting for 80 to 90% of current procedures—several new radiopharmaceuticals will drive molecular imaging scans in new clinical areas. Examples include flutemetamol F-18 and florbetapir F-18 for early diagnosis of neurodegenerative diseases such as Alzheimer’s, and 99mTc – UBI Ubiquicidin used to detect bacterial infections on the sites of orthopedic implants. In the cardiovascular imaging space, new PET perfusion agents for MPI, such as ammonia N-13 and flurpiridaz F-18, coupled with recent approvals of RUBY-FILL® Rb-82 generator (Jubilant Draximage) and the Elution system to produce a generic variant of CardioGen-82 (Rb-82), will drive the adoption of cardiac PET procedures. Several new oncology radiopharmaceuticals have been launched , with several more in varying stages of development. Notable examples include Axumin from Blue Earth Diagnostics for the detection of recurrent prostate cancer, and Gallium-68 Dotatate to detect rare endocrine tumors. Additionally, oncology agents are increasingly being used in clinical trials because of their ability to detect both staging and spread of tumors.

Dynamics related to the production and supply of Tc-99m has hampered the SPECT-CT market. A number of alternative, non-reactor based approaches to manufacture Tc-99m are in varying stages of trials. If approved, these processes are widely expected to replace reactor-based approaches, allowing SPECT to recapture lost ground from cardiac PET, despite the use of branded and generic Rb-82 radiopharmaceuticals by the latter.

Like PET, a slew of new SPECT radiopharmaceuticals are under development for use in new clinical areas, such as to detect and differentiate between traumatic brain injury and post-traumatic stress disorder—conditions that present with similar symptoms but require different treatments.

Molecular Imaging in an Era of Quality and Value-Based Payments 
Molecular imaging continues to face stiff competition from high-end MRI and CT modalities, which are lower cost and have favorable reimbursement policies. However, with reimbursements shifting toward value-based payments, clinicians are hard pressed to demonstrate improved quality of care. Early diagnosis and staging of diseases and better tracking of efficacy of treatment protocols in order to make timely changes are key factors that make molecular imaging more attractive to clinicians. While there is still a long way to go in terms of securing reimbursement across a broad spectrum of diseases, the stage is set for molecular imaging to become an integral part of the care pathway.

Copyright © 2017 Frost & Sullivan

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