Table of Contents
New Growth Opportunities Emerge in a Strenuous Market
This research service pertains to the US market for medical radiopharmaceuticals. A thorough market sizing and forecasting model of market revenue, procedure volumes, and average pricing is included, along with analyses of market trends, drivers and restraints, and the reimbursement and the competitive environments at the total level as well as within each segment. The three market segments considered are diagnostic SPECT radiopharmaceuticals, diagnostic PET radiopharmaceuticals and therapeutic radiopharmaceuticals. The base year of the study is 2012 and the forecast period extends seven years through 2019.
•The US medical radiopharmaceuticals market is comprised mostly of mature market segments arising from traditional molecular imaging procedures such as cardiovascular single-photon emission computed tomography (SPECT) imaging using technetium (Tc-99m) and myocardial positron emission tomography (PET) perfusion imaging using fludeoxyglucose (18F-FDG).
•However, with several new radiopharmaceutical products currently in the pipeline for both diagnostic and therapeutic applications, there remains much room for market growth, and growth prospects for the next seven years remain fairly high.
•After continued reimbursement pressure starting with but not limited to the Deficit Reduction Act of 2006, the most recent revisions by the Center of Medicare and Medicaid Services (CMS) has a slightly more positive note.
•In fact, 2013 fee schedule updates provided of an increase in reimbursement levels of between X and X% for both SPECT and PET imaging procedures.
•With the stabilization of molybdenum supply in 2012, after a 3-year phase during 2008 to 2010 characterized by radioisotope shortages and uncertain availability, the US radiopharmaceuticals market is now back on track to recover its lost momentum.
•Owing to ongoing advances both on the side of imaging technology and pharmaceutical research, each of SPECT and PET radiopharmaceuticals are expected to continue to evolve beyond their respective stronghold—cardiology for SPECT and oncology for PET.
•Indeed, the competition between these two modalities continues to intensify in various procedures and indications, particularly with PET imaging making forays into cardiac imaging and gaining higher acceptance among cardiology specialists.
•However, it is the application areas of neurology and oncology that hold the greatest growth potential both for diagnostic and therapeutic radiopharmaceuticals.
•In the case of neurology, new amyloid imaging agents hold high promise in applications such as diagnosing Parkinson's and Alzheimer's diseases. In oncology, one new major therapeutic radiopharmaceutical agent has been developed for treating prostate cancer.
1. Nuclear medicine and molecular imaging modalities continue to slowly grow in capability and adoption.
2. SPECT radiopharmaceuticals segment revenue reinstate and maintain single-digit growth rates.
3. PET radiopharmaceuticals continue to demonstrate robust growth, making strides into cardiology.
4. Several radiopharmaceuticals currently in development will enter the market during the next five years.
5. Therapeutic radiopharmaceuticals segment takes off starting in 2014, achieving double-digit growth.
•Radiopharmaceuticals are used to perform several types of nuclear medicine and molecular imaging procedures in the US primarily in hospitals, but also in various outpatient settings such as cardiology private practices.
•A pioneering country in the field of nuclear medicine and molecular imaging, the US healthcare system maintains the highest rate of utilization of these modalities globally and is at the forefront of technological advances and market adoption in these areas.
•Accordingly, the US market is the single largest radiopharmaceuticals market globally, representing about X% of worldwide market revenues in 2012, although higher growth rates can be observed in certain other European and Asia-Pacific countries.
•Given the severe regulatory limitations for the operation of nuclear reactors on US soil, it follows naturally that Canada continues to be the world’s largest exporter of nuclear products and technology including, but not limited, to medical purposes.
•Canada’s central role in the supply and production chains might start to decrease gradually, however, with the signing into law of the American Medical Isotopes Production Act of 2011 (AMIPA) on January 2, 2013. It is aimed at curtailing the use and export of highly enriched uranium (HEU) for the production of medical isotopes by promoting the alternative use of medical radiopharmaceuticals produced from non-highly enriched uranium.
Distribution Structure and Clinical Applications Discussion
•The clinical end customers for radiopharmaceutical products include nuclear medicine and molecular imaging specialists, as well as various medical specialists in radiology, cardiology, neurology, or oncology, having access to SPECT and PET imaging equipment across hospitals, private practices, and diagnostic imaging centers.
•The two main distribution channels for radiopharmaceuticals include either a radiopharmaceutical precursor shipped alongside a generator or as part of a cold kit. This is then prepared by providers on site, or a ready-to-use radiopharmaceutical dose prepared in and shipped from a radiopharmacy.
•The generator-based channel to market is a more recent one, with only a limited number of industry participants providing these products. For example, only Lantheus Medical Imaging and Covidien (now Mallinckrodt) are currently in the market for technetium generators, while only Bracco currently sells Rubidium generators.
•The types of generators available on the market today do not encompass all radiopharmaceutical agents, and are limited Mo-99/Tc-99m generators, Sr-82/Rb-82 generators, Ge-68/Ga-68 generators, Sr-90/Y-90 generators, and W-188/Re-188 generators.
•In the radiopharmacy model, providers rely on same-day shipping from a geographically close radiopharmacy, of read-to-use radiopharmaceutical does having a relatively short shelf-life.
Market Overview—Scope of Study
•This research service pertains to the US market, with a base year of 2012, and discusses medical radiopharmaceuticals used in nuclear medicine and molecular imaging during diagnostic and therapeutic procedures on humans across US healthcare facilities.
•Not included in the market sizing assessment for the purpose of this study are products that are ancillary to the actual radiopharmaceutical doses, including:
- Nuclear medicine and PET equipment and accessories are used in conjunction with or for the injection of radiopharmaceuticals.
- Adjunct pharmacological (non-radioactive) are agents commonly used alongside radiopharmaceuticals such as dipyridamole, adenosine, regadenoson, dobutamine (used for stress imaging), aminophylline (antidote used to reverse stress agents), and sincalide (used to empty gallbladder hepatobiliary imaging).
- Ancillary products sold as part of cold kits (e.g. ligand, reducing agent, buffer to adjust the pH, and stabilizing agents and excipients) are used on-site for the preparation of radiopharmaceutical injections that can be sold bundled or separately from the associated radioisotope dose.
- Medical devices that use radiopharmaceuticals, such as Yttrium-90 microsphere devices, are specialty products
- Radiopharmaceuticals used during radiotherapy applications such as brachytherapy and radiation therapy (e.g. external beam radiotherapy, intensity-modulated radiation therapy, and image-guided radiation therapy).
Key Questions This Study Will Answer
• Is the recent market slowdown a permanent readjustment of the market, or will the current stability give way to an increasing growth pattern?
• Which segments of the market are most likely to drive market growth back to its historical rates, and over which period of time?
• What are the key radiopharmaceutical products in the market and on the horizon that will stimulate growth in market demand for SPECT and PET radiopharmaceuticals?
• What role are evolving clinical guidelines expected to play in favor or to the detriment of each imaging modality in the current and future market?
• What type of impact is the trend toward personalized medicine expected to have on the evolution of the therapeutic radiopharmaceuticals market?
• What is the outlook on the current industry dynamics and the expected evolution of market concentration around the top five industry participants?
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