Radiopharmaceuticals Market: Inconsistent Transportation Logistics of Radioactive Substances Act as Major Restraint

Radiopharmaceuticals are medicinal formulations containing radioisotopes that are found to be harmless for humans and can be safely administered for a therapy or diagnosis. Certain radiotracers (called radiopharmaceuticals), the chemical compounds with one or more atoms replaced by a radioisotope, have been traditionally used for imaging disease states and functional morphology of organs. Unlike other popular imaging modalities such as magnetic resonance imaging (MRI), ultrasonography (US), and computed tomography (CT), imaging procedures that use radiopharmaceuticals can also map metabolic activities and physiological functions, thereby giving more precise and specific information about function or dysfunction of an organ or metabolic activity.

Studying the use of radiotracers for therapeutic purposes had begun immediately after the discovery of radioactivity, however, it was not until cyclotrons became available for the acceleration of particles to fabricate radioisotopes that a significant medical application of radiotracers came into being. Radioiodine, for instance, was introduced in 1946 for treating thyroid cancer, and remains till date the most effective method for the treatment of the condition as well as hyperthyroidism.

Mapping the distribution of a radiopharmaceutical element in a body provides images of organ functions in a non-invasive manner and helps diagnose many common health conditions associated with malfunctioning organs as well as the detection of certain cancers. The extensive use and rising demand for imaging techniques that use radiopharmaceuticals are directly attributable to the enormous development observed in the global market for radiopharmaceuticals and has led to the availability of a huge range of specific radiopharmaceuticals.

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Market Scenario

Currently, there are more than 100 radiopharmaceuticals in the global market, which are used for the diagnosis of a variety of diseases and for the therapy of a few, including cancer. Transparency Market Research, a U.S.-based market intelligence firm, states in one of its reports that the global radiopharmaceuticals market will grow at a remarkable CAGR of 18.3% between 2012 and 2018. The report also states that the market, which had a net worth of US$3.8 billion in 2011, will reach US$12.2 billion by 2018. Canada’s prominence in the global radiopharmaceuticals market as the largest exporter of uranium and nuclear technology has led the regional market in North America towards a position of dominance in the global marketplace.

While the market’s growth prospects are huge, the market faces a number of challenges that make exploitation of these opportunities a bit difficult. Elucidated below are some key challenges that the market for radiopharmaceuticals faces:

Low global production of Radiopharmaceuticals: Unlike the production of conventional pharmaceuticals, the production of radiopharmaceuticals still happens on a relatively small scale across the globe. Implementing the current good manufacturing practices (cGMP) guidelines in radiopharmaceutical manufacture is also a very difficult and expensive process. Ensuring cGMP compliances can especially become a demanding task for small-scale manufacturers. 

Complex manufacturing cGMP code compliance: Manufacturing of radiopharmaceuticals involves taking care of a number of aspects prior to, during, and after the manufacturing process. It requires the use of controlled procedures and materials, qualified personnel to look after the entire process, production in designated clean rooms, detailed documentation of the process, application of analytical and validated methods, and the release of the final product by a qualified person. 

Troubles and delays in transportation of radioactive substances: Transport of radioactive materials is a highly complex matter. Many troubles and delays, the need for obeying transport regulations, and the denial of shipment by certain transport bodies often affect the final use of imported radiopharmaceuticals. Some countries follow the practice of holding up all the cargo for 24 or 48 hours before loading it on the plane, for security purposes. This also leads to a negative effect on the overall properties of radiopharmaceuticals due to radioactive decay of the substance, especially in radioactive materials of extremely short half lives.