Sunitinib malate is a small-molecule medicine that has been proven to be effective in blocking multiple receptor tyrosine kinases (RTKs). The potential antineoplastic activity of sunitinib has led to it being regarded as an effective agent in inhibiting cell proliferation and angiogenesis. Sunitinib capsules have been approved for use in treating pancreatic neuroendocrine tumors, kidney cancer, and gastrointestinal stromal tumor (GIST).
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Sunitinib malate capsules received the U.S. FDA’s approval for use in the treatment of renal cell carcinoma and GIST on January 26, 2006. They also subsequently received approval from the European Medicine Agency in July 2006. Two years later, on April 16, 2008, the drug was approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
The aforementioned regions have thus emerged as the leading markets for sunitinib malate capsules, which are marketed by Pfizer as Sutent. Pfizer has market exclusivity over sunitinib malate capsules until 2021, which has made them an important revenue source for Pfizer, which had been losing revenue owing to the patent expiration of Lipitor in November 2011. The total sales of sunitinib malate were estimated at more than US$1 bn as of 2015.
This report examines the sales potential of sunitinib malate capsules in key regional markets such as the U.K., Japan, and the U.S. It also analyzes changes in the regulatory environment that could potentially impact the trajectory of the global sunitinib malate capsules market. Protected by patents, Sutent is expected to enjoy a healthy rise in revenue for the better part of the report’s forecast period.
Global Sunitinib Malate Capsules Market: Drivers and Restraints
The increasing prevalence of pancreatic cancer is a major driver for the global sunitinib capsules market. According to the American Cancer Society, around 53,000 Americans are expected to be diagnosed with pancreatic cancer in 2016, with close to 42,000 of them expected to succumb to it. Due to the relative inaccessibility of the pancreas, detecting and removing pancreatic tumors is more difficult than other tumors. As a result, the use of sunitinib malate capsules to treat pancreatic tumors is increasing.
The increasing prevalence of pancreatic neuroendocrine tumors, in particular, is a key driver for the global sunitinib malate capsules market. Sunitinib malate was approved by the FDA in May 2011 for the treatment of pancreatic neuroendocrine tumors that have proven difficult to extract surgically or have already metastasized.
However, one of the key restraints acting against the global sunitinib malate capsules market’s growth is the high cost of Sutent. It ranks among the most expensive drugs currently being marketed, which puts it out of the reach of the average consumer in the absence of sufficient reimbursement. Moreover, studies have also shown that Sutent is associated with hepatotoxicity – a condition that can lead to liver failure and even death. Adverse cardiovascular events have also been reported during clinical trials, which could discourage adoption of the drug.
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Global Sunitinib Malate Capsules Market: Regional Outlook
It is estimated that the global market for sunitinib malate capsules will remain concentrated in the developed G7 countries, where the sales of the drug are currently the highest. Through the latter half of the report’s forecast period, after the expiration of the patents on Sutent, the market for sunitinib malate capsules is expected to develop rapidly in the mass volume markets of China and India. This could cause a significant shift in the overall dynamics of the global market for sunitinib malate capsules.
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