Global Sunitinib Malate Market: Overview

Sunitinib malate – a drug that has been approved for treating pancreatic neuroendocrine tumors, kidney cancer, and gastrointestinal stromal tumor – received the U.S. FDA’s approval on January 26, 2006. It 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 abovementioned regions have thus emerged as the leading markets for sunitinib malate, which is marketed by Pfizer as Sutent® in the form of a capsule. Sutent® enjoys market exclusivity until 2021, leading it to be touted as an important revenue source for Pfizer, which had been losing revenues from the patent expiration of Lipitor in November 2011. It is estimated that the total sales of sunitinib malate, by value, are upward of US$1 bn as of 2015.

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Sunitinib malate is a small molecule that has been clinically proven effective in blocking multiple receptor tyrosine kinases (RTKs). The potential antineoplastic activity of sunitinib has led it to be regarded as an effective agent in inhibiting cell proliferation and angiogenesis.

Global Sunitinib Malate Market: Drivers and Restraints

This report examines the global sales potential of sunitinib malate in the key regional markets such as the United Kingdom, Japan, and the United States. It also analyzes changes in the regulatory environment that could potentially impact the trajectory of the global sunitinib malate market. Protected by patents, Sutent® is expected to enjoy a healthy rise in revenue for the better part of the report’s forecast period.

The diagnosis rates of pancreatic and kidney cancer continue to remain below the desired levels. In the case of pancreatic cancer especially, early symptoms are virtually non-existent. This is causing a rise in the adoption of sunitinib malate in treating pancreatic cancer. Factors such as this are expected to indirectly boost the demand for sunitinib malate.

However, one of the key restraints acting against the 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 enough reimbursements. Moreover, studies have evidenced that Sutent® is associated with hepatotoxicity – a condition that could lead to liver failure and even death. Adverse cardiovascular events have also been reported during clinical trials, which could discourage the adoption of the drug.

Global Sunitinib Malate Market: Region-wise Outlook

It is estimated that the global market for sunitinib malate will remain largely 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®, a market for sunitinib malate is expected to develop in the mass volume markets of China and India. This could cause a shift in the overall dynamics of the global market for sunitinib malate. The report analyzes the pricing of sunitinib malate in the leading regional markets.

The report has been compiled as a decision-making tool for entities such as contract research organizations, pharmaceutical companies, regulatory authorities, and health insurance companies.

The report offers a comprehensive evaluation of the market. It does so via in-depth qualitative insights, historical data, and verifiable projections about market size. The projections featured in the report have been derived using proven research methodologies and assumptions. By doing so, the research report serves as a repository of analysis and information for every facet of the market, including but not limited to: Regional markets, technology, types, and applications.

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