Through 2021, Small-Molecule Angiogenesis Inhibitors Will Dominate the Renal Cell Carcinoma Treatment Landscape and the Market Share for this Drug Class Will Peak in 2017 at Nearly 85 Percent

Bristol-Myers Squibb/Ono Pharmaceuticals’ Novel Immunotherapy Nivolumab Will Earn Sales of Nearly $400 Million in 2021, According to Findings from Decision Resources

November 26, 2012-Burlington, Mass. –Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, through 2021, small-molecule angiogenesis inhibitors will dominate the renal cell carcinoma (RCC) drug market. In 2011, this drug class held a 68 percent market share—this share will peak in 2017 at nearly 85 percent. In 2021, the market share of small-molecule angiogenesis inhibitors will fall to 75 percent, owing to the generic erosion of some therapies in this class and to the launch of Bristol-Myers Squibb/Ono Pharmaceuticals’ novel immunotherapy, nivolumab.

The Pharmacor Renal Cell Carcinoma advisory service finds that, over the next decade, two new small-molecule angiogenesis inhibitors will launch for the treatment of advanced RCC (in addition to the 2012 launch of Pfizer’s Inlyta) – Aveo Oncology/Astellas Pharma/Kyowa Hakko Kirin’s tivozanib and Novartis’s dovitinib. In 2021, these agents will together capture 18 percent of RCC therapy sales. Pfizer’s Sutent is currently the RCC market leader, but in 2016, Decision Resources expects GlaxoSmithKline’s Votrient to become the top-selling agent, owing to its deepening first-line penetration.

Nivolumab will launch for the treatment of advanced RCC in the second- and third-line settings in 2017 in the United States and Europe and in 2018 in Japan.

“Nivolumab will become the sales leader in the third-line setting in 2018 and the patient-share leader in 2020,” said Decision Resources Analyst Karen Pomeranz, Ph.D. “In the second-line setting, it will become the sales leader in 2020. Overall, by 2021, nivolumab will be the second-highest-selling agent for RCC in the markets under study, with sales of nearly $400 million.”

The findings also reveal that, overall, the RCC therapy market will increase from $1.6 billion in 2011 to nearly $2.1 billion in 2019 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Thereafter, the market will plateau at about $2 billion in 2021.

The Pharmacor Patient Flow Model for Renal Cell Carcinoma, which contains detailed methodology that includes the modeling of recurrent cases of RCC, finds that growth in key RCC patient populations will be relatively flat over the next decade as disease risk is forecast to remain stable. New therapies launched in stage IV unresectable disease setting will partly contribute to a projected six month improvement in life expectancy over the next ten years, with a further four months by 2031 if historic trends continue.

Approximately 30 percent of patients diagnosed in stages I-III present with intermittent to high risk of relapse, equating to more than 20,000 cases across all major markets and growing by 1.4 percent annually through 2031. This presents a treatment opportunity in the adjuvant setting, although there is no current approved therapy in this setting. The risk of disease recurrence is forecast to decrease over the next 20 years, with the largest drop set to occur in stage III at an annual decrease of about 3 percent.

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