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Report: Generics and Biosimilars Expected to Dominate Colorectal Cancer Market Through 2021

Bevacizumab (Avastin) will remain sales leader (Nov. 1)

Decision Resources, a research and advisory firm located in Burlington, Massachusetts, reports that, through 2021, growth in the market for colorectal cancer (CRC) treatments will decline in the face of generic competition for a key cytotoxic agent, oxaliplatin (Eloxatin, Sanofi), as well as the entry of biosimilar competitors for key targeted biological agents. The CRC market totaled $8.3 billion in 2011 and is expected to decrease to $7.8 billion in 2021 in the U.S., the U.K., France, Germany, Italy, Spain, and Japan.

The company also predicts that bevacizumab (Avastin, Genentech/Roche) will be minimally challenged as the sales leader in the CRC market over the next 10 years. The drug is expected to dominate the CRC market, with sales totaling approximately $2.5 billion, or nearly one-third of the total CRC treatment sales in 2021, despite erosion from biosimilar versions and from launches of the new angiogenesis inhibitors ziv-aflibercept (Zaltrap, Sanofi/Regeneron) and ramucirumab (formerly IMC-1121B, ImClone Systems/Eli Lilly).

“Zaltrap and ramucirumab, which will enter the second-line metastatic CRC treatment setting over the next decade, will face strong competition from Avastin,” said analyst Gemma McConnell, PhD. “With data from the TML/ML18147 study demonstrating the benefit of Avastin treatment beyond disease progression, Zaltrap and ramucirumab will fail to garner high patient share, collectively earning less than $300 million in 2021.”

The findings also show that major market sales of epidermal growth factor receptor (EGFR) inhibitors will decline from 2011 to 2021 as a result of competition from biosimilars and, importantly, as increased use of angiogenesis inhibitors in the second-line setting push EGFR-targeted therapies into the smaller later-line treatment settings. In 2021, cetuximab (Erbitux, Bristol-Myers Squibb/Eli Lilly/Merck Serono) and panitumumab (Vectibix, Amgen/Takeda) are forecast to garner collective sales of approximately $1.3 billion.

Regorafenib (Stivarga, Bayer HealthCare), the first small-molecule multikinase inhibitor to gain FDA approval for CRC, is expected to address a significant unmet need in the third- and fourth-line treatment settings and to increase treatment rates in these settings over the forecast period. However, the small patient populations will significantly constrain sales, and in 2021 major-market sales of regorafenib will reach less than $200 million.

The company also predicts that continuing improvements in screening will modify both the risk and stage distribution of diagnosed CRC over the coming decade. Despite the disease risk being strongly associated with age, the effect of population aging will be limited by a reduced risk of invasive disease due to screening, and the growth in the number of stage I cases will be double that of stage IV cases at 1.6% and 0.7% per year, respectively, up to 2021.

Forecast improvements in survival among patients with metastatic CRC will increase the number of people living with metastatic disease over the next 20 years, despite the fact that the number of persons developing metastatic disease per year will remain relatively stable because of the combined effects of screening and forecast improvements in the management of metastatic recurrence. The number of people living with unresectable CRC will increase at an annualized rate of 2.3% per year over the coming 20 years, compared with 1.5% yearly growth in the number of people in clinical remission.

Source: Decision Resources, November 1, 2012.

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