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Report: Sales of Antiretroviral Agents for HIV Will Decline Slightly Over Next Decade

Generic drugs expected to limit market growth (Dec. 17)

Decision Resources, a research and advisory firm based in Burlington, Mass., finds that major-market sales of antiretroviral (ARV) agents for human immunodeficiency virus (HIV) infection will decline slightly over the next decade, from an estimated $13.3 billion in 2011 to $12.9 billion in 2021 in the U.S., Europe, and Japan.

The company also finds that the primary factor constraining the HIV therapy market is the generic erosion of numerous commonly prescribed ARV drugs, such as efavirenz (Sustiva, Bristol-Myers Squibb), tenofovir (Viread, Gilead), atazanavir (Reyataz, Bristol-Myers Squibb), darunavir (Prezista, Janssen), emtricitabine/tenofovir (Truvada, Gilead), efavirenz/emtricitabine/tenofovir (Atripla , Gilead/Bristol-Myers Squibb), and lopinavir/ritonavir (Kaletra, Abbott). The increasing use of generics is expected to inhibit the uptake of new, higher-priced agents. All three active pharmaceutical compounds in the 2011 sales leader — single-tablet regimen (STR) Atripla — will lose patent protection during the 2011–2021 forecast period.

“The anticipated drop in Atripla’s price in response to the launch of generic efavirenz, along with Atripla’s patent expiry in major markets starting in 2018, will motivate physicians to maintain their patients on this regimen rather than introduce novel STRs, particularly in acutely cost-conscious European markets,” said analyst Seamus Levine-Wilkinson, PhD. “Therefore, we forecast a modest patient-share decline for Atripla in the major markets from 23% in 2011 to approximately 19% in 2021.”

The company anticipates that a key growth driver in the HIV therapy market will be the increasing uptake of new, premium-priced agents, including integrase inhibitors and integrase inhibitor-based STRs. The HIV therapy market, particularly in the U.S., will also be expanded by increased diagnosis as a result of broadening screening efforts and by increased drug treatment as a result of therapy guidelines recommending the treatment of HIV cases regardless of CD4 cell levels.

The company’s findings also indicate that, of the emerging therapies, the integrase inhibitor dolutegravir (ViiV Healthcare) is best poised for commercial success during the 2011–2021 forecast period. Dolutegravir will be marketed both as a stand-alone product that can be used with different nucleoside reverse transcriptase inhibitor (NRTI) backbone regimens and as the key component of a new STR called 572-Trii, which combines dolutegravir with the NRTI abacavir/lamivudine (Epzicom/Kivexa, ViiV Healthcare). The uptake of dolutegravir will be constrained, however, by the availability of generics for heavily prescribed, currently marketed ARV drugs, such as Atripla. As a result of its strong clinical profile, dolutegravir is expected to earn sales of $1 billion as a stand-alone agent and $2 billion as part of 572-Trii in 2021.

Source: Decision Resources; December 17, 2012.

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