The Primary Factor Constraining the HIV Market is the Generic Erosion of Numerous Commonly Prescribed Antiretroviral Agents, According to Findings from Decision Resources
December 17, 2012-Burlington, Mass. –Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that major-market sales of antiretroviral (ARV) agents for HIV will decline slightly over the next decade, from an estimated $13.3 billion in 2011 to $12.9 billion in 2021 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
The Pharmacor advisory service entitled Human Immunodeficiency Virus (HIV) finds that the primary factor constraining the HIV therapy market is the generic erosion of numerous commonly prescribed ARV drugs, such as efavirenz (Bristol-Myers Squibb’s Sustiva, Merck/Banyu’s Stocrin), tenofovir (Gilead/Japan Tobacco’s Viread), atazanavir (Bristol-Myers Squibb’s Reyataz), darunavir (Janssen’s Prezista), emtricitabine/tenofovir (Gilead/Japan Tobacco’s Truvada), efavirenz/emtricitabine/tenofovir (Gilead/ Bristol-Myers Squibb’s Atripla) and lopinavir/ritonavir (Abbott’s Kaletra). Increasing use of generics will inhibit uptake of new, high-priced agents and is the key dynamic responsible for reduced sales in European markets, where the impact of generic erosion will be greatest. All three active pharmaceutical agents in the 2011 sales leader, Gilead/ Bristol-Myers Squibb’s single-tablet regimen (STR) Atripla will lose patent protection during the 2011 to 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 Decision Resources Analyst Seamus Levine-Wilkinson, Ph.D. “Therefore, we forecast a modest patient-share decline for Atripla in the major markets from 23 percent in 2011 to approximately 19 percent in 2021.”
A key growth driver of the HIV therapy market will be the increasing uptake of new, premium-priced agents, including integrase inhibitors and integrase inhibitor-based STRs. Increased diagnosis as a result of broadening screening efforts and increased drug treatment as a result of treatment guidelines recommending treatment of HIV cases regardless of CD4 cell levels will also expand the HIV therapy market, particularly in the United States.
The findings also reveal that, of the emerging therapies, ViiV’s integrase inhibitor dolutegravir is best poised for commercial success during the 2011-2021 forecast period. ViiV intends to market dolutegravir both as a stand-alone product that can be used with different NRTI backbone regimens and as the key component of a new STR called 572-Trii, which combines dolutegravir with ViiV’s FDC NRTI Epzicom/Kivexa. Uptake of dolutegravir will be constrained by the availability of generics for heavily prescribed currently marketed ARV drugs, such as Atripla. Dolutegravir’s strong clinical profile will allow it to earn sales of $1 billion in 2021 as a stand-alone agent and $2 billion as part of 572-Trii.
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