The Strongest Dynamic Decreasing Sales in the HIV Market is Generic Erosion of Key Antiretroviral Drugs, According to a New Report from Decision Resources
December 4, 2013 - 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) drugs for HIV will decrease marginally over the next decade, from an estimated $13.4 billion in 2012 to $13.1 billion in 2022 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 strongest factor constraining the HIV therapy market is the generic erosion of numerous key ARV drugs, such as efavirenz (Bristol-Myers Squibb’s Sustiva, Merck/Banyu’s Stocrin), tenofovir disoproxil fumarate [TDF] (Gilead/Japan Tobacco’s Viread), atazanavir (Bristol-Myers Squibb’s Reyataz), darunavir (Janssen’s Prezista), emtricitabine/TDF (Gilead/Japan Tobacco’s Truvada) and efavirenz/emtricitabine/TDF (Gilead/ Bristol-Myers Squibb’s Atripla). Increasing availability of generics in cost-constrained markets will inhibit uptake of new, higher-priced agents and is responsible for decreased ARV sales in major pharmaceutical markets, particularly European markets where the impact of generic erosion will be the heaviest. Notably, all three active pharmaceutical agents in the 2012 sales leader, Gilead/ Bristol-Myers Squibb’s single-tablet regimen (STR) Atripla will lose patent protection during the 2012 to 2022 forecast period, paving the way for generic STR prescribing in the major markets.
A key driver of sales growth in the HIV market is the increasing uptake of new, premium-priced agents, including integrase inhibitors and integrase inhibitor-based STRs. Diagnosis will also increase owing to broadening screening efforts and an expansion of the treatment-eligible population as a result of treatment guidelines urging treatment for HIV patients irrespective of CD4 cell levels, particularly in the United States.
The findings also reveal that, of the emerging therapies, the recently launched integrase inhibitor dolutegravir (ViiV’s Tivicay) is best poised for commercial success during the 2012-2022 forecast period. ViiV is already marketing dolutegravir as a stand-alone product that can be used with different NRTI backbone regimens in the United States and has submitted regulatory filings to the EMA to support this usage.
“Uptake of dolutegravir will be somewhat constrained by the availability of generics for heavily prescribed, currently marketed ARV drugs such as Atripla and Gilead’s newly available integrase inhibitor- based STR Stribild,” said Decision Resources Analyst Seamus Levine-Wilkinson, Ph.D. “Nevertheless, dolutegravir’s strong clinical profile will enable this agent to achieve blockbuster status as both a stand-alone agent and as a component of the recently filed 572-Trii STR.”
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