In 2007, HIV drugs generated sales of $9.3 billion across the seven major markets (7MM), expanding with a compound annual growth rate (CAGR) of 11.3% (2004-2007). Over the next 10 years a new report expects the market’s growth to slow down somewhat, but still reach total sales of $15.1 billion in 2017.

Despite the increasing prevalence of HIV, factors such as the rising emphasis on cost containment, combined with patent expiries of key marketed drugs could inhibit future expansion. At the same time, newly launched drugs and drug classes and the greater number of patients accessing treatment will counteract these effects and contribute to the growth of the market. Patient numbers will rise predominantly because of an increased life expectancy, a steady number of new infections and immigration from areas of high prevalence to the 7MM.

The HIV market is dominated by just a few companies. Gilead is the current market leader with a portfolio of four marketed products and an integrase inhibitor in late stage development. The Californian biotech company’s NRTI fixed dose combination (FDC) Truvada remained the bestselling drug in 2007 with revenues of $1.5 billion, while Atripla, a novel cross-class fixed-dose combination brand only available in the US in 2007 generated sales of $920 million.

Atripla, a joint venture between Gilead and Bristol-Myers Squibb (BMS), rapidly established itself as the new gold standard for newly diagnosed patients. By 2007 it was the fourth best selling HIV drug worldwide despite only being available in the US.

GSK, the market leader for much of the history of antiretroviral therapy, has eight marketed products, but many of its brands are relatively old and face patent expiration. In addition, several late-stage R&D setbacks over the past two years have left the company bereft of any HIV compounds in clinical development.

In the space of just five months between September 2007 and January 2008, three new HIV drugs were approved by the regulators for the first time: Pfizer’s Selzentry, Merck & Co’s Isentress and Tibotec’s Intelence. Isentress and Intelence are already being widely used in highly active antiretroviral therapy (HAART) regimens for treatment experienced patients, but Selzentry’s launch has been very sluggish. Datamonitor has found that Intelence, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), is being used as early as second line therapy despite the lack of supporting data for this patient group. This off-label use risks cannibalizing the future franchise of Tibotec’s second NNRTI TMC278, which is targeted specifically at the treatment-naïve population this market, when launched around 2011.

Building on Isentress’ efficacy and benign side-effect profile, Merck & Co. is pursuing approval for Isentress in the much larger early-stage and treatment-naïve patient population. Since traditionally a dual NRTI backbone in combination with either an NNRTI or a PI form the first line treatment, it is still unclear how integrase inhibitors drugs will fit in. Many different combinations are currently being investigated in various clinical trials. Given the optimism surrounding Isentress, integrase inhibitors have the potential to change first line regimens significantly over the next 10 years and really make a mark in this increasingly difficult market.

Related research: Commercial Insight: HIV – The battle for market share is getting fiercer