The HIV market is forecast to grow from $7.1 billion in 2005 to an estimated $10.6 billion in 2015. This growth is to be driven by a combination of several factors, including an increase in the number of people diagnosed, and the launch of several new drugs and drug classes which offer new hope to patients who otherwise would have at-best limited, but perhaps no therapeutic options left at all.

Over the next 10 years, the HIV market is set to undergo significant changes, with the launch of several new products such as Atripla, the first product combining three drugs from two different classes into one convenient once-a-day pill. Meanwhile, despite countless efforts by governments and non-government organizations, the total number of people living with HIV continues to increase. According to UNAIDS, over the past year alone, a staggering 65,000 patients were newly infected and 30,000 patients were reported to have died from AIDS.

Rising incidence

The rise in prevalence has been driven by a number of factors, including a growing number of heterosexual transmissions, immigration from countries with a high HIV prevalence and a growth in high-risk sexual behavior among men who have sex with men. As new lines of therapy become available, patients who currently have limited or even no therapeutic options left will have a greater choice, mercifully leading to a decline of the HIV/AIDS mortality rate.

At the same time, new diagnostic tests, campaigns to increase HIV awareness and the destigmatization of the disease are expected to increase the percentage of the infected population receiving treatment. Therefore, the population is expected to continue to grow.

New product launches

Of the recently launched products, Atripla, a fixed dose combination of Truvada and Sustiva, has been the first drug to combine the components of highly active antiretroviral therapy (HAART) into a single pill that can be taken once-daily and is set to dominate in the first-line treatment market. It has been developed through a unique collaboration between Gilead (Truvada's originator) and Bristol-Myers Squibb, which developed Sustiva.

New classes of drugs such as Pfizer's Celsentri/maraviroc (CCR5 inhibitor) and Merck's Isentress/raltegravir (integrase inhibitor) which are expected to be launched in 2007 and 2008 respectively, are to be used - at least initially - in late-stage therapy, a market that is currently dominated by Roche's Fuzeon, the only entry inhibitor approved so far. However, Fuzeon's cumbersome administration - it has to be injected twice daily and frequently causes side effects such as injection site reactions - has led to a slow uptake, with first year sales of only $35 million in 2003.

Although sales increased to $249 million in 2006, its use is still restricted because of its high cost and the limited number of patients in salvage therapy. The launch of newer products, such as Celsentri, Isentress as well as new generation NNRTIs and PIs like Tibotec's TMC125 and Prezista, all of which are orally bio-available and less expensive, will have a significantly negative impact on the sales of Fuzeon. Despite the latter's proven synergy with some of these new drugs, its use is expected to become even more limited to patients with no other available treatment options.

Regardless of the line of therapy these new drugs will eventually be used in, they will contribute to the significant increase in the value of the antiretroviral market. It is more than likely that the majority of new products will at least initially be reserved for use in late-stage therapy. Nonetheless, their availability will extend treatment options for patients with more advanced HIV and those with AIDS. As a result, patients' life expectancies will improve and therefore an increase in the value of the total antiretroviral market can be expected.

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Commercial Insight: HIV - Change of guard

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