The HIV drug market, worth $9.3 billion in 2007, is expected to grow to $15.1 billion by 2017, driven by the increasing prevalence of HIV worldwide and the longer life expectancy of patients receiving treatment.
Despite this growth, the competition is getting tougher across antiretroviral drug classes. According to a new report by the Britain-based market analysis firm Datamonitor, drug company competition is becoming so intense that some big players in the HIV market may eventually be either squeezed or decide to opt out.
In 2007, HIV drugs generated sales of $9.3 billion across the seven major markets, or 7MM (which include France, Germany, Italy, Japan, Spain, Britain and the United States), expanding with a compound annual growth rate of 11.3 percent (2004-2007). Over the next 10 years, Datamonitor 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.
Although the 7MM are commercially the most significant for HIV, they only account for 3 percent to 6 percent of the globally infected population. HIV prevalence across the rest of the world is much higher, and access to antiretroviral therapy has been improving in low and middle-income countries.
As a result, Datamonitor says many pharmaceutical companies are turning toward fast-growing emerging markets as new sources of revenue growth. For instance, Canada's HIV market was worth $272 million in 2007, growing at a CAGR of 24 percent from 2004-2007. While larger than Japan's, it remains smaller than any of the big five EU markets. Given Canada's high HIV prevalence compared with Japan and reasonable price levels, Datamonitor believes there are significant opportunities within this market.
The battle for market share
Few companies dominate the HIV market. Gilead is the current market leader, with a portfolio of four marketed products and an integrase inhibitor in late stage development, said Datamonitor infectious diseases analyst Mansi Shah.
"The Californian biotech company's NRTI fixed dose combination Truvada remained the best-selling drug in 2007 with revenues of $1.5 billion, while Atripla, a novel cross-class fixed-dose combination brand only available in the U.S. in 2007, generated sales of $920 million," Shah said. "Atripla, a joint venture between Gilead and Bristol-Myers Squibb, 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 U.S."
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. Shah said several late-stage R&D setbacks over the past two years have left the company bereft of any HIV compounds in clinical development.
Competition in the Protease Inhibitor class has also intensified. Shah said two trials, the CASTLE and ARTEMIS studies, are largely responsible for changing the dynamics there. Kaletra, the previous leader, has come out looking slightly worse than two newer challengers, BMS' Reyataz and Tibotec/Johnson & Johnson's Prezista.
Kaletra continued to lead in the EU and Japan in terms of sales in 2007, while Reyataz has topped the U.S. market for the last three years. Datamonitor expects the EU to favor Reyataz as well once it receives first-line approval there, probably in 2009.
Shah anticipates that by 2017, Reyataz and Prezista will become the leading PIs across the 7MM, pushing Kaletra out.
Between September 2007 and January 2008, three new HIV drugs were approved by regulators: Pfizer's Selzentry, Merck & Co.'s Isentress and Tibotec's Intelence. The latter two are already being widely used in highly active antiretroviral therapy regimens for treatment of experienced patients, but Selzentry's launch has been sluggish.
"Many different combinations are currently being investigated in various clinical trials," Shah said. "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."