Patent expiries combined with new drugs, drug classes and an increased need worldwide will stir up the HIV market in the coming years, according to a new Datamonitor report.
The report anticipates a growth of $5.8 billion over the next 10 years – from $9.3 billion in 2007 to $15.1 billion in 2017 – across the seven major markets: France, Germany, Italy, Japan, Spain, UK and the US.
In conjunction with the market's growth, the competition will grow as well, across all antiretroviral drug classes, the report posits. According to Mansi Shah, an analyst at Datamonitor, California biotech Gilead leads the market currently with four marketed products plus an integrase inhibitor in late stage development. Merck was the first to launch an integrase inhibitor, Isentress, in fall of 2007.
Gilead's Truvada, a nucleoside reverse transcriptase inhibitor fixed-dose combination (FDC) was the “bestselling drug in 2007 with revenues of $1.5 billion, while [Gilead and Bristol-Myers Squibb's (BMS) product] Atripla, a novel cross-class fixed-dose combination brand only available in the US in 2007 generated sales of $920 million,” Shah said in a release.
GlaxoSmithKline has eight marketed products and has led the category in the past, but faces patent expiries and other R&D hurdles. A further setback for GSK arrived when several independent studies found its Epzicom FDC – a Truvada competitor – is both less efficacious in certain patients and associated with an increased risk of myocardial infarction, explained Shah in the release.
Competition among protease inhibitors (PIs) has accelerated based on two pivotal clinical trials, CASTLE and ARTEMIS. The trial results caused Kaletra, previously the undisputed leader in the category, to falter, with BMS's Reyataz and Tibotec/Johnson & Johnson's Prezista picking up the slack, according to the release. Datamonitor predicts that Reyataz and Prezista will become the leading PIs by 2017.
Between September 2007 and January 2008, three new HIV drugs were approved, two of which have seen a significant uptake in the market. Merck's aforementioned integrase inhibitor, Isentris, and Tibotec's Intelence are already being widely used in highly active antiretroviral therapy regimens. Additionally, Integrase inhibitors like Isentris “have the potential to change first line regimens significantly over the next 10 years, and really make a mark in this increasingly difficult market,” notes Shah in the release.
The Datamonitor report, titled Commercial Insight: HIV – The battle for market share is getting fiercer, also points out that emerging markets outside of the major seven will become more important, given that HIV rates in the major seven markets represent only three to six percent of the globally infected population. Canada's HIV market, for instance, grew by 24% from 2004 to 2007, to $272 million, according to the report.