Latest news from Datamonitor
pharmafile | October 13, 2008 | News story | Sales and Marketing | HIV
Battle for HIV drug market share getting fiercer
The HIV 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 all antiretroviral drug classes, which may cause some of the big players in the HIV market to opt out or be squeezed out.
In 2007, HIV drugs generated sales of $9.3 billion across the seven major markets of France, Germany, Italy, Japan, Spain, the UK and the US, expanding at a compound annual growth rate (CAGR) of 11.3% between 2004 and 2007. However, despite the increasing prevalence of HIV, factors such as the rising emphasis on cost containment, combined with the 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 seven major markets. As a result, although Datamonitor expects the market's growth to slow down somewhat in the next 10 years, it is still expected to reach total sales of $15.1 billion in 2017.
Although the seven major markets are commercially the most significant for HIV, they in fact only account for 3% to 6% 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 of which many pharmaceutical companies are turning towards fast-growing emerging markets as new sources of revenue growth.
Among the former seven major market countries, Canada's HIV market was worth $272 million in 2007, growing at a CAGR of 24% from 2004 to 2007. While larger than Japan's, it remains smaller than any of the big five EU markets of France, Germany, Italy, Spain and the UK. Given Canada's high HIV prevalence compared with Japan, and its reasonable price levels, Datamonitor believes that there are significant opportunities within this market.
Although the HIV market is dominated by just a few companies, new innovations and results from various trials are increasing competition within the sector. Californian biotech firm Gilead is the current market leader, with a portfolio of four marketed products and an integrase inhibitor in late stage development. The 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.
Meanwhile, 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.
GlaxoSmithKline, 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. The company had to face further problems this year when several independent studies highlighted that GSK's main hope, Epzicom, an FDC competing with Gilead's Truvada, is both less efficacious in certain patients and associated with an increased risk of myocardial infarction. These data from the ACTG5202 and SMART trials and the D:A:D cohort come on top of the well-known risk of hypersensitivity reactions to Epzicom's abacavir component.
The competition within the protease inhibitor (PI) class has also intensified. Two trials, the CASTLE and ARTEMIS studies, are largely responsible for changing the dynamics here. Kaletra, the previously undisputed leader has come out looking slightly, if not always, statistically significantly worse than the two newer challengers, BMS's Reyataz and Tibotec/Johnson & Johnson's Prezista. Although Kaletra continued to lead in the EU and Japan in terms of sales in 2007, Reyataz has been the number one in the US market for the last three years. Datamonitor expects that the EU will also favor Reyataz once it receives first line approval there, probably in 2009.
With no HIV candidates in the pipeline, Abbott's commitment to the sector beyond Kaletra and Norvir remains doubtful. By 2017, Datamonitor anticipates Reyataz and Prezista to become the leading PIs across the seven major markets, pushing Kaletra out from leading the PI market to being in third place. Despite Reyataz's success, BMS's overall franchise success is also at risk, as Sustiva's patent expiry falls in 2013 and the company has no visible follow-up compounds in development to make up for the shortfall. Tibotec, on the other hand, is in a better position thanks to two successfully approved products and one late stage candidate, which are likely to strengthen its presence in HIV over the next 10 years.
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 used widely 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 cannibalising the future franchise of Tibotec's second NNRTI TMC278, which, when launched around 2011, will be targeted specifically at the treatment-naive population in this market.
Building on Isentress' efficacy and benign side-effect profile, Merck & Co. is pursuing approval for Isentress in the much larger early-stage and treatment-naive patient population. Traditionally, a dual NRTI backbone in combination with either an NNRTI or a PI form is the first line treatment and, as a result, it is still unclear how integrase inhibitor 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
The Global HIV/AIDS Market Outlook to 2012
Pipeline Insight: HIV – Novel NNRTIs address crucial unmet need
Related Content
Gilead and Merck share data from phase 2 trial of HIV treatment
Gilead Sciences and Merck (known as MSD outside of the US and Canada) have announced …
ViiV Healthcare shares interim data from phase 3 trial for injectable HIV treatment
ViiV Healthcare has announced results from an interim analysis of the phase 3 LATITUDE trial, …
China’s NMPA approves ViiV Healthcare’s Vocabria in combination with Rekambys for HIV treatment
ViiV Healthcare has announced that the National Medical Products Administration (NMPA) of China has approved …
