Companies Fight for Growing Share of HIV Market
At the end of 2016, there were an estimated 36.7 million people living with HIV across the globe. Of those, there were an estimated 1.8 million people who became infected with the disease and 1 million who died from HIV that same year, according to data from the United Nations.
With a large and growing patient population, the market for HIV treatments is expected to grow to $22.5 billion by 2025. The continued increase in the number of global HIV infection can be attributed to changing lifestyle, injection drug usage and unprotected sex. But, what was once considered a terminal and untreatable disease has now become one that can be managed like a chronic illness. With the continued threat of HIV, drugmakers will have ample opportunity to carve out a portion of an HIV treatment market share that is predicted to continue to grow by 7.6 percent over the course of the next five years.
The HIV market is primarily dominated by Gilead Sciences, which has three of the top four best-selling HIV drugs on the market, as reported by Statista. The California-based company’s HIV pipeline has been led by drug offerings such as Truvada, Atripla and Stribild. Gilead is likely to continue its dominance of the HIV market with the February approval of Biktarvy, a triple combination treatment of bictegravir and emtricitabine/tenofovir alafenamide for the treatment of HIV-1 Gilead’s HIV cocktail combines the potency of an integrase inhibitor, bictegravir, and the demonstrated long-term safety profile of the FTC/TAF backbone. The drug is largely expected to hit blockbuster status, despite a boxed warning that use of the medication could exacerbate hepatitis B. The drug recently became available to U.S. patients, according to its website, and the next few quarterly reports filed by Gilead should indicate if those analysts are correct.
However, Gilead is not the only big player in the HIV market. GlaxoSmithKline also has a robust portfolio with its subsidiary ViiV Healthcare. During the first quarter of 2018 ViiV saw 14 percent growth driven by two of its top drugs, Tivicay and Triumeq. During the quarterly call David Redfern, chairman and chief strategy officer of ViiV, said that during the first quarter Viiv saw an increased share of the market for dolutegravir-based regimes in the U.S. HIV market. In November 2017 the company added Juluca to its arsenal of HIV weapons. The FDA approved Juluca as the first two-drug combination, dolutegravir and rilpivirine, used to treat HIV-1, the same indication that Gilead won approval for with Biktarvy. The use of a two-drug regimen is something that many healthcare experts believe could reduce toxicity in patients. During this quarter Redfern said Juluca gained a 3 percent share of new to brand prescriptions, more than half of which came from non-dolutegravir based regimes. Viiv partnered with Janssen Pharmaceuticals for the development of Juluca. Janssen will market the drug in the United States as Edurant.
Not to be outdone in the HIV market, Merck is eying an Oct, 28 PDUFA date for its drug doravirine. Dr. George Hanna, head of clinical research at Merck Research Laboratories, told BioSpace that trial data at 48 weeks shows doravirine, a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI), is slightly more effective than the commonly used drug Atripla, which is a triple cocktail of efavirenz (EFV), emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) in treatment-naïve adults infected with HIV-1.
In March Mylan also snagged approval for its HIV treatment Symfi (efavirnenz, lamivudine and tenofovir disoproxil fumarate) for adult and pediatric HIV-1 patients who weigh at least 40 kilograms. That FDA nod was the third the company earned for its HIV treatments. The other two approved Mylan HIV drugs are Cimduo and Symvi Lo. When Symfi was approved Heather Bresch, Mylan’s chief executive officer said the company has a “longstanding commitment to expand affordable access to treatments for people living with HIV.”
While companies are all vying for a slice of the HIV market share, Gilead, which earned $14 billion from its HIV pipeline last year, could be on its way to actually finding an effective cure for the disease. In preclinical models, a two-drug combination appeared to eliminate the disease from an infected monkey. Any potential human trial results are years away though and the company’s HIV pipeline is safe for the time being. But, more and more companies will be fighting for a bigger share, so Gilead will have to work to continue its dominance.