HIV Market To Meet Patent Cliff In 2026-27 But Novel Products Coming
Two-Drug Regimens Make Headway
Executive Summary
Market Snapshot: Gilead’s Biktarvy and ViiV’s two-drug regimens are expected to dominate the HIV market over the next few years as market exclusivity losses loom, but drugs with new mechanisms of action, and longer-acting products, might influence market dynamics.
The market value for HIV treatments is expected to increase over the first half of this decade, but then decline during the second half of the decade because of increasing competition from generic versions of key products. In 2018, just under 40 million people were infected with HIV worldwide.
Up to 2026, the continued growth of Gilead Sciences, Inc.’s blockbuster Biktarvy (emtricitabine/tenofovir alafenamide fumarate and bictegravir) and ViiV Healthcare’s portfolio of two-drug regimens, is expected to increase the value of the HIV treatment market, in the US and five major European markets, France, Germany, Italy, Spain and the UK.
In addition, likely premium-priced therapies with novel mechanisms, such as ViiV Healthcare’s new HIV attachment inhibitor, Rukobia (fostemsavir) and Gilead Sciences’s late-stage capsid inhibitor, lenacapavir, for heavily treatment-experienced individuals, will also drive growth, as will increased disease prevalence in some countries.
Rukobia was approved for marketing in the US in July 2020 and in the EU in February 2021, while lenacapavir is in advanced Phase II/III studies. (Also see "Merck & Co./Gilead Team To Take On ViiV In Long-Term HIV Treatment" - Scrip, 15 Mar, 2021.) and (Also see "Pipeline Watch: Phase III Starts In Myelofibrosis, Birch Allergy, Non-Hodgkin's Lymphoma" - Scrip, 12 Feb, 2021.)
However, patent expiries will then tip the market into decline from 2027, such as those involving the treatment backbone therapy, Gilead’s oral nucleoside RTI combination, Descovy (emtricitabine/tenofovir alafenamide fumarate), and ViiV’s integrase strand transfer inhibitor (INSTI), Tivicay (dolutegravir), with the latter expected to lose US exclusivity in 2027, says a recent report from Datamonitor Healthcare, HIV Treatment.
Integrase inhibitors such as bictegravir and dolutegravir have become required treatment components for patients because of their excellent tolerability, efficacy and high barriers to the development of resistance, and INSTI-based regimens are now favored in clinical guidelines. This has led to declines in markets shares for older protease inhibitor- and non-nucleoside RTI-based regimens in the first-line setting in recent years.
Furthermore, recent launches two-drug regimens containing an INSTI, such as ViiV’s oral Juluca (dolutegravir and the NNRTI, rilpivirine), Dovato (dolutegravir and the NRTI, lamivudine), and long-acting injectable, Cabenuva (cabotegravir/rilpivirine) are expected to drive the use of integrase inhibitor-based regimens – they offer patients the opportunity to simplify their treatment regimens from three drugs to two.
The single-table regimen Biktarvy became the market leader in 2020 with sales of more than $7bn, and further growth is likely to be driven by patients switching from Gilead’s older single-tablet regimens like Atripla and Odefsey, new patients and US price rises. But Gilead is facing increasing competition from ViiV’s two-drug regimens, which may be preferred by some patients.
Remaining unmet needs in the HIV space include longer-acting drugs, simplified dosing regimens, and more treatment options for heavily pre-treated patients, including drugs with new mechanisms of action. Candidate products in late-stage clinical studies include CytoDyn, Inc.’s CCR5 inhibitor, Vyrologix (leronlimab), and Merck & Co., Inc.’s nucleoside reverse transcriptase inhibitor, islatravir. (Also see "Merck & Co./Gilead Team To Take On ViiV In Long-Term HIV Treatment" - Scrip, 15 Mar, 2021.)
Consensus sales forecasts for 2021 and 2025, for a selection of HIV therapies, are given in the report as follows: