The HIV treatment landscape is evolving with innovative, long-acting therapies and simpler regimens.

The market for HIV (human immunodeficiency virus) treatments in seven major countries is expected to grow from $26.5 billion in 2023 to $32.1 billion by 2033, at an average yearly growth rate of 1.9 per cent, according to a new report by GlobalData. This growth is mainly driven by the increasing use of long-acting injectable treatments and the expected launch of newer, more convenient single-tablet regimens (STRs).

The report highlights a clear shift in the HIV drug pipeline, moving away from traditional three-drug STRs towards newer two-drug versions. According to Anaelle Tannen, Infectious Disease Analyst at GlobalData, the goal with these two-drug regimens is to reduce side effects and lower drug toxicity, which can improve the overall quality of life for people living with HIV.

Six new HIV treatments are currently in the final stages of development and are expected to be launched by 2033. Four of these are two-drug STRs, including once-daily and once-weekly combinations being developed by Gilead Sciences and Merck. These include promising combinations like bictegravir with lenacapavir, doravirine with islatravir and other long-acting regimens that aim to reduce the burden of daily pill-taking for patients.

Currently, all available STRs must be taken every day, but the new once-weekly and injectable options in development could offer more convenience. Treatments like islatravir combined with lenacapavir and the GS-1720 and GS-4182 combination could change the standard approach to HIV therapy by offering patients easier and less frequent dosing schedules.

Beyond daily tablets, other innovative therapies are also in late-stage development. CytoDyn’s leronlimab, a once-weekly injection, is being tested for use in patients with a specific type of HIV (CCR5-tropic virus). Gilead is also developing a twice-yearly injectable form of lenacapavir for HIV prevention, known as pre-exposure prophylaxis (PrEP). Tannen explains that long-acting injectables like lenacapavir are likely to gain a significant share of the market due to their convenience. Lenacapavir is initially planned to be given every six months via a subcutaneous injection, and trials are underway to explore its use as an annual intramuscular injection.

One of the major breakthroughs in this area comes from the Phase III PURPOSE1 trial, where subcutaneous lenacapavir showed 100 per cent effectiveness in preventing new HIV infections. This result highlights the strong potential of lenacapavir as a preventive option. However, its higher cost compared to daily oral PrEP may be a challenge, especially when it comes to accessibility. GlobalData’s expert interviews indicate that affordability may limit how widely such treatments are used.

Despite the exciting developments, the HIV market is also expected to face some challenges. Generic versions of key treatments like Biktarvy and Dovato are expected to enter the market once their patents expire, which could reduce sales of branded drugs. Even with the launch of new and effective therapies, this “generic erosion” is expected to slow down market growth.

Tannen concludes: “Whilst many pipeline drugs have demonstrated promising efficacy and safety profiles, none will be superior, in terms of commercial success, to the current standard of care Biktarvy.”