HIV Market to Surpass $32 Billion in 2033

The human immunodeficiency virus (HIV) market across the seven major markets (7MM*) is forecast to grow at a compound annual growth rate (CAGR) of 1.9% from $26.5 billion in 2023 to $32.1 billion in 2033, forecasts GlobalData, a leading data and analytics company.

GlobalData’s report, Human Immunodeficiency Virus (HIV): Seven-Market Drug Forecast, reveals that market growth will primarily be driven by the increased uptake of long-acting injectable therapies, as well as the anticipated launch of novel single tablet regimens (STRs).

Anaelle Tannen, Infectious Disease Analyst at GlobalData, comments: “The pipeline analysis indicates a shift away from 3-drug STRs and towards 2-drug STRs. These are hoped to have reduced toxicities and side effects as a result.”

Six products are currently in Phase III development and are expected to launch by 2033, including four two-drug STRs. These are Gilead Sciences’ (Gilead) once-daily combination of bictegravir and lenacapavir, Merck’s once-daily doravirine and islatravir, Gilead’s once-weekly islatravir and lenacapavir, and a once-weekly regimen of GS-1720 and GS-4182 developed jointly by Gilead and Merck.

Tannen continues: “Currently all STRs require daily administration and there is a need for alternative and more convenient options for patients which islatravir+lenacapavir and GS-1720+GS-4182 could address.”

Other notable therapies in late-stage development include CytoDyn’s once-weekly leronlimab, which is expected to be used in patients with CCR5-type virus, and Gilead’s biannual injectable lenacapavir for pre-exposure prophylaxis (PrEP)**.

Tannen adds: “Long-acting injectable therapies will gain significant market share across the 7MM as this method requires infrequent dosing and is thus more convenient. Lenacapavir, for example, is initially expected to be administered subcutaneously biannually for PrEP, and clinical trials are underway to see its efficacy when administered once a year. Data from a Phase I trial has demonstrated lenacapavir’s potential when administered intramuscularly once yearly.”

Subcutaneous lenacapavir has demonstrated 100% efficacy in preventing new HIV infections in the PURPOSE1 Phase III trial and thus has shown its potential as an important new tool for PrEP. However, subcutaneous lenacapavir is expected to be more expensive than daily oral PrEP and the key opinion leaders (KOLs) interviewed by GlobalData have highlighted that this may be a barrier to access.

Furthermore, despite the anticipated launch of several innovative products, generic erosion will represent a barrier to growth over the forecast period, with key products such as Biktarvy and Dovato losing patent protection and becoming vulnerable to competition from generics.

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.”

*The US, France, Germany, Italy, Spain, the UK, and Japan.

**Lenacapavir is already marketed across the 7MM under the brand name Sunlenca for usage in treatment-experienced patients with multidrug-resistant HIV.

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