The human immunodeficiency virus (HIV) market across the seven major markets (7MM), comprising the US, France, Germany, Italy, Spain, the UK, and Japan, is forecast to grow from $26.5bn in 2023 to $32.1bn in 2033 at a compound annual growth rate (CAGR) of 1.9%. The US accounts for the majority of market sales, and is projected to grow from $23bn in 2023 to $27.4bn in 2033 at a CAGR of 1.8%.
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 launch of novel single-tablet regimens (STRs).
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GlobalData’s pipeline analysis indicates a shift away from three-drug STRs and toward two-drug STRs. There are six products in late-stage development (Phase III) that have potential to launch by 2033, including four two-drug STRs. These include Gilead’s once-daily bictegravir plus lenacapavir, Merck’s once-daily doravirine plus islatravir, Gilead and Merck’s once-weekly GS-1720 plus GS-4182, and Gilead’s once-weekly islatravir plus lenacapavir.
If approved, GS-1720 plus GS4182 and islatravir plus lenacapavir will be the first available oral once-weekly STRs for the treatment of HIV. Less frequent dosing may be preferred by some patients, although, for some, remembering to take a pill once a week may be more difficult than daily.
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) (lenacapavir is already marketed across the 7MM under the brand name Sunlenca for usage in treatment-experienced patients with multidrug-resistant HIV).
Lenacapavir 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 key opinion leaders have highlighted that this may be a barrier to access.
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By GlobalDataLong-acting drugs, which require less-frequent dosing, may be preferred by many patients. However, drugs that need to be administered intramuscularly or subcutaneously by a healthcare professional may mean more hospital visits are needed, which some patients may regard as more inconvenient.
Furthermore, while 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. Generic erosion will also 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.
