Global HIV Market to 2024
Globally, around 35 million people are infected with HIV. Approximately 3 million people in the U.S and 2.5 million in top 5 European regions live with HIV. Around 70% of HIV infections live in Sub-Saharan Africa, considered to be the epicenter of the HIV epidemic according to the Joint United Nations Program on AIDS (UNAIDS).
Despite significantly improved safety, convenience and tolerability profile of current antiviral drugs, development of drug resistance remains a significant challenge as a result of its high mutation rate.
Global HIV Prevalence in Key Markets (2015)
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Traditionally, most patients start on two NRTIs (nucleoside reverse transcriptase inhibitor) and one NNRTI (non-nucleoside reverse transcriptase inhibitor) while patients not eligible for an NNRTI are started on two NRTIs and a protease inhibitor. However, with the introduction of a once-daily integrase inhibitor (dolutegravir), NNRTIs are losing market share to integrase inhibitors as the companion to dual NRTI therapy. The current market for HIV treatment is dominated by once-daily regimens. The trend toward regimen simplification and reduced pill burden has driven rapid penetration of several once-daily treatment options including Gilead’s Atripla, Complera, Genvoya, Odefsey and Stribild along with GSK/ViiV’s Triumeq.
“Gilead, ViiV Healthcare, Bristol Myers, J&J, Abbvie, & Merck & are some of the key players in HIV market"
In 2009, Pfizer and GlaxoSmithKline formed a JV focused on research, development and commercialization of HIV medicines. The new company, called ViiV Healthcare, majority owned by GSK, with Pfizer and Shionogi as shareholders was seeded with a marketed product portfolio, including Combivir and Kivexa (GSK) and Selzentry/Celsentri (Pfizer). ViiV has a pipeline of medicines, including compounds in Phase III & II. ViiV Healthcare in collaboration with Shionogi has two integrase inhibitors, dolutegravir (Tivicay) and cabotegravir (GSK, Phase II).
While GSK remained the leader of the NRTI class, following the launch of Atripla, Truvada, Viread, Complera, Stribild and more recently Genvoya, Descovy and Odefsey, Gilead has captured the majority of first line market share in the HIV space. Recently, Gilead launched TAF-based regimens that offered additional franchise strength.
“Innovations in HIV Treatment”
The success in treating HIV is driven by antiretroviral agents that offer fewer side effects, require fewer pills, and have pharmacokinetic profiles that allow for less frequent dosing.
HIV’s tendency toward developing drug resistance has resulted in a standard of care for HIV viral control that involves concomitant use of three antiviral drugs. Treatment generally consists of two nucleoside reverse transcriptase inhibitors (NRTIs) and either a protease inhibitor (PI), integrase inhibitor (II) or a non-nucleoside reverse transcriptase inhibitor (NNRTI).
ViiV Healthcare’s HIV franchise has been reinvigorated by the launch of inhibitor Tivicay and its one pill once a day co-formulation with Ziagen and Emtriva. This single-tablet regimen is sold under the brand name Triumeq and represents the first non-Gilead single-tablet regimen and helping ViiV Healthcare’s NRTI franchise regain some market share.
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Most diagnosed with HIV in the U.S. has access to reimbursed antiviral therapies from either private insurance or government programs. However, it has become harder to prescribe newly launched HIV drugs as insurers have begun to restrict access to new drugs. Most insurers will require prior authorizations for any HIV drugs that are not on formulary.
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