High costs and limited access threaten progress in HIV treatment despite new drug advances: GlobalData

Despite major strides in antiretroviral therapy (ART), the human immunodeficiency virus (HIV) market still faces serious challenges that threaten long-term control of the disease. The most pressing issue is the lack of affordable access to newer therapies, which—despite offering better adherence and fewer side effects—remain out of reach for many patients due to high costs and limited insurance coverage, according to GlobalData.

GlobalData’s report, “Human Immunodeficiency Virus (HIV): Seven-Market (7M) Drug Forecast and Market Analysis to 2033,” reveals that unmet needs, including underfunding of prevention programs, poor mental health integration, adherence challenges and affordability barriers, remain the key obstacles in achieving HIV control and reducing transmission.

Abigail Harris, Infectious Disease Analyst, GlobalData, comments, “HIV prevention and diagnostic programs are consistently underfunded, with stigma, structural barriers, and unequal access continuing to drive new infections. Targeted investment is needed to expand pre-exposure prophylaxis (PrEP) access, normalise HIV testing, and support earlier diagnosis.”

Increased uptake of long-acting therapies holds promise to improve adherence, a critical issue in the HIV market. These include PrEP therapies such as ViiV Healthcare’s Apretude (cabotegravir), injected every two months, and Gilead Science’s Yeztugo (lenacapavir), injected every six months, as well as upcoming ART options such as Gilead’s islatravir + lenacapavir, a once weekly tablet.

Yet the high cost and regulatory hurdles associated with the newer agents threaten equitable access. In the US, the uptake of newer PrEP agents such as Apretude and Descovy (emtricitabine + tenofovir alafenamide) is limited due to insurance restrictions. Additionally, in Japan, high costs and limited availability of generic PrEP options have made these tools inaccessible for most.

Harris continues, “Affordability is a recurring challenge, even in high-income countries. Patients are too often forced to rely on older, less convenient therapies due to insurance limitations or out-of-pocket costs. This is especially concerning when newer options could reduce pill burden and improve adherence.”

Mental health and social support also remain the overlooked pillars of HIV care. Depression, anxiety, and substance use significantly impact treatment engagement and adherence, yet mental health services remain poorly integrated within HIV programs. Ancillary services such as transportation and housing support are often underfunded or unavailable.

Harris adds: “Some people living with HIV may have to navigate intersecting challenges, from mental health conditions to social instability. Without addressing these layers, even the most effective drugs will not reach their full potential.”

Drug resistance adds another layer of concern. Some key opinion leaders (KOLs) interviewed by GlobalData have cautioned that as the uptake of novel therapies like lenacapavir increases, improper or widespread use, particularly when used for both treatment and prevention, could reduce long-term efficacy.

Harris concludes: “Despite these barriers, there are several areas of opportunity. Models for progress include investment in community-based services, innovative diagnostic strategies like opt-out testing, where any person who visits an emergency department is automatically offered HIV testing, and programs that reduce out-of-pocket costs and improve access to patients.”

*7MM: The US, France, Germany, Italy, Spain, the UK, and Japan.