Pre-exposure prophylaxis (PrEP) is a key prevention strategy for ending the human immunodeficiency virus (HIV) epidemic. The FDA’s approval of Gilead’s Truvada in 2012 and Descovy in 2019 provided the first two PrEP options for HIV prevention in individuals who are HIV-negative but at risk of sexually acquired HIV-1 infection. The FDA’s approval of ViiV’s Apretude (cabotegravir) in December 2021 will provide an additional option and enable preferential prescribing to the HIV PrEP-eligible population. In addition, many late-phase PrEP therapies, such as Gilead’s lenacapavir and Merck’s islatravir, are expected to offer less-frequent dosing, as well as improved safety, to become key differentiating attributes in HIV prevention. The HIV PrEP market will continue to grow owing to the launch of generic versions of Truvada, increasing initiatives by the government and companies to provide free PrEP drugs, and growing awareness of PrEP that will lead to an increase in the target population. In this report, we explore the clinical and commercial potential of approved and emerging HIV PrEP therapies.
Questions answered
How large is the HIV PrEP-eligible population in the United States, EU5, and Japan? How will the population change over the forecast period?
What is the current market landscape for HIV PrEP? How will HIV PrEP emerging therapies like lenacapavir and islatravir compete with Apretude and other entrenched brands like Descovy and Truvada?
What are the healthcare policies that will influence access and reimbursement of HIV PrEP therapies, and how much of an impact will these strategies have?
What are the most promising agents in the HIV PrEP pipeline, and how will they be differentiated from current therapies? What sales / uptake could emerging therapies secure during the forecast period?
GEOGRAPHIES
United States, EU5, Japan
PRIMARYRESEARCH
17 country-specific interviews with thought-leading infectious disease and internal medicine physicians
Supported by survey data collected for this and other Clarivate research
EPIDEMIOLOGY
Number of PrEP-eligible populations by country
FORECAST
10-year, annualized, drug-level sales and patient share of key HIV PrEP therapies through 2031, segmented by brands / generics
EMERGING THERAPIES
Phase III / PR / Approved: 12 drugs; coverage of select early-phase products
Marketed drugs: 3
Product description
Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
Solution enhancement
Disease Landscape & Forecast will feature continual updates in 2022 to provide timely insights and analyses as meaningful indication-specific news and events unfold.
Market share of long-acting regimens for HIV PrEP: 2031
HIV PrEP SWOT analysis
Market drivers and constraints
What factors are driving the market for HIV PrEP?
What factors are constraining the market for HIV PrEP?
Drug-class-specific trends
Major-market sales of nucleoside/nucleotide reverse transcriptase inhibitors for HIV PrEP: 2021-2031
Major-market patient shares of nucleoside/nucleotide reverse transcriptase inhibitors for HIV PrEP: 2021-2031
Major-market sales of long-acting regimens for HIV PrEP: 2021-2031
Major-market patient shares of long-acting regimens for HIV PrEP: 2021-2031
Forecast
Market forecast assumptions
Market forecast dashboard
Etiology and pathophysiology
Disease overview
The mucosal barrier
HIV mucosal transmission and infection
Transmission routes for HIV infection
Key pathways and drug targets
Key drug targets in HIV PrEP
Epidemiology
Introduction
Key findings
Epidemiology populations
Disease definition
Methods and sources used
Number of PrEP-eligible people in the major pharmaceutical markets: 2021-2031
Current treatment
Key findings
Treatment goals
Key endpoints used in clinical trials for HIV PrEP
Key current therapies
Overview
Mechanism of action of key current therapies for the prevention of HIV infection
Current treatments used for HIV PrEP
Market events impacting the use of key current therapies for HIV PrEP
Truvada
Advantages and disadvantages of Truvada
Key results from select clinical trials investigating Truvada as HIV PrEP
Ongoing clinical development of Truvada
Key ongoing clinical trials of Truvada as HIV PrEP
Expert insight: Truvada
Descovy
Advantages and disadvantages of Descovy
Key results from select clinical trials investigating Descovy as HIV-1 PrEP
Ongoing clinical development of Descovy
Key ongoing clinical trials of Descovy as HIV-1 PrEP
Expert insight: Descovy
Apretude
Advantages and disadvantages of Apretude
Clinical trial outcomes for Apretude
Key results from select clinical trials investigating Apretude as HIV-1 PrEP
Ongoing clinical development of Apretude
Key ongoing clinical trials of Apretude as HIV-1 PrEP
Expert insight: Apretude
Medical practice
Overview
Factors influencing drug selection in HIV PrEP
Decision tree for HIV PrEP: United States
Decision tree for HIV PrEP: Europe
Unmet need overview
Current and future attainment of unmet needs in HIV PrEP
Top unmet needs in HIV PrEP: current and future attainment
Expert insight: unmet need in HIV PrEP
Emerging therapies
Key findings
Key emerging therapies
Notable developments among key emerging therapies for HIV PrEP
Key therapies in development for HIV PrEP
Estimated launch dates of key emerging therapies for HIV PrEP
Key results of select clinical trials investigating lenacapavir for HIV PrEP
Key ongoing clinical trials of lenacapavir for HIV PrEP
Analysis of the clinical development program for lenacapavir
Expert insight: lenacapavir
Expectations for launch and sales opportunity of lenacapavir in HIV PrEP
Early-phase pipeline analysis
Notable developments in the early-phase pipeline for HIV PrEP
Select compounds in early-phase development for HIV PrEP
Key discontinuations and failures in HIV PrEP
Key results of select clinical trials investigating islatravir for HIV PrEP
Key ongoing clinical trials of islatravir for HIV PrEP
Analysis of the clinical development program for islatravir
Expert insight: islatravir
Expectations for launch and sales opportunity of islatravir in HIV PrEP
Access & reimbursement overview
Region-specific reimbursement practices
Key market access considerations for HIV PrEP: United States
General reimbursement environment: United States
Key market access considerations for HIV PrEP: EU5
General reimbursement environment: EU5
Key market access considerations in HIV PrEP: Japan
General reimbursement environment: Japan
Appendix
Abbreviations
HIV PrEP bibliography
Archita Kukreja
Archita Kukreja, M.B.A., M.S., is a principal analyst on the Infectious, Niche, and Rare Diseases team at Clarivate. Prior to joining the company, she was a lead associate of healthcare operations at WNS Global Services. She has also worked as an associate analyst at Aspect Ratio. Ms. Kukreja holds a master of science degree in biotechnology from Jamia Millia Islamia in New Delhi and an M.B.A. from Amity University in Noida.
Sunali D. Goonesekera, S.M.
Sunali D. Goonesekera, S.M., Senior Manager, Epidemiology. Prior to joining Clarivate, Ms. Goonesekera conducted epidemiological research on racial/ethnic disparities in metabolic diseases at the New England Research Institute and lead-authored two manuscripts. She has contributed to multiple publications in peer-reviewed journals in epidemiology and the biological sciences. She holds a master’s degree in epidemiology from the Harvard School of Public Health and a B.A. in biology (Honors) from Dartmouth College.