Human Immunodeficiency Virus – Landscape & Forecast – Disease Landscape & Forecast
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
PRIMARY RESEARCH
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.
Table of contents
- Human Immunodeficiency Virus - Landscape & Forecast - Disease Landscape & Forecast
- Key findings
- HIV PrEP Key Findings - December 2022
- Key updates
- Q4 2022
- December 2022
- November 2022
- October 2022
- Q3 2022
- September 2022
- August 2022
- July 2022
- Q4 2022
- Market outlook
- Key findings
- Market share of drug classes for HIV PrEP: 2021
- Market share of drug classes for HIV PrEP: 2031
- 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
- Key findings
- 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
- Disease overview
- Epidemiology
- Introduction
- Key findings
- Epidemiology populations
- Disease definition
- Methods and sources used
- Number of PrEP-eligible people in the major pharmaceutical markets: 2021-2031
- Introduction
- 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
- Key findings
- 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
- Key findings
- 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
- Region-specific reimbursement practices
- Appendix
- Abbreviations
- HIV PrEP bibliography
- Key findings
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., 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.