The human immunodeficiency virus (HIV) therapy market is dynamic and growing as many effective antiretroviral therapies (ARTs), such as Gilead’s Biktarvy, continue to launch, prompting safety and tolerability to become the key differentiating attributes between ART regimens. The rise of single-pill nuc-sparing and nuc-reduced regimens (e.g., ViiV’s Juluca and dolutegravir/lamivudine) with a reduced long-term risk of comorbidities will expand treatment options and allow preferential prescribing among HIV patients who closely adhere to therpay. Commercial opportunity in the HIV market will be driven by a large and aging prevalent viremic patient population whose needs will shift to their comorbidities as their HIV infections become well managed.
QUESTIONS ANSWERED
What is the current market landscape for the treatment of HIV? How will emerging therapies like Biktarvy compete with entrenched brands like ViiV’s Triumeq?
How will changing prevalence, diagnosis, and drug-treatment rates for HIV affect overall market growth? What are the healthcare policies that will influence drug-treatment rates, and how much of an impact will these strategies have?
What emerging therapies and/or interventions have the potential to offer a “functional cure” for HIV infection?
What are the most-promising agents in the late-stage pipeline, and how will they be differentiated from current therapies?
PRODUCT DESCRIPTION
Disease Landscape & Forecast: Comprehensive market intelligence providing world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
RELEASE DATE
August 2018
GEOGRAPHIES
United States, EU5, Japan
PRIMARY RESEARCH:
19 country-specific interviews with infectious disease experts.
Supported by survey data collected for this report and other DRG research.
EPIDEMIOLOGY:
Total seroprevalent cases of HIV, diagnosed incident and drug-treated cases by country as well as the HIVPrEP-indicated population.
FORECAST
Ten-year, annualized, drug-level sales and patient share of key HIV therapies through 2027, segmented by brands/generics.
EMERGING THERAPIES
Phase III/PR: 7 drugs; Phase II: 5 drugs. Coverage of select preclinical and Phase I products.
Market Share of Human Immunodeficiency Virus Drug Classes in 2017
Market Share of Human Immunodeficiency Virus Drug Classes in 2027
Human Immunodeficiency Virus SWOT Analysis
Market Drivers and Constraints
What Factors Are Constraining the Market for Human Immunodeficiency Virus?
Key Market Events for Human Immunodeficiency Virus: 2017-2027
Major-Market Brand and Generic Sales in Human Immunodeficiency Virus, 2017-2027
Major-Market Brand and Generic Patient Share in Human Immunodeficiency Virus, 2017-2027
Drug-Class-Specific Trends
Major-Market Sales of Single-Tablet Regimens for Human Immunodeficiency Virus, 2017-2027
Major-Market Patient Shares of Single-Tablet Regimens for Human Immunodeficiency Virus, 2017-2027
Major-Market Sales of Long-Acting Regimens for Human Immunodeficiency Virus, 2017-2027
Major-Market Patient Shares of Long-Acting Regimens for Human Immunodeficiency Virus, 2017-2027
Major-Market Sales of Nucleoside/Nucleotide Reverse Transcriptase Inhibitors for Human Immunodeficiency Virus, 2017-2027
Major-Market Patient Shares of Nucleoside/Nucleotide Reverse Transcriptase Inhibitors for Human Immunodeficiency Virus, 2017-2027
Major-Market Sales of Integrase Inhibitors for Human Immunodeficiency Virus, 2017-2027
Major-Market Patient Shares of Integrase Inhibitors for Human Immunodeficiency Virus, 2017-2027
Major-Market Sales of Protease Inhibitors for Human Immunodeficiency Virus, 2017-2027
Major-Market Patient Shares of Protease Inhibitors for Human Immunodeficiency Virus, 2017-2027
Major-Market Sales of Non-Nucleoside Reverse Transcriptase Inhibitors for Human Immunodeficiency Virus, 2017-2027
Major-Market Patient Shares of Non-Nucleoside Reverse Transcriptase Inhibitors for Human Immunodeficiency Virus, 2017-2027
Major-Market Sales of Other Antiretroviral Agents for Human Immunodeficiency Virus, 2017-2027
Major-Market Patient Shares of Other Antiretrovirals for Human Immunodeficiency Virus, 2017-2027
Forecast
Market Forecast Assumptions
Market Forecast Dashboard
Sales of Drugs to Treat Human Immunodeficiency Virus in the Major Pharmaceutical Markets: 2017-2027
Etiology and Pathophysiology
Disease Overview
Human Immunodeficiency Virus Disease Process
AIDS-Defining Conditions According to the 1993 U.S. Centers for Disease Control and Prevention AIDS Case Definition
Viral Structure
Human Immunodeficiency Virus Structure
Viral Life Cycle
The Life Cycle of HIV-1
Classification of Human Immunodeficiency Virus and Co-Receptor Tropism
Key Pathways and Drug Targets
Key Steps and Drug Targets in the Human Immunodeficiency Virus Life Cycle
Epidemiology Overview
Introduction
Key Findings
Epidemiology Populations
Disease Definition
Methods
Sources Used for Diagnosed Incident Cases of Human Immunodeficiency Virus Infection
Number of Diagnosed Incident Cases of Human Immunodeficiency Virus in the Major Pharmaceutical Markets: 2017-2027
Disease Definition
Methods
Sources Used for Total Prevalent Cases of Human Immunodeficiency Virus Infection
Number of Total Prevalent Cases of Human Immunodeficiency Virus in the Major Pharmaceutical Markets (Thousands): 2017-2027
Disease Definition
Methods
Sources Used for the PrEP-Eligible Population
Number of PrEP-Eligible Persons in the Major Pharmaceutical Markets (Thousands): 2017-2027
Number of Total, Diagnosed, and Drug-Treated Prevalent Cases of Human Immunodeficiency Virus Infection in the Major Pharmaceutical Markets, 2017-2027 (thousands)
Current Treatment Overview
Key Findings
Treatment Goals
Key End Points Used in Clinical Trials for Human Immunodeficiency Virus
Key Current Therapies
Overview
Mechanism of Action of Key Current Drug Classes Used for Human Immunodeficiency Virus
Current Treatments Used for Human Immunodeficiency Virus
Market Events Impacting the Use of Key Current Therapies in Human Immunodeficiency Virus
Advantages and Disadvantages of NRTIs
Advantages and Disadvantages of NNRTIs
Expert Insight: NNRTIs
Advantages and Disadvantages of Protease Inhibitors
Expert Insight: Protease Inhibitors
Advantages and Disadvantages of Integrase Inhibitors
Expert Insight: Integrase Inhibitors
Advantages and Disadvantages of Single-Tablet Regimens
Expert Insight: Single-Tablet Regimens
Advantages and Disadvantages of Pharmacokinetic Enhancers
Expert Insight: Pharmacokinetic Enhancers
Monoclonal Antibodies
Advantages and Disadvantages of Monoclonal Antibodies
Pre-Exposure Prophylaxis
Advantages and Disadvantages of Pre-Exposure Prophylaxis Therapies
Expert Insight: Pre-Exposure Prophylaxis
Medical Practice
Treatment Guidelines
Country-Specific Human Immunodeficiency Virus Treatment Guidelines
Factors Influencing Drug Selection in Human Immunodeficiency Virus
Treatment Decision Tree for HIV: United States
Treatment Decision Tree for HIV: Europe
Treatment Decision Tree for HIV: Japan
Unmet Need Overview
Current and Future Attainment of Unmet Needs in Human Immunodeficiency Virus
Top Unmet Needs in Human Immunodeficiency Virus: Current and Future Attainment
Expert Insight: Unmet Need in Human Immunodeficiency Virus
Emerging Therapies Overview
Key Findings
Pipeline Trends for Human Immunodeficiency Virus
Key Emerging Therapies
Notable Developments Among Key Emerging Therapies for Human Immunodeficiency Virus
Key Therapies in Development for Human Immunodeficiency Virus
Estimated Launch Dates of Key Emerging Therapies for the Treatment of Human Immunodeficiency Virus
Dolutegravir/Lamivudine Profile
Analysis of the Clinical Development Program for Dolutegravir/Lamivudine
Expert Insight: Dolutegravir/Lamivudine
Expectations for Launch and Sales Opportunity of Dolutegravir/Lamivudine in Human Immunodeficiency Virus
Cabotegravir/Rilpivirine Profile
Analysis of the Clinical Development Program for Cabotegravir/Rilpivirine
Expert Insight: Cabotegravir/Rilpivirine
Expectations for Launch and Sales Opportunity of Cabotegravir/Rilpivirine in Human Immunodeficiency Virus
Fostemsavir
Fostemsavir Profile
Analysis of the Clinical Development Program for Fostemsavir
Expert Insight: Fostemsavir
Expectations for Launch and Sales Opportunity of Fostemsavir in Human Immunodeficiency Virus
PRO-140 Profile
Analysis of the Clinical Development Program for PRO-140
Expectations for Launch and Sales Opportunity of PRO-140 in Human Immunodeficiency Virus
Early-Phase Pipeline Analysis
Notable Developments in the Early-Phase Pipeline for Human Immunodeficiency Virus
Select Phase II Compounds in Development for Human Immunodeficiency Virus
Access and Reimbursement Overview
Region-Specific Reimbursement Practices
Key Market Access Considerations in Human Immunodeficiency Virus: United States
General Reimbursement Environment: United States
Key Market Access Considerations in Human Immunodeficiency Virus: EU5
General Reimbursement Environment: EU5
Key Market Access Considerations in Human Immunodeficiency Virus: Japan
General Reimbursement Environment: Japan
Looking for More?
Appendix
Key Abbreviations Related to Human Immunodeficiency Virus
Brands, Marketers, and Generic Availability of Current Therapies Used for Human Immunodeficiency Virus by Market
Human Immunodeficiency Virus Bibliography
Supplemental Epidemiology Bibliography
Steven F. Trueman, Ph.D.
Steven Trueman, Ph.D., is a principal analyst in the Infectious, Niche, and Rare Diseases team at DRG, part of Clarivate. Since 2015, he has specialized in both product development and the production of high-value market analysis reports, forecasts, and custom client decision and strategy solutions. His expertise spans numerous therapy areas, including antiviral indications, niche and rare markets, and oncology indications for all major pharmaceutical markets, including China. Prior to joining DRG, he received his doctorate in biomedical sciences from the University of Massachusetts Medical School and his B.S. in biochemistry from Worcester Polytechnic Institute.
Sunali D. Goonesekera, S.M.
Sunali Goonesekera, S.M., is a senior epidemiologist at Clarivate. Previously, 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.