Human Immunodeficiency Virus (HIV) Therapeutics – Global Drug Forecast and Market Analysis to 2029

The human immunodeficiency virus (HIV) therapeutics market was worth an estimated $22.9bn across the seven major markets (7MM*) in 2019. The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 2%. Growth in the market will be driven by the entry of injectable therapies that can be administered intramuscularly or subcutaneously.

HIV-infected patients are normally managed with oral therapies. One type of treatment regimen involves the administration of one tablet per day. These single-tablet regimens (STRs) are made up of fixed-dose combinations of individual antiretroviral drugs.

Magdalene Crabbe, MA, Senior Ophthalmology and Infectious Diseases Analyst at GlobalData, comments: “The launch of STRs revolutionized the treatment landscape of HIV and met major unmet needs by increasing patient compliance and improving the safety and tolerability profiles of antiretroviral drugs.”

Crabbe adds: “By 2029, other injectable therapies will be available in the market. CytoDyn’s leronlimab and Gilead Sciences’ Lenacapavir are expected to become available in the US and European markets. Additionally, TaiMed’s Trogarzo (ibalizumab), which is an intravenously administered monoclonal antibody, launched in the US in 2018 and in Europe in 2020.”

Cabotegravir-based therapies are projected to generate 79% of the sales of injectable therapeutics in the HIV market in 2029, equating to estimated sales of $1.5bn towards the end of the forecast window.

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Most of the drugs entering the market between 2019 and 2029 are expected to be used as salvage or add-on therapies that can be used in combination with first-line drugs. Sales of injectable therapies are expected to exceed $1.8bn in 2029.

The current activities of drug developers in the HIV space reflect a desire to meet the needs of patients who have difficulty swallowing or remembering to take their pills. Addressing these longstanding unmet needs will drive growth in the HIV market.

Although injectable drugs will be well received by patients, a significant number of infected people are unaware of their seropositive status because the disease has few recognizable symptoms in its early stages.

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

Scope

  • Overview HIV epidemiological data, including the presence of hepatitis coinfection and incident cases in each of the 7MM.
  • Examination of pathophysiology, symptoms, diagnosis, and disease management.
  • Annualized forecast of sales of HIV therapeutics in the 7MM.
  • Discussion of the impact of COVID-19 on the market.
  • Examination of unmet needs, ongoing clinical trials, and profiles of individual marketed drugs.
  • Assessment of pipeline drugs, including clinical and commercial aspects of each therapy in development for the treatment of HIV-1 infection in children and adults.
  • Review of key market drivers and barriers.
  • Discussion of market potential and opportunities for drug developers in the HIV space.

Key Highlights

The global HIV market was worth an estimated $22.9B in 2019. GlobalData projects that this market will expand at a Compound Annual Growth Rate (CAGR) of 2%, reaching $28B in 2029.

Growth in the market is expected to be facilitated by the entry of non-oral therapies and pre-exposure prophylactic (PrEP) drugs, which will launch in all of the 7MM by the end of the forecast period.

The long-term efficacy of the pharmacologic management of HIV is highly dependent on patient compliance. Poor compliance is a risk factor for a shortened life expectancy and greater chance of contracting opportunistic infections. Pharmaceutical companies are attempting to address this issue by developing injectable therapies that are administered less frequently than market-leading oral drugs which are taken daily and are linked to side effects such as osteoporosis, hepatotoxicity, and kidney dysfunction.

By 2029, the US and 5EU markets will benefit from an influx of therapeutic agents that address different stages of HIV infection, including viral entry, reverse transcription, and integration of viral DNA into the host genome.

There will be several drivers that promote growth in the HIV therapeutics market. One example is the fact that non-oral therapies will launch in the 7MM. These drugs will diversify treatment options for patients. Other market drivers include the use of drugs with low frequencies of administration and the emergence of biologic drugs that have high annual costs of therapy (ACOT) which can be used to treat patients with multidrug-resistant infections.

Major barriers to growth in the HIV market during the forecast period will include the fact that social stigma prevents patients from seeking a diagnosis leading to a low diagnosis rate, increased disease transmission, and delayed initiation of antiretroviral therapy (ART). GlobalData also expects that lack of compliance among patients will persist, either because of the need to take multiple oral tablets on a daily basis in some treatment regimens, or because of undesirable side effects such as weight gain, changes in bone mineral density, lactic acidosis, or mental disorders.

Furthermore, marketed products such as ViiV Healthcare’s Tivicay (dolutegravir) and Mylan’s Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) will lose their patent protection during the forecast period, allowing cheaper generics to erode the sales of branded products.

The US accounted for the vast majority of sales, generating $19.5B in the base year of the forecast window. This equates to a market share of 85.2%. The 5EU markets generated a combined $3.2B in sales in 2019. GlobalData valued the Japanese market at $152.1M in 2019. Sales in all of the 7MM except for Germany are expected to increase over the course of the forecast window. The US is projected to gain market share during the forecast period, generating 85.8% of sales in 2029.

In 2029, the 5EU markets will generate $3.8B. Japan is expected to contribute $225M in sales in the final year of the forecast window.

The PrEP market was valued at $2.6B in 2019. Sales of therapeutics used in PrEP are expected to reach $3.3B in 2029. Drug sales will be limited by the impact of generic erosion.

Reasons to buy

The report will enable you to:

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the HIV therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the HIV therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Key Questions Answered in This Report

  • What were the market leading drugs for HIV in 2019?
  • When will the late-stage pipeline products launch in each of the 7MM?
  • What are the major clinical and environmental unmet needs in the HIV market?
  • What are the key commercial opportunities for pharmaceutical companies developing therapies for HIV?
  • What effect has COVID-19 had on the development and administration of HIV therapeutics?

Companies mentioned

Abbvie

Aelix Therapeutics

BioNTech

Biosantech

BMS

Boehringer Ingelheim

CytoDyn

Dewpoint Therapeutics

Gilead Sciences

GlaxoSmithKline

Starpharma

ImmunityBio

Janssen

Japan Tobacco

Johnson and Johnson

Merck

Mylan

Roche

Shionogi

TaiMed Biologics

Theratechnologies

ViiV Healthcare

AIM ImmunoTech

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Human Immunodeficiency Virus: Executive Summary

2.1 Convincing Progress in the Development of Non-Oral Therapies Will Boost Sales in the HIV Therapeutics Market, Which Will Reach $28B in 2029

2.2 Dominance of Gilead and ViiV Expected to Remain Unchallenged by Market Entrants Developed by Other Pharmaceutical Companies

2.3 Dynamic Deal-Making Landscape Will Contribute to Synchronized Growth for Key Players in the HIV Market

2.4 Japanese HIV Market Lags Behind the US and 5EU Due to Lack of New Entry Inhibitors Expected to Launch During the Forecast Period

2.5 Focus on Prophylaxis Will Diversify Treatment Options for Patients from 2019–2029

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Overview

4.1.2 Etiology

4.1.3 Pathophysiology

4.2 Clinical Stages of HIV Infection

4.3 Prognosis and Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.3.1 Total Prevalence of HIV

5.3.2 Diagnosed Prevalence of HIV

5.3.3 Diagnosed Incidence of HIV

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Sources Not Used

5.4.3 Forecast Assumptions and Methods

5.4.4 Total Prevalent Cases of HIV

5.4.5 Diagnosed Prevalent Cases of HIV

5.4.6 Diagnosed Prevalent Cases of HIV with HBV/HCV Coinfection

5.4.7 Diagnosed Prevalent Cases of HIV on ART

5.4.8 Diagnosed Incident Cases of HIV

5.4.9 Prophylactic Population on PrEP

5.5 Epidemiological Forecast for HIV (2019–2029)

5.5.1 Total Prevalent Cases of HIV

5.5.2 Diagnosed Prevalent Cases of HIV

5.5.3 Age-Specific Diagnosed Prevalent Cases of HIV

5.5.4 Sex-Specific Diagnosed Prevalent Cases of HIV

5.5.5 Diagnosed Prevalent Cases of HIV with Coinfection

5.5.6 Diagnosed Prevalent Cases of HIV on ART

5.5.7 Diagnosed Incident Cases of HIV

5.5.8 Age-Specific Diagnosed Incident Cases of HIV

5.5.9 Sex-Specific Diagnosed Incident Cases of HIV

5.5.10 Prophylactic Population on PrEP

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 COVID-19 Impact

5.6.3 Limitations of the Analysis

5.6.4 Strengths of the Analysis

6 Disease Management

6.1 Diagnostic Tools and Clinical Monitoring

6.2 Treatment Overview

6.2.1 Treatment Guidelines

6.2.2 Reverse Transcriptase Inhibitors

6.2.3 Integrase Inhibitors

6.2.4 Protease Inhibitors

6.2.5 Pharmacokinetic Enhancers

6.2.6 Entry Inhibitors

6.2.7 Single-Tablet Regimens and Fixed-Dose Combination Therapies

6.2.8 Other Drugs

6.3 Impact of COVID-19 on the Management of HIV Patients

6.4 US

6.5 5EU

6.6 Japan

7 Competitive Assessment

7.1 Overview

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Introducing Non-Oral Therapies to Diversify Treatment Options for Patients

8.3 Therapies with Improved Safety and Tolerability Profiles

8.4 Improved Diagnosis Rates and Access to PrEP

8.5 Clearer Treatment Guidelines for General Practitioners and Primary Care Providers

9 Pipeline Assessment

9.1 Overview

9.2 Clinical Trials

9.3 Late-Stage Pipeline Agents

9.4 Innovative Drugs in Clinical Development

9.5 Vaccines

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Gilead Sciences

10.3.1 Overview

10.3.2 Portfolio Assessment

10.4 ViiV Healthcare

10.4.1 Overview

10.4.2 Portfolio Assessment

10.5 GlaxoSmithKline

10.5.1 Overview

10.5.2 Portfolio Assessment

10.6 Janssen

10.6.1 Overview

10.6.2 Portfolio Assessment

10.7 Merck

10.7.1 Overview

10.7.2 Portfolio Assessment

10.8 TaiMed Biologics

10.8.1 Overview

10.8.2 Portfolio Assessment

10.9 CytoDyn

10.9.1 Overview

10.9.2 Portfolio Assessment

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Drivers and Barriers – Global Issues

11.2 US

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Patients

12.3.3 Percentage of Patients on ART

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic Erosion

12.3.9 Pricing of Pipeline Agents

12.4 Primary Research – KOLs Interviewed for This Report

12.4.1 KOLs

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Senior Analyst

12.6.3 Therapy Area Director

12.6.4 Epidemiologist

12.6.5 Managing Epidemiologist

12.6.6 Global Director of Therapy Analysis and Epidemiology

12.6.7 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

List of Tables

Table 1: HIV: Key Metrics in the 7MM

Table 2: Symptoms of Acute, Chronic, and Advanced Stages of HIV Infection

Table 3: CDC Classification of the Stages of HIV-1 Infection in Patients Ages ≥6 Years

Table 4: Risk Factors and Comorbidities for HIV

Table 5: National and International Treatment Guidelines for HIV-1 Infections in the 7MM

Table 6: Antiretroviral Regimen Choices for Specific Clinical Scenarios

Table 7: Other Approved HIV Drugs

Table 8: Disease Management in the US

Table 9: Disease Management in the 5EU

Table 10: Disease Management in Japan

Table 11: Marketed Therapies for HIV Across the 7MM

Table 12: Comparison of Therapeutic Classes in Development for HIV, 2019–2029

Table 13: Gilead Sciences’ HIV Portfolio Assessment, 2020

Table 14: ViiV Healthcare’s HIV Portfolio Assessment, 2020

Table 15: GSK’s HIV Portfolio Assessment, 2020

Table 16: Janssen’s HIV Portfolio Assessment, 2020

Table 17: Merck’s HIV Portfolio Assessment, 2020

Table 18: TaiMed Biologics’ HIV Portfolio Assessment, 2020

Table 19: CytoDyn’s HIV Portfolio Assessment, 2020

Table 20: HIV Market – Global Drivers and Barriers, 2019–2029

Table 21: Key Events Impacting Sales of HIV Therapeutics in the US, 2019–2029

Table 22: HIV Therapeutics Market – Drivers and Barriers in the US, 2019–2029

Table 23: Key Events Impacting Sales for HIV in the 5EU, 2019–2029

Table 24: HIV Market – Drivers and Barriers in the 5EU, 2019–2029

Table 25: Key Events Impacting Sales for HIV in Japan, 2019–2029

Table 26: HIV Market – Global Drivers and Barriers in Japan, 2019–2029

Table 27: Key Historical and Projected Launch Dates for HIV

Table 28: Key Historical and Projected Patent Expiry Dates for HIV

Table 29: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for HIV in 2019 and 2029

Figure 2: Analysis of the Company Portfolio Gap in HIV During the Forecast Period

Figure 3: Competitive Assessment of Anti-HIV Therapeutics Expected to Launch in the 7MM During the Forecast Period

Figure 4: HIV Replication Cycle

Figure 5: 7MM, Total Prevalence of HIV, Men and Women, All Ages, 2009–2029 (%)

Figure 6: 7MM, Diagnosed Prevalence of HIV, Men and Women, All Ages, 2009–2029 (%)

Figure 7: 7MM, Diagnosed Incidence of HIV, Men and Women, All Ages, 2009–2029 (Cases per 100,000 Population)

Figure 8: Sources Used for Total Prevalent Cases of HIV

Figure 9: Sources Used for Diagnosed Prevalent Cases of HIV

Figure 10: Sources Used for Diagnosed Prevalent Cases of HIV Coinfected with HBV or HCV

Figure 11: Sources Used for Diagnosed Prevalent Cases of HIV on ART

Figure 12: Sources Used for Diagnosed Incident Cases of HIV

Figure 13: Sources Used for the Prophylactic Population on PrEP

Figure 14: 7MM, Total Prevalent Cases of HIV, Men and Women, All Ages, 2019 (N)

Figure 15: 7MM, Diagnosed Prevalent Cases of HIV, Men and Women, All Ages, 2019 (N)

Figure 16: 7MM, Age-Specific Diagnosed Prevalent Cases of HIV, Men and Women, 2019 (N)

Figure 17: 7MM, Sex-Specific Diagnosed Prevalent Cases of HIV, All Ages, 2019 (N)

Figure 18: 7MM, Diagnosed Prevalent Cases of HIV with Coinfection, Men and Women, All Ages, 2019 (N)

Figure 19: 7MM, Diagnosed Prevalent Cases of HIV on ART, Men and Women, All Ages, 2019 (N)

Figure 20: 7MM, Diagnosed Incident Cases of HIV, Men and Women, All Ages, 2019 (N)

Figure 21: 7MM, Age-Specific Diagnosed Incident Cases of HIV, Men and Women, 2019 (N)

Figure 22: 7MM, Sex-Specific Diagnosed Incident Cases of HIV, All Ages, 2019 (N)

Figure 23: 7MM, Prophylactic Population on PrEP, Men and Women, All Ages, 2019 (N)

Figure 24: Unmet Needs and Opportunities in HIV

Figure 25: Overview of the Drug Development Pipeline for HIV

Figure 26: Significant Phase II/III Trials for the Pipeline Agents that GlobalData Expects to Be Licensed for HIV in the 7MM, 2019–2029

Figure 27: Competitive Assessment of Anti-HIV Therapeutics Expected to Launch in the 7MM During the Forecast Period

Figure 28: Company Portfolio Gap Analysis in HIV, 2019–2029

Figure 29: Co-development Deals Concerning Non-oral HIV Therapeutics in the 7MM, 2010–Q3 2020

Figure 30: Global (7MM) Sales Forecast by Country for HIV in 2019 and 2029

Figure 31: Global (7MM) Sales of Late-Stage Pipeline Agents, 2029

Figure 32: Sales of HIV Therapeutics in the US by Drug Type, 2019 and 2029

Figure 33: Sales of Individual STRs in the US, 2019 and 2029

Figure 34: Sales of PrEP Therapies in the US, 2019 and 2029

Figure 35: Sales of Late-Stage Pipeline Agents in the US, 2029

Figure 36: Sales of HIV Therapeutics in the 5EU by Drug Type, 2019 and 2029

Figure 37: Sales of Individual STRs in the 5EU, 2019 and 2029

Figure 38: Sales of PrEP Therapies in the 5EU, 2019 and 2029

Figure 39: Sales of Late-Stage Pipeline Agents in the 5EU, 2029

Figure 40: Sales of HIV Therapeutics in Japan by Drug Type, 2019 and 2029

Figure 41: Sales of Individual STRs in Japan, 2019 and 2029

Figure 42: Sales of Late-Stage Pipeline Agents in Japan, 2029

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